Process for the production of oral slow-release forms of alpha-(2,5-dimethoxyphenyl)-beta-glycinamidoethanol

Abstract

Abstract Process for the production of oral pharmaceutical forms of alpha-(2,5-dimethoxyphenyl)-beta-glycinamidoethanol (midodrine) in the form of solid pharmaceutical articles produced by compression, consisting of the active ingredient, of a poly-D(-)-3-hydroxybutyric acid obtained by microbial fermentation, and, where appropriate, excipients and additives customary in pharmaceutical technology. The process consists of the active ingredient alpha-(2,5-dimethoxyphenyl)-beta-glycinamidoethanol in the form of the hydrochloride (midodrine hydrochloride) and poly-D(-)-3-hydroxybutyric acid with a molecular weight of at least 50 000, which has been obtained from the fermentation product by grinding and sieve analysis in a selected particle size fraction in the range from 0.05 to 0.6 mm, being mechanically mixed in the ratio of from 1:1 to 1:15 by weight, homogenized and, where appropriate with the addition of excipients and additives customary in pharmaceutical technology, compressed to pharmaceutical articles under a pressure of from 9.81 to 981 N/mm<2>.

Inventors

• 👤 Werner Dr Korsatko
• 👤 Brigitta Mag Korsatko-Wabnegg

Bibliographic Details