MX2023010365A - Proteina liofilizada estable a temperatura ambiente. - Google Patents
Proteina liofilizada estable a temperatura ambiente.Info
- Publication number
- MX2023010365A MX2023010365A MX2023010365A MX2023010365A MX2023010365A MX 2023010365 A MX2023010365 A MX 2023010365A MX 2023010365 A MX2023010365 A MX 2023010365A MX 2023010365 A MX2023010365 A MX 2023010365A MX 2023010365 A MX2023010365 A MX 2023010365A
- Authority
- MX
- Mexico
- Prior art keywords
- room temperature
- stable lyophilized
- temperature stable
- protein
- lyophilized protein
- Prior art date
Links
- 102000004169 proteins and genes Human genes 0.000 title abstract 4
- 108090000623 proteins and genes Proteins 0.000 title abstract 4
- 238000000137 annealing Methods 0.000 abstract 1
- 238000001035 drying Methods 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 239000004014 plasticizer Substances 0.000 abstract 1
- 229940124272 protein stabilizer Drugs 0.000 abstract 1
- 239000007787 solid Substances 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 230000001225 therapeutic effect Effects 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
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
- 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
- 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
- A61J1/1412—Containers with closing means, e.g. caps
-
- 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
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
Se proporcionan composiciones de proteínas terapéuticas liofilizadas estables y sus métodos de fabricación. Específicamente, se describe el uso de agua como plastificante de torta sólido y estabilizante de proteínas. Además, se describe la inclusión de un estabilizante multicomponente que comprende una entidad molecular más grande y una entidad molecular más pequeña. Además, la inclusión del recocido posterior al secado en ciertas condiciones mejora la estabilidad de la proteína. Se predice que las proteínas permanecerán estables durante 24 meses a 25°C.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201662405610P | 2016-10-07 | 2016-10-07 |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2023010365A true MX2023010365A (es) | 2023-09-12 |
Family
ID=60302444
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2019003800A MX2019003800A (es) | 2016-10-07 | 2017-10-06 | Proteina liofilizada estable a temperatura ambiente. |
MX2023010365A MX2023010365A (es) | 2016-10-07 | 2019-04-02 | Proteina liofilizada estable a temperatura ambiente. |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2019003800A MX2019003800A (es) | 2016-10-07 | 2017-10-06 | Proteina liofilizada estable a temperatura ambiente. |
Country Status (14)
Country | Link |
---|---|
US (3) | US11351256B2 (es) |
EP (1) | EP3522867A1 (es) |
JP (1) | JP2019534263A (es) |
KR (2) | KR20230164205A (es) |
CN (1) | CN110022855B (es) |
AU (2) | AU2017341067B2 (es) |
BR (1) | BR112019006907A2 (es) |
CA (1) | CA3039655A1 (es) |
EA (1) | EA201990900A1 (es) |
IL (2) | IL265665B2 (es) |
MX (2) | MX2019003800A (es) |
MY (1) | MY197672A (es) |
TW (2) | TW202237071A (es) |
WO (1) | WO2018068012A1 (es) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SG11202010684YA (en) * | 2018-05-10 | 2020-11-27 | Regeneron Pharma | High concentration vegf receptor fusion protein containing formulations |
WO2020021330A2 (en) * | 2018-07-12 | 2020-01-30 | Endo Global Aesthetics Limited | Injection techniques for the treatment of cellulite |
WO2020142701A1 (en) * | 2019-01-06 | 2020-07-09 | Endo Global Aesthetics Limited | Collagenase formulations and methods of producing the same |
MX2021009851A (es) | 2019-02-18 | 2021-09-10 | Lilly Co Eli | Formulacion de anticuerpos terapeuticos. |
DK3744319T3 (da) * | 2019-05-28 | 2023-01-16 | Ilkogen Ilac Sanayi Ve Ticaret A S | Stabil lyofiliseret formulering til hybrid fc-fusioneret g-csf |
CN113116831A (zh) * | 2019-12-26 | 2021-07-16 | 天士力生物医药股份有限公司 | 一种注射用重组人尿激酶原的冻干方法 |
MX2022009558A (es) * | 2020-02-04 | 2022-09-09 | Regeneron Pharma | Contenido de humedad residual objetivo para farmaco liofilizado. |
EP4210679A1 (en) * | 2020-09-14 | 2023-07-19 | Amgen Inc. | Method of making lyophilized protein formulations |
TW202417038A (zh) | 2022-06-15 | 2024-05-01 | 法商賽諾菲公司 | 高度濃縮的抗體組成物 |
Family Cites Families (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5798032A (en) * | 1994-06-02 | 1998-08-25 | The Perkin-Elmer Corporation | Method and apparatus for automated carbohydrate mapping and sequencing |
