Ophthalmic Blister Packs

Abstract

The goal is to improve or facilitate reliable delivery of the drug. [Solution] A blister package for ophthalmic medications includes a base layer having a first side and a second side. At least one dome extends from the first side, each dome defining a cavity for receiving a dose of liquid medication. An intermediate layer extends onto the second side of the base layer and covers each cavity. The intermediate layer includes an integrally formed nozzle aligned with each cavity. A removable layer extends over the intermediate layer and is removable from the intermediate layer to expose each nozzle opening.

Description

[Technical Field]

[0001] Related Applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 396,357, filed August 9, 2022, the entire contents of which are incorporated herein by reference.

[0002]

[0002] The present invention relates generally to pharmaceutical packaging, and more particularly to single-dose ophthalmic blister packs. [Background technology]

[0003] Blister packaging is used for both solid and gel medications to aid in the storage and dispensing of the medication. In some cases, the aluminum layer of the packaging is pierced or otherwise removed to allow access to the medication. However, these traditional piercing-based packaging are not ideal for delivering liquid medications because portions of the aluminum layer may obstruct or inhibit the flow of the medication from the package, making medication delivery unreliable and / or difficult. Summary of the Invention

[0004]

[0004] In one example, a blister package for an ophthalmic medication includes a base layer having a first side and a second side. At least one dome extends from the first side, each dome defining a cavity for receiving a dose of liquid medication. An intermediate layer extends onto the second side of the base layer and covers each cavity in the base layer. The intermediate layer includes an integrally formed precision nozzle opening or pattern of nozzle openings aligned with each cavity, the nozzle openings being small enough to prevent leakage of liquid unless internal pressure is applied to the dome. A top peelable layer extends over the nozzle openings to cover each nozzle. The removable layer prevents water vapor transmission through the nozzle openings for long-term storage of the medication within the blister pack.

[0005]

[0005] In another example, a blister package for ophthalmic medications includes a polymer base layer having a first side and a second side. Hemispherical domes extend from the first side, each defining a cavity for receiving a liquid medication. An intermediate layer extends onto the second side of the base layer and covers each cavity. The intermediate layer includes an integrally formed nozzle aligned with each cavity and having a slit extending entirely through the intermediate layer. A peelable top composite layer can be formed from a "blister foil" layer laminate incorporating a release lining for easy peeling to expose the nozzle opening in the intermediate layer. The blister foil layer can be an aluminum composite layer, with an aluminum core for low water vapor transmission, a thin, printable top protective film such as polypropylene (PP), and a bottom protective layer such as polyvinyl chloride (PVC). It can also have a release layer such as a PVC or polyester (PE) film to provide easy peel functionality.

[0006] In another example, a blister package for an ophthalmic medication includes a base layer having a first side and a second side. A nozzle opening extends from the first side toward the second side, and a cavity extends from the second side toward the first side and is in fluid communication with the nozzle. The cavity is configured to receive a medication dose placed therein before the layers are sealed by localized heat welding or adhesive. A removable top sealing layer extends over the first side of the base layer and covers the nozzle opening. A second sealing layer extends over the second side of the base layer and forms a cavity for depositing the liquid medication. A top outer sealing layer is removable from the base layer to expose the nozzle. When a force is applied to the dome feature toward the nozzle opening, the medication dose is forced out of the package through the nozzle opening when the top outer layer is peeled away.

[0007]

[0007] Other objects and advantages of the present invention, as well as a more complete understanding of the present invention, will be obtained from the following detailed description and the accompanying drawings. [Brief explanation of the drawings]

[0008] [Figure 1]

[0008] FIG. 1 is a schematic diagram of an example of a blister package according to one aspect of the present invention. [Figure 2]

[0009] 2 is a cross-sectional view of the package of FIG. 1 taken along line 2-2. [Figure 3]

[0010] 2 is a schematic diagram of a method for forming the package of FIG. 1. [Figure 4]

[0011] 2 shows a first step using the blister package of FIG. 1. [Figure 5]

[0012] 1 illustrates a second step using the blister package of FIG. 1. [Figure 6A]

[0013] FIG. 10 is a schematic diagram of another example of a blister package in an exploded state. [Figure 6B]

[0014] 6B shows an assembled version of the blister package of FIG. 6A. DETAILED DESCRIPTION OF THE INVENTION

[0009]

[0015] The present invention relates generally to pharmaceutical packaging, and more particularly to single-dose ophthalmic blister packs. Figures 1-2 show an example of a blister package 10 according to the present invention. Package 10 includes a base film or layer 20 extending generally along a centerline 22 from a first end 24 to a second end 26. Base layer 20 has a first side 30 and an opposing second side 32. As shown, base layer 20 is substantially planar, although other non-planar shapes and profiles (not shown) are contemplated. Base layer 20 can be formed from a polymer, such as polyvinyl chloride (PVC), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), or other layer(s) of material commonly used in pharmaceutical packaging.

