AR063149A1 - Formulaciones a base de polipeptidos estables - Google Patents
Formulaciones a base de polipeptidos establesInfo
- Publication number
- AR063149A1 AR063149A1 ARP070104421A ARP070104421A AR063149A1 AR 063149 A1 AR063149 A1 AR 063149A1 AR P070104421 A ARP070104421 A AR P070104421A AR P070104421 A ARP070104421 A AR P070104421A AR 063149 A1 AR063149 A1 AR 063149A1
- Authority
- AR
- Argentina
- Prior art keywords
- polyol
- excipient
- sugar
- less
- buffer solution
- Prior art date
Links
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
- A61K47/06—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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
Abstract
Una formulacion que incluye una solucion amortiguadora que tiene un pH menor que 6; un cation divalente entre 5 y 200 mM, aproximadamente; un excipiente que comprende un azucar o poliol y una cantidad eficaz de un polipéptido terapéutico. También se proporciona un método para estabilizar un polipéptido. El método incluye poner en contacto un polipéptido terapéutico con una concentracion de cationes divalentes de entre 5 y 150 mM, aproximadamente, en una solucion amortiguadora a pH menor que 6; y un excipiente que comprende un azucar o poliol. Reivindicacion 1: Una formulacion que comprende una solucion amortiguadora que tiene un pH entre 4 y menos de 6, aproximadamente; un cation divalente entre 5 y 150 mM, aproximadamente; un excipiente que comprende un azucar o poliol y una cantidad eficaz de un anticuerpo terapéutico que tiene actividad de enlace específica al receptor del factor de crecimiento epidérmico humano (EGFR), donde dicho anticuerpo terapéutico retiene, al menos, el 80% de estabilidad durante dos meses, como máximo, en solucion.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US85318106P | 2006-10-20 | 2006-10-20 |
Publications (1)
Publication Number | Publication Date |
---|---|
AR063149A1 true AR063149A1 (es) | 2008-12-30 |
Family
ID=39325098
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ARP070104421A AR063149A1 (es) | 2006-10-20 | 2007-10-09 | Formulaciones a base de polipeptidos estables |
Country Status (12)
Country | Link |
---|---|
US (2) | US7705132B2 (es) |
EP (1) | EP2094247B1 (es) |
JP (1) | JP5623743B2 (es) |
AR (1) | AR063149A1 (es) |
AU (1) | AU2007309616B2 (es) |
CA (1) | CA2666492C (es) |
CL (1) | CL2007002881A1 (es) |
ES (1) | ES2925992T3 (es) |
MX (1) | MX2009003982A (es) |
PE (1) | PE20080857A1 (es) |
TW (1) | TW200833357A (es) |
WO (1) | WO2008051363A2 (es) |
Families Citing this family (34)
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JP2012526121A (ja) * | 2009-05-04 | 2012-10-25 | アボツト・バイオテクノロジー・リミテツド | ヒト抗tnfアルファ抗体の安定した高蛋白質濃度製剤 |
US8221753B2 (en) | 2009-09-30 | 2012-07-17 | Tracon Pharmaceuticals, Inc. | Endoglin antibodies |
JP2013515754A (ja) * | 2009-12-29 | 2013-05-09 | エフ・ホフマン−ラ・ロシュ・アクチェンゲゼルシャフト | 新規な抗体製剤 |
US9956165B2 (en) * | 2010-03-01 | 2018-05-01 | Cytodyn Inc. | Concentrated protein formulations and uses thereof |
US20140005128A1 (en) | 2010-08-11 | 2014-01-02 | Forest Laboratories Holdings Limited | Treatments of gastrointestinal disorders |
SG188487A1 (en) * | 2010-09-17 | 2013-05-31 | Baxter Int | Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral ph |
MX344727B (es) | 2010-11-11 | 2017-01-05 | Abbvie Biotechnology Ltd | Formulaciones liquidas de anticuerpos anti-tnf-alfa de alta concentracion mejoradas. |
TW201247222A (en) * | 2011-04-21 | 2012-12-01 | Daiichi Sankyo Co Ltd | Antibody liquid formulation |
UA116189C2 (uk) | 2011-05-02 | 2018-02-26 | Мілленніум Фармасьютікалз, Інк. | КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА |
JP6463968B2 (ja) | 2011-07-01 | 2019-02-06 | バイオジェン・エムエイ・インコーポレイテッドBiogen MA Inc. | アルギニンを含まない腫瘍壊死因子受容体:fc融合ポリペプチド組成物およびその使用方法 |
US10493151B2 (en) | 2011-10-18 | 2019-12-03 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with sodium chloride |
