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)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Analytical Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (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 (cg-RX-API-DMAC7.html) |
| EP (1) | EP2376522A4 (cg-RX-API-DMAC7.html) |
| JP (2) | JP5711138B2 (cg-RX-API-DMAC7.html) |
| KR (1) | KR20110103961A (cg-RX-API-DMAC7.html) |
| CA (1) | CA2743789C (cg-RX-API-DMAC7.html) |
| IL (1) | IL212919A (cg-RX-API-DMAC7.html) |
| WO (1) | WO2010056657A2 (cg-RX-API-DMAC7.html) |
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2691531C (en) | 2007-06-22 | 2016-11-01 | Board Of Regents,The University Of Texas System | Formation of stable submicron peptide or protein particles by thin film freezing |
| US9072668B2 (en) | 2010-03-09 | 2015-07-07 | Janssen Biotech, Inc. | Non-aqueous high concentration reduced viscosity suspension formulations of antibodies |
| 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 |
| US9445990B2 (en) * | 2010-10-06 | 2016-09-20 | Medtronic, Inc. | TNF inhibitor formulation for use in implantable infusion devices |
| AU2012225277A1 (en) * | 2011-03-10 | 2013-09-26 | Board Of Regents, The University Of Texas System | Protein nanoparticle dispersions |
| BR112014010186A2 (pt) * | 2011-10-28 | 2017-05-02 | Integritybio Inc | formulação farmacêutica estável, kit, composição farmacêutica, método para preparar uma formulação farmacêutica, e, método para tratar um humano ou animal |
| US9737662B2 (en) | 2011-11-07 | 2017-08-22 | Battelle Memorial Institute | Processes for delivery of viscous drug therapies |
| CN104427974B (zh) * | 2012-05-18 | 2018-03-23 | 基因泰克公司 | 高浓度单克隆抗体配制剂 |
| WO2014151705A1 (en) * | 2013-03-15 | 2014-09-25 | 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 |
| CN107743396B (zh) | 2014-12-12 | 2021-01-15 | Motejo股份有限公司 | 皮下注射用剂 |
| 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 |
| US11459401B2 (en) | 2016-10-06 | 2022-10-04 | Amgen Inc. | Reduced viscosity protein pharmaceutical formulations |
| JP7341061B2 (ja) | 2016-11-22 | 2023-09-08 | エレクトロファイ, インコーポレイテッド | 治療用又は診断用薬剤を含む粒子並びにその懸濁液及び使用方法 |
| AU2018306303A1 (en) | 2017-07-25 | 2020-02-20 | Elektrofi, Inc. | Formation of particles including agents |
| US12115262B2 (en) | 2018-05-24 | 2024-10-15 | 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 |
| CN113365609A (zh) | 2019-01-31 | 2021-09-07 | 伊勒卓菲公司 | 颗粒形成和形态 |
| JP2022519690A (ja) | 2019-02-05 | 2022-03-24 | リンディー バイオサイエンシーズ,インク. | 単離された細胞培養成分、及びそれを液状の細胞培養培地から単離する方法 |
| US20200376128A1 (en) * | 2019-06-01 | 2020-12-03 | Lupin Holdings B.V. | Monodisperse resorbable polyester polymer compositions, systems, and methods |
| AU2020344675A1 (en) | 2019-09-13 | 2022-03-31 | Elektrofi, Inc. | Compositions and methods for the delivery of therapeutic biologics for treatment of disease |
| 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 |
| ZA932273B (en) | 1992-03-30 | 1993-11-26 | Alza Corp | Additives for bioerodible polymers to regulate degradation |
| WO1993019739A1 (en) | 1992-03-30 | 1993-10-14 | 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 |
| 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 |
| US5932547A (en) | 1996-07-03 | 1999-08-03 | Alza Corporation | Non-aqueous polar aprotic peptide formulations |
