MX2009003982A - Formulaciones de polipeptido estables. - Google Patents
Formulaciones de polipeptido estables.Info
- Publication number
- MX2009003982A MX2009003982A MX2009003982A MX2009003982A MX2009003982A MX 2009003982 A MX2009003982 A MX 2009003982A MX 2009003982 A MX2009003982 A MX 2009003982A MX 2009003982 A MX2009003982 A MX 2009003982A MX 2009003982 A MX2009003982 A MX 2009003982A
- Authority
- MX
- Mexico
- Prior art keywords
- polypeptide formulations
- stable polypeptide
- polyol
- excipient
- sugar
- 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
La invención proporciona una formulación la cual incluye un amortiguador el cual tiene un pH menor a 6.0, un catión divalente entre aproximadamente 5-200 mM, un excipiente el cual comprende un azúcar o poliol y una cantidad efectiva de un polipéptido terapéutico. También se proporciona un método para estabilizar un polipéptido. El método incluye poner en contacto un polipéptido terapéutico con una concentración de catión divalente entre aproximadamente 5-510 mM en un amortiguador el cual tiene un pH menor a 6.0 y un excipiente el cual comprende un azúcar o poliol.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US85318106P | 2006-10-20 | 2006-10-20 | |
PCT/US2007/021475 WO2008051363A2 (en) | 2006-10-20 | 2007-10-05 | Stable polypeptide formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2009003982A true MX2009003982A (es) | 2009-04-27 |
Family
ID=39325098
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2009003982A MX2009003982A (es) | 2006-10-20 | 2007-10-05 | Formulaciones de polipeptido 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) |
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WO2011109365A2 (en) * | 2010-03-01 | 2011-09-09 | Progenics Pharmaceuticals, Inc. | Concentrated protein formulations and uses thereof |
PL2603232T3 (pl) | 2010-08-11 | 2020-05-18 | Ironwood Pharmaceuticals, Inc. | Stabilne formulacje linaklotydu |
PL2616090T3 (pl) | 2010-09-17 | 2023-12-18 | Takeda Pharmaceutical Company Limited | Stabilizowanie immunoglobulin poprzez wodną formulację z histydyną o ph od słabo kwaśnego do obojętnego |
CA2815689C (en) | 2010-11-11 | 2016-11-22 | Abbvie Biotechnology Ltd. | Improved high concentration anti-tnf.alpha. antibody liquid formulations |
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 |
KR102061355B1 (ko) | 2011-07-01 | 2019-12-31 | 바이오젠 엠에이 인코포레이티드 | 아르기닌-없는 tnfr : fc-융합 폴리펩티드 조성물 및 이용 방법 |
JP6220789B2 (ja) * | 2011-10-18 | 2017-10-25 | コヒラス・バイオサイエンシズ・インコーポレイテッド | 糖およびポリオールの組合せによって安定化されたエタネルセプト製剤 |
US10485869B2 (en) | 2011-10-18 | 2019-11-26 | Coherus Biosciences, Inc. | Etanercept formulations stabilized with meglumine |
MX354988B (es) | 2011-10-25 | 2018-03-28 | Prothena Biosciences Ltd | Formulaciones de anticuerpo y metodos. |
BR112015000203A2 (pt) * | 2012-07-09 | 2017-06-27 | Coherus Biosciences Inc | formulações de etanercept que exibem redução marcada em partículas sub-visíveis |
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 |
KR102238677B1 (ko) | 2012-09-07 | 2021-04-12 | 코히러스 바이오사이언시즈, 인코포레이티드 | 아달리무맙의 안정한 수성 제형 |
CN104902914B (zh) | 2012-09-11 | 2019-01-01 | 科荣生生物科学公司 | 高纯度和优异产量的正确折叠的依那西普 |
UA117466C2 (uk) | 2012-12-13 | 2018-08-10 | Мерк Шарп Енд Доме Корп. | СТАБІЛЬНИЙ СКЛАД У ВИГЛЯДІ РОЗЧИНУ АНТИТІЛА ДО IL-23p19 |
AU2013370928B2 (en) * | 2012-12-28 | 2019-05-02 | QIAGEN Australia Holding Pty. Ltd. | A cell mediated immune response assay |
AR095398A1 (es) * | 2013-03-13 | 2015-10-14 | Genentech Inc | Formulaciones con oxidación reducida |
MX2017005692A (es) | 2014-10-31 | 2017-08-07 | Glaxosmithkline Ip Dev Ltd | Formulacion en polvo. |
US11229702B1 (en) | 2015-10-28 | 2022-01-25 | Coherus Biosciences, Inc. | High concentration formulations of adalimumab |
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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 AU AU2007309616A patent/AU2007309616B2/en active Active
- 2007-10-05 ES ES07839333T patent/ES2925992T3/es active Active
- 2007-10-05 TW TW096137621A patent/TW200833357A/zh unknown
- 2007-10-05 WO PCT/US2007/021475 patent/WO2008051363A2/en active Application Filing
- 2007-10-05 CL CL200702881A patent/CL2007002881A1/es unknown
- 2007-10-05 MX MX2009003982A patent/MX2009003982A/es active IP Right Grant
- 2007-10-05 PE PE2007001356A patent/PE20080857A1/es not_active Application Discontinuation
- 2007-10-05 CA CA2666492A patent/CA2666492C/en active Active
- 2007-10-05 JP JP2009533310A patent/JP5623743B2/ja active Active
- 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 |
---|---|
TW200833357A (en) | 2008-08-16 |
WO2008051363A3 (en) | 2008-09-12 |
CA2666492A1 (en) | 2008-05-02 |
AU2007309616A1 (en) | 2008-05-02 |
WO2008051363A2 (en) | 2008-05-02 |
CA2666492C (en) | 2012-07-17 |
US8241632B2 (en) | 2012-08-14 |
PE20080857A1 (es) | 2008-08-19 |
US20100158908A1 (en) | 2010-06-24 |
JP2010506911A (ja) | 2010-03-04 |
JP5623743B2 (ja) | 2014-11-12 |
AR063149A1 (es) | 2008-12-30 |
EP2094247B1 (en) | 2022-06-29 |
CL2007002881A1 (es) | 2008-05-09 |
AU2007309616B2 (en) | 2011-10-06 |
US20080124326A1 (en) | 2008-05-29 |
US7705132B2 (en) | 2010-04-27 |
EP2094247A2 (en) | 2009-09-02 |
ES2925992T3 (es) | 2022-10-20 |
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