MX351148B - Formulacion de anticuerpo beta amiloide. - Google Patents
Formulacion de anticuerpo beta amiloide.Info
- Publication number
- MX351148B MX351148B MX2014009662A MX2014009662A MX351148B MX 351148 B MX351148 B MX 351148B MX 2014009662 A MX2014009662 A MX 2014009662A MX 2014009662 A MX2014009662 A MX 2014009662A MX 351148 B MX351148 B MX 351148B
- Authority
- MX
- Mexico
- Prior art keywords
- abeta antibody
- antibody formulation
- abeta
- formulation
- poloxamer
- Prior art date
Links
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 229960000502 poloxamer Drugs 0.000 abstract 1
- 229920001983 poloxamer Polymers 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/515—Complete light chain, i.e. VL + CL
-
- 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]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Endocrinology (AREA)
- Inorganic Chemistry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hospice & Palliative Care (AREA)
- Psychiatry (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
Abstract
La presente invención se refiere a una formulación farmacéutica que comprende aproximadamente 50 mg/ml-200 mg/ml de un anticuerpo Abeta, aproximadamente 0.01%-0.1% de poloxámero, aproximadamente 5 mM-50mM de una solución amortiguadora, aproximadamente 100 mM-300 mM de un estabilizador a un pH de aproximadamente 4.5-7.0.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12158602 | 2012-03-08 | ||
| PCT/EP2013/054313 WO2013131866A1 (en) | 2012-03-08 | 2013-03-05 | Abeta antibody formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2014009662A MX2014009662A (es) | 2014-09-25 |
| MX351148B true MX351148B (es) | 2017-10-04 |
Family
ID=47780075
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2014009662A MX351148B (es) | 2012-03-08 | 2013-03-05 | Formulacion de anticuerpo beta amiloide. |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US20150030589A1 (es) |
| EP (1) | EP2822587B1 (es) |
| JP (1) | JP5859148B2 (es) |
| KR (1) | KR101666289B1 (es) |
| CN (1) | CN104159613B (es) |
| AR (2) | AR090272A1 (es) |
| AU (1) | AU2013229613B2 (es) |
| BR (1) | BR112014019667B1 (es) |
| CA (1) | CA2860543C (es) |
| CY (1) | CY1117363T1 (es) |
| DK (1) | DK2822587T3 (es) |
| ES (1) | ES2564281T3 (es) |
| HR (1) | HRP20160434T1 (es) |
| HU (1) | HUE028440T2 (es) |
| IL (1) | IL234120B (es) |
| MX (1) | MX351148B (es) |
| MY (1) | MY166045A (es) |
| NZ (1) | NZ626955A (es) |
| PL (1) | PL2822587T3 (es) |
| RS (1) | RS54644B1 (es) |
| RU (1) | RU2014140137A (es) |
| SG (1) | SG11201404481RA (es) |
| SI (1) | SI2822587T1 (es) |
| WO (1) | WO2013131866A1 (es) |
| ZA (1) | ZA201405103B (es) |
Families Citing this family (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3050963B1 (en) | 2005-03-31 | 2019-09-18 | Chugai Seiyaku Kabushiki Kaisha | Process for production of polypeptide by regulation of assembly |
| CA2647846C (en) | 2006-03-31 | 2016-06-21 | Chugai Seiyaku Kabushiki Kaisha | Methods for controlling blood pharmacokinetics of antibodies |
| CN105177091A (zh) | 2006-03-31 | 2015-12-23 | 中外制药株式会社 | 用于纯化双特异性抗体的抗体修饰方法 |
| CN106519025B (zh) | 2007-09-26 | 2021-04-23 | 中外制药株式会社 | 利用cdr的氨基酸取代来改变抗体等电点的方法 |
| JO3672B1 (ar) | 2008-12-15 | 2020-08-27 | Regeneron Pharma | أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9). |
