HK1135590A - Oral care compositions, methods, devices and systems - Google Patents

Description

Oral care compositions, methods, devices, and systems

Technical Field

The present invention relates to oral care compositions, methods, devices and systems.

Background

Although the use of two or more oral care compositions is known, it is still desirable to provide improved products and methods for delivering one or more compositions to the oral cavity.

Summary of The Invention

In general, the invention features oral care treatments that include: a multi-component oral care composition; a method of oral care comprising a regimen for delivering a plurality of components to an oral cavity; and oral care devices, kits and systems.

Brief description of the drawings

Fig. 1 is a side perspective view of an embodiment of an oral care system.

Fig. 2A is a front perspective view of an embodiment of an oral care device.

Fig. 2B is a rear perspective view of the oral care device of fig. 2A.

Fig. 3A is a transparent front view of the oral care device of fig. 2A.

Fig. 3B is a transparent rear view of the oral care device of fig. 2A.

Fig. 4A and 4B are rear and front views, respectively, of a head and neck of another oral care device embodiment, wherein the neck is shown as transparent.

Fig. 5 is a rear view of a head and neck of another oral care device embodiment, wherein the neck is shown as transparent.

Fig. 6 and 7 are front perspective views of two brush embodiments.

Fig. 8A is a side perspective view of one embodiment of a docking station.

Fig. 8B is a transparent side perspective view of the docking station of fig. 8A.

Figure 9 shows a docking station embodiment.

Figure 10 shows another docking station embodiment.

Fig. 11 is a perspective view of an embodiment of an oral care system.

Fig. 12 is a perspective view of a base portion B of the docking station shown in fig. 11.

Figure 13 is a cross-sectional view of a dual compartment dispenser suitable for use with the present invention.

Figure 14 is a cross-sectional view of two dispensers suitable for use with the present invention.

Fig. 15 is a front view of a dispensing toothbrush suitable for use with the present invention.

Fig. 16 is a schematic view of an oral care system according to the present invention.

Fig. 17 is a schematic view of an electrical assembly suitable for use with the present invention.

Detailed Description

The following text sets forth a broad description of numerous different embodiments of the invention. The description is to be construed as exemplary only and does not describe every possible embodiment since describing every possible embodiment would be impractical, if not impossible, and it will be understood that any feature, characteristic, component, composition, ingredient, dose, product, step, or method described herein can be deleted, combined with or substituted for, in whole or in part, any other feature, characteristic, component, composition, ingredient, dose, product, step, or method described herein. Numerous alternative embodiments could be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims. All publications and patents cited herein are incorporated herein by reference.

It will also be understood that, unless a term is expressly defined in this patent with the sentence "as used herein, the term '- - - -' is defined to mean" or an analogous sentence, it is not intended that the meaning of that term be limited, either expressly or implicitly, beyond its plain or ordinary meaning, and that such terms should not be construed as being limited in scope to any statement made in any part of this patent (other than the language of the claims). No term is essential to the invention unless so stated. To the extent that any term recited in the claims at the end of this patent is referred to in this patent in a manner consistent with a single meaning, that is done for sake of clarity only so as to not confuse the reader, and it is not intended that such claim term by limited, by implication or otherwise, to that single meaning. Finally, unless a claim element is defined by the language "means" and function without describing any structure, it is not intended that the scope of any claim element be construed based on the use of 35u.s.c. § 112 sixth.

Generally, the following discussion will be directed to oral care treatments that deliver into the oral cavity: two or more oral care compositions, multiple-serving compositions, substances, formulations, or ingredients (hereinafter collectively referred to as "components"). In particular, two components that are mechanically separated from each other prior to delivery will be discussed below. The components can be delivered from a variety of oral care devices, such as manual toothbrushes, electric toothbrushes, packages, or dispensers. The components may be delivered simultaneously or sequentially. In some cases, the two components (when mixed together) react or otherwise interact together during delivery or in the oral cavity to form an oral care composition, such as a two-component dentifrice described in U.S. patent 6,375,933 and discussed in the "oral care composition and components" section below. In other instances, the components are self-contained oral care compositions; for example, a certain component may be a dentifrice or mouthwash. We will first discuss various oral care processes that may be performed. Next, we will discuss embodiments of devices suitable for delivering the components. Finally, we will discuss examples of the various components that can be delivered. The components may be in any form that can be delivered by a desired delivery device, such as a newtonian fluid or a non-newtonian fluid, a liquid, a paste, or a gel.

Application method

In the discussion that follows, we will refer to the delivery of two mechanically separated components. However, it will be apparent that the methods discussed may be extended to three or more components. The methods described below may be performed, for example, using a dispensing device having a microprocessor controller. In a toothbrush, a fixed or movable head (or movable portion of the head) may be used. Such as a suitable toothbrush having a head (or portion of a head, including bristles or elements) that rotates, oscillates, reciprocates, translates, vibrates, etc., as described in U.S. patent applications 09/993,167, 10/036,613, 10/114,870, 10/128,018, 10/208,213 and 10/830,693, and U.S. patent 5,378,153. Additionally, toothbrushes with light emitting diodes may also be used, including toothbrushes that emit light (including blue light), as described in U.S. patent applications 10/832,168, 10/847,429, 10/842,302, 10/887,644, 10/887,667, and 10/888,206. Suitable toothbrushes may or may not include bristles or cleaning elements. In another embodiment, a dispenser such as a multi-compartment package may be used with the present invention, as discussed further below. Examples of suitable devices are discussed in detail in the "oral care device" section below.

The components may be delivered into the oral cavity simultaneously or sequentially. In the case of sequential delivery, both components may be delivered during a single oral care period, such as during a single brushing period or other single treatment period (single use, start to finish, typically about 0.1 to 5 minutes by a particular user); or alternatively, the components may be delivered individually over multiple oral care sessions. Many combinations are possible, for example, both components are delivered during a first oral care period and only one of the components is delivered during a second oral care period. Examples of possible delivery sequences and schemes are discussed below.

Simultaneous delivery

The simplest case is to deliver equal amounts of these two components or a constant ratio of the components simultaneously and continuously during a single oral care session. In some cases, for example when one of the components is a liquid such as a mouthwash, the ratio can be between about 1: 20 and about 20: 1. For example, when it is desired to deliver two components that are unreactive with each other but are incompatible in dosage form, the regimen of the present invention may be suitable. For example, it may be desirable to deliver two components that require different pH levels to be active, such as stannous pyrophosphate (which is active at low pH values) and sodium fluoride (which is active at high pH values). The two components can be provided separately with a binder system having different pH levels and then delivered simultaneously into the oral cavity. The brushing duration may be short enough so that the components do not deactivate. Another system for simultaneous and continuous delivery is the following: they comprise two components that react relatively slowly and they will remain in the oral cavity after brushing to be absorbed by the teeth and/or gums.

Alternatively, during brushing, delivery may be simultaneous and continuous, but the ratio of the two components may vary. In some cases, it may be desirable to initially deliver a relatively large mass of the first component, along with a lesser amount of the second component (e.g., an 80: 20 ratio or between about 1: 20 and about 20: 1), and then reduce the amount of the first component and increase the amount of the second component during brushing, e.g., until the ratio is reversed (e.g., a 20: 80 ratio). This change in relative amount may be linear or may be non-linear, for example, by initially ejecting a large amount of toothpaste to have enough paste to begin brushing with a small amount of mouthwash, and then almost immediately significantly reducing the amount of paste and increasing the amount of mouthwash. The components and their ratios may also be selected to provide a brushing experience to the user that can change from an initially soft mouthfeel to a strong clean/fresh mouthfeel.

Further, the two components can be delivered simultaneously during different time periods of a single oral care session (e.g., during 1 second to 5 seconds and 60 seconds to 65 seconds of a 120 second oral care session), or the two components can be delivered simultaneously during different time periods (e.g., every other time period).

Sequential delivery-Single oral Care periods

Sequential delivery during a single oral care session can take various forms. In one case, the two components are delivered alternately, such as in cycles of relatively long duration (ABAB) during brushing, or in a number of rapid-fire alternating patterns (abababab.. AB). Examples of treatments well suited for this type of delivery are remineralization and treatment with peroxide and an activator for the peroxide. The preferred cycle time will depend on the chemistry used and may be optimized for a given chemical reaction. For example, in the case of peroxides and activators, the cycle time may be relatively long, such as 15 seconds, to allow the peroxide and activator to react. Other chemicals, such as remineralizing systems such as those described herein (see "composition" section below) can be used for faster cycle times, e.g., 5 seconds or less.

In another case, the two or more components are delivered sequentially during a single oral care session without subsequent alternate delivery (a followed by B) during that oral care session. For example, the dentifrice may be delivered initially to initiate brushing and provide cleaning, followed by a mouthwash, fluoride treatment, or temporary sealer. Other options include peroxide followed by activators or dentifrices to enhance fluoridation; the copper tooth powder is connected with chlorous acid; an anti-gingivitis treatment agent followed by an anti-inflammatory treatment agent; or a pair of components having different flavors to provide a sensory signal to the user. The change in flavor may indicate: for example, the user should brush for a longer period of time or may terminate brushing, or the user should change the brushing mode, e.g., to a higher or lower brushing speed.

Sequential delivery-multiple oral care sessions

Other sequential treatment regimens involve multiple oral care sessions. In some implementations, the delivery device includes a clock function and is programmed to deliver a predetermined treatment agent at a predetermined time or time range during the day. Depending on the time of day, different components, different ratios, or different sequences of components may be delivered. For example, one component may be delivered in the morning and a second, different component may be delivered in the evening, such as two different dentifrices, or mouthwash and dentifrice. As another example, two components, such as a dentifrice and a mouthwash, may be delivered in the morning, and only the dentifrice may be delivered in the evening. This clock-based approach may allow a user to have two different sensory experiences when brushing twice a day, receive two different active ingredients, or receive an active ingredient only once a day (morning or evening only).

Similarly, some treatment regimens may involve the delivery of a specific treatment agent, e.g., a prescription drug, according to a specified treatment regimen, e.g., only morning or evening, every other day (morning and/or evening), or once a week (morning and/or evening). The delivery device may be programmed to deliver a precise dose at a desired time during brushing. The toothpaste can be delivered at other times and, if desired, simultaneously with the special treatment. The special treatment agent may be a prescription toothpaste, wherein a standard over-the-counter toothpaste may be dispensed between the intended uses of the prescription toothpaste.

Another practice applicable to multiple oral care sessions is a "count" feature, in which the delivery device is programmed to deliver one of the components per x number of oral care sessions. For example, if multiple users use the same toothbrush handle, the delivery device can be programmed to identify the replaceable toothbrush head of a particular user, e.g., by RFID, and only count the user's usage periods.

In some cases, it may be desirable to program the delivery device to include both a clock component and a volume monitoring component that, for example, accumulates data for a plurality of oral care sessions so that only a predetermined volume of one or both of the components is delivered over a given period of time (e.g., less than x grams of component a is delivered over a 24 hour period). The volume monitoring component can also be used to meter precise doses of the components during a single oral care session. Volume monitoring is desirable, for example, when the components cause toxicity or other safety issues due to higher than normal doses. For example, in the case of fluoride treatments for children, it is important not to have children receive too much fluoride because of the risk of fluorosis. The delivered dose may be measured by any suitable method, such as by accurately calibrating the device and then indirectly calculating the dose based on the number of pumping cycles. In some cases, the delivery device may be used to closely control the dosage of a particular active while allowing a second composition, such as a standard dentifrice, to be delivered as needed.

For example, the delivery device may be programmed to accumulate data regarding brushing times and/or the amount of each component dispensed to allow the user and/or the user's dentist or other clinician to track the user's compliance with a specified treatment regimen. This information may be displayed on the LCD display of the delivery device.

When the delivery device (e.g., an electric toothbrush) is used by multiple users, the device can be programmed to allow each user to select the desired components to be used during that user's oral care session. For example, different users may prefer different toothpaste flavors, or may desire a toothpaste having particular performance attributes such as whitening or reduced sensitivity.

In the case of a toothbrush, it may be configured to deliver the two components onto different toothbrush heads. Delivering a first component, such as a dentifrice, while a first head (e.g., the head of a standard electric toothbrush) is secured in place; while another component, such as mouthwash, is delivered when the second head (e.g., toothpick (pic), tongue scraper, or gum brush) is secured in place. The toothbrush may be configured to automatically identify the different heads, for example, by RFID identification or by mechanical components such as pin settings. Oral care devices that identify various heads with RFID are described in published U.S. patent application 2002/0129454, the entire disclosure of which is incorporated herein by reference.

Delivery parameters

Delivery according to any of the treatment protocols described herein may be intermittent, i.e., with a pause time during which delivery does not occur. It should be noted that even "continuous" delivery may be intermittent in the sense that: the pumping mechanism of the delivery device may be operated in a pulsed manner. However, additional and/or longer pause times may be included in the treatment protocol by programming the delivery device accordingly.

A first component of about 0.05g, 0.1g, 0.15g, 0.2g, 0.25g, 0.3g, 0.4g, 0.5g, 0.6g, 0.7g, 0.8g, 0.9g, 1g, 1.2g, 1.4g, 1.5g, 1.6g, 1.8g, or 2g (or about 0.05mL, 0.1mL, 0.15mL, 0.2mL, 0.25mL, 0.3mL, 0.4mL, 0.5mL, 0.6mL, 0.7mL, 0.8mL, 0.9mL, 1mL, 1.2mL, 1.4mL, 1.5mL, 1.6mL, 1.8mL, 2mL, 5mL, 7mL, 10mL, 12mL, 15mL, 20mL, 25mL, or 30mL) can be dispensed from any delivery device in a second of about 0.05g, 0.1g, 0.15g, 0.7g, 0.5g, 0.6g, 0.7g, 0.1.2 g, 0.5g, 0.1.6 g, 0.2s, 0.2g, 0.5g, 0.4s, 0.4S, 0.7g, 0.8g, 0.9g, 1g, 1.2g, 1.4g, 1.5g, 1.6g, 1.8g, or 2g (or about 0.05mL, 0.1mL, 0.15mL, 0.2mL, 0.25mL, 0.3mL, 0.4mL, 0.5mL, 0.6mL, 0.7mL, 0.8mL, 0.9mL, 1mL, 1.2mL, 1.4mL, 1.5mL, 1.6mL, 1.8mL, 2mL, 5mL, 7mL, 10mL, 12mL, 15mL, 20mL, 25mL, or 30mL) of the second component is dispensed within about 0.2s, 0.4s, 0.6s, 0.8s, 1s, 1.2s, 1.5s, 1.8s, 2s, 4s, 6s, 10s, 30s, 120s, 90s, or 180 s. In the case of a manually pumped delivery device (e.g., the dual compartment dispenser shown in fig. 13), the first and/or second components may be dispensed by about 1,2, 3,4, or 10 or more actuations of the pump. Further, the first and second components may be dispensed at a ratio (first component/second component) of about 90/10, 80/20, 70/30, 60/40, 50/50, 40/60, 30/70, 20/80, or 10/90. Other ratios may be between about 1: 20 and about 20: 1.

