Development and evaluation of a digestive formulation using a microbial enzyme for treatment of dyspepsia

Purpose: A digestive enzyme is prepared as a treatment for dyspepsia by aiding in the breakdown of food, and its representative ingredient is porcine pancreatin. This study aims to develop a fast and effective digestive formulation by replacing animal pancreatin with a microbial enzyme. Methods: A non-animal digestive tablet was developed as a film-coated tablet, and its digestibility and disintegration properties were evaluated by the KP (Korean Pharmacopeia 12th edition) method. Results: Porcine pancreatin has amylase activity, protease activity, and lipase activity, and the activity scores of the three enzymes differ slightly. The microbial digestive enzyme has various characteristics depending on the source. A coated tablet containing microbial digestive enzymes, simethicone for gas removal, soluble azulene as a mucosal repair agent, and swertia as a stomachic was developed. It showed stable results for 6 months under long-term and accelerated storage conditions. The coating layer of the tablet dissolved rapidly at gastric pH, and the tablet completely disintegrated within 26 min. The amylase activity, protease activity, and lipase activity of the tablet were relatively higher than those of the commercial product at gastric pH after meals. In particular, lipase activity was higher than that of the commercial products at both gastric and small intestinal pH after meals. Conclusion: Reflecting the food intake of modern Koreans, we developed a non-animal complex digestive tablet containing microbial enzymes. The tablet disintegrated rapidly at postprandial gastric pH and showed high digestive activities in the range from gastric pH to small intestine pH after meals.