Transdermal therapeutic system for the transdermal administration of solifenacin
Inventors
Wauer, Gabriel • Seibertz, Frank
Assignees
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Publication Number
US-12121616-B2
Publication Date
2024-10-22
Expiration Date
Abstract
The present invention relates to transdermal therapeutic systems (TTS) for the transdermal administration of solifenacin.
Core Innovation
The invention relates to a transdermal therapeutic system for the transdermal administration of solifenacin that comprises a solifenacin-containing layer structure including a backing layer and a solifenacin-containing layer or solifenacin-containing matrix layer having a therapeutically effective amount of solifenacin base. The solifenacin-containing layer structure comprises at least one polymer selected from polysiloxane-based polymers, silicone acrylic hybrid polymers, polyisobutylene-based polymers, and acrylate polymers.
The system is defined by the absence of a transdermal permeation enhancer selected from a fatty acid ester, a terpene, and a carboxylic acid having 2 to 10 carbon atoms. This exclusion is part of the defined layer structure and polymer selection, and the combination is used to achieve the required solifenacin base release over 72 hours.
In disclosed examples, solifenacin base is formulated in solifenacin-containing coating compositions and applied as coated layers on a release liner and/or as part of the solifenacin-containing layer structure, which can then be laminated to a backing layer.
Claims Coverage
The patent provides three independent claims. Across these claims, the coverage centers on a solifenacin-containing layer structure with specified polymer classes, the exclusion of certain permeation enhancers, and a quantified release requirement over 72 hours.
Solifenacin-containing layer structure with backing layer
A transdermal therapeutic system for transdermal administration of solifenacin comprising a solifenacin-containing layer structure including a backing layer and a solifenacin-containing layer or solifenacin-containing matrix layer.
Specific polymer selection for the solifenacin-containing layer
The solifenacin-containing layer or matrix layer comprises at least one polymer selected from polymer based on polysiloxanes, a silicone acrylic hybrid polymer, a polymer based on polyisobutylenes, and an acrylate polymer.
Exclusion of fatty acid ester, terpene, and C2-C10 carboxylic acid permeation enhancers
The transdermal therapeutic system does not contain a transdermal permeation enhancer selected from fatty acid ester, terpene, and a carboxylic acid having 2 to 10 carbon atoms.
Enhanced solifenacin base release over 72 hours
The transdermal therapeutic system releases more than 25% of the solifenacin base contained in the transdermal therapeutic system over a period of administration of 72 hours.
Taken together, the independent claims require a solifenacin-containing layer structure with a backing layer, a polymer system selected from the specified polymer classes, the explicit exclusion of fatty acid ester, terpene, and C2-C10 carboxylic acid permeation enhancers, and a defined performance requirement of releasing more than 25% of the solifenacin base over 72 hours.
Stated Advantages
Releases more than 25% of the solifenacin base over 72 hours.
Documented Applications
Not explicitly described in patent.
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