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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共 92 条
[1]  
Mwila C(2016)Development and assessment of a USP Apparatus 3 dissolution test method for sustained-release nevirapine matrix tablets Dissolut Technol 23 22-30
[2]  
Khamanga S(2007)In vitro–in vivo correlation: importance of dissolution in IVIVC Dissolut Technol 14 15-19
[3]  
Walker R(2001)Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract Adv Drug Deliv Rev 46 75-87
[4]  
Cardot J-M(2016)A brief review of the FDA dissolution methods database Dissolut Technol 23 6-10
[5]  
Beyssac E(1997)New and extended applications for USP drug release apparatus 3 Dissolut Technol 4 11-18
[6]  
Alric M(2015)Applications of USP apparatus 3 in assessing the in vitro release of solid oral dosage forms Braz J Pharm Sci 51 265-272
[7]  
Hörter D(2002)Evaluation of USP apparatus 3 for dissolution testing of immediate-release products AAPS PharmSci 4 1):1-1):5
[8]  
Dressman J(2009)2009 trends in small-volume dissolution apparatus for low-dose compounds Dissolut Technol 16 19-22
[9]  
Shohin IE(2002)In vitro evaluation of dissolution behavior for a colon-specific drug delivery system (CODES) in multi-pH media using United States Pharmacopeia apparatus II and III AAPS PharmSciTech 3 E33-E22
[10]  
Grebenkin DY(2002)Drug release characteristics of different mesalazine products using USP apparatus 3 to simulate passage through the GI tract Dissolut Technol 9 6-12
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