{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,9,24]],"date-time":"2025-09-24T20:40:24Z","timestamp":1758746424947,"version":"3.44.0"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2025,6,26]],"date-time":"2025-06-26T00:00:00Z","timestamp":1750896000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2025,6,26]],"date-time":"2025-06-26T00:00:00Z","timestamp":1750896000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs R D"],"published-print":{"date-parts":[[2025,9]]},"DOI":"10.1007\/s40268-025-00515-8","type":"journal-article","created":{"date-parts":[[2025,6,26]],"date-time":"2025-06-26T05:18:59Z","timestamp":1750915139000},"page":"231-240","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["In-Vitro Comparison of Physical Characteristics, Enzyme Content, and Release Kinetics of Pancreatic Enzyme Preparations Available in Europe and Canada"],"prefix":"10.1007","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-2061-3747","authenticated-orcid":false,"given":"Sven","family":"Hartmann","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonas","family":"Rosendahl","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy","family":"Todd","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Bennett-Huntley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. Enrique","family":"Dom\u00ednguez-Mu\u00f1oz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,6,26]]},"reference":[{"key":"515_CR1","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1177\/2050640613476500","volume":"1","author":"J-M L\u00f6hr","year":"2013","unstructured":"L\u00f6hr J-M, Oliver MR, Frulloni L. Synopsis of recent guidelines on pancreatic exocrine insufficiency. United Eur Gastroenterol J. 2013;1:79\u201383.","journal-title":"United Eur Gastroenterol J"},{"key":"515_CR2","unstructured":"Ghodeif AO, Azer SA. Pancreatic insufficiency. StatPearls [Internet]: StatPearls Publishing; 2022."},{"key":"515_CR3","doi-asserted-by":"publisher","first-page":"7059","DOI":"10.3748\/wjg.v23.i39.7059","volume":"23","author":"VK Singh","year":"2017","unstructured":"Singh VK, Haupt ME, Geller DE, Hall JA, Quintana Diez PM. Less common etiologies of exocrine pancreatic insufficiency. World J Gastroenterol. 2017;23:7059\u201376.","journal-title":"World J Gastroenterol"},{"key":"515_CR4","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1177\/2050640616684695","volume":"5","author":"JM L\u00f6hr","year":"2017","unstructured":"L\u00f6hr JM, et al. United European Gastroenterology evidence-based guidelines for the diagnosis and therapy of chronic pancreatitis (HaPanEU). United Eur Gastroenterol J. 2017;5:153\u201399.","journal-title":"United Eur Gastroenterol J"},{"key":"515_CR5","doi-asserted-by":"crossref","unstructured":"Working Party of the Australasian Pancreatic Club et al. Summary and recommendations from the Australasian guidelines for the management of pancreatic exocrine insufficiency. Pancreatology. 2016;16: 164\u201380","DOI":"10.1016\/j.pan.2015.12.006"},{"key":"515_CR6","doi-asserted-by":"publisher","first-page":"117","DOI":"10.15403\/jgld.2014.1121.app","volume":"24","author":"C Gheorghe","year":"2015","unstructured":"Gheorghe C, et al. Romanian guidelines on the diagnosis and treatment of exocrine pancreatic insufficiency. J Gastrointestin Liver Dis. 2015;24:117\u201323.","journal-title":"J Gastrointestin Liver Dis"},{"key":"515_CR7","doi-asserted-by":"publisher","first-page":"25","DOI":"10.1080\/03007995.2017.1389704","volume":"34","author":"P Durie","year":"2018","unstructured":"Durie P, et al. Diagnosis and management of pancreatic exocrine insufficiency (PEI) in primary care: consensus guidance of a Canadian expert panel. Curr Med Res Opin. 2018;34:25\u201333.","journal-title":"Curr Med Res Opin"},{"key":"515_CR8","doi-asserted-by":"publisher","first-page":"39","DOI":"10.4292\/wjgpt.v9.i5.39","volume":"9","author":"BM Shandro","year":"2018","unstructured":"Shandro BM, Nagarajah R, Poullis A. Challenges in the management of pancreatic exocrine insufficiency. World J Gastrointest Pharmacol Ther. 2018;9:39\u201346.","journal-title":"World