As described above, the first and second components may be dispensed simultaneously or sequentially (such that the second component may be dispensed at about 0.2s, 0.4s, 0.6s, 0.8s, 1s, 1.2s, 1.5s, 1.8s, 2s, 4s, 6s, 8s, 10s, 15s, 20s, 25s, 30s, 35s, 40s, 45s, 50s, 55s, 60s, 75s, 90s, 105s, or 120s after the first component). Additionally, the second component may be dispensed during a second brushing period subsequent to the first brushing period, wherein at least about 4 hours, 6 hours, 8 hours, 10 hours, or 12 hours of time separates the beginning of the second brushing period and the end of the first brushing period. Further, the second component may also be dispensed during the same oral care regimen, but after the time interval between use of the first component and use of the second component has elapsed. For example, the dentifrice (first component) may be used for 2 minutes, and the mouthwash (second component) may be applied seconds or minutes after the use of the dentifrice is completed.

During the brushing session, there may be several sequences including various combinations of the above weights, volumes, and times. These sequences may be simultaneous or sequential and may include pause times as described above. For example, within a 2 minute brushing period, a first sequence may include a volume of a first component and a volume of a second component being dispensed simultaneously, then a second sequence may include a volume of the first component being dispensed, then a period of no dispensing may occur, then a third sequence may include a volume of the second component being dispensed, then a period of no dispensing may occur, then a fourth sequence may include a volume of the first component being dispensed.

Delivery device

A wide variety of oral care devices can be used to dispense the components of the present invention, including manual toothbrushes, electric toothbrushes, as well as a variety of other packages (e.g., hand pumps, etc.) and devices. First, we will discuss an oral care device capable of delivering two components simultaneously.

Referring to fig. 1, one embodiment of an oral care system 10 is shown that includes an oral care device 12 (in this example, a toothbrush) and a docking station 14 that maintains the oral care device 12 in an upright position in a receiving portion of the docking station. The oral care device 12 is an electric toothbrush having an motorized head and is designed to discharge two components, such as dentifrice and mouthwash, during a brushing cycle. The docking station 14 is designed to recharge batteries located within the oral care device and refill the oral care device with the components.

Turning to fig. 2A and 2B, the oral care device 12 includes a detachable housing 16 that is made up of three interconnected components 152, 154, and 156. When assembled, the oral care device 12 includes a distal portion 18 on which the head 20 is located and a proximal portion 22 on which the handle 24 is located. Connecting the handle 24 and the head 20 is a neck 26. The head 20 is sized to fit in the mouth of a user for brushing teeth, while the handle 24 can be grasped by the user and facilitates manipulation of the head 20 during use.

Referring to fig. 2B, which shows a rear view of the oral care device 12, the inlet 28 is disposed proximate an end face 30 at the proximal portion 22 of the oral care device. The inlet 28 may mate with a corresponding outlet 280 (fig. 8A) provided on the docking station 14 for refilling the oral care device.

Referring now to fig. 3A and 3B, the internal components of the oral care device 12 are shown. The oral care device 12 includes motors 34 and 36. Motor 34 drives pumping assembly 38, which conveys a pair of components along respective channels (only one of which, channel 40, is visible in fig. 3A and 3B) toward distal portion 18 of oral care device 12. Pumping assembly 38 may deliver each component through a respective channel by compressing a portion of tubes 514 and 516 (fig. 4A) with a compression element, as described in U.S. serial No. 10/861,253, the entire disclosure of which is incorporated herein by reference. When the tubes are progressively compressed with a row of fingers (as in the pump assembly described in USSN 10/861,253), the fingers should be dimensioned so that they can extend across the width of the two tubes and thus can compress the tubes simultaneously.

The motor 36 drives a drive shaft 42, which in turn moves (e.g., rotates) the head 20. To power the motors 34, 36, and 37, a rechargeable battery 44 may be electrically connected to the motors. A suitable rechargeable battery is lithium ion UR 14500P available from Sanyo.

Referring to fig. 4A and 4B, the oral care device includes a pair of tubes 514 and 516 to direct the two fluid streams within the oral care device. As shown, each of the tubes 514 and 516 is connected to the head at a location offset from a longitudinal axis 531 that is perpendicular to the axis of rotation 518 of the movable head 20. In some embodiments, one of the tubes may be connected to the head at the axis of rotation and the other may be connected at a location offset from the axis of rotation. Referring to fig. 5, a variation is shown in which tubes 550 and 552 are fluidly connected to each other at the head downstream of the pumping assembly and upstream of the fluid outlet. This embodiment may be advantageous if it is desired to mix the components within the channel at some time just prior to delivery onto the brushing surface.

We should note that in fig. 3A-3B, only a single channel 40 is shown for clarity, due to the scale of these pictures. The oral care device 12 generally includes two channels, as described above (e.g., tubes 514 and 516 in fig. 4A and 4B). However, in some cases, a single channel may be used, for example, where the two components may mix upstream of the head, near separate chambers that store the two components.

Referring again to fig. 3A, the oral care device 12 includes a control circuit or controller 400 that is electrically connected to the motors 34 and 36 and generally governs the operation of the motors. The user interface 402 may provide external interaction with the controller 400. The user interface 402 includes on and off buttons 404 and 406 and a fluid level switch 408, all of which are accessible from outside the housing 16 (see fig. 2A).

Although the controller may be programmed as desired, as one example, the controller is designed such that depressing the button 404 activates the motors 34 and 36 and depressing the button 406 activates only one of the motors, such as the motor 36. Both head movement and fluid flow can be initiated by depressing either button 404 or 405, with button 404 initiating one flow and button 405 initiating the other flow. By depressing the button 406, only one of fluid flow and head movement may be initiated. Depressing either button 404 or 406 after activation may also stop the associated motor. In the case where the button 406 only starts and stops the motor 36, the user may, for example, brush without delivering either component, and may rinse the oral care device 12 while the head is rotating. The fluid level switches 408, 409 allow the user to select between preselected fluid delivery rates such as high, medium and low. Three LEDs 410 may be selectively illuminated to indicate a selected fluid delivery level. Alternatively or additionally, an LCD display may be included to communicate the fluid delivery level, and/or may be used to display other information such as the fluid level in the oral care device 12 and/or the charge status of the battery.

The controller 400 may also be programmed to adjust the paste delivery level upon activation of the motor 34. For example, in some embodiments, the controller is programmed so that a relatively large bolus of both components is delivered shortly after the motor 34 is started so as to have enough paste to begin brushing, and then the delivery level is reduced to, for example, a lower delivery level throughout the remainder of the brushing cycle. For example, the level of paste delivery may be reduced by intermittently emitting fluid and/or by slowing the rate of fluid delivery. For example, the controller may be programmed to provide three delivery settings, i.e., low, medium, and high. In one embodiment, at the low delivery setting, the controller is programmed to deliver the bolus by activating the motor 34 for about 7 seconds. After about 7 seconds, the controller intermittently activates the motor 34 for about 0.75 seconds and deactivates the motor 34 for about 2.4 seconds (i.e., cyclically turning the motor on and off at these intervals). In the same embodiment, at the mid-range delivery setting, the controller is programmed to deliver the bolus by starting the motor 34 for about 7 seconds, then cyclically turning the motor on for about 0.75 seconds and off for about 1.63 seconds. In the high range delivery setting, the controller is programmed to deliver the bolus by starting the motor 34 for about 7 seconds, then cyclically turning the motor on for about 0.75 seconds and off for about 1.2 seconds. More or fewer user interface controls may be used to initiate various functions depending on the desired programming of the controller 400.

Referring again to fig. 3A, the motor 36 moves (e.g., linearly translates) the pivoting drive shaft 42, which in turn moves (e.g., rotationally oscillates) the rotatable head 20. The drive shaft 42 is connected to the rotatable head 20 using an offset design that facilitates placement of a fluid outlet at the head 20 and a tube 82 (or a pair of tubes if the two streams are intended to remain separate) that forms part of the fluid passageway within the neck 26 of the housing 16. This offset design is described in more detail in U.S. serial No. 10/861,253. The movement of the rotatable head 20 may be achieved in part by: a cam and follower system is used that converts the rotational output of the motor 36 into linear motion for driving the drive shaft 42 back and forth. Such an arrangement is described in U.S. serial No. 10/861,253, incorporated by reference above.

Referring now to fig. 6 and 7, the head 20 includes a base 136 having an opening 124 through which the valve 122, such as the illustrated duckbill valve, projects outwardly. In some embodiments, the distal end of the tube 82 forms the fluid outlet without the use of a valve bonded thereto. If it is desired to keep the two streams separated until they exit the head, two valves or a double duckbill valve such as that described in U.S. serial No. 11/114,987 filed on 26.4.2005 may be used, the entire disclosure of which is incorporated herein by reference. Extending from the base 136 is a series of bristle tufts 138. Although each tuft 138 is shown in the figures as solid, the tufts are actually each comprised of a large number of individual plastic bristles. For a more detailed discussion of a toothbrush head, applicants refer to pending U.S. patent application No. 10/666,497 filed 9/2003, the disclosure of which is hereby incorporated by reference in its entirety.

When not in use, the oral care device 12 can be coupled with the docking station 14. Docking station 14 may be connected to an electrical outlet (not shown) or other suitable power source. Referring to fig. 8A and 8B, the docking station 14 is shaped to hold the oral care device 12 in an upright position within the receiving portion 273. Receiving portion 273 includes a bottom plate 275 that extends between a vertical groove 295 formed in housing 291 and a housing extension 297. The groove 295 is contoured to receive a portion of the oral care device 12. The docking station 14 includes a reactive device, such as a sensor (not shown) that detects an input when the oral care device is received by the docking station and sends a signal in response to this input to a controller, the details of which will be described in greater detail below.

Referring now to fig. 8B and 9, docking station 14 includes a multi-chamber fluid reservoir 274, the two chambers of which are coupled with a tube 276 leading to an outlet 280. In some embodiments, such as shown in fig. 9, the fluid reservoir 274 is formed as an integral part of the detachable and replaceable portion 301 of the docking station 14. In other embodiments shown in fig. 10, two replaceable pouches 303 (only one of which is shown in fig. 10) form the fluid reservoir. In this case, the upper portion 301 of the docking station is removable to allow the consumer to easily remove the pouch 303 when the contents of the pouch are exhausted or when the user wishes to use a different product and thus insert a replacement pouch. Referring to fig. 8B, to move the components from the fluid reservoir to the oral care device, the docking station includes a pump assembly 282. Details of the refill mechanism in the docking station are provided in U.S. serial No. 10/861,253.

Referring again to fig. 8B, a pair of leads 336, 338 are exposed within a receiving portion 273 of docking station 14. The leads 336, 338 are configured to contact a pair of contacts 340, 342 (fig. 2A) on the oral care device 12 when the oral care device 12 is placed within the receiving portion 173. This contact will electrically couple the oral care device 12 and the docking station 14 so that the docking station connects to the power source rechargeable batteries within the rechargeable oral care device. The contacts 340, 342 are electrically connected with the rechargeable battery, allowing current to flow from the docking station to the battery.

An oral care system 600 suitable for delivering two components sequentially is shown in fig. 11. The oral care system 600 includes an oral care device 602 in the form of a toothbrush and a docking station 604. The oral care device 602 is connected to the docking base 604 by a length of tubing 605, only a small portion of which is shown in fig. 11. Conduit 605 is flexible and long enough to allow a user to easily manipulate the oral care device, for example, about 2.5 feet to 3.5 feet long. The conduit 605 may be connected to the oral care device at any desired location, such as on the head or handle, as will be discussed below.

The oral care device 602 includes a handle 606 and a detachable head/neck portion 608. The handle 606 does not include a pumping mechanism or pump motor as these components would be provided in the docking station, as will be discussed below. The handle 606 contains the motor and other components necessary to drive the head, and may contain two fluid channels.

Docking station 604 includes a tower portion T and a base portion B. The tower portion contains two reservoirs (not shown) and is removable from the base portion so that the reservoirs can be refilled or replaced by a user. The base portion B (shown in detail in fig. 12) carries two pumps 610, 612 which receive the two components from the reservoirs via tubes 614, 616 and deliver them to the downstream portions 618, 620 of the tubes. After the tubes exit the docking station, they may be wrapped or otherwise contained in a single skin to form the conduit 605 shown in fig. 11. The pumps 610 and 612 are independently driven by motors 622, 624. Activation of the motor is driven by a controller, such as one or more microprocessors, which may be mounted on printed circuit boards 626, 628.

If the conduit 605 enters the oral care device at the base or in the handle, the handle will contain a conduit defining two fluid paths. If the conduit 605 enters the oral care device at the head, a standard handle containing only the head drive assembly may be used.

Any desired type of reservoir may be used to contain both of the components of the oral care device described above. Suitable storage is described in U.S. serial number 10/861,253, incorporated by reference above.

In another embodiment, the delivery device may be provided in the form of a dual compartment dispenser that may be used alone or in combination with the aforementioned electric toothbrush. Referring to fig. 13, a dual compartment dispenser 700 having a first outlet 705 and a second outlet 710 is shown. The dispenser 700 has a first compartment 715 that stores a first component and a second compartment 720 that stores a second component. The first compartment 715 is in fluid communication with the first outlet 705 via a tube 722, and the second compartment 720 is in fluid communication with the second outlet 710 via a tube 724. In this embodiment, the first and second compartments 715 and 720 are not in downstream fluid communication with each other so that the first and second components do not mix, substantially mix, blend, or otherwise partition together. A piston pump 726 may be used to pump the first component from the first compartment 715 and a separate piston pump 728 may be used to pump the second component from the second compartment 720. Pumps 726 and 728 may be biased by springs 730 and 732. One or more valves 736 may be provided to facilitate the action of the piston pump. Valve 736 may be provided as a check valve to allow fluid to travel in only one direction. The first and second compartments may have the same or similar capacities. In another embodiment, the first and second compartments have different capacities, which may be suitable for situations where the amounts of the first and second components dispensed during the oral care regimen are not the same. An orifice 734 may be provided to meter the dose of the first or second component expelled per stroke of the piston pump. The dosage may also be controlled by the size (e.g., inner diameter) and/or stroke of the piston pump.

The first and second compartments 715 and 720 may be provided as replaceable cartridges that releasably engage the housing 734 of the dispenser 700. For example, the compartments 715 and 720 may threadably engage the housing 734. If there are different amounts or dosages between the first and second components, the compartments 715 and 720 may have different threads (pitch or size) so that each compartment can be properly mated with a piston pump or orifice. Although a first outlet and a second outlet are shown, a single piston pump and outlet may be provided, wherein the single piston pump and outlet may be placed in selective fluid communication with the first or second compartment. Any of the components, amounts, or protocols described herein may be used in whole or in part in the dispenser 700. While the dispenser 700 is one type of dispensing device suitable for use with the present invention, it should be understood that other dispensing devices may be used.

