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Pancreatic enzymes (medication)

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Pancreatic enzymes, also known as pancreases or pancrelipase and pancreatin, are commercial mixtures of amylase, lipase, protease and lactase.[3][4] They are used to treat malabsorption syndrome due to certain pancreatic problems.[3] These pancreatic problems may be due to cystic fibrosis, surgical removal of the pancreas, long term pancreatitis, pancreatic cancer, or MODY 5, among others.[3][5] The preparation is taken by mouth.[3]

Pancreatic enzymes
Complex of lipase with colipase
Clinical data
Trade namesCreon, Pancreaze, Pertzye, others[1]
AHFS/Drugs.comMonograph
MedlinePlusa604035
Routes of
administration		By mouth
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • EU: Rx-only[2]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
CompTox Dashboard (EPA)
ECHA InfoCard100.053.309 Edit this at Wikidata

Common side effects include vomiting, abdominal pain, constipation, and diarrhea.[3] Other side effects include perianal irritation and high blood uric acid.[5] The enzymes are from pigs.[5] Use is believed to be safe during pregnancy.[5] The components are digestive enzymes similar to those normally produced by the human pancreas.[6] They help the person digest fats, starches, and proteins.[5]

Pancreatic enzymes have been used as medications since at least the 1800s.[7] They are on the World Health Organization's List of Essential Medicines.[8] In 2021, it was the 243rd most commonly prescribed medication in the United States, with more than 1 million prescriptions.[9][10]

Medical uses

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Pancrelipases are generally a first line approach in treatment of exocrine pancreatic insufficiency and other digestive disorders, accompanying cystic fibrosis, complicating surgical pancreatectomy, or resulting from chronic pancreatitis. The formulations are generally hard capsules filled with gastro-resistant granules. Pancrelipases and pancreatins are similar, except pancrelipases has an increased lipase component.[citation needed]

Pancreatin is a mixture of several digestive enzymes produced by the exocrine cells of the pancreas. It is composed of amylase, lipase and protease.[11] This mixture is used to treat conditions in which pancreatic secretions are deficient, such as surgical pancreatectomy, pancreatitis and cystic fibrosis.[11][12] 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.[13]

Pancreatin reduces the absorption of iron from food in the duodenum during digestion.[14]

Some contact lens-cleaning solutions contain porcine pancreatin extractives to assist in the intended protein-removal process.[15]

Side effects

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High doses over a long period of time are associated with fibrosing colonopathy.[16] Due to this association a maximum dose of 10,000 IU of lipase per kilogram per day is recommended.[17]

Though never reported there is a theoretical risk of a viral infection as they are from pigs.[18]

Society and culture

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Brand names

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Brand names include Creon,[19] Pancreaze, Pertzye, Sollpura[20] (Liprotamase[21][note 1]), Ultresa,[22] and Zenpep.[23]

In some countries, Creon is marketed by Viatris after Upjohn merged with Mylan to create Viatris.[24][25]

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United States

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Longstanding pancreatic enzyme replacement products (PERPs)—some in use for a century or more—fell under a 2006 FDA requirement that pharmaceutical companies with porcine-derived PERP products submit a New Drug Application (NDA) for each; Creon (AbbVie Inc.), the first of the commercial PERP products approved after the FDA directive, reached market in 2009.[19]

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.[19]

Shortages and alternatives

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Due to its non-constant supply, being sourced from pigs, there have been several pancreatin shortages in different markets.[26][27][28]

This has led for alternative sources of enzymes to be studied and commercialised, mainly being of bacterial or fungal origin.[29][30]

Notes

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  1. ^ Did not make it past Phase 3 trials

