Transdermal packaging membranes
Inventors
Kydonieus, Agis • ARNOLD, C. Gregory • Conway, Robert G. • Rossi, Thomas M.
Assignees
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Publication Number
US-12226534-B2
Publication Date
2025-02-18
Expiration Date
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.
Core Innovation
The described invention relates to a package for storing a transdermal delivery patch that comprises an active pharmaceutical ingredient and at least one skin penetration enhancer. The invention addresses a need to substantially reduce absorption of skin permeation enhancers by the packaging during storage, including long storage periods at room temperature.
The package is configured as a pouch that fully encloses the transdermal delivery patch and comprises a multilayered packaging film. The pouch includes an article side polymer film that forms the innermost layer of the pouch, where the article side polymer film is heat sealable upon itself to effect the full enclosure of the transdermal patch and is selected from a thermoplastic fluoropolymer, amorphous polyethylene terephthalate, or polyacrylonitrile/methyl acrylate-acrylonitrile/butadiene graft copolymer.
The invention further requires that the article side polymer film absorbs less than about 0.5% by weight of the skin penetration enhancer(s) from the patch during a storage period of 6 months or longer at room temperature. The skin penetration enhancer(s) are defined as either a keto acid with an additional enhancer that is a long chain monoglyceride or a C8-C16 ester of a short chain carboxylic acid, or as at least one sulfoxide.
Claims Coverage
The provided independent claims share a common inventive concept: a fully enclosed transdermal patch in a pouch using a specific heat-sealable innermost article-side polymer film with low enhancer absorption over extended room-temperature storage. One independent claim additionally specifies contraceptive hormones.
Fully enclosed pouch with heat-sealable innermost article-side polymer film
A pouch that fully encloses a transdermal delivery patch and comprises a multilayered packaging film having an article side polymer film that forms the innermost layer of the pouch, where the article side polymer film is heat sealable upon itself to effect the full enclosure of the transdermal patch.
Innermost film selected for low enhancer absorption
The article side polymer film is selected from a thermoplastic fluoropolymer, amorphous polyethylene terephthalate, or polyacrylonitrile/methyl acrylate-acrylonitrile/butadiene graft copolymer, and absorbs less than about 0.5% by weight of the skin penetration enhancer(s) from the patch during a storage period of 6 months or longer at room temperature.
Skin penetration enhancer system defined by keto acid plus additional enhancer or sulfoxide
The transdermal delivery patch includes 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 includes at least one skin penetration enhancer that is a sulfoxide.
Contraceptive hormones with low-absorption enhancer pouch packaging
An article of manufacture comprising a transdermal delivery patch that includes contraceptive hormones contained within a package that fully encloses the transdermal delivery patch and comprises a multilayered packaging film with an article side polymer film as the innermost pouch layer, where the article side polymer film is heat sealable upon itself and selected from thermoplastic fluoropolymer, amorphous polyethylene terephthalate, or polyacrylonitrile/methyl acrylate-acrylonitrile/butadiene graft copolymer, and where the article side polymer film absorbs less than about 0.5% by weight of the skin penetration enhancer(s) during a storage period of 6 months or longer at room temperature.
The inventive coverage centers on a fully enclosing pouch for a transdermal patch using a heat-sealable innermost article-side polymer film selected from specified polymer classes, combined with a performance requirement that the innermost film absorbs less than about 0.5% by weight of the skin penetration enhancer(s) over at least 6 months at room temperature. The enhancer system is limited to the defined keto acid plus additional enhancer set or a sulfoxide set, and one independent claim further limits the transdermal patch to contraceptive hormones.
Stated Advantages
Absorbs less than about 0.5% by weight of the skin penetration enhancer(s) from the patch during storage for 6 months or longer at room temperature.
Enables pouch heat sealing via an article side polymer film that is heat sealable upon itself to effect full enclosure of the transdermal patch.
Documented Applications
Storing transdermal delivery patches comprising active pharmaceutical ingredients, including contraceptive hormones.
Contraceptive patch use in which the transdermal delivery patch includes contraceptive hormones.
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