JP5711138B2 - 高濃度の低粘度懸濁液 - Google Patents

高濃度の低粘度懸濁液 Download PDF

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Publication number
JP5711138B2
JP5711138B2 JP2011536414A JP2011536414A JP5711138B2 JP 5711138 B2 JP5711138 B2 JP 5711138B2 JP 2011536414 A JP2011536414 A JP 2011536414A JP 2011536414 A JP2011536414 A JP 2011536414A JP 5711138 B2 JP5711138 B2 JP 5711138B2
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JP
Japan
Prior art keywords
suspension
particles
viscosity
protein
concentration
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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
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JP2011536414A
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English (en)
Japanese (ja)
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JP2012508744A5 (enExample
JP2012508744A (ja
Inventor
キース ピー． ジョンストン
キース ピー． ジョンストン
マリア アンドレア マズスキー
マリア アンドレア マズスキー
ジョシュア イングストロム
ジョシュア イングストロム
ミゲル アンジェロ ロドリゲス
ミゲル アンジェロ ロドリゲス
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University of Texas System
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University of Texas System
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Publication of JP2012508744A5 publication Critical patent/JP2012508744A5/ja
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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/107—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
    • C07K1/113—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides without change of the primary structure
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38—Albumins
    • A61K38/385—Serum albumin
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
JP2011536414A 2008-11-16 2009-11-10 高濃度の低粘度懸濁液 Expired - Fee Related JP5711138B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11508008P 2008-11-16 2008-11-16
US61/115,080 2008-11-16
PCT/US2009/063852 WO2010056657A2 (en) 2008-11-16 2009-11-10 Low viscosity highly concentrated suspensions

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2014247793A Division JP2015083582A (ja) 2008-11-16 2014-12-08 高濃度の低粘度懸濁液

Publications (3)

Publication Number Publication Date
JP2012508744A JP2012508744A (ja) 2012-04-12
JP2012508744A5 JP2012508744A5 (enExample) 2013-02-21
JP5711138B2 true JP5711138B2 (ja) 2015-04-30

Family

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Family Applications (2)

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JP2011536414A Expired - Fee Related JP5711138B2 (ja) 2008-11-16 2009-11-10 高濃度の低粘度懸濁液
JP2014247793A Pending JP2015083582A (ja) 2008-11-16 2014-12-08 高濃度の低粘度懸濁液

Family Applications After (1)

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JP2014247793A Pending JP2015083582A (ja) 2008-11-16 2014-12-08 高濃度の低粘度懸濁液

Country Status (7)

Country Link
US (2) US8779094B2 (enExample)
EP (1) EP2376522A4 (enExample)
JP (2) JP5711138B2 (enExample)
KR (1) KR20110103961A (enExample)
CA (1) CA2743789C (enExample)
IL (1) IL212919A (enExample)
WO (1) WO2010056657A2 (enExample)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2170283B1 (en) 2007-06-22 2019-01-09 Board of Regents, The University of Texas System Formation of stable submicron peptide or protein particles by thin film freezing
US20110223208A1 (en) * 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
CN103096934A (zh) * 2010-03-09 2013-05-08 詹森生物科技公司 非水性高浓度低粘度混悬剂
US9072668B2 (en) 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
US9445990B2 (en) * 2010-10-06 2016-09-20 Medtronic, Inc. TNF inhibitor formulation for use in implantable infusion devices
JP2014514275A (ja) * 2011-03-10 2014-06-19 ボード・オブ・リージエンツ，ザ・ユニバーシテイ・オブ・テキサス・システム タンパク質ナノ粒子分散系
CN104023748B (zh) 2011-10-28 2018-03-02 诚信生物公司 含有氨基酸的蛋白质制剂
WO2013070692A1 (en) 2011-11-07 2013-05-16 Battelle Memorial Institute Processes for delivery of viscous drug therapies
AU2013262611B2 (en) * 2012-05-18 2018-03-01 Genentech, Inc. High-concentration monoclonal antibody formulations
HK1220120A1 (zh) * 2013-03-15 2017-04-28 Ansun Biopharma, Inc. 制造注射蛋白质微粒悬浮液的方法
IL312865B2 (en) 2013-09-11 2025-06-01 Eagle Biologics Inc Liquid protein formulations containing viscosity-lowering agents
CN103976947B (zh) * 2014-06-05 2016-08-17 段明星 一种含酶油悬浮剂及其制备方法与应用
JP6716577B2 (ja) 2014-10-01 2020-07-01 イーグル・バイオロジクス・インコーポレイテッドＥａｇｌｅ Ｂｉｏｌｏｇｉｃｓ， Ｉｎｃ． 粘度低下物質を含有する、多糖および核酸の調合薬
JP5774190B1 (ja) * 2014-12-12 2015-09-09 ジーンメディカル株式会社 皮下注射用剤及び皮下注射用剤を含有する注射器の製造方法
EP3231433B1 (en) * 2014-12-12 2023-12-27 Motejo. Ltd Agent for hypodermic injection
WO2018067987A1 (en) * 2016-10-06 2018-04-12 Amgen Inc. Reduced viscosity protein pharmaceutical formulations
AU2017364077A1 (en) 2016-11-22 2019-06-20 Elektrofi, Inc. Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
EP3658612A4 (en) 2017-07-25 2021-06-02 Elektrofi, Inc. FORMATION OF PARTICLES WITH SUBSTANCES
WO2019226969A1 (en) 2018-05-24 2019-11-28 Elektrofi, Inc. Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof
KR102051808B1 (ko) 2018-07-23 2019-12-04 주식회사 종근당 테스토스테론 운데카노에이트를 포함하는 안정한 약제학적 조성물
WO2020160323A2 (en) 2019-01-31 2020-08-06 Elektrofi, Inc. Particle formation and morphology
CN113661006A (zh) 2019-02-05 2021-11-16 林迪生物科学公司 分离的细胞培养物组分以及用于从液体细胞培养基中分离其的方法
US20200376128A1 (en) * 2019-06-01 2020-12-03 Lupin Holdings B.V. Monodisperse resorbable polyester polymer compositions, systems, and methods
JP7781743B2 (ja) * 2019-09-13 2025-12-08 エレクトロフィ，インコーポレイテッド 疾患の処置のための治療用生物学的作用剤の送達のための組成物及び方法
CN115484934A (zh) 2020-04-17 2022-12-16 伊勒卓菲公司 通过连续液滴形成和脱水形成颗粒的方法