[0010]

[0016] At least one dome 40 extends from the first side 30 of the base layer 20. Each dome 40 can be integrally formed with the base layer 20 (as shown) or formed separately and secured to the base layer 20 (not shown). For example, thermal vacuum forming can be used to stretch a portion or portions of the sheet of base layer 20 into one or more dome shapes, such that the domes 40 are integrally formed with the base layer. In a multi-dome 40 configuration, the domes can be arranged in a square or rectangular array around the periphery of the base layer 20.

[0011]

[0017] Each dome 40 has a thickness and configuration that allows it to elastically deform relative to the remainder of the base layer 20 while remaining connected to the base layer 20. Additionally, each dome 40 has a generally hemispherical shape and defines a cavity 42 for containing a liquid medication 44. In one example, the cavity 42 can contain a single dose of the liquid ophthalmic medication 44.

[0012]

[0018] The patterned intermediate film or layer 60 extends over the second side 32 of the base layer 20 and has substantially the same footprint as the base layer. The patterned intermediate layer 60 has a first side 62 that abuts the second side 32 of the base layer 20 and a second side 64 that faces away from the base layer. Thus, the intermediate layer 60 cooperates with each dome 40 to completely encapsulate the medication 44 within each cavity 42. The intermediate layer 60 can be formed from a polymer such as PVC, PE, PP, PET, or other layer(s) commonly used in pharmaceutical packaging. The intermediate layer 60 can be secured to the base layer 20 by, for example, heat sealing or adhesive.

[0013]

[0019] A pattern of nozzle openings 70 is formed in the patterned intermediate layer 60 and arranged on the intermediate layer in the same pattern as the dome(s) 40 are arranged on the base layer 20. That is, each nozzle 70 is aligned with a corresponding dome 40 across the thickness of the base layer 20. The nozzles 70 may be formed as a series of openings or slits 72 arranged in a predetermined pattern, parallel to one another as shown. Other patterns for the nozzles 70, such as concentric, aligned, random, and / or circular openings, are also contemplated. As described below, the nozzles 70 aid in the controlled and predetermined ejection of the medicament 44 within each cavity 42.

[0014]

[0020] The nozzle 70 can be precisely formed by laser etching the intermediate layer 60 using a microscale or nanoscale laser patterning process. Lithography can also be used to precisely define the nozzle 70 within the intermediate layer 60. The diameter or cross-sectional width of the opening 70 can range from 10 to 200 microns, where capillary and surface tension forces can dominate the flow of liquid through the opening. Thus, the nozzle opening 70 extends from the first side 62 to the second side 64 of the intermediate layer 60 and has a very narrow and precisely controlled cross-section through the intermediate layer. The use of a hydrophobic intermediate layer material can restrict flow through the narrow nozzle opening 70.

[0015]

[0021] Typically, PP film can be naturally hydrophobic. In this case, hydrophobic surface tension forces do not naturally support immediate liquid flow out of the nozzles 70 without applying additional external forces, such as pressure, to the drug 44. Furthermore, the residual vacuum backpressure helps retain the drug. Because most drug combinations are aqueous-based, an additional protective layer is desirable to prevent water vapor from escaping and evaporating the drug over time. As a result, a peelable or removable second outer layer 80 is provided over the middle layer 60 to cover all of the nozzles 70, thereby helping to prevent evaporation of the drug 44 in the vapor phase.

[0016]

[0022] With this in mind, removable layer 80 includes a first side 82 that abuts second side 64 of barrier layer 60 and a second side 84 that faces away from the barrier layer. Removable layer 80 has substantially the same footprint as the barrier layer. Removable layer 80 can be secured to intermediate layer 60 by, for example, heat sealing or adhesive. Removable layer 80 can also be a multi-layer film formed as a blister foil composite.

[0017]

[0023] Specifically, removable layer 80 can have an aluminum core for low water vapor transmission, a thin top layer that can be printed as a protective film (e.g., PP) on one side of the core, and a bottom protective layer (e.g., PVC) on the opposite side of the core. It can also include a release layer, such as a PVC or PE film, to facilitate peeling of layer 80 from middle layer 60. Tabs or protrusions 86 are provided on removable layer 80 and extend laterally beyond the edge of middle layer 60.

