PE20220932A1 - Composicion farmaceutica acuosa de anticuerpo anti-pd1 prolgolimab y su uso - Google Patents
Composicion farmaceutica acuosa de anticuerpo anti-pd1 prolgolimab y su usoInfo
- Publication number
- PE20220932A1 PE20220932A1 PE2022000293A PE2022000293A PE20220932A1 PE 20220932 A1 PE20220932 A1 PE 20220932A1 PE 2022000293 A PE2022000293 A PE 2022000293A PE 2022000293 A PE2022000293 A PE 2022000293A PE 20220932 A1 PE20220932 A1 PE 20220932A1
- Authority
- PE
- Peru
- Prior art keywords
- antibody
- concentration
- prolgolimab
- pharmaceutical composition
- aqueous pharmaceutical
- Prior art date
Links
Classifications
-
- 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
- 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
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- 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
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
-
- 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
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- 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
- A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/52—Constant or Fc region; Isotype
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/71—Decreased effector function due to an Fc-modification
-
- 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)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Dermatology (AREA)
- Endocrinology (AREA)
- Oncology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
Abstract
La presente invencion se refiere a una composicion farmaceutica acuosa de anticuerpo anti-PD-1 que comprende: (a) prolgolimab a una concentracion de 15 mg/mL hasta 150 mg/mL como anticuerpo; (b) dihidrato de trehalosa a una concentracion de 50 mg/mL hasta 110 mg/mL; (c) acetato de sodio trihidratado a una concentracion de 0,2 mg/mL hasta 2,5 mg/mL; y (d) acido acetico a un pH de 4,5 a 5,5. Tambien se refiere a una composicion farmaceutica acuosa de anticuerpo anti-PD-1 que comprende: (a) prolgolimab a una concentracion de 5 mg/mL hasta 150 mg/mL como anticuerpo; (b) dihidrato de trehalosa a una concentracion de 70 mg/mL hasta 110 mg/mL; (c) L-histidina a una concentracion de 0,2 mg/mL hasta 2,5 mg/mL; y (d) clorhidrato de L-histidina a una concentracion de 0,2 mg/mL hasta 3,5 mg/mL. Dicha composicion es una composicion farmaceutica acuosa estable mejorada del anticuerpo anti-PD-1 prolgolimab, siendo util en el tratamiento del cancer.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| RU2019126511A RU2806320C2 (ru) | 2019-08-22 | Водная фармацевтическая композиция антитела к pd-1 пролголимаба и ее применение | |
| PCT/RU2020/050197 WO2021034228A1 (ru) | 2019-08-22 | 2020-08-21 | Водная фармацевтическая композиция антитела к pd-1 пролголимаба и ее применение |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20220932A1 true PE20220932A1 (es) | 2022-05-31 |
Family
ID=71558267
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2022000293A PE20220932A1 (es) | 2019-08-22 | 2020-08-21 | Composicion farmaceutica acuosa de anticuerpo anti-pd1 prolgolimab y su uso |
Country Status (17)
| Country | Link |
|---|---|
| EP (1) | EP4019047A4 (es) |
| JP (1) | JP2022544850A (es) |
| KR (1) | KR20220147061A (es) |
| CN (1) | CN111420049A (es) |
| AR (1) | AR119805A1 (es) |
| AU (1) | AU2020333023A1 (es) |
| BR (1) | BR112022003378A2 (es) |
| CA (1) | CA3148978A1 (es) |
| CO (1) | CO2022001829A2 (es) |
| EC (1) | ECSP22021881A (es) |
| JO (1) | JOP20220045A1 (es) |
| MA (2) | MA61742A1 (es) |
| MX (1) | MX2022002185A (es) |
| PE (1) | PE20220932A1 (es) |
| TW (1) | TWI844666B (es) |
| UY (1) | UY38851A (es) |
| WO (1) | WO2021034228A1 (es) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111965372B (zh) * | 2020-09-03 | 2024-05-31 | 北京安图生物工程有限公司 | 免疫球蛋白e检测试剂盒及其制备方法 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| UA123270C2 (uk) * | 2015-12-07 | 2021-03-10 | Мерк Патент Гмбх | Водний фармацевтичний препарат, який містить антитіло до pd-l1 авелумаб |
| RS61510B1 (sr) * | 2016-05-18 | 2021-03-31 | Boehringer Ingelheim Int | Anti pd-1 i anti-lag3 antitela za lečenje kancera |
| RU2656181C1 (ru) * | 2016-07-13 | 2018-05-31 | Закрытое Акционерное Общество "Биокад" | Анти-pd-1-антитела, способ их получения и способ применения |
