MX387269B - Formulaciones de factor ix liofilizadas. - Google Patents

Formulaciones de factor ix liofilizadas.

Info

Publication number
MX387269B
MX387269B MX2016012447A MX2016012447A MX387269B MX 387269 B MX387269 B MX 387269B MX 2016012447 A MX2016012447 A MX 2016012447A MX 2016012447 A MX2016012447 A MX 2016012447A MX 387269 B MX387269 B MX 387269B
Authority
MX
Mexico
Prior art keywords
fix
polypeptide
formulations
present
factor
Prior art date
Application number
MX2016012447A
Other languages
English (en)
Other versions
MX2016012447A (es
Inventor
Brandon W Leveille
Brian M Thome
Cherie Parkhurst-Lang
Original Assignee
Bioverativ Therapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=54196282&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX387269(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bioverativ Therapeutics Inc filed Critical Bioverativ Therapeutics Inc
Publication of MX2016012447A publication Critical patent/MX2016012447A/es
Publication of MX387269B publication Critical patent/MX387269B/es

Links

Classifications

    • 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
    • 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
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • 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)
    • 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (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)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Monitoring And Testing Of Transmission In General (AREA)
  • Mobile Radio Communication Systems (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 mL 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.
MX2016012447A 2014-03-24 2015-03-24 Formulaciones de factor ix liofilizadas. MX387269B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201461969801P 2014-03-24 2014-03-24
PCT/US2015/022141 WO2015148444A1 (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations

Publications (2)

Publication Number Publication Date
MX2016012447A MX2016012447A (es) 2017-01-06
MX387269B true MX387269B (es) 2025-03-18

Family

ID=54196282

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2016012447A MX387269B (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 After (1)

Application Number Title Priority Date Filing Date
MX2021012939A MX2021012939A (es) 2014-03-24 2016-09-23 Formulaciones de factor ix liofilizadas.

Country Status (16)

Country Link
US (3) 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) EA038573B1 (es)
IL (3) IL247869B (es)
MA (1) MA39779A (es)
MX (2) MX387269B (es)
PH (1) PH12016501877A1 (es)
SG (3) SG10201808249VA (es)
TW (1) TWI700101B (es)
WO (1) WO2015148444A1 (es)

Families Citing this family (8)

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EA037906B1 (ru) * 2013-03-15 2021-06-04 Биовератив Терапьютикс Инк. Препараты полипептида фактора ix
EP3123090A4 (en) 2014-03-24 2017-12-13 Bioverativ Therapeutics Inc. Lyophilized factor ix formulations
WO2018102743A1 (en) * 2016-12-02 2018-06-07 Bioverativ Therapeutics Inc. Methods of treating hemophilic arthropathy using chimeric clotting factors
US11400051B2 (en) * 2017-07-11 2022-08-02 Universal Stabilization Technologies, Inc. Method for preserving biopharmaceuticals
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
AU2021217370A1 (en) * 2020-02-04 2022-08-18 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product
EP4149514A4 (en) * 2020-05-11 2024-06-26 Alkermes Pharma Ireland Limited IL-2 FUSION POLYPEPTIDE COMPOSITIONS AND METHODS OF MAKING AND USING THEM
CN118557531B (zh) * 2024-08-02 2024-10-18 成都蓉生药业有限责任公司 一种重组人凝血因子VIII-Fc融合蛋白冻干制剂的制备方法

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Also Published As

Publication number Publication date
WO2015148444A1 (en) 2015-10-01
IL247869B (en) 2020-02-27
EP3123090A1 (en) 2017-02-01
IL272257B (en) 2021-03-25
JP7058940B2 (ja) 2022-04-25
JP2024053015A (ja) 2024-04-12
AU2020202863B2 (en) 2022-09-01
MX2016012447A (es) 2017-01-06
TW201605492A (zh) 2016-02-16
JP2022044689A (ja) 2022-03-17
AU2022215218B2 (en) 2025-12-18
EA202092926A2 (ru) 2021-07-30
JP2020063313A (ja) 2020-04-23
AU2015236340A1 (en) 2016-09-29
JP2017510585A (ja) 2017-04-13
EA201691807A1 (ru) 2017-03-31
TWI700101B (zh) 2020-08-01
SG10201913735SA (en) 2020-03-30
US20210069307A1 (en) 2021-03-11
US20250121042A1 (en) 2025-04-17
IL281197A (en) 2021-04-29
MX2021012939A (es) 2021-11-25
PH12016501877A1 (en) 2016-12-19
US10772942B2 (en) 2020-09-15
AU2022215218A1 (en) 2022-09-01
IL281197B (en) 2022-06-01
MA39779A (fr) 2017-02-01
EA202092926A3 (ru) 2021-10-29
AU2020202863A1 (en) 2020-05-21
CA2943034C (en) 2022-06-14
EP3123090A4 (en) 2017-12-13
JP7759978B2 (ja) 2025-10-24
NZ724351A (en) 2023-10-27
KR102385372B1 (ko) 2022-04-11
IL272257A (en) 2020-02-27
BR112016021777A2 (pt) 2017-10-03
EA038573B1 (ru) 2021-09-16
JP7503583B2 (ja) 2024-06-20
US12128092B2 (en) 2024-10-29
AR099838A1 (es) 2016-08-24
US20170173122A1 (en) 2017-06-22
KR20160137577A (ko) 2016-11-30
AU2015236340B2 (en) 2020-02-06
CL2016002386A1 (es) 2017-06-23
SG11201607642RA (en) 2016-10-28
SG10201808249VA (en) 2018-10-30
IL247869A0 (en) 2016-11-30
CA2943034A1 (en) 2015-10-01

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