Identification
- Summary
Pancrelipase is a purified form of porcine pancreatic lipase, amylase, and protease enzymes used to treat malabsorption associated with pancreatic insufficiency resulting from cystic fibrosis and pancreatitis.
- Generic Name
- Pancrelipase
- DrugBank Accession Number
- DB00085
- Background
Pancrelipase, in general, is composed of a mixture of pancreatic enzymes which include amylases, lipases, and proteases. These enzymes are extracted from porcine pancreatic glands.5 The pancrelipase mixture was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010.6 For further information on the components of this mixture please visit Pancrelipase amylase, Pancrelipase protease and Pancrelipase lipase.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - Protein Chemical Formula
- Not Available
- Protein Average Weight
- 131000.0 Da
- Sequences
- Not Available
- Synonyms
- Pancrealipase
- Pancreatic extract pancrelipase
- Pancreatic protease
- Pancreatin
- Pancreatinum
- Pancrelipase
- Pancrelipase (amylase;lipase;protease)
- External IDs
- EUR-1008
- EUR-1066
- SA-001
Pharmacology
- Indication
The use of pancrelipase amylase is part of the pancreatic enzyme replacement therapy. This therapy is indicated for the treatment of pancreatic insufficiency attributed to cystic fibrosis, chronic pancreatitis or any other medically defined pancreatic disease that might require it.2,1 Pancreatic diseases are associated with the deterioration of pancreatic parenchyma and of the dual physiological functions of the pancreas. Once established, pancreatic insufficiency results in malnutrition, weight loss, and steatorrhea.3
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
- Associated Therapies
- Contraindications & Blackbox Warnings
Avoid life-threatening adverse drug eventsImprove clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events & improve clinical decision support.- Pharmacodynamics
The major maldigestion/malabsorption problems arise from incomplete fat digestion. In clinical trials, the administration of pancrelipase as a mixture of amylase, lipase, and protease demonstrated a significant improvement in the coefficient of fat absorption and nitrogen absorption. These effects are accompanied by increased in body weight and body mass index.2
- Mechanism of action
Pancrelipase is used to replace the deficiency of pancreatic enzymes. As abovementioned, pancrelipase is formed by a mixture of lipase, protease, and amylase which are able to break down fat, protein, and starches, respectively, in the small intestine.4 For a more specific description of each mechanism of action, please visit Pancrelipase amylase, Pancrelipase protease and Pancrelipase lipase.
Target Actions Organism ADietary fat cleavageHumans ADietary protein cleavageHumans ADietary starch cleavageHumans - Absorption
Pancrelipase acts locally in the GI tract and it is not absorbed in any significant amount.7
- Volume of distribution
Pancrelipase acts locally in the GI tract and it is not absorbed in any significant amount thus, the volume of distribution is not relevant.7
- Protein binding
Pancrelipase acts locally in the GI tract and it is not absorbed in any significant amount thus, the protein binding is not relevant.7
- Metabolism
Pancrelipase acts locally in the GI tract and it is not absorbed in any significant amount thus, the metabolism is not relevant.7
- Route of elimination
Pancrelipase is entirely eliminated in the feces.7
- Half-life
Pancrelipase acts locally in the GI tract and it is not absorbed in any significant amount thus, the elimination half-life is not relevant.7
- Clearance
Pancrelipase acts locally in the GI tract and it is not absorbed in any significant amount thus, the clearance rate is not relevant.7
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
The studies of the toxicology of pancrelipase are not needed as this drug has been used clinically for a long time.8 Clinical overdose studies proved no effect on lungs, pancreas, liver and kidneys but it can produce symptoms such as diarrhea or stomach upset. Carcinogenicity studies have not shown any increased incidence with the use of pancrelipase. As pancrelipase is not absorbed, the effect on fetal development or reproduction is not expected.9
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareFerric ammonium citrate Pancrelipase can cause a decrease in the absorption of Ferric ammonium citrate resulting in a reduced serum concentration and potentially a decrease in efficacy. Ferric cation Pancrelipase can cause a decrease in the absorption of Ferric cation resulting in a reduced serum concentration and potentially a decrease in efficacy. Ferric maltol Pancrelipase can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy. Ferric sulfate Pancrelipase can cause a decrease in the absorption of Ferric sulfate resulting in a reduced serum concentration and potentially a decrease in efficacy. Ferrous bisglycinate Pancrelipase can cause a decrease in the absorption of Ferrous bisglycinate resulting in a reduced serum concentration and potentially a decrease in efficacy. Ferrous fumarate Pancrelipase can cause a decrease in the absorption of Ferrous fumarate resulting in a reduced serum concentration and potentially a decrease in efficacy. Ferrous gluconate Pancrelipase can cause a decrease in the absorption of Ferrous gluconate resulting in a reduced serum concentration and potentially a decrease in efficacy. Ferrous succinate Pancrelipase can cause a decrease in the absorption of Ferrous succinate resulting in a reduced serum concentration and potentially a decrease in efficacy. Ferrous sulfate anhydrous Pancrelipase can cause a decrease in the absorption of Ferrous sulfate anhydrous resulting in a reduced serum concentration and potentially a decrease in efficacy. Ferumoxides Pancrelipase can cause a decrease in the absorption of Ferumoxides resulting in a reduced serum concentration and potentially a decrease in efficacy. 
