CA2774269C - Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency - Google Patents

Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency Download PDF

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Publication number
CA2774269C
CA2774269C CA2774269A CA2774269A CA2774269C CA 2774269 C CA2774269 C CA 2774269C CA 2774269 A CA2774269 A CA 2774269A CA 2774269 A CA2774269 A CA 2774269A CA 2774269 C CA2774269 C CA 2774269C
Authority
CA
Canada
Prior art keywords
digestive enzyme
lipase
units
protease
usp
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA2774269A
Other languages
English (en)
French (fr)
Other versions
CA2774269A1 (en
Inventor
Gopi M. Venkatesh
Stephen Perrett
Ruth Thieroff-Ekerdt
Konstantino Efthymiopoulos
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Allergan Pharmaceuticals Holdings Ireland ULC
Original Assignee
Aptalis Pharma Ltd
Allergan Therapeudics LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43730817&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2774269(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Aptalis Pharma Ltd, Allergan Therapeudics LLC filed Critical Aptalis Pharma Ltd
Publication of CA2774269A1 publication Critical patent/CA2774269A1/en
Application granted granted Critical
Publication of CA2774269C publication Critical patent/CA2774269C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/465Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2813Inorganic compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Inorganic Chemistry (AREA)
  • Rheumatology (AREA)
  • Nutrition Science (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pain & Pain Management (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CA2774269A 2009-09-17 2010-09-17 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency Expired - Fee Related CA2774269C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US24346709P 2009-09-17 2009-09-17
US61/243,467 2009-09-17
PCT/US2010/049203 WO2011035079A1 (en) 2009-09-17 2010-09-17 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency

Publications (2)

Publication Number Publication Date
CA2774269A1 CA2774269A1 (en) 2011-03-24
CA2774269C true CA2774269C (en) 2017-03-21

Family

ID=43730817

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2774269A Expired - Fee Related CA2774269C (en) 2009-09-17 2010-09-17 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency

Country Status (23)

Country Link
US (2) US8784884B2 (https=)
EP (1) EP2477645B1 (https=)
JP (1) JP5877399B2 (https=)
KR (1) KR101771752B1 (https=)
CN (2) CN102630164B (https=)
AR (1) AR078291A1 (https=)
AU (1) AU2010295494B2 (https=)
BR (1) BR112012005837A8 (https=)
CA (1) CA2774269C (https=)
CL (1) CL2012000658A1 (https=)
CO (1) CO6531419A2 (https=)
ES (1) ES2690661T3 (https=)
HK (1) HK1218886A1 (https=)
IL (2) IL218656A (https=)
MX (1) MX2012003214A (https=)
MY (1) MY161843A (https=)
NZ (1) NZ599143A (https=)
RU (1) RU2570376C2 (https=)
SA (1) SA110310695B1 (https=)
TW (2) TW201639545A (https=)
UY (1) UY32896A (https=)
WO (1) WO2011035079A1 (https=)
ZA (1) ZA201202761B (https=)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1319655B1 (it) 2000-11-15 2003-10-23 Eurand Int Microsfere di enzimi pancreatici con elevata stabilita' e relativometodo di preparazione.
JP5966202B2 (ja) 2007-02-20 2016-08-10 アラガン ファーマシューティカルズ インターナショナル リミテッド 安定な消化酵素組成物
US10087493B2 (en) 2008-03-07 2018-10-02 Aptalis Pharma Canada Ulc Method for detecting infectious parvovirus in pharmaceutical preparations
ES2657673T3 (es) * 2010-10-01 2018-03-06 Aptalis Pharma Limited Formulaciones recubiertas entéricas de pancrelipasa, de baja intensidad
CA2843556A1 (en) * 2011-08-08 2013-02-14 Aptalis Pharma Ltd. Method for dissolution testing of solid compositions containing digestive enzymes
US10184121B2 (en) 2013-06-28 2019-01-22 Allergan Pharmaceuticals International Limited Methods for removing viral contaminants from pancreatic extracts
CA2920844A1 (en) 2013-08-09 2015-02-12 Allergan Pharmaceuticals International Limited Digestive enzyme composition suitable for enteral administration
FR3079146B1 (fr) * 2018-03-23 2020-04-17 Karim Ioualalen Formulation gastroprotectrice de complexes d’enzymes permettant de restaurer la fonction digestive.
US20230138700A1 (en) * 2020-03-30 2023-05-04 Jai WALL Combined animal-derived and synthetically produced pancreatic enzyme replacement therapy

Family Cites Families (31)

