Considerations for the development of in vitro dissolution tests to reduce or replace preclinical oral absorption studies

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• 作者：Elise Grignard^a ; Robert Taylor^b ; Mark McAllister^c ; Karl Box^b ; Nikoletta Fotaki^a ; ^{n.fotaki@bath.ac.uk}
• 关键词：Animal ; Gastrointestinal physiology ; Biorelevant media ; In vitro ; Dissolution testing
• 刊名：European Journal of Pharmaceutical Sciences
• 出版年：2017
• 出版时间：1 March 2017
• 年：2017
• 卷：99
• 期：Complete
• 页码：193-201
• 全文大小：376 K
• 卷排序：99

文摘

The pharmaceutical development of new chemical entities can be hampered by their solubility and/or dissolution limitations. Currently, these properties are characterised mostly during in vivo pre-clinical studies. The development of appropriate in vitro methods to study the solubility and dissolution properties in preclinical species would lead to a significant reduction or replacement of the animal experiments at this stage of development. During clinical development, media simulating the human gastrointestinal tract fluids are commonly used and a similar approach mimicking laboratory animals' gastrointestinal tract fluids would impact on the preclinical stage of development. This review summarises the current knowledge regarding the gastrointestinal physiology of the most common laboratory animals, and animal simulated gastric and intestinal media are proposed.