Comparative in vitro and in vivo studies of enteric-coated pancrelipase preparations for pancreatic insufficiency

Thomson, M., Clague, A., Cleghorn, Geoffrey J., & Shepherd, R. W. (1993) Comparative in vitro and in vivo studies of enteric-coated pancrelipase preparations for pancreatic insufficiency. Journal of Pediatric Gastroenterology and Nutrition, 17(4), pp. 407-413.

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Abstract

We evaluated three acid-resistant pancreatic enzyme preparations by in vitro assays, and by comparing degree of steatorrhea, creatorrhea, fecal wet weight, and stool energy losses in a randomized crossover study of patients with pancreatic insufficient cystic fibrosis. Aims of the study were to assess (a) the most practicable and reliable indicator of malabsorption; (b) the variation in enzyme batch potency; (c) the decline in enzyme batch potency with prolonged shelf life; and (d) the relative bio-efficacy of the different preparations. In the in vivo study, absorption of energy, nitrogen, and fat did not differ when comparing the three preparations at roughly pharmaceu-tically equivalent doses, but when expressed per capsule of pancreatic supplement ingested, absorption reflected relative enzyme content, favoring the higher potency preparations. Although steatorrhea was reasonably controlled by these preparations, stool energy losses varied from 800 to 1,100 kJ per day, suggesting greater attention be paid to overall energy absorption rather than absorption of individual nutrients. In addition, fecal energy loss correlated more closely with fecal wet weight (r = 0.81; p < 0.05) than with steatorrhea (r = 0.40; ns), such that 1 g wet feces = 8.37 kJ (± 0.14). In vitro enzyme potency varied markedly between batches of the same brand, and also a decline of up to 20% in amylase, lipase, and trypsin activity was noted over an 8-month period for each batch. Both observations have clinical implications at times of represcription. Finally, the higher potency preparations were more effective per capsule and reduced capsule dosage is therefore attainable. © 1993 Raven Press, Ltd., New York.

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ID Code: 90013
Item Type: Journal Article
Refereed: Yes
Additional Information: Cited By :13
Export Date: 1 September 2015
Correspondence Address: Shepherd, R.W.; Department of Gastroenterology and Nutrition, Royal Children’s Hospital, Brisbane, QLD, 4029, Australia
Additional URLs:
Keywords: Cystic fibrosis, Malabsorption, Pancreatic enzyme preparation, Pancreatic insufficiency, amylase, pancrelipase, triacylglycerol lipase, trypsin, article, clinical article, clinical trial, crossover procedure, drug effect, drug potency, enteric coated tablet, enzyme activity, feces analysis, human, pancreas insufficiency, priority journal, steatorrhea, Amino Acid Sequence, Child, Comparative Study, Intestinal Absorption, Lipase, Molecular Sequence Data, Pancreatic Extracts, Support, Non-U.S. Gov't, Tablets, Enteric-Coated
ISSN: 0277-2116
Divisions: Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Current > Schools > School of Exercise & Nutrition Sciences
Deposited On: 13 Nov 2015 00:28
Last Modified: 13 Nov 2015 00:28

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