Shailesh V Shrikhande1, V G Mohan Prasad2, J Enrique Domínguez-Muñoz3, Kevin E Weigl4, Kushal D Sarda5. 1. Division of Cancer Surgery and Gastrointestinal and Hepato-Pancreato-Biliary Service, Tata Memorial Hospital, Mumbai, Maharashtra, India. 2. Department of Gastroenterology, Dr. M.G.R. Medical University and VGM Hospital, Coimbatore, Tamil Nadu, India. 3. Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain. 4. Department of Gastroenterology, Abbott Laboratories GmbH, Hannover, Germany. 5. Established Pharmaceuticals Division - Medical Affairs, Abbott India Ltd, Mumbai, Maharashtra, India.
Abstract
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.
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.
Authors: J Matthias Löhr; Enrique Dominguez-Munoz; Jonas Rosendahl; Marc Besselink; Julia Mayerle; Markus M Lerch; Stephan Haas; Fatih Akisik; Nikolaos Kartalis; Julio Iglesias-Garcia; Jutta Keller; Marja Boermeester; Jens Werner; Jean-Marc Dumonceau; Paul Fockens; Asbjorn Drewes; Gürlap Ceyhan; Björn Lindkvist; Joost Drenth; Nils Ewald; Philip Hardt; Enrique de Madaria; Heiko Witt; Alexander Schneider; Riccardo Manfredi; Frøkjer J Brøndum; Sasa Rudolf; Thomas Bollen; Marco Bruno Journal: United European Gastroenterol J Date: 2017-01-16 Impact factor: 4.623
Authors: Igor V Maev; Yury A Kucheryavyy; Natalya B Gubergrits; Ingo Bonnacker; Ekaterina A Shelest; Gwendolyn P Janssen-van Solingen; J Enrique Domínguez-Muñoz Journal: Drugs R D Date: 2020-11-19