Pancrelipase protease

Identification

Summary

Pancrelipase protease is a lipase used to treat pancreatic exocrine insufficiency.

Brand Names
Cotazym, Creon, Pancrease MT, Pancreaze, Pertzye, Viokace, Zenpep
Generic Name
Pancrelipase protease
DrugBank Accession Number
DB11066
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.2 The pancrelipase protease is a mix of enzymes, formed by trypsin and chymotrypsin, that proteolytically cleave peptide bonds and are involved in food digestion.1,4 The pancrelipase mixture, including pancrelipase protease, was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010.3

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Other protein based therapies
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
>sp|P00761|TRYP_PIG Trypsin OS=Sus scrofa OX=9823 PE=1 SV=1
FPTDDDDKIVGGYTCAANSIPYQVSLNSGSHFCGGSLINSQWVVSAAHCYKSRIQVRLGE
HNIDVLEGNEQFINAAKIITHPNFNGNTLDNDIMLIKLSSPATLNSRVATVSLPRSCAAA
GTECLISGWGNTKSSGSSYPSLLQCLKAPVLSDSSCKSSYPGQITGNMICVGFLEGGKDS
CQGDSGGPVVCNGQLQGIVSWGYGCAQKNKPGVYTKVCNYVNWIQQTIAAN
>AEC11098.1 chymotrypsin C [Sus scrofa]
MLGITVLAALLAYASSCGVPSFPPNLSARVVGGENAVPHSWPWQISLQYLSGDTWKHTCG
GTLITSTHVLTAAHCISNSRTYRVALGKNNLEVEDEEGSLVVGVDSIFVHEKWNSLLIRN
DIALIKLAEPVELSDTIQVLCLPEEGSLLPQDYPCYVTGWGRLWTNGPIAAELQQGLQPV
VDHATCSQRDWWGSTVRDTMVCAGGDGVISACNGDSGGPLNCQAENGSWEVRGIVSFGSG
LGCNTYKKPTVFTRVSAYIDWIDQKIQL
Download FASTA Format
Synonyms
  • Protease, pancreatic

Pharmacology

Indication

Please refer to Pancrelipase.

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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Pharmacodynamics

Please refer to Pancrelipase.

Mechanism of action

Pancrelipase protease acts on the peptide bonds within the proteins. The two constituents of the pancrelipase protease, trypsin, and chymotrypsin, are grouped under the family of serine proteases. Trypsin acts on lysine and arginine residues while chymotrypsin acts in hydrophobic residues such as tryptophan, tyrosine and phenylalanine. Both constituents present a catalytic site in the S1 binding pocket formed by a triad of serine, histidine and aspartate.5

TargetActionsOrganism
ADietary protein
cleavage
Humans
Absorption

Please refer to Pancrelipase.

Volume of distribution

Please refer to Pancrelipase.

Protein binding

Please refer to Pancrelipase.

Metabolism

Please refer to Pancrelipase.

Route of elimination

Please refer to Pancrelipase.

Half-life

Please refer to Pancrelipase.

Clearance

Please refer to Pancrelipase.

Adverse Effects
Medicalerrors
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Toxicity

Please refer to Pancrelipase.

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.
Not Available
Food Interactions
  • Take with food.

