JP5877399B2 - 膵炎及び膵不全を治療するための膵酵素組成物及び方法 - Google Patents

膵炎及び膵不全を治療するための膵酵素組成物及び方法 Download PDF

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Publication number
JP5877399B2
JP5877399B2 JP2012529909A JP2012529909A JP5877399B2 JP 5877399 B2 JP5877399 B2 JP 5877399B2 JP 2012529909 A JP2012529909 A JP 2012529909A JP 2012529909 A JP2012529909 A JP 2012529909A JP 5877399 B2 JP5877399 B2 JP 5877399B2
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Prior art keywords
digestive enzyme
coating
lipase
multiparticulate
beads
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Expired - Fee Related
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JP2012529909A
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Japanese (ja)
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JP2013505255A (ja
JP2013505255A5 (cg-RX-API-DMAC7.html
Inventor
ヴェンカテッシュ,ゴーピ,エム.
ペレット,スティーヴン
ティエロフ−エケルト,ルース
エフティミオパオロス,コンスタンティーノ
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Allergan Pharmaceuticals Holdings Ireland ULC
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Aptalis Pharma Ltd
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    • 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
    • A61K9/14Particulate 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
    • 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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2813Inorganic compounds
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Nutrition Science (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
JP2012529909A 2009-09-17 2010-09-17 膵炎及び膵不全を治療するための膵酵素組成物及び方法 Expired - Fee Related JP5877399B2 (ja)

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 (3)

Publication Number Publication Date
JP2013505255A JP2013505255A (ja) 2013-02-14
JP2013505255A5 JP2013505255A5 (cg-RX-API-DMAC7.html) 2013-11-07
JP5877399B2 true JP5877399B2 (ja) 2016-03-08

Family

ID=43730817

Family Applications (1)

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JP2012529909A Expired - Fee Related JP5877399B2 (ja) 2009-09-17 2010-09-17 膵炎及び膵不全を治療するための膵酵素組成物及び方法

Country Status (23)

Country Link
US (2) US8784884B2 (cg-RX-API-DMAC7.html)
EP (1) EP2477645B1 (cg-RX-API-DMAC7.html)
JP (1) JP5877399B2 (cg-RX-API-DMAC7.html)
KR (1) KR101771752B1 (cg-RX-API-DMAC7.html)
CN (2) CN105214073A (cg-RX-API-DMAC7.html)
AR (1) AR078291A1 (cg-RX-API-DMAC7.html)
AU (1) AU2010295494B2 (cg-RX-API-DMAC7.html)
BR (1) BR112012005837A8 (cg-RX-API-DMAC7.html)
CA (1) CA2774269C (cg-RX-API-DMAC7.html)
CL (1) CL2012000658A1 (cg-RX-API-DMAC7.html)
CO (1) CO6531419A2 (cg-RX-API-DMAC7.html)
ES (1) ES2690661T3 (cg-RX-API-DMAC7.html)
HK (1) HK1218886A1 (cg-RX-API-DMAC7.html)
IL (2) IL218656A (cg-RX-API-DMAC7.html)
MX (1) MX2012003214A (cg-RX-API-DMAC7.html)
MY (1) MY161843A (cg-RX-API-DMAC7.html)
NZ (1) NZ599143A (cg-RX-API-DMAC7.html)
RU (1) RU2570376C2 (cg-RX-API-DMAC7.html)
SA (1) SA110310695B1 (cg-RX-API-DMAC7.html)
TW (2) TW201639545A (cg-RX-API-DMAC7.html)
UY (1) UY32896A (cg-RX-API-DMAC7.html)
WO (1) WO2011035079A1 (cg-RX-API-DMAC7.html)
ZA (1) ZA201202761B (cg-RX-API-DMAC7.html)

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.
CN101686943B (zh) 2007-02-20 2014-03-26 阿普塔利斯制药有限公司 稳定的消化酶组合物
US10087493B2 (en) 2008-03-07 2018-10-02 Aptalis Pharma Canada Ulc Method for detecting infectious parvovirus in pharmaceutical preparations
EP2818160B1 (en) * 2010-10-01 2017-11-08 Aptalis Pharma Limited Enteric coated, low-strength pancrelipase formulations
KR101953413B1 (ko) 2011-08-08 2019-02-28 앨러간 파마슈티컬스 인터내셔널 리미티드 소화효소들을 함유하는 고형 조성물들의 용해 시험 방법
ES2784227T3 (es) 2013-08-09 2020-09-23 Allergan Pharmaceuticals Int Ltd Composición de enzimas digestivos adecuada para la administración entérica
WO2015193730A1 (en) 2014-06-19 2015-12-23 Aptalis Pharma Ltd. Methods for removing viral contaminants from pancreatic extracts
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

