渐进式水化技术口腔缓释片的研制、评价与优化

Amit Gupta, R. Gaud, S. Ganga
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引用次数: 8

摘要

采用渐进式水化技术,研制了尼索地平缓释片。技术涉及不同量的卡波醇972P (CP)、羟丙甲糖K15M (HPMC)和多酚(PC)。采用32全因子设计设计实验,探讨CP和HPMC对烟叶黏附强度(BAS)和药物释放的影响。两种聚合物对溶胀指数、BAS和药物释放均有显著性影响(p < 0.05)。利用二次项建立了描述扭曲响应平面的二阶线性模型,以说明聚合物的作用。还考虑了三个检查点来验证多项式方程。结果表明,聚合物极大地改变了药物的释放机制,并通过模型拟合得到了证实。通过优化聚合物配比定制配方,F10批在第6小时获得了理想的释放度(90%),获得了良好的BAS。关键词:Buccoadhesive;Nisoldipine;的阶乘设计;多项式方程
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development, evaluation and optimization of extended release buccal tablets prepared using progressive hydration technology
Extended release Buccoadhesive buccal tablet for delivery of Nisoldipine were developed using Progressive hydration technology. Technology involves Carbopol 972P (CP), Hypromellose K15M (HPMC) and Polycarbophil (PC) in different amounts. Experiments were designed based on 32 full factorial design to explore effects of CP and HPMC on buccoadhesive strength (BAS) and drug release. Both polymers were found to have effect on swelling index, BAS and drug release which was confirmed by level of significance (p < 0.05). Using quadratic terms a linear second order model that describes a twisted plane of responses were also drawn for elucidation of effect of polymers. Three check points were also taken into account to validate the polynomial equation. Results show that polymers drastically change the drug release mechanism which was confirmed by model fitting into dissolution profile. By customizing the formulation by optimizing the ratio of polymers, desired release (90%) was obtained in the sixth hour and good BAS were obtained for batch F10. Keywords: Buccoadhesive; Nisoldipine; Factorial design; Polynomial equation
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