WO2004000660A2

WO2004000660A2 - Blister package

Info

Publication number: WO2004000660A2
Application number: PCT/US2003/019717
Authority: WO
Inventors: Joseph J. Urban; Steve Barger
Original assignee: ProClinical Inc
Current assignee: ProClinical Inc
Priority date: 2002-06-21
Filing date: 2003-06-20
Publication date: 2003-12-31
Anticipated expiration: 2004-12-21
Also published as: AU2003243731A1; US20030234203A1; WO2004000660A3; AU2003243731A8

Abstract

A child-resistant package for a product is provided. The package (10) comprises a double cover comprised of separate outer (100) and inner (110) layers, wherein the outer layer is disposed adjacent the inner layer, and a barrier (130) disposed adjacent the inner (110) layer of the double cover, wherein the inner (110) layer and the barrier (130) together define at least one compartment (120) into which a product (140) can be positioned. Also included are embodiments (30, 40) where the cover (300) is a single layer and the bottom barrier is a double layer (330, 310) , and where both the cover and the barrier are multiple layers (420, 410, 440,450). Included in the invention is a method of making a child-resistant package consistent with the package consistent with the package of the invention.

Description

BLISTER PACKAGE

FIELD OF THE INVENTION

The present invention relates to packaging, and more specifically to child-resistant packaging for dosed products. BACKGROUND OF THE INVENTION

It is known to use blister packages to contain small articles such as pharmaceutical or dose form products. These packages allow the user to access the product by applying pressure to the blister to force the product from an individual blister or capsule through a rupturable layer. Known blister packages comprise a first sheet of transparent or translucent thermoformable material such as polyvinyl chloride or polystyrene having a plurality of flexible bubbles or blisters preformed therein and projecting outwardly from one surface to define separate compartments for individual doses of a product, typically a single pill or capsule, and a second sheet to cover the product. The second layer is often made from a rupturable foil so that the user can push the product from the bubble side out through the foil. This construction did not offer much in the way of child resistance, and presented a potential hazard to children.

In order to render blister packages resistant to access by children, improved child-resistant blister packages have been developed. Exemplary structures of such child-resistant blister packages, as well as exemplary methods of forming such packages, are disclosed in U.S. Patent No. 6,161,699 to Gartland, which is hereby incorporated by reference herein.

Despite the fact that such child-resistant packages have improved safety characteristics, there is room for further improvements. Many of the known package- forming methods and package constructions, although offering varying degrees of child resistance, sometimes compromised accessibility. Specifically, in some cases, known methods and constructions made the product so inaccessible that even adults had trouble accessing the product. This later case is especially problematic where older adults or others who have lost some degree of manual dexterity are the users of the products.

Thus, there remains a need for an improved packaging method and construction that provide the desired^' level of resistance to a child while maintaining acceptable levels of accessibility for adults. SUMMARY OF THE INVENTION

The present invention includes a child-resistant package for a dose form product and a method of forming a child - resistant package for such a dose form product. According to one exemplary embodiment, the invention provides a child- resistant package for a product comprising a double cover comprised of separate outer and inner layers, wherein the outer layer is disposed adjacent the inner layer, and a barrier is disposed adjacent the inner layer of the double cover. The inner layer and the barrier together define at least one compartment into which a product can be positioned. In another exemplary embodiment of the invention, a child-resistant package for a product is provided which comprises a cover and a double barrier disposed adjacent the cover, where the double barrier comprises separate outer and inner layers. In this embodiment, the outer layer is disposed adjacent the inner layer and the inner layer of the double barrier and the cover together define at least one compartment into which a product can be positioned.

The invention also provides a method of forming a child - resistant package for a product. According to one exemplary embodiment, the method includes the steps of forming a double cover by disposing an outer layer adjacent an inner layer, the double cover defining at least one cavity. The method also includes the steps of placing a product in the cavity of the double cover and disposing a barrier adjacent the inner layer of the double cover, thereby defining at least one compartment between the inner layer of the double cover and the barrier in which the product is contained.