CN102416176A (zh) * | 1995-07-27 | 2012-04-18 | 基因技术股份有限公司 | 稳定等渗的冻干蛋白质制剂 |
EP0852951A1 (de) | 1996-11-19 | 1998-07-15 | Roche Diagnostics GmbH | Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern |
US6149626A (en) | 1997-10-03 | 2000-11-21 | Bachynsky; Nicholas | Automatic injecting syringe apparatus |
US6436897B2 (en) | 1998-06-01 | 2002-08-20 | Celtrix Pharmaceuticals, Inc. | Pharmaceutical formulations for IGF/IGFBP |
US6927044B2 (en) | 1998-09-25 | 2005-08-09 | Regeneron Pharmaceuticals, Inc. | IL-1 receptor based cytokine traps |
US7087411B2 (en) | 1999-06-08 | 2006-08-08 | Regeneron Pharmaceuticals, Inc. | Fusion protein capable of binding VEGF |
JP3727317B2 (ja) | 2002-03-08 | 2005-12-14 | エイエスエムエル ネザランドズ ベスローテン フエンノートシャップ | リソグラフィに使用するためのマスク、マスクを作成する方法、リソグラフィ装置、およびデバイス製造方法 |
US7959600B2 (en) | 2004-12-30 | 2011-06-14 | Byeong S. Chang | Container closure delivery system |
SI1861116T1 (sl) | 2005-03-25 | 2015-12-31 | Regeneron Pharmaceuticals, Inc. | Formulacije antagonistov VEGF |
PL2150617T3 (pl) | 2007-06-04 | 2015-04-30 | Regeneron Pharma | Wzmocniona ekspresja i regiony stabilności |
US20090208492A1 (en) * | 2007-06-14 | 2009-08-20 | Elan Pharmaceuticals, Inc. | Lyophilized Immunoglobulin Formulations and Methods of Preparation |
CN102695499A (zh) * | 2009-06-18 | 2012-09-26 | 惠氏有限责任公司 | 小模块免疫药物的冻干制剂 |
US9458240B2 (en) * | 2010-12-10 | 2016-10-04 | Novartis Pharma Ag | Anti-BAFFR antibody formulations |
UA116189C2 (uk) * | 2011-05-02 | 2018-02-26 | Мілленніум Фармасьютікалз, Інк. | КОМПОЗИЦІЯ АНТИ-α4β7 АНТИТІЛА |
DE102011078922A1 (de) | 2011-07-11 | 2013-01-17 | BSH Bosch und Siemens Hausgeräte GmbH | Abluft-Wäschetrocknung mit Zusatzheizung und Wärmetauscheraggregat |
WO2014140361A1 (en) * | 2013-03-15 | 2014-09-18 | Takeda Gmbh | Formulation of an antibody and use thereof |
US11272503B2 (en) | 2017-06-30 | 2022-03-08 | Lg Electronics Inc. | Method and apparatus for UE transmitting signal in wireless communication system supporting plurality of TTI lengths |
-
2017
- 2017-10-06 KR KR1020237039757A patent/KR20230164205A/ko active Application Filing
- 2017-10-06 MX MX2019003800A patent/MX2019003800A/es unknown
- 2017-10-06 WO PCT/US2017/055651 patent/WO2018068012A1/en unknown
- 2017-10-06 TW TW111121369A patent/TW202237071A/zh unknown
- 2017-10-06 CN CN201780062179.5A patent/CN110022855B/zh active Active
- 2017-10-06 TW TW106134589A patent/TWI766890B/zh active
- 2017-10-06 CA CA3039655A patent/CA3039655A1/en active Pending
- 2017-10-06 IL IL265665A patent/IL265665B2/en unknown
- 2017-10-06 KR KR1020197009983A patent/KR102605317B1/ko active IP Right Grant
- 2017-10-06 AU AU2017341067A patent/AU2017341067B2/en active Active
- 2017-10-06 IL IL310367A patent/IL310367A/en unknown
- 2017-10-06 BR BR112019006907A patent/BR112019006907A2/pt active Search and Examination
- 2017-10-06 JP JP2019518462A patent/JP2019534263A/ja active Pending
- 2017-10-06 EA EA201990900A patent/EA201990900A1/ru unknown
- 2017-10-06 MY MYPI2019001476A patent/MY197672A/en unknown
- 2017-10-06 US US15/727,457 patent/US11351256B2/en active Active
- 2017-10-06 EP EP17797465.6A patent/EP3522867A1/en active Pending
-
2019
- 2019-04-02 MX MX2023010365A patent/MX2023010365A/es unknown
- 2019-10-17 US US16/655,634 patent/US11241498B2/en active Active
-
2022
- 2022-05-06 US US17/738,870 patent/US20220257763A1/en active Pending
-
2024
- 2024-01-25 AU AU2024200482A patent/AU2024200482A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
US20180099049A1 (en) | 2018-04-12 |
AU2024200482A1 (en) | 2024-02-15 |
IL265665B1 (en) | 2024-03-01 |
TW202237071A (zh) | 2022-10-01 |
KR20230164205A (ko) | 2023-12-01 |
BR112019006907A2 (pt) | 2019-07-02 |
IL265665B2 (en) | 2024-07-01 |
TW201818924A (zh) | 2018-06-01 |
US20200046834A1 (en) | 2020-02-13 |
MX2019003800A (es) | 2019-08-12 |
WO2018068012A1 (en) | 2018-04-12 |
TWI766890B (zh) | 2022-06-11 |
CN110022855A (zh) | 2019-07-16 |
US11351256B2 (en) | 2022-06-07 |
EP3522867A1 (en) | 2019-08-14 |
EA201990900A1 (ru) | 2019-07-31 |
MY197672A (en) | 2023-07-03 |
JP2019534263A (ja) | 2019-11-28 |
US20220257763A1 (en) | 2022-08-18 |
IL265665A (en) | 2019-05-30 |
AU2017341067B2 (en) | 2023-10-26 |
AU2017341067A1 (en) | 2019-04-11 |
CA3039655A1 (en) | 2018-04-12 |
IL310367A (en) | 2024-03-01 |
US11241498B2 (en) | 2022-02-08 |
KR102605317B1 (ko) | 2023-11-24 |
KR20190066014A (ko) | 2019-06-12 |
CN110022855B (zh) | 2024-07-16 |
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