Pancrelipase amylase

Identification

Name
Pancrelipase amylase
Accession Number
DB11065
Type
Biotech
Groups
Approved
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.4 The amylases are enzymes that help in the chemical process of digestion by hydrolizing starch into more available saccharide forms.3 The pancrelipase amylase is a single polypeptide chain containing two SH groups and four disulfide bridges.6 The pancrelipase mixture, including pancrelipase amylase, was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010.5

Protein structure
Db11065
Protein chemical formula
Not Available
Protein average weight
57086.0 Da
Sequences
>sp|P00690|AMYP_PIG Pancreatic alpha-amylase OS=Sus scrofa OX=9823 GN=AMY2 PE=1 SV=3
MKLFLLLSAFGFCWAQYAPQTQSGRTSIVHLFEWRWVDIALECERYLGPKGFGGVQVSPP
NENIVVTNPSRPWWERYQPVSYKLCTRSGNENEFRDMVTRCNNVGVRIYVDAVINHMCGS
GAAAGTGTTCGSYCNPGNREFPAVPYSAWDFNDGKCKTASGGIESYNDPYQVRDCQLVGL
LDLALEKDYVRSMIADYLNKLIDIGVAGFRIDASKHMWPGDIKAVLDKLHNLNTNWFPAG
SRPFIFQEVIDLGGEAIQSSEYFGNGRVTEFKYGAKLGTVVRKWSGEKMSYLKNWGEGWG
FMPSDRALVFVDNHDNQRGHGAGGASILTFWDARLYKVAVGFMLAHPYGFTRVMSSYRWA
RNFVNGQDVNDWIGPPNNNGVIKEVTINADTTCGNDWVCEHRWRQIRNMVWFRNVVDGQP
FANWWANGSNQVAFGRGNRGFIVFNNDDWQLSSTLQTGLPGGTYCDVISGDKVGNSCTGI
KVYVSSDGTAQFSISNSAEDPFIAIHAESKL
Download FASTA Format
Synonyms
  • 1,4-alpha-D-Glucan glucanohydrolase
  • alpha-Amylase
  • alpha-amylase (porcine)
  • Alpha-amylase swine pancreas
  • alpha-Amylases
  • Amylase A
  • Amylase AD
  • Amylase, pancreatic
  • Porcine pancreas alpha-amylase
Product Images
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Chewable Enzymes TabletsPancrelipase amylase (5 mg) + Bromelains (15 mg) + Papain (100 mg)TabletOralGahler Enterprises Ltd.1988-12-312002-07-17Canada
CotazymPancrelipase amylase (40000 units) + Pancrelipase lipase (10000 units) + Pancrelipase protease (35000 units)CapsuleOralMerck Ltd.1973-12-31Not applicableCanada
Cotazym Ecs 20Pancrelipase amylase (100000 units) + Pancrelipase lipase (25000 units) + Pancrelipase protease (100000 units)Capsule, delayed releaseOralMerck Ltd.1989-12-31Not applicableCanada
Cotazym Ecs 4Pancrelipase amylase (11000 unit) + Pancrelipase lipase (4000 unit) + Pancrelipase protease (11000 unit)CapsuleOralMerck Ltd.1997-08-182012-01-23Canada
Cotazym Ecs 8Pancrelipase amylase (42000 units) + Pancrelipase lipase (10800 units) + Pancrelipase protease (45000 units)Capsule, delayed releaseOralMerck Ltd.1980-12-31Not applicableCanada
CreonPancrelipase amylase (180000 [USP'U]/1) + Pancrelipase lipase (36000 [USP'U]/1) + Pancrelipase protease (114000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2013-03-14Not applicableUs0032 301620171018 3478 1xzy1f3
CreonPancrelipase amylase (15000 [USP'U]/1) + Pancrelipase lipase (3000 [USP'U]/1) + Pancrelipase protease (9500 [USP'U]/1)Capsule, delayed releaseOralAbbVie Inc.2009-04-30Not applicableUs
CreonPancrelipase amylase (120000 [USP'U]/1) + Pancrelipase lipase (24000 [USP'U]/1) + Pancrelipase protease (76000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2009-04-30Not applicableUs0032 122420171018 3478 3zx10l
CreonPancrelipase amylase (60000 [USP'U]/1) + Pancrelipase lipase (12000 [USP'U]/1) + Pancrelipase protease (38000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2009-04-30Not applicableUs0032 121220171018 3478 1gpsri6
CreonPancrelipase amylase (30000 [USP'U]/1) + Pancrelipase lipase (6000 [USP'U]/1) + Pancrelipase protease (19000 [USP'U]/1)Capsule, delayed release pelletsOralAbbVie Inc.2009-04-30Not applicableUs0032 120620170907 23695 1ti1sat
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Creon 10 MinimicrospheresPancrelipase amylase (33200 [USP'U]/1) + Pancrelipase lipase (10000 [USP'U]/1) + Pancrelipase protease (37500 [USP'U]/1)Capsule, delayed releaseOralPhysicians Total Care, Inc.2006-09-122009-09-30Us
Creon 20 MinimicrospheresPancrelipase amylase (66400 [USP'U]/1) + Pancrelipase lipase (20000 [USP'U]/1) + Pancrelipase protease (75000 [USP'U]/1)Capsule, delayed releaseOralPhysicians Total Care, Inc.1995-01-172009-09-30Us
PancrelipasePancrelipase amylase (56000 [USP'U]/1) + Pancrelipase lipase (20000 [USP'U]/1) + Pancrelipase protease (44000 [USP'U]/1)Capsule, delayed releaseOralKaiser Foundations Hospitals2010-02-012010-12-31Us
Categories
UNII
YOJ58O116E
CAS number
9000-90-2

