CN102630164B - 用于治疗胰腺炎和胰腺功能不全的胰酶组合物及其用途 - Google Patents

用于治疗胰腺炎和胰腺功能不全的胰酶组合物及其用途 Download PDF

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Publication number
CN102630164B
CN102630164B CN201080041366.3A CN201080041366A CN102630164B CN 102630164 B CN102630164 B CN 102630164B CN 201080041366 A CN201080041366 A CN 201080041366A CN 102630164 B CN102630164 B CN 102630164B
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CN
China
Prior art keywords
digestive enzyme
lipase
coating
enteric
protease
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
CN201080041366.3A
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English (en)
Chinese (zh)
Other versions
CN102630164A (zh
Inventor
戈皮·M·文卡特施
斯蒂芬·佩雷特
鲁思·泰洛夫-艾克德特
康斯坦蒂诺·艾弗西米奥普罗斯
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.)
Erjian Medical Co ltd
Elastagen Pty Ltd
Original Assignee
Aptalis Pharma Ltd
Aptalis Pharmatech Inc
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Application filed by Aptalis Pharma Ltd, Aptalis Pharmatech Inc filed Critical Aptalis Pharma Ltd
Priority to CN201510490337.XA priority Critical patent/CN105214073A/zh
Publication of CN102630164A publication Critical patent/CN102630164A/zh
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Expired - Fee Related legal-status Critical Current
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5084—Mixtures 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic 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)
CN201080041366.3A 2009-09-17 2010-09-17 用于治疗胰腺炎和胰腺功能不全的胰酶组合物及其用途 Expired - Fee Related CN102630164B (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201510490337.XA CN105214073A (zh) 2009-09-17 2010-09-17 用于治疗胰腺炎和胰腺功能不全的胰酶组合物和方法

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
CN201510490337.XA Division CN105214073A (zh) 2009-09-17 2010-09-17 用于治疗胰腺炎和胰腺功能不全的胰酶组合物和方法

Publications (2)

Publication Number Publication Date
CN102630164A CN102630164A (zh) 2012-08-08
CN102630164B true CN102630164B (zh) 2015-09-16

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ID=43730817

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Application Number Title Priority Date Filing Date
CN201080041366.3A Expired - Fee Related CN102630164B (zh) 2009-09-17 2010-09-17 用于治疗胰腺炎和胰腺功能不全的胰酶组合物及其用途
CN201510490337.XA Pending CN105214073A (zh) 2009-09-17 2010-09-17 用于治疗胰腺炎和胰腺功能不全的胰酶组合物和方法

Family Applications After (1)

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CN201510490337.XA Pending CN105214073A (zh) 2009-09-17 2010-09-17 用于治疗胰腺炎和胰腺功能不全的胰酶组合物和方法

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)

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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 (1)

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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
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
AU2010295494B2 (en) 2014-09-25
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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C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
ASS Succession or assignment of patent right

Owner name: APTALIS PHARMA INC.

Free format text: FORMER OWNER: APTALIS PHARMACEUTICAL TECHNOLOGIES, INC.

Effective date: 20150417

C41 Transfer of patent application or patent right or utility model
TA01 Transfer of patent application right

Effective date of registration: 20150417

Address after: Wicklow

Applicant after: Aptalis Pharma Ltd.

Address before: Ohio, USA

Applicant before: APTALIS PHARMATECH, Inc.

C14 Grant of patent or utility model
GR01 Patent grant
CP01 Change in the name or title of a patent holder
CP01 Change in the name or title of a patent holder

Address after: Ai Erlanweikeluo

Patentee after: ELASTAGEN Pty Ltd.

Address before: Ai Erlanweikeluo

Patentee before: Aptalis Pharma Ltd.

TR01 Transfer of patent right
TR01 Transfer of patent right

Effective date of registration: 20200610

Address after: New jersey, USA

Patentee after: Erjian Medical Co.,Ltd.

Address before: Ai Erlanweikeluo

Patentee before: ELASTAGEN Pty Ltd.

CF01 Termination of patent right due to non-payment of annual fee
CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20150916