Correlation of dissolution and disintegration results for an immediate-release tablet

被引：27

作者：

Nickerson, Beverly ^{[1
]}

Kong, Angela ^{[2
]}

Gerst, Paul ^{[1
]}

Kao, Shangming ^{[1
]}

机构：

[1] Pfizer Worldwide Res & Dev, Analyt Res & Dev, 558 Eastern Point Rd, Groton, CT 06340 USA

[2] Pfizer Worldwide Res & Dev, Drug Prod Design, 558 Eastern Point Rd, Groton, CT 06340 USA

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2018年 / 150卷

关键词：

Dissolution; Disintegration; Correlation; Immediate-release tablets; SCALE-UP MODEL; DRUG;

D O I：

10.1016/j.jpba.2017.12.017

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

The drug release rate of a rapidly dissolving immediate-release tablet formulation with a highly soluble drug is proposed to be controlled by the disintegration rate of the tablet. Disintegration and dissolution test methods used to evaluate the tablets were shown to discriminate manufacturing process differences and compositionally variant tablets. In addition, a correlation was established between disintegration and dissolution. In accordance with ICH Q6A, this work demonstrates that disintegration in lieu of dissolution is suitable as the drug product quality control method for evaluating this drug product. (C) 2017 Elsevier B.V. All rights reserved.

引用

页码：333 / 340

页数：8

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