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MULTIPARTICLE PHARMACEUTICAL DOSAGE FORM FOR LOW-SOLUBLE ACTIVE SUBSTANCES AND METHOD FOR PRODUCING SAID PHARMACEUTICAL DOSAGE FORM
MULTIPARTICLE PHARMACEUTICAL DOSAGE FORM FOR LOW-SOLUBLE ACTIVE SUBSTANCES AND METHOD FOR PRODUCING SAID PHARMACEUTICAL DOSAGE FORM
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机译:低溶解度活性物质的多颗粒药物剂型和制备所述药物剂型的方法
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摘要
The present invention provides a composition comprising: a) active ingredients other than peptides or proteins and derivatives or combinations thereof; Lipophilic matrix having a melting point of at least 37 ° C; And an inner matrix layer comprising a mucoadhesive polymer, b) a film-applied outer coating consisting essentially of an anionic polymer or copolymer, which may optionally be formulated with pharmaceutically customary excipients, wherein the active ingredient is 1 30 parts by volume or more of water for dissolving the active ingredient has a water-solubility as defined in DAB 10, is put in a lipophilic matrix, and the lipophilic matrix with the active ingredient is again made of a mucoadhesive polymer. It is directed to an oral multiparticulate dosage form in the form of a case, characterized in that it is put in a matrix and disintegrates in the pH range of the stomach and contains a number of pellets, particles, granules or aggregates with an average diameter of 50 to 2500 μm. Also disclosed are methods of making the multiparticulate pharmaceutical forms of the invention.;Lipophilic matrix, mucoadhesive polymer, water-solubility, active ingredient
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