Pancrelipase
Identification
- Name
- Pancrelipase
- Accession Number
- DB00085 (BTD00067, BIOD00067, DB05356)
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Other protein based therapies - Description
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.
- Protein chemical formula
- Not Available
- Protein average weight
- 131000.0 Da
- Sequences
- Not Available
- Synonyms
- Pancrealipase
- Pancreatic extract pancrelipase
- Pancreatic protease
- Pancreatin
- Pancreatinum
- Pancrelipase (amylase;lipase;protease)
- External IDs
- EUR-1008 / EUR-1066 / SA-001
- Over the Counter Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Unlock Additional DataBio-zyme Tab 50mg Tablet Oral Metagenics, Inc. 1997-01-27 2012-08-07 Canada 
Pancreatin Tab 400mg Tablet Oral Jamieson Laboratories Ltd 1979-12-31 2000-09-08 Canada Pancrex Granules Oral Paines and Byrne Ltd. 1953-12-31 1996-08-21 Canada Pancrex V Capsules Capsule Oral Paines and Byrne Ltd. 1962-12-31 1996-08-21 Canada Pancrex V Forte Tablets 1gm/tab Tablet, delayed release 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 Oral Paines and Byrne Ltd. 1955-12-31 1996-08-21 Canada Phytozyme Tab 150mg Tablet Oral Phyto Health Corporation 1976-12-31 2008-07-21 Canada Additional Data Available- Application NumberApplication Number
A unique ID assigned by the FDA when a product is submitted for approval by the labeller.
Learn more - Product CodeProduct Code
A governmentally-recognized ID which uniquely identifies the product within its regulatory market.
Learn more
- Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Alka-pan Tablets Pancrelipase (135 mg) + Bromelains (50 mg) + Betaine hydrochloride (20 mg) + Ox bile extract (35 mg) + Papaya (125 mg) Tablet Oral Morter Healthsystem Not applicable Not applicable Canada 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 
Medichol Pancrelipase (200 mg) + Dehydrocholic acid (30 mg) + Deoxycholic acid (30 mg) + Pepsin (200 mg) + Sodium taurocholate (100 mg) Tablet Oral Medic Laboratory LtÉe 1959-12-31 2007-10-22 Canada Neo Life Enzyme Tab Pancrelipase (200 mg) + Papain (50 mg) + Pepsin (125 mg) Tablet Oral Golden Neo Life International Ltd. 1979-12-31 1997-08-01 Canada Pancreatin and Enzyme Formula - Tablet Pancrelipase (350 mg) + Bromelains (50 mg) + Ox bile extract (5 mg) + Pancrelipase lipase (50 mg) + Pepsin (100 mg) Tablet Oral Health Wise Nutrition Inc. 1997-08-15 2000-07-29 Canada Pancreatine Enzymes Pancrelipase (300 mg) + Pancrelipase lipase (50 mg) + Pepsin (100 mg) Tablet Oral Gahler Enterprises Ltd. 1984-12-31 2002-07-17 Canada Pro Gest Tab Pancrelipase (11.4 mg) + Betaine hydrochloride (105.3 mg) + Papain (64.8 mg) + Pepsin (32.4 mg) + Sodium taurocholate (64.8 mg) Tablet Oral Pure Life International Prods Inc. 1992-12-31 2000-07-27 Canada - Unapproved/Other Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End 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 - 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)
- Categories
- UNII
- FQ3DRG0N5K
- CAS number
- 53608-75-6
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
- Associated Conditions
- 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
- 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
- Affected organisms
- Humans and other mammals
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.
Learn moreStructured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.
Learn moreStructured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.
Learn moreInteractions
- 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 Unlock Additional DataFerric 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 hydroxide Pancrelipase can cause a decrease in the absorption of Ferric hydroxide 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 oxide Pancrelipase can cause a decrease in the absorption of Ferric oxide resulting in a reduced serum concentration and potentially a decrease in efficacy. Ferric oxyhydroxide Pancrelipase can cause a decrease in the absorption of Ferric oxyhydroxide 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 chloride Pancrelipase can cause a decrease in the absorption of Ferrous chloride 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. Additional Data Available- Extended DescriptionExtended Description
Extended description of the mechanism of action and particular properties of each drug interaction.
Learn more - Severity
- Evidence Level
- ActionAction
An effect category for each drug interaction. Know how this interaction affects the subject drug.
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- Food Interactions
- 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.
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. [PubMed:21086085]
- 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. [PubMed:22936895]
- 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. [PubMed:20510825]
- 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
- RxNav
- 235379
- ChEMBL
- CHEMBL2108074
- PharmGKB
- PA448428
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Pancrelipase
- ATC Codes
- A09AA02 — Multienzymes (lipase, protease etc.)
- AHFS Codes
- 56:16.00 — Digestants
- FDA label
- Download (79.5 KB)
- MSDS
- Download (42.5 KB)
Clinical Trials
- Clinical Trials
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, delayed release Oral Tablet Oral Tablet Oral Powder Not applicable 1 kg/1kg Capsule Oral Tablet, delayed release Oral Powder Oral - 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) Unlock Additional DataUS9198871 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 Additional Data Available- Filed On
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
Taxonomy
- 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
Targets
References
- Svendsen A: Lipase protein engineering. Biochim Biophys Acta. 2000 Dec 29;1543(2):223-238. [PubMed:11150608]
References
- Rawlings ND, Barrett AJ: Families of serine peptidases. Methods Enzymol. 1994;244:19-61. [PubMed:7845208]
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. [PubMed:15005645]
Drug created on June 13, 2005 07:24 / Updated on July 06, 2020 07:41
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