In one method of the invention, the user dispenses the first component onto the toothbrush and then applies the first component into the oral cavity as part of a brushing regimen. After the first component is used, the user sequentially dispenses the second component onto the toothbrush and applies the second component into the oral cavity as part of a brushing regimen. Optionally, the user may rinse the brush and/or his/her mouth before applying the second component to the toothbrush. The toothbrush may include a timer that initiates a signal when a predetermined period of time has elapsed to alert the user that it is time to switch between the first and second components or that use of the second component is complete. In one embodiment, the second component is applied to the toothbrush or to the oral cavity within about 15s, 30s, 45s, 60s, 120s, 180s, 240s, 300s, 360s, 420s or 10 minutes, 15 minutes, or 20 minutes after the first component is applied to the toothbrush or to the oral cavity.

Although the dispenser 700 has been shown to include first and second compartments, it should be understood that more than two compartments may be provided. The dispenser 700 may be provided in a variety of shapes, sizes, and configurations.

Referring to fig. 14, in another embodiment, the first component and the second component may be provided in completely separate packages that may be bundled together into a kit. For example, a first component provided as a dentifrice may be provided in a first dentifrice dispenser 800 and a second component provided as a dentifrice may be provided in a second, separate dentifrice dispenser 805. The first and second dispensers may be the same or different and have been shown for simplicity to include the same structure as dispenser 700 (fig. 13). A user may dispense a first amount of a first component from a first dentifrice package onto a toothbrush and, after brushing with the first component for a certain period of time, dispense an amount of a second component from a second dentifrice package onto the same toothbrush and complete a brushing regimen with the second component. The first and second dentifrice packages may be provided in visually different shapes, sizes or colors so that the user can easily distinguish the two packages. The first and second dentifrice packages may also have graphics, text, icons, or numeric characters to distinguish the two packages. In some embodiments, the first and second dentifrice packages may meter the first and second components so as to deliver a specific dose, so that a controlled ratio between the first and second components may be applied.

In another embodiment, the delivery device may be provided in the form of an oral care device that can dispense a liquid, such as mouthwash. Oral care devices can be provided in the form of toothbrushes, some examples of which are described in USPN 6,331,088, 6,047,429, 6,689,078, and 6,739,782. Toothbrushes can have moving bristle holders and/or static or non-moving bristle holders. The toothbrush head may be releasably bonded to the toothbrush handle. Referring to fig. 15, one embodiment of a fluid dispensing toothbrush suitable for use with the present invention will now be described. The toothbrush 900 has a handle 905, a head 910, and a liquid reservoir 915 disposed in the handle. The liquid reservoir 915 may be a replaceable single-use reservoir or may be refillable by the user of the toothbrush. The liquid reservoir 915 is in liquid communication with one or more outlets 920 disposed in the head 910. The outlet 920 is connected to a liquid reservoir 915 by a conduit 925. A pump 930 is provided to pump the liquid 913 within the liquid reservoir 915 or to pressurize the liquid 913 within the liquid reservoir 915. The pump 930 may be provided in a variety of forms as are known in the art. For example, a piston pump such as that described in USPN 6,689,078 may be used. In one embodiment, the pump 930 may be an air pump that is used to pressurize the liquid in the reservoir 915. Once pressurized, the liquid can exit the reservoir when valve 935 opens. The valve 935 may be opened or activated by depressing a button (not shown) on the handle 905.

The user can apply a first component or composition, preferably in the form of a dentifrice (although other forms may be used), to the bristle tufts 945 (or other tooth cleaning elements) of the head 910 of the toothbrush 900. The first component can include any of the ingredients described herein (and combinations thereof) and/or other ingredients known in the art. The first component is then applied to the hard and/or soft tissue of the oral cavity while the toothbrush is in use. The user can then selectively apply a second component or composition, preferably in the form of a liquid or mouthwash, to all or part of the oral cavity with the toothbrush 900 by actuating or opening the valve 935 at the beginning, during, or at the end of a tooth brushing regimen (or a combination thereof). The second component can include any of the ingredients described herein (and combinations thereof) and/or other ingredients known in the art.

Referring to fig. 16, one or more of the devices described herein may be used with a display 950 having a screen 952. Various arrangements are also described more in US S/N60/859,226 filed on month 11 and 15 of 2006, 60/920,698 filed on month 3 and 29 of 2007 and 60/912,111 filed on month 4 and 16 of 2007. A system 955 is shown that includes one or more oral care products, such as a dispensing toothbrush 900, a manual or electric toothbrush 958, a packaged dentifrice 960, a packaged mouthwash 965, and a dual compartment dispenser 700. Examples of some manual or electric toothbrushes 955 suitable for use in the present invention are described in USPN 5,974,615, 5,930,858, 6,006,394, 6,108,869, 5,943,723, 6,308,367, 2003/0101,526, 2003/0154,567, 6,536,068, 2002/0129454, and 5,987,688. While certain devices and products are shown in fig. 16 for simplicity, it should be understood that a variety of oral care devices may be used with the system 955, including other oral care devices and products described in this application. Each oral care product can communicate using a data link 970, 972, 974, 976, and 978 with the display 950 or using an intermediary device that maintains data communication with the display 950. One or more of the oral care products, displays, and/or system components described herein can be bundled together for dispensing or sale to a user as a kit. The system 955 may also be connected to the network 982 by a data link 984. The network 982 may include one or more computers, servers and clients, or electronic devices 985.

The oral care products and devices of system 955 can use a variety of methods and devices to store, transfer, and/or communicate data between the devices/products and the display 950. The term "data" is intended to refer to any digital or analog information in any form that is communicated or conveyed. The data may include any data that is actively transmitted by the data transmitter and/or data that is passively detected by the data reader. If the data transmitted is digital, the data may include ones and zeros. In another embodiment, the data may be a series of numbers such as "12345678," where each number may represent information related to a characteristic of the oral care device (e.g., for a manual toothbrush, the first number may represent brushing time in minutes, the second number may represent the number of months until the toothbrush should be replaced, the third and fourth numbers may represent a unique reward, etc.). The data may include an arrangement of optical elements (e.g., barcodes) representing the information. The data may include the presence or absence of electromagnetic energy (e.g., such as a magnetic field), etc. The data may be stored, interpreted, decoded, or analyzed by the processor 986 shown in fig. 17. For example, if the data is a series of numbers, such as "12345678," the processor 986 and/or associated memory 987 may include a set of instructions that will be capable of decoding or interpreting the data to determine the information that the data represents.

A data transmitter is a device or component that actively transmits data to a data reader. A radio frequency identification tag or RFID tag is an example of a data transmitter. A data communicator is a device or component that may or may not actively transmit data, but nevertheless has data that can be detected. Although a data transmitter, such as a radio frequency identification tag, is a data communicator, the data communicator need not actively transmit data. Examples of data communicators that include data that can be detected or read by a data reader, but that do not actively transmit data, include bar codes (where the bar code reader is a data reader), point codes, or hall effect magnets (where the hall effect sensor is a data reader). Thus, as will be appreciated, the phrases "data communicator," "data transmitter," and "data reader" are intended to include a wide variety of devices and arrangements for transmitting, communicating, and/or detecting a wide variety of analog or digital data, including merely detecting the presence of a data communicator. The phrase "data communication" is intended to encompass all methods and forms by which the devices of the present invention (including data readers, data transmitters, data communicators) can transmit, communicate and/or detect data, as well as data communication between two components, such as a display and either oral care product.

The data stored and/or transmitted or communicated by the RFID tag or other data transmitter/communicator may be quite extensive. Some categories of data include product identification data (e.g., brand name or product name) and product usage or regimen data (e.g., time of use such as 1 minute of mouth rinse regimen, textual or graphical instructions related to product use, information related to sequence of use, etc.), one or more rewards and component or product replacement data (e.g., number of times or length of time that a component or product can be used before it should be replaced). The illustrative images, text or data may be particularly useful for children in establishing a suitable brushing regimen. Data may be displayed directly on the display 950 or may be used as input to the processor 986 for functions or features of the display 950. For example, each of the oral care products can have an RFID tag 988 that can send usage or regimen data to a reader 990 associated with the display 950. In one embodiment, usage data may be used as an input to an up-count timer or a down-count timer displayed on the display 950. To initiate data transmission from the RFID tag to the data reader 990 associated with the display 950, the oral care product containing the RFID tag need only be placed close enough to the reader 990 to power up the RFID tag.

In one embodiment, an oral care regimen may include placing a dentifrice package 960 (which may be any package including a tube or outer package containing a dentifrice, such as a carton) and a mouthwash package 965 in data communication with the display 950 (or an intermediate component in data communication with the display 950) so as to communicate data relating to the dentifrice (e.g., the amount of time the dentifrice is to be applied into the oral cavity) and data relating to the mouthwash to the display 950. Dentifrice is applied to the head 910 of the toothbrush 900 and liquid mouthwash is loaded into the liquid reservoir 913. The toothbrush 900 is then placed in data communication with the display 950, which starts a timer (the time interval of which is displayed on the display 950) and is set according to the data transmitted by the RFID tag associated with the dentifrice package 960. The display 950 can display or send one or more audible and/or visual signals at the beginning, during, or at the end of the time interval that indicate to the user of the toothbrush 900 that the mouthwash 965 should be dispensed based on the data communicated to the reader 990 by the data communicator of the packaged mouthwash 965. In one embodiment, the timer can initiate a second time interval displayed on the display 950, which can communicate the time interval for dispensing the mouthwash into the oral cavity in order to approximate the amount of mouthwash, and/or can communicate the time interval for using the mouthwash in the oral cavity that approximates the time of administration. The second time interval can be set according to data transmitted by an RFID tag (or other data communicator) associated with the mouthwash package 965. The dentifrice or first time interval may be between about 30 seconds and 3 minutes and the liquid rinse or second time interval may be between about 30 seconds and 3 minutes. The length of the time interval can vary depending on the desired interaction between the dentifrice and liquid rinse. It should be understood that the steps described herein can be performed in a variety of sequences, and that some steps may not need to be performed for each oral care or brushing cycle. For example, the liquid reservoir 913 may not have to be refilled every time, and the dentifrice and rinse packages may only need to be placed in data communication with the display 950 once, such as when the dentifrice and rinse are first used. Thereafter, the data transmitted by the RFID tag can be stored in the memory 987 until deleted or replaced, such as when a new package of dentifrice and rinse is purchased and used for the first time. Further, while the process of applying the dentifrice and mouthwash to the oral cavity is described as occurring sequentially, it is also contemplated that the application process may occur simultaneously or substantially simultaneously (e.g., applying the dentifrice to the oral cavity and applying the mouthwash shortly thereafter). The display 950 may also display other information such as visual guides to assist in applying the dentifrice or mouthwash to the four quadrants of the oral cavity. For example, a view of each quadrant of the oral cavity may be displayed on the display 950 to indicate when or for how long a dentifrice, rinse, or brushing action should be applied to that quadrant of the oral cavity.

In another embodiment, the dual compartment dispenser 700 and/or the toothbrush 958 may be placed in data communication with the display 950. The dual compartment dispenser 700 may have one or more data communicators. In some embodiments, there may be one data communicator associated with each compartment. Data communication with the display 950 may start a timer. The display 950 may then display the time interval of the up-count or down-count based on data sent by the toothbrush 958 and/or the data communicator of the compartment dispenser 700. For example, a data communicator such as an RFID tag 988 can transmit data representing the amount of time that the oral care composition of the first compartment 715 should be used. The RFID tag 988 associated with the second compartment 720 or the second RFID tag can also transmit data representative of the amount of time the oral care composition of the second compartment should be used. For example, the RFID tag 988 may communicate that the oral care composition of the first compartment 715 should be applied to the oral cavity for 1 minute and the oral care composition of the second compartment 720 should be applied to the oral cavity for 2 minutes. Upon transmitting this data (or upon some other data communication such as placing toothbrush 958 in data communication with display 950, or even upon manually starting the timer of the display by actuating button or touch screen element 953), display 950 may display a first time interval or timer for 1 minute. Upon expiration of the first time interval, the display 950 may display a signal or prompt to indicate that the second oral care composition is to be applied to the head of the toothbrush 958 from the second compartment 720 (and/or to perform an additional action, such as rinsing the toothbrush and/or oral cavity prior to applying the second oral care composition, etc.), followed by applying the second oral care composition from the second compartment 720 into the oral cavity. The display 950 can display a second time interval or period, such as the aforementioned 2 minutes for applying the second oral care composition into the oral cavity. By placing toothbrush 958 in data communication with display 950, the user may initiate a second time interval by activating a switch, button, or other control on or associated with display 950; or automatically initiate the second time interval after a predetermined period of time. Upon expiration of the second time interval, the display 950 may provide an audible and/or visual signal indicating that the second time interval has elapsed. After the second time interval has elapsed, use of the second oral care composition can be discontinued. As will be appreciated, the display 950 can display other information associated with the compartmentalized package 700 and/or oral care composition stored therein (e.g., instructional information, regimen or usage information (including historical user information), rewards, educational information, tickets, etc.). Further, while the system 955 is described herein with respect to the dual-compartment dispenser 700 for simplicity, it should be understood that the methods of the present invention can be used with any package or plurality of individual packages comprising one or more compartments and/or one or more oral care compositions, each of the plurality of individual packages containing one or more oral care compositions.

Oral care compositions and components

Two-component oral care compositions are described below. In certain instances, it may be beneficial or necessary to deliver the two components separately into the oral cavity of a user, or to keep the two components of the oral care composition separate until use, and then mix them during delivery or in the oral cavity. This may be the case, for example, where the two components will react and/or neutralize each other if kept together, or where the ingredients in the two components are active at different pH values, as described in the methods section above. The following are examples of various two-component compositions and their use. As described below, several of the compositions may in some cases be provided as a single component, which may be delivered sequentially or simultaneously with any other desired component, such as a standard dentifrice or mouthwash as discussed in the methods above.

The following discussion focuses on two-component compositions that may be advantageously delivered in whole or in part using the above-described methods and devices. However, it is noted that the above-described methods and devices are equally applicable to the delivery of two unrelated components such as dentifrices and mouthwashes, two differently flavored dentifrices, and the like, as well as other two-component compositions not mentioned below.

Malodor treatment agent

The hard and soft oral tissues are covered with microbial populations comprising bacteria with different metabolic capabilities. Of these groups of microorganisms, gram-positive bacteria tend to catabolize carbohydrates to form acids that attack the hard tissues of the oral cavity, resulting in the formation of carious lesions (cavities). In contrast, gram-negative bacteria, especially anaerobic microorganisms, tend to catabolize various amino acids contained in saliva (and to a lesser extent other peptides and proteins in the oral cavity) to form end products that contribute to oral malodor and periodontitis.

Oral malodor, clinically known as halitosis, can be caused by the putrefaction of these microorganisms on plaque, dead cells adhering to mucous membranes, and salivary cell molecules, producing volatile sulfur compounds- -mainly hydrogen sulfide, methyl mercaptan, and small amounts of methyl sulfide.

