MULTIPARTICLE PHARMACEUTICAL DOSAGE FORM FOR A LOW-SOLUBLE ACTIVE SUBSTANCES AND METHOD FOR PRODUCING SAID PHARMACEUTICAL DOSAGE FORM.

摘要

The invention relates to an oral multiparticle pharmaceutical dosage form in the form of a receptacle reducing the pH values of stomach, containing a plurality of pellets, particles, granules or agglomerates whose mean diameter ranges from 50 to 2500 n substantially consisting of a) an internal matrix layer containing an active agent which is neither peptide or protein, nor the derivatives or conjugates thereof, a lipophilic matrix whose melting point is greater than 37 C and a polymer with mucoadhesive effect, b) an external film coating substantially consisting of a polymer or an anionic copolymer which is optionally formulated with conventional pharmaceutical additives, wherein the active agent has a water solubility according to DAB 10, of at least 30 volume parts of water for one part by weight of the active agent and is coated with the lipophilic matrix and said active agent-containing lipophilic matrix is coated with a matrix made of a polymer with mucoadhesive effect. A me thod for producing the inventive multiparticle pharmaceutical dosage is also disclosed.