Yet another embodiment of the method according to the present invention includes a method of forming a child - resistant package for a product including the steps of forming a double barrier by disposing an outer layer adjacent an inner layer, placing a product in a cavity of a cover, and disposing the cover adjacent the inner layer of the double barrier. In this way, at least one compartment is formed between the inner layer of the double barrier and the cover in which the product is contained. The present invention also includes embodiments where both the cover and barrier are multi-layered. In such embodiments, the cover is multi-layered and the product is disposed between the multi-layered cover and a multi-layered barrier. BRIEF DESCRIPTION OF THE FIGURES

The features of the invention believed to be novel and the elements characteristic of the invention are set forth with particularity in the appended claims. The figures are for illustration purposes only and are not drawn to scale. The invention itself, however, both as to organization and method of operation, may best be understood by reference to the detailed description that follows taken in conjunction with the accompanying drawings in which:

FIG. 1 is a cross-sectional side view of a portion of one embodiment of the present invention in which a double cover is disposed atop a barrier; FIG. 2 is an illustration of the embodiment of FIG. 1 but with an exaggerated view of bonding adhesives for illustration purposes;

FIG. 3 is a cross-sectional side view of a portion of another embodiment of the present invention in which a cover is disposed atop a double barrier;

FIG. 4 is a cross-sectional side view of a portion of yet another exemplary embodiment in which both the cover is double layered and the barrier is double layered;

FIG. 5 is a cross-sectional side view of yet another embodiment in which each of the layers of a double barrier is multi-layered;

FIG. 6 shows an exemplary embodiment of a ten-product package consistent with aspects of the present invention;

FIG. 7 shows the embodiment of FIG. 5 but with a card disposed atop the cover of the package; and

FIG. 8 shows the compilation of each layer in accordance with an exemplary embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

This invention will now be described with reference to specific embodiments selected for illustration in the figures. It will be appreciated that the spirit and scope of this invention is not limited to the embodiments selected for illustration. Instead, the scope of this invention is defined separately in the appended claims. Also, it will be appreciated that the drawings are not rendered to any particular proportion or scale.

The present invention includes child-resistant packages and methods for packaging dose form products. Generally, the packages according to the present invention are optionally formed with three or more layers, with the packaged product disposed within a. bubble or other compartment formed between an inner layer and an outer layer. The products which can be packaged in accordance with the present invention include many varieties, most notably dose form products such as pharmaceuticals in pill or capsule form. Other products to which the present invention can be applied include, without limitation, medicaments (in pill, tablet, capsule, or lozenge form), drugs, vitamins, cosmetics, foods, nutriceutical products, pharmaceutical products, devices, and any other product for which dose-form consumption, or use, is desired. One embodiment of the present invention includes a child-resistant package for a dose form product comprising a double cover and a single barrier. This embodiment is comprised of separate outer and inner layers, wherein the outer layer is disposed adjacent the inner layer, and a barrier is disposed adjacent the inner layer of the double cover. The inner layer and the barrier together define at least one compartment into which a product can be positioned.

FIG. 1 shows such a package embodiment of the present invention, generally designated by the numeral "10," where the cover is formed from two layers and the barrier layer is formed from one layer. The package 10 has a cover including an outer cover layer 100 and an inner cover layer 110. More specifically, outer cover layer 100 of package 10 is disposed atop, but adjacent to, inner cover layer 110. Together outer cover layer 100 and inner cover layer 110 therefore form a double- layered cover that, in the illustrated embodiment, includes a bubble 120. Disposed below the two layered-cover is a barrier such as a backing layer 130. Barrier 130 is disposed adjacent inner cover layer 110 of the double cover to enclose a product 140 within the compartment formed by the bubble 120 and barrier 130.

Generally, each layer can be comprised of either foil, film, plastic or paper, or combinations thereof. Each respective layer is optionally bonded, using an appropriate adhesive or other attachment material or method, to its adjacent layers, where contact is made between them. In other words, with the exception of the bubble area, inner cover layer 110 can be bonded to barrier 130, and with the exception of the air space 150 defined between the inner cover layer 110 and the outer cover layer 100 (discussed below), outer cover layer 100 can be bonded to inner cover layer 110.