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GB1509866A (en) 1975-06-10 1978-05-04 Johnson & Johnson Enteric coated digestive enzyme compositions
US4447412A (en) * 1983-02-01 1984-05-08 Bilton Gerald L Enzyme-containing digestive aid compostions
US5260074A (en) 1992-06-22 1993-11-09 Digestive Care Inc. Compositions of digestive enzymes and salts of bile acids and process for preparation thereof
US5460812A (en) 1992-06-22 1995-10-24 Digestive Care Inc. Compositions of digestive enzymes and salts of bile acids and process for preparation thereof
US5302400A (en) 1992-06-22 1994-04-12 Digestive Care Inc. Preparation of gastric acid-resistant microspheres containing digestive enzymes and buffered-bile acids
US5578304A (en) 1992-06-22 1996-11-26 Digestive Care Inc. Compositions of digestive enzymes and salts of bile acids and process for preparation thereof
DE4227385A1 (de) 1992-08-19 1994-02-24 Kali Chemie Pharma Gmbh Pankreatinmikropellets
JP2000505801A (ja) 1996-02-09 2000-05-16 クアドラント・ホールディングズ・ケンブリッジ・リミテッド トレハロースを含む固形製剤
US5750104A (en) 1996-05-29 1998-05-12 Digestive Care Inc. High buffer-containing enteric coating digestive enzyme bile acid compositions and method of treating digestive disorders therewith
US20010046493A1 (en) 2000-02-24 2001-11-29 Alex Margolin Lipase-containing composition and methods of use thereof
CN1156308C (zh) * 2002-04-19 2004-07-07 北京世诺医药科技有限公司 多酶组合胶囊
US20040132826A1 (en) * 2002-10-25 2004-07-08 Collegium Pharmaceutical, Inc. Modified release compositions of milnacipran
WO2004071374A2 (en) 2003-02-11 2004-08-26 Torrent Pharmaceuticals Limited Once a day orally administered pharmaceutical compositions
WO2005042012A1 (en) * 2003-10-29 2005-05-12 Altus Pharmaceuticals Inc. Non-pancreatic proteases for controlling plasma cholecystokinin (cck) concentration and for treating pain
US7387793B2 (en) 2003-11-14 2008-06-17 Eurand, Inc. Modified release dosage forms of skeletal muscle relaxants
US7470435B2 (en) 2003-11-17 2008-12-30 Andrx Pharmaceuticals, Llc Extended release venlafaxine formulation
CA2560613C (en) 2004-03-22 2015-11-24 Solvay Pharmaceuticals Gmbh Oral pharmaceutical compositions of lipase-containing products, in particular of pancreatin, containing surfactants
EP1755656B1 (en) * 2004-05-24 2010-07-07 Novozymes A/S Enzymes for pharmaceutical use
WO2006044529A1 (en) * 2004-10-14 2006-04-27 Altus Pharmaceuticals Inc. Compositions containing lipase; protease and amylase for treating pancreatic insufficiency
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CN101208429A (zh) * 2005-06-24 2008-06-25 诺维信公司 用于药物用途的脂肪酶
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Also Published As

Publication number Publication date
MX2012003214A (es) 2012-08-01
BR112012005837A2 (pt) 2017-05-30
TW201639545A (zh) 2016-11-16
HK1218886A1 (zh) 2017-03-17
CN102630164A (zh) 2012-08-08
JP5877399B2 (ja) 2016-03-08
ZA201202761B (en) 2012-12-27
KR20120100915A (ko) 2012-09-12
UY32896A (es) 2011-02-28
TWI572372B (zh) 2017-03-01
CO6531419A2 (es) 2012-09-28
SA110310695B1 (ar) 2014-11-26
RU2570376C2 (ru) 2015-12-10
TW201113052A (en) 2011-04-16
JP2013505255A (ja) 2013-02-14
EP2477645A4 (en) 2014-06-25
KR101771752B1 (ko) 2017-08-25
RU2012113253A (ru) 2013-10-27
CA2774269A1 (en) 2011-03-24
EP2477645A1 (en) 2012-07-25
IL218656A0 (en) 2012-05-31
CL2012000658A1 (es) 2012-09-28
CN102630164B (zh) 2015-09-16
IL218656A (en) 2017-12-31
ES2690661T3 (es) 2018-11-21
US8784884B2 (en) 2014-07-22
US20140287035A1 (en) 2014-09-25
WO2011035079A1 (en) 2011-03-24
CN105214073A (zh) 2016-01-06
AR078291A1 (es) 2011-10-26
NZ599143A (en) 2014-05-30
EP2477645B1 (en) 2018-08-15
AU2010295494B2 (en) 2014-09-25
BR112012005837A8 (pt) 2017-10-10
US20110064799A1 (en) 2011-03-17
US20160051472A9 (en) 2016-02-25
IL245875A0 (en) 2016-07-31
AU2010295494A1 (en) 2012-03-29
MY161843A (en) 2017-05-15

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Effective date: 20140922

MKLA Lapsed

Effective date: 20220920