[0018]

[0024] 3 illustrates an exemplary process for forming the package 10. In step 100, a film is formed, for example, by providing a base layer 20 and separately co-extruding an intermediate layer 60 and a removable layer 80. In step 110, a drug 44 is provided within each cavity 42 of the base layer 20, for example, distributed therethrough. In step 120, the co-extruded intermediate layer 60 / removable layer 80 is disposed on the base layer 20 and secured thereto, for example, by heat sealing. In step 130, individual packages 10 containing predetermined doses of drug 44 are cut from the finished roll. The individual packages 10 may be single-dose packages or may be configured as a collection of single-dose packages arranged in a magazine, for example, a strip, ring, or the like.

[0019]

[0025] It will be appreciated that the removable layer 80 may already be attached to the bottom of the two-layer composite, to the middle layer 60 and nozzle 70 formed therein, in a roll-to-roll process. This two-layer composite may then be washed and sterilized with ultraviolet light before the composite is secured to the base layer 20 to form the entire package 10.

[0020]

[0026] In use, a user grasps protrusion 86 and peels removable layer 80 away from intermediate layer 60, exposing intermediate layer nozzle 70 (FIG. 4). Once this occurs, the user can apply force to dome 40 (shown at A in FIG. 5) to urge the dome toward and through intermediate layer 60. This increases pressure within cavity 42 until medicament 44 passes through nozzle 70 and leaves second side 64 of intermediate layer 60.

[0021]

[0027] More specifically, the pressure increases sufficiently to force the medicament 44 through the nozzle 70 and out of the package 10 as a spray or microstream. It will be appreciated that the use of multiple slit openings to form each nozzle 70 allows for easier squeezing of larger doses of more viscous medicament 44 despite surface tension forces that prevent the liquid from immediately spilling when the release layer 80 is removed. In this manner, the slits remain sealed until / unless sufficient force is applied to the dome 40 to overcome the hermetic seal.

[0022]

[0028] 6A-6B show another example of a blister package 200 according to the present invention. Blister package 200 includes a micro-molded or stamped base or structural layer 210 having a first side 212 and a second side 214. Nozzles 220 are formed in first side 212 and extend toward second side 214. Nozzles 220 may be formed as a series of slits or openings.

[0023]

[0029] Cavities 226 are formed in second side 214 and extend toward first side 212 to be in fluid communication with the nozzles. Cavities 226 are aligned with nozzles 220 through the thickness of structural layer 210, and there are an equal number of cavities and nozzles. Structural layer 210 is formed of a polymer and may be micromolded, such that nozzles 220 and cavities 226 are formed integrally with layer 210 in a single step. Each cavity 226 is capable of receiving a single dose of liquid ophthalmic medication 230.

[0024]

[0030] A first or top sealing layer 240 is disposed on the structural layer 210 to cover all of the cavities 226. More specifically, the first sealing layer 240 includes a first side 242 that abuts the second side 214 of the structural layer 210 and a second side 244 that faces away from the structural layer. The first sealing layer 240 has substantially the same footprint as the structural layer 210. The first sealing layer 240 can be secured to the structural layer 210 by, for example, heat sealing or an adhesive. Both the structural layer 210 and the first sealing layer 240 can be formed from a polymer.

[0025]

[0031] A second or bottom sealing layer 250 is disposed on the structural layer 210 to cover all of the nozzles 220. More specifically, the second sealing layer 250 includes a first side 252 facing away from the structural layer 210 and a second side 254 abutting the first side 212 of the structural layer. The second sealing layer 250 has substantially the same footprint as the structural layer 210. The second sealing layer 250 may be secured to the structural layer 210 by, for example, an adhesive. The second sealing layer 250 includes a tab 256 extending laterally beyond the end of the structural layer 210. The second sealing layer 250 may be formed from a peelable blister foil composite, as described above.

[0026]

[0032] In one example, both the first sealing layer 240 and the second sealing layer 250 are thermally sealed to respective sides 212, 214 of the structural layer 210. With this in mind, both sides 212, 214 of the structural layer 210 may be substantially planar to facilitate roll application of the film layers 240, 250 to opposite sides of the base layer.

[0027]

[0033] Once package 200 is assembled, a user grasps tab 256 and peels a portion of second seal layer 250 away from structural layer 210, thereby exposing one or more nozzles 220 in the structural layer (shown in phantom in FIG. 6B ). Once this occurs, the user can apply a force, as shown at A, to the portion of first seal layer 240 that is aligned with cavity 226. In response to force A, first seal layer 240 elastically deforms toward and engages medicament 230.

[0028]

[0034] It will be appreciated that force A can be applied manually or using a controlled mechanical strike, such as a strike from a mechanical lever arm or an electromagnetic solenoid, directed toward first sealing layer 240. In either case, the force must be sufficient to force medicament 230 through nozzle 220 and away from side 214 of structural layer 210 and beyond side 212. This increases the pressure sufficiently to force medicament 230 out of nozzle 220 and out of package 200 as a spray or microstream.