Some two-component oral care compositions can reduce oral malodor, improve breath, and/or prevent dental plaque accumulation. The first component in the oral care composition comprises a metal salt, for example a copper salt such as cu (ii), and the second component in the oral care composition comprises an oxidizing agent, for example a chlorite. For example, in two compartments of a delivery device such as those described above, the two components are kept separate until use, or until immediately prior to use. The components can be applied by the user in a single step using, for example, the device described herein, rather than in a two-step process, such as first brushing the teeth with a dentifrice and then applying an oral care rinse.

Without being bound by theory, such compositions may reduce malodor in a dual pathway. First, the metal salt reduces the concentration of Volatile Sulfur Compounds (VSC) by precipitating the VSC as metal sulfides. Using different chemical routes, the oxidizing agent can oxidize malodorous compounds (including amines and sulfides) to non-volatile forms, and thus to odorless forms. In addition, the oxidizing agents and metal salts, especially Cu (II) salts, have antibacterial activity, and they may also have anti-caries efficacy for the user.

In some embodiments, the two-component composition can provide enhanced efficacy relative to an oral care regimen using a one-component oral care product (e.g., a single dentifrice or mouthwash), or even in some cases relative to an oral care regimen using a dentifrice followed by a mouthwash. Thus, in some embodiments, a smaller amount of active ingredient may be applied to the two-part composition relative to the amount applied to the one-part system to achieve substantially the same efficacy, or conversely, the same amount of active ingredient will provide greater efficacy.

Examples of suitable metal salts include salts of Cu, Zn, Ag, Sn, Mg, Fe and Mn. In some preferred embodiments, the first component comprises a copper salt capable of releasing cu (ii) ions into solution. Examples of suitable copper salts include copper gluconate, copper chlorate, copper chloride, copper fluoride and copper nitrate. Generally, the concentration of copper salt in the first component is about 50 to 10,000ppm, or about 200 to about 2000ppm, for example 500 to about 1000 ppm.

Examples of suitable oxidizing agents include chlorite, hydrogen peroxide, and perborate, perchlorate, peroxyacid, and perchlorate salts. In some preferred embodiments, the second component comprises a chlorite salt capable of releasing chlorite ions into solution. Examples of suitable chlorites include sodium chlorite. Generally, the concentration of chlorite in the second component is about 100 to 10,000ppm, or about 1000 to about 4000ppm, for example about 1600 to about 2400 ppm.

Each of the two components of the oral care composition can be independently formulated as a dentifrice or mouthwash. Generally, when each component of the oral care composition is formulated as a dentifrice, the components may be delivered to the oral cavity of the user simultaneously or sequentially. Delivery devices such as those described above may be used to deliver the first and second components. Each component of the oral care composition can be delivered in the form of a single dose pill, or alternatively can be delivered continuously during a user's brushing of the teeth, such as at a rate of from about 0.01mL/min to about 20mL/min, or from about 0.15mL/min to about 1mL/min, or from about 0.15mL/min to about 0.5mL/min during two separate toothbrushing.

In another embodiment, both components of the oral care composition are delivered as a mouthwash. Each component may be applied separately or, alternatively, the two components may be mixed immediately prior to use. Generally, for example, at a 1: 1 ratio of components, a total of about 15mL to about 30mL of mouthwash is used for about 30 seconds.

In another embodiment, one component may be administered as a dentifrice and the other component as a mouthwash. The components may be administered simultaneously or sequentially. In one embodiment, when the first and second components are applied simultaneously, the ratio of the first and second components may vary during application of the oral care composition. For example, the oral care composition can be applied using the oral care device described herein such that the oral care composition is initially applied at a first component to second component ratio of about 80: 20, and during application, the ratio of the first component to the second component is varied to about 20: 80.

Other examples of oral care compositions that ameliorate oral malodor include the two-component dentifrice described in U.S. patent publication 6,375,933, which is incorporated herein by reference in its entirety. These dentifrices comprise a compound that releases zinc and chlorite ions in a separate semi-solid aqueous component. In some embodiments, the first component comprises a zinc salt as the zinc ion source and a chlorite salt as the chlorite ion source in an orally acceptable carrier having a substantially neutral pH of about 6.0 to 7.5, for example about 6.8. The second component has an acidic pH of about 2.0 to about 6.0, preferably about 4.0 to about 5.5. Mixing and combining the two components of the oral care composition can provide a final product pH of no greater than 6.5, preferably from about 5.8 to about 6.4, to generate chlorine dioxide. The two components are preferably formulated together with water, humectant, surfactant and abrasive to have similar physical characteristics, while an acid compound has been added to the acidic component to adjust the pH to the desired acidity.

Suitable zinc ion releasable compounds are typically water soluble zinc salts including zinc nitrate, zinc citrate, zinc chloride, zinc sulphate, zinc bicarbonate and zinc oxalate, preferably zinc nitrate. The zinc salt is typically incorporated into the neutral pH dentifrice component at a concentration of about 0.25% to about 10% by weight, and preferably about 0.5% to about 2.0% by weight. The chlorite ion releasable compound includes alkali metal chlorite, alkaline earth metal chlorite, and any other transition metal chlorite, internal transition metal chlorite, and/or polymer salt. Water soluble chlorites are preferred. Examples of suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. Mixtures of two or more chlorite sources may also be used. The chlorite ion releasable salt is typically incorporated into the neutral pH dentifrice component at a concentration of about 0.5% to about 5% by weight, and preferably about 0.1% to about 1% by weight.

When the two components are combined prior to use, the acidic dentifrice component of the dentifrice composition comprises an acid or acid mixture to acidify and thereby activate the chlorite compound present in the neutral dentifrice component, releasing chlorine dioxide.

Acidic compounds present in the acidic dentifrice components of the present invention include inorganic and organic acids such as sulfuric, hydrochloric, malic, alginic, citric, succinic, lactic, tartaric, potassium hydrogen tartrate, sodium acid citrate, phosphoric and sodium acid phosphate. Preferably an acid phosphate, including phosphoric acid, or containing PO₄Ionic phosphates, as such acids or their acid salts such as sodium dihydrogen phosphate not only provide the desired acidity, but also provide phosphate ions to inhibit the application of two-component dentifrices to teethAny demineralization of the enamel that may occur. The preferred acid, phosphoric acid, is commercially available as a liquid at 85% concentration. An amount of acid is added to the dentifrice components to maintain the pH of the dentifrice at a pH of about 2.0 to about 6.0, and preferably about 4.0 to about 5.5, the pH of the combined composition being between about 5.8 to about 6.4 when the neutral and acidic dentifrice components of the present invention are combined.

The composition may also comprise pyrophosphate salts having anticalculus efficacy, for example water soluble salts such as dialkali or tetraalkali metal pyrophosphate salts, such as Na₄P₂O₇(TSPP)、K₄P₂O₇、Na₂K₂P₂O₇、Na₂H₂P₂O₇And K₂H₂P₂O₇. Polyphosphates may include water-soluble alkali metal tripolyphosphates, such as sodium tripolyphosphate and potassium tripolyphosphate. The pyrophosphate salt may be incorporated at a concentration of about 0.05% to about 2.0% by weight, and preferably about 0.5% to about 2% by weight, while the polyphosphate salt may be incorporated at a concentration of about 1.0% to about 7.0% by weight.

Tooth whitening composition

Examples of two-component oral care compositions useful for tooth whitening are described, for example, in U.S. patent publication 6,174,516, which is incorporated herein by reference in its entirety.

The tooth whitening efficacy of a peroxide-containing dentifrice component can be significantly enhanced by first applying to the teeth an aqueous rinse component having an alkaline pH followed by application to the teeth of a peroxide dentifrice. Alkaline mouthwashes tend to activate and promote the rapid release of oxygen from the peroxide contained within the dentifrice. Such sequential administration can be carried out using the methods and devices described above. For example, the delivery device can be programmed to deliver the alkaline rinse and the peroxide dentifrice sequentially, either in a single application of rinse followed by a single application of dentifrice, or in an alternating manner (rinse, dentifrice, etc.).

In some embodiments, the aqueous rinse component comprises from about 70% to about 95% water or a combination of water and ethanol, and preferably from about 65% to 95% water and from about 0% to 35% ethanol.

The peroxide compound is included in an amount sufficient to release sufficient oxygen during brushing to achieve its whitening purpose. The peroxide compound is preferably present in an amount of from about 5% to about 15% by weight of the component. Examples of suitable peroxide compounds for preparing dentifrice components used in the practice of the present invention include calcium peroxide, hydrogen peroxide, and peroxides including urea peroxide, glycerol peroxide, benzoyl peroxide, and the like. A preferred peroxide compound is carbamide peroxide.

When included in the peroxide dentifrice component, the metal ion chelating agent may aid in the chemical stability of the peroxide component when an abrasive such as calcined alumina or calcium pyrophosphate is also present in the dentifrice. Examples of suitable metal ion chelating agents include alkali metal stannates, such as sodium and potassium stannate, ethylenediaminetetraacetic acid (EDTA) and salts thereof. The metal ion chelating agent is incorporated into the dentifrice component at a concentration of about 0.01% to about 1% by weight.

In preparing the peroxide dentifrice component, the pH is adjusted with an acid such as phosphoric acid to a range of between about 3.0 to about 8, and preferably between about 5 to about 7.

Flavouring agent

Examples of oral care compositions that can promote flavor improvement include those described in U.S. patent publication 6,696,047, which is hereby incorporated by reference in its entirety. Some two-component oral compositions containing chlorite are stable against chlorite reduction via conversion to chlorine dioxide, as well as against degradation of other composition ingredients such as flavors and sweeteners. In addition to maintaining the specified level of chlorite ion for efficacy, it is especially important for oral care compositions that the flavor component not degrade, since consumer acceptance of the product is significantly affected by the flavor and taste of the product.

In some embodiments, the aqueous component is formulated at an alkaline pH so that no significant pH change occurs during storage. In some embodiments, when the two components are mixed, the resulting composition also does not exhibit a harsh and unpleasant chlorine dioxide odor that would alter the flavor characteristics of the product.

The first component may comprise chlorite ions; and the second component may comprise a pharmaceutically acceptable topical oral carrier and no chlorite. The first component may also comprise a pharmaceutically acceptable topical oral carrier which is compatible with the chlorite ion. The first component preferably further comprises one (or more) compatible binders, buffers and/or preservatives. The second component, which does not comprise chlorite, preferably comprises a fragrance, surfactant, fluoride ion, humectant and/or abrasive.

The two components may be delivered simultaneously, and may be combined during dispensing, for example in a 1: 1 volume: the volume ratios are combined to form the composition.

Due to differences in the efficiency of the compositions in contacting tissue and teeth and due to the amounts typically used in such compositions, the concentration of chlorite ion in the composition depends on the type of composition (e.g., toothpaste or mouthwash) used to apply chlorite ion to gingival/mucosal tissue and/or teeth. The concentration also depends on the disease or condition to be treated.

Mouthwashes ingested into the oral cavity generally preferably have a chlorite ion concentration in the range of about 0.02% to about 0.5%, more preferably about 0.10% to about 0.30%, by weight of the composition. When about 15mL of mouthwash is used, the mouthwash composition of the invention preferably can deliver about 3.75 to about 30.0mg of chlorite ion to the oral cavity. For dentifrices (including toothpastes and toothgels) and non-abrasive gels, the concentration of chlorite ion is preferably in the range of about 0.5% to about 3.0% by weight of the composition. The above concentrations of chlorite ion represent the concentration of chlorite ion after the components are mixed together to form the composition. Thus, the concentration of chlorite ion in the chlorite salt-containing component will vary depending on the amount of the second or additional component to be mixed with the chlorite salt-containing component to obtain the final composition.

General state of health

In some embodiments, the overall health status of humans and animals may be promoted by the use of one or two component topical oral compositions comprising a safe and effective amount of chlorite ion in admixture with a pharmaceutically acceptable carrier, which compositions are effective in controlling bacteria-mediated diseases and conditions present in the oral cavity and inhibiting diffusion of oral pathogen bacteria and associated bacterial toxins and resulting inflammatory cytokines and mediators into the bloodstream. These compositions can be topically applied to the oral cavity using a safe and effective amount of chlorite ion to promote and/or enhance the overall health status of humans and other animals.

Examples of oral care compositions effective for promoting overall health can be found, for example, in U.S. patent publication No. US6,846,478, which is incorporated by reference in its entirety. In some embodiments, topical oral compositions comprising a safe and effective amount of chlorite ion in admixture with a pharmaceutically acceptable carrier are useful for promoting overall health in humans and animals, and are effective in controlling bacteria-mediated diseases and conditions present in the oral cavity and inhibiting diffusion of pathogenic bacteria, associated bacterial toxins and resultant inflammatory cytokines and mediators into the bloodstream.

Some embodiments include methods of use for promoting and/or enhancing the overall health status of humans and other animals by topically applying these compositions to the oral cavity. More specifically, the compositions are useful for reducing the risk of developing cardiovascular disease, stroke, atherosclerosis, diabetes, severe respiratory infections, premature labor and low birth weight (as well as post-partum neurological and developmental dysfunction), and reducing the associated risk of mortality. In preferred methods, the compositions are useful for the treatment and prevention of diseases and disorders of the oral cavity, including periodontal disease, thereby promoting and/or enhancing an increase in the overall health status of the individual to be treated, as evidenced by the following health indices or biomarkers:

1) reducing the risk of developing heart attacks, stroke, diabetes, respiratory infections, low birth weight infants, and postpartum neurological/developmental dysfunction, and reducing the risk of concomitant mortality;

2) reducing the incidence of fatty arterial streaking, the incidence of atherosclerotic plaques, the incidence of plaque formation, the incidence of thinning of the fibrous cap on atherosclerotic plaques, the incidence of atherosclerotic plaque rupture, and the incidence of secondary blood clotting events;

3) reducing carotid (intimal) wall thickness (as identified with ultrasound techniques);

4) reducing exposure of blood and systemic circulation to oral pathogens and/or their toxic components, in particular, resulting in reduced levels of oral bacteria, Lipopolysaccharide (LPS) in blood, and/or reduced appearance of oral pathogens and/or their components present in arterial plaque, arterial structures, and/or distant organs (e.g., heart, liver, pancreas, kidney);

5) reducing exposure of the lower respiratory tract to inhaled bacterial pathogens, and reducing exacerbations of secondary and/or chronic obstructive pulmonary disease of pneumonia;

6) reducing changes in circulating blood cell density, hemoglobin, white blood cell count and/or platelet count;

7) reducing the incidence of dysregulation of the levels of inflammatory mediators/cytokines such as TNF- α, IL-6, CD-14 and IL-1 in the blood/serum;

8) reducing the incidence of imbalance in the levels of acute phase reactants in the blood/serum, including C-reactive protein, fibrinogen and haptoglobin;

9) reducing the occurrence of metabolic disorder blood/serum marker disorders including homocysteine, glycosylated hemoglobin, 8-iso-PGF-2-alpha, and uric acid;

10) reduced occurrence of glucose metabolism disorders (typically identified by glucose tolerance abnormality tests), increased fasting blood glucose levels, and abnormal fasting insulin levels; and

11) to reduce disorders in blood lipid levels, including in particular blood or serum cholesterol, triglycerides, LDL, HDL, VLDL, apolipoprotein B and/or apolipoprotein A-1.