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- Drink plenty of fluids.
- Take with fluids.
- Take with food. If swallowing the oral capsule is not tolerated, sprinkle on acidic soft foods with a pH of 4 or less.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- International/Other Brands
- Cotazym (Organon) / Ku-Zyme (Koichi) / Pancrease (Ortho-McNeil) / Ultrase (Axcan Scandipharm) / Ultresa (delayed-release enteric coated capsules) (APTALIS PHARMA US) / Viokace (tablets) (APTALIS PHARMA US) / Zymase (Organon)
- Over the Counter Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Bio-zyme Tab 50mg Tablet 50 mg Oral Metagenics, Inc. 1997-01-27 2012-08-07 Canada 
CREON 10,000 CAPSULE Capsule Oral ABBOTT LABORATORIES (M) SDN. BHD. 2020-09-08 Not applicable Malaysia 
CREON 40000 Capsule 400 mg Oral บริษัท แอ๊บบอต ลาบอแรตอรีส จำกัด 2010-12-20 Not applicable Thailand 
Pancreatin Tab 400mg Tablet 400 mg / tab Oral Jamieson Laboratories Ltd 1979-12-31 2000-09-08 Canada Pancrex Granules 1 g / g Oral Paines and Byrne Ltd. 1953-12-31 1996-08-21 Canada Pancrex V Capsules Capsule 340 mg / cap Oral Paines and Byrne Ltd. 1962-12-31 1996-08-21 Canada Pancrex V Forte Tablets 1gm/tab Tablet, delayed release 1 g / tab Oral Paines and Byrne Ltd. 1955-12-31 1996-08-21 Canada Pancrex V Powder Powder Oral Paines and Byrne Ltd. 1955-12-31 1996-08-21 Canada Pancrex V Tab 0.33gm Tablet, delayed release 330 mg / tab Oral Paines and Byrne Ltd. 1955-12-31 1996-08-21 Canada Phytozyme Tab 150mg Tablet 150 mg Oral Phyto Health Corporation 1976-12-31 2008-07-21 Canada - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Alka-pan Tablets Pancrelipase (135 mg) + Betaine hydrochloride (20 mg) + Bromelains (50 mg) + Ox bile extract (35 mg) + Papaya (125 mg) Tablet Oral Morter Healthsystem Not applicable Not applicable Canada BONDIGEST COMPLEX® TABLETAS Pancrelipase (170 mg) + Mosapride Citrate (5 mg) + Simethicone (125 mg) Tablet, coated Oral 2008-10-01 Not applicable Colombia 
DIMOFLAX® ENZIMATICO TABLETAS RECUBIERTAS Pancrelipase (150 mg) + Levosulpiride (25 mg) + Simethicone (80 mg) Tablet, delayed release Oral C.I. FARMACAPSULAS S.A.S - PLANTA NO. 2 2016-12-07 Not applicable Colombia Duchol Ect Pancrelipase (200 mg) + Dehydrocholic acid (30 mg) + Deoxycholic acid (30 mg) + Pepsin (200 mg) + Sodium taurocholate (100 mg) Tablet, delayed release Oral Duchesnay Inc. 1977-12-31 2003-07-18 Canada Dygest Pancrelipase (200 mg) + Betaine hydrochloride (90 mg) + Ox bile extract (75 mg) + Papain (100 mg) + Peppermint (50 mg) + Pepsin (125 mg) Tablet Oral Creative Nutrition Canada Corp. 1987-12-31 2007-07-11 Canada Enzyme Tablets Pancrelipase (100 mg) + Betaine hydrochloride (65 mg) + Ox bile extract (8.125 mg) + Pancrelipase amylase (130 mg) + Papain (65 mg) + Pepsin (65 mg) Tablet Oral General Nutrition Canada Inc. 2001-10-20 2007-08-01 Canada Festal Plus Pancrelipase (315 mg/1) + Dimethicone (30 mg/1) + Ursodeoxycholic acid (10 mg/1) Tablet Oral OASIS TRADING 2018-11-21 Not applicable US 
FLATOL® Pancrelipase (175 mg) + Aspergillus niger var. niger (50 mg) + Ox bile extract (25 mg) + Simethicone (40 mg) Tablet, coated Oral FABRIFARMA S.A. 2018-04-23 Not applicable Colombia GASZYM Pancrelipase (200 MG) + Simethicone (40 MG) Tablet, film coated Oral บริษัท โอลิค (ประเทศไทย) จำกัด 1998-11-16 Not applicable Thailand INTESTAL ENTERIK KAPLI ,120 DRAJE Pancrelipase (59.4 mg) + Activated charcoal (71.1 mg) + Ox bile extract (21.3 mg) Tablet, coated Oral FARMAKO ECZACILIK A.Ş. 2020-08-14 Not applicable Turkey 
- Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Festal Plus Pancrelipase (315 mg/1) + Dimethicone (30 mg/1) + Ursodeoxycholic acid (10 mg/1) Tablet Oral OASIS TRADING 2018-11-21 Not applicable US KREON 8000 IU KAPSUL, 20 ADET Pancrelipase (8000 iu) Capsule Oral DR.F.FRIK 2020-08-14 Not applicable Turkey KREON KAPSUL 25000 300 MG 100 KAPSUL Pancrelipase (25000 iu) Capsule Oral ABBOTT LABORATUARLARI İTHALAT İHRACAT VE TİC. LTD. ŞTİ. 2020-08-14 Not applicable Turkey Stozyme Pancrelipase (36.46 1/1001) + Dimethicone (5.21 1/1001) + Hemicellulase (10.42 1/1001) + Ox bile extract (5.21 1/1001) Tablet Oral Chunwoo Pharmaceutical Co., Ltd. 2019-10-19 Not applicable US
Categories
- ATC Codes
- A09AA02 — Multienzymes (lipase, protease etc.)
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- FQ3DRG0N5K
- CAS number
- 53608-75-6
References
- General References
- Kuhn RJ, Gelrud A, Munck A, Caras S: CREON (Pancrelipase Delayed-Release Capsules) for the treatment of exocrine pancreatic insufficiency. Adv Ther. 2010 Dec;27(12):895-916. doi: 10.1007/s12325-010-0085-7. Epub 2010 Nov 15. [Article]
- Nakajima K, Oshida H, Muneyuki T, Kakei M: Pancrelipase: an evidence-based review of its use for treating pancreatic exocrine insufficiency. Core Evid. 2012;7:77-91. doi: 10.2147/CE.S26705. Epub 2012 Jul 19. [Article]
- Dominguez Munoz JE: Diagnosis of chronic pancreatitis: Functional testing. Best Pract Res Clin Gastroenterol. 2010 Jun;24(3):233-41. doi: 10.1016/j.bpg.2010.03.008. [Article]
- Shorr R., Hoth A. and Rawls N. (2007). Drugs for the Geriatric Patient. Elsevier. [ISBN:978-1-4160-0208-6]
- Creon monograph [Link]
- FDA approval [Link]
- FDA reports [Link]
- CENTER FOR DRUG EVALUATION AND RESEARCH- 20755 [Link]
- EMA reports [Link]
- External Links
- UniProt
- P04746
- Genbank
- M18785
- KEGG Drug
- D05349
- PubChem Substance
- 46504728
- 235379
- ChEMBL
- CHEMBL2108074
- PharmGKB
- PA448428
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Pancreatic_enzymes_(medication)
- FDA label
- Download (79.5 KB)
- MSDS
- Download (42.5 KB)
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Active Not Recruiting Treatment Exocrine Pancreatic Insufficiency 1 4 Completed Treatment Cystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency 2 4 Completed Treatment Gastric Resection 1 4 Completed Treatment Irritable Bowel Syndrome (IBS) 1 4 Enrolling by Invitation Prevention Bifidobacteri / Colon Polyps / Combizym 1 4 Not Yet Recruiting Treatment Patients With Dyspeptic Symptoms After Cholecystectomy 1 4 Recruiting Treatment Cystic Fibrosis (CF) 1 4 Recruiting Treatment Cystic Fibrosis (CF) / Pancreatitis, Chronic 1 4 Terminated Supportive Care Cystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency / Pancreatitis, Chronic 1 4 Terminated Treatment Gluten Enteropathy 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Axcan Pharma Inc.
- Confab Laboratories Inc.
- Eurand Pharmaceuticals Inc.
- Global Pharmaceuticals
- Kaiser Foundation Hospital
- Ortho Mcneil Janssen Pharmaceutical Inc.
- Ortho-McNeil-Janssen Pharmaceuticals Inc.
- Physicians Total Care Inc.
- Schwarz Pharma Inc.
- Solvay Pharmaceuticals
- X-Gen Pharmaceuticals
- Yung Shin Pharmaceutical Industry Ltd.