References

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  1. ^ "Pancrelipase Uses, Side Effects & Warnings".
  2. ^ "Micrazym and associated names". European Medicines Agency. 21 March 2024. Retrieved 13 June 2024.
  3. ^ a b c d e "Pancrelipase". The American Society of Health-System Pharmacists. Archived from the original on 18 January 2017. Retrieved 8 January 2017.
  4. ^ "Pancreatin". The American Society of Health-System Pharmacists. Archived from the original on 18 January 2017. Retrieved 8 January 2017.
  5. ^ a b c d e British national formulary: BNF 69 (69 ed.). British Medical Association. 2015. pp. 82–83. ISBN 978-0-85711-156-2.
  6. ^ Stuhan MA (2013). Understanding Pharmacology for Pharmacy Technicians. ASHP. p. 597. ISBN 978-1-58528-360-6. Archived from the original on 14 September 2017.
  7. ^ Banik SP, Khowala S, Pal C, Mukherjee S (2015). "Proteomic approaches to identify novel therapeutics and nutraceuticals from filamentous fungi: prospects and challenges". In Bagchi D, Swaroop A, Bagchi M (eds.). Genomics, Proteomics and Metabolomics in Nutraceuticals and Functional Foods. John Wiley & Sons. p. 274. ISBN 978-1-118-93046-5. Archived from the original on 18 September 2017.
  8. ^ 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.
  9. ^ "The Top 300 of 2021". ClinCalc. Archived from the original on 15 January 2024. Retrieved 14 January 2024.
  10. ^ "Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease - Drug Usage Statistics". ClinCalc. Retrieved 14 January 2024.
  11. ^ a b Whitehead 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. PMID 2451209. S2CID 41763055.
  12. ^ 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. PMID 19352190. S2CID 13480750.
  13. ^ Thorat V, Reddy N, Bhatia S, Bapaye A, Rajkumar JS, Kini DD, et al. (September 2012). "Randomised clinical trial: the efficacy and safety of pancreatin enteric-coated minimicrospheres (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis--a double-blind, placebo-controlled study". Alimentary Pharmacology & Therapeutics. 36 (5): 426–436. doi:10.1111/j.1365-2036.2012.05202.x. PMC 3528066. PMID 22762290. PDF version
  14. ^ Smith RS (August 1965). "Iron Deficiency and Iron Overload". Archives of Disease in Childhood. 40 (212): 343–363. doi:10.1136/adc.40.212.343. PMC 2019287. PMID 14329251.
  15. ^ Baines MG, Cai F, Backman HA (November 1990). "Adsorption and removal of protein bound to hydrogel contact lenses". Optometry and Vision Science. 67 (11): 807–810. doi:10.1097/00006324-199011000-00003. PMID 2250887. S2CID 29228849.
  16. ^ Lloyd-Still JD, Beno DW, Kimura RM (June 1999). "Cystic fibrosis colonopathy". Current Gastroenterology Reports. 1 (3): 231–237. doi:10.1007/s11894-999-0040-4. PMID 10980955. S2CID 37595322.
  17. ^ Schibli S, Durie PR, Tullis ED (November 2002). "Proper usage of pancreatic enzymes". Current Opinion in Pulmonary Medicine. 8 (6): 542–546. doi:10.1097/00063198-200211000-00010. PMID 12394164. S2CID 8935747.
  18. ^ "CREON® (pancrelipase) Delayed-Release Capsule | Official Website". www.creon.com. Retrieved 10 October 2019.
  19. ^ a b c U.S. Food and Drug Administration (7 May 2009). "FDA Approves Pancreatic Enzyme Replacement Product for Marketing in United States: Creon designed to help those with cystic fibrosis, others with exocrine pancreatic insufficiency". News & Events, FDA News Release. Retrieved 20 July 2014.
  20. ^ Adams B (12 March 2018). "Anthera's Sollpura canned after phase 3 flop, shares plunge". Fierce Biotech. Retrieved 23 October 2021.
  21. ^ "FDA Committee Declines to Recommend Liprotamase for EPI". The Boomer Esiason Foundation. 19 March 2019. Retrieved 22 May 2021.
  22. ^ "Ultresa - Search results. Page 1 of about 39 results". Drugs.com. Retrieved 22 May 2021.
  23. ^ "Zenpep: Uses, Dosage & Side Effects Information". Drugs.com. Retrieved 22 May 2021.
  24. ^ "Pfizer Completes Transaction to Combine Its Upjohn Business with Mylan". Pfizer. 16 November 2020. Retrieved 17 June 2024 – via Business Wire.
  25. ^ "Brands". Viatris. 16 November 2020. Retrieved 17 June 2024.
  26. ^ Pancreatic cancer action (21 April 2020). "Temporary shortage of Creon (Pancreatin) 25k". Pancreatic cancer news. Retrieved 15 July 2020.
  27. ^ Mylan (1 February 2019). "Pancreatin - Cambridgeshire and Peterborough CCG" (PDF). Archived from the original on 28 August 2021. Retrieved 15 July 2020.
  28. ^ Greater Glasgow and Clyde Medicines (July 2016). "Medicines Update Primary Care". Archived from the original on 15 July 2020. Retrieved 15 July 2020.
  29. ^ Layer P, Keller J (January 2003). "Lipase supplementation therapy: standards, alternatives, and perspectives". Pancreas. 26 (1): 1–7. doi:10.1097/00006676-200301000-00001. PMID 12499909. S2CID 12365426.
  30. ^ Roxas M (December 2008). "The role of enzyme supplementation in digestive disorders". Alternative Medicine Review. 13 (4): 307–314. PMID 19152478.
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