The standard for enteric-coated gelatin empty capsules (taking the April 2019 appendix version as an example) clarifies the product's definition, properties, identification methods, inspection items (such as friability, disintegration time, and loss on drying), category, and storage conditions. The drafting unit was the Zhejiang Provincial Institute for Food and Drug Control, and the review units were the Institute for Food and Drug Control, China Pharmaceutical University, and the National Institutes for Food and Drug Control. Participating units included the China Pharmaceutical Packaging Association and several manufacturing companies.
Enteric-coated gelatin empty capsules, as a pharmaceutical excipient, are mainly used in the preparation of delayed-release capsules. Their "enteric-coated" characteristic ensures that the capsule contents only disintegrate and are released in the specific environment of the intestine (small intestine or colon).
