# US 2025/0367136 A1 · Transdermal packaging membranes

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- Number: US 2025/0367136 A1
- Document ID: US20250367136A1
- Status: Published application
- Kind: A1
- Application number: 19/016,438
- Filed: 2025-01-10
- Published: 2025-12-04
- Earliest claimed: 2016-07-06
- Assignees: Agile Therapeutics, Inc.
- Applicants: Agile Therapeutics, Inc.
- Inventors: Agis KYDONIEUS; C. Gregory ARNOLD; Robert G. CONWAY; Thomas M. ROSSI
- Web page: https://patentgrep.com/patent/US20250367136A1

## CPC

- A61K 9/7038: {Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer}
- A61J 1/00: Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00)
- A61J 1/10: Bag-type containers
- A61K 31/565: not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K 31/567: substituted in position 17 alpha, e.g. mestranol, norethandrolone
- A61K 47/12: Carboxylic acids; Salts or anhydrides thereof
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- B32B 5/18: characterised by features of a layer {of} foamed material
- B32B 7/06: permitting easy separation
- B32B 7/12: using interposed adhesives or interposed materials with bonding properties
- B32B 15/085: comprising polyolefins
- B32B 15/09: comprising polyesters
- B32B 15/20: comprising aluminium or copper {(B32B15/016 and B32B15/017 take precedence)}
- B32B 27/00: Layered products comprising {a layer of} synthetic resin {(fibrous or filamentary layer made of a synthetic resin B32B5/02; particulate layer made of a synthetic resin B32B5/16; foamed layer made of a synthetic resin B32B5/18)}
- B32B 27/065: {of foam}
- B32B 27/08: of synthetic resin
- B32B 27/10: of paper or cardboard
- B32B 27/28: comprising synthetic resins not wholly covered by any one of the sub-groups {B32B27/30 - B32B27/42}
- B32B 27/30: comprising vinyl {(co)polymers; comprising acrylic (co)polymers}
- B32B 27/304: {comprising vinyl halide (co)polymers, e.g. PVC, PVDC, PVF, PVDF}
- B32B 27/306: {comprising vinyl acetate or vinyl alcohol (co)polymers}
- B32B 27/32: comprising polyolefins {(comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30)}
- B32B 27/322: {comprising halogenated polyolefins, e.g. PTFE}
- B32B 27/325: {comprising polycycloolefins}
- B32B 27/36: comprising polyesters
- B32B 27/40: comprising polyurethanes
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- B32B 2250/05: 5 or more layers
- B32B 2255/10: on synthetic resin layer or on natural or synthetic rubber layer
- B32B 2255/26: Polymeric coating
- B32B 2266/025: Polyolefin
- B32B 2266/08: Closed cell foam
- B32B 2307/54: Yield strength; Tensile strength
- B32B 2307/7244: Oxygen barrier
- B32B 2307/7246: Water vapor barrier
- B32B 2307/748: Releasability
- B32B 2405/00: Adhesive articles, e.g. adhesive tapes
- B32B 2439/80: Medical packaging
- B32B 2556/00: Patches, e.g. medical patches, repair patches
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM

## Abstract

Article side polymers useful in the packaging of transdermal patches are disclosed. These films do not absorb skin permeation enhancers that are contained in transdermal patches including keto acids such as levulinic acid or sulfoxides such as an alkyl sulfoxide, e.g., dimethyl sulfoxide. Using such polymeric film, multilayer pouch constructions can be manufactured which include other polymeric layers, such as aluminum foil for moisture and oxygen barrier properties, polyester for tear resistance and paper layers for optimal printing and design.

## Claims

### Claim 1

A package for storing a transdermal delivery patch comprising an active pharmaceutical ingredient and
(i) at least one skin penetration enhancer that is a keto acid and at least one additional enhancer that is a long chain monoglyceride or a C8-C16 ester of a short chain carboxylic acid, or (ii) at least one skin penetration enhancer that is a sulfoxide,
wherein the package comprises a multilayered packaging film having an article side polymer film selected from a thermoplastic fluoropolymer, amorphous polyethylene terephthalate, or polyacrylonitrile/methyl acrylate-acrylonitrile/butadiene graft copolymer.

### Claim 2 (depends on 1)

The package of claim 1 comprising an active pharmaceutical ingredient and at least one skin penetration enhancer that is a keto acid and at least one additional enhancer that is a long chain monoglyceride or a C8-C16 ester of a short chain carboxylic acid.

