Loading patent…
AssigneeElf Sanofi
InventorHenri Desmolin
Estimating the term…
The microbeads are composed of a core containing the active ingredient and a microporous membrane, insoluble in aqueous medium, consisting of a film-forming polymer, a plasticizer and a filling material. The membrane has a thickness such that diltiazem is released in vitro at an approximately constant rate for at least 6 hours after a latent period of less than one hour. The active ingredient can be intimately mixed with the core or included in a polyvinyl pyrrolidone layer coating an inert grain. The sustained-release microbeads are formed by application to the core of a dispersion of the constituents of the membrane in a solvent and evaporation of the solvent. The pharmaceutical compositions consist of capsules containing the microbeads. They are administered orally one or twice per day, depending on the dose, for the treatment of angina or hypertension.
Sustained-release diltiazem microbeads each of which comprises (a) a core including an inert grain substrate coated with a layer of the active ingredient combined with a binder surrounded by (b) a microporous membrane consisting essentially of a film-forming polymer insoluble in aqueous medium, a plasticizing agent, representing from 10 to 30% by weight of said film-forming agent, and a filling material representing 35 to 75% by weight of said membrane, wherein, as determined in vitro at a pH of between 1.5 and 7, a diltiazem release rate of approximately 10% per hour for at least 6 hours is attained after a latent period of less than one hour.
Dependencies are inferred from the claim text.