HK1090313A - Dispensing devices - Google Patents

Description

Dispensing device

The present invention relates to a dispensing device, and in particular to a spray device for dispensing a pharmaceutical composition in a controlled and safe manner.

A wide variety of pharmaceutical compositions are dispensed as sprays, the compositions being in the form of a fluid, i.e., a solution or a suspension, a gel, or a dry powder. These sprayed compositions are provided by a variety of modes of administration including inhalation, nasal administration or oral or sublingual administration.

The most widely used spray devices are mostly metered dose inhalers or MDIs, which are commonly used for administering pharmaceutical compositions as inhalants to the lungs. These devices are generally popular because they are very small and portable, and allow the user to carry them around and use them when necessary. These devices are also inexpensive and disposable so that they can be simply discarded when the dose provided is used.

When conventional MDIs and other simple spray devices are used to dispense some types of pharmaceutical compositions, their use is limited by the fact that the use of the device has little or no control. Therefore, these conventional types of devices are generally considered to be unsuitable for dispensing drugs with a narrow therapeutic window, and therefore present the objective risk of the user overdosing without any control elements.

Analgesics with a short duration of action are highly desirable in situations where acute intense pain must be rapidly eliminated, such as in the case of cancer patients. In view of the potent analgesic effect of such compositions, their use is carefully controlled and monitored. Of particular concern is the risk of inadvertent overdose of such potent compositions, which may even lead to death due to poor control of the dosing regimen.

The management of the supply of potent substances has been studied in the last decade and various locking mechanisms have been proposed which lock the device after opening for a predetermined length of time. These devices combine the ability of electronic intelligence with delivery devices such as MDIs and medication delivery lumens. Many devices with locking mechanisms are reliable and they are commonly used for nasal or pulmonary delivery.

However, such known delivery devices with locking mechanisms have the significant disadvantage that they are not disposable. Unlike conventional MDIs without a locking mechanism, existing devices with locking mechanisms are very expensive, require regular maintenance and calibration and they are also very large and bulky. It is generally known that third party suppliers have delivered, cleaned and repaired devices with locking mechanisms and that the cost is such that the devices are indeed available for rental.

Thus, according to a first aspect of the invention, there is provided a dispensing device having a locking mechanism, which is compact and disposable. The device may be discarded as soon as the dose contained by the device has been dispensed.

In a preferred embodiment, the dispensing device comprises a composition to be dispensed, a container for containing the composition, an electronically controlled actuator, and a housing in which the various device components are housed.

The container is preferably made of glass, preferably type 1 pharmaceutical grade glass, such as commercially available Schott Glas (Mainz, Germany) or Bormioli Rocco (Findenza, Italy). Preferably, the glass container is encased in a protective plastic outer coating. Such coated containers are readily available from the sources mentioned above.

The locking mechanism of the dispensing device according to the invention is preferably powered by a battery pack or battery forming an integral part of the dispensing device. In a preferred embodiment of the invention, the battery pack is incorporated within the housing of the device. This may be accomplished by having a predetermined space suitable for storage of the battery pack inside the housing. Alternatively, the battery may actually be incorporated in the housing, e.g. it may be embedded in the housing material, preferably on the inner surface. In another alternative embodiment, the battery pack is embedded in the plastic coating of the glass container. In another embodiment, the battery is printed on the surface of a plastic part of the device, such as the housing or a coated container.

The batteries used in the devices of the present invention are preferably very small in size so that they do not substantially increase the size and/or weight of the device.

Although the power required depends on the size and number of doses to be dispensed by the device, a 1.5V power supply is typically required. A1.5V battery is suitable for dispensing a single dose of 25 to 150. mu.l. Such a battery is also suitable for devices having a lifetime of 2-3 years. Larger, more powerful batteries may be used and these are preferably housed in the housing of the device, for example in a predetermined space between the housing and the container.

A suitable battery label can be used to provide the necessary energy for dispensing a 50 low capacity dose of say 10 mug per dose.