| US5916582A (en) | 1996-07-03 | 1999-06-29 | Alza Corporation | Aqueous formulations of peptides |
| NZ333580A (en) | 1996-07-03 | 2000-06-23 | Alza Corp | Non-Aqueous protic peptide formulations, preferably LHRH |
| IN184589B (cg-RX-API-DMAC7.html) | 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 |
| US7258869B1 (en) | 1999-02-08 | 2007-08-21 | Alza Corporation | Stable non-aqueous single phase viscous vehicles and formulations utilizing such vehicle |
| EP1666026B2 (en) | 1999-02-08 | 2015-02-25 | Intarcia Therapeutics, Inc | Non-aqueous single phase biocompatible viscous vehicles and methods for preparing the same |
| 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 |
| CA2439120C (en) * | 2001-02-23 | 2011-07-05 | Genentech, Inc. | Erodible polymers for injection |
| EP1492554B1 (en) * | 2001-06-21 | 2019-08-21 | Althea Technologies, Inc. | Spherical protein particles |
| US20050053666A1 (en) | 2002-12-31 | 2005-03-10 | Stelios Tzannis | Antibody-containing particles and compositions |
| JP4869064B2 (ja) * | 2003-04-04 | 2012-02-01 | ジェネンテック, インコーポレイテッド | 高濃度抗体及びタンパク質製剤 |
| US9044381B2 (en) * | 2003-06-24 | 2015-06-02 | Baxter International Inc. | Method for delivering drugs to the brain |
| KR101137785B1 (ko) | 2003-07-18 | 2012-04-25 | 백스터 인터내셔널 인코포레이티드 | 제어된 상 분리에 의해 제조된 작은 구형 입자의 제조방법, 이용 방법 및 조성물 |
| 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 |
| CA2566075A1 (en) | 2004-05-12 | 2005-12-01 | Baxter Healthcare S.A. | 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 |
| US7651770B2 (en) | 2005-12-16 | 2010-01-26 | The University Of Kansas | Nanoclusters for delivery of therapeutics |
| WO2007072982A1 (en) | 2005-12-20 | 2007-06-28 | Fujifilm Corporation | Protein nanoparticles and the use of the same |
| 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 |
| CA2691531C (en) | 2007-06-22 | 2016-11-01 | 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 |
| EP2259798B1 (en) | 2008-03-05 | 2013-12-11 | Baxter International Inc. | Surface-modified particles and methods for targeted drug delivery |
| JP5546532B2 (ja) | 2008-05-09 | 2014-07-09 | サウス ダコタ ステート ユニバーシティー | 非免疫原生の疎水性タンパク質ナノ粒子の形成方法、及びその利用 |
| 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 WO PCT/US2009/063852 patent/WO2010056657A2/en not_active Ceased
- 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
- 2009-11-10 CA CA2743789A patent/CA2743789C/en active Active
- 2009-11-10 KR KR1020117013867A patent/KR20110103961A/ko not_active Withdrawn
- 2009-11-10 EP EP09826617.4A patent/EP2376522A4/en 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 |
|---|---|
| WO2010056657A2 (en) | 2010-05-20 |
| JP2015083582A (ja) | 2015-04-30 |
| JP5711138B2 (ja) | 2015-04-30 |
| EP2376522A4 (en) | 2013-12-25 |
| CA2743789A1 (en) | 2010-05-20 |
| KR20110103961A (ko) | 2011-09-21 |
| IL212919A (en) | 2017-07-31 |
| IL212919A0 (en) | 2011-07-31 |
| US20110280864A1 (en) | 2011-11-17 |
| WO2010056657A3 (en) | 2010-10-14 |
| US20140378370A1 (en) | 2014-12-25 |
| US8779094B2 (en) | 2014-07-15 |
| JP2012508744A (ja) | 2012-04-12 |
| WO2010056657A8 (en) | 2010-08-26 |
| EP2376522A2 (en) | 2011-10-19 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20141106 |