Preparation of micronized nimodipine push-pull osmotic pump tablets
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摘要: 目的 制备尼莫地平微粉化物双层渗透泵控释片。 方法 以尼莫地平为模型药物,将微粉化增溶技术应用于控释双层渗透泵剂型中,设计并制备体外控释12 h的尼莫地平双层渗透泵片,采用相似因子法(f2)对不同处方释药行为的相似性进行评价,并对处方进行优化。 结果 成功制备了尼莫地平微粉化物双层渗透泵控释片,零级释放特征明显,符合渗透泵的释药机制。 结论 将微粉化增溶技术与控释双层渗透泵技术相结合,显著提高了难溶性药物尼莫地平的体外释放,成功制备了控释制剂。Abstract: Objective To prepare micronized nimodipine push-pull osmotic pump (PPOP) controlled release tablets. Methods The nimodipine as a model drug, micronization technique was applied to the PPOP method. Designed and prepared the controlled release of the nimodipine tablet for 12 hours in vitro. The factor f2 was used to evaluate the similarities of different dissolution profiles, and the optimal formulation was performed. Results The micronized nimodipine PPOP controlled release tablets were successfully prepared with excellent zero-order release characteristics. The PPOP tablet's release behavior was close to the zero-order release equation (r=0.998 4). Conclusions The controlled-release formulation was prepared successfully. Micronized technique combined with the PPOP method significantly increased the release of the nimodipine tablet, the poorly soluble drug, in vitro.
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Key words:
- nimodipine /
- micronization /
- push-pull osmotic pump tablets /
- release /
- factor f2
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