Products

Products
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Product Images
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
CotazymPancrelipase protease (35000 units) + Pancrelipase amylase (40000 units) + Pancrelipase lipase (10000 units)CapsuleOralOrganon Canada Inc.1973-12-31Not applicableCanada flag
Cotazym Ecs 20Pancrelipase protease (100000 units) + Pancrelipase amylase (100000 units) + Pancrelipase lipase (25000 units)Capsule, delayed releaseOralOrganon Canada Inc.1989-12-31Not applicableCanada flag
Cotazym Ecs 4Pancrelipase protease (11000 unit) + Pancrelipase amylase (11000 unit) + Pancrelipase lipase (4000 unit)CapsuleOralMerck Ltd.1997-08-182012-01-23Canada flag
Cotazym Ecs 8Pancrelipase protease (45000 units) + Pancrelipase amylase (42000 units) + Pancrelipase lipase (10800 units)Capsule, delayed releaseOralOrganon Canada Inc.1980-12-31Not applicableCanada flag
CreonPancrelipase protease (19000 [USP'U]/1) + Pancrelipase amylase (30000 [USP'U]/1) + Pancrelipase lipase (6000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2009-04-30Not applicableUS flag0032 120620170907 23695 1ti1sat
CreonPancrelipase protease (38000 [USP'U]/1) + Pancrelipase amylase (60000 [USP'U]/1) + Pancrelipase lipase (12000 [USP'U]/1)Capsule, delayed release pelletsOralPhysicians Total Care, Inc.2009-09-29Not applicableUS flag54868 606720171018 3478 196a4lp
CreonPancrelipase protease (76000 [USP'U]/1) + Pancrelipase amylase (120000 [USP'U]/1) + Pancrelipase lipase (24000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2009-04-30Not applicableUS flag0032 122420171018 3478 3zx10l
CreonPancrelipase protease (38000 [USP'U]/1) + Pancrelipase amylase (60000 [USP'U]/1) + Pancrelipase lipase (12000 [USP'U]/1)Capsule, delayed release pelletsOralAtlantic Biologicals Corps.2010-08-13Not applicableUS flag17856 121220171018 3478 1444e92
CreonPancrelipase protease (114000 [USP'U]/1) + Pancrelipase amylase (180000 [USP'U]/1) + Pancrelipase lipase (36000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2013-03-14Not applicableUS flag0032 301620171018 3478 1xzy1f3
CreonPancrelipase protease (38000 [USP'U]/1) + Pancrelipase amylase (60000 [USP'U]/1) + Pancrelipase lipase (12000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2009-04-30Not applicableUS flag0032 121220171018 3478 1gpsri6
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Creon 10 MinimicrospheresPancrelipase protease (37500 [USP'U]/1) + Pancrelipase amylase (33200 [USP'U]/1) + Pancrelipase lipase (10000 [USP'U]/1)Capsule, delayed releaseOralPhysicians Total Care, Inc.2006-09-122009-09-30US flag
Creon 20 MinimicrospheresPancrelipase protease (75000 [USP'U]/1) + Pancrelipase amylase (66400 [USP'U]/1) + Pancrelipase lipase (20000 [USP'U]/1)Capsule, delayed releaseOralPhysicians Total Care, Inc.1995-01-172009-09-30US flag
PancrelipasePancrelipase protease (44000 [USP'U]/1) + Pancrelipase amylase (56000 [USP'U]/1) + Pancrelipase lipase (20000 [USP'U]/1)Capsule, delayed releaseOralKaiser Foundations Hospitals2010-02-012010-12-31US flag

Categories

Drug Categories
Not Available
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
3560D81V50
CAS number
9001-94-9

References

General References
  1. Schauperl M, Fuchs JE, Waldner BJ, Huber RG, Kramer C, Liedl KR: Characterizing Protease Specificity: How Many Substrates Do We Need? PLoS One. 2015 Nov 11;10(11):e0142658. doi: 10.1371/journal.pone.0142658. eCollection 2015. [Article]
  2. Creon monograph [Link]
  3. FDA approval [Link]
  4. VIVO pathophysiology [Link]
  5. EMBL-EBI [Link]
RxNav
1427034
FDA label
Download (483 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingTreatmentExocrine Pancreatic Insufficiency1
4CompletedNot AvailableHuman Immunodeficiency Virus (HIV) Infections / Proteinuria1
4CompletedOtherCoinfection, HIV / Hepatitis C Viral Infection1
4CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency2
4CompletedTreatmentHIV-Associated Lipodystrophy Syndrome1
4CompletedTreatmentHuman Immunodeficiency Virus (HIV) Infections1
4CompletedTreatmentHuman Immunodeficiency Virus Type 1 (HIV-1)1
4CompletedTreatmentHuman Immunodeficiency Virus Type 1 (HIV-1) Infection1
4CompletedTreatmentPancreatic Insufficiency1
4CompletedTreatmentPancreatitis, Chronic1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Capsule, delayed release pelletsOral
Capsule, delayed releaseOral
CapsuleOral
Capsule, coated pelletsOral
Tablet, coatedOral
Granule, delayed releaseOral
Capsule, extended releaseOral
Capsule, coatedOral22500 U Ph.Eu
TabletOral
PowderOral
Prices
Not Available
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
water solubility1 mg/mlMonograph

Drug created on December 03, 2015 16:51 / Updated on May 21, 2021 10:21