AU2014236938B2 - Composition of a sustained-release delivery and method of stabilizing proteins during fabrication process - Google Patents

Composition of a sustained-release delivery and method of stabilizing proteins during fabrication process Download PDF

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Publication number
AU2014236938B2
AU2014236938B2 AU2014236938A AU2014236938A AU2014236938B2 AU 2014236938 B2 AU2014236938 B2 AU 2014236938B2 AU 2014236938 A AU2014236938 A AU 2014236938A AU 2014236938 A AU2014236938 A AU 2014236938A AU 2014236938 B2 AU2014236938 B2 AU 2014236938B2
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AU
Australia
Prior art keywords
protein
formulation
microsphere
weight
excipients
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
AU2014236938A
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English (en)
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AU2014236938A1 (en
Inventor
Simon H. Tran
Cindy Wu
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 Inc
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Allergan Inc
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Filing date
Publication date
Application filed by Allergan Inc filed Critical Allergan Inc
Publication of AU2014236938A1 publication Critical patent/AU2014236938A1/en
Application granted granted Critical
Publication of AU2014236938B2 publication Critical patent/AU2014236938B2/en
Priority to AU2019201884A priority Critical patent/AU2019201884B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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

Landscapes

  • 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)
AU2014236938A 2013-03-14 2014-03-13 Composition of a sustained-release delivery and method of stabilizing proteins during fabrication process Ceased AU2014236938B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2019201884A AU2019201884B2 (en) 2013-03-14 2019-03-19 Composition of a sustained-release delivery and method of stabilizing proteins during fabrication process

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
AU2019201884A Division AU2019201884B2 (en) 2013-03-14 2019-03-19 Composition of a sustained-release delivery and method of stabilizing proteins during fabrication process

Publications (2)

Publication Number Publication Date
AU2014236938A1 AU2014236938A1 (en) 2015-09-03
AU2014236938B2 true AU2014236938B2 (en) 2018-12-20

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
AU2014236938A Ceased AU2014236938B2 (en) 2013-03-14 2014-03-13 Composition of a sustained-release delivery and method of stabilizing proteins during fabrication process
AU2019201884A Ceased AU2019201884B2 (en) 2013-03-14 2019-03-19 Composition of a sustained-release delivery and method of stabilizing proteins during fabrication process

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2019201884A Ceased AU2019201884B2 (en) 2013-03-14 2019-03-19 Composition of a sustained-release delivery and method of stabilizing proteins during fabrication process

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

Citations (2)

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Publication number Priority date Publication date Assignee Title
US5730969A (en) * 1988-10-05 1998-03-24 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
US6346274B1 (en) * 1995-03-10 2002-02-12 Roche Diagnostics Gmbh Polypeptide-containing pharmaceutical forms of administration in the form of microparticles and method for the preparation thereof

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US4777043A (en) * 1985-12-17 1988-10-11 Genentech, Inc. Stabilized human tissue plasminogen activator compositions
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
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.
JP5074750B2 (ja) * 2005-12-07 2012-11-14 一般財団法人化学及血清療法研究所 シクロデキストリン類を含有する液状フィブリノゲン製剤
US8642067B2 (en) * 2007-04-02 2014-02-04 Allergen, Inc. Methods and compositions for intraocular administration to treat ocular conditions
WO2009031011A2 (en) * 2007-09-05 2009-03-12 Pfizer Limited Xinafoate salt of n4-(2, 2-difluoro-4h-benz0 [1,4] 0xazin-3-one) -6-yl] -5-fluoro-n2- [3- (methylaminocar bonylmethyleneoxy) phenyl] 2, 4-pyrimidinediamine
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Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
US5730969A (en) * 1988-10-05 1998-03-24 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
US6346274B1 (en) * 1995-03-10 2002-02-12 Roche Diagnostics Gmbh Polypeptide-containing pharmaceutical forms of administration in the form of microparticles and method for the preparation thereof

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Also Published As

Publication number Publication date
JP6649246B2 (ja) 2020-02-19
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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MK14 Patent ceased section 143(a) (annual fees not paid) or expired