固体分散体配方新方法的研究——第一部分:配方、表征和选择

Rakesh Sharma, A. Middha
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引用次数: 0

摘要

采用冻干法制备了吲哚美辛亲水性聚合物固体分散体。研究中使用的聚合物有HPMC、PVP K30、CBR和PLF 127。研究了制备的冻干固体分散体在0.1盐酸、纯净水和USP-NF溶出介质中的溶解度和溶出度。从F1到F15的15个冻干制剂中,F2、F5、F8、F12和F14 5个制剂在纯净水中的溶解度最高。处方F2、F8不符合吲哚美辛胶囊的USP-NF溶出度试验。F14在溶出介质中溶出时间为60min, F2和F8在USP-NF介质中缓释时间为6h。采用调制DSC和FT-IR对配方F2、F5、F8、F12和F14进行了表征。稳定性试验表明,某些配方在加速温度条件下是物理化学稳定的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Investigations on noval method for the formulation of solid dispersions part- I Formulation, characterization and selection
The solid dispersions of indomethacin with hydrophilic polymers were prepared by lyophilization. The polymers used in the investigation were HPMC, PVP K30, CBR and PLF 127. The solubility and dissolution of indomethacin from prepared lyophilized solid dispersions were investigated in 0.1 N HCl, purified water and USP-NF dissolution media.  Out of fifteen lyophilized formulations from F1 to F15, five formulations F2, F5, F8, F12 and F14 showed highest solubility in purified water. Formulation F2, F8 failed to comply with the USP-NF dissolution test for indomethacin capsules. Formulation F14 showed maximum dissolution in the respective dissolution media within 60 min.  Sustained drug release was observed for 6 h with formulations F2 and F8 in USP-NF media. The formulations F2, F5, F8, F12 and F14 were characterized by modulated DSC and FT-IR spectroscopy. Some Formulations on stability testing were found physico-chemically stable at accelerated temperature conditions.
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