Pancrelipase amylase

Identification

Name
Pancrelipase amylase
Accession Number
DB11065
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

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Other protein based therapies
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

Pharmacology

Pharmacology
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Indication

Please refer to Pancrelipase.

Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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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
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
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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

Products

Products
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Product Images
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
Chewable Enzymes TabletsPancrelipase amylase (5 mg) + Bromelains (15 mg) + Papain (100 mg)TabletOralGahler Enterprises Ltd.1988-12-312002-07-17Canada flag
CotazymPancrelipase amylase (40000 units) + Pancrelipase lipase (10000 units) + Pancrelipase protease (35000 units)CapsuleOralOrganon Canada Inc.1973-12-31Not applicableCanada flag
Cotazym Ecs 20Pancrelipase amylase (100000 units) + Pancrelipase lipase (25000 units) + Pancrelipase protease (100000 units)Capsule, delayed releaseOralOrganon Canada Inc.1989-12-31Not applicableCanada flag
Cotazym Ecs 4Pancrelipase amylase (11000 unit) + Pancrelipase lipase (4000 unit) + Pancrelipase protease (11000 unit)CapsuleOralMerck Ltd.1997-08-182012-01-23Canada flag
Cotazym Ecs 8Pancrelipase amylase (42000 units) + Pancrelipase lipase (10800 units) + Pancrelipase protease (45000 units)Capsule, delayed releaseOralOrganon Canada Inc.1980-12-31Not applicableCanada flag
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 applicableUS flag0032 301620171018 3478 1xzy1f3
CreonPancrelipase amylase (30000 [USP'U]/1) + Pancrelipase lipase (6000 [USP'U]/1) + Pancrelipase protease (19000 [USP'U]/1)Capsule, delayed release pelletsOralAtlantic Biologicals Corps.2010-08-13Not applicableUS flag17856 120620171018 3478 1x59skm
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 applicableUS flag0032 121220171018 3478 1gpsri6
CreonPancrelipase amylase (60000 [USP'U]/1) + Pancrelipase lipase (12000 [USP'U]/1) + Pancrelipase protease (38000 [USP'U]/1)Capsule, delayed release pelletsOralPhysicians Total Care, Inc.2009-09-29Not applicableUS flag54868 606720171018 3478 196a4lp
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 flag
Unapproved/Other Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
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 flag
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 flag
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 flag

Categories

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

Chemical Identifiers

UNII
YOJ58O116E
CAS number
9000-90-2

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]
  10. INVIMA Product Authorization: Panzytrat (pancreatic lipase/amylase/protease) gastroresistant tablets [Link]
  11. TITCK Product Information: Fermento (pancreatic lipase/amylase/protease with dimethicone) oral capsules [Link]
RxNav
1427033
FDA label
Download (483 KB)
MSDS
Download (274 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency2
4CompletedTreatmentPancreatic Insufficiency1
4CompletedTreatmentPancreatitis, Chronic1
4Not Yet RecruitingTreatmentExocrine Pancreatic Insufficiency1
4RecruitingTreatmentCystic Fibrosis (CF)1
4RecruitingTreatmentExocrine Pancreatic Insufficiency1
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
3CompletedTreatmentCystic Fibrosis (CF) / Exocrine Pancreatic Insufficiency1
3CompletedTreatmentDiarrhea / Severe Malnutrition1

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
isoelectric point5.25-5.95Pasero L. et al. 1979. HAL archives ouvertes

Drug created on December 03, 2015 16:51 / Updated on November 13, 2020 04:14