In an exemplary embodiment, outer cover layer 100 is comprised of a transparent film, such as a polyethylene or polyvinyl chloride or other polymeric film, and inner cover layer 110 is comprised of either a similar transparent polymeric film, plastic, paper, or opaque foil material. In the former embodiment, the user is allowed to see product 140, but where light could be damaging to the product, such as reducing its shelf life, opaque foil or some other light-blocking or light-reducing material would be preferred. In this embodiment, the outer cover layer can be comprised of a tough, penetration resistant polymeric film such that access to the product can only be made through the barrier.

It is also optional that a space, either air, vacuum, or inert gas, is provided between inner cover layer 110 and outer cover layer 100. This interstitial space 150 allows penetration through outer cover layer 100 (when penetration occurs, although outer cover layer 110 is designed, as noted above, to be penetration- resistant) without penetration of inner cover layer 110.

Barrier 130 is optionally comprised of paper, plastic, film, or foil, or other suitable materially, and is optionally bonded to, in the case of the embodiment illustrated in FIG. 1, inner cover layer 110 over at least a portion of inner cover layer 110 that is not raised to form a compartment such as bubble 120 for product 140.

In an exemplary embodiment, generally designated by the numeral "20" in FIG. 2, there is a region of contact between inner cover layer 110 and barrier 130 immediately adjacent bubble 120 where no bonding exists. No-bond region 200 is shown in FIG. 2 and allows for the peeling away of barrier 130 in that no-bond region so that product 140 can be accessed. FIG. 2 shows such an embodiment in detail, with features deliberately exaggerated and shown out of scale for the purpose of illustration. FIG. 2 shows adhesive 230 in exemplary locations as well as no-bond region 200 set apart from bonded region 210 by a perforation 220. The user can thus peel barrier 130 away from inner cover layer 110 beginning at perforation 220, thereby providing access to the product 140.

In another embodiment of the invention, a child-resistant package for a product is provided which comprises a cover and a double barrier disposed adjacent the cover, where the double barrier comprises separate outer and inner layers. In this embodiment, the outer layer is disposed adjacent the inner layer and the inner layer of the double barrier and the cover together define at least one compartment into which a product can be positioned. This embodiment is similar to the first embodiment described above but the bubble is comprised of only one layer and the barrier is comprised of multiple layers.

FIG. 3 shows an embodiment, generally designated by the numeral "30," with cover layer 300 disposed around product 140. Inner barrier layer 310 and cover layer 300 together define a compartment optionally configured in the form of a bubble 320. Outer barrier layer 330 is disposed adjacent inner barrier layer 310. Materials, and adhesives or other bonding methods are the same as those described above in regard to FIG. 1. In this embodiment, the main difference is that the user must first peel away outer barrier layer 330 before being able to penetrate or otherwise remove inner barrier 310.

FIG. 4 shows yet another exemplary embodiment of the present invention, generally designated by the numeral "40," which is essentially a combination of the embodiments shown in FIGS. 1 and 3. Specifically, FIG. 4 shows an embodiment that can be considered a double-double containment embodiment.

Product 140 is disposed within a compartment such as a bubble 400, which is formed by inner cover layer 410 and outer cover layer 420. An optional air space 430 is disposed between layers 410 and 420. A double barrier layer is disposed below product 140 and is comprised of inner barrier layer 440 and outer barrier layer 450. In order to access product 140 from the blister package 40 shown in FIG.

4, the user can peel away outer barrier layer 450 and then remove inner barrier layer 440. Removal of inner barrier layer 440 is typically accomplished by the user pulling on a tap or perforated portion of inner barrier layer 440, and peeling or tearing it away.