[0029]

[0035] The packaging of the present invention advantageously provides a clean, well-defined nozzle for reliable and consistent delivery of a single dose of ophthalmic medication as a spray or micro-stream toward a user's eye. Thus, the removable layer prevents complete blockage of the nozzle opening for medication delivery, compared to existing blister pack designs that require active puncturing of the outer layer, which can result in a broken layer partially blocking the delivery opening(s). The provision of a removable layer also allows for reusability, lower manufacturing costs, and ease of use compared to previously described puncture-related blister packs.

[0030]

[0036] Furthermore, fully sealed liquid blister pack cartridges can be less costly and less wasteful than blow-fill-seal-fill packaging. Such packaging may exist in the form of a reel, or as a perforated array (similar to a Pez dispenser) that is dispensed one at a time using an applicator that serves to peel the removable layer from the individual units. The back of the blister pack can be made of a thin polymer with a bistable geometric dome configuration that, when impacted by, for example, a solenoid, buckles and breaks from one state to another, projecting a single dose of liquid toward the eye and forcing the liquid through a nozzle as long as there is a front support plate.

[0031]

[0037] Furthermore, the provision of a removable layer over / covering the nozzle allows the packaging to withstand pressure and / or temperature changes. In other words, the nozzle is sealed to accommodate the pressure changes and temperature changes that occur on an airplane. This construction also allows the packaging to not contain preservatives.

[0032]

[0038] The foregoing are exemplary embodiments of the present invention. Of course, it is not possible to describe every conceivable combination of components or methodologies in order to describe the present invention, but those skilled in the art will recognize that the present invention is susceptible to many more combinations and permutations. Accordingly, the present invention is intended to embrace all such alterations, modifications, and variations that fall within the spirit and scope of the appended claims.

Claims

1. 1. A blister package for an ophthalmic medication, comprising: a base layer having a first side and a second side, at least one dome extending from the first side, each dome defining a cavity for receiving a liquid medication dose; an intermediate layer extending over the second side of the base layer and covering each cavity, the intermediate layer including an integrally formed nozzle opening aligned with each cavity; a removable layer extending over the intermediate layer and peelable from the intermediate layer to expose each nozzle opening; A blister package.

2. The package of claim 1 , wherein the removable layer comprises a blister foil composite with an aluminum core.

3. The package of claim 1 , wherein the base layer comprises at least one of PE, PVC, PP, and PET.

4. The package of claim 1 , wherein the removable layer comprises at least one of PE, PVC, PP, and PET.

5. The package of claim 1 , wherein each nozzle opening is patterned in the intermediate layer.

6. The package of claim 1 , wherein each nozzle opening is etched into the intermediate layer.

7. The package of claim 1 , wherein each nozzle opening comprises an array of slits.

8. The package of claim 7 , wherein the slits extend parallel to one another and are capable of forming an extended drop pattern opening relief.

9. The package of claim 7, wherein the width of the slit is between 10 and 200 μm.

10. The package of claim 1 , wherein the removable layer provides a moisture barrier to the nozzle opening.

11. The package of claim 1 , wherein the removable layer includes a tab to assist in separating the removable layer from the intermediate layer.

12. 10. The package of claim 1, wherein the at least one dome is configured to buckle in response to a force pushing the dome toward the middle layer, forcing the medicament out of the nozzle opening.

13. The package of claim 1 , wherein each nozzle opening is aligned with a respective one of the cavities through the thickness of the base layer.

14. 1. A blister package for an ophthalmic medication, comprising: a polymer-based layer having a first side and a second side, with hemispherical domes extending from the first side, each dome defining a cavity for receiving a liquid drug dose; a polymer interlayer extending over the second side of the base layer and covering each cavity, the interlayer including an integrally formed nozzle aligned with each cavity and including a slit extending completely through the interlayer; and a strippable composite layer extending over the intermediate layer and peelable from the intermediate layer to expose each nozzle; Includes a blister package.

15. 1. A blister package for an ophthalmic medication, comprising: a structural layer having a first side and a second side, a nozzle extending from the first side toward the second side, and a cavity extending from the second side toward the first side in fluid communication with the nozzle and configured to receive a medicament dose; a first sealing layer covering the second side of the structural layer for sealing the medication within the cavity; a second sealing layer covering the first side of the structural layer and covering the nozzle, the second sealing layer being removable from the structural layer to expose the nozzle, and wherein applying a force to the first sealing layer toward the nozzle urges the medicament to be forced out of the package through the nozzle; and Includes a blister package.

16. 16. The package of claim 15, wherein the second sealing layer comprises a blister foil composite with an aluminum core.

17. The package of claim 15 , wherein the nozzle and the cavity are micromolded with the structural layer.

18. The package of claim 15 , wherein the nozzle and the cavity are stamped into the structural layer.

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