Family Cites Families (49)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE795516A (fr) 1972-02-17 1973-08-16 Ciba Geigy Preparations de peptides huileuses et injectables et procede pour leur preparation
US4310516A (en) 1980-02-01 1982-01-12 Block Drug Company Inc. Cosmetic and pharmaceutical vehicle thickened with solid emulsifier
EP0079143A3 (en) 1981-10-20 1984-11-21 Adnovum Ag Pseudoplastic gel transfer
US4594108A (en) 1983-09-19 1986-06-10 The Dow Chemical Company Highly pseudoplastic polymer solutions
US5411951A (en) 1984-10-04 1995-05-02 Monsanto Company Prolonged release of biologically active somatotropin
US5288479A (en) 1989-01-17 1994-02-22 Sterling Drug, Inc. Extrudable elastic oral pharmaceutical gel compositions and metered dose dispensers containing them and method of making and method of use thereof
SE465950B (sv) 1989-10-23 1991-11-25 Medinvent Sa Kombination av ett aggregat partikelformat, kristallint eller frystorkat laekemedel med en pseudoplastisk gel foer beredning av ett injicerbart preparat samt foerfarande foer dess framstaellning
US5300302A (en) 1990-10-04 1994-04-05 Nestec S.A. Pharmaceutical composition in gel form in a dispensing package
YU87892A (sh) 1991-10-01 1995-12-04 Eli Lilly And Company Lilly Corporate Center Injektibilne formulacije produženog otpuštanja i postupci za njihovo dobijanje i primenu
ZA932272B (en) 1992-03-30 1993-10-19 Alza Corp Viscous suspensions of controlled-release drug particles
EP0633907A1 (en) 1992-03-30 1995-01-18 Alza Corporation Additives for bioerodible polymers to regulate degradation
US5512293A (en) 1992-07-23 1996-04-30 Alza Corporation Oral sustained release drug delivery device
SE9203594D0 (sv) 1992-11-30 1992-11-30 Christer Nystroem Laekemedel i dispersa system
EP0768867B1 (en) 1994-06-13 2002-10-09 Alza Corporation Dosage form for administering drug in liquid formulation
US5904935A (en) 1995-06-07 1999-05-18 Alza Corporation Peptide/protein suspending formulations
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
US5916582A (en) 1996-07-03 1999-06-29 Alza Corporation Aqueous formulations of peptides
US5932547A (en) 1996-07-03 1999-08-03 Alza Corporation Non-aqueous polar aprotic peptide formulations
RO119862B1 (ro) 1996-07-03 2005-05-30 Alza Corporation Formulare stabilă neapoasă şi procedeu pentru prepararea acesteia
IN184589B (enExample) 1996-10-16 2000-09-09 Alza Corp
US7393630B2 (en) 1997-12-16 2008-07-01 Novartis Vaccines And Diagnostics, Inc. Use of microparticles combined with submicron oil-in-water emulsions
ES2261190T3 (es) 1999-02-08 2006-11-16 Alza Corporation Vehiculos viscosos no acuosos estables de fase unica y formulaciones que utilizan dichos vehiculos.
US7258869B1 (en) 1999-02-08 2007-08-21 Alza Corporation Stable non-aqueous single phase viscous vehicles and formulations utilizing such vehicle
FR2809309B1 (fr) * 2000-05-23 2004-06-11 Mainelab Microspheres a liberation prolongee pour administration injectable
DE60138641D1 (de) 2000-10-27 2009-06-18 Baxter Healthcare Sa Herstellung von mikrokügelchen
US20040022861A1 (en) * 2001-01-30 2004-02-05 Williams Robert O. Process for production of nanoparticles and microparticles by spray freezing into liquid
ATE427760T1 (de) * 2001-02-23 2009-04-15 Genentech Inc Erodierbare polymere zur injektion
