AU2010295494B2 - 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
AU2010295494B2
AU2010295494B2 AU2010295494A AU2010295494A AU2010295494B2 AU 2010295494 B2 AU2010295494 B2 AU 2010295494B2 AU 2010295494 A AU2010295494 A AU 2010295494A AU 2010295494 A AU2010295494 A AU 2010295494A AU 2010295494 B2 AU2010295494 B2 AU 2010295494B2
Authority
AU
Australia
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.)
Ceased
Application number
AU2010295494A
Other languages
English (en)
Other versions
AU2010295494A1 (en
Inventor
Konstantino Efthymiopoulos
Stephen Perrett
Ruth Thieroff-Ekerdt
Gopi M. Venkatesh
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 Therapeudics LLC
Original Assignee
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
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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=AU2010295494(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Allergan Therapeudics LLC filed Critical Allergan Therapeudics LLC
Publication of AU2010295494A1 publication Critical patent/AU2010295494A1/en
Application granted granted Critical
Publication of AU2010295494B2 publication Critical patent/AU2010295494B2/en
Priority to AU2014253526A priority Critical patent/AU2014253526B2/en
Assigned to APTALIS PHARMA LIMITED reassignment APTALIS PHARMA LIMITED Request for Assignment Assignors: APTALIS PHARMATECH, INC.
Priority to AU2016216662A priority patent/AU2016216662B2/en
Assigned to ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED reassignment ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED Request to Amend Deed and Register Assignors: APTALIS PHARMA LIMITED
Assigned to Allergan Therapeutics LLC reassignment Allergan Therapeutics LLC Request for Assignment Assignors: ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K38/00Medicinal preparations containing peptides
    • 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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Nutrition Science (AREA)
  • Emergency Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
AU2010295494A 2009-09-17 2010-09-17 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency Ceased AU2010295494B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2014253526A AU2014253526B2 (en) 2009-09-17 2014-10-23 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency
AU2016216662A AU2016216662B2 (en) 2009-09-17 2016-08-18 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2014253526A Division AU2014253526B2 (en) 2009-09-17 2014-10-23 Pancreatic enzyme compositions and methods for treating pancreatitis and pancreatic insufficiency

Publications (2)

Publication Number Publication Date
AU2010295494A1 AU2010295494A1 (en) 2012-03-29
AU2010295494B2 true AU2010295494B2 (en) 2014-09-25

Family

ID=43730817

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2010295494A Ceased AU2010295494B2 (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 (enExample)
EP (1) EP2477645B1 (enExample)
JP (1) JP5877399B2 (enExample)
KR (1) KR101771752B1 (enExample)
CN (2) CN102630164B (enExample)
AR (1) AR078291A1 (enExample)
AU (1) AU2010295494B2 (enExample)
BR (1) BR112012005837A8 (enExample)
CA (1) CA2774269C (enExample)
CL (1) CL2012000658A1 (enExample)
CO (1) CO6531419A2 (enExample)
ES (1) ES2690661T3 (enExample)
HK (1) HK1218886A1 (enExample)
IL (2) IL218656A (enExample)
MX (1) MX2012003214A (enExample)
MY (1) MY161843A (enExample)
NZ (1) NZ599143A (enExample)
RU (1) RU2570376C2 (enExample)
SA (1) SA110310695B1 (enExample)
TW (2) TW201639545A (enExample)
UY (1) UY32896A (enExample)
WO (1) WO2011035079A1 (enExample)
ZA (1) ZA201202761B (enExample)

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.
EP2079445B1 (en) 2007-02-20 2015-11-04 Aptalis Pharma Limited Stable digestive enzyme compositions
WO2009109856A2 (en) 2008-03-07 2009-09-11 Axcan Pharma Inc. Method for detecting infectious parvovirus in pharmaceutical preparations
EP2621476B8 (en) * 2010-10-01 2020-12-23 Société des Produits Nestlé S.A. Enteric coated, low-strength pancrelipase formulations
RU2602183C2 (ru) * 2011-08-08 2016-11-10 Апталис Фарма Лтд. Способ проведения теста на растворение твердых композиций, содержащих пищеварительные ферменты
US10184121B2 (en) 2013-06-28 2019-01-22 Allergan Pharmaceuticals International Limited Methods for removing viral contaminants from pancreatic extracts
WO2015020943A2 (en) 2013-08-09 2015-02-12 Aptalis Pharma Ltd. 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.
WO2021202363A1 (en) * 2020-03-30 2021-10-07 Wall Jai Combined animal-derived and synthetically produced pancreatic enzyme replacement therapy

Citations (3)

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US20040121010A1 (en) * 2002-10-25 2004-06-24 Collegium Pharmaceutical, Inc. Pulsatile release compositions of milnacipran
US20060121017A1 (en) * 2004-10-14 2006-06-08 Margolin Alexey L Compositions and methods for treating pancreatic insufficiency
US20090117180A1 (en) * 2007-02-20 2009-05-07 Giovanni Ortenzi Stable digestive enzyme compositions

