BR112020020707A2 - Formulação farmacêutica estável de um anticorpo alfa4beta7 - Google Patents
Formulação farmacêutica estável de um anticorpo alfa4beta7 Download PDFInfo
- Publication number
- BR112020020707A2 BR112020020707A2 BR112020020707-1A BR112020020707A BR112020020707A2 BR 112020020707 A2 BR112020020707 A2 BR 112020020707A2 BR 112020020707 A BR112020020707 A BR 112020020707A BR 112020020707 A2 BR112020020707 A2 BR 112020020707A2
- Authority
- BR
- Brazil
- Prior art keywords
- antibody
- formulation
- vedolizumab
- vmab
- 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
- A61K47/16—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
-
- 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
- A61K9/14—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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2839—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
- C07K16/2842—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily against integrin beta1-subunit-containing molecules, e.g. CD29, CD49
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2839—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the integrin superfamily
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Immunology (AREA)
- Biochemistry (AREA)
- Organic Chemistry (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN201841013646 | 2018-04-10 | ||
| IN201841013646 | 2018-04-10 | ||
| PCT/IN2019/050292 WO2019198100A1 (en) | 2018-04-10 | 2019-04-10 | Antibody formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR112020020707A2 true BR112020020707A2 (pt) | 2021-01-12 |
Family
ID=68163986
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112020020707-1A BR112020020707A2 (pt) | 2018-04-10 | 2019-04-10 | Formulação farmacêutica estável de um anticorpo alfa4beta7 |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US12030948B2 (https=) |
| EP (1) | EP3773694A4 (https=) |
| JP (2) | JP2021521159A (https=) |
| CN (1) | CN112218654A (https=) |
| AU (1) | AU2019253070A1 (https=) |
| BR (1) | BR112020020707A2 (https=) |
| CO (1) | CO2020013552A2 (https=) |
| SG (1) | SG11202009874QA (https=) |
| WO (1) | WO2019198100A1 (https=) |
| ZA (1) | ZA202006263B (https=) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SG10202012778YA (en) | 2015-12-18 | 2021-01-28 | Astellas Pharma Inc | Pharmaceutical composition comprising anti-human tslp receptor antibody |
| WO2019198099A1 (en) * | 2018-04-10 | 2019-10-17 | Dr. Reddy's Laboratories Limited | Stable antibody formulation |
| JP7804590B2 (ja) * | 2020-05-11 | 2026-01-22 | メディミューン リミテッド | 抗ｉｌ－３３抗体の処方物 |
| WO2024098180A1 (en) * | 2022-11-07 | 2024-05-16 | Wuxi Biologics (Hong Kong) Limited | Pharmaceutical compositions comprising anti-human tslp receptor antibodies and methods of using the same |
| EP4243859A4 (en) * | 2020-11-12 | 2024-10-16 | Dr. Reddy's Laboratories Ltd. | STABLE AQUEOUS FORMULATION WITH HIGH CONCENTRATION OF ANTI-INTEGRIN ANTIBODY |
| WO2022157806A1 (en) * | 2021-01-20 | 2022-07-28 | Dr. Reddy's Laboratories Limited | Freeze dried antibody formulations and methods thereof |
| WO2022234594A1 (en) * | 2021-05-07 | 2022-11-10 | Dr. Reddy’S Laboratories Limited | A method of improving stability of an antibody formulation |
| EP4346899A1 (en) * | 2021-06-04 | 2024-04-10 | Polpharma Biologics S.A. | Vedolizumab formulation |
| CN113813377A (zh) * | 2021-09-07 | 2021-12-21 | 杭州远大生物制药有限公司 | 抗α4β7抗体制剂及其应用 |
| TW202432601A (zh) | 2022-11-07 | 2024-08-16 | 美商上游生物公司 | 包含抗人類ｔｓｌｐ受體抗體之醫藥組成物及其使用方法 |
| WO2024249568A1 (en) | 2023-05-30 | 2024-12-05 | Paragon Therapeutics, Inc. | Alpha4beta7 integrin antibody compositions and methods of use |
| CN121889424A (zh) | 2023-08-14 | 2026-04-17 | 派拉冈医疗公司 | α4β7整联蛋白结合蛋白及使用方法 |
| WO2025041000A1 (en) * | 2023-08-21 | 2025-02-27 | Intas Pharmaceuticals Ltd. | STABLE LIQUID CITRATE FREE FORMULATION OF AN ANTI-α4β7 ANTIBODY |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK2236154T3 (en) * | 2003-02-10 | 2018-06-25 | Biogen Ma Inc | IMMUNOGLOBULIN INFORMATION AND METHOD OF PREPARING IT |
| JO3000B1 (ar) * | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
| US20090208492A1 (en) * | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
| WO2012076670A2 (en) * | 2010-12-10 | 2012-06-14 | Novartis Ag | Antibody formulation |
| UA116189C2 (uk) * | 2011-05-02 | 2018-02-26 | Мілленніум Фармасьютікалз, Інк. | КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА |
| MX367097B (es) * | 2011-05-02 | 2019-08-05 | Millennium Pharm Inc | FORMULACION PARA ANTICUERPO ANTI-A4ß7. |
| TWI752912B (zh) * | 2015-07-17 | 2022-01-21 | 美商寇西勒斯生物科技股份有限公司 | 那他珠單抗的穩定水性調配物 |
| WO2019147824A1 (en) * | 2018-01-26 | 2019-08-01 | Progenity, Inc. | Treatment of a disease of the gastrointestinal tract with a pde4 inhibitor |
| US20220364171A1 (en) * | 2018-11-23 | 2022-11-17 | Katholieke Universiteit Leuven | Predicting a treatment response in inflammatory bowel disease |
-
2019
- 2019-04-10 WO PCT/IN2019/050292 patent/WO2019198100A1/en not_active Ceased
- 2019-04-10 US US17/045,380 patent/US12030948B2/en active Active
- 2019-04-10 JP JP2020555387A patent/JP2021521159A/ja active Pending
- 2019-04-10 BR BR112020020707-1A patent/BR112020020707A2/pt unknown
- 2019-04-10 AU AU2019253070A patent/AU2019253070A1/en not_active Abandoned
- 2019-04-10 EP EP19784340.2A patent/EP3773694A4/en active Pending
- 2019-04-10 CN CN201980037792.0A patent/CN112218654A/zh active Pending
- 2019-04-10 SG SG11202009874QA patent/SG11202009874QA/en unknown
-
2020
- 2020-10-08 ZA ZA2020/06263A patent/ZA202006263B/en unknown
- 2020-10-28 CO CONC2020/0013552A patent/CO2020013552A2/es unknown
-
2023
- 2023-11-06 JP JP2023189255A patent/JP7793581B2/ja active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CO2020013552A2 (es) | 2021-01-18 |
| WO2019198100A1 (en) | 2019-10-17 |
| JP7793581B2 (ja) | 2026-01-05 |
| EP3773694A4 (en) | 2021-12-29 |
| AU2019253070A1 (en) | 2020-11-26 |
| CN112218654A (zh) | 2021-01-12 |
| AU2019253070A2 (en) | 2020-12-03 |
| JP2021521159A (ja) | 2021-08-26 |
| JP2024001364A (ja) | 2024-01-09 |
| EP3773694A1 (en) | 2021-02-17 |
| SG11202009874QA (en) | 2020-11-27 |
| US12030948B2 (en) | 2024-07-09 |
| ZA202006263B (en) | 2022-01-26 |
| US20210147555A1 (en) | 2021-05-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B350 | Update of information on the portal [chapter 15.35 patent gazette] | ||
| B06W | Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette] |