| JP5918246B2 (ja) * | 2010-10-06 | 2016-05-18 | リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． | 抗インターロイキン−４受容体（ｉｌ−４ｒ）抗体を含有する安定化製剤 |
| RU2620071C2 (ru) | 2010-11-17 | 2017-05-22 | Чугаи Сеияку Кабушики Каиша | Мультиспецифическая связывающая антиген молекула, которая обладает альтернативной функцией к функции фактора свертывания крови viii |
| MX347602B (es) | 2011-01-28 | 2017-05-03 | Sanofi Biotechnology | Composiciones farmaceuticas que comprenden anticuerpos humanos frente a pcsk9. |
| AR087305A1 (es) | 2011-07-28 | 2014-03-12 | Regeneron Pharma | Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit |
| CN105764922B (zh) | 2013-09-27 | 2020-07-17 | 中外制药株式会社 | 多肽异源多聚体的制备方法 |
| TWI701435B (zh) | 2014-09-26 | 2020-08-11 | 日商中外製藥股份有限公司 | 測定ｆｖｉｉｉ的反應性之方法 |
| TWI700300B (zh) | 2014-09-26 | 2020-08-01 | 日商中外製藥股份有限公司 | 中和具有第ｖｉｉｉ凝血因子（ｆｖｉｉｉ）機能替代活性的物質之抗體 |
| WO2016159213A1 (ja) | 2015-04-01 | 2016-10-06 | 中外製薬株式会社 | ポリペプチド異種多量体の製造方法 |
| IL302486A (en) | 2015-06-24 | 2023-06-01 | Hoffmann La Roche | Antibodies against the transnephrine receptor with adapted affinity |
| US10772956B2 (en) | 2015-08-18 | 2020-09-15 | Regeneron Pharmaceuticals, Inc. | Methods for reducing or eliminating the need for lipoprotein apheresis in patients with hyperlipidemia by administering alirocumab |
| AR106189A1 (es) | 2015-10-02 | 2017-12-20 | Hoffmann La Roche | ANTICUERPOS BIESPECÍFICOS CONTRA EL A-b HUMANO Y EL RECEPTOR DE TRANSFERRINA HUMANO Y MÉTODOS DE USO |
| CN114057885A (zh) | 2015-10-02 | 2022-02-18 | 豪夫迈·罗氏有限公司 | 双特异性抗人cd20/人转铁蛋白受体抗体及使用方法 |
| EP3395835B1 (en) | 2015-12-25 | 2021-02-03 | Chugai Seiyaku Kabushiki Kaisha | Antibody having enhanced activity, and method for modifying same |
| CA3004288C (en) | 2015-12-28 | 2025-05-27 | Chugai Seiyaku Kabushiki Kaisha | METHOD FOR PROMOTING THE CLEARANCE EFFICIENCY OF A POLYPEPTIDE CONTAINING THE FC REGION |
| TWI820000B (zh) | 2016-04-28 | 2023-11-01 | 日商中外製藥股份有限公司 | 含抗體製劑 |
| JP7125932B2 (ja) | 2016-09-06 | 2022-08-25 | 中外製薬株式会社 | 凝固第ｉｘ因子および／または活性化凝固第ｉｘ因子ならびに凝固第ｘ因子および／または活性化凝固第ｘ因子を認識する二重特異性抗体の使用法 |
| EP3632421B1 (en) * | 2017-05-30 | 2025-08-13 | Morinaga Milk Industry Co., Ltd. | Acetic acid and/or an acetic acid salt for use in the treatment of alzheimer-type dementia |
| KR20250053967A (ko) * | 2017-08-22 | 2025-04-22 | 바이오젠 엠에이 인코포레이티드 | 항-베타 아밀로이드 항체를 함유하는 약제학적 조성물 |
| EP3690050A4 (en) | 2017-09-29 | 2021-06-16 | Chugai Seiyaku Kabushiki Kaisha | MULTISPECIFIC ANTIGENBINDING MOLECULE WITH BLOOD CLOG FACTOR VIII (FVIII) COFACTOR FUNCTION SUBSTITUATING ACTIVITY AND PHARMACEUTICAL FORMULATION WITH THIS MOLECULE AS THE ACTIVE SUBSTANCE |
| AR113816A1 (es) | 2017-11-01 | 2020-06-17 | Chugai Pharmaceutical Co Ltd | Variantes e isoformas de anticuerpos con actividad biológica reducida |
| WO2022000046A1 (en) * | 2020-07-03 | 2022-01-06 | CSL Innovation Pty Ltd | High concentration formulation of factor xii antigen binding proteins |
| US20250042984A1 (en) * | 2021-12-20 | 2025-02-06 | CSL Innovation Pty Ltd | Protein formulations and uses thereof |
| WO2023215267A1 (en) * | 2022-05-02 | 2023-11-09 | Regeneron Pharmaceuticals, Inc. | Anti-interleukin-4 receptor (il-4r) antibody formulations |
| AU2024283314A1 (en) | 2023-05-31 | 2025-11-13 | F. Hoffmann-La Roche Ag | Therapeutic use of bispecific anti-abeta/tfr antibodies |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4816567A (en) | 1983-04-08 | 1989-03-28 | Genentech, Inc. | Recombinant immunoglobin preparations |
