MX2021012939A - Formulaciones de factor ix liofilizadas. - Google Patents
Formulaciones de factor ix liofilizadas.Info
- Publication number
- MX2021012939A MX2021012939A MX2021012939A MX2021012939A MX2021012939A MX 2021012939 A MX2021012939 A MX 2021012939A MX 2021012939 A MX2021012939 A MX 2021012939A MX 2021012939 A MX2021012939 A MX 2021012939A MX 2021012939 A MX2021012939 A MX 2021012939A
- Authority
- MX
- Mexico
- Prior art keywords
- fix
- polypeptide
- formulations
- present
- factor
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21022—Coagulation factor IXa (3.4.21.22)
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Mechanical Engineering (AREA)
- Zoology (AREA)
- Wood Science & Technology (AREA)
- Genetics & Genomics (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
La presente invención provee, entre otras cosas, formulaciones pre-liofilización, formulaciones reconstituidas y formulaciones de polvo liofilizado que comprenden un polipéptido de Factor IX (FIX). La presente invención proporciona también métodos de liofilización para producir un polvo liofilizado que comprende un polipéptido de FIX. La presente invención se refiere a una formulación pre-liofilización que comprende: (a) un polipéptido (FIX) de Factor IX que tiene actividad de coagulación FIX; (b) un agente amortiguador; (c) un agente estabilizante; (d) un agente espesante; y (e) un tensioactivo, donde la formulación tiene un volumen de relleno menor que alrededor de 5 L y donde cada uno de (a)-(e) se encuentran en una cantidad por vial (mg/vial) suficiente para permitir (1) mejor estabilidad del polipéptido de FIX al liofilizarse.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201461969801P | 2014-03-24 | 2014-03-24 |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2021012939A true MX2021012939A (es) | 2021-11-25 |
Family
ID=54196282
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2016012447A MX2016012447A (es) | 2014-03-24 | 2015-03-24 | Formulaciones de factor ix liofilizadas. |
MX2021012939A MX2021012939A (es) | 2014-03-24 | 2016-09-23 | Formulaciones de factor ix liofilizadas. |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2016012447A MX2016012447A (es) | 2014-03-24 | 2015-03-24 | Formulaciones de factor ix liofilizadas. |
Country Status (16)
Country | Link |
---|---|
US (2) | US10772942B2 (es) |
EP (1) | EP3123090A4 (es) |
JP (4) | JP7058940B2 (es) |
KR (1) | KR102385372B1 (es) |
AR (1) | AR099838A1 (es) |
AU (3) | AU2015236340B2 (es) |
CA (1) | CA2943034C (es) |
CL (1) | CL2016002386A1 (es) |
EA (2) | EA202092926A3 (es) |
IL (3) | IL247869B (es) |
MA (1) | MA39779A (es) |
MX (2) | MX2016012447A (es) |
PH (1) | PH12016501877A1 (es) |
SG (3) | SG10201913735SA (es) |
TW (1) | TWI700101B (es) |
WO (1) | WO2015148444A1 (es) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SG11201505926VA (en) * | 2013-03-15 | 2015-09-29 | Biogen Ma Inc | Factor ix polypeptide formulations |
TWI700101B (zh) | 2014-03-24 | 2020-08-01 | 美商百歐維拉提夫治療公司 | 凍乾之因子ix調配物 |
WO2019014338A1 (en) * | 2017-07-11 | 2019-01-17 | Universal Stabilization Technologies, Inc. | METHOD FOR PRESERVING BIOPHARMACEUTICAL PRODUCTS |
CN112175088B (zh) * | 2019-07-02 | 2023-03-28 | 江苏晟斯生物制药有限公司 | 改进的fix融合蛋白、缀合物及其应用 |
BR112022015272A2 (pt) | 2020-02-04 | 2022-09-20 | Regeneron Pharma | Teor de umidade residual alvo para produto de fármaco liofilizado |
WO2021231319A1 (en) * | 2020-05-11 | 2021-11-18 | Alkermes Pharma Ireland Limited | Il-2 fusion polypeptide compositions and methods of making and using the same |
