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Soft gelatin capsules. I. Factors affecting capsule shell dissolution rate.

Abstract: A method to study the relationship between various factors influencing the dissolution rate of the soft gelatin capsule shell is reported. The gelatin disk method makes use of the current USP rotating-basket dissolution apparatus. The effects of agitation, temperature, dissolution medium, and shell composition on the capsule shell dissolution rate are illustrated and discussed. A knowledge of these factors and their influence on dissolution should be of assistance in the formulation of soft gelatin capsule shells for various purposes.