首页> 美国卫生研究院文献>other >Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from Golem: A Novel Apparatus
【2h】

Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from Golem: A Novel Apparatus

机译:使用魔像的隔室动态溶出数据开发即时释放制剂的体外-体内相关/关系建模方法:一种新型仪器

代理获取
本网站仅为用户提供外文OA文献查询和代理获取服务,本网站没有原文。下单后我们将采用程序或人工为您竭诚获取高质量的原文,但由于OA文献来源多样且变更频繁,仍可能出现获取不到、文献不完整或与标题不符等情况,如果获取不到我们将提供退款服务。请知悉。

摘要

Different batches of atorvastatin, represented by two immediate release formulation designs, were studied using a novel dynamic dissolution apparatus, simulating stomach and small intestine. A universal dissolution method was employed which simulated the physiology of human gastrointestinal tract, including the precise chyme transit behavior and biorelevant conditions. The multicompartmental dissolution data allowed direct observation and qualitative discrimination of the differences resulting from highly pH dependent dissolution behavior of the tested batches. Further evaluation of results was performed using IVIVC/IVIVR development. While satisfactory correlation could not be achieved using a conventional deconvolution based-model, promising results were obtained through the use of a nonconventional approach exploiting the complex compartmental dissolution data.
机译:使用新型动态溶出仪(模拟胃和小肠)研究了以两种即释制剂设计为代表的不同批次的阿托伐他汀。一种通用的溶出方法被用来模拟人胃肠道的生理,包括精确的食糜转运行为和生物相关条件。多隔室的溶出度数据可以直接观察和定性区分由测试批次的高度pH依赖性溶出行为所导致的差异。使用IVIVC / IVIVR开发进行结果的进一步评估。尽管使用传统的基于卷积的模型无法获得令人满意的相关性,但通过使用利用非常规方法利用复杂的部分溶出度数据获得了可喜的结果。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
代理获取

客服邮箱:kefu@zhangqiaokeyan.com

京公网安备:11010802029741号 ICP备案号:京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有
  • 客服微信

  • 服务号