Research Strategy of Dissolution Test of Soft Capsules

Abstract

OBJECTIVE: To provide references for effective quality control of soft capsules and discuss the applicability of method for dissolution test of soft capsules. METHODS: Based on analyzing dissolution requirements of soft capsules, we were compared the differences of methods for dissolution test in the pharmacopoeias of several countries with current correlative research from home and abord. RESULTS: The dissolution characteristics of soft capsules are more complex than common oral solid dosage forms, and the requirments are different in the pharmacopoeias of several countries. The formula of contents, hydrophilicity, rupture test and crossliking have impacts on the dissolution characteristics as well as dissolution device and so on. CONCLUSION: In order to develop the method for dissolution test of soft capsules, the dissolution device and medium, rupture test and in vitro-in vivo correlation etc. should be studied.