Pharmaceutically acceptable solubilizing composition and pharmaceutical dosage form containing same

摘要

A pharmaceutically acceptable solubilizing composition comprising (i) at least one tocopheryl compound having a polyalkylene glycol moiety and (ii) at least one alkylene glycol fatty acid monoester or mixture of alkylene glycol fatty acid mono- and diester is disclosed. The solubilizing composition is useful in the manufacture of a pharmaceutical dosage form which comprises a melt-processed mixture of at least one active ingredient, at least one pharmaceutically acceptable polymer. The active ingredient(s) may be inhibitors of HIV protease. The solubilizing composition enhances the bioavailability of the active ingredient after oral intake.

主权项

1. A pharmaceutical dosage form which comprises a melt-processed mixture of at least one active ingredient that is present as a solid dispersion, at least one pharmaceutically acceptable homopolymer or copolymer of N-vinylpyrrolidone and a solubilizing composition, the solubilizing composition comprising (i) at least one tocopheryi compound having a polyalkylene glycol moiety and (ii) at least one alkylene glycol fatty acid monoester or mixture of alkylene glycol fatty acid mono- and diester,
wherein said dosage form comprises, relative o the weight of the melt-processed mixture, from about 0.5 to 40% by weight of said active ingredient, 40 to 99% by weight of said pharmaceutically acceptable homopolymer or copolymer of N-vinylpyrrolidone, 0.5 to 20% by weight of said solubilizing composition, and 0 to 15% by weight of additives.