Research Formulation, Pfizer PGRD, Sandwich, Kent, CT13 9NJ, UK.
Mol Pharm. 2010 Oct 4;7(5):1374-87. doi: 10.1021/mp1001203. Epub 2010 Aug 10.
The use of compendial dissolution techniques to characterize the performance of oral drug delivery systems is an established area of pharmaceutical science. However, compendial equipment is recognized as being limited in its ability to replicate the dynamic aspects of in vivo dissolution that are associated with dosage form transit through a rapidly changing and complex gastrointestinal lumenal environment. This review provides an overview of noncompendial dissolution models which have been developed to address the deficiencies of the traditional dissolution bath and provide scientists with a way of assessing product performance under physiologically relevant conditions.
采用药典溶出技术来表征口服药物传递系统的性能是药物科学的一个既定领域。然而，药典设备被认为在复制与剂型通过快速变化和复杂的胃肠道腔环境的传递相关的体内溶出的动态方面的能力有限。本综述提供了对非药典溶出模型的概述，这些模型已经被开发出来以解决传统溶出槽的缺陷，并为科学家提供了一种在生理相关条件下评估产品性能的方法。