### Claim 3 (depends on 2)

The package of claim 2 wherein the keto acid is levulinic acid (LA), the long chain monoglyceride is glycerol monooleate (GMO), and the C8-C16 ester of a short chain carboxylic acid is lauryl lactate (LL).

### Claim 4 (depends on 3)

The package of claim 3 wherein the amount of the first penetration enhancer is about 0.5 wt % to about 10 wt % and the amount of the second penetration enhancer is about 0.5 wt % to about 10 wt %.

### Claim 5 (depends on 1)

The package of claim 1, wherein the package comprises an active pharmaceutical ingredient, and at least one skin penetration enhancer that is a sulfoxide, and at least one additional skin penetration enhancer that is either a C8-C16 ester of a short chain carboxylic acid or a lower alkyl ester of a short chain carboxylic acid.

### Claim 6 (depends on 5)

The package of claim 5, wherein the sulfoxide is dimethyl sulfoxide (DMSO), C8-C16 ester of a short chain carboxylic acid is LL, and the lower alkyl ester of a short chain carboxylic acid is ethyl lactate (EL).

### Claim 7 (depends on 5)

The package of claim 5, wherein the enhancers comprise DMSO, LL, EL, and a medium chain fatty acid.

### Claim 8 (depends on 7)

The package of claim 7, wherein the enhancers comprise about 4% to about 12% of DMSO, about 4% to about 13% of LL, about 0.5% to about 2.5% of EL; and from about 3% to about 9% of capric acid.

### Claim 9 (depends on 1)

The package of claim 1, wherein the article side polymer film absorbs less than 0.5% by weight of the skin permeation enhancer(s) during a storage period of 6 months or longer at room temperature.

### Claim 10 (depends on 1)

The package of claim 1, the active pharmaceutical ingredient is a progestin or a progestin and an estrogen.

### Claim 11 (depends on 1)

The package of claim 1, wherein the transdermal patch delivers a contraceptive amount of the active pharmaceutical ingredient during a 7 day wear period.

### Claim 12 (depends on 10)

The package of claim claim 10, wherein the progestin is levonorgestrel and the estrogen is ethinyl estradiol.

### Claim 13 (depends on 1)

The package of claim 1, wherein the transdermal delivery patch comprises a backing layer affixed to an adhesive polymer matrix, wherein the adhesive polymer matrix comprises:
a. an active pharmaceutical ingredient;
b. an adhesive polymer; and
c. (i) a first penetration enhancer selected from the group consisting of a keto acid and a pharmaceutically acceptable salt thereof and a second penetration enhancer selected from the group consisting of long chain monoglycerides and C8-C16 esters of short chain carboxylic acid or
(ii) a first penetration enhancer selected from the group consisting of alkyl sulfoxides and a second penetration enhancer selected from the group consisting of C8-C16 esters of a short chain carboxylic acid, lower alkyl esters of a short chain carboxylic acid, or both.

### Claim 14 (depends on 1)

The package of claim 1, wherein the article side polymer film is an acrylonitrile/methyl acrylate-acrylonitrile/butadiene graft copolymer.

### Claim 15 (depends on 1)

The package of claim 1, wherein the article side polymer film is an amorphous polyethylene terephthalate.

### Claim 16 (depends on 1)

The package of claim 1, wherein the article side polymer film is a thermoplastic fluoropolymer.

### Claim 17 (depends on 1)

The package of claim 1, wherein the article side polymer film is a polypropylene.

### Claim 18

An article of manufacture comprising a transdermal delivery patch that includes contraceptive hormones and (i) at least one skin penetration enhancer that is a keto acid and at least one additional enhancer that is a long chain monoglyceride or a C8-C16 ester of a short chain carboxylic acid, or (ii) at least one skin penetration enhancer that is a sulfoxide; wherein the package comprises a multilayered packaging film having an article side polymer film selected from thermoplastic fluoropolymer, amorphous polyethylene terephthalate, or polyacrylonitrile/methyl acrylate-acrylonitrile/butadiene graft copolymer.

### Claim 19 (depends on 18)

The article of manufacture of claim 18, wherein the contraceptive hormones include a progestin and an estrogen.

### Claim 20 (depends on 19)

The article of manufacture of claim 19, wherein the progestin is levonorgestrel and the estrogen is ethinyl estradiol.