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Recent Advances in Dissolution Testing and Their Use to Improve In Vitro–In Vivo Correlations in Oral Drug Formulations
Journal of Pharmaceutical Innovation ( IF 2.7 ) Pub Date : 2021-05-28 , DOI: 10.1007/s12247-021-09565-2
Alok Ranjan , Prateek K. Jha

Bioavailability of oral drug formulations is strongly dependent on the composition of the gastric and intestinal fluids and hydrodynamic conditions in the gastrointestinal tract. These affect the dissolution behavior of oral formulations and their subsequent absorption to the bloodstream. A detailed characterization of all these factors is almost impossible in an in vivo setting, which necessitates the use of in vitro experiments. However, the drug release/drug solubility information in the media representing the gastrointestinal tract obtained in an in vitro study is typically not directly determined in an in vivo experiment. Instead, it is more convenient to determine in vivo the drug concentration in plasma. In vitro–in vivo correlation (IVIVC) typically refers to mathematical relationships between in vitro dissolution behavior and in vivo drug concentration in plasma. IVIVC may be improved by approaches that better mimic in vivo conditions in an in vitro setting. These include mimicking of drug absorption and the composition and hydrodynamics of the release medium. Artificial gastrointestinal (GI) systems are designed to meet this objective. In this review, we discuss our current understanding of the IVIVC and the experimental approaches to improve the IVIVC. Some ex vivo approaches also fall within the scope of this review.



中文翻译:

溶出度测试的最新进展及其用于改善口服药物制剂的体外-体内相关性

口服药物制剂的生物利用度在很大程度上取决于胃液和肠液的组成以及胃肠道中的流体动力学条件。这些会影响口服制剂的溶解行为及其随后的血液吸收。在体内环境中对所有这些因素进行详细表征几乎是不可能的,这需要使用体外实验。然而,在体外研究中获得的代表胃肠道的介质中的药物释放/药物溶解度信息通常不会在体内实验中直接确定。相反,在体内测定血浆中的药物浓度更为方便。体外-体内相关性 (IVIVC) 通常是指体外溶出行为与体内血浆药物浓度之间的数学关系。IVIVC 可以通过在体外环境中更好地模拟体内条件的方法来改进。这些包括模拟药物吸收以及释放介质的组成和流体动力学。人造胃肠 (GI) 系统旨在满足这一目标。在这篇评论中,我们讨论了我们目前对 IVIVC 的理解以及改进 IVIVC 的实验方法。一些体外方法也属于本次审查的范围。人造胃肠 (GI) 系统旨在满足这一目标。在这篇评论中,我们讨论了我们目前对 IVIVC 的理解以及改进 IVIVC 的实验方法。一些体外方法也属于本次审查的范围。人造胃肠 (GI) 系统旨在满足这一目标。在这篇评论中,我们讨论了我们目前对 IVIVC 的理解以及改进 IVIVC 的实验方法。一些体外方法也属于本次审查的范围。

更新日期:2021-05-30
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