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.