Dermal delivery compositions and methods

摘要

A composition for transdermal delivery of a progestin for progestin hormone therapy is disclosed. Also disclosed is a transdermal delivery device comprising the composition. For progestin-only hormone therapy, the composition contains an anti-oxidant and does not contain an estrogen. For therapy involving a progestin and an estrogen, the composition contains the progestin, the estrogen and an additional anti-oxidant. Methods of improving the stability of progestin-containing compositions comprising oxidative agents are also disclosed. The methods comprise including one or more anti-oxidants in the compositions.

主权项

1. An adhesive polymer matrix composition for transdermal delivery of levonorgestrel, wherein the matrix comprises:
a) a polymeric pressure sensitive adhesive (PSA) b) levonorgestrel, c) a skin permeation enhancer comprising an organic solvent, d) polyvinyl pyrrolidone (PVP) or a PVP copolymer, and e) an anti-oxidant wherein
(i) the anti-oxidant protects against oxidative degradation of the levonorgestrel by the organic solvent or the PVP or PVP copolymer;(ii) the composition lacks and estrogen; and(iii) the stability of the composition is improved over the stability of such composition lacking and anti-oxidant.