RU2017109249A - Стабилизированные препараты, содержащие антитела против ngf - Google Patents
Стабилизированные препараты, содержащие антитела против ngf Download PDFInfo
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- RU2017109249A RU2017109249A RU2017109249A RU2017109249A RU2017109249A RU 2017109249 A RU2017109249 A RU 2017109249A RU 2017109249 A RU2017109249 A RU 2017109249A RU 2017109249 A RU2017109249 A RU 2017109249A RU 2017109249 A RU2017109249 A RU 2017109249A
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- 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
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- 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
- C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/06—Ampoules or carpules
- A61J1/065—Rigid ampoules, e.g. glass ampoules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1468—Containers characterised by specific material properties
-
- 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
-
- 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
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- 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
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- 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
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- 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
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- 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
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
-
- 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
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
-
- 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
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- 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
Claims (17)
1. Способ сохранения стабильности антитела в препарате, включающий:
хранение препарата антитела в течение шести месяцев или более при 5°C или более;
где препарат антитела включает:
(i) приблизительно 0,1-100 мг/мл антитела человека, которое специфически связывается с фактором роста нервов человека (hNGF), где антитело содержит пару аминокислотных последовательностей вариабельной области тяжелой цепи и вариабельной области легкой цепи (HCVR/LCVR), выбранную из группы, состоящей из: (i) SEQ ID NO: 20/22 и (ii) SEQ ID NO: 4/12;
(ii) приблизительно 0,01-1,0% полисорбата 20;
(iii) приблизительно 1-20% сахарозы и
(iv) от приблизительно 1 мМ до приблизительно 50 мМ ацетата; вследствие чего находящийся на хранении препарат сохраняет такую стабильность, при которой 90% или более антител выявляют эксклюзионной жидкостной хроматографией высокого разрешения (эксклюзионной HPLC).
2. Способ сохранения стабильности антитела по п.1, в котором препарат включает: (i) приблизительно 0,2-75 мг/мл антитела человека, которое специфически связывается с hNGF; (ii) приблизительно 0,02-0,5% полисорбата 20 и (iii) приблизительно 5-10% сахарозы.
3. Способ сохранения стабильности антитела по п.2, в котором препарат включает: (i) приблизительно 0,6-60 мг/мл антитела человека, которое специфически связывается с hNGF; (ii) приблизительно 0,5% полисорбата 20 и (iii) приблизительно 8% сахарозы.
4. Способ сохранения стабильности антитела по п.1, в котором препарат находится в контейнере, выбранном из группы, состоящей из стеклянного флакона, стеклянного шприца, пластикового флакона и пластикового шприца.
5. Способ сохранения стабильности антитела по п.4, в котором контейнером является стеклянный флакон, покрытый диоксидом кремния.
6. Способ сохранения стабильности антитела по п.5, в котором стеклянный флакон заполнен препаратом, а оставшееся свободное пространство заполнено инертным газом.
7. Способ сохранения стабильности антитела по п.6, в котором инертный газ выбран из группы, состоящей из аргона и азота.
8. Способ сохранения стабильности антитела по п.1, в котором препарат находится в контейнере, выбранном из группы, состоящей из автоинжектора и микроинфузионного устройства.
9. Способ сохранения стабильности антитела по п.4, в котором контейнером является шприц, содержащий покрытую слоем фтороуглеводорода манжетку поршня.
10. Способ сохранения стабильности антитела по п.1, в котором препарат представлен в шприце, содержащем низкое содержание вольфрама.
11. Способ сохранения стабильности антитела по п.1, в котором препарат представлен в шприце, содержащем покрытую слоем фтороуглеводорода манжетку поршня.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US36411210P | 2010-07-14 | 2010-07-14 | |
| US61/364,112 | 2010-07-14 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2013106275/15A Division RU2013106275A (ru) | 2010-07-14 | 2011-07-11 | Стабилизированные препараты, содержащие антитела против ngf |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| RU2017109249A true RU2017109249A (ru) | 2019-01-23 |
| RU2017109249A3 RU2017109249A3 (ru) | 2019-01-23 |
| RU2700174C2 RU2700174C2 (ru) | 2019-09-16 |
Family
ID=44628867
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2017109249A RU2700174C2 (ru) | 2010-07-14 | 2011-07-11 | Стабилизированные препараты, содержащие антитела против ngf |
| RU2013106275/15A RU2013106275A (ru) | 2010-07-14 | 2011-07-11 | Стабилизированные препараты, содержащие антитела против ngf |
| RU2019126172A RU2728575C1 (ru) | 2010-07-14 | 2019-08-20 | Стабилизированные препараты, содержащие антитела против ngf |
| RU2020123963A RU2020123963A (ru) | 2010-07-14 | 2020-07-20 | Стабилизированные препараты, содержащие антитела против ngf |
Family Applications After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2013106275/15A RU2013106275A (ru) | 2010-07-14 | 2011-07-11 | Стабилизированные препараты, содержащие антитела против ngf |
| RU2019126172A RU2728575C1 (ru) | 2010-07-14 | 2019-08-20 | Стабилизированные препараты, содержащие антитела против ngf |
| RU2020123963A RU2020123963A (ru) | 2010-07-14 | 2020-07-20 | Стабилизированные препараты, содержащие антитела против ngf |
Country Status (19)
| Country | Link |
|---|---|
| US (4) | US20120014968A1 (ru) |
| EP (3) | EP3881867A1 (ru) |
| KR (1) | KR101869682B1 (ru) |
| CN (1) | CN103108656B (ru) |
| AR (1) | AR082171A1 (ru) |
| AU (3) | AU2011279450B2 (ru) |
| BR (1) | BR112013002764B1 (ru) |
| CA (1) | CA2805388C (ru) |
| ES (2) | ES2694771T3 (ru) |
| JO (2) | JOP20190250A1 (ru) |
| MX (1) | MX340524B (ru) |
| MY (1) | MY164610A (ru) |
| NZ (1) | NZ606078A (ru) |
| RU (4) | RU2700174C2 (ru) |
| SG (1) | SG187128A1 (ru) |
| TW (1) | TWI481414B (ru) |
| UA (1) | UA111825C2 (ru) |
| UY (1) | UY33515A (ru) |
| WO (1) | WO2012009254A1 (ru) |
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