In vitro Comparison of Pancreatic Enzyme Preparations Available in the Indian Market.

PURPOSE: Pancreatic enzyme replacement therapy (PERT) involves exogenous enzyme supplementation and is used in the treatment of pancreatic exocrine insufficiency. Clinical efficacy of PERT preparations is a function of physical properties and release kinetics that vary between commercially available products. In this study, we evaluated the physical properties, in vitro dissolution, and release kinetics of commercially available pancreatic enzyme preparations available in the Indian market. METHODS: Physical properties such as particle size distribution and water content of the capsules were measured by dynamic light scattering and Karl-Fischer titration method, respectively. An analytical procedure based on the European pharmacopoeia (EP) method was used to determine lipase activity, and a modified United States pharmacopoeia (USP)-based method was used for dissolution studies. Enzyme release was ascertained under gastroduodenal conditions in buffered media. RESULTS: Considerable variations in physical properties such as particle size and water content were observed between pancreatic enzyme preparations. Some preparations failed to meet the labeled lipase content as per USP standards (>90% label claim) and showed inconsistent release behavior (>5% relative standard deviation). CONCLUSION: Differences exist between pancreatic enzyme preparations in terms of physical properties, dissolution, and release behavior that can affect their clinical efficacy. The present study suggests, therefore, that these preparations should not be used interchangeably.

Fat gram target to achieve high energy intake in cystic fibrosis.

OBJECTIVE: Higher fat and energy intakes confer a survival advantage in cystic fibrosis (CF). There is a need to develop effective nutrition programmes that ensure optimal energy intake in CF. METHODOLOGY: A cross-sectional measurement of clinical characteristics and energy and fat intakes in patients attending the CF outpatients clinic of the John Hunter Hospital, Newcastle was undertaken. Twenty-nine subjects, mean age 12 years (range 4.3-20.2), completed weighed food records to determine the contribution of fat to the percentage of the recommended energy intake obtained and to document use of pancreatic enzyme replacement therapy. RESULTS: Diets with a high percentage of energy derived from fat did not guarantee that individuals with CF met their energy requirements. Subjects with total fat intakes of 100 g per day or greater, however, achieved in excess of 110% recommended daily intake (RDI) for energy. Up to 47% of subjects consumed more pancreatic enzyme replacement capsules than shown to give maximum effectiveness. CONCLUSION: Setting a 100 g daily fat target is a realistic way of ensuring high energy intakes in CF. Fat ready reckoners would identify the fat content of food and prescribe specific numbers of pancreatic enzyme replacement capsules to be consumed with each meal or food item.

[In vitro studies of pancreatic enzyme substitution]. / In-vitro-Untersuchungen zur Pankreasenzymsubstitution.

In-vitro activity of 14 commercial pancreatin preparations, commonly used in the Federal Republic of Germany, were tested. All had been declared by their manufacturers to contain more than 6000 FIP (Fédération International Pharmaceutique) units of lipase and to be acid resistant. The declared lipase and amylase amounts were found to be present in 11 of the 14 preparations. Three of the 14 preparations, said to be acid resistant were found not to be so in buffer with falling pH values between 4.0 and 2.5, so that there occurred an, at times marked, loss of enzyme activity. Most noticeable was the poor solubility of most preparations at pH 6.6. Only three of the 14 liberated their total enzyme content within 60 minutes, as they should for theoretical reasons, based on the relatively short duodeno-cecal transit time.

In vitro enzyme activity of commercially available pancreatic enzyme extracts.

An in vitro study was performed to measure the enzyme activity in commerically available preparations of pancreatic enzyme extracts. Particular attention was paid to lipase content, because lipase deficiency is the most clinically relevant enzyme deficiency. Individual preparations varied greatly with regard to enzyme content, and Cotazym and Viokase proved the most effective preparations of those tested.

Porcine pancreatin as a source of salmonella infection in children with cystic fibrosis.

Contamination of a powdered preparation of pancreatin with Salmonella schwarzengrund and S. eimsbuettel resulted in the infection of at least 31% of one group of paediatric patients with cystic fibrosis. The pancreatin contained very small numbers of Salmonellae, the infecting dose in at least one child being less than 44 organisms. More stringent bacteriological standards are needed for pharmaceuticals and foods used by paediatric patients.