AR125470A1 - Composición farmacéutica de pembrolizumab y su uso - Google Patents
Composición farmacéutica de pembrolizumab y su usoInfo
- Publication number
- AR125470A1 AR125470A1 ARP220101106A ARP220101106A AR125470A1 AR 125470 A1 AR125470 A1 AR 125470A1 AR P220101106 A ARP220101106 A AR P220101106A AR P220101106 A ARP220101106 A AR P220101106A AR 125470 A1 AR125470 A1 AR 125470A1
- Authority
- AR
- Argentina
- Prior art keywords
- pembrolizumab
- compositions
- pharmaceutical composition
- histidine
- poloxamer
- Prior art date
Links
- 229960002621 pembrolizumab Drugs 0.000 title abstract 5
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 4
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 4
- 239000000203 mixture Substances 0.000 abstract 3
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 abstract 2
- CMXXUDSWGMGYLZ-XRIGFGBMSA-N (2s)-2-amino-3-(1h-imidazol-5-yl)propanoic acid;hydron;chloride;hydrate Chemical compound O.Cl.OC(=O)[C@@H](N)CC1=CN=CN1 CMXXUDSWGMGYLZ-XRIGFGBMSA-N 0.000 abstract 2
- 208000035473 Communicable disease Diseases 0.000 abstract 2
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 abstract 2
- 206010028980 Neoplasm Diseases 0.000 abstract 2
- ONIBWKKTOPOVIA-UHFFFAOYSA-N Proline Natural products OC(=O)C1CCCN1 ONIBWKKTOPOVIA-UHFFFAOYSA-N 0.000 abstract 2
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 abstract 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 abstract 2
- 201000011510 cancer Diseases 0.000 abstract 2
- 239000003814 drug Substances 0.000 abstract 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 2
- 229920001993 poloxamer 188 Polymers 0.000 abstract 2
- 229940044519 poloxamer 188 Drugs 0.000 abstract 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 2
- 239000008215 water for injection Substances 0.000 abstract 2
- ONIBWKKTOPOVIA-BYPYZUCNSA-N L-Proline Chemical compound OC(=O)[C@@H]1CCCN1 ONIBWKKTOPOVIA-BYPYZUCNSA-N 0.000 abstract 1
Classifications
-
- 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
- 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
-
- 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
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- 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
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biochemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Microbiology (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Mycology (AREA)
- Dermatology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La invención se refiere al campo de la farmacia y la medicina, específicamente a las composiciones farmacéuticas del anticuerpo anti-PD-1 pembrolizumab, que pueden ser composiciones acuosas o liofilizadas. La invención se refiere además al uso de dichas composiciones para el tratamiento de neoplasias malignas o enfermedades infecciosas, así como al uso de dichas composiciones para producir un medicamento destinado a tratar neoplasias malignas o enfermedades infecciosas. Reivindicación 1: Una composición farmacéutica de pembrolizumab que comprende: (i) pembrolizumab; (ii) histidina (iii) clorhidrato de histidina monohidratado; (iv) glicina; (v) trehalosa y poloxamer 188, o prolina; y (vi) agua para inyección. Reivindicación 9: La composición farmacéutica según la reivindicación 1, que comprende: (i) 5 - 50 mg/ml de pembrolizumab; (ii) 0,087 - 0,432 mg/ml de histidina; (iii) 0,464 - 0,931 mg/ml de clorhidrato de histidina monohidratado; (iv) 1 - 2 mg/ml de glicina; (v) 70 - 130 mg/ml de trehalosa y 0,8 - 1,2 mg/ml de poloxamer 188, o 20 - 34 mg/ml de prolina; y (vi) agua para inyección a 1 ml.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| RU2021112111A RU2791857C2 (ru) | 2021-04-27 | Фармацевтическая композиция пембролизумаба и ее применение |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR125470A1 true AR125470A1 (es) | 2023-07-19 |
Family
ID=83848424
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP220101106A AR125470A1 (es) | 2021-04-27 | 2022-04-27 | Composición farmacéutica de pembrolizumab y su uso |
Country Status (12)
| Country | Link |
|---|---|
| EP (1) | EP4329729A4 (es) |
| CN (1) | CN117835965A (es) |
| AR (1) | AR125470A1 (es) |
| CL (1) | CL2023003209A1 (es) |
| CO (1) | CO2023014166A2 (es) |
| CR (1) | CR20230527A (es) |
| EC (1) | ECSP23081880A (es) |
| MA (1) | MA62939A1 (es) |
| MX (1) | MX2023012745A (es) |
| PE (1) | PE20250072A1 (es) |
| TW (1) | TW202308692A (es) |
| WO (1) | WO2022231481A1 (es) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2024221025A1 (en) * | 2023-02-16 | 2025-08-21 | Sun Pharmaceutical Industries Limited | Stable protein compositions of anti-pd1 antibody |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK3283107T3 (da) * | 2015-04-17 | 2020-08-31 | Bristol Myers Squibb Co | Sammensætninger omfattende en kombination af ipilimumab og nivolumab |
| US11608357B2 (en) * | 2018-08-28 | 2023-03-21 | Arecor Limited | Stabilized antibody protein solutions |
| JOP20190260A1 (ar) * | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| CA3063324A1 (en) * | 2017-05-16 | 2018-11-22 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
| EP3876978A4 (en) * | 2018-11-07 | 2022-09-28 | Merck Sharp & Dohme Corp. | STABLE FORMULATIONS OF PROGRAMMED DEATH RECEPTOR 1 (PD-1) ANTIBODIES AND METHODS OF USE THEREOF |
-
2022
- 2022-04-26 TW TW111115864A patent/TW202308692A/zh unknown
- 2022-04-27 CN CN202280030892.2A patent/CN117835965A/zh active Pending
- 2022-04-27 WO PCT/RU2022/050140 patent/WO2022231481A1/en not_active Ceased
- 2022-04-27 AR ARP220101106A patent/AR125470A1/es unknown
- 2022-04-27 MX MX2023012745A patent/MX2023012745A/es unknown
- 2022-04-27 EP EP22796265.1A patent/EP4329729A4/en active Pending
- 2022-04-27 CR CR20230527A patent/CR20230527A/es unknown
- 2022-04-27 MA MA62939A patent/MA62939A1/fr unknown
- 2022-04-27 PE PE2023002957A patent/PE20250072A1/es unknown
-
2023
- 2023-10-23 CO CONC2023/0014166A patent/CO2023014166A2/es unknown
- 2023-10-25 EC ECSENADI202381880A patent/ECSP23081880A/es unknown
- 2023-10-26 CL CL2023003209A patent/CL2023003209A1/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CO2023014166A2 (es) | 2024-02-05 |
| EP4329729A1 (en) | 2024-03-06 |
| WO2022231481A1 (en) | 2022-11-03 |
| CR20230527A (es) | 2024-02-13 |
| PE20250072A1 (es) | 2025-01-13 |
| CN117835965A (zh) | 2024-04-05 |
| CL2023003209A1 (es) | 2024-05-31 |
| MX2023012745A (es) | 2023-11-09 |
| TW202308692A (zh) | 2023-03-01 |
| MA62939A1 (fr) | 2024-02-29 |
| ECSP23081880A (es) | 2023-11-30 |
| EP4329729A4 (en) | 2025-04-02 |
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