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PIII‐44
Author(s) -
Behm M. O.,
Lennartz P.,
Mulberg A. E.
Publication year - 2006
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2005.12.252
Subject(s) - enteric coated , enteric fever , chemistry , chromatography , medicine , virology , typhoid fever
BACKGROUND Diseases that result in significant reduction of exocrine pancreatic enzyme secretion, such as cystic fibrosis (CF), disrupt the normal digestion of nutrients. The immediate consequence of an absence of these enzymes, e.g., lipase, protease, amylase, is steatorrhea and abdominal symptoms. In the longer term, malnutrition occurs due to significantly impaired absorption of nutrients. The improvement of mean survival in patients with CF is due at least in part to the development and use of enteric‐coated exocrine pancreatic enzymes. Conventional wisdom had suggested that enzymes were unstable in infant formula resulting in reduced activity proportional to exposure time in formula. AIMS To understand this interaction, stability testing in formula was performed. METHODS Enteric coated Pancrease® MT (Pancrelipase) was incubated with infant formula in a dissolution tester at 100 rpm and 37 C. The resulting pH and remaining lipolytic activity were measured at 15, 30, 45, 60, 90, 120, and 150 minutes in 2 different batches and analyzed in duplicate. RESULTS The results are provided in the figure below. Pancrease® MT retains greater than 90% of its lipolytic activity for the first 60 minutes of exposure in formula. CONCLUSIONS This is the first report of stability of pancreatic enzymes in formula and demonstrates a potential for Pancrease® MT to assist in meeting the nutritional needs of infants with CF.Clinical Pharmacology & Therapeutics (2005) 79 , P70–P70; doi: 10.1016/j.clpt.2005.12.252