AR103544A1 - FORMULACIONES FARMACÉUTICAS PARA ANTICUERPOS ANTI-TNF-a - Google Patents
FORMULACIONES FARMACÉUTICAS PARA ANTICUERPOS ANTI-TNF-aInfo
- Publication number
- AR103544A1 AR103544A1 ARP160100234A ARP160100234A AR103544A1 AR 103544 A1 AR103544 A1 AR 103544A1 AR P160100234 A ARP160100234 A AR P160100234A AR P160100234 A ARP160100234 A AR P160100234A AR 103544 A1 AR103544 A1 AR 103544A1
- Authority
- AR
- Argentina
- Prior art keywords
- buffer
- citrate
- composition
- acetate buffer
- composition according
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 abstract 14
- 239000008351 acetate buffer Substances 0.000 abstract 8
- 239000000872 buffer Substances 0.000 abstract 6
- FXAGBTBXSJBNMD-UHFFFAOYSA-N acetic acid;2-hydroxypropane-1,2,3-tricarboxylic acid Chemical compound CC(O)=O.OC(=O)CC(O)(C(O)=O)CC(O)=O FXAGBTBXSJBNMD-UHFFFAOYSA-N 0.000 abstract 5
- 229920005862 polyol Polymers 0.000 abstract 4
- 150000003077 polyols Chemical class 0.000 abstract 4
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 abstract 3
- 239000007979 citrate buffer Substances 0.000 abstract 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 2
- 229930195725 Mannitol Natural products 0.000 abstract 2
- 150000002016 disaccharides Chemical class 0.000 abstract 2
- 239000000594 mannitol Substances 0.000 abstract 2
- 235000010355 mannitol Nutrition 0.000 abstract 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 abstract 2
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 2
- 239000001509 sodium citrate Substances 0.000 abstract 2
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 abstract 2
- 239000004094 surface-active agent Substances 0.000 abstract 2
- -1 treitol Chemical compound 0.000 abstract 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 abstract 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 abstract 1
- 239000004386 Erythritol Substances 0.000 abstract 1
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 abstract 1
- JVWLUVNSQYXYBE-UHFFFAOYSA-N Ribitol Natural products OCC(C)C(O)C(O)CO JVWLUVNSQYXYBE-UHFFFAOYSA-N 0.000 abstract 1
- 108700012920 TNF Proteins 0.000 abstract 1
- 108060008682 Tumor Necrosis Factor Proteins 0.000 abstract 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 abstract 1
- 229960002964 adalimumab Drugs 0.000 abstract 1
- 201000010099 disease Diseases 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
- 235000019414 erythritol Nutrition 0.000 abstract 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 abstract 1
- 229940009714 erythritol Drugs 0.000 abstract 1
- FBPFZTCFMRRESA-GUCUJZIJSA-N galactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-GUCUJZIJSA-N 0.000 abstract 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 abstract 1
- 210000000987 immune system Anatomy 0.000 abstract 1
- 230000002757 inflammatory effect Effects 0.000 abstract 1
- 230000007774 longterm Effects 0.000 abstract 1
- 229960001855 mannitol Drugs 0.000 abstract 1
- 230000001404 mediated effect Effects 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract 1
- 229920000053 polysorbate 80 Polymers 0.000 abstract 1
- 229940068968 polysorbate 80 Drugs 0.000 abstract 1
- HEBKCHPVOIAQTA-ZXFHETKHSA-N ribitol Chemical compound OC[C@H](O)[C@H](O)[C@H](O)CO HEBKCHPVOIAQTA-ZXFHETKHSA-N 0.000 abstract 1
- 239000007974 sodium acetate buffer Substances 0.000 abstract 1
- 239000000600 sorbitol Substances 0.000 abstract 1
- 102000003390 tumor necrosis factor Human genes 0.000 abstract 1
- 239000000811 xylitol Substances 0.000 abstract 1
- 235000010447 xylitol Nutrition 0.000 abstract 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 abstract 1
- 229960002675 xylitol Drugs 0.000 abstract 1
Classifications
-
- 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
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
-
- 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
- A61K47/12—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
- A61K47/26—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- 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
- C07K2317/70—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)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Immunology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Genetics & Genomics (AREA)
- Dermatology (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Composiciones de anticuerpos estables acuosas adecuadas para almacenamiento a largo plazo, en particular que comprenden anticuerpos contra factor de necrosis tumoral a (anti-TNFa). Más específicamente, proporciona una composición acuosa que comprende: un anticuerpo anti-TNFa; un tampón seleccionado de la lista que consiste en un tampón acetato, un tampón citrato y un tampón citrato-acetato; y un excipiente, en la que dicho excipiente se selecciona al menos de un disacárido, un poliol y una combinación de los mismos; en la que cuando el tampón comprende o consiste en un tampón acetato, dicha composición comprende un disacárido a una concentración de menos de 240 mM; en la que cuando el tampón comprende o consiste en un tampón citrato o un tampón citrato-acetato, dicha composición comprende un poliol a una concentración de desde 50 mM hasta 300 