Standardized in vitro drug release test for colloidal drug carriers using modified USP dissolution apparatus I
Standardized in vitro drug release test for colloidal drug carriers using modified USP dissolution apparatus I
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DOI：
10.3109/03639045.2010.502534
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发表时间：
2011-02-01
影响因子：
3.4
通讯作者：
Lamprecht, Alf
中科院分区：
文献类型：
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作者：
Abdel-Mottaleb, Mona M. A.;Lamprecht, Alf
背景：近年来，使用胶体载体作为药物递送系统越来越受到关注。体外药物释放的评估被认为是此类系统的开发和质量控制过程中的重要步骤。因此，需要一种标准测试技术来研究胶体系统的体外药物释放。方法：玻璃篮透析法是对USP溶出度仪I进行改造，将篮子替换为下端由透析膜封闭的玻璃圆筒。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、聚合物和脂质纳米颗粒）的透析袋技术进行了比较。结果：事实证明，该方法比传统的透析袋方法更具辨别力，并且可以更好地比较不同的配方参数或实验条件。一般来说，该设计易于执行、简单，并且可在相同设置下的所有制药实验室中使用。结论：所描述的方法是朝着胶体药物递送系统标准化溶出测试和结果可能的可比性迈出的一步。
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.