Pancreatic enzymes have been used as medications since at least the 1800s.[8] They are on theWorld Health Organization's List of Essential Medicines.[9] In 2022, it was the 253rd most commonly prescribed medication in the United States, with more than 1million prescriptions.[10][11]
Pancreatin is a mixture of several digestiveenzymes produced by theexocrine cells of thepancreas. It is composed ofamylase,lipase andprotease.[12] This mixture is used to treat conditions in which pancreatic secretions are deficient, such assurgical pancreatectomy,pancreatitis andcystic fibrosis.[12][13] It has been claimed to help with food allergies, celiac disease, autoimmune disease, cancer and weight loss. Pancreatin is sometimes called "pancreatic acid", although it is neither a single chemical substance nor an acid.[citation needed]
A similar mixture of enzymes is sold as pancrelipase, which contains more active lipase enzyme than does pancreatin. The trypsin found in pancreatin works to hydrolyze proteins into oligopeptides; amylase hydrolyzes starches into oligosaccharides and the disaccharide maltose; and lipase hydrolyzes triglycerides into fatty acids and glycerols. Pancreatin is an effective enzyme supplement for replacing missing pancreatic enzymes, and aids in the digestion of foods in cases of pancreatic insufficiency.[14]
Pancreatin reduces the absorption of iron from food in the duodenum during digestion.[15]
Somecontact lens-cleaning solutions containporcine pancreatin extractives to assist in the intended protein-removal process.[16]
High doses over a long period of time are associated withfibrosing colonopathy.[17] Due to this association a maximum dose of 10,000 IU of lipase per kilogram per day is recommended.[18]
Though never reported there is a theoretical risk of a viral infection as they are from pigs.[19]
Longstanding pancreatic enzyme replacement products (PERPs)—some in use for a century or more—fell under a 2006FDA requirement that pharmaceutical companies with porcine-derived PERP products submit aNew Drug Application (NDA) for each;Creon (AbbVie Inc.), the first of the commercial PERP products approved after the FDA directive, reached market in 2009.[20]
The specific requirement and reasoning for the FDA directive was that manufacturers submit a Risk Evaluation and Mitigation Strategy (REMS) and Medication Guide to ensure patients are adequately informed regarding potential risks associated with administration of high doses of porcine-derived PERP products, especially with regard to "the theoretical risk of transmission of viral disease from pigs to patients", the risk of which (alongside other off-target effects) is reduced by patient adherence to label dosing instructions.[20]
^World Health Organization (2019).World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization.hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
^abWhitehead AM (February 1988). "Study to compare the enzyme activity, acid resistance and dissolution characteristics of currently available pancreatic enzyme preparations".Pharmaceutisch Weekblad. Scientific Edition.10 (1):12–16.doi:10.1007/BF01966429.PMID2451209.S2CID41763055.
^Löhr JM, Hummel FM, Pirilis KT, Steinkamp G, Körner A, Henniges F (September 2009). "Properties of different pancreatin preparations used in pancreatic exocrine insufficiency".European Journal of Gastroenterology & Hepatology.21 (9):1024–1031.doi:10.1097/MEG.0b013e328328f414.PMID19352190.S2CID13480750.
