SOLID DOSAGE FORMS WITH HIGH ACTIVE AGENT LOADING

This disclosure concerns oral pharmaceutical compositions comprising a solid dosage form (SDF). The SDF comprises (i) a solid amorphous dispersion (SAD) comprising a poorly water soluble active agentand a matrix material comprising poly[(methyl methacrylate)-co-(methacrylic acid)] (PMMAMA), and (ii)...

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Bibliographic Details
Main Authors MUDIE DEANNA, MORGEN MICHAEL M, SHEPARD KIMBERLY
Format Patent
LanguageChinese
English
Published 22.12.2020
Subjects
HUMAN NECESSITIES
HYGIENE
MEDICAL OR VETERINARY SCIENCE
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
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Summary:This disclosure concerns oral pharmaceutical compositions comprising a solid dosage form (SDF). The SDF comprises (i) a solid amorphous dispersion (SAD) comprising a poorly water soluble active agentand a matrix material comprising poly[(methyl methacrylate)-co-(methacrylic acid)] (PMMAMA), and (ii) a concentration-sustaining polymer (CSP), wherein the CSP is not dispersed in the SAD, and the SADis at least 35 wt% of the SDF. The SAD and CSP together may be at least 50 wt% of the SDF. The SDF may be, for example, a tablet, a caplet, or a capsule. 本公开涉及包含固体剂型(SDF)的口服药物组合物。该SDF包括(i)包含水溶性差的活性剂的固体无定形分散体(SAD)和包含聚[(甲基丙烯酸甲酯)-共-(甲基丙烯酸)](PMMAMA)的基质材料，以及(ii)维持浓度的聚合物(CSP)，其中所述CSP未分散在SAD中，并且SAD为SDF的至少35wt％。SAD和CSP合计可以是SDF的至少50wt％。SDF可以是例如片剂、囊片或胶囊。
Bibliography:Application Number: CN201980032838