Other power supply means for the dispensing device include mechanical windings that provide short bursts of energy, fuel cells, preferably of the chemical or nuclear type, and solar energy. A small solar panel can be connected to the mechanism either as a primary power source or as a secondary back-up power source within the device for charging rechargeable batteries and the like.

It is also desirable to have a reliable backup power source available when the first power source fails or runs out of power. Sudden failure of the power source is particularly undesirable if the device is used to dispense emergency and/or life-saving medications.

In a preferred embodiment, the device is further provided with an indicator of the amount of charge remaining in the device.

The dispensing device will preferably be capable of holding between 25 and 50 doses of medicament, although it is also envisaged that the device may hold more or less doses of medicament.

Once the battery pack is connected to the actuator, the device is ready for use. Power from the battery pack is used to turn the actuator on or off as needed.

Observing a minimum time between doses of the composition to be dispensed, the actuator locks after actuation, making it impossible to dispense the next dose until the predetermined time has elapsed. This prevents inadvertent or deliberate overdose.

The device therefore comprises a control mechanism which is powered by the battery pack and which controls the action of the actuator. This control mechanism is preferably an electronic mechanism and the details of suitable control mechanisms are known to the skilled person. The control mechanism is pre-programmed to lock for a given time after actuation.

In a preferred embodiment, the control program includes a counter which monitors the number of doses dispensed by the device and indicates the number of doses the device has dispensed to the user or the number of doses remaining in the device.

The electronic control mechanism for controlling the action of the device is preferably located within the housing of the device. In one embodiment of the invention, the control mechanism is a strip (strip) printed on the interior surface of the device housing. Alternatively, the instructions may be embedded in a plastic moulding.

According to a second aspect of the invention, a mechanism is provided to prevent inadvertent actuation of the device, for example when the device is stored, and in particular when the device is carried around by a user.

In a preferred embodiment of the invention, a device having a folding actuator or dispensing tube is provided. The dispensing tube is movable between a closed position in which it is folded up at the side of the housing or in a recess in the side of the housing of the device, and an open or use position. In the open or use position, the dispensing tube is positioned at an angle to the surface of the housing in a position suitable for comfortable and accurate dispensing of the composition into the mouth for sublingual or pulmonary delivery or into the nose for nasal delivery.

When the dispensing tube is in the use position, only one dose of the composition is dispensed. Once a dose of medicament has been dispensed, the dispensing tube must be returned to the closed position and then once again brought into the active position before the next dose can be dispensed. This prevents the user from inadvertently dispensing multiple doses of medication.

Where the device comprises a locking mechanism, the device dispenses a dose of medicament only when the dispensing tube is in the active position and when the locking mechanism allows. Thus, moving the dispensing tube of the device to the use position does not disable the locking mechanism.

This device design with a folded dispensing tube means that no separate lid is required to cover the end of the dispensing tube. This is very convenient as such a cover is easily lost and easily falls off, especially when the device is carried around by a user.

It is thus clear that the device according to the invention described above is simple, inexpensive and disposable.

It is often necessary to ensure that the container carrying the pharmaceutical composition to be dispensed cannot be removed from the housing of the device. Thus, the device preferably has a locking mechanism, such as a detent, which allows the container to be easily inserted into the housing, but does not allow it to be removed. In an alternative embodiment, the housing includes components that are permanently connected to each other once the container is connected with other device components that have been inserted, thereby encasing the container and preventing it from being removed or damaged. The housing parts may be glued together or more preferably they are welded together, for example by ultrasonic welding.

The device of the present invention is particularly suitable for dispensing pharmaceutical compositions such as the potent analgesic drug fentanyl and other opioid analgesics such as alfentanil, carfentanil, lofentanil, sufentanil, buprenorphine, morphine, heroin and the like. Opioid analgesics are often used for moderate relief of severe pain and their rapid onset of effect can make them ideal candidates for treating breakthrough pain. However, the use of such opioid analgesics is limited by the need to strictly control dosing to prevent overdosing or abuse of the drug.

