Laboratory of Pharmaceutical Technology and Biopharmaceutics, Institute of Pharmacy, University of Bonn, Bonn, Germany.
Drug Dev Ind Pharm. 2011 Feb;37(2):178-84. doi: 10.3109/03639045.2010.502534. Epub 2010 Aug 12.
BACKGROUND: Recently the use of colloidal carriers as drug delivery systems is gaining more attention. Evaluation of the in vitro drug release is considered an important step during the development and quality control of such systems. Therefore, there is a need for a standard test technique to study in vitro drug release from colloidal systems. METHODS: The glass basket dialysis method was performed by a modification to the USP dissolution apparatus I by replacing the baskets with glass cylinders closed at the lower end by dialysis membrane. This method was characterized for the essential test parameters and compared to the dialysis bags technique using different types of colloidal drug carriers, namely liposomes, polymeric, and lipid nanoparticles. RESULTS: The method proved to be more discriminating than the conventional dialysis bag method and allowed for better comparison between different formulation parameters or experimental conditions. In general, the design is easy to perform, simple, and available in all pharmaceutical laboratories under the same setup. CONCLUSION: The described method is a step toward standardized dissolution tests on colloidal drug delivery systems and the possible comparability of results.
背景:最近,胶体载体作为药物传递系统的应用越来越受到关注。评估体外药物释放被认为是开发和质量控制此类系统的重要步骤。因此,需要一种标准的测试技术来研究胶体系统的体外药物释放。
方法:通过对 USP 溶解仪 I 的修改,采用玻璃篮透析法,用玻璃圆柱体代替篮,并在其下端用透析膜封闭。该方法对基本测试参数进行了表征,并与使用不同类型胶体药物载体(即脂质体、聚合物和脂质纳米粒)的透析袋技术进行了比较。
结果:该方法被证明比常规透析袋方法更具鉴别力,并允许更好地比较不同制剂参数或实验条件。一般来说,该设计易于操作,简单,并且在相同的设置下,所有制药实验室都可以使用。
结论:所描述的方法是朝着胶体药物传递系统标准化溶解试验和可能的结果可比性迈出的一步。
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