Without being bound by theory, it is believed that the composition promotes overall health by controlling bacteria-mediated diseases and conditions present in the oral cavity, preventing the spread of bacteria, bacterial toxins and endotoxins and inflammatory mediators/cytokines into the bloodstream and other parts of the body.

In some embodiments, the oral care compositions include therapeutic mouthwashes, especially mouthrinses, as well as toothpastes, tooth gels, tooth powders, non-abrasive gels (including subgingival gels), comprising:

(a) a safe and effective amount, preferably a minimal effective amount, of chlorite ion agent; and

(b) a pharmaceutically acceptable topical oral carrier; wherein the final composition is substantially free of chlorine dioxide or chlorous acid, and wherein the composition is substantially free of hypochlorite ions or hypochlorites, and has a final pH of greater than 7, preferably greater than 7.5, and even more preferably from about 8 to 12. Preferably, the chlorite ion agent is incorporated into the composition of the present invention in an amount to comprise from about 0.02% to about 6.0% by weight chlorite ion.

As used herein, "substantially free of chlorous acid or chlorine dioxide" means that the composition contains a very low level of chlorine dioxide or chlorous acid, e.g., less than about 2ppm, preferably less than about 1ppm, using known analytical methods for the determination of chlorine dioxide or chlorous acid, including highly specific Electron Spin Resonance (ESR) spectroscopy.

The compositions of the present invention also preferably comprise one or more additional therapeutic agents selected from the group consisting of: antimicrobial/antiplaque agents, biofilm inhibitors, anti-inflammatory agents (including cyclooxygenase inhibitors and lipoxygenase inhibitors), H2-antagonists, metalloproteinase inhibitors, cytokine receptor antagonists, lipopolysaccharide complexing agents, tissue growth factors, immunostimulants, cell redox modulators (antioxidants), analgesics, hormones, vitamins and minerals.

In some embodiments, for example, when the composition comprises an additional therapeutic agent, the composition may comprise a first component comprising chlorite ions and a second component comprising the additional therapeutic agent.

Chlorite ion source

In some embodiments, chlorite ion is an essential ingredient in the compositions and methods. The chlorite ion can be from any type of chlorite salt. Examples include alkali metal chlorites, alkaline earth metal chlorites, and any other transition metal chlorites, internal transition metal chlorites, and/or polymer salts. Water soluble chlorites are preferred. Examples of suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. Sodium chlorite and potassium chlorite are preferred. Sodium chlorite is especially preferred. Mixtures of two or more chlorite sources may also be used.

For dentifrice compositions, the chlorite ion content is greater than about 0.005%, 0.01%, 0.02%, 0.4%, 0.6%, 0.75%, and/or less than about 2%, 1.5%, or 1% by weight of the composition.

For mouthwash compositions, the chlorite ion is present in an amount greater than about 0.02%, preferably greater than about 0.075%, and more preferably greater than about 0.15%, by weight of the composition.

For methods of treating or preventing gingivitis, the composition preferably comprises from about 0.1% to about 6% chlorite ion, by weight of the composition.

Chlorite is available as sodium chlorite from a number of suppliers. Sodium chlorite is commercially available as technical grade powder or flake, as well as aqueous liquid concentrates in a range of concentrations. Examples of sodium chlorite sources include: sodium chlorite, available from aragonisas and Vulcan. These sources also typically have no more than 4% sodium chlorite.

The chlorite ion source preferably has a high purity of, for example, 70% or greater. Furthermore, the composition of the present invention is preferably substantially free of metal hypochlorite or hypochlorite ion, dichloroisocyanuric acid or a salt thereof.

The chlorite Ion content is preferably determined by gradient separation of inorganic and organic acid anions using an Ion Pac ASII exchange column from Dionex Corporation (Sunnyvale, Calif).

The final composition of the invention preferably contains low levels of chlorine dioxide or chlorous acid, or is substantially free of chlorine dioxide or chlorous acid (i.e., contains less than about 2ppm, preferably less than about 1ppm, chlorine dioxide or chlorous acid).

For two-component compositions, the chlorine dioxide or chlorous acid content is measured within about 2 to 3 minutes after the two components are mixed together.

The pH of the final composition is generally greater than 7, preferably greater than 7.5, more preferably from 8 to 12; the pH is still more preferably 9 to 10.

Improved sensory characteristics

Examples of dentifrices with improved sensory characteristics are described, for example, in U.S. patent publication No.5,820,854, which is incorporated herein by reference in its entirety. These dentifrices may be provided and delivered as a single component, or as a two-component composition.

The sensory characteristics of dentifrices having high ionic strength, i.e., from about 1,000 to about 50,000. mu.mho, can be organoleptically improved by the addition of polyoxyethylene. The dentifrice provides increased foam volume, increased foam viscosity, and a smooth feel to the teeth. In a dual component dentifrice, the polyoxyethylene may be present in a second dentifrice component which is dispensed in parallel with the high ionic strength dentifrice component. Alternatively, the polyoxyethylene may be included in a high ionic strength dentifrice component and the second stream of liquid dispensed by the delivery device may be a different component, such as a mouthwash or another type of dentifrice. The polyoxyethylene has a molecular weight of about 100,000 to about 10,000,000, or about 200,000 to about 7,000,000.

In some embodiments, a dual component dentifrice comprises a first dentifrice component having an ionic strength of about 1,000 to about 50,000 μmho and comprising from about 0.1 to about 8% of a polyoxyethylene having a molecular weight of about 100,000 to about 10,000,000, or about 200,000 to about 7,000,000, and from about 92 to about 99.5% of one or more aqueous carriers and a second dentifrice component. In an alternative embodiment, the dentifrice comprises a first dentifrice component and a second dentifrice component. The first dentifrice component has an ionic strength of about 1,000 to about 50,000 μmho; the second dentifrice component comprises from about 0.1% to about 8% of a polyoxyethylene having a molecular weight of from about 100,000 to about 10,000,000, or from about 200,000 to about 7,000,000, and from about 92% to about 99.5% of one or more aqueous carriers.

Examples of suitable polyoxyethylenes include those having a molecular weight of from about 100,000 to about 10,000,000, or from about 200,000 to about 7,000,000. The molecular weight is preferably from about 600,000 to about 2,000,000, and more preferably from about 800,000 to about 1,000,000. "Polyox" is a trade name for high molecular weight polyoxyethylene made by Union Carbide. The polyoxyethylene is generally present at a level of from about 0.1% to about 8%, preferably from about 0.2% to about 5%, and more preferably from about 0.3% to about 2%, by weight of the dentifrice component.

High ionic strength will occur in dentifrices when they contain ingredients with ionic character. Commonly used ingredients with ionic character include such substances as salts and surfactants. A dentifrice with a high level of salt and/or a high level of surfactant will have a high ionic strength. The ionic strength of the dentifrice was determined by the conductivity of the diluted slurry. The slurry was a 3: 1 ratio of water to dentifrice. The dentifrice will preferably have an ionic strength of from about 5,000 to about 40,000 μmho, and more preferably from about 10,000 to about 25,000 μmho. The total content of salts in dentifrices having high ionic strength is generally from about 4% to about 70%, preferably from about 6% to about 60%, and more preferably from about 8% to about 50%.

Remineralisation of

Examples of two-component oral care compositions having remineralization characteristics are described, for example, in U.S. patent No.4,083,955, which is incorporated by reference herein in its entirety.

Sub-surface enamel is remineralized by successive administration of certain soluble salts, producing ions that can react to form the desired remineralization precipitate. Salt solutions such as calcium and phosphate solutions may be applied sequentially to the tooth enamel to achieve remineralization.

Remineralization of the tooth enamel subsurface with the desired precipitate can be achieved by a method using a first component comprising a water soluble compound capable of acting as a source of the desired precipitation cation and a second component comprising a water soluble compound capable of acting as a source of the desired precipitation anion. The method comprises the following steps: (1) applying one of the above components to the tooth surface followed by (2) applying the other component to the tooth surface whereby the desired ions of the other component diffuse to the demineralized subsurface and form the desired precipitates with the ions of the first component, thereby remineralizing the demineralized subsurface. The duration of step (1) may be selected to enable diffusion of the desired ions onto the demineralized subsurface.

For example, in a first step, the components comprising the soluble salt reactant solution are placed in contact with the tooth surface closest to the demineralized subsurface. In this first reactant solution, the selected cations can diffuse across the tooth surface to its demineralized subsurface. In a second step, a second component comprising a reactant solution containing the selected anion is placed in contact with the tooth surface proximate the demineralized subsurface. The anions diffuse across the tooth surface to the demineralized subsurface where they come into contact with previously deposited cations and form a precipitate that adheres to the tooth structure. Thus, the tooth subsurface is remineralized.

The concentration of the cationic and anionic solutions may be from 0.005% to 10%, or the solubility limit of the salt, preferably from about 0.05% to about 5%. Excess salt may be present if desired. In the cationic solution, more than one type of cation may be used. The concentrations of the cationic and anionic solutions need not be equal, since an excess of reactants is required in each step to facilitate diffusion to the tooth demineralization subsurface. Similarly, more than one anion may be used in the anionic solution. Visible "white spot" effects appear after as few as eight consecutive applications, and it is expected that the best beneficial effect will be obtained after several consecutive applications.

To effect remineralization of tooth enamel, therapeutic doses of the desired cations and anions can be administered into the oral cavity. The amount of solution placed in the oral cavity should generally comprise at least about 0.001g of the desired cation and about 0.001g of the desired anion, and preferably comprises greater than about 0.1g of the desired cation and about 0.1g of the desired anion, and/or less than about 10g of the desired cation/anion, and/or less than about 5g of the desired cation/anion, or less than about 2g of the desired cation/anion.

Although the length of time the saline solution is in contact with the tooth surface is not critical, the time must be long enough to allow diffusion of ions through the tooth surface to the demineralized subsurface. It is believed that at least ten seconds are required for this diffusion.

Each solution should have a pH of about 3 to about 10 before and after the precipitation reaction, and should also be compatible in the oral environment. The ions in solution must not combine prematurely to form a precipitate, but must be able to diffuse across the tooth surface to the demineralized subsurface region and be able to form an insoluble salt with the ions in the other solution. The solution and insoluble precipitate are preferably colorless and, of course, have an acceptable degree of toxicity (i.e., the particular ion must be non-toxic at the amounts used during remineralization).

Although there are many precipitates that can be used for remineralization by depositing precipitates that are less soluble than the original enamel, the remineralized subsurface can be made more resistant to demineralization than the original enamel. If remineralization is carried out in the presence of heavy metal ions or fluoride ions, the remineralized enamel is more resistant to demineralization than the original enamel. If both ions are present, the remineralized tooth enamel is even more resistant to demineralization. The concentration of the salt comprising the heavy metal ion and the fluoride ion in their respective solutions may be from about 0.005% to about 10%, for example from about 0.005% to about 0.1%.

Examples of suitable heavy metal ions are aluminium, manganese, tin, zinc, indium and rare earth metals such as lanthanum and cerium.

In certain implementations, the remineralizing cationic solution comprises from about 0.005% to about 10%, preferably about 1%, soluble calcium salt that can produce calcium ions, and from about 0.005% to about 10%, preferably from about 0.005% to 0.1%, soluble indium salt that can produce indium ions. The remineralizing anion solution comprises from about 0.005% to about 10%, preferably about 1%, of a soluble phosphate salt that produces phosphate ions and from about 0.005% to about 10%, preferably from about 0.005% to about 0.1%, of a soluble fluoride salt that produces fluoride ions. The resulting precipitate is calcium phosphate or hydroxyapatite with incorporated indium and fluoride ions, which is a natural component of the enamel. This process not only results in remineralization of enamel, but the remineralized enamel is more resistant to subsequent demineralization than the original enamel.

Suitable soluble fluoride and indium salts include, but are not limited to, sodium fluoride, zinc fluoride, fluorobetaines, alanine stannous fluoride, hexylamine fluoride, indium chloride, indium sulfate, and indium nitrate.

Anions that provide the desired insoluble precipitate include phosphate, fatty acid radicals having from 8 to 18 carbon atoms, fluoride, fluorophosphate, fluorosilicate, sulfate, tartrate, sorbate, alkyl sulfonate radicals having from 6 to 18 carbon atoms, carbonate, and the like. Mixtures of these anions are desirable.

The cations that provide the desired insoluble precipitate include the heavy metal ions described above, as well as calcium and magnesium. Mixtures of these cations are desirable.

These cations and anions that form insoluble remineralizing precipitates can be obtained from solutions of the corresponding soluble salts. Suitable soluble salts of the cations for use in the present invention include halides, such as chlorides, nitrates, sulfates, acetates and gluconates of the desired cation. Similarly, suitable soluble salts of the anions of the present invention include alkali metal (e.g., sodium and potassium) salts, ammonium salts, and low molecular weight substituted ammonium salts. Examples of low molecular weight substituted ammonium salts are those in which one or more hydrogens on the ammonium ion are replaced by an alkyl or hydroxyalkyl group having 1 to 3 carbon atoms, such as methyl, ethyl, propyl, hydroxyethyl, 2-hydroxypropyl, or 3-hydroxypropyl, for example, a monoethanolammonium, diethanolammonium, or triethanolammonium salt, or a monoethylammonium, diethylammonium, or triethylammonium salt.

Many different cations and anions that can remineralize tooth enamel are combined to form many different precipitates. The most preferred precipitate is a calcium phosphate compound having incorporated therein small amounts of indium and fluorine. The following precipitation discloses not only the desired remineralisation precipitate but naturally also the cations and anions required to form the precipitate. Those skilled in the art will recognize that some of these precipitates will be formed by first forming an initial precipitate, which then reacts further to form the precipitate shown. For example, a hydroxide may be formed first and then reacted further to form the corresponding oxide.

Preferred precipitations are: calcium phosphate; ZnNH₄PO₄；InPO₄(ii) a Phosphates of rare earth elements such as lanthanum phosphate, cerium phosphate and samarium phosphate; rare earth fluorides such as lanthanum fluoride, cerium fluoride, praseodymium fluoride, neodymium fluoride and samarium fluoride; magnesium alkylsulfonate, wherein the alkyl group has from 10 to 22 carbon atoms; magnesium stearate; calcium stearate; zinc stearate; and aluminum phosphate.

The precipitated component may then be delivered to the tooth surface via two separate delivery vehicles, each vehicle containing one component, such as mouthwash and toothpaste. For example, the oral care devices described herein can be used to deliver a deposition component.

Relieving tooth hypersensitivity

Examples of two-component oral care compositions that can alleviate dental hypersensitivity are described, for example, in U.S. patent publication 6,953,817, which is incorporated herein by reference in its entirety.