The device of the invention is particularly suitable for patient-controlled analgesia, where the patient self-administers a drug corresponding to the pain he or she experiences. In order for such patient-controlled analgesic therapy to be effective, the drug must be available to be provided to the patient in a manner that the patient can easily and safely administer the drug. In particular, it is important that the patient not be overdosed. Large doses of these drugs can lead to respiratory depression and euphoric effects (eupolyphacactivity) that can lead to abuse and dependence. The side effects of respiratory depression are another reason why self-dosing of these drugs is very attractive. Self-administration allows the patient to adjust the frequency of administration based on the perceived respiratory depression.

The device according to the invention may comprise any known type of valve, such as a non-return valve or a vertical valve. Devices having check valves are generally preferred because the amount of pharmaceutical composition they dispense is precise and constant. Dispensing accurate doses is particularly important when administering drastic drugs such as opioid analgesics. Examples of suitable vertical valve devices for dispensing the pharmaceutical compositions described herein are readily available from Bespak PLC of Bergen Way, kings lynn, Norfolk PE 302 JJ, United Kingdom. Devices with vertical valves include those disclosed in WO92/11190, US-A-4819834 and US-A-4407481.

An example of a device according to the invention will now be described by way of example only with reference to the following drawings.

Fig. 1 is an exploded view of one embodiment of a device according to the present invention for sublingual administration of a pharmaceutical composition.

Fig. 2 shows an assembled view of the device of fig. 1.

Fig. 3 shows an example of a device according to the invention with the actuator in the closed position.

Fig. 4 shows the device of fig. 3 with the actuator in the position of use.

The device shown in figures 1 and 2 comprises a substantially cylindrical container 2 sealed with a lid 3. Both the container 2 and the lid 3 may be made of various materials. The container and lid may be lined with polyester (e.g., Celanex  2500) or paint (not shown). The glass container 2 has a moulded plastic coating 4 on its outer surface.

The container 2 is enclosed in a housing comprising a housing body 6 and a housing cover 7. The two-part housing configuration allows the container 2 and other device parts to be placed within the housing and then sealed therein.

Printed or embedded in the plastic coating 4 is a battery or battery pack 5. In an alternative embodiment not shown, the battery or battery pack may be positioned on the inner surface of the housing body 6 or the housing cover 7. In another embodiment, not shown, a more conventional battery, such as those used in watches and hearing aids, may be fitted inside the housing cover 7 in the space between the housing cover and the end of the container 2.

An electronic control mechanism 8 powered by a battery pack or battery 5 is positioned on the inner surface of the housing body 6.

The device is provided with a dispensing tube or actuator 9 through which the composition passes when dispensed. This tube 9 forms a passage between the container 2 and the outside of the device and must be correctly positioned in the mouth of the user when the device is used.

Arrow a shows the range of motion of the dispensing tube 9. The tube moves between a closed position at the side of the housing body 6 and an open or use position as illustrated. Naturally, the exact orientation of the use position depends on the intended mode of administration, the direction being chosen for easy and comfortable use.

The actuator or dispensing tube 9 is moved by means of a flexible hinge 10. Preferably, the hinge has two predetermined positions, so that the dispensing tube is either in the closed position or in the use position. Preferably, the device is capable of sensing whether the dispensing tube is in the open position, and thus whether a dose of medicament can be dispensed.

The device shown in figures 3 and 4 is a more modified form of device. The device comprises a container 2 in a housing body 6. A window 11 in the body of the housing allows the container and its contents to be seen from the outside of the housing, allowing the user to see when the formulation stored in the container is reduced.

The device has an actuator 9 which is movable between a closed position shown in figure 3 and a use position shown in figure 4. When the actuator 9 is in the use position shown in fig. 4, the device can only dispense a formulation. Again, the actuator moves about the hinge 12, which locks in two positions, the closed position and the use position.

This is supplemented by the fact that: the button 13 which allows the device to dispense a dose of the pharmaceutical formulation is hidden when the actuator 9 is in the closed position and cannot be seen or triggered until the actuator is moved to the use position.