Alternatively, the user can peel away outer barrier layer 450 and then remove a product-containing blister (formed from a portion of the inner cover layer 410 and the inner barrier layer 440) from the space between the outer barrier layer 450 and the outer cover layer 420. The removal of the blister can be facilitated by the absence of adhesion between (1) the inner cover layer 410 of the product-containing blister and the outer cover layer 420 and (2) the inner barrier layer 440 of the product- containing blister and the outer barrier layer 450. Once removed from the outer barrier layer 450 and the outer cover layer 420, the product-containing blister can be opened by the user either by removing the inner barrier layer 440 to access the product 140 or by pushing the product 140 through the inner barrier layer 440 by pressing the inner cover layer 410 against the product 140. FIG. 5 shows yet a more specific embodiment, generally designated by the numeral "50," wherein each of inner barrier layer 440 and outer barrier layer 450 are comprised of two or more layers. In this embodiment, inner barrier layer 440 is a laminate of outer paper layer 510 and inner foil layer 520. Outer barrier layer 450 is comprised of perforated paper layer 530 and peel-away polymeric layer 540. In order to access product 140 for the exemplary embodiment of package 50, peel-away polymeric layer 540 is peeled-away, perforated paper layer 530 is torn away, and inner barrier 440 (comprised of a combination or lamination of the paper layer 510 and foil layer 520) is peeled away or otherwise removed or pierced to access product 140.

FIG. 6 shows another version of the embodiment shown in FIG. 5, which is generally designated by the numeral "60." Package 60 is a double-double containment blistercard package for ten (10) dose-form products. FIG. 6 shows the outer cover layer 420 having recesses 611 disposed therein to assist in a user's grabbing and peeling away of portions of the inner barrier layer 440. In FIG. 6, inner cover layer 410 is shown together with inner barrier layer 440, and the inner barrier layer 440 is provided with lines of perforations so that distinct portions of the inner barrier layer 440 can be separated from the inner cover layer 410. The inner cover ' layer 410 and the inner barrier layer 440 together define the bubbles or compartments in which the product is placed.

Outer barrier layer 450 is comprised of perforated paper layer 530 and a pair of peel-away polymeric layers 540. This outer barrier layer 450 is disposed on or adjacent inner barrier layer 440, which in turn is placed adjacent inner cover layer 410, which is in turn placed adjacent or into outer cover layer 420 as shown by the arrows in FIG. 6. In order to access product 140 in this embodiment 60, peel-away polymeric layer 540 is peeled-away, along with perforated paper layer 530, and inner barrier layer 440 (comprised of the paper layer 510/foil layer 520 laminate) is peeled away or otherwise removed to access product 140 disposed within inner cover layer 410.

FIG. 7 shows an additional embodiment, generally designated by the numeral "70," where outer card 700 is disposed on top of the blistercard packages described above. Typically, outer card 700 is disposed atop the package for labeling or other packaging purposes. Outer card 700 simply has holes disposed therein to allow for the presence of each blister or bubble 120.

FIG. 8 shows an embodiment, generally designated by the numeral "80," similar to that shown in FIG. 6 but with the addition of outer card 700 shown in FIG. 7. In this embodiment, and consistent with the method described below, the product is put into inner cover layer 410, before inner barrier layer 440 is placed thereon. At this point, a product is disposed within and between inner cover layer 410 and inner barrier layer 440. This combination is then inserted into outer cover layer 420, which together are put into outer card 700 so that individual blisters extend through openings in the outer card 700. Outer card 700 is attached to outer barrier 450, which is then folded along line 800 to enclose the product, inner barrier layer 440, inner cover layer 410, and outer cover layer 420. Bonding, using adhesives or other methods, is contemplated between layers as appropriate and consistent with the above description. The invention also includes a method of forming a child - resistant package for a product. The method comprises the steps of forming a double cover by disposing an outer layer adjacent an inner layer, the double cover defining at least one cavity. The double cover is as defined above. The method also includes the steps of placing a product in the cavity of the double cover and disposing a barrier adjacent the inner layer of the double cover, thereby defining at least one compartment between the inner layer of the double cover and the barrier in which the product is contained. The barrier is as defined above. In this embodiment, the cover or bubble formed is comprised of two layers.

Yet another embodiment of the method according to the present invention includes a method of forming a child - resistant package for a product comprising the steps of forming a double barrier by disposing an outer layer adjacent an inner layer, placing a product in a cavity of a cover, and disposing the cover adjacent the inner layer of the double barrier. The cover and barrier are as defined above. In this way, at least one compartment is formed between the inner layer of the double barrier and the cover in which the product is contained. This embodiment of the method is similar to the one described just above but the cover or bubble formed is comprised of only one layer.