J Gastrointest Pharmacol Ther"},{"key":"515_CR9","doi-asserted-by":"publisher","first-page":"161","DOI":"10.5694\/mja16.00851","volume":"207","author":"M Nikfarjam","year":"2017","unstructured":"Nikfarjam M, Wilson JS, Smith RC, Australasian Pancreatic Club Pancreatic Enzyme Replacement Therapy Guidelines Working Group. Diagnosis and management of pancreatic exocrine insufficiency. Med J Aust. 2017;207:161\u20135.","journal-title":"Med J Aust"},{"key":"515_CR10","doi-asserted-by":"publisher","first-page":"2430","DOI":"10.3748\/wjg.v25.i20.2430","volume":"25","author":"P Layer","year":"2019","unstructured":"Layer P, Kashirskaya N, Gubergrits N. Contribution of pancreatic enzyme replacement therapy to survival and quality of life in patients with pancreatic exocrine insufficiency. World J Gastroenterol. 2019;25:2430\u201341.","journal-title":"World J Gastroenterol"},{"key":"515_CR11","first-page":"CD008227","volume":"8","author":"URR Somaraju","year":"2020","unstructured":"Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020;8:CD008227.","journal-title":"Cochrane Database Syst Rev"},{"key":"515_CR12","doi-asserted-by":"publisher","first-page":"1024","DOI":"10.1097\/MEG.0b013e328328f414","volume":"21","author":"J-M L\u00f6hr","year":"2009","unstructured":"L\u00f6hr J-M, et al. Properties of different pancreatin preparations used in pancreatic exocrine insufficiency. Eur J Gastroenterol Hepatol. 2009;21:1024\u201331.","journal-title":"Eur J Gastroenterol Hepatol"},{"key":"515_CR13","doi-asserted-by":"publisher","first-page":"369","DOI":"10.1007\/s40268-020-00326-z","volume":"20","author":"IV Maev","year":"2020","unstructured":"Maev IV, et al. Differences in in vitro properties of pancreatin preparations for pancreatic exocrine insufficiency as marketed in Russia and CIS. Drugs R D. 2020;20:369\u201376.","journal-title":"Drugs R D"},{"key":"515_CR14","doi-asserted-by":"publisher","first-page":"3835","DOI":"10.2147\/DDDT.S319949","volume":"15","author":"SV Shrikhande","year":"2021","unstructured":"Shrikhande SV, Prasad VGM, Dom\u00ednguez-Mu\u00f1oz JE, Weigl KE, Sarda KD. In vitro comparison of pancreatic enzyme preparations available in the Indian Market. Drug Des Devel Ther. 2021;15:3835\u201343.","journal-title":"Drug Des Devel Ther"},{"key":"515_CR15","doi-asserted-by":"crossref","unstructured":"Hartmann S, Rydzewska G, Dom\u00ednguez-Mu\u00f1oz JE. Kreon\u00ae (Creon\u00ae) vs. Lipancrea\u00ae: in vitro comparison of two encapsulated pancreatin preparations. Pharmaceuticals (Basel). 2022;15:1\u201311.","DOI":"10.3390\/ph15121570"},{"key":"515_CR16","doi-asserted-by":"crossref","unstructured":"Todd A, Bennett-Huntley E, Rosendahl J, Schnekenburger J, Uhl W. Comparative investigation of pH-dependent availability of pancreatic enzyme preparations in vitro. Pharmaceuticals (Basel). 2024;17:1\u201316.","DOI":"10.3390\/ph17050552"},{"key":"515_CR17","doi-asserted-by":"publisher","first-page":"1324","DOI":"10.1136\/gut.31.11.1324","volume":"31","author":"S Mundlos","year":"1990","unstructured":"Mundlos S, K\u00fchnelt P, Adler G. Monitoring enzyme replacement treatment in exocrine pancreatic insufficiency using the cholesteryl octanoate breath test. Gut. 1990;31:1324\u20138.","journal-title":"Gut"},{"key":"515_CR18","doi-asserted-by":"publisher","first-page":"125","DOI":"10.1002\/ueg2.12674","volume":"13","author":"JE Dominguez-Mu\u00f1oz","year":"2025","unstructured":"Dominguez-Mu\u00f1oz JE, et al. European guidelines for the diagnosis and treatment of pancreatic exocrine insufficiency: UEG, EPC, EDS, ESPEN, ESPGHAN, ESDO, and ESPCG evidence-based recommendations. United Eur Gastroenterol J. 2025;13:125\u201372.","journal-title":"United Eur Gastroenterol J"},{"key":"515_CR19","first-page":"417","volume":"29","author":"P K\u00fchnelt","year":"1991","unstructured":"K\u00fchnelt P, Mundlos S, Adler G. Effect of pellet size of a pancreas enzyme preparation on duodenal lipolytic activity. Z Gastroenterol. 