Pancrelipase

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

Pharmacology
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Associated Conditions
Associated Therapies
Contraindications & Blackbox Warnings
Contraindications
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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
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
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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.
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 maltolPancrelipase can cause a decrease in the absorption of Ferric maltol 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 fumaratePancrelipase can cause a decrease in the absorption of Ferrous fumarate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferrous gluconatePancrelipase can cause a decrease in the absorption of Ferrous gluconate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferrous succinatePancrelipase can cause a decrease in the absorption of Ferrous succinate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferrous sulfate anhydrousPancrelipase can cause a decrease in the absorption of Ferrous sulfate anhydrous resulting in a reduced serum concentration and potentially a decrease in efficacy.
FerumoxidesPancrelipase can cause a decrease in the absorption of Ferumoxides resulting in a reduced serum concentration and potentially a decrease in efficacy.
Interactions
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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.

Products

Products
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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
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Bio-zyme Tab 50mgTablet50 mgOralMetagenics, Inc.1997-01-272012-08-07Canada flag
CREON 10,000 CAPSULECapsuleOralABBOTT LABORATORIES (M) SDN. BHD.2020-09-08Not applicableMalaysia flag
CREON 40000Capsule400 mgOralบริษัท แอ๊บบอต ลาบอแรตอรีส จำกัด2010-12-20Not applicableThailand flag
Pancreatin Tab 400mgTablet400 mg / tabOralJamieson Laboratories Ltd1979-12-312000-09-08Canada flag
Pancrex Granules1 g / gOralPaines and Byrne Ltd.1953-12-311996-08-21Canada flag
Pancrex V CapsulesCapsule340 mg / capOralPaines and Byrne Ltd.1962-12-311996-08-21Canada flag
Pancrex V Forte Tablets 1gm/tabTablet, delayed release1 g / tabOralPaines and Byrne Ltd.1955-12-311996-08-21Canada flag
Pancrex V PowderPowderOralPaines and Byrne Ltd.1955-12-311996-08-21Canada flag
Pancrex V Tab 0.33gmTablet, delayed release330 mg / tabOralPaines and Byrne Ltd.1955-12-311996-08-21Canada flag
Phytozyme Tab 150mgTablet150 mgOralPhyto Health Corporation1976-12-312008-07-21Canada flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Alka-pan TabletsPancrelipase (135 mg) + Betaine hydrochloride (20 mg) + Bromelains (50 mg) + Ox bile extract (35 mg) + Papaya (125 mg)TabletOralMorter HealthsystemNot applicableNot applicableCanada flag
BONDIGEST COMPLEX® TABLETASPancrelipase (170 mg) + Mosapride Citrate (5 mg) + Simethicone (125 mg)Tablet, coatedOral2008-10-01Not applicableColombia flag
DIMOFLAX® ENZIMATICO TABLETAS RECUBIERTASPancrelipase (150 mg) + Levosulpiride (25 mg) + Simethicone (80 mg)Tablet, delayed releaseOral2016-12-07Not applicableColombia flag
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 flag
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 flag
ENZIMAR ENZIMATICOPancrelipase (150 mg) + Metoclopramide (6 mg) + Simethicone (50 mg)Tablet, coatedOral2006-11-10Not applicableColombia flag
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 flag
Festal PlusPancrelipase (315 mg/1) + Dimethicone (30 mg/1) + Ursodeoxycholic acid (10 mg/1)TabletOralOASIS TRADING2018-11-21Not applicableUS flag
FLATOL®Pancrelipase (175 mg) + Aspergillus niger var. niger (50 mg) + Ox bile extract (25 mg) + Simethicone (40 mg)Tablet, coatedOral2018-04-23Not applicableColombia flag
GASZYMPancrelipase (200 MG) + Simethicone (40 MG)Tablet, film coatedOralบริษัท โอลิค (ประเทศไทย) จำกัด1998-11-16Not applicableThailand flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Festal PlusPancrelipase (315 mg/1) + Dimethicone (30 mg/1) + Ursodeoxycholic acid (10 mg/1)TabletOralOASIS TRADING2018-11-21Not applicableUS flag
KREON 8000 IU KAPSUL, 20 ADETPancrelipase (8000 iu)CapsuleOralDR.F.FRIK2020-08-14Not applicableTurkey flag
KREON KAPSUL 25000 300 MG 100 KAPSULPancrelipase (25000 iu)CapsuleOralABBOTT LABORATUARLARI İTHALAT İHRACAT VE TİC. LTD. ŞTİ.2020-08-14Not applicableTurkey flag
StozymePancrelipase (36.46 1/1001) + Dimethicone (5.21 1/1001) + Hemicellulase (10.42 1/1001) + Ox bile extract (5.21 1/1001)TabletOralChunwoo Pharmaceutical Co., Ltd.2019-10-19Not applicableUS flag

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
  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. [Article]
  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. [Article]
  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. [Article]
  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]
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
Pancreatic_enzymes_(medication)
AHFS Codes
  • 56:16.00 — Digestants
FDA label
Download (79.5 KB)
MSDS
Download (42.5 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingTreatmentExocrine Pancreatic Insufficiency1
4CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency2
4CompletedTreatmentGastric Resection1
4CompletedTreatmentIrritable Bowel Syndrome (IBS)1
4Enrolling by InvitationPreventionBifidobacteri / Colon Polyps / Combizym1
4Not Yet RecruitingTreatmentExocrine Pancreatic Insufficiency1
4Not Yet RecruitingTreatmentPatients With Dyspeptic Symptoms After Cholecystectomy1
4RecruitingTreatmentCystic Fibrosis (CF)1
4TerminatedSupportive CareCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency / Pancreatitis, Chronic1
4TerminatedTreatmentGluten Enteropathy1

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
TabletOral50 mg
Capsule, coated, extended releaseOral
CapsuleOral400 mg
Capsule, coatedOral300 mg
Capsule, coatedOral150 mg
Capsule, delayed releaseOral
Tablet, delayed releaseOral
TabletOral
Tablet, sugar coatedOral
CapsuleOral
Capsule, coated pellets
Granule, delayed releaseOral
GranuleOral
Tablet, film coatedOral
TabletOral400 mg / tab
PowderNot applicable1 kg/1kg
CapsuleOral340 mg / cap
Tablet, delayed releaseOral1 g / tab
PowderOral
Tablet, delayed releaseOral330 mg / tab
GranuleOral
Tablet, coatedOral
TabletOral
TabletOral150 mg
Capsule, coatedOral
Tablet, coatedOral
Tablet, film coatedOral
Tablet, delayed releaseOral
CapsuleOral150 mg
Capsule
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)Region
US9198871No2015-12-012030-02-07US flag
US8562979No2013-10-222028-02-20US flag
US8562980No2013-10-222028-02-20US flag
US8562981No2013-10-222028-02-20US flag
US8221747No2012-07-172028-02-20US flag
US8562978No2013-10-222028-02-20US flag
US8246950No2012-08-212028-02-20US flag
US7658918No2010-02-092028-02-20US flag

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

Targets

Drugtargets
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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. [Article]
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. [Article]
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. [Article]

Drug created on June 13, 2005 13:24 / Updated on May 15, 2021 12:14