Departamento de Ciências Farmacêuticas, Universidade Federal de Santa Catarina, Campus Reitor João David Ferreira Lima, Trindade, Florianópolis, Santa Catarina, 88040-970, Brazil.
AAPS PharmSciTech. 2018 Oct;19(7):2866-2874. doi: 10.1208/s12249-018-1086-0. Epub 2018 Jun 22.
The USP Apparatus 3 is a compendial dissolution Apparatus that has been mainly used to assess the performance of modified-release drug products. However, this Apparatus can be applied to dissolution testing of immediate-release tablets as well, with several advantages such as lower consumption of dissolution media, reduced setup time in quality control routine, and minimized hydrodynamic issues. In this work, three immediate-release (IR) tablets containing antihypertensive drugs of different Biopharmaceutic Classification System (BCS) classes were evaluated in order to assess the possible interchangeability between the official dissolution method using typical USP Apparatus 1 or 2 and the proposed methods using USP Apparatus 3. Depending on the selection of the appropriate operational conditions, such as dip rate and sieve mesh size, it was observed that USP Apparatus 3 could provide similar dissolution profiles compared to USP Apparatus 1 or 2 to the drug products tested. In addition, USP Apparatus 3 avoided conning issues related to USP Apparatus 2. The successful application of USP Apparatus 3 in dissolution tests for IR drug products depends on the definition of specific test conditions for each product, considering all the equipment variables, as well as drug and formulation characteristics.
USP 装置 3 是一种已广泛用于评估控释药物制剂性能的溶出度仪，但也可应用于即释片剂的溶出度试验，具有以下优势，如消耗更少的溶出介质、减少质量控制常规的设置时间以及最小化流体动力学问题。在这项工作中，评估了三种含有不同生物药剂学分类系统 (BCS) 级别的降压药物的即释片剂，以评估使用典型 USP 装置 1 或 2 的官方溶出度方法和使用 USP 装置 3 的建议方法之间的可能可互换性。根据适当操作条件的选择，如浸渍速率和筛网尺寸，可以观察到 USP 装置 3 可以为所测试的药物提供与 USP 装置 1 或 2 相似的溶出度曲线。此外，USP 装置 3 避免了与 USP 装置 2 相关的“conning”问题。USP 装置 3 在即释药物制剂溶出度试验中的成功应用取决于为每个产品定义特定的测试条件，考虑到所有设备变量以及药物和制剂特性。
