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
NameDosageStrengthRouteLabellerMarketing StartMarketing End
Bio-zyme Tab 50mgTabletOralMetagenics, Inc.1997-01-272012-08-07Canada
Pancreatin Tab 400mgTabletOralJamieson Laboratories Ltd1979-12-312000-09-08Canada
Pancrex GranulesOralPaines and Byrne Ltd.1953-12-311996-08-21Canada
Pancrex V CapsulesCapsuleOralPaines and Byrne Ltd.1962-12-311996-08-21Canada
Pancrex V Forte Tablets 1gm/tabTablet, delayed releaseOralPaines and Byrne Ltd.1955-12-311996-08-21Canada
Pancrex V PowderPowderOralPaines and Byrne Ltd.1955-12-311996-08-21Canada
Pancrex V Tab 0.33gmTablet, delayed releaseOralPaines and Byrne Ltd.1955-12-311996-08-21Canada
Phytozyme Tab 150mgTabletOralPhyto Health Corporation1976-12-312008-07-21Canada
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

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

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Alka-pan TabletsPancrelipase (135 mg) + Bromelains (50 mg) + Betaine hydrochloride (20 mg) + Ox bile extract (35 mg) + Papaya (125 mg)TabletOralMorter HealthsystemNot applicableNot applicableCanada
Duchol EctPancrelipase (200 mg) + Dehydrocholic acid (30 mg) + Deoxycholic acid (30 mg) + Pepsin (200 mg) + Sodium taurocholate (100 mg)Tablet, delayed releaseOralDuchesnay Inc.1977-12-312003-07-18Canada
DygestPancrelipase (200 mg) + Betaine hydrochloride (90 mg) + Ox bile extract (75 mg) + Papain (100 mg) + Peppermint (50 mg) + Pepsin (125 mg)TabletOralCreative Nutrition Canada Corp.1987-12-312007-07-11Canada
Enzyme TabletsPancrelipase (100 mg) + Betaine hydrochloride (65 mg) + Ox bile extract (8.125 mg) + Pancrelipase amylase (130 mg) + Papain (65 mg) + Pepsin (65 mg)TabletOralGeneral Nutrition Canada Inc.2001-10-202007-08-01Canada
Festal PlusPancrelipase (315 mg/1) + Dimethicone (30 mg/1) + Ursodeoxycholic acid (10 mg/1)TabletOralOASIS TRADING2018-11-21Not applicableUs
MedicholPancrelipase (200 mg) + Dehydrocholic acid (30 mg) + Deoxycholic acid (30 mg) + Pepsin (200 mg) + Sodium taurocholate (100 mg)TabletOralMedic Laboratory LtÉe1959-12-312007-10-22Canada
Neo Life Enzyme TabPancrelipase (200 mg) + Papain (50 mg) + Pepsin (125 mg)TabletOralGolden Neo Life International Ltd.1979-12-311997-08-01Canada
Pancreatin and Enzyme Formula - TabletPancrelipase (350 mg) + Bromelains (50 mg) + Ox bile extract (5 mg) + Pancrelipase lipase (50 mg) + Pepsin (100 mg)TabletOralHealth Wise Nutrition Inc.1997-08-152000-07-29Canada
Pancreatine EnzymesPancrelipase (300 mg) + Pancrelipase lipase (50 mg) + Pepsin (100 mg)TabletOralGahler Enterprises Ltd.1984-12-312002-07-17Canada
Pro Gest TabPancrelipase (11.4 mg) + Betaine hydrochloride (105.3 mg) + Papain (64.8 mg) + Pepsin (32.4 mg) + Sodium taurocholate (64.8 mg)TabletOralPure Life International Prods Inc.1992-12-312000-07-27Canada
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Festal PlusPancrelipase (315 mg/1) + Dimethicone (30 mg/1) + Ursodeoxycholic acid (10 mg/1)TabletOralOASIS TRADING2018-11-21Not applicableUs
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.

TargetActionsOrganism
ADietary fat
cleavage
Humans
ADietary protein
cleavage
Humans
ADietary starch
cleavage
Humans
Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

Structured 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.

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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
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.
DrugInteraction
Ferric ammonium citratePancrelipase can cause a decrease in the absorption of Ferric ammonium citrate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferric cationPancrelipase can cause a decrease in the absorption of Ferric cation resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferric hydroxidePancrelipase can cause a decrease in the absorption of Ferric hydroxide resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferric maltolPancrelipase can cause a decrease in the absorption of Ferric maltol resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferric oxidePancrelipase can cause a decrease in the absorption of Ferric oxide resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferric oxyhydroxidePancrelipase can cause a decrease in the absorption of Ferric oxyhydroxide resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferric sulfatePancrelipase can cause a decrease in the absorption of Ferric sulfate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferrous bisglycinatePancrelipase can cause a decrease in the absorption of Ferrous bisglycinate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferrous chloridePancrelipase can cause a decrease in the absorption of Ferrous chloride resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferrous fumaratePancrelipase 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 Description
    Extended Description