| US5204244A (en) | 1987-10-27 | 1993-04-20 | Oncogen | Production of chimeric antibodies by homologous recombination |
| US5202238A (en) | 1987-10-27 | 1993-04-13 | Oncogen | Production of chimeric antibodies by homologous recombination |
| US5959177A (en) | 1989-10-27 | 1999-09-28 | The Scripps Research Institute | Transgenic plants expressing assembled secretory antibodies |
| EP0604580A1 (en) | 1991-09-19 | 1994-07-06 | Genentech, Inc. | EXPRESSION IN E. COLI OF ANTIBODY FRAGMENTS HAVING AT LEAST A CYSTEINE PRESENT AS A FREE THIOL, USE FOR THE PRODUCTION OF BIFUNCTIONAL F(ab') 2? ANTIBODIES |
| US5789199A (en) | 1994-11-03 | 1998-08-04 | Genentech, Inc. | Process for bacterial production of polypeptides |
| US5840523A (en) | 1995-03-01 | 1998-11-24 | Genetech, Inc. | Methods and compositions for secretion of heterologous polypeptides |
| US6040498A (en) | 1998-08-11 | 2000-03-21 | North Caroline State University | Genetically engineered duckweed |
| US7125978B1 (en) | 1999-10-04 | 2006-10-24 | Medicago Inc. | Promoter for regulating expression of foreign genes |
| DE60022369T2 (de) | 1999-10-04 | 2006-05-18 | Medicago Inc., Sainte Foy | Verfahren zur regulation der transkription von fremden genen in gegenwart von stickstoff |
| CN101351476B (zh) * | 2005-12-12 | 2013-04-03 | 豪夫迈·罗氏有限公司 | 抗体可变区的糖基化 |
| CA2671968A1 (en) * | 2006-12-11 | 2008-06-19 | F. Hoffmann-La Roche Ag | Abeta antibody parenteral formulation |
-
2013
- 2013-03-05 JP JP2014560323A patent/JP5859148B2/ja active Active
- 2013-03-05 RU RU2014140137A patent/RU2014140137A/ru not_active Application Discontinuation
- 2013-03-05 SG SG11201404481RA patent/SG11201404481RA/en unknown
- 2013-03-05 AU AU2013229613A patent/AU2013229613B2/en active Active
- 2013-03-05 PL PL13707176T patent/PL2822587T3/pl unknown
- 2013-03-05 WO PCT/EP2013/054313 patent/WO2013131866A1/en not_active Ceased
- 2013-03-05 MX MX2014009662A patent/MX351148B/es active IP Right Grant
- 2013-03-05 NZ NZ626955A patent/NZ626955A/en unknown
- 2013-03-05 ES ES13707176.7T patent/ES2564281T3/es active Active
- 2013-03-05 EP EP13707176.7A patent/EP2822587B1/en active Active
- 2013-03-05 SI SI201330150T patent/SI2822587T1/sl unknown
- 2013-03-05 HR HRP20160434TT patent/HRP20160434T1/hr unknown
- 2013-03-05 BR BR112014019667-2A patent/BR112014019667B1/pt active IP Right Grant
- 2013-03-05 KR KR1020147025086A patent/KR101666289B1/ko active Active
- 2013-03-05 DK DK13707176.7T patent/DK2822587T3/en active
- 2013-03-05 RS RS20160187A patent/RS54644B1/sr unknown
- 2013-03-05 CA CA2860543A patent/CA2860543C/en active Active
- 2013-03-05 MY MYPI2014002221A patent/MY166045A/en unknown
- 2013-03-05 HU HUE13707176A patent/HUE028440T2/en unknown
- 2013-03-05 US US14/381,849 patent/US20150030589A1/en not_active Abandoned
- 2013-03-05 CN CN201380012493.4A patent/CN104159613B/zh active Active
- 2013-03-07 AR ARP130100743A patent/AR090272A1/es not_active Application Discontinuation
-
2014
- 2014-07-11 ZA ZA2014/05103A patent/ZA201405103B/en unknown
- 2014-08-14 IL IL234120A patent/IL234120B/en active IP Right Grant
-
2016
- 2016-04-12 CY CY20161100295T patent/CY1117363T1/el unknown
-
2021
- 2021-06-25 AR ARP210101758A patent/AR122746A2/es unknown
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant or registration |