Desensitizing dentifrice compositions are formulated to eliminate or alleviate discomfort and pain associated with dentinal hypersensitivity. Such compositions include two-component desensitizing dental compositions containing a potassium salt desensitizing agent.

The dental composition may comprise two semi-solid aqueous components: a first component buffered to maintain an alkaline pH of at least about 9.0, and preferably from about 9.0 to about 12.0, and a second component maintained at a pH of 6.5 to 7.5 with a phosphate buffering ingredient. At least one component comprises a fluoride ion releasable salt compound and a potassium releasable salt compound in an orally acceptable carrier, the fluoride being present in a concentration sufficient to release from the compounds about 2500 to 8800 parts per million (ppm) fluorine. Upon mixing and combining of the components, a composition having a pH of about 6.5 to about 7.0 is formed. After repeated application of the mixture to the teeth, the user feels less and less of a dentinal hypersensitivity.

Preferably, the two components are combined in approximately equal weight proportions so that when the components are combined and applied to the teeth, as by brushing, about one-half the concentration of any particular ingredient will be present in either component. Preferably, the two components are formulated to have similar physical characteristics so that the two components can be delivered simultaneously in the desired predetermined amounts.

To prepare a dentifrice component having a substantially neutral pH, a buffering agent is incorporated, which is typically prepared using a carrier comprising water, humectant, surfactant, and abrasive. The buffer is preferably a mixture of monosodium phosphate and disodium phosphate and is incorporated into the dentifrice component at a concentration of about 5% to about 10% by weight and preferably about 6% to about 10% by weight in the component.

Dentifrice components having an alkaline pH are prepared using carriers having a composition similar to the composition of the buffered neutral pH components. The alkaline component is incorporated with an alkaline agent such as an alkali metal compound including sodium hydroxide, potassium hydroxide, sodium bicarbonate, sodium carbonate, N-sodium silicate (34.6% sodium silicate in a weight ratio of 3.22 in water, available from PQ Corporation) in an amount in the range of about 0.5% to about 15% by weight of the component, preferably about 1.0% to about 8% by weight of the component, and most preferably about 1.0% to about 5.0% by weight of the component. Mixtures of the above alkali metal compounds may also be used.

Fluoride ion releasable salts are characterized by their ability to release fluoride ions in water. Preferably, water soluble fluoride salts are used which provide from about 1000 to about 9000ppm of fluoride ion, and preferably from about 2500 to about 8800ppm of fluoride ion. Suitable examples of fluoride ion releasable salts include water soluble inorganic metal salts such as sodium fluoride, potassium fluoride, sodium monofluorophosphate, stannous fluoride, and sodium fluorosilicate. Sodium fluoride, sodium monofluorophosphate, and stannous fluoride are preferred fluoride ion releasable salts.

The source of desensitizing potassium ions is typically a water soluble potassium salt including potassium nitrate, potassium citrate, potassium chloride, potassium bicarbonate and potassium oxalate, preferably potassium nitrate. The potassium salt is typically incorporated into one or more dentifrice components at a concentration of about 1% to about 20% by weight, and preferably about 3% to about 10% by weight.

Preventing gum disease

Examples of two-component oral care compositions for the prevention of gum disease are described, for example, in U.S. patent publication 5,281,410, U.S. patent publication 5,145,666, U.S. patent publication 4,849,213, U.S. patent publication 4,528,180, and U.S. patent publication 5,632,972, which are incorporated herein by reference in their entirety.

Certain oral care compositions are capable of reducing plaque and gingivitis while not incurring significant tooth staining. Dental discoloration may be reduced by using a bi-component composition comprising pyrophosphate ions and a stannous compound, such as stannous fluoride and another stannous compound in one component and pyrophosphate ions in another component. Both components generally comprise a pharmaceutically acceptable carrier.

Stannous fluoride is the first essential component in the stannous component. This material is present in the stannous composition in an amount of from about 0.05% to about 1.1%, preferably from about 0.4% to about 0.95%. It should be recognized that the separate soluble stannous and fluoride salts can be used to form stannous fluoride in situ and to add this salt directly. Salts suitable for forming stannous fluoride in situ include stannous chloride and sodium fluoride, among others.

A second stannous compound is typically included in the stannous component. The second stannous compound is a stannous salt of an alpha-hydroxy acid, phytic acid, ethylenediaminetetraacetic acid, glycine, and mixtures thereof. In some embodiments, the second stannous compound is stannous gluconate. These materials are known stannous chelates and may be provided to the compositions of the invention as chelates or as soluble stannous salts alone and in situ formed chelates with, for example, stannous fluoride. Suitable alpha-hydroxy acids include gluconic acid, citric acid, malic acid, tartaric acid and lactic acid. Such salts include stannous chloride and stannous fluoride. The second stannous compound is generally present in the present component in an amount of from about 0.1% to about 11%, preferably from about 2% to about 4%.

The second component is a component that contains or is capable of providing an effective amount of pyrophosphate ions. The pyrophosphate ion may be, for example, pyrophosphate or any readily water soluble pyrophosphate salt. Such salts include any alkali metal salts, such as sodium, potassium and lithium salts, and also ammonium salts.

The amount of pyrophosphate ion is any effective amount, generally from about 1% to about 15%, preferably from about 1% to about 10%, most preferably from about 3% to about 7%.

In some embodiments, a safe and effective amount of the components can be administered into the oral cavity. In the case of toothpaste or mouthwash, these amounts (e.g., about 0.3g to about 15g) are allowed to remain in the oral cavity for about 15 to about 60 seconds. The components may be used in any order, but preferably the stannous component is used first.

In some embodiments, hydrogen peroxide or carbamide peroxide is dissolved in a non-toxic gel for use in combination with a separately stored but substantially simultaneously dispensed paste comprising sodium bicarbonate, a salt (or other suitable), and preferably additional cleaning, anticaries and polishing agents, and an effective concentration of flavor.

Controlled amounts of the gel and paste can be simultaneously released onto the toothbrush and immediately applied to the teeth and gums. Thus, peroxides, salts and NaHCO₃The amount delivered is controlled by the orifice opening specification and the concentration of the active ingredient in each tube (or pump chamber). When brushing is applied to the teeth and gums, immediate mixing of the product occurs followed by rapid generation of reactive oxygen and carbon dioxide. At the same time, the effervescence that occurs with the release of active oxygen activates the flavors contained in the bicarbonate paste and produces a long lasting highly fresh taste in the mouth, which is different from any other flavor provided by existing toothpastes or gels.

Peroxidation ofThe hydrogel may contain the following ingredient- -H in the following amounts₂O₂: about 1.0% to 10.0%, and preferably about 3.0% to 6.5%; acrylic acid copolymer: about 0.05% to 1.20%, and preferably about 0.3% to 0.8%; non-ionic cellulose gum: about 0.1% to 1.5%, and preferably about 0.3% to 0.8%; neutralizer (triethanolamine, diisopropanolamine, NaOH, KOH): an amount sufficient to raise the gel pH to about 3.0 to 6.0. The balance being purified (distilled or deionized) water.

The sodium bicarbonate paste contains sodium bicarbonate, sodium chloride, purified (distilled or deionized) water and thickeners/stabilizers such as cellulose gum and magnesium aluminum silicate as essential ingredients. In order to break up the "chalky" taste imparted by most of the bicarbonate, an mouthfeel agent such as sorbitol, glycerol or ethylene glycol is added. In addition, if the paste is combined with a gel, completely replacing the toothpaste, cleansing agents such as calcium sulfate, calcium phosphate, and hydrated alumina, and foaming agents such as sodium lauryl sulfate (which may also enhance the peroxide-bicarbonate interaction) may be added.

The components and amounts of the bicarbonate paste are as follows: sodium bicarbonate: about 10% to 50%, and preferably 20% to 40%; polyol compound (b): about 5% to 30%, and preferably 15% to 25%; cellulose gum: about 1% to 3%, and preferably 1.2% to 1.8%; sodium chloride: about 1% to 6%, and preferably about 2% to 4%; polish/cleaner: about 1% to 40%, and preferably about 1.5% to 30%; foaming agent: about 0.1% to 2.5%, and preferably about 0.2% to 0.5%; flavoring agent: to tasting, less than about 1%; preservative: about 0.1% to 0.5%. The balance being purified water. The pastes and gels are preferably used in substantially equal volume proportions.

In some embodiments, gingival bleeding can be inhibited and the texture and consistency of gingival and periodontal tissue can be improved by delivering to the oral cavity a first component comprising from about 0.1% to about 10% by weight of a zinc salt in a pharmaceutically acceptable carrier and a second component comprising from about 1% to about 80% by weight of a bicarbonate salt in a pharmaceutically acceptable carrier, and agitating the combination of the first and second compositions in the oral cavity in vigorous contact with the gingival and periodontal tissues, or brushing the gingiva and periodontal surfaces around the teeth simultaneously with the combination of the first and second components.

In a preferred embodiment, the first component further comprises a peroxide. Another embodiment uses ascorbic acid or citric acid instead of peroxide.

This combination of zinc salt and bicarbonate can deliver extremely effective efficacy in inhibiting gingival and periodontal tissue damage. This efficacy requires that the zinc salt and bicarbonate be packaged separately before they are added to the oral cavity. For example, packaged in an oral care device as described herein.

The first component comprises a salt capable of delivering zinc ions. The term "zinc ion" means that the portion of the zinc atom in a solid or undissociated zinc compound molecule is capable of separating into simple or complexed zinc ions, particularly when dispersed in an aqueous medium. Examples of such compounds that can be used are the following zinc salts of inorganic ions: borate, bromide, carbonate, hexafluorosilicate, pyrophosphate, silicate, sulfate, and titanate. Organic anions are those having from 2 to 22 carbon atoms with a charged group selected from the group consisting of carboxylate, sulfonate, sulfate and phosphate. Specific examples include, but are not limited to, acetate, benzoate, citrate, glycinate, lactate, hydroxybenzenesulfonate, salicylate, tartrate, acetylacetonate, maleate, succinate, ascorbate, and gluconate.

Zinc salts are generally present in oral care compositions at levels of from about 0.05% to about 10%, preferably from about 0.2% to 5%, and most desirably from about 0.8% to 3% by weight.

The first component may be a gel and the second composition may be in the form of an opaque paste. The gel contains peroxides such as hydrogen peroxide, carbamide peroxide, calcium peroxide, as well as perborates, persilicates, perphosphates, and percarbonates. The amount of peroxide ranges from about 0.1% to about 10% by weight. The amount ranges from about 0.5% to about 5%, preferably from about 0.8% to about 4%, and most desirably from about 1% to 3% by weight with respect to the weight of the hydrogen peroxide active.

The first component may comprise C₂-C₂₀Carboxylic acids instead of peroxides. Exemplary acids include citric acid, malic acid, lactic acid and ascorbic acid. The acid content is similar to the amount of peroxide, i.e., in the range of about 0.1% to about 10% by weight. Citric acid is most preferred. These acids, if present, may be in liquid, gel or paste form compositions.

Advantageously, the pH of the first component will be maintained between about 3.2 to 5.0, preferably 4.0 to 4.5.

The second bicarbonate-containing component may also contain anticaries fluoride selected from the same fluorides as those described above in the first composition, in substantially the same amounts as those described above in the first composition. Sodium fluoride is particularly preferred. The bicarbonate is present in the form of an alkali metal salt, examples of which are sodium bicarbonate and potassium bicarbonate. Typically, the concentration of bicarbonate is in the range of about 0.5% to about 80%, preferably about 5% to about 50%, and most desirably about 8% to about 20% by weight. The pH of the bicarbonate composition can range from about 7.0 to about 9.5, most preferably from about 8.0 to 9.0. When the bicarbonate composition is in the form of a toothpaste or gel, it typically comprises a natural or synthetic thickener in an amount of about 0.1% to 10%, preferably about 0.5% to 5% by weight.

The relative weight ratio of the first composition to the second composition is in the range of about 1: 2 to 2: 1, preferably about 1: 1.

Dentifrice compositions and components

Oral care compositions and components formulated as dentifrices generally comprise a binder, a carrier, and an active ingredient. In some cases, the dentifrice may also contain one or more of the following: surfactants and/or detergents, thickeners, polishes, carriers, humectants, salts, and the like. Examples of suitable dentifrice ingredients are described below.

Adhesive agent

The binder system is generally the primary factor determining the rheological properties of the oral care composition. The binder also serves to keep any solid phase in the oral care component in suspension, thus preventing the solid phase portion of the oral care component from separating from the liquid phase portion. In addition, the binder can provide a consistency or concentration to the oral care composition. Thus, in some cases, the binder may also provide a thickening function to the oral care composition.

Examples of binders include sodium carboxymethylcellulose, cellulose ethers, xanthan gum, carrageenan, sodium alginate, acrylic polymers or silicates such as hydrated lithium magnesium sodium silicate. Other examples of suitable binders include polymers such as hydroxypropyl methylcellulose, hydroxyethyl cellulose, guar gum, tragacanth gum, karaya gum, gum arabic, irish moss, starch and alginates. Alternatively, the binder may comprise a clay, for example, a synthetic clay such as hectorite, or a natural clay. Each binder may be used alone or in combination with other binders.

Surfactant/detergent

In some instances, the dentifrice may contain one or more surfactants or detergents to provide the desired foaming properties.

Surfactants generally include anionic, nonionic, cationic, and zwitterionic or amphoteric compositions. Examples of surfactants include soaps, sulfates (e.g., sodium lauryl sulfate and sodium dodecylbenzenesulfonate), sodium lauryl sarcosinate, sorbitan esters of fatty acids, sultaines (e.g., cocamidopropyl betaine), and D-glucopyranoside C_10-16An alkyl oligomer. In some embodiments, the surface is activatedThe sexual agent includes sodium lauryl sulfate, cocamidopropyl betaine and C₁₀-C₁₆Alkyl D-glucopyranoside oligomers. Generally, the surfactant is present in an amount of about 0.2 to about 8% (e.g., about 1 to about 5% or about 1.5 to about 3.5%) by weight.

Thickening agent

Examples of thickeners include thickening silicas, polymers, clays, and combinations thereof. A thickening silica, such as SILODENT 15 hydrated silica, in an amount between about 4% to about 8% (e.g., about 6%) by weight provides desirable oral properties. The phrase "oral properties" as used herein refers to the consistency and concentration of the dentifrice as it foams in the mouth of a user.

Polishing agent

Examples of polishing agents include abrasives such as carbonates (e.g., sodium bicarbonate, calcium carbonate), water-colloidal silica, precipitated silica (e.g., silica hydrate), sodium aluminosilicate, grades of silica including alumina, hydrated alumina, dicalcium phosphate, insoluble sodium metaphosphate, and magnesium (e.g., trimagnesium phosphate). The suitable amount of polishing agent is an amount that safely provides good polishing and cleaning, and when mixed with other ingredients, provides a composition that is smooth, flowable, and free of excessive grittiness. Generally, when polishing agents are included, they are present in an amount of about 5% to about 50% (e.g., about 5% to about 35%, or about 7% to about 25%) by weight.

