JP5711138B2 - 高濃度の低粘度懸濁液 - Google Patents
高濃度の低粘度懸濁液 Download PDFInfo
- 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
- Authority
- JP
- Japan
- Prior art keywords
- suspension
- particles
- viscosity
- protein
- concentration
- 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
Links
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
Landscapes
- 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)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Gastroenterology & Hepatology (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)
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 (https=) | 2013-02-21 |
| JP5711138B2 true JP5711138B2 (ja) | 2015-04-30 |
Family
ID=42170660
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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 (https=) |
| EP (1) | EP2376522A4 (https=) |
| JP (2) | JP5711138B2 (https=) |
| KR (1) | KR20110103961A (https=) |
| CA (1) | CA2743789C (https=) |
| IL (1) | IL212919A (https=) |
| WO (1) | WO2010056657A2 (https=) |
Families Citing this family (25)
| 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 |
| 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 |
| US20110223208A1 (en) * | 2010-03-09 | 2011-09-15 | Beth Hill | Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations |
| 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 |
| AU2012328524B2 (en) | 2011-10-28 | 2017-05-18 | Excelse Bio, Inc. | Protein formulations containing amino acids |
| EP2776091B1 (en) | 2011-11-07 | 2021-03-03 | Battelle Memorial Institute | Processes for delivery of viscous drug therapies |
| NZ701915A (en) * | 2012-05-18 | 2016-11-25 | Genentech Inc | High-concentration monoclonal antibody formulations |
| US20140342006A1 (en) * | 2013-03-15 | 2014-11-20 | Ansun Biopharma, Inc. | Methods for Preparing Injectable Protein Microparticle Suspensions |
| 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 |
| EP3200804A4 (en) | 2014-10-01 | 2018-04-18 | Eagle Biologics, Inc. | Polysaccharide and nucleic acid formulations containing viscosity-lowering agents |
| BR112017012289B1 (pt) | 2014-12-12 | 2022-11-16 | Motejo. Ltd | Agente para injeção hipodérmica |
| 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 |
| EP3522918A1 (en) * | 2016-10-06 | 2019-08-14 | Amgen Inc. | Reduced viscosity protein pharmaceutical formulations |
| US11654112B2 (en) | 2016-11-22 | 2023-05-23 | Elektrofi, Inc. | Particles comprising a therapeutic or diagnostic agent and suspensions and methods of use thereof |
| AU2018306303A1 (en) | 2017-07-25 | 2020-02-20 | Elektrofi, Inc. | Formation of particles including agents |
| 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 |
| EP3917500A2 (en) | 2019-01-31 | 2021-12-08 | Elektrofi, Inc. | Particle formation and morphology |
| KR102941878B1 (ko) | 2019-02-05 | 2026-03-23 | 린디 바이오사이언시스, 아이엔씨. | 단리된 세포 배양 성분 및 액체 세포 배양 배지로부터 이를 단리하는 방법 |
| US20200376128A1 (en) * | 2019-06-01 | 2020-12-03 | Lupin Holdings B.V. | Monodisperse resorbable polyester polymer compositions, systems, and methods |
| WO2021050953A1 (en) | 2019-09-13 | 2021-03-18 | Elektrofi, Inc. | Compositions and methods for the delivery of therapeutic biologics for treatment of disease |
| JP2023522627A (ja) | 2020-04-17 | 2023-05-31 | エレクトロフィ,インコーポレイテッド | 連続的な液滴形成及び脱水によって粒子を形成する方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
| EP0633907A1 (en) | 1992-03-30 | 1995-01-18 | Alza Corporation | Additives for bioerodible polymers to regulate degradation |
| AU3941493A (en) | 1992-03-30 | 1993-11-08 | Alza Corporation | Viscous suspensions of controlled-release drug particles |
