发明名称 Stabilization of solid thyroid drug formulations
摘要 A stable drug dosage form prepared by compression techniques comprising: a thyroid hormone susceptible to moisture induced degradation, and particles of at least one pharmaceutically acceptable excipient, each particle having an exterior surface, an interior, equilibrium moisture disposed within the interior of the particles, the thyroid hormone being in contact with the exterior surface of the particles of the dosage form prepared by: admixing the thyroid hormone and the at least on excipient; and compacting the thyroid hormone and the excipient into unit dosage forms using compression pressures of less than about 5000 psi/g; wherein the compression pressure limits the amount of equilibrium moisture available to react with the thyroid hormone at the exterior surface of the particles of at least one pharmaceutically acceptable excipient; and the drug dosage form exhibits improved stability to moisture-induced degradation of the hormone as compared with a tabletted form of the hormone.
申请公布号 NZ524567(A) 申请公布日期 2004.12.24
申请号 NZ20010524567 申请日期 2001.09.26
申请人 SIGMAPHARM, INC 发明人 SPIREAS, SPIRIDON
分类号 A61K9/20;A61K9/48;A61K31/198;(IPC1-7):A61K9/00 主分类号 A61K9/20
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