Carrier

Examples of carriers include water, polyethylene glycol, glycerol, polypropylene glycol, starch, sucrose, alcohols (e.g., methanol, ethanol, isopropanol, etc.), or combinations thereof. Examples of combinations include various water and alcohol combinations and various polyethylene glycol and polypropylene glycol combinations. In general, the carrier content is determined by the concentration of the adhesive system, and the amount of dissolved salts, surfactants, and dispersed phase.

Wetting agent

Typically, the humectant is a polyol. Examples of humectants include glycerin, sorbitol, propylene glycol, xylitol, lactitol, polypropylene glycol, polyethylene glycol, hydrogenated corn syrup, and mixtures thereof. Generally, when humectants are included, they are present in an amount of from about 10% to about 60% by weight.

Buffers and/or salts

Examples of buffers and salts include primary, secondary or tertiary alkali metal phosphates, citric acid, sodium citrate, sodium saccharin, tetrasodium pyrophosphate, sodium hydroxide, and the like.

Active ingredient

Dentifrices may contain active ingredients to, for example, prevent cavities, whiten teeth, freshen breath, deliver oral medications, and provide other therapeutic and cosmetic benefits, such as those described above. Examples of active ingredients include the following: anticaries agents (e.g., water-soluble fluoride salts, fluorosilicates, fluorozirconates, fluorostannates, fluoroborates, fluorotitanates, fluorogermanates, mixed halides, and casein); anti-tartar agents; anticalculus agents (e.g., alkali metal pyrophosphates, hypophosphite-containing polymers, organophosphate citrates, phosphate citrates, polyphosphates); antibacterial agents (e.g., bacteriocins, antibodies, enzymes); an antibacterial enhancing agent; antimicrobial agents (e.g., triclosan, chlorhexidine, copper, zinc and stannous salts such as zinc citrate, zinc sulfate, zinc glycinate, sanguinarine extract, metronidazole, quaternary ammonium compounds such as cetylpyridinium chloride; biguanides such as chlorhexidine gluconate, hexetidine, decanediximidine, alexidine; and halogenated bisphenol compounds such as 2, 2' -methylenebis- (4-chloro-6-bromophenol)); desensitizing agents (e.g., potassium citrate, potassium chloride, potassium tartrate, potassium bicarbonate, potassium oxalate, potassium nitrate, and strontium salts); whitening agents (e.g., bleaching agents such as peroxy compounds, e.g., potassium peroxydiphosphate); an antiplaque agent; gum protectants (e.g., vegetable oils such as sunflower, rapeseed, soybean, and safflower oils, and other oils such as silicone and hydrocarbon oils). The gum protectant may be a substance capable of improving the permeability barrier of the gums. Other active ingredients include wound healing agents (e.g., urea, allantoin, panthenol, alkali metal thiocyanates, chamomile-based actives and acetylsalicylic acid derivatives, ibuprofen, flurbiprofen, aspirin, indomethacin, etc.); a tooth buffering agent; remineralizing agent; an anti-inflammatory agent; a malodor removing agent; a breath freshener; and agents for treating oral disorders such as gingivitis or periodontitis.

Other ingredients

In some cases, the dentifrice may contain an effervescent system, such as a sodium bicarbonate citric acid system, or a color change system.

The dentifrice may also contain one or more of the following: phenol compounds (e.g., phenol and its homologs, including 2-methylphenol, 3-methylphenol, 4-ethylphenol, 2, 4-dimethylolphenol and 3, 4-dimethylolphenol); sweetening agents (e.g., sodium saccharin, sodium cyclamate, sucrose, lactose, maltose, and fructose); flavoring agents (e.g., peppermint, spearmint, eucalyptus, anise, fennel, caraway, methyl acetate, cinnamaldehyde, anethole, vanillin, thymol, and other natural or natural equivalent essential oils or synthetic flavors); preservatives (e.g., methyl, ethyl or propyl parabens, sodium sorbate, sodium benzoate, bromochlorophene, triclosan, hexetidine, phenyl salicylate, biguanide, and peroxides); opacifiers and colorants such as titanium dioxide or F D & C dyes; and vitamins such as retinol, tocopherol, or ascorbic acid.

Mouthwash compositions and components

The compositions and components described herein may be provided in the form of a mouthwash or mouthrinse.

Ingredients in such mouthwashes and rinses typically include one or more of water (about 45% to about 95%), ethanol (about 0% to about 25%), humectants (about 0% to about 50%), surfactants (about 0.01% to about 7%), flavoring agents (about 0.04% to about 2%), sweetening agents (about 0.1% to about 3%), and coloring agents (about 0.001% to about 0.5%). Such mouthwashes and rinses may also contain one or more anticaries agents (from about 0.05% to about 0.3%, by fluoride ion) and anticalculus agents (from about 0.1% to about 3%).

The compositions and components described herein may also be in the form of dental solutions and irrigation fluids. The components in such dental solutions typically include one or more of water (about 90% to about 99%), preservatives (about 0.01% to about 0.5%), thickeners (0% to about 5%), flavoring agents (about 0.04% to about 2%), sweeteners (about 0.1% to about 3%), and surfactants (0% to about 5%). Certain examples of mouthwashes that can be used with the present invention are described in U.S.6,440,395; U.S.6,355,229 to Adamy; U.S.6,344,184 to Rolla; U.S.6,117,417 to Wi cks et al; U.S.5,980,925 to jampan et al; U.S.5,948,390 to Nelson et al; U.S.5,686,063 and U.S.5,681,549, both to McLaughlin et al; U.S.5,626,837 to Shimada et al; U.S.5,560,906 to Scodari et al; U.S.5,407,664 and U.S.5,292,527 both to Konopa; US5,405,604 to Hall; U.S.5,374,418 and U.S.5,370,865, both to Yamagishi et al; U.S.5,286,479 to Garlich et al; U.S. No.5,525,330, 5,256,396, 5,158,763, 4,370,314, 4,339,430, 4,273,759, 4,224,309, 4,188,372, 4,137,303, 4,123,512, 4,118,476, 4,118,475, 4,118,474, 4,118,473, 4,118,472, 4,110,429, 4,102,993, 4,100,270, 4,089,880, 4,080,441, 4,042,679 and 3,864,472 and WO 03/075865 (all assigned to colgate palmolive); U.S.4,994,262 to Charbonneau et al; U.S. nos. 4,959,204, 4,663,154 and 4,472,373, all to Ryan; U.S.44,325,939 to Shah; U.S.4,323,551 to Parran, jr; WO 96/15770, WO94/27566 and WO 94/18939; WO 00/44338; U.S.2006/0171907A 1; U.S.7,195,753; U.S.7,192,573; U.S.7,153,493; U.S.6,696,047; U.S.6,361,762; U.S.6,350,438; US6,348,187; US6,261,540; US6,251,372; US5,707,610; U.S.5,681,548; U.S.5,945,088; U.S.5,945,087; U.S.5,723,106; U.S.5,338,538; U.S.5,330,749; US5,310,546; US5,302,373; U.S.5,236,699; US5,229,103; US5,256,401; U.S.5,174,990; U.S.5,104,644; U.S.5,087,444; U.S.5,043,183; U.S.4,894,220; U.S.4,684,517; and U.S.4,537,778.

Some non-limiting examples of first and second components/compositions that may be delivered simultaneously or sequentially (i.e., first component followed by second component) via a variety of devices and/or packages, some of which are described herein, are shown in table 1 below. The first and second components of table 1 can be delivered in whole or in part using any of the regimens, dosages, procedures, or methods described herein, and can be provided in a variety of forms including, but not limited to, a dentifrice, mouthwash, gel, liquid, or paste.

TABLE 1

	A first component	A second component
			1	Stannous salts such as stannous chloride, stannous fluoride, stannous lactate, stannous gluconate, and combinations thereof.	A peroxide source, such as hydrogen peroxide or a precursor thereof, and combinations thereof.
2	Stannous salts such as stannous chloride, stannous fluoride, stannous lactate, stannous gluconate, and combinations thereof.	Chlorite sources such as sodium chlorite, calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, potassium chlorite, and combinations thereof.
			3	Calcium salts such as calcium fluoride, calcium chloride, calcium nitrate, calcium sulfate, calcium acetate, calcium gluconate, and combinations thereof.	Phosphates, such as phosphoric acid or containing PO4Ionic phosphate salts, such as acids or salts thereof, such as sodium dihydrogen phosphate, disodium hydrogen phosphate, trisodium phosphate, and combinations thereof.
4	Stannous salts such as stannous chloride, stannous fluoride, stannous lactate, and stannous gluconate; and/or optionally a quaternary ammonium compound such as cetylpyridinium chloride; biguanides such as chlorhexidine gluconate, hexetidine, decanediximidine, alexidine; and halogenated bisphenol compounds such as 2, 2' -methylenebis- (4-chloro-6-bromophenol); and/or optionally in combination with flavoring agents such as peppermint oil, spearmint oil, eucalyptus oil, anise oil, fennel oil, caraway oil, methyl acetate, cinnamaldehyde, anethole, vanillin, thymol, and other natural or naturally equivalent essential oils or synthetic flavors; and combinations of the foregoing.	Abrasives such as carbonates (e.g., sodium bicarbonate, calcium carbonate), water-colloidal silica, precipitated silica (e.g., silica hydrate), sodium aluminosilicate, grades of silica including alumina, hydrated alumina, dicalcium phosphate, insoluble sodium metaphosphate, and magnesium (e.g., trimagnesium phosphate); and/or optionally with surfactants (e.g. anionic, nonionic, cationic and zwitterionic or amphoteric compositions)Combinations such as soaps, sulfates (e.g., sodium lauryl sulfate and sodium dodecylbenzenesulfonate), sodium lauryl sarcosinate, sorbitan esters of fatty acids, sultaines (e.g., cocamidopropyl betaine), and D-glucopyranoside C10- 16An alkyl oligomer; and combinations of the foregoing.
			5	Phosphates, such as phosphoric acid or containing PO4Ionic phosphate salts, such as acids or salts thereof, such as sodium dihydrogen phosphate, disodium hydrogen phosphate, trisodium phosphate, and combinations thereof.	Calcium salts such as calcium fluoride, calcium chloride, calcium nitrate, calcium sulfate, calcium acetate, calcium gluconate, and combinations thereof.

6	Fluoride sources such as sodium fluoride, zinc fluoride, fluorobetaines, alanine stannous fluoride, hexylamine fluoride, and combinations thereof at a pH between about 2 to about 6.	Any composition having a pH greater than about 7.
			7	Primary flavoring agents such as peppermint oil, spearmint oil, eucalyptus oil, anise oil, fennel oil, caraway oil, methyl acetate, cinnamaldehyde, anethole, vanillin, thymol, and other natural or naturally equivalent essential oils or mixturesA flavoring agent, and combinations thereof.	Secondary flavoring agents such as peppermint, spearmint, eucalyptus, anise, fennel, caraway, methyl acetate, cinnamaldehyde, anethole, vanillin, thymol, and other natural or naturally equivalent essential oils or synthetic flavors, and combinations thereof.
8	Quaternary ammonium compounds such as cetylpyridinium chloride; biguanides such as chlorhexidine gluconate, hexetidine, decanediximidine, alexidine; and halogenated bisphenol compounds such as 2, 2' -methylenebis- (4-chloro-6-bromophenol); and combinations thereof.	A peroxide source, such as hydrogen peroxide or a precursor thereof, and combinations thereof.
			9	Flavoring agents such as peppermint, spearmint, eucalyptus, anise, fennel, caraway, methyl acetate, cinnamaldehyde, anethole, vanillin, thymol and other natural or naturally equivalent essential oils or synthetic flavors, and combinations thereof.	A peroxide source, such as hydrogen peroxide or a precursor thereof, and combinations thereof.
10	Quaternary ammonium compounds such as cetylpyridinium chloride; biguanides such as chlorhexidine gluconate, hexetidine, decanediximidine, alexidine; and halogenated bisphenol compounds such as 2, 2' -methylenebis- (4-chloro-6-bromophenol)); and combinations thereof.	Chlorite sources such as sodium chlorite, calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, potassium chlorite, and combinations thereof.

11	Flavoring agents such as peppermint, spearmint, eucalyptus, anise, fennel, caraway, methyl acetate, cinnamaldehyde, anethole, vanillin, thymol and other natural or naturally equivalent essential oils or synthetic flavors, and combinations thereof.	Chlorite sources such as sodium chlorite, calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, potassium chlorite, and combinations thereof.
			12	Calcium salts such as calcium fluoride, calcium chloride, calcium nitrate, calcium sulfate, calcium acetate, calcium gluconate, and combinations thereof.	Fluoride sources such as sodium fluoride, zinc fluoride, fluorobetaines, alanine stannous fluoride, hexylamine fluoride, and combinations thereof.
13	Fluoride sources such as sodium fluoride, zinc fluoride, fluorobetaines, alanine stannous fluoride, hexylamine fluoride, and combinations thereof.	Calcium salts such as calcium fluoride, calcium chloride, calcium nitrate, calcium sulfate, calcium acetate, calcium gluconate, and combinations thereof.
			14	Revealing agents, such as fluorescein, dibromofluorescein, tribromofluorescein, tetrabromofluorescein, other fluorescein derivatives (including their salts), xanthene, pyrene (e.g. pyrans), D&C blue No. 1, D&C blue No. 2, D&C Green No. 3, D&C Red No. 3, D&C Red No. 6, D&C Red No. 7, D&C Red No. 21, D&C Red No. 22, D&C Red 27, D&C Red No. 28, D&C Red No. 33, D&C Red No. 40, D&C yellow No.5, D&C yellow No. 6, D&C yellow No. 10, combinations thereof or any other dyes approved by regulatory agencies for use in pharmaceuticals and cosmetics, and combinations thereof.	Abrasives such as carbonates (e.g., sodium bicarbonate, calcium carbonate), water-colloidal silica, precipitated silica (e.g., silica hydrate), sodium aluminosilicate, grades of silica including alumina, hydrated alumina, dicalcium phosphate, insoluble sodium metaphosphate, and magnesium (e.g., trimagnesium phosphate); and/or optionally in combination with surfactants (e.g., anionic, nonionic, cationic and zwitterionic or amphoteric compositions), such as soaps, sulfates (e.g., sodium lauryl sulfate and sodium dodecylbenzenesulfonate), sodium lauryl sarcosinate, sorbitan fatty acid esters, sultaines (e.g., cocamidopropyl betaine), and D-glucopyranoside C10-16An alkyl oligomer; and any combination of the foregoing.

