Differences in In Vitro Properties of Pancreatin Preparations for Pancreatic Exocrine Insufficiency as Marketed in Russi
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ORIGINAL RESEARCH ARTICLE
Differences in In Vitro Properties of Pancreatin Preparations for Pancreatic Exocrine Insufficiency as Marketed in Russia and CIS Igor V. Maev1 · Yury A. Kucheryavyy1 · Natalya B. Gubergrits2 · Ingo Bonnacker3 · Ekaterina A. Shelest4 · Gwendolyn P. Janssen‑van Solingen5 · J. Enrique Domínguez‑Muñoz6 Accepted: 9 October 2020 / Published online: 19 November 2020 © The Author(s) 2020
Abstract Background Pancreatic enzyme-replacement therapy (PERT), provided as pancreatin to patients with pancreatic exocrine insufficiency (PEI), is considered an essential substitute for the pivotal physiological function the pancreas fulfills in digestion. PEI involves a reduction in the synthesis and secretion of pancreatic enzymes (lipase, protease, amylase), which leads to an inadequate enzymatic response to a meal and consequently to maldigestion and malabsorption of nutrients. The efficacy of PERT is strongly dependent on enzyme activity, dissolution, and pancreatin particle size. Objective The physiological properties of eight pancreatin preparations (nine batches; five different brands) available in Russia and CIS (Commonwealth of Independent States: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Uzbekistan) were investigated. Methods The lipase activity, dissolution, and particle size distribution of samples from multiple batches of pancreatin of different strengths were measured. Results Regarding lipase activities, all pancreatin preparations except Micrazim® matched the labeled content. Considerable differences were observed in particle size and dissolution. Conclusion Pancreatin preparations available in Russia and CIS demonstrate product-to-product and batch-to-batch variability regarding the measured properties of lipase activity, dissolution, and particle size. This may impact the efficacy of PERT and therefore clinical outcomes.
1 Introduction
* Gwendolyn P. Janssen‑van Solingen [email protected] 1
A.I. Evdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia, Moscow, Russia
2
Donetsk National Medical University, Ministry of Health of Ukraine, Lyman, Ukraine
3
Abbott Laboratories GmbH, Hannover, Germany
4
Abbott Laboratories, Moscow, Russia
5
Abbott Product Operations AG, Allschwil, Switzerland
6
Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain
Pancreatic exocrine insufficiency (PEI) is defined as an insufficient secretion of pancreatic enzymes (acinar function) and/or sodium bicarbonate (ductal function), with the main causes being loss of pancreatic parenchyma, obstruction of the main pancreatic duct, decreased stimulation of the exocrine pancreas and inactivation of pancreatic enzymes [1]. The pancreas has a large reserve capacity; patients with pancreatic secretion
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