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Solid composition for controlled release of ionizable active agents with poor aqueous solubility at low pH and methods of use thereof
Solid composition for controlled release of ionizable active agents with poor aqueous solubility at low pH and methods of use thereof
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机译:在低pH值下水溶性差的可控制释放可电离活性剂的固体组合物及其使用方法
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摘要
A novel solid composition and methods for making and using the solid composition are provided. The solid composition comprises: (a) at least one active agent with a solubility of less than about 0.3 mg/ml in an aqueous solution with a pH of at most about 6.8 at a temperature of about 37C; and (b) a hydrophilic polymer matrix composition comprising: i) a hydrophilic polymer selected from the group consisting of METHOCELTM, POLYOX WSR 1105 and combinations thereof; and optionally ii) a hydrophobic polymer selected from the group consisting of Ethocel 20 premium; and (c) an alkalizer selected from the group consisting of calcium carbonate, magnesium oxide heavy and sodium bicarbonate; wherein the composition provides at least about 70% release of the active between about 7 to about 12 hours following oral administration.
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