Discussion on Capsule Dissolution Method and Influencing Factors

OBJECTIVE To summarize the main concerns of the design of capsule dissolution testing methods, and discuss the influence on capsule dissolution from the aspects of capsule shell, capsule content, packaging materials, etc. METHODS Refer to USP General Chapter <1094> to summarize the design considerations of capsule dissolution testing. The capsule dissolution methods in FDA dissolution database were summarized; combining research papers and practical work, put forward the thinking of dissolution method development. RESULTS Capsule dissolution methods should focus on dissolution media, dissolution apparatus and gelatin cross-linking; the ratio of paddle apparatus in the marketed capsule was higher than that of basket apparatus, and 6.7% of capsule used enzymatic method to break gelatin cross-linking. The quality of the capsule shell, capsule content, packaging might affect the capsule dissolution, causing the failure of acceptance criteria during stability storage. CONCLUSION The capsule dissolution control is first determined by the formulation development and then by testing method. During the development, attention should pay to the key factors such as capsule shell quality, capsule content and packaging that may affect the capsule dissolution. On this basis, the capsule dissolution test method should be designed reasonably to reduce the difference of the dissolution results caused by the test method.