Transdermal Therapeutic System for Extended Dosing of Pramipexole in Treating Neurological Disorders

摘要

This disclosure relates to a transdermal therapeutic system (TTS) containing pramipexole or related compounds and methods of making the system as well as its use in administering such compounds as a single dose over an extended period, for example, one week. The system comprises an acrylic-based or silicone-based matrix layer containing pramipexole at concentrations of at least about 5 wt. % of the matrix, which is resistant to crystallizing and discoloration of the active ingredient even when stored over long periods.

主权项

1. A transdermal therapeutic system (TTS) for the administration of one or more active ingredients selected from the group consisting of pramipexole, pharmaceutically acceptable pramipexole salts, and pharmaceutically acceptable pramipexole derivatives, the system comprising:
(i) a substantially active-ingredient-impermeable backing layer, (ii) at least one matrix layer which contains at least about 5% w/w active ingredient(s), and (iii) a substantially impermeable protective release liner layer which releasably contacts the matrix layer or another adhesive layer; wherein 1) the matrix layer comprises an adhesive selected from acrylate-based adhesive and silicone-based adhesive, 2) the transdermal therapeutic system provides a therapeutically effective administration of the active ingredient(s), at a flux rate ranging from about 1 μg/cm2/hr to about 13 μg/cm2/hr for at least 48 hours after treatment is initiated, and 3) the matrix layer is color-stable and lacks crystal growth of the active ingredient, over an extended storage period of at least one of 30 or more days, 90 or more days, and 180 or more days.