| 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 |
| WO1995034285A1 (en) | 1994-06-13 | 1995-12-21 | 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 |
| RU2203085C2 (ru) | 1996-07-03 | 2003-04-27 | Элзэ Копэрейшн | Стабильный неводный препарат пептидного соединения, способ его получения и способ лечения гормон-зависимого заболевания у субъекта |
| IN184589B (https=) | 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 |
| EP1152749B1 (en) | 1999-02-08 | 2006-04-12 | ALZA Corporation | Stable non-aqueous single phase viscous vehicles and formulations utilizing such vehicles |
| 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 |
| EP1335661B1 (en) | 2000-10-27 | 2009-05-06 | Baxter Healthcare S.A. | Production of microspheres |
| US20040022861A1 (en) * | 2001-01-30 | 2004-02-05 | Williams Robert O. | Process for production of nanoparticles and microparticles by spray freezing into liquid |
| DK1372729T3 (da) * | 2001-02-23 | 2009-06-22 | Genentech Inc | Nedbrydelige polymere til injektion |
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| BRPI0414970A2 (pt) | 2003-06-24 | 2012-12-11 | Baxter Int | método para transporte de drogas ao cérebro |
| RU2426590C2 (ru) | 2003-07-18 | 2011-08-20 | Бакстер Интернэшнл Инк. | Способы изготовления, применение и композиции небольших сферических частиц, приготовленных регулируемым фазовым разделением |
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| US8333995B2 (en) | 2004-05-12 | 2012-12-18 | Baxter International, Inc. | Protein microspheres having injectable properties at high concentrations |
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| CA2633380A1 (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 |
| RU2496482C2 (ru) | 2008-03-05 | 2013-10-27 | Бакстер Интернэшнл Инк. | Композиции и способы для доставки лекарственных средств |
| BRPI0908686B8 (pt) | 2008-05-09 | 2021-05-25 | South Dakota State Univ | método de produção de nanopartículas não-imunogênicas, nanopartícula não-imunogênica terapeuticamente ativa, composição terapêutica, uso de uma nanopartícula não-imunogênica e kit para a produção de nanopartículas não-imunogênicas |
| 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 |
| WO2010100200A2 (en) | 2009-03-05 | 2010-09-10 | Novartis Ag | Lyophilised antibody formulation |
-
2009
- 2009-11-10 EP EP09826617.4A patent/EP2376522A4/en not_active Withdrawn
- 2009-11-10 CA CA2743789A patent/CA2743789C/en active Active
- 2009-11-10 WO PCT/US2009/063852 patent/WO2010056657A2/en not_active Ceased
- 2009-11-10 KR KR1020117013867A patent/KR20110103961A/ko not_active Withdrawn
- 2009-11-10 JP JP2011536414A patent/JP5711138B2/ja not_active Expired - Fee Related
- 2009-11-10 US US13/129,283 patent/US8779094B2/en active Active
-
2011
- 2011-05-16 IL IL212919A patent/IL212919A/en active IP Right Grant
-
2014
- 2014-06-05 US US14/297,403 patent/US20140378370A1/en not_active Abandoned
- 2014-12-08 JP JP2014247793A patent/JP2015083582A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| JP2012508744A (ja) | 2012-04-12 |
| US20140378370A1 (en) | 2014-12-25 |
| US8779094B2 (en) | 2014-07-15 |
| WO2010056657A3 (en) | 2010-10-14 |
| WO2010056657A2 (en) | 2010-05-20 |
| WO2010056657A8 (en) | 2010-08-26 |
| CA2743789A1 (en) | 2010-05-20 |
| EP2376522A2 (en) | 2011-10-19 |
| EP2376522A4 (en) | 2013-12-25 |
| IL212919A (en) | 2017-07-31 |
| KR20110103961A (ko) | 2011-09-21 |
| CA2743789C (en) | 2017-10-31 |
| US20110280864A1 (en) | 2011-11-17 |
| JP2015083582A (ja) | 2015-04-30 |
| IL212919A0 (en) | 2011-07-31 |
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