Pancreatic enzymes (medication)

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Short description: Amylase, lipase, and protease mixture.

Pancreatic enzymes

Complex of lipase with colipase

Clinical data
Trade names| Creon, Pancreaze, Pertzye, others[1]
AHFS/Drugs.com| Monograph
MedlinePlus| a604035
Routes of
administration| By mouth
ATC code|

* A09AA02 (WHO)

Legal status
Legal status|

* In general: ℞ (Prescription only)

Identifiers
CAS Number|

* 53608-75-6

DrugBank|

* DB00085

ChemSpider|

* none

UNII|

* FQ3DRG0N5K

Pancreatic enzymes, also known as pancreases or pancrelipase and pancreatin, are commercial mixtures of amylase, lipase, protease and lactase.[2][3] They are used to treat malabsorption syndrome due to certain pancreatic problems.[2] These pancreatic problems may be due to cystic fibrosis, surgical removal of the pancreas, long term pancreatitis, pancreatic cancer, or MODY 5, among others.[2][4] The preparation is taken by mouth.[2]

Common side effects include vomiting, abdominal pain, constipation, and diarrhea.[2] Other side effects include perianal irritation and high blood uric acid.[4] The enzymes are from pigs.[4] Use is believed to be safe during pregnancy.[4] The components are digestive enzymes similar to those normally produced by the human pancreas.[5] They help the person digest fats, starches, and proteins.[4]

Pancreatic enzymes have been used as medications since at least the 1800s.[6] They are on the World Health Organization's List of Essential Medicines.[7] In 2020, it was the 262nd most commonly prescribed medication in the United States, with more than 1 million prescriptions.[8][9]

## Contents

* 1 Medical uses
* 2 Side effects
* 3 Society and culture
* 3.1 Brand names
* 3.2 Legal status
* 3.2.1 United States
* 3.3 Shortages and alternatives
* 4 Notes
* 5 References

## Medical uses

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.[10] This mixture is used to treat conditions in which pancreatic secretions are deficient, such as surgical pancreatectomy, pancreatitis and cystic fibrosis.[10][11] 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]

Pancreatin contains the pancreatic enzymes trypsin, amylase and lipase. 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.[12]

Pancreatin reduces the absorption of iron from food in the duodenum during digestion.[13]

Some contact lens-cleaning solutions contain porcine pancreatin extractives to assist in the intended protein-removal process.[14]

## Side effects

High doses over a long period of time are associated with fibrosing colonopathy.[15] Due to this association a maximum dose of 10,000 IU of lipase per kilogram per day is recommended.[16]

Though never reported there is a theoretical risk of a viral infection as they are from pigs.[17]

## Society and culture

### Brand names

Brand names include Creon,[18] Pancreaze, Pertzye, Sollpura[19] (Liprotamase[20][note 1]), Ultresa,[21] and Zenpep.[22]

### Legal status

#### United States

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.[18]

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.[18]

### Shortages and alternatives

Due to its non-constant supply, being sourced from pigs, there have been several pancreatin shortages in different markets.[23][24][25]

This has led for alternative sources of enzymes to be studied and commercialised, mainly being of bacterial or fungal origin.[26][27]

