In Vitro Comparison of Physical Parameters, Enzyme Activity, Acid Resistance, and pH Dissolution Characteristics of Enteric-Coated Pancreatic Enzyme Preparations: Implications for Clinical Variability and Pharmacy Substitution

OBJECTIVE Pancreatic enzyme products were available before the 1938 passage of the Federal Food, Drug, and Cosmetic Act and have to date been marketed without required safety and efficacy testing. Despite a lack of demonstrated bioequivalence, they are often substituted for each other without physician or patient consent or monitoring. We investigated the in vitro variability of key performance parameters among a representative group of currently available pancreatic enzyme formulations. MATERIALS AND METHODS Three “branded” preparations (Creon 20 Minimicrospheres, Pancrease MT 20, Ultrase MT 20) and 3 “generic” formulations (Pangestyme CN-20, Pancrelipase 20,000 URL, and Lipram CR 20) were evaluated in vitro for physical parameters of the capsules, actual vs. labeled enzyme activity, resistance of the enteric coating to simulated gastric acid, and kinetics of simulated duodenal lipase release. All products were labeled as providing 20,000 units of lipase activity per capsule. RESULTS All products varied ...