- Dosage Forms
Form Route Strength Tablet Oral 50 mg Capsule, delayed release Oral 20000 USP Capsule, delayed release Oral 30000 USP Capsule, delayed release Oral 40000 USP Capsule, coated, extended release Oral 150 mg Capsule, coated, extended release Oral 300 mg Capsule, coated, extended release Oral 400 mg Capsule, coated pellets Oral 150 MG Capsule Oral 400 mg Granule Oral 60.12 mg Capsule, coated Oral 300 mg Capsule, coated Oral 150 mg Capsule, delayed release Oral 420 mg Capsule Oral 209.3 mg Capsule Oral 334.9 mg Capsule Oral 39.8 mg Capsule Oral 83.7 mg Tablet, delayed release Oral Tablet Oral Tablet, sugar coated Oral Tablet, coated Oral Capsule, delayed release Oral 10000 USP Capsule Oral Capsule, delayed release Oral 25000 USP Capsule, coated pellets Oral 25000 iu Capsule, delayed release Oral 35000 USP Capsule, coated pellets Oral 40000 iu Granule, delayed release Oral 50000 USP Granule Oral Tablet, film coated Oral 10000 USP Tablet Oral 400 mg / tab Powder Not applicable 1 kg/1kg Capsule Oral 340 mg / cap Tablet, delayed release Oral 1 g / tab Powder Oral Tablet, delayed release Oral 330 mg / tab Tablet, film coated Oral 20000 USP Capsule, delayed release Oral 36000 USP Granule Oral Tablet, coated Oral Tablet Oral 50000 USP Tablet Oral 150 mg Capsule, coated Oral Tablet, delayed release Oral Tablet, film coated Oral Capsule Oral 150 mg Capsule - Prices
Unit description Cost Unit Creon 24000 unit Enteric Coated Capsule 3.32USD capsule Ultrase MT 20 65-20-65mu Enteric Coated Capsule 3.06USD capsule Pancrease MT 20 56-20-44mu Enteric Coated Capsule 2.99USD capsule Creon 20 66.4-20-75mu Enteric Coated Capsule 2.83USD capsule Ultrase MT 18 58.5-18-58.5mu Enteric Coated Capsule 2.65USD capsule Pancrease MT 16 48-16-48mu Enteric Coated Capsule 2.4USD capsule Pancrelipase 16000 48-16-48mu Enteric Coated Capsule 2.02USD capsule Ultrase MT 12 39-12-39mu Enteric Coated Capsule 1.65USD capsule Creon 10 33.2-10-37.5mu Enteric Coated Capsule 1.54USD capsule Pancrease MT 10 30-10-30mu Enteric Coated Capsule 1.49USD capsule Pancrelipase 10000 30-10-30mu Enteric Coated Capsule 1.38USD capsule Pancrelipase MST-16 48-16-48mu Enteric Coated Capsule 1.03USD capsule Pancrease 4500 unit Enteric Coated Capsule 0.87USD capsule Creon 5 16.6-5-18.75mu Enteric Coated Capsule 0.86USD capsule Ultrase 4500 unit Enteric Coated Capsule 0.8USD capsule Pancrease ec capsule 0.76USD capsule Pancrelipase ec 4500 capsule 0.64USD capsule DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.- Patents
Patent Number Pediatric Extension Approved Expires (estimated) Region US9198871 No 2015-12-01 2030-02-07 US US8562979 No 2013-10-22 2028-02-20 US US8562980 No 2013-10-22 2028-02-20 US US8562981 No 2013-10-22 2028-02-20 US US8221747 No 2012-07-17 2028-02-20 US US8562978 No 2013-10-22 2028-02-20 US US8246950 No 2012-08-21 2028-02-20 US US7658918 No 2010-02-09 2028-02-20 US
Properties
- State
- Solid
- Experimental Properties
Property Value Source melting point (°C) 48-50 °C Vinogradov, A.A. et al., Protein Eng. 14:683-689 (2001) water solubility 1 mg/ml Monograph
Targets
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1. Dietary fat
Yes
Cleavage
References
- Svendsen A: Lipase protein engineering. Biochim Biophys Acta. 2000 Dec 29;1543(2):223-238. [Article]
2. Dietary protein
Yes
Cleavage
References
- Rawlings ND, Barrett AJ: Families of serine peptidases. Methods Enzymol. 1994;244:19-61. [Article]
3. Dietary starch
Yes
Cleavage
References
- Udani J, Hardy M, Madsen DC: Blocking carbohydrate absorption and weight loss: a clinical trial using Phase 2 brand proprietary fractionated white bean extract. Altern Med Rev. 2004 Mar;9(1):63-9. [Article]
Drug created at June 13, 2005 13:24 / Updated at December 01, 2021 01:05