New Approach for the Application of USP Apparatus 3 in Dissolution Tests: Case Studies of Three Antihypertensive Immediate-Release Tablets

被引：0
作者：
Brenda Espíndola
Francieli Furlan Bortolon
Juliana Munari Oliveira Pinto
Bianca Ramos Pezzini
Hellen Karine Stulzer
机构：
[1] Universidade Federal de Santa Catarina,Departamento de Ciências Farmacêuticas
来源：
AAPS PharmSciTech | 2018年 / 19卷
关键词：
dissolution testing; immediate-release tablets; USP Apparatus 3; USP Apparatus 1 and 2; antihypertensive drugs;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
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.
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页码：2866 / 2874
页数：8
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