## Notes

1. ↑ Did not make it past Phase 3 trials

## References

1. ↑ "Pancrelipase Uses, Side Effects & Warnings". https://www.drugs.com/mtm/pancrelipase.html.
2. ↑ 2.0 2.1 2.2 2.3 2.4 "Pancrelipase". The American Society of Health-System Pharmacists. https://www.drugs.com/monograph/pancrelipase.html.
3. ↑ "Pancreatin". The American Society of Health-System Pharmacists. https://www.drugs.com/monograph/pancreatin.html.
4. ↑ 4.0 4.1 4.2 4.3 4.4 British national formulary: BNF 69 (69 ed.). British Medical Association. 2015. pp. 82–83. ISBN 9780857111562.
5. ↑ (in en) Understanding Pharmacology for Pharmacy Technicians. ASHP. 2013. p. 597. ISBN 9781585283606. https://books.google.com/books?id=L902nod-xOIC&pg=PT597.
6. ↑ "Proteomic approaches to identify novel therapeutics and nutraceuticals from filamentous fungi: prospects and challenges" (in en). Genomics, Proteomics and Metabolomics in Nutraceuticals and Functional Foods. John Wiley & Sons. 2015. p. 274. ISBN 9781118930465. https://books.google.com/books?id=wOudCgAAQBAJ&pg=PA274.
7. ↑ World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. 2019. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
8. ↑ "The Top 300 of 2020". https://clincalc.com/DrugStats/Top300Drugs.aspx.
9. ↑ "Pancrelipase Amylase; Pancrelipase Lipase; Pancrelipase Protease - Drug Usage Statistics". https://clincalc.com/DrugStats/Drugs/PancrelipaseAmylasePancrelipaseLipasePancrelipaseProtease.
10. ↑ 10.0 10.1 "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. February 1988. doi:10.1007/BF01966429. PMID 2451209.
11. ↑ "Properties of different pancreatin preparations used in pancreatic exocrine insufficiency". European Journal of Gastroenterology & Hepatology 21 (9): 1024–1031. September 2009. doi:10.1097/MEG.0b013e328328f414. PMID 19352190.
12. ↑ "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. September 2012. doi:10.1111/j.1365-2036.2012.05202.x. PMID 22762290. PDF version
13. ↑ "Iron Deficiency and Iron Overload". Archives of Disease in Childhood 40 (212): 343–363. August 1965. doi:10.1136/adc.40.212.343. PMID 14329251.
14. ↑ "Adsorption and removal of protein bound to hydrogel contact lenses". Optometry and Vision Science 67 (11): 807–810. November 1990. doi:10.1097/00006324-199011000-00003. PMID 2250887.
15. ↑ "Cystic fibrosis colonopathy". Current Gastroenterology Reports 1 (3): 231–237. June 1999. doi:10.1007/s11894-999-0040-4. PMID 10980955.
16. ↑ "Proper usage of pancreatic enzymes". Current Opinion in Pulmonary Medicine 8 (6): 542–546. November 2002. doi:10.1097/00063198-200211000-00010. PMID 12394164.
17. ↑ "CREON® (pancrelipase) Delayed-Release Capsule | Official Website". https://www.creon.com/.
18. ↑ 18.0 18.1 18.2 U.S. Food and Drug Administration (May 7, 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. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149579.htm.
19. ↑ "Anthera's Sollpura canned after phase 3 flop, shares plunge". Fierce Biotech. 12 March 2018. https://www.fiercebiotech.com/biotech/anthera-s-sollpura-canned-after-phase-3-flop-shares-plunge.
20. ↑ "FDA Committee Declines to Recommend Liprotamase for EPI" (in en-US). 2019-03-19. https://www.esiason.org/fda-committee-declines-to-recommend-liprotamase-for-epi/.
21. ↑ "Ultresa - Search results. Page 1 of about 39 results" (in en). https://www.drugs.com/search.php?searchterm=ultresa.
22. ↑ "Zenpep: Uses, Dosage & Side Effects Information". https://www.drugs.com/zenpep.html.
23. ↑ Pancreatic cancer action (April 21, 2020). "Temporary shortage of Creon (Pancreatin) 25k". Pancreatic cancer news. https://pancreaticcanceraction.org/news/temporary-shortage-of-creon-25k/.
24. ↑ Mylan (February 1, 2019). "Pancreatin - Cambridgeshire and Peterborough CCG". https://www.cambridgeshireandpeterboroughccg.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=17434.
25. ↑ Greater Glasgow and Clyde Medicines (July 2016). "Medicines Update Primary Care". http://www.ggcprescribing.org.uk/blog/medicines-update-primary-care-july-2016/.
26. ↑ "Lipase supplementation therapy: standards, alternatives, and perspectives". Pancreas 26 (1): 1–7. January 2003. doi:10.1097/00006676-200301000-00001. PMID 12499909.
27. ↑ "The role of enzyme supplementation in digestive disorders". Alternative Medicine Review 13 (4): 307–314. December 2008. PMID 19152478.

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Digestives, including enzymes (A09)

Enzymes|

* Diastase
* Pancreatin
* Pancrelipase
* Pepsin

Acid preparations|

* Citric acid
* Hydrochloric acid

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