Claims (31)

1. A device for dispensing a pharmaceutical composition comprising a composition to be dispensed, a container for containing the composition, an electronically controlled actuator, and a housing having various device components enclosed therein.

2. The device of claim 1, wherein the device is compact and disposable.

3. The device according to any one of claims 1 and 2, wherein the container is made of glass, preferably type 1 pharmaceutical grade glass.

4. The device of claim 3, wherein the glass container is encased in a protective plastic outer coating.

5. The device of any one of the preceding claims, wherein the device further comprises a locking mechanism that is compact and disposable.

6. A device as claimed in claim 5, wherein the locking mechanism is powered by a battery or batteries forming an integral part of the dispensing device.

7. The device of claim 6, wherein the battery or cells are incorporated within a housing of the device.

8. The device of claim 6, wherein the battery or cell is incorporated into the housing.

9. The device of claim 6, wherein the battery or cell is embedded in a plastic coating surrounding the glass container.

10. A device as claimed in claim 6, wherein the battery or cells are printed on the surface of a plastic part of the device, such as a housing or a plastic coated container.

11. The device of any one of claims 6-10, wherein the battery or cells provide a power source of 1.5V.

12. The device of any one of the preceding claims, wherein the device comprises a power source comprising mechanical windings, a fuel cell, preferably of chemical or nuclear type, or solar energy.

13. The apparatus of any one of the preceding claims, wherein the apparatus comprises a backup power source.

14. The device of any one of the preceding claims, wherein the device further comprises an indicator indicating the amount of power remaining in the device.

15. A device as claimed in any preceding claim, wherein the energy provided by the battery or battery is used to turn the actuator on or off.

16. A device as claimed in any preceding claim, wherein the device comprises a control mechanism which is powered by the battery pack and controls the action of the actuator.

17. The device of claim 16, wherein the control mechanism is an electronic mechanism.

18. A device as claimed in any one of claims 16 or 17, wherein the control mechanism is pre-programmed to lock for a given time after actuation.

19. A device as claimed in any preceding claim, wherein the device comprises a counter to monitor the number of doses dispensed by the device.

20. The device of any one of claims 17 or 18, wherein the electronic control mechanism is positioned within a housing of the device.

21. The device of claim 20, wherein the electronic control mechanism is a strip printed on an interior surface of the device housing.

22. The device of claim 20, wherein the electronic control mechanism is embedded in a plastic moulding forming part of the device.

23. A device as claimed in any preceding claim, wherein the device has a folding actuator or dispensing tube which moves between a closed position in which it folds up on the side of the housing or in a recess in the side of the housing of the device, and an open or in-use position in which it is positioned at an angle to the surface of the housing in a position suitable for comfortable and accurate dispensing of a composition into the mouth for sublingual or pulmonary delivery or into the nose for nasal delivery.

24. The device of claim 23, wherein the composition is dispensed only when the actuator or dispensing tube is in the use position.

25. A device as claimed in any one of claims 23 and 24 wherein the actuator or dispensing tube must return to the closed position after a dose of the pharmaceutical composition has been dispensed and then move back to the in use position before another dose of the pharmaceutical composition can be dispensed.

26. A device according to any of claims 23-25, wherein the device comprises a locking mechanism and the actuator or dispensing tube is movable to the in-use position only when the locking mechanism allows it.

27. A device as claimed in any preceding claim wherein the container containing the pharmaceutical composition is not removable from the housing of the device.

28. The device of claim 27, wherein a detent prevents removal of the container from the housing.

29. The device of claim 27, wherein the housing includes components that are permanently connected to each other once the receptacle is connected with other device components that have been inserted, thereby preventing removal of the receptacle from the housing.

30. A device according to claim 29, wherein the housing parts are permanently attached to each other by means of an adhesive or they are welded together, for example by ultrasonic welding.

31. The device of any one of the preceding claims, wherein the pharmaceutical composition comprises an opioid analgesic.