Family Cites Families (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
DE4227385A1 (de) 1992-08-19 1994-02-24 Kali Chemie Pharma Gmbh Pankreatinmikropellets
EP0879048B2 (en) 1996-02-09 2009-07-29 Quadrant Drug Delivery Limited Method for making tablets using 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
US20040121010A1 (en) * 2002-10-25 2004-06-24 Collegium Pharmaceutical, Inc. Pulsatile release compositions of milnacipran
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
RU2381813C2 (ru) 2004-03-22 2010-02-20 Зольвай Фармасьютиклз Гмбх Пероральные фармацевтические композиции на основе продуктов, содержащих липазы, прежде всего панкреатин, и пав
WO2005115445A1 (en) * 2004-05-24 2005-12-08 Novozymes A/S Enzymes for pharmaceutical use
DE602005022471D1 (de) * 2004-10-14 2010-09-02 Altus Pharmaceuticals Inc Zusammensetzungen enthaltend lipase, protease und amylase zur behandlung von pankreasinsuffizienz
US9161918B2 (en) 2005-05-02 2015-10-20 Adare Pharmaceuticals, Inc. Timed, pulsatile release systems
MX2007015472A (es) * 2005-06-24 2008-04-17 Novozymes As Lipasas para uso farmaceutico.
US20070025977A1 (en) 2005-07-21 2007-02-01 Mulberg Andrew E Method of treating steatorrhea in infants
CA2616943C (en) 2005-07-29 2016-04-12 Solvay Pharmaceuticals Gmbh Processes for the manufacture of sterilized pancreatin powder
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
WO2007053619A2 (en) * 2005-11-01 2007-05-10 Bio-Cat, Inc. A composition with a fungal (yeast) lipase and method for treating lipid malabsorption in cystic fibrous as well as people suffering from pancreatic lipase insufficiency
MX2008015031A (es) * 2006-05-26 2008-12-05 Nestec Sa Metodos de uso y composiciones nutritivas de extracto de touchi.
US20080199448A1 (en) * 2007-02-16 2008-08-21 Ross Mairi R Enzyme composition for improving food digestion
CN101686943B (zh) 2007-02-20 2014-03-26 阿普塔利斯制药有限公司 稳定的消化酶组合物
US20090117180A1 (en) * 2007-02-20 2009-05-07 Giovanni Ortenzi Stable digestive enzyme compositions
EP2328566A1 (en) 2008-09-30 2011-06-08 DSM IP Assets B.V. Enzyme composition and application thereof in the treatment of pancreatic insufficiency

Also Published As

Publication number Publication date
NZ599143A (en) 2014-05-30
JP2013505255A (ja) 2013-02-14
CO6531419A2 (es) 2012-09-28
US20140287035A1 (en) 2014-09-25
IL218656A0 (en) 2012-05-31
CA2774269A1 (en) 2011-03-24
ES2690661T3 (es) 2018-11-21
TW201113052A (en) 2011-04-16
CL2012000658A1 (es) 2012-09-28
US20110064799A1 (en) 2011-03-17
EP2477645A1 (en) 2012-07-25
EP2477645B1 (en) 2018-08-15
TW201639545A (zh) 2016-11-16
BR112012005837A8 (pt) 2017-10-10
UY32896A (es) 2011-02-28
EP2477645A4 (en) 2014-06-25
US20160051472A9 (en) 2016-02-25
RU2570376C2 (ru) 2015-12-10
AU2010295494A1 (en) 2012-03-29
CN102630164B (zh) 2015-09-16
CN105214073A (zh) 2016-01-06
SA110310695B1 (ar) 2014-11-26
ZA201202761B (en) 2012-12-27
BR112012005837A2 (pt) 2017-05-30
IL218656A (en) 2017-12-31
RU2012113253A (ru) 2013-10-27
CN102630164A (zh) 2012-08-08
US8784884B2 (en) 2014-07-22
CA2774269C (en) 2017-03-21
KR101771752B1 (ko) 2017-08-25
IL245875A0 (en) 2016-07-31
HK1218886A1 (zh) 2017-03-17
MX2012003214A (es) 2012-08-01
AU2010295494B2 (en) 2014-09-25
AR078291A1 (es) 2011-10-26
MY161843A (en) 2017-05-15
TWI572372B (zh) 2017-03-01
WO2011035079A1 (en) 2011-03-24
KR20120100915A (ko) 2012-09-12

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