JP6649246B2 - タンパク質の徐放性送達の組成物及び製造プロセス中のタンパク質の安定化方法 - Google Patents

タンパク質の徐放性送達の組成物及び製造プロセス中のタンパク質の安定化方法 Download PDF

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Publication number
JP6649246B2
JP6649246B2 JP2016502103A JP2016502103A JP6649246B2 JP 6649246 B2 JP6649246 B2 JP 6649246B2 JP 2016502103 A JP2016502103 A JP 2016502103A JP 2016502103 A JP2016502103 A JP 2016502103A JP 6649246 B2 JP6649246 B2 JP 6649246B2
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formulation
protein
microsphere
microspheres
cyclodextrin
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Expired - Fee Related
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Japanese (ja)
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JP2016517418A (ja
JP2016517418A5 (https=
Inventor
サイモン エイチ トラン
サイモン エイチ トラン
シンディー ウー
シンディー ウー
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Allergan Inc
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Allergan Inc
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    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/02—Peptides of undefined number of amino acids; Derivatives thereof
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Ophthalmology & Optometry (AREA)
JP2016502103A 2013-03-14 2014-03-13 タンパク質の徐放性送達の組成物及び製造プロセス中のタンパク質の安定化方法 Expired - Fee Related JP6649246B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361786035P 2013-03-14 2013-03-14
US61/786,035 2013-03-14
PCT/US2014/026320 WO2014151725A1 (en) 2013-03-14 2014-03-13 Composition of a sustained-release delivery and method of stabilizing proteins during fabrication process

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2019217753A Division JP2020029466A (ja) 2013-03-14 2019-12-02 タンパク質の徐放性送達の組成物及び製造プロセス中のタンパク質の安定化方法

Publications (3)

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JP2016517418A JP2016517418A (ja) 2016-06-16
JP2016517418A5 JP2016517418A5 (https=) 2018-08-02
JP6649246B2 true JP6649246B2 (ja) 2020-02-19

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JP2016502103A Expired - Fee Related JP6649246B2 (ja) 2013-03-14 2014-03-13 タンパク質の徐放性送達の組成物及び製造プロセス中のタンパク質の安定化方法
JP2019217753A Pending JP2020029466A (ja) 2013-03-14 2019-12-02 タンパク質の徐放性送達の組成物及び製造プロセス中のタンパク質の安定化方法

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JP2019217753A Pending JP2020029466A (ja) 2013-03-14 2019-12-02 タンパク質の徐放性送達の組成物及び製造プロセス中のタンパク質の安定化方法

Country Status (10)

Country Link
US (1) US20140274873A1 (https=)
EP (2) EP2968574A1 (https=)
JP (2) JP6649246B2 (https=)
KR (1) KR20150128857A (https=)
CN (1) CN105188759A (https=)
AU (2) AU2014236938B2 (https=)
BR (1) BR112015021000A2 (https=)
CA (1) CA2902547A1 (https=)
RU (1) RU2720412C2 (https=)
WO (1) WO2014151725A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106076214B (zh) * 2016-07-15 2019-12-17 沈阳化工大学 一种具有核壳结构的海藻酸钙微球制备方法
GB201906835D0 (en) * 2019-05-15 2019-06-26 Ucb Biopharma Sprl Dry microparticles
WO2022163966A1 (ko) * 2021-01-29 2022-08-04 주식회사 티온랩테라퓨틱스 초기 방출 제어된 데포 조성물 및 이의 제조방법

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US4777043A (en) * 1985-12-17 1988-10-11 Genentech, Inc. Stabilized human tissue plasminogen activator compositions
US5997856A (en) * 1988-10-05 1999-12-07 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
KR0166088B1 (ko) * 1990-01-23 1999-01-15 . 수용해도가 증가된 시클로덱스트린 유도체 및 이의 용도
US6448077B1 (en) 1994-02-10 2002-09-10 Imclone Systems, Inc. Chimeric and humanized monoclonal antibodies specific to VEGF receptors
ATE201983T1 (de) * 1995-03-10 2001-06-15 Roche Diagnostics Gmbh Polypeptid-enthaltende pharmazeutische darreichungsformen in form von mikropartikeln und verfahren zu deren herstellung
GB9514285D0 (en) * 1995-07-13 1995-09-13 Univ Nottingham Polymeric lamellar substrate particles for drug delivery
US5665428A (en) * 1995-10-25 1997-09-09 Macromed, Inc. Preparation of peptide containing biodegradable microspheres by melt process
US6884879B1 (en) 1997-04-07 2005-04-26 Genentech, Inc. Anti-VEGF antibodies
JP4360758B2 (ja) * 1999-04-08 2009-11-11 ジェネンテック・インコーポレーテッド 逆の電荷のポリペプチド類をベースにした組成物
DE60127175T2 (de) * 2000-12-21 2007-11-08 Nektar Therapeutics, San Carlos Lagerstabile pulverzusammensetzungen mit interleukin-4 rezeptor
EP1436329A4 (en) 2001-09-20 2005-04-27 Alexion Pharma Inc ANTI-PDGF ANTIBODIES AND METHODS FOR PRODUCING FOCUSED ANTIBODIES
US7265084B2 (en) * 2001-10-10 2007-09-04 Neose Technologies, Inc. Glycopegylation methods and proteins/peptides produced by the methods
US9415102B2 (en) * 2002-09-06 2016-08-16 Alexion Pharmaceuticals, Inc. High concentration formulations of anti-C5 antibodies
KR100466637B1 (ko) * 2003-06-26 2005-01-13 주식회사 펩트론 서방성 미립구의 혼합 제형을 연속한 단일 공정으로제조하는 방법
US20060182783A1 (en) * 2004-04-30 2006-08-17 Allergan, Inc. Sustained release intraocular drug delivery systems
US7993634B2 (en) * 2004-04-30 2011-08-09 Allergan, Inc. Oil-in-oil emulsified polymeric implants containing a hypotensive lipid and related methods
US8591885B2 (en) * 2004-04-30 2013-11-26 Allergan, Inc. Carbonic anhydrase inhibitor sustained release intraocular drug delivery systems
WO2005110374A1 (en) * 2004-04-30 2005-11-24 Allergan, Inc. Intraocular drug delivery systems containing a therapeutic component, a cyclodextrin, and a polymeric component
CA2593112A1 (en) * 2005-01-21 2006-07-27 Alza Corporation Therapeutic peptide formulations for coating microneedles with improved stability containing at least one counterion
MX2007013213A (es) * 2005-04-25 2007-12-12 Amgen Inc Composiciones de liberacion prolongada de peptidos biodegradables que contienen porogenos.
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Also Published As

Publication number Publication date
AU2014236938B2 (en) 2018-12-20
KR20150128857A (ko) 2015-11-18
AU2019201884A1 (en) 2019-04-11
RU2720412C2 (ru) 2020-04-29
EP3693021A1 (en) 2020-08-12
JP2016517418A (ja) 2016-06-16
US20140274873A1 (en) 2014-09-18
CA2902547A1 (en) 2014-09-25
RU2015135147A (ru) 2017-04-18
JP2020029466A (ja) 2020-02-27
EP2968574A1 (en) 2016-01-20
AU2019201884B2 (en) 2020-08-27
BR112015021000A2 (pt) 2017-07-18
CN105188759A (zh) 2015-12-23
AU2014236938A1 (en) 2015-09-03
WO2014151725A1 (en) 2014-09-25

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