{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T01:02:19Z","timestamp":1760144539982,"version":"build-2065373602"},"reference-count":33,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T00:00:00Z","timestamp":1714003200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Viatris Healthcare GmbH, Bad Homburg, Germany"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>This study aimed to compare different pancreatic enzyme preparations (PEPs) available in Germany regarding particle geometry and size, and to evaluate enzyme activity under physiologically relevant conditions in vitro. Pancreatic endocrine insufficiency is characterized by deficiency of pancreatic enzymes resulting in maldigestion. It is orally treated by pancreatic enzyme replacement therapy. The formulations differ in their physical properties and enzyme release behavior, potentially resulting in inconsistent dosages and poor interchangeability of products. A total of 25 products were analyzed for particle size and number of particles per capsule. Enzyme activities of lipase, amylase, and protease were measured by digestion of olive oil emulsion, starch, and casein, respectively. To analyze enzyme release, gastric environments were simulated by incubating PEPs at pH 1, 4, or 5. Duodenal conditions were simulated by subsequent incubation at pH 6. Regarding physical properties and enzyme release kinetics, considerable differences between different PEPs were found. Furthermore, compared to the label claim, excess lipase activity was observed for most products, reaching up to 148%. These in vitro results suggest poor interchangeability of PEPs, potentially explained by physical and release characteristics. Physicians and patients should be aware of the potential gap between label claims and the real-life performance of different PEPs.<\/jats:p>","DOI":"10.3390\/ph17050552","type":"journal-article","created":{"date-parts":[[2024,4,26]],"date-time":"2024-04-26T08:18:27Z","timestamp":1714119507000},"page":"552","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Comparative Investigation of pH\u2013Dependent Availability of Pancreatic Enzyme Preparations In Vitro"],"prefix":"10.3390","volume":"17","author":[{"given":"Amy","family":"Todd","sequence":"first","affiliation":[{"name":"Viatris\/Mylan Pharma UK Ltd., Sandwich CT13 9ND, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Bennett-Huntley","sequence":"additional","affiliation":[{"name":"Viatris\/Mylan Pharma UK Ltd., Sandwich CT13 9ND, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4513-0506","authenticated-orcid":false,"given":"Jonas","family":"Rosendahl","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I, University Hospital Halle (Saale), 06120 Halle, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0199-2908","authenticated-orcid":false,"given":"J\u00fcrgen","family":"Schnekenburger","sequence":"additional","affiliation":[{"name":"Biomedizinisches Technologiezentrum (BMTZ), Faculty of Medicine, University of M\u00fcnster, 48149 M\u00fcnster, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7719-3192","authenticated-orcid":false,"given":"Waldemar","family":"Uhl","sequence":"additional","affiliation":[{"name":"Department of General and Visceral Surgery, St.-Josef-Hospital, Clinic of Ruhr-University Bochum, 44791 Bochum, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2024,4,25]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1159\/000501675","article-title":"Pancreatic exocrine insufficiency as a complication of gastrointestinal surgery and the impact of pancreatic enzyme replacement therapy","volume":"38","author":"Chaudhary","year":"2020","journal-title":"Dig. 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