15	Abrasives, such as carbonates (e.g. sodium bicarbonate)Calcium carbonate), water-colloidal silica, precipitated silica (e.g., silica hydrate), sodium aluminosilicate, grades of silica containing alumina, hydrated alumina, dicalcium phosphate, insoluble sodium metaphosphate, and magnesium (e.g., trimagnesium phosphate); and/or optionally in combination with surfactants (e.g., anionic, nonionic, cationic and zwitterionic or amphoteric compositions), such as soaps, sulfates (e.g., sodium lauryl sulfate and sodium dodecylbenzenesulfonate), sodium lauryl sarcosinate, sorbitan fatty acid esters, sultaines (e.g., cocamidopropyl betaine), and D-glucopyranoside C10-16An alkyl oligomer; and combinations of the foregoing.	Revealing agents, such as fluorescein, dibromofluorescein, tribromofluorescein, tetrabromofluorescein, other fluorescein derivatives (including their salts), xanthene, pyrene (e.g. pyrans), D&C blue No. 1, D&C blue No. 2 and D&C green No. 3, D&C Red No. 3, D&C Red No. 6, D&C Red No. 7 and D&C Red No. 21, D&C Red No. 22, D&C Red No. 27, D&C Red No. 28, D&C red No. 33, D&C red No. 40, D&C yellow No.5 and D&C yellow No. 6 and D&C yellow No. 10, combinations thereof or any other dyes approved by regulatory agencies for use in pharmaceuticals and cosmetics, and combinations thereof.
			16	Calcium salts such as calcium fluoride, calcium chloride, calcium nitrate, calcium sulfate, calcium acetate, calcium gluconate, and combinations thereof.	Phosphates, such as phosphoric acid or containing PO4Ionic phosphates such as acids or salts thereof, such as sodium dihydrogen phosphate, disodium hydrogen phosphate, and trisodium phosphate; in combination with a fluoride source such as sodium fluoride, zinc fluoride, fluorobetaine, alanine stannous fluoride, hexylamine fluoride; and combinations of the foregoing.
17	Zinc salt, such asSuch as zinc nitrate, zinc citrate, zinc chloride, zinc sulfate, zinc bicarbonate, zinc oxalate, zinc fluoride, zinc lactate, zinc gluconate, and combinations thereof.	A peroxide source, such as hydrogen peroxide or a precursor thereof, and combinations thereof.
			18	Zinc salts such as zinc nitrate, zinc citrate, zinc chloride, zinc sulfate, zinc bicarbonate, zinc oxalate, zinc fluoride, zinc lactate, zinc gluconate, and combinations thereof.	Chlorite sources such as sodium chlorite, calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, potassium chlorite, and combinations of the foregoing.

19	Copper salts such as copper gluconate, copper chlorate, copper chloride, copper fluoride, copper nitrate, and combinations thereof.	Chlorite sources such as sodium chlorite, calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, potassium chlorite, and combinations thereof.
			20	Copper salts such as copper gluconate, copper chlorate, copper chloride, copper fluoride, copper nitrate, and combinations thereof.	A peroxide source, such as hydrogen peroxide or a precursor thereof, and combinations thereof.
21	Peroxide sources such as hydrogen peroxide and precursors thereof, and combinations thereof.	Metal catalysts such as iron, copper, manganese, and molybdates, and combinations thereof.
			22	Metal catalysts such as iron, copper, manganese, and molybdates, and combinations thereof.	A peroxide source, such as hydrogen peroxide or a precursor thereof, and combinations thereof.
23	Stannous salts such as stannous chloride, stannous fluoride, stannous lactate, stannous gluconate, and combinations thereof.	Pyrophosphates, such as dialkali or tetraalkali metal pyrophosphates, e.g. Na4P2O7(TSPP)、K4P2O7、Na2K2P2O7、Na2H2P2O7And K2H2P2O7And wherein the polyphosphate salt can include water soluble alkali metal tripolyphosphates, such as sodium tripolyphosphate and potassium tripolyphosphate; and/or/and optionally in combination with a polyphosphate, such as sodium hexametaphosphate or any Polyphosphate (PO)4)nWherein n is 2 to 40; and combinations of the foregoing.
			24	Pyrophosphates, such as dialkali or tetraalkali metal pyrophosphates, e.g. Na4P2O7(TSPP)、K4P2O7、Na2K2P2O7、Na2H2P2O7And K2H2P2O7And wherein the polyphosphate salt can include water soluble alkali metal tripolyphosphates, such as sodium tripolyphosphate and potassium tripolyphosphate; and/or/and optionally in combination with a polyphosphate, such as sodium hexametaphosphate or any Polyphosphate (PO)4)nWherein n is 2 to 40; and combinations of the foregoing.	Stannous salts such as stannous chloride, stannous fluoride, stannous lactate, stannous gluconate, and combinations thereof.

25	Zinc salts such as zinc nitrate, zinc citrate, zinc chloride, zinc sulfate, zinc bicarbonate, zinc oxalate, zinc fluoride, zinc lactate, zinc gluconate, and combinations thereof.	Pyrophosphates, such as dialkali or tetraalkali metal pyrophosphates, e.g. Na4P2O7(TSPP)、K4P2O7、Na2K2P2O7、Na2H2P2O7And K2H2P2O7(ii) a And wherein the polyphosphate salt can include water soluble alkali metal tripolyphosphates, such as sodium tripolyphosphate and potassium tripolyphosphate; and/or/and optionally in combination with a polyphosphate, such as sodium hexametaphosphate or any Polyphosphate (PO)4)nWherein n is 2 to 40; and combinations of the foregoing.
			26	Pyrophosphates, such as dialkali or tetraalkali metal pyrophosphates, e.g. Na4P2O7(TSPP)、K4P2O7、Na2K2P2O7、Na2H2P2O7And K2H2P2O7And wherein the polyphosphate salt can include water soluble alkali metal tripolyphosphates, such as sodium tripolyphosphate and potassium tripolyphosphate; and/or/and optionally in combination with a polyphosphate, such as sodium hexametaphosphate or any Polyphosphate (PO)4)nWherein n is 2 to 40; and combinations of the foregoing.	Zinc salts such as zinc nitrate, zinc citrate, zinc chloride, zinc sulfate, zinc bicarbonate, zinc oxalate, zinc fluoride, zinc lactate, zinc gluconate, and combinations thereof.
27	Copper salts such as copper gluconate, copper chlorate, copper chloride, copper fluoride, copper nitrate, and combinations thereof.	Pyrophosphates, such as dialkali or tetraalkali metal pyrophosphates, e.g. Na4P2O7(TSPP)、K4P2O7、Na2K2P2O7、Na2H2P2O7And K2H2P2O7And wherein the polyphosphate salt can include water soluble alkali metal tripolyphosphates, such as sodium tripolyphosphate and potassium tripolyphosphate; and/or/and optionally in combination with a polyphosphate, such as sodium hexametaphosphate or any Polyphosphate (PO)4)nWherein n is 2 to 40; and combinations of the foregoing.

28	Pyrophosphates, such as dialkali or tetraalkali metal pyrophosphates, e.g. Na4P2O7(TSPP)、K4P2O7、Na2K2P2O7、Na2H2P2O7And K2H2P2O7And wherein the polyphosphate salt can include water soluble alkali metal tripolyphosphates, such as sodium tripolyphosphate and potassium tripolyphosphate; and/or/and optionally in combination with a polyphosphate, such as sodium hexametaphosphate or any Polyphosphate (PO)4)nWherein n is 2 to 40; and combinations of the foregoing.	Copper salts such as copper gluconate, copper chlorate, copper chloride, copper fluoride, copper nitrate, and combinations thereof.
			29	Metal salts such as stannous, copper, zinc, silver, tin, manganese, iron, magnesium, and combinations thereof.	Pyrophosphates, such as dialkali or tetraalkali metal pyrophosphates, e.g. Na4P2O7(TSPP)、K4P2O7、Na2K2P2O7、Na2H2P2O7And K2H2P2O7And wherein the polyphosphate salt can include water soluble alkali metal tripolyphosphates, such as sodium tripolyphosphate and potassium tripolyphosphate; and/or optionally with polyphosphatesCombinations, such as sodium hexametaphosphate or any Polyphosphate (PO)4)nWherein n is 2 to 40; and combinations of the foregoing.
30	Pyrophosphates, such as dialkali or tetraalkali metal pyrophosphates, e.g. Na4P2O7(TSPP)、K4P2O7、Na2K2P2O7、Na2H2P2O7And K2H2P2O7And wherein the polyphosphate salt can include water soluble alkali metal tripolyphosphates, such as sodium tripolyphosphate and potassium tripolyphosphate; and/or/and optionally in combination with a polyphosphate, such as sodium hexametaphosphate or any Polyphosphate (PO)4)nWherein n is 2 to 40; and combinations of the foregoing.	Metal salts such as stannous, copper, zinc, silver, tin, manganese, iron, magnesium, and combinations thereof.
			31	Metal salts such as stannous, copper, zinc, silver, tin, manganese, iron, magnesium, and combinations thereof.	Oxidizing agents such as chlorite, hydrogen peroxide (or a peroxide source), perborate, perchlorate salts, and combinations thereof.

32	Antibacterial agents such as triclosan (2, 4, 4-trichloro-2' -hydroxydiphenyl ether), chlorhexidine, copper, zinc and stannous salts (such as zinc citrate, zinc sulphate, zinc glycinate), sanguinarine extract, metronidazole, quaternary ammonium compounds such as cetylpyridinium chloride; biguanides such as chlorhexidine gluconate, hexetidine, decanediximidine, alexidine; and halogenated bisphenol compounds such as 2, 2' -methylenebis- (4-chloro-6-bromophenol); and combinations thereof.	Polyphosphates, such as sodium hexametaphosphate or any Polyphosphate (PO)4)nWherein n is 2 to 40; and/or optionally oxidizing agents such as chlorites, hydrogen peroxide, perborates, perchlorates and perchlorates; and/or optionally a chelating agent, such as alkali metal stannates such as sodium stannate and potassium stannate, ethylenediaminetetraacetic acid (EDTA) and salts thereof, citrates and malates, and salts and acids thereof; and combinations of the foregoing.
			33	Revealing agents, such as fluorescein, dibromofluorescein, tribromofluorescein, tetrabromofluorescein, other fluorescein derivatives (including their salts), xanthene, pyrene (e.g. pyrans), D&C blue No. 1, D&C blue No. 2, D&C Green No. 3, D&C Red No. 3, D&C Red No. 6, D&C Red No. 7, D&C Red No. 21, D&C Red No. 22, D&C Red 27, D&C Red No. 28, D&C Red No. 33, D&C Red No. 40, D&C yellow No.5, D&C yellow No. 6, D&C yellow No. 10, combinations thereof or any other dyes approved by regulatory agencies for use in pharmaceuticals and cosmetics, and combinations thereof.	Polyphosphates, such as sodium hexametaphosphate or any Polyphosphate (PO)4)nWherein n is 2 to 40; and/or optionally oxidizing agents such as chlorites, hydrogen peroxide, perborates, perchlorates and perchlorates; and/or optionally a chelating agent, such as an alkali metal stannate such asSodium and potassium stannates, ethylenediaminetetraacetic acid (EDTA) and its salts, citrates and malates, and their salts and acids; and combinations of the foregoing.
34	Stannous salts such as stannous chloride, stannous fluoride, stannous lactate, stannous gluconate, and combinations thereof.	Quaternary ammonium compounds such as cetylpyridinium chloride; biguanides such as chlorhexidine gluconate, hexetidine, decanediximidine, alexidine; and halogenated bisphenol compounds such as 2, 2' -methylenebis- (4-chloro-6-bromophenol)); and combinations thereof; in combination with a peroxide source, such as hydrogen peroxide or a precursor thereof, and combinations thereof.

Other embodiments

While many embodiments of the invention have been described, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

All documents cited in the detailed description of the invention are incorporated herein by reference. The citation of any document is not to be construed as an admission that it is prior art with respect to the present invention. To the extent that any meaning or definition of a term in this document conflicts with any meaning or definition of the term in a document incorporated by reference, the meaning or definition assigned to the term in this document shall govern.

Claims (28)

1. An oral care method using a display and a toothbrush having a handle, a head, a liquid reservoir in fluid communication with an outlet, and a pump, the method comprising:

dispensing an oral care composition from a package onto the head of the toothbrush;

applying the oral care composition into an oral cavity using the toothbrush; and is

Wherein the display provides a signal to a user to dispense liquid from the liquid reservoir of the toothbrush through the outlet.

2. The method of claim 1, wherein the signal is an audible signal, a visual signal, or a combination thereof.

3. The method of claim 1, wherein the toothbrush further comprises a data communicator in data communication with the display.

4. The method of claim 3, wherein the data communicator is a radio frequency tag.

5. The method of claim 4, wherein the oral care composition is a dentifrice stored in a dentifrice package.

6. The method of claim 5, further comprising dispensing the liquid from a liquid package into the liquid reservoir.

7. The method of claim 6, wherein the dentifrice package and the liquid package each further comprise a data communicator.

8. The method of claim 7, wherein the data communicators of the dentifrice package and the liquid package are radio frequency tags.

9. The method of claim 8, further comprising placing the toothbrush, dentifrice package, and rinse package proximate to the display so that the data communicator can communicate with the display.

10. The method of claim 1, wherein the pump pressurizes the liquid reservoir.

11. The method of claim 1, wherein the pump pumps the liquid from the liquid reservoir to the outlet.

12. The method of claim 1, wherein the display displays a time interval for using the dentifrice in the oral cavity.

13. The method of claim 12, wherein the time interval for using the dentifrice in the oral cavity is between about 1 minute and about 3 minutes.

14. The method of claim 13, wherein the display displays a time interval for using the liquid in the oral cavity.

15. The method of claim 14, wherein the liquid is applied in the oral cavity for a time interval of between about 20 seconds and about 2 minutes.

16. An oral care method using a display, a toothbrush, and a package comprising a first compartment having a first composition and a second compartment having a second composition, the method comprising:

dispensing the first composition from the package onto the head of the toothbrush;

applying the first composition to the oral cavity using the toothbrush;

wherein the display provides a signal to a user to dispense the second composition from the package onto the head of the toothbrush; and

applying the second composition to the oral cavity using the toothbrush.

17. The method of claim 16, wherein the signal is an audible signal, a visual signal, or a combination thereof.

18. The method of claim 16, wherein the toothbrush further comprises a data communicator in data communication with the display.

19. The method of claim 18, wherein the data communicator is a radio frequency tag.

20. The method of claim 19, wherein the package comprises a data communicator.

21. The method of claim 20, wherein the data communicator of the package is a radio frequency tag.

22. The method of claim 21, further comprising placing the toothbrush and the package proximate the display so that the data communicator can communicate with the display.

23. The method of claim 16, wherein the display displays a time interval for using the first composition in the oral cavity.

24. The method of claim 23, wherein the time interval for using the first composition in the oral cavity is between about 30 seconds and about 3 minutes.

25. The method of claim 23, wherein the display displays a time interval for using the second composition in the oral cavity.

26. The method of claim 25, wherein the time interval for using the second composition in the oral cavity is between about 30 seconds and about 2 minutes.

27. The method of claim 25, wherein a time interval of use of the second composition is displayed after a time interval of use of the first composition.

28. A kit, the kit comprising:

a dentifrice package having a data communicator;

a liquid package having a data communicator;

a toothbrush having a liquid reservoir and a data communicator; and

a display capable of data communication with the data communicator.