JP2005500304A (ja) * 2001-06-21 2005-01-06 アルタス バイオロジックス インコーポレイテッド 球状タンパク質粒子およびそれらの作製方法および使用方法
EP1578394A4 (en) 2002-12-31 2011-02-23 Nektar Therapeutics ANTIBODY PARTICLES AND COMPOSITIONS
HRP20050934B1 (hr) * 2003-04-04 2014-09-26 Genentech, Inc. Formulacije s visokom koncentracijom antitijela i proteina
BRPI0414970A2 (pt) * 2003-06-24 2012-12-11 Baxter Int método para transporte de drogas ao cérebro
BRPI0412735A (pt) 2003-07-18 2006-09-26 Baxter Int métodos para a fabricação, uso e composição de partìculas esféricas pequenas preparadas mediante a separação de fase controlada
FR2862536B1 (fr) * 2003-11-21 2007-11-23 Flamel Tech Sa Formulations pharmaceutiques pour la liberation prolongee de principe(s) actif(s), ainsi que leurs applications notamment therapeutiques
WO2005112893A1 (en) 2004-05-12 2005-12-01 Baxter International Inc. Microspheres comprising protein and showing injectability at high concentrations of said agent
US8728525B2 (en) 2004-05-12 2014-05-20 Baxter International Inc. Protein microspheres retaining pharmacokinetic and pharmacodynamic properties
US20060141040A1 (en) * 2004-12-23 2006-06-29 Guohua Chen Injectable non-aqueous suspension
WO2006083761A2 (en) * 2005-02-03 2006-08-10 Alza Corporation Solvent/polymer solutions as suspension vehicles
US20070015689A1 (en) 2005-06-23 2007-01-18 Alza Corporation Complexation of metal ions with polypeptides
WO2007076295A2 (en) 2005-12-16 2007-07-05 University Of Kansas Nanoclusters for delivery of therapeutics
JP5147699B2 (ja) 2005-12-20 2013-02-20 富士フイルム株式会社 タンパク質ナノ粒子およびその使用
US20080102128A1 (en) * 2006-07-28 2008-05-01 Flamel Technologies, Inc. Modified-release microparticles based on amphiphilic copolymer and on active principles(s) and pharmaceutical formulations comprising them
EP2170283B1 (en) 2007-06-22 2019-01-09 Board of Regents, The University of Texas System Formation of stable submicron peptide or protein particles by thin film freezing
CN101081882A (zh) * 2007-07-06 2007-12-05 天津大学 大分子印迹交联聚乙烯基吡咯烷酮微球及低温悬浮聚合制备方法
JP2009173610A (ja) 2008-01-28 2009-08-06 Fujifilm Corp タンパク質ナノ粒子
WO2009111638A1 (en) 2008-03-05 2009-09-11 Baxter International Inc. Compositions and methods for drug delivery
WO2009137112A1 (en) 2008-05-09 2009-11-12 South Dakota State University Method of forming non-immunogenic hydrophobic protein nanoparticles and uses therefor
US20100009007A1 (en) 2008-07-10 2010-01-14 Baxter International Inc. Non-covalent modification of microparticles and process of preparing same
US8323685B2 (en) 2008-08-20 2012-12-04 Baxter International Inc. Methods of processing compositions containing microparticles
AR075715A1 (es) 2009-03-05 2011-04-20 Novartis Ag Formulacion de anticuerpo liofilizado

Also Published As

Publication number Publication date
KR20110103961A (ko) 2011-09-21
WO2010056657A8 (en) 2010-08-26
WO2010056657A3 (en) 2010-10-14
CA2743789C (en) 2017-10-31
US8779094B2 (en) 2014-07-15
WO2010056657A2 (en) 2010-05-20
IL212919A0 (en) 2011-07-31
CA2743789A1 (en) 2010-05-20
IL212919A (en) 2017-07-31
US20140378370A1 (en) 2014-12-25
JP2015083582A (ja) 2015-04-30
US20110280864A1 (en) 2011-11-17
JP2012508744A (ja) 2012-04-12
EP2376522A4 (en) 2013-12-25
EP2376522A2 (en) 2011-10-19

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