1991;29:417\u201321.","journal-title":"Z Gastroenterol"},{"key":"515_CR20","doi-asserted-by":"publisher","first-page":"427","DOI":"10.1111\/j.0953-0673.1996.00427.x","volume":"10","author":"P N\u00f8rregaard","year":"1996","unstructured":"N\u00f8rregaard P, Lysgaard Madsen J, Larsen S, Worning H. Gastric emptying of pancreatin granules and dietary lipids in pancreatic insufficiency. Aliment Pharmacol Ther. 1996;10:427\u201332.","journal-title":"Aliment Pharmacol Ther"},{"key":"515_CR21","unstructured":"EMA. Guideline on the clinical development of medicinal products for the treatment of cystic fibrosis: European Medicines Agency; 2009. 11 Jan 2023."},{"key":"515_CR22","doi-asserted-by":"publisher","first-page":"187","DOI":"10.1023\/A:1018970323716","volume":"10","author":"TL Russell","year":"1993","unstructured":"Russell TL, et al. Upper gastrointestinal pH in seventy-nine healthy, elderly, North American men and women. Pharm Res. 1993;10:187\u201396.","journal-title":"Pharm Res"},{"key":"515_CR23","doi-asserted-by":"publisher","first-page":"756","DOI":"10.1023\/A:1015827908309","volume":"7","author":"JB Dressman","year":"1990","unstructured":"Dressman JB, et al. Upper gastrointestinal (GI) pH in young, healthy men and women. Pharm Res. 1990;7:756\u201361.","journal-title":"Pharm Res"}],"container-title":["Drugs in R&D"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40268-025-00515-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40268-025-00515-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40268-025-00515-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,24]],"date-time":"2025-09-24T20:03:12Z","timestamp":1758744192000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40268-025-00515-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,26]]},"references-count":23,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,9]]}},"alternative-id":["515"],"URL":"https:\/\/doi.org\/10.1007\/s40268-025-00515-8","relation":{},"ISSN":["1174-5886","1179-6901"],"issn-type":[{"type":"print","value":"1174-5886"},{"type":"electronic","value":"1179-6901"}],"subject":[],"published":{"date-parts":[[2025,6,26]]},"assertion":[{"value":"28 May 2025","order":1,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"26 June 2025","order":2,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Funding for conducting the study and preparation of the manuscript was provided by Viatris.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Sven Hartmann, Emma Bennett-Huntley, and Amy Todd are employees of Viatris. J. Enrique Dom\u00ednguez-Mu\u00f1oz received a research grant from Viatris and worked as a paid consultant\/speaker for Viatris, Abbott, AbbVie, and Boston Scientific. Authors have no other competing interests to declare. Viatris (formerly Mylan) is the marketing authorization holder and distributor of Creon in Europe and Canada. Views in this manuscript are not necessarily those of Viatris.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"The authors declare that the data supporting the findings of this study are available within the paper and\u00a0its supplementary information files.\u00a0","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability statement"}},{"value":"Not applicable as this is an in-vitro study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable as this is an in-vitro study.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"SH contributed to conception, study design, execution, acquisition of data, analysis, and interpretation, drafting, revising, and reviewing the manuscript. JR contributed to conception, analysis, and interpretation, revising, and reviewing the manuscript. AT contributed to conception, study design, execution, acquisition of data, analysis, and interpretation. EBH contributed to conception, study design, execution, acquisition of data, analysis, and interpretation. JEDM contributed to conception, analysis, and interpretation, revising, and reviewing the manuscript. All authors have read and approved the final version, agreed on the journal to which the article has been submitted and agree to be accountable for all aspects of the work.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors' contributions"}}]}}