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
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Bio-zyme Tab 50mg	Tablet	50 mg	Oral	Metagenics, Inc.	1997-01-27	2012-08-07
Pancreatin Tab 400mg	Tablet	400 mg	Oral	Jamieson Laboratories Ltd	1979-12-31	2000-09-08
Pancrex Granules		1 g	Oral	Paines and Byrne Ltd.	1953-12-31	1996-08-21
Pancrex V Capsules	Capsule	340 mg	Oral	Paines and Byrne Ltd.	1962-12-31	1996-08-21
Pancrex V Forte Tablets 1gm/tab	Tablet, delayed release	1 g	Oral	Paines and Byrne Ltd.	1955-12-31	1996-08-21
Pancrex V Powder	Powder		Oral	Paines and Byrne Ltd.	1955-12-31	1996-08-21
Pancrex V Tab 0.33gm	Tablet, delayed release	330 mg	Oral	Paines and Byrne Ltd.	1955-12-31	1996-08-21
Phytozyme Tab 150mg	Tablet	150 mg	Oral	Phyto Health Corporation	1976-12-31	2008-07-21

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Application Number

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Product Code

A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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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
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
Festal Plus	Pancrelipase (315 mg/1) + Dimethicone (30 mg/1) + Ursodeoxycholic acid (10 mg/1)	Tablet	Oral	OASIS TRADING	2018-11-21	Not applicable
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
Zypanax	Pancrelipase (90 mg) + Ammonium chloride (9 mg) + Betaine hydrochloride (165 mg) + Pepsin (.03 mg)	Tablet	Oral	Therapeutic Foods Co.	1980-04-02	1996-09-09

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

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	cleavage	Humans
ADietary protein	cleavage	Humans
ADietary starch	cleavage	Humans

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Adverse Effects

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Contraindications

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Blackbox Warnings

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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

Interactions

Drug Interactions

Drug	Interaction
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Ferric 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 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.
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.

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Extended Description

Extended description of the mechanism of action and particular properties of each drug interaction.

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Severity

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Food Interactions

Delayed release capsules should not be broken or crushed, but for those patients who cannot swallow the capsules, sprinkle the contents of the capsule onto soft acidic foods (pH of ≤4.5). Alkaline foods with a higher pH will promote early release of pancrelipase followed by enzyme inactivation in the stomach.
Multivitamins/minerals which have vitamins ADEK, folate, or iron: If pancrelipase is used in combination with multivitamins/minerals that have vitamins ADEK, folate, or iron then monitor therapy because pancrelipase may decrease absorption of iron in these multivitamin/mineral products.
Take pancrelipase with meals and a sufficient amount of water.

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
ChEMBL: CHEMBL2108074
PharmGKB: PA448428
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

Phase	Status	Purpose	Conditions	Count
1	Unknown Status	Treatment	Pancreatitis, Chronic	1
1, 2	Recruiting	Treatment	Malignant Neoplasm of Pancreas / Pancreatic enzyme abnormality / Pancreatic Insufficiency	1
2	Completed	Diagnostic	Pancreatitis, Chronic	1
2	Completed	Treatment	Conjunctivitis, Seasonal Allergic	1
2	Completed	Treatment	Poisoning by BCG Vaccine	1
2	Completed	Treatment	Pulmonary Tuberculosis (TB)	1
2	Recruiting	Supportive Care	Malignant Neoplasm of Pancreas	1
2	Withdrawn	Treatment	Pancreatitis	1
3	Active Not Recruiting	Treatment	Pulmonary Tuberculosis (TB)	1
3	Completed	Treatment	Cystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency	2
3	Completed	Treatment	Cystic Fibrosis (CF) / Pancreatic Insufficiency	1
3	Completed	Treatment	Exocrine Pancreatic Insufficiency, Chronic Pancreatitis	1
3	Completed	Treatment	Exocrine Pancreatic Insufficiency / Pancreatitis, Chronic	1
3	Completed	Treatment	Pancreatic Exocrine Insufficiency	1
3	Completed	Treatment	Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy	1
3	Completed	Treatment	Pancreatic Insufficiency	1
4	Completed	Treatment	Crohn's Disease (CD) / Ulcerative Colitis (UC)	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	Treatment	Gluten Enteropathy	1
4	Not Yet Recruiting	Treatment	Exocrine Pancreatic Insufficiency (EPI)	1
4	Terminated	Supportive Care	Cystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency / Pancreatitis, Chronic	1
Not Available	Completed	Treatment	Cystic Fibrosis (CF)	1
Not Available	Recruiting	Not Available	Fibrosing colonopathy / Fibrosing Colonopathy in Patients With Cystic Fibrosis	1
Not Available	Terminated	Not Available	Exocrine Pancreatic Insufficiency	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
Tablet	Oral
Tablet	Oral	400 mg
Powder	Not applicable	1 kg/1kg
Capsule	Oral	340 mg
Tablet, delayed release	Oral	1 g
Powder	Oral
Tablet, delayed release	Oral	330 mg
Tablet	Oral	150 mg

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)
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US9198871	No	2015-12-01	2030-02-07
US8562979	No	2013-10-22	2028-02-20
US8562980	No	2013-10-22	2028-02-20
US8562981	No	2013-10-22	2028-02-20
US8221747	No	2012-07-17	2028-02-20
US8562978	No	2013-10-22	2028-02-20
US8246950	No	2012-08-21	2028-02-20
US7658918	No	2010-02-09	2028-02-20

Additional Data Available

Filed On

The date on which a patent was filed with the relevant government.

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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

1. Dietary fat

Kind

Group

Organism

Humans

Pharmacological action

Yes

Actions

Cleavage

References

Svendsen A: Lipase protein engineering. Biochim Biophys Acta. 2000 Dec 29;1543(2):223-238. [PubMed:11150608]

2. Dietary protein

Kind

Group

Organism

Humans

Pharmacological action

Yes

Actions

Cleavage

References

Rawlings ND, Barrett AJ: Families of serine peptidases. Methods Enzymol. 1994;244:19-61. [PubMed:7845208]

3. Dietary starch

Kind

Group

Organism

Humans

Pharmacological action

Yes

Actions

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. [PubMed:15005645]

Drug created on June 13, 2005 07:24 / Updated on July 18, 2019 18:45