Journal
DRUGS IN R&D
Volume 20, Issue 4, Pages 369-376Publisher
SPRINGER INTERNATIONAL PUBLISHING AG
DOI: 10.1007/s40268-020-00326-z
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Funding
- Abbott Pharmaceuticals
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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 (R) 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.
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