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  • Severity
    Severity

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  • Evidence Level
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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
  1. 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]
  2. 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]
  3. 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]
  4. Shorr R., Hoth A. and Rawls N. (2007). Drugs for the Geriatric Patient. Elsevier. [ISBN:978-1-4160-0208-6]
  5. Creon monograph [Link]
  6. FDA approval [Link]
  7. FDA reports [Link]
  8. CENTER FOR DRUG EVALUATION AND RESEARCH- 20755 [Link]
  9. 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
PhaseStatusPurposeConditionsCount
1CompletedNot AvailableExocrine Pancreatic Insufficiency / Fat malabsorption / Pancreatitis / Pancreatitis, Chronic1
1RecruitingNot AvailableHealthy Volunteers1
1TerminatedTreatmentPancreatitis, Chronic2
1, 2RecruitingTreatmentMalignant Neoplasm of Pancreas / Pancreatic enzyme abnormality / Pancreatic Insufficiency1
2Active Not RecruitingTreatmentDry Eye Syndrome (DES)1
2CompletedDiagnosticPancreatitis, Chronic1
2CompletedTreatmentCystic Fibrosis (CF) / Fat malabsorption1
2TerminatedSupportive CareMalignant Neoplasm of Pancreas1
2WithdrawnTreatmentPancreatitis1
3CompletedTreatmentCystic Fibrosis (CF)1
3CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency3
3CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency / Fat malabsorption / Intestinal Malabsorption1
3CompletedTreatmentCystic Fibrosis (CF) / Pancreatic Exocrine Insufficiency2
3CompletedTreatmentCystic Fibrosis (CF) / Pancreatic Insufficiency3
3CompletedTreatmentExocrine Pancreatic Insufficiency, Chronic Pancreatitis1
3CompletedTreatmentExocrine Pancreatic Insufficiency: Cystic Fibrosis1
3CompletedTreatmentExocrine Pancreatic Insufficiency / Pancreatitis, Chronic1
3CompletedTreatmentPancreatic Exocrine Insufficiency1
3CompletedTreatmentPancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy1
3CompletedTreatmentPancreatic Exocrine Insufficiency / Pancreatitis, Chronic / Post-pancreatectomy1
3CompletedTreatmentPancreatic Insufficiency1
3CompletedTreatmentPostprandial Belching / Postprandial Bloating / Postprandial Eructation1
4CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency2
4CompletedTreatmentGastric Resection1
4CompletedTreatmentIrritable Bowel Syndrome (IBS)1
4Enrolling by InvitationPreventionBifidobacteri / Colon Polyps / Combizym1
4Not Yet RecruitingTreatmentExocrine Pancreatic Insufficiency (EPI)1
4RecruitingTreatmentCystic Fibrosis (CF)1
4RecruitingTreatmentExocrine Pancreatic Insufficiency (EPI)1
4TerminatedSupportive CareCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency / Pancreatitis, Chronic1
4TerminatedTreatmentGluten Enteropathy1
Not AvailableCompletedTreatmentCystic Fibrosis (CF)2
Not AvailableNot Yet RecruitingNot AvailableAdenocarcinoma of the Pancreas1
Not AvailableNot Yet RecruitingTreatmentLiver Cirrhosis1
Not AvailableRecruitingNot AvailableFibrosing colonopathy / Fibrosing Colonopathy in Patients With Cystic Fibrosis1
Not AvailableTerminatedNot AvailableExocrine Pancreatic Insufficiency1

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
FormRouteStrength
Tablet, delayed releaseOral
TabletOral
TabletOral
PowderNot applicable1 kg/1kg
CapsuleOral
Tablet, delayed releaseOral
PowderOral
Prices
Unit descriptionCostUnit
Creon 24000 unit Enteric Coated Capsule3.32USD capsule
Ultrase MT 20 65-20-65mu Enteric Coated Capsule3.06USD capsule
Pancrease MT 20 56-20-44mu Enteric Coated Capsule2.99USD capsule
Creon 20 66.4-20-75mu Enteric Coated Capsule2.83USD capsule
Ultrase MT 18 58.5-18-58.5mu Enteric Coated Capsule2.65USD capsule
Pancrease MT 16 48-16-48mu Enteric Coated Capsule2.4USD capsule
Pancrelipase 16000 48-16-48mu Enteric Coated Capsule2.02USD capsule
Ultrase MT 12 39-12-39mu Enteric Coated Capsule1.65USD capsule
Creon 10 33.2-10-37.5mu Enteric Coated Capsule1.54USD capsule
Pancrease MT 10 30-10-30mu Enteric Coated Capsule1.49USD capsule
Pancrelipase 10000 30-10-30mu Enteric Coated Capsule1.38USD capsule
Pancrelipase MST-16 48-16-48mu Enteric Coated Capsule1.03USD capsule
Pancrease 4500 unit Enteric Coated Capsule0.87USD capsule
Creon 5 16.6-5-18.75mu Enteric Coated Capsule0.86USD capsule
Ultrase 4500 unit Enteric Coated Capsule0.8USD capsule
Pancrease ec capsule0.76USD capsule
Pancrelipase ec 4500 capsule0.64USD capsule
DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US9198871No2015-12-012030-02-07Us
US8562979No2013-10-222028-02-20Us
US8562980No2013-10-222028-02-20Us
US8562981No2013-10-222028-02-20Us
US8221747No2012-07-172028-02-20Us
US8562978No2013-10-222028-02-20Us
US8246950No2012-08-212028-02-20Us
US7658918No2010-02-092028-02-20Us
Additional Data Available
  • Filed On
    Filed On

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

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Properties

State
Solid
Experimental Properties
PropertyValueSource
melting point (°C)48-50 °CVinogradov, A.A. et al., Protein Eng. 14:683-689 (2001)
water solubility1 mg/mlMonograph

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
  1. 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
  1. 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
  1. 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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