Transdermal therapeutic system comprising buprenorphine
AssigneeHexal AG
InventorsJens Fleschhut, Susanne Feinaeugle, Karin Lauer
Life of this patent
Estimating the term…
Abstract
The invention is concerned with a transdermal therapeutic system (TTS) comprising buprenorphine and a method of manufacturing such a TTS. The transdermal therapeutic system is used for the transdermal administration of buprenorphine and analogues thereof. In particular, the invention relates to the use of a transdermal therapeutic system (TTS) for analgesic purposes. The TTS according to the invention comprises a transdermal drug delivery composition comprising buprenorphine and an adhesive component, which is a mixture of a crosslinked and a non-crosslinked acrylic polymer and a penetration enhancer comprising a keto acid.
Claims7
A transdermal therapeutic system comprising:
- 1) a backing layer,
- 2) at least one drug containing adhesive layer containing a transdermal drug delivery composition consisting of:
- i. 5 to 15% by weight of buprenorphine, based on the total weight of the composition,
- ii. an adhesive component, which preferably forms an amorphous mass, comprising 20 to 50% by weight of a crosslinked acrylic polymer and 5 to 25% by weight of a non-crosslinked acrylic polymer, based on the total weight of the composition, in a ratio of 80 to 20 parts by weight to 60 to 40 parts by weight,
- iii. and 5 to 15% by weight of levulinic acid, based on the total weight of the composition,
- iv. 10 to 20% by weight of oleyl oleate, based on the total weight of the composition, and
- v. 5 to 15% by weight of polyvinyl pyrrolidone, based on the total weight of the composition;
- and
- 3) optionally at least one further adhesive layer, and
- 4) further optionally, a release liner,
- wherein the crosslinked acrylic polymer is obtained from one or more non-functional monomers and one or more functional monomers, the functional monomer comprising a carboxy group, an epoxy group and/or a hydroxy group,
- wherein the transdermal therapeutic system releases buprenorphine in an amount sufficient to achieve a constant blood plasma of at least 200 pg/ml for up to 4 days.
Dependencies are inferred from the claim text.