Pharmacology

Indication

Please refer to Pancrelipase.

Associated Conditions
Pharmacodynamics

Please refer to Pancrelipase.

Mechanism of action

The pancrelipase amylase acts by replacing the lack of physiological amylase. The amylase activity is done by the hydrolyzation of the alpha 1-4 linkages in the polysaccharides of three or more linked glucose units. The linkages alpha 1-6 are not hydrolyzed and thus, the starch is only reduced to lower molecule compounds.6

TargetActionsOrganism
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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Additional Data Available
Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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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.

Toxicity

Please refer to Pancrelipase.

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.
Not Available
Food Interactions
Not Available

References

General References
  1. 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]
  2. 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]
  3. Silverman R. (2002). The organic chemistry of enzyme-catalyzed reactions. Academic Press.
  4. Creon monograph [Link]
  5. FDA approval [Link]
  6. Amylase product information [Link]
  7. FDA reports [Link]
  8. CENTER FOR DRUG EVALUATION AND RESEARCH- 20755 [Link]
  9. EMA reports [Link]
External Links
RxNav
1427033
FDA label
Download (483 KB)
MSDS
Download (274 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1TerminatedTreatmentHypoglycemia1
1TerminatedTreatmentPancreatitis, Chronic1
1, 2RecruitingTreatmentMalignant Neoplasm of Pancreas / Pancreatic enzyme abnormality / Pancreatic Insufficiency1
2CompletedNot AvailableExocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis1
2CompletedDiagnosticPancreatitis, Chronic1
2CompletedTreatmentShort bowel condition / Short Bowel Syndrome (SBS)1
2Not Yet RecruitingBasic ScienceAdolescent Development / Borderline Personality Disorder (BPD)1
2TerminatedSupportive CareMalignant Neoplasm of Pancreas1
3CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency1
3CompletedTreatmentDiarrhea / Severe Malnutrition1
3CompletedTreatmentExocrine Pancreatic Insufficiency: Cystic Fibrosis1
3CompletedTreatmentExocrine Pancreatic Insufficiency / Pancreatitis, Chronic1
3CompletedTreatmentPancreatic Exocrine Insufficiency1
3CompletedTreatmentPancreatic Exocrine Insufficiency Due to Cystic Fibrosis1
3CompletedTreatmentPostprandial Belching / Postprandial Bloating / Postprandial Eructation1
3RecruitingTreatmentPancreatic Insufficiency1
3TerminatedTreatmentFat malabsorption1
4CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency2
4CompletedTreatmentPancreatic Insufficiency1
4CompletedTreatmentPancreatitis, Chronic1
4Not Yet RecruitingTreatmentExocrine Pancreatic Insufficiency (EPI)1
4RecruitingTreatmentCystic Fibrosis (CF)1
4RecruitingTreatmentExocrine Pancreatic Insufficiency (EPI)1
4TerminatedTreatmentPatients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks) / Patients With Pancreatic Exocrine Insufficiency1
4WithdrawnTreatmentExocrine Pancreatic Insufficiency in Subjects With Diabetes Mellitus Type 21
Not AvailableCompletedBasic SciencePancreatitis1
Not AvailableCompletedTreatmentBMI >30 kg/m21
Not AvailableCompletedTreatmentCystic Fibrosis (CF)1
Not AvailableNot Yet RecruitingNot AvailableAdenocarcinoma of the Pancreas1
Not AvailableNot Yet RecruitingNot AvailablePancreatic Fistula1
Not AvailableRecruitingNot AvailableFibrosing colonopathy / Fibrosing Colonopathy in Patients With Cystic Fibrosis1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Capsule, delayed release pelletsOral
Capsule, delayed releaseOral
Granule, delayed releaseOral
CapsuleOral
Capsule, extended releaseOral
TabletOral
PowderOral
Prices
Not Available
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.

    Learn more

Properties

State
Solid
Experimental Properties
PropertyValueSource
water solubility1 mg/mlMonograph
isoelectric point5.25-5.95Pasero L. et al. 1979. HAL archives ouvertes

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 starch
Kind
Group
Organism
Humans
Pharmacological action
Yes
Actions
Cleavage
References
  1. Amylase product information [Link]

Drug created on December 03, 2015 09:51 / Updated on June 12, 2020 10:53

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