Drug Design, Development and Therapy (Sep 2021)
In vitro Comparison of Pancreatic Enzyme Preparations Available in the Indian Market
Abstract
Shailesh V Shrikhande,1 VG Mohan Prasad,2 J Enrique Domínguez-Muñoz,3 Kevin E Weigl,4 Kushal D Sarda5 1Division of Cancer Surgery and Gastrointestinal and Hepato-Pancreato-Biliary Service, Tata Memorial Hospital, Mumbai, Maharashtra, India; 2Department of Gastroenterology, Dr. M.G.R. Medical University and VGM Hospital, Coimbatore, Tamil Nadu, India; 3Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain; 4Department of Gastroenterology, Abbott Laboratories GmbH, Hannover, Germany; 5Established Pharmaceuticals Division – Medical Affairs, Abbott India Ltd, Mumbai, Maharashtra, IndiaCorrespondence: Kushal D SardaAbbott India Ltd, Floor 16, Godrej BKC, Plot No. C – 68, Bandra-Kurla Complex, Near MCA Club, Bandra (E), Mumbai, 400051, Maharashtra, IndiaTel +91-22-38160938Fax +91 22 38162400Email [email protected]: 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.Keywords: pancreatic enzyme, physical properties, in vitro dissolution, lipase activity, release kinetics