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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
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
US5302400A (en) 1992-06-22 1994-04-12 Digestive Care Inc. Preparation of gastric acid-resistant microspheres containing digestive enzymes and buffered-bile acids
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
DE4227385A1 (de) 1992-08-19 1994-02-24 Kali Chemie Pharma Gmbh Pankreatinmikropellets
DE69728857T3 (de) 1996-02-09 2010-02-18 Quadrant Drug Delivery Ltd., Ruddington Feste arzneimittel enthaltend trehalose
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
EP1596838A2 (en) 2003-02-11 2005-11-23 Torrent Pharmaceuticals Ltd Once a day orally administered pharmaceutical compositions comprising a proton pump inhibitor and a prokinetic agent
AU2004285558A1 (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
DE602005009677D1 (de) 2004-03-22 2008-10-23 Solvay Pharm Gmbh Orale pharmazeutische zusammensetzungen von produkten mit lipase, insbesondere von pankreatin, mit tensiden
DK1755656T3 (da) * 2004-05-24 2010-10-04 Novozymes As Enzymer til farmaceutisk anvendelse
US9161918B2 (en) 2005-05-02 2015-10-20 Adare Pharmaceuticals, Inc. Timed, pulsatile release systems
CA2612648A1 (en) * 2005-06-24 2006-12-28 Novozymes A/S Lipases for pharmaceutical use
US20070025977A1 (en) 2005-07-21 2007-02-01 Mulberg Andrew E Method of treating steatorrhea in infants
MX2008000850A (es) 2005-07-29 2008-03-18 Solvay Pharm Gmbh Procedimientos para la fabricacion de polvo de pancreatina esterilizada.
US11266607B2 (en) * 2005-08-15 2022-03-08 AbbVie Pharmaceuticals GmbH Process for the manufacture and use of pancreatin micropellet cores
US9198871B2 (en) 2005-08-15 2015-12-01 Abbott Products Gmbh Delayed release pancreatin compositions
US8071089B2 (en) 2005-11-01 2011-12-06 Bio-Cat, Inc. Composition with a fungal (yeast) lipase and method for treating lipid malabsorption in cystic fibrosis as well as people suffering from pancreatic lipase insufficiency
MY147954A (en) * 2006-05-26 2013-02-15 Nestec Sa Methods of use and nutritional compositions of touchi extract
US20080199448A1 (en) * 2007-02-16 2008-08-21 Ross Mairi R Enzyme composition for improving food digestion
EP2079445B1 (en) 2007-02-20 2015-11-04 Aptalis Pharma Limited Stable digestive enzyme compositions
US20110171294A1 (en) 2008-09-30 2011-07-14 Dsm Ip Assets B.V. Enzyme composition and application thereof in the treatment of pancreatic insufficiency

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040121010A1 (en) * 2002-10-25 2004-06-24 Collegium Pharmaceutical, Inc. Pulsatile release compositions of milnacipran
US20060121017A1 (en) * 2004-10-14 2006-06-08 Margolin Alexey L Compositions and methods for treating pancreatic insufficiency
US20090117180A1 (en) * 2007-02-20 2009-05-07 Giovanni Ortenzi Stable digestive enzyme compositions

Also Published As

Publication number Publication date
CN102630164A (zh) 2012-08-08
EP2477645B1 (en) 2018-08-15
TWI572372B (zh) 2017-03-01
IL245875A0 (en) 2016-07-31
US8784884B2 (en) 2014-07-22
CA2774269C (en) 2017-03-21
KR101771752B1 (ko) 2017-08-25
RU2570376C2 (ru) 2015-12-10
MY161843A (en) 2017-05-15
MX2012003214A (es) 2012-08-01
BR112012005837A2 (pt) 2017-05-30
SA110310695B1 (ar) 2014-11-26
US20140287035A1 (en) 2014-09-25
HK1218886A1 (zh) 2017-03-17
NZ599143A (en) 2014-05-30
AU2010295494A1 (en) 2012-03-29
IL218656A (en) 2017-12-31
EP2477645A1 (en) 2012-07-25
RU2012113253A (ru) 2013-10-27
IL218656A0 (en) 2012-05-31
CA2774269A1 (en) 2011-03-24
US20110064799A1 (en) 2011-03-17
JP5877399B2 (ja) 2016-03-08
CO6531419A2 (es) 2012-09-28
UY32896A (es) 2011-02-28
CN102630164B (zh) 2015-09-16
WO2011035079A1 (en) 2011-03-24
JP2013505255A (ja) 2013-02-14
ZA201202761B (en) 2012-12-27
AR078291A1 (es) 2011-10-26
TW201113052A (en) 2011-04-16
ES2690661T3 (es) 2018-11-21
EP2477645A4 (en) 2014-06-25
KR20120100915A (ko) 2012-09-12
CL2012000658A1 (es) 2012-09-28
CN105214073A (zh) 2016-01-06
US20160051472A9 (en) 2016-02-25
TW201639545A (zh) 2016-11-16
BR112012005837A8 (pt) 2017-10-10

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Legal Events

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FGA Letters patent sealed or granted (standard patent)
PC Assignment registered

Owner name: APTALIS PHARMA LIMITED

Free format text: FORMER OWNER WAS: APTALIS PHARMATECH, INC.

HB Alteration of name in register

Owner name: ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED

Free format text: FORMER NAME(S): APTALIS PHARMA LIMITED

PC Assignment registered

Owner name: ALLERGAN THERAPEUTICS LLC

Free format text: FORMER OWNER(S): ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED

MK14 Patent ceased section 143(a) (annual fees not paid) or expired