Pancreatic Enzyme Products Research Articles

Fibrosing colonopathy in cystic fibrosis.

The introduction of enteric coated pancreatic enzyme supplements in the early 1980s was undoubtedly one of the major advances in the care of children with cystic fibrosis. Further refinements in the presentation of these preparations inevitably followed, to improve patient acceptability and compliance. The emergence of fibrosing colonopathy took clinicians dealing with cystic fibrosis completely by surprise, and in the last two years there has been a gradual appreciation that as far as pancreatic enzyme products are concerned 'More is not necessarily better'. However, it is encouraging that, in the UK, there have been no histologically confirmed cases in children receiving high strength pancreatic enzyme preparations since July 1994. Hopefully this trend will continue and the causal factors will be defined, ensuring that this serious complication can be effectively prevented in the future.

Treatment Failure After Substitution of Generic Pancrelipase Capsules

Pancreatic enzyme products are formulated, manufactured, and sold without submitting efficacy or bioavailability data to the Food and Drug Administration because of a quirk in the law. We documented therapeutic failures in three patients with cystic fibrosis after pharmacists substituted generic pancrelipase capsules for the Pancrease brand. Gastrointestinal symptoms and fat malabsorption rapidly resolved after therapy was reinstituted with brand name products. In vitro analysis indicated that after 1 hour of exposure to simulated gastric fluid, lipase activity was less than 200 U per capsule from all three generic capsules dispensed to the patients compared with 6820 U per capsule from Pancrease. These data indicate that the enteric coating of the generic product was defective and that the substituted product was not bioequivalent to the prescribed brand. We conclude that the Food and Drug Administration should institute regulations over this group of products.

4859471 Pancreatic enzyme products and a process for the preparation thereof: Werner Fulberth, Hans-Georg Freuer, D 6230 Frankfurt am Main 80, Federal Republic of Germany

4859471 Pancreatic enzyme products and a process for the preparation thereof: Werner Fulberth, Hans-Georg Freuer, D 6230 Frankfurt am Main 80, Federal Republic of Germany

Comparison of gastrointestinal pH in cystic fibrosis and healthy subjects

The primary objective of this study was to define the pH conditions under which supplemental pancreatic enzyme preparations must function in the upper gastrointestinal tract. The hypothesis was that normal or greater acid output in patients with cystic fibrosis (CF), combined with low pancreatic bicarbonate output, results in an acidic duodenal pH, compromising both dosage-form performance and enzyme activity. Gastrointestinal pH profiles were obtained in 10 CF and 10 healthy volunteers under fasting and postprandial conditions. A radiotelemetric monitoring method, the Heidelberg capsule, was used to continuously monitor pH. Postprandial duodenal pH was lower in CF than in healthy subjects, especially in the first postprandial hour (mean time greater than pH 6 was 5 min in CF, 11 min in healthy subjects, P less than 0.05). Based on the dissolution pH profiles of current enteric-coated pancreatic enzyme products, the duodenal postprandial pH in CF subjects may be too acidic to permit rapid dissolution of current enteric-coated dosage forms. However, the pH was above 4 more than 90% of the time on the average, suggesting that irreversible lipase inactivation in the duodenum is not likely to be a significant limitation to enzyme efficacy. Overall results suggest that slow dissolution of pH-sensitive coatings, rather than enzyme inactivation, may contribute to the failure of enteric-coated enzyme supplements to normalize fat absorption.