Accordingly, while illustrated and described herein with reference to certain specific embodiments, the present invention is not intended to be limited to the embodiments and details shown. Rather, the appended claims are intended to include all embodiments and modifications that may be made to these embodiments and details, which are nevertheless within the true spirit and scope of the present invention.

Claims

What is Claimed: 1. A child-resistant package for a product comprising: a double cover comprised of separate outer and inner layers, wherein the outer layer is disposed adjacent the inner layer; and a barrier disposed adjacent the inner layer of the double cover; wherein the inner layer and the barrier together define at least one compartment into which a product can be positioned.

2. The package of claim 1 wherein at least one of the inner and outer layers of the double cover defines at least one blister cavity.

3. The package of claim 1 wherein at least one of the inner and outer layers of the double cover is formed from a film.

4. The package of claim 3 wherein the film is translucent.

5. The package of claim 1 wherein at least one of the inner and outer layers of the double cover is formed from a foil.

6. The package of claim 1 wherein the outer layer of the double cover is formed from a film and the inner layer of the double cover is formed from a foil.

7. The package of claim 1 wherein each of the outer and inner layers defines at least one blister cavity integrally formed therein and projecting from one side thereof, together forming a double blister cover.

8. The package of claim 7 wherein each of the outer and inner layers of the double cover is formed from a film.

9. The package of claim 1 wherein the barrier is comprised of at least two separate layers.

10. The package of claim 9 wherein the barrier is formed from any one or more of foil, film, plastic, or paper.

11. The package of claim 10 wherein the barrier has a frangible section overlying each compartment, the frangible section being defined by a perforated or scored line in the barrier.

12. A method for forming a child - resistant package for a product, said method comprising the steps of: (a) forming a double cover by disposing an outer layer adjacent an inner layer, the double cover defining at least one cavity; (b) placing a product in the cavity of the double cover; and (c) disposing a barrier adjacent the inner layer of the double cover, thereby defining at least one compartment between the inner layer of the double cover and the barrier in which the product is contained.

13. The method of claim 12 wherein the forming step comprises forming at least one blister cavity in at least one of the inner and outer layers of the double cover.

14. The method of claim 12 wherein the forming step comprises disposing a film adjacent a foil.

15. The method of claim 12 wherein the forming step comprises disposing a film adjacent a film.

16. The method of claim 12 wherein the disposing step comprises laminating a foil to the side of the inner layer opposite the outer layer.

17. The method of claim 16 wherein the disposing step further comprises disposing a backing adjacent the foil opposite the inner layer of the double cover.

18. The method of claim 17 wherein the backing is formed from any one or more of film, plastic, paper, or foil.

19. The method of claim 17 further comprising defining a frangible section in the backing overlying each cavity.

20. A child-resistant package for a product comprising: a cover; and a double barrier disposed adjacent the cover, said double barrier comprising separate outer and inner layers, wherein the outer layer is disposed adjacent the inner layer; wherein the inner layer of the double barrier and the cover together define at least one compartment into which a product can be positioned.

21. The package of claim 20 wherein the inner layer of the double barrier is formed from any one or more of foil, film, plastic or paper.

22. The package of claim 20 wherein the outer layer of the double barrier is formed from any one or more of foil, film, plastic or paper, or combinations thereof.

23. The package of claim 20 wherein the inner layer of the double barrier is formed from any one or more of foil, film, plastic, or paper, or combinations thereof.

24. The package of claim 20 wherein the inner layer of the double barrier is a foil and paper laminate.

25. The package of claim 20 wherein the inner layer of the double barrier is accessible only after at least partial removal of the outer layer of the double barrier.

26. The package of claim 20 wherein the cover is a double cover comprised of separate outer and inner layers, wherein the outer layer is disposed adjacent the inner layer.

27. A method for forming a child - resistant package for a product, said method comprising the steps of: (a) forming a double barrier by disposing an outer layer adjacent an inner layer; (b) placing a product in a cavity of a cover; and (c) disposing the cover adjacent the inner layer of the double barrier, thereby defining at least one compartment between the inner layer of the double barrier and the cover in which the product is contained.