Weight Variation of Test Components of Multiple Digestive Enzyme Capsules and Relationship between Their Weight and Activity

Pharmaceutical properties of 4 kinds (A to D) of multiple digestive enzyme capsules were investigated. Weight variations of the capsules as a whole and those of gastricsoluble and enteric-soluble parts of each capsule were determined. Coefficient of variation (CV) of capsule was less than 2 % for all capsules. However, CV's of gastric-soluble part and that of enteric-soluble one for each capsule were larger than that of the whole capsule (range 2-8%); coefficients of variation of both parts of sample A were less than 4% and those of sample D were 7-8%. For 3 samples except sample A, reciprocal correlation was observed between weights of gastric-soluble part and of enteric-soluble one. Further, relationship between weight of enteric-soluble part and the activity of alkaline protease was good in any capsule, with the favorable correlation coefficient 0.9. From these results, it is suggested that weight variation should be reduced not only of whole capsule but of respective contents.