CA2743789C - Low viscosity highly concentrated suspensions - Google Patents
Low viscosity highly concentrated suspensions Download PDFInfo
- Publication number
- CA2743789C CA2743789C CA2743789A CA2743789A CA2743789C CA 2743789 C CA2743789 C CA 2743789C CA 2743789 A CA2743789 A CA 2743789A CA 2743789 A CA2743789 A CA 2743789A CA 2743789 C CA2743789 C CA 2743789C
- Authority
- CA
- Canada
- Prior art keywords
- suspension
- antibody
- salt
- micron
- particles
- 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.)
- Active
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)
- 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)
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 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2743789A1 CA2743789A1 (en) | 2010-05-20 |
| CA2743789C true CA2743789C (en) | 2017-10-31 |
Family
ID=42170660
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2743789A Active CA2743789C (en) | 2008-11-16 | 2009-11-10 | Low viscosity highly concentrated suspensions |
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)
| 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)
| 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 |
-
2009
- 2009-11-10 JP JP2011536414A patent/JP5711138B2/ja not_active Expired - Fee Related
- 2009-11-10 EP EP09826617.4A patent/EP2376522A4/en not_active Withdrawn
- 2009-11-10 US US13/129,283 patent/US8779094B2/en active Active
- 2009-11-10 WO PCT/US2009/063852 patent/WO2010056657A2/en not_active Ceased
- 2009-11-10 CA CA2743789A patent/CA2743789C/en active Active
- 2009-11-10 KR KR1020117013867A patent/KR20110103961A/ko not_active Withdrawn
-
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 |
|---|---|
| KR20110103961A (ko) | 2011-09-21 |
| WO2010056657A8 (en) | 2010-08-26 |
| WO2010056657A3 (en) | 2010-10-14 |
| JP5711138B2 (ja) | 2015-04-30 |
| 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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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20141106 |