WO2013059406A1 (en) | 2011-10-18 | 2013-04-25 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with metal ions |
EA037797B1 (ru) | 2011-10-25 | 2021-05-21 | Протена Байосайенсиз Лимитед | Состав антитела, пригодный для профилактики и лечения амилоидоза, его варианты и способ его получения |
EP2869817A4 (en) * | 2012-07-09 | 2016-04-06 | Coherus Biosciences Inc | STABLE AQUEOUS FORMULATIONS OF ETANERCEPT |
FR2994390B1 (fr) | 2012-08-10 | 2014-08-15 | Adocia | Procede d'abaissement de la viscosite de solutions de proteines a concentration elevee |
UA115789C2 (uk) * | 2012-09-05 | 2017-12-26 | Трейкон Фармасутікалз, Інк. | Композиція антитіла до cd105 та її застосування |
PE20191815A1 (es) | 2012-09-07 | 2019-12-27 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab |
BR112015005161A2 (pt) | 2012-09-11 | 2017-07-04 | Coherus Biosciences Inc | etanercepte corretamente dobrado em alta pureza e excelente rendimento |
UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
US10564150B2 (en) * | 2012-12-28 | 2020-02-18 | Cellestis Limited | Cell mediated immune response assay |
US20140314778A1 (en) * | 2013-03-13 | 2014-10-23 | Genentech, Inc. | Formulations with reduced oxidation |
AU2015338717B2 (en) * | 2014-10-31 | 2018-12-20 | Glaxosmithkline Intellectual Property Development Limited | Powder formulation |
US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
US11071782B2 (en) | 2016-04-20 | 2021-07-27 | Coherus Biosciences, Inc. | Method of filling a container with no headspace |
US11608357B2 (en) | 2018-08-28 | 2023-03-21 | Arecor Limited | Stabilized antibody protein solutions |
GB201703062D0 (en) * | 2017-02-24 | 2017-04-12 | Arecor Ltd | Stabilized antibody protein solutions |
EP3372242A1 (en) | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
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US11845798B2 (en) | 2017-05-02 | 2023-12-19 | Merck Sharp & Dohme Llc | Formulations of anti-LAG3 antibodies and co-formulations of anti-LAG3 antibodies and anti-PD-1 antibodies |
JOP20190260A1 (ar) | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
MX2021009851A (es) | 2019-02-18 | 2021-09-10 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos. |
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-
2007
- 2007-10-05 EP EP07839333.7A patent/EP2094247B1/en active Active
- 2007-10-05 US US11/973,051 patent/US7705132B2/en active Active
- 2007-10-05 ES ES07839333T patent/ES2925992T3/es active Active
- 2007-10-05 JP JP2009533310A patent/JP5623743B2/ja active Active
- 2007-10-05 CL CL200702881A patent/CL2007002881A1/es unknown
- 2007-10-05 PE PE2007001356A patent/PE20080857A1/es not_active Application Discontinuation
- 2007-10-05 TW TW096137621A patent/TW200833357A/zh unknown
- 2007-10-05 AU AU2007309616A patent/AU2007309616B2/en active Active
- 2007-10-05 CA CA2666492A patent/CA2666492C/en active Active
- 2007-10-05 MX MX2009003982A patent/MX2009003982A/es active IP Right Grant
- 2007-10-05 WO PCT/US2007/021475 patent/WO2008051363A2/en active Application Filing
- 2007-10-09 AR ARP070104421A patent/AR063149A1/es not_active Application Discontinuation
-
2010
- 2010-03-05 US US12/718,898 patent/US8241632B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
PE20080857A1 (es) | 2008-08-19 |
EP2094247A2 (en) | 2009-09-02 |
CL2007002881A1 (es) | 2008-05-09 |
US8241632B2 (en) | 2012-08-14 |
AU2007309616B2 (en) | 2011-10-06 |
JP2010506911A (ja) | 2010-03-04 |
CA2666492C (en) | 2012-07-17 |
WO2008051363A3 (en) | 2008-09-12 |
AU2007309616A1 (en) | 2008-05-02 |
US20100158908A1 (en) | 2010-06-24 |
WO2008051363A2 (en) | 2008-05-02 |
JP5623743B2 (ja) | 2014-11-12 |
MX2009003982A (es) | 2009-04-27 |
US7705132B2 (en) | 2010-04-27 |
EP2094247B1 (en) | 2022-06-29 |
ES2925992T3 (es) | 2022-10-20 |
US20080124326A1 (en) | 2008-05-29 |
CA2666492A1 (en) | 2008-05-02 |
TW200833357A (en) | 2008-08-16 |
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