mM; y en la que el pH de la composición es de desde pH 4,0 hasta pH 7,0. Uso farmacéutico de dicha composición, en particular en el tratamiento de enfermedades inflamatorias y mediadas por el sistema inmunitario asociadas a un aumento de TNFa. Métodos para obtener dicha composición y a dispositivos que la comprenden. Reivindicación 5: La composición según cualquiera de las reivindicaciones 1 a 4, en la que el anticuerpo anti-TNFa es un anticuerpo anti-hTNFa humano, preferiblemente el anticuerpo anti-TNFa es adalimumab. Reivindicación 6: La composición según cualquiera de las reivindicaciones 1 a 5, en la que el poliol se selecciona del grupo que consiste en manitol, xilitol, eritritol, treitol, ribitol, mioinisitol, galactitol, sorbitol y glicerol, preferiblemente donde el poliol es manitol. Reivindicación 10: La composición según cualquiera de las reivindicaciones 1 a 9, en la que dicho tampón es seleccionado del grupo que consiste en un tampón citrato de sodio, un tampón citrato-acetato, un tampón acetato de sodio y un tampón histidina acetato, preferiblemente es un tampón citrato de sodio o un tampón citrato-acetato. Reivindicación 18: La composición según cualquiera de las reivindicaciones 1 a 15, en la que cuando la composición comprende un tampón citrato o un tampón citrato-acetato, la composición comprende además un surfactante. Reivindicación 20: La composición según cualquiera de las reivindicaciones 3 a 15 y 18 - 19, en la que dicho surfactante es polisorbato 80.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15152923 | 2015-01-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR103544A1 true AR103544A1 (es) | 2017-05-17 |
Family
ID=52464156
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP160100234A AR103544A1 (es) | 2015-01-28 | 2016-01-28 | FORMULACIONES FARMACÉUTICAS PARA ANTICUERPOS ANTI-TNF-a |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US20180016333A1 (es) |
| EP (1) | EP3250598A1 (es) |
| AR (1) | AR103544A1 (es) |
| TW (1) | TW201636047A (es) |
| UY (1) | UY36542A (es) |
| WO (1) | WO2016120413A1 (es) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10376582B2 (en) | 2013-10-16 | 2019-08-13 | Outlook Therapeutics, Inc. | Buffer formulations for enhanced antibody stability |
| IN2014MU01248A (es) | 2014-04-02 | 2015-10-09 | Intas Pharmaceuticals Ltd | |
| US10696735B2 (en) | 2015-01-21 | 2020-06-30 | Outlook Therapeutics, Inc. | Modulation of charge variants in a monoclonal antibody composition |
| US11285210B2 (en) | 2016-02-03 | 2022-03-29 | Outlook Therapeutics, Inc. | Buffer formulations for enhanced antibody stability |
| EP3824906A1 (en) * | 2016-12-21 | 2021-05-26 | Amgen Inc. | Anti-tnf alpha antibody formulations |
| RU2665966C2 (ru) * | 2016-12-30 | 2018-09-05 | Закрытое Акционерное Общество "Биокад" | Водная фармацевтическая композиция рекомбинантного моноклонального антитела к ФНОα |
| JOP20190162A1 (ar) * | 2016-12-30 | 2019-06-27 | Biocad Joint Stock Co | تركيبة صيدلانية مائية من جسم مضاد لـ tnf? أحادي النسيلة معاود الارتباط الجيني |
| US11608357B2 (en) | 2018-08-28 | 2023-03-21 | Arecor Limited | Stabilized antibody protein solutions |
| EP3372242A1 (en) | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
| EP3372241A1 (en) * | 2017-03-06 | 2018-09-12 | Ares Trading S.A. | Liquid pharmaceutical composition |
| NZ757965A (en) * | 2017-03-16 | 2022-07-01 | Lg Chemical Ltd | Liquid formulation of anti-tnf alpha antibody |
| US11898184B2 (en) * | 2017-09-07 | 2024-02-13 | Sweet Sense Inc. | Low glycemic sugar composition |
| MX2017016884A (es) * | 2017-12-19 | 2019-06-20 | Probiomed S A De C V | Formulacion farmaceutica estable de una proteina anti-tnfa. |
| EP4108258A4 (en) * | 2020-02-20 | 2024-03-06 | Bio-Thera Solutions, Ltd. | PREPARATION OF ANTI-TNF-ALPHA ANTIBODY, METHOD OF PREPARATION AND USE THEREOF |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102458469B (zh) * | 2009-05-04 | 2014-12-24 | 艾伯维生物技术有限公司 | 人抗TNF-α抗体的稳定高蛋白质浓度制剂 |
| GB201112429D0 (en) * | 2011-07-19 | 2011-08-31 | Glaxo Group Ltd | Antigen-binding proteins with increased FcRn binding |
| EP2863951A1 (en) * | 2012-06-12 | 2015-04-29 | Boehringer Ingelheim International GmbH | Pharmaceutical formulation for a therapeutic antibody |
| PE20150964A1 (es) * | 2012-09-07 | 2015-07-25 | Coherus Biosciences Inc | Formulaciones acuosas estables de adalimumab |
| EP2934587A4 (en) * | 2012-12-18 | 2016-08-03 | Merck Sharp & Dohme | Liquid formulations for an anti-TNF-alpha-antibody |
-
2016
- 2016-01-28 EP EP16701947.0A patent/EP3250598A1/en not_active Withdrawn
- 2016-01-28 AR ARP160100234A patent/AR103544A1/es unknown
- 2016-01-28 TW TW105102741A patent/TW201636047A/zh unknown
- 2016-01-28 UY UY0001036542A patent/UY36542A/es unknown
- 2016-01-28 US US15/546,598 patent/US20180016333A1/en not_active Abandoned
- 2016-01-28 WO PCT/EP2016/051850 patent/WO2016120413A1/en not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| US20180016333A1 (en) | 2018-01-18 |
| EP3250598A1 (en) | 2017-12-06 |
| WO2016120413A1 (en) | 2016-08-04 |
| TW201636047A (zh) | 2016-10-16 |
| UY36542A (es) | 2016-08-31 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FB | Suspension of granting procedure |