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首页> 外文期刊>BioMed research international >Development of In Vitro-In Vivo Correlation/Relationship Modeling Approaches for Immediate Release Formulations Using Compartmental Dynamic Dissolution Data from 'Golem': A Novel Apparatus
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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“GoLEM”的间隔动态溶出数据的立即释放配方的体外体内相关/关系建模方法的发展:一种新颖的装置

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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 IVTVC/IVTVR 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:使用新型动态溶出装置,模拟胃和小肠代表两种立即释放制剂设计的不同批次的阿托伐他汀。 采用通用溶解方法,其模拟人胃肠道的生理学,包括精确的木豆交通行为和生物轮辋条件。 多组分溶出数据允许直接观察和定性辨别由测试批次的高pH依赖性溶解行为产生的差异。 使用IVTVC / IVTVR发育进行结果进一步评价。 虽然使用基于常规的解构模型无法实现令人满意的相关性,但是通过使用非传统方法利用复杂隔间溶解数据来获得有希望的结果。

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