ITRACONAZOLE-CONTAINING SOLID DISPERSION AND PROCESS FOR THE PREPARATION THEREOF

摘要

An itraconazole-containing solid dispersion is provided to improve dissolution rate, prevent gelation and prepare high amount of itraconazole-containing formulation by modifying the surface of itraconazole-containing solid dispersion with a specific disintegrant. An itraconazole-containing solid dispersion contains 100 parts by weight of itraconazole, 50-150 parts by weight of hydrophilic polymer, 20-50 parts by weight of acidifying agent and is coated by 30-60 parts by weight of disintegrant selected from sodium starch glycolate, carboxy methyl cellulose calcium, cross-linked carboxy methyl cellulose, cross-linked polyvinyl pyrrolidone and crosscamelose sodium. A pharmaceutical composition contains the itraconazole-containing solid dispersion and pharmaceutically acceptable carriers. Further, a form of the pharmaceutical composition is tablets.