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EP0154316B1 (en) | 1984-03-06 | 1989-09-13 | Takeda Chemical Industries, Ltd. | Chemically modified lymphokine and production thereof |
ATE135370T1 (de) | 1988-12-22 | 1996-03-15 | Kirin Amgen Inc | Chemisch modifizierte granulocytenkolonie erregender faktor |
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JP3693671B2 (ja) | 1991-03-15 | 2005-09-07 | アムゲン インコーポレーテッド | ポリペプチドのpeg化 |
FR2686899B1 (fr) | 1992-01-31 | 1995-09-01 | Rhone Poulenc Rorer Sa | Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant. |
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JP2001151694A (ja) | 1999-09-17 | 2001-06-05 | Takeda Chem Ind Ltd | タンパク質粉体の製造法 |
CA2383144A1 (en) * | 1999-09-17 | 2001-03-29 | Takeda Chemical Industries, Ltd. | Process for producing protein powder |
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WO2002040544A2 (en) | 2000-11-14 | 2002-05-23 | Board Of Regents, University Of Texas Systems | Mutant human factor ix with an increased resistance to inhibition by heparin |
HUP0401534A3 (en) | 2001-09-04 | 2006-01-30 | Merck Patent Gmbh | Modified factor ix |
EP2277910A1 (en) | 2001-12-21 | 2011-01-26 | Human Genome Sciences, Inc. | Albumin fusion proteins |
PL2298347T3 (pl) | 2003-05-06 | 2016-03-31 | Bioverativ Therapeutics Inc | Białka chimeryczne czynnika krzepnięcia do leczenia zaburzenia hemostazy |
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2015
- 2015-03-24 TW TW104109389A patent/TWI700101B/zh active
- 2015-03-24 KR KR1020167028692A patent/KR102385372B1/ko active IP Right Grant
- 2015-03-24 EP EP15769411.8A patent/EP3123090A4/en active Pending
- 2015-03-24 WO PCT/US2015/022141 patent/WO2015148444A1/en active Application Filing
- 2015-03-24 SG SG10201913735SA patent/SG10201913735SA/en unknown
- 2015-03-24 JP JP2016558751A patent/JP7058940B2/ja active Active
- 2015-03-24 EA EA202092926A patent/EA202092926A3/ru unknown
- 2015-03-24 MX MX2016012447A patent/MX2016012447A/es unknown
- 2015-03-24 AU AU2015236340A patent/AU2015236340B2/en not_active Withdrawn - After Issue
- 2015-03-24 US US15/128,951 patent/US10772942B2/en active Active
- 2015-03-24 MA MA039779A patent/MA39779A/fr unknown
- 2015-03-24 CA CA2943034A patent/CA2943034C/en active Active
- 2015-03-24 EA EA201691807A patent/EA038573B1/ru unknown
- 2015-03-24 SG SG11201607642RA patent/SG11201607642RA/en unknown
- 2015-03-24 SG SG10201808249VA patent/SG10201808249VA/en unknown
- 2015-03-25 AR ARP150100880A patent/AR099838A1/es unknown
-
2016
- 2016-09-18 IL IL247869A patent/IL247869B/en active IP Right Grant
- 2016-09-22 CL CL2016002386A patent/CL2016002386A1/es unknown
- 2016-09-23 PH PH12016501877A patent/PH12016501877A1/en unknown
- 2016-09-23 MX MX2021012939A patent/MX2021012939A/es unknown
-
2020
- 2020-01-26 IL IL272257A patent/IL272257B/en active IP Right Grant
- 2020-02-03 JP JP2020016131A patent/JP2020063313A/ja active Pending
- 2020-04-30 AU AU2020202863A patent/AU2020202863B2/en active Active
- 2020-08-17 US US16/995,173 patent/US20210069307A1/en active Pending
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2021
- 2021-03-02 IL IL281197A patent/IL281197B/en unknown
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2022
- 2022-01-20 JP JP2022007013A patent/JP7503583B2/ja active Active
- 2022-08-10 AU AU2022215218A patent/AU2022215218A1/en active Pending
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2024
- 2024-03-06 JP JP2024033771A patent/JP2024053015A/ja active Pending
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