| WO2019122941A1 (en) * | 2017-12-21 | 2019-06-27 | Debiopharm International Sa | Combination anti cancer therapy with an iap antagonist and an anti pd-1 molecule |
-
2020
- 2020-04-15 TW TW109112698A patent/TWI844666B/zh active
- 2020-04-15 CN CN202010297418.9A patent/CN111420049A/zh active Pending
- 2020-08-21 JO JOP/2022/0045A patent/JOP20220045A1/ar unknown
- 2020-08-21 MA MA61742A patent/MA61742A1/fr unknown
- 2020-08-21 JP JP2022512336A patent/JP2022544850A/ja active Pending
- 2020-08-21 BR BR112022003378A patent/BR112022003378A2/pt unknown
- 2020-08-21 AU AU2020333023A patent/AU2020333023A1/en active Pending
- 2020-08-21 MA MA56263A patent/MA56263A1/fr unknown
- 2020-08-21 UY UY0001038851A patent/UY38851A/es unknown
- 2020-08-21 WO PCT/RU2020/050197 patent/WO2021034228A1/ru unknown
- 2020-08-21 CA CA3148978A patent/CA3148978A1/en active Pending
- 2020-08-21 KR KR1020227009582A patent/KR20220147061A/ko unknown
- 2020-08-21 MX MX2022002185A patent/MX2022002185A/es unknown
- 2020-08-21 EP EP20853868.6A patent/EP4019047A4/en active Pending
- 2020-08-21 PE PE2022000293A patent/PE20220932A1/es unknown
- 2020-08-24 AR ARP200102365A patent/AR119805A1/es unknown
-
2022
- 2022-02-21 CO CONC2022/0001829A patent/CO2022001829A2/es unknown
- 2022-03-22 EC ECSENADI202221881A patent/ECSP22021881A/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP4019047A1 (en) | 2022-06-29 |
| MA56263A1 (fr) | 2022-11-30 |
| MX2022002185A (es) | 2022-04-20 |
| EP4019047A4 (en) | 2023-06-07 |
| JP2022544850A (ja) | 2022-10-21 |
| TW202114637A (zh) | 2021-04-16 |
| CA3148978A1 (en) | 2021-02-25 |
| ECSP22021881A (es) | 2022-04-29 |
| MA61742A1 (fr) | 2023-11-30 |
| UY38851A (es) | 2021-02-26 |
| JOP20220045A1 (ar) | 2023-01-30 |
| BR112022003378A2 (pt) | 2022-05-17 |
| CN111420049A (zh) | 2020-07-17 |
| WO2021034228A1 (ru) | 2021-02-25 |
| AR119805A1 (es) | 2022-01-12 |
| RU2019126511A (ru) | 2021-02-24 |
| CO2022001829A2 (es) | 2022-03-29 |
| AU2020333023A1 (en) | 2022-11-03 |
| TWI844666B (zh) | 2024-06-11 |
| RU2019126511A3 (es) | 2021-04-30 |
| KR20220147061A (ko) | 2022-11-02 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| AR107014A1 (es) | Formulación farmacéutica acuosa | |
| NZ719036A (en) | Anti-pdl1 antibody formulations | |
| AR063150A1 (es) | Formulaciones estables | |
| HRP20201268T1 (hr) | Stabilne formulacije koje sadrže anti-pcsk9 antitijela | |
| EA201790989A1 (ru) | Стабильный препарат раствора белка, содержащего анти-vegf антитело в высокой концентрации | |
| AR109461A2 (es) | Formulación de anticuerpo anti-cd20 y su uso para preparar un medicamento | |
| RU2011140498A (ru) | Препарат антител | |
| PE20181365A1 (es) | Formulaciones subcutaneas de anticuerpos anti-cd38 y sus usos | |
| RU2015132431A (ru) | Составы, содержащие антитела | |
| RU2018140960A (ru) | Композиции, содержащие комбинированный состав на основе антител к pd-l1 и ctla-4 | |
| PE20091327A1 (es) | Composicion farmaceutica que comprende anticuerpos monoclonales | |
| AR079746A1 (es) | Formulacion farmaceutica de anticuerpo | |
| PH12014502778B1 (en) | Antibody formulation | |
| EA201592256A1 (ru) | Производные имидазопирролидинона и их применение при лечении заболеваний | |
| PE20130579A1 (es) | Composiciones y metodos para suministro al sistema nervioso central de iduronato-2-sulfatasa | |
| PE20141413A1 (es) | Formulaciones de anticuerpo y metodos | |
| RU2017101667A (ru) | Фармацевтические композиции | |
| PE20160012A1 (es) | Tratamiento de enfermedades miopaticas y neurogenerativas por agregacion de proteina mediante administracion parenteral | |
| AR114324A1 (es) | Péptidos de la cadena b de la relaxina lipidados modificados y su uso terapéutico | |
| CO2020008308A2 (es) | Péptidos de la cadena b de la relaxina lipidados modificados y su uso terapéutico | |
| AR114323A1 (es) | Péptidos de la cadena b de la relaxina modificados y su uso terapéutico | |
| PE20220932A1 (es) | Composicion farmaceutica acuosa de anticuerpo anti-pd1 prolgolimab y su uso | |
| MX2019003470A (es) | Composicion farmaceutica y metodo para el tratamiento de la enfermedad del higado graso no alcoholico. | |
| PE20191550A1 (es) | COMPOSICION FARMACEUTICA ACUOSA DE ANTICUERPO MONOCLONAL ANTI-TNFalfa RECOMBINANTE | |
| PE20190168A1 (es) | Complejos radiofarmaceuticos |