Studies on the quality of pancreatic preparations: enzyme content, prospective bioavailability, bile acid pattern, and contamination with purines.

Of the 72 pancreatic preparations currently on the market 24 were randomly selected for study and compared with 3 US preparations with different dosage forms. The activities of amylase, lipase, and proteases were measured with natural substrates. Prospective bioavailability was determined using amylase as indicator enzyme. Total bile acid content and distribution pattern were analyzed. The risk of renal changes due to prolonged ingestion of purines was estimated by qualitative and quantitative determination of these contaminants. Enzyme activities differed up to 16-fold. At pH 6, the drugs released the indicator enzyme with very different velocities. The efficacy of the drugs varied between 0.78% and 80.9%. The bioavailability of capsules was generally better than that of coated tablets; pellet capsules were not absolutely superior in this regard. All pancreatic preparations contained the purine bases guanine and hypoxanthine; only one drug had no adenine. Fifteen drugs contained 2.2%-10.6% bile acids by weight. Monohydroxy bile acids, which should not be administered to patients with liver disease, were detected in eight of these preparations.