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

Pharmaceutics

Peter Langguth¹  Maoqi Fu¹  JohannesAndreas Blechar¹  Jozef Al-Gousous¹ 

[1] Department of Biopharmaceutics and Pharmaceutical Technology, Johannes Gutenberg University Mainz, D-55099 Mainz, Germany;

关键词: disintegration;    dissolution;    enteric-coated;    ich;    quality control;   

DOI  :  10.3390/pharmaceutics12020123

来源: DOAJ

【 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.

【 授权许可】

Unknown