Klein S
Department of Pharmacy, Ernst Moritz Arndt University, Greifswald, Germany.
Pharmazie. 2013 Jul;68(7):565-71.
In the past decades, the vertical diffusion cell has emerged as a useful device for testing drug release of topical dosage forms. However, to date neither a general USP method nor formulation-related monographs have been published in international pharmacopoeia. The purpose of the present work was to examine the influence of different test parameters in a vertical diffusion cell setup on in vitro drug release from semi-solid preparations for cutaneous application. Diclofenac was selected as the model compound. Release experiments were performed in a 7 ml Microett vertical diffusion cell system. Various test parameters, including the media composition and pH, degassing, membrane material and pore size, stirring speed and stirrer type, were varied. Results obtained with different test parameter settings clearly indicate that both drug properties and instrumental details can have a huge impact on the outcome of in vitro diffusion/drug release studies with the vertical diffusion cell. Thus, the selection of adequate test parameters is crucial for the success of the release experiments and, as shown in the present study, optimal test parameters/conditions need to be established and validated on a case by case study.
在过去几十年中，垂直扩散池已成为一种用于测试局部剂型药物释放的有用装置。然而，迄今为止，国际药典中尚未发布通用的美国药典方法或与制剂相关的专论。本研究的目的是考察垂直扩散池装置中不同测试参数对用于皮肤给药的半固体制剂体外药物释放的影响。选择双氯芬酸作为模型化合物。在7毫升Microett垂直扩散池系统中进行释放实验。改变了各种测试参数，包括介质组成和pH值、脱气、膜材料和孔径、搅拌速度和搅拌器类型。不同测试参数设置所获得的结果清楚地表明，药物性质和仪器细节都可能对垂直扩散池体外扩散/药物释放研究的结果产生巨大影响。因此，选择合适的测试参数对于释放实验的成功至关重要，并且如本研究所示，需要根据具体情况建立并验证最佳测试参数/条件。
