Enteric Hard Capsules for Targeting the Small Intestine: Positive Correlation between In Vitro Disintegration and Dissolution Times

被引：12

作者：

Fu, Maoqi ^{[1
]}

Al-Gousous, Jozef ^{[1
]}

Blechar, Johannes Andreas ^{[1
]}

Langguth, Peter ^{[1
]}

机构：

[1] Johannes Gutenberg Univ Mainz, Dept Biopharmaceut & Pharmaceut Technol, D-55099 Mainz, Germany

来源：

PHARMACEUTICS | 2020年 / 12卷 / 02期

关键词：

disintegration; dissolution; enteric-coated; ICH; quality control; FOSAMPRENAVIR; TABLETS;

D O I：

10.3390/pharmaceutics12020123

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

In this study, the potential for correlation between disintegration and dissolution performance of enteric-coated (EC) dosage forms was investigated. Different enteric hard shell capsule formulations containing caffeine as model drug were tested for disintegration (in a compendial disintegration tester) and for dissolution in both USP type I (basket) and type II (paddle) apparatuses using different media. Overall, good correlations were obtained. This was observed for both the basket and the paddle apparatus, indicating that the use of disintegration testing as a surrogate for dissolution testing (allowed by International Conference on Harmonization (ICH) for immediate release dosage forms in case, in addition to other conditions, a correlation between disintegration and dissolution is proven) could be extended to include delayed release dosage forms.

引用

页数：13

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