MX2016012869A - Estabilizacion del factor viii sin calcio como un excipiente. - Google Patents

Estabilizacion del factor viii sin calcio como un excipiente.

Info

Publication number
MX2016012869A
MX2016012869A MX2016012869A MX2016012869A MX2016012869A MX 2016012869 A MX2016012869 A MX 2016012869A MX 2016012869 A MX2016012869 A MX 2016012869A MX 2016012869 A MX2016012869 A MX 2016012869A MX 2016012869 A MX2016012869 A MX 2016012869A
Authority
MX
Mexico
Prior art keywords
formulation
factor viii
absence
calcium
excipient
Prior art date
Application number
MX2016012869A
Other languages
English (en)
Inventor
Rajiv Nayar
Original Assignee
Advantech Bioscience Farmacêutica Ltda
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
Application filed by Advantech Bioscience Farmacêutica Ltda filed Critical Advantech Bioscience Farmacêutica Ltda
Publication of MX2016012869A publication Critical patent/MX2016012869A/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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • 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
    • A61K47/16—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
    • A61K9/14—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

Abstract

La presente invención proporciona una nueva formulación libre de albúmina de factor VIII recombinante que no requiere de iones de calcio como un excipiente de formulación adicionado. La ausencia de cloruro de calcio en la formulación resulta en varias mejoras y beneficios para una formulación de factor VIII. Esta invención permite que una formulación de factor VIII pueda ser liofilizada con más eficiencia, toda vez que la ausencia de iones de calcio aumentará la transición vítrea primaria de la fase amorfa. La ausencia de iones de calcio libre en la formulación también vendrá a mejorar la estabilidad de la formulación, toda vez que serán evitadas reacciones de oxidación dependientes de metal y la molécula de proteína no estará sujeta a inestabilidades químicas. Finalmente, la ausencia de calcio vendrá a simplificar aún más la formulación de factor VIII por la reducción del número de excipientes en la formulación.
MX2016012869A 2014-04-01 2015-03-30 Estabilizacion del factor viii sin calcio como un excipiente. MX2016012869A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201461973280P 2014-04-01 2014-04-01
PCT/BR2015/000045 WO2015149144A2 (en) 2014-04-01 2015-03-30 Stabilization of factor viii without calcium as an excipient

Publications (1)

Publication Number Publication Date
MX2016012869A true MX2016012869A (es) 2017-05-12

Family

ID=54241376

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016012869A MX2016012869A (es) 2014-04-01 2015-03-30 Estabilizacion del factor viii sin calcio como un excipiente.

Country Status (10)

Country Link
US (1) US9855319B2 (es)
EP (1) EP3125925A4 (es)
JP (1) JP2017509658A (es)
KR (1) KR20160146763A (es)
CN (1) CN106456720A (es)
AU (1) AU2015240354A1 (es)
CA (1) CA2944183A1 (es)
CL (1) CL2016002493A1 (es)
MX (1) MX2016012869A (es)
WO (1) WO2015149144A2 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3126003A4 (en) 2014-04-01 2017-11-29 Advantech Bioscience Farmacêutica Ltda. Stable factor viii formulations with low sugar-glycine

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE198277T1 (de) * 1992-10-02 2001-01-15 Genetics Inst Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator
US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
US5804420A (en) 1997-04-18 1998-09-08 Bayer Corporation Preparation of recombinant Factor VIII in a protein free medium
US6200560B1 (en) 1998-10-20 2001-03-13 Avigen, Inc. Adeno-associated virus vectors for expression of factor VIII by target cells
PT2130554E (pt) * 1999-02-22 2012-11-19 Univ Connecticut Formulações de factor viii isentas de albumina
ES2252028T3 (es) 1999-07-13 2006-05-16 Biovitrum Ab Composiciones estables del factor viii.
US20040185535A1 (en) 2003-03-21 2004-09-23 Giles Wilson Industrial-scale serum-free production of recombinant FVII in mammalian cells
EP1233064A1 (en) 2001-02-09 2002-08-21 Aventis Behring Gesellschaft mit beschränkter Haftung Modified factor VIII cDNA and its use for the production of factor VIII
US20040229335A1 (en) 2003-05-15 2004-11-18 Introgen Therapeutics, Inc. Methods and compositions for the production of adenoviral vectors
KR100624013B1 (ko) * 2004-06-25 2006-09-19 주식회사 녹십자홀딩스 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제
WO2008005847A2 (en) 2006-06-30 2008-01-10 The Regents Of The University Of Michigan Method of producing factor viii proteins by recombinant methods
US20090035807A1 (en) 2007-07-31 2009-02-05 Wyeth Analysis of polypeptide production
US8580554B2 (en) 2009-07-31 2013-11-12 Baxter International Inc. Method of producing a polypeptide or virus of interest in a continuous cell culture
EP3431608A3 (en) 2009-11-17 2019-02-20 E. R. Squibb & Sons, L.L.C. Method for enhanced protein production
WO2012122611A1 (en) 2011-03-11 2012-09-20 Universidade De São Paulo - Usp Method for the production of recombinant human factor viii
US8668886B2 (en) 2011-04-24 2014-03-11 Therapeutic Proteins International, LLC Separative bioreactor
US9394353B2 (en) * 2011-10-18 2016-07-19 Csl Limited Method for improving the stability of purified factor VIII after reconstitution
JP2017506077A (ja) 2014-02-17 2017-03-02 アドヴァンテック・バイオサイエンス・ファルマスーティカ・リミターダ 膜系細胞保持システムを利用する組換えタンパク質の発現向上
CA2942770A1 (en) 2014-03-23 2015-10-01 Advantech Bioscience Farmaceutica Ltda. Enhancement of recombinant protein expression with copper
EP3126003A4 (en) 2014-04-01 2017-11-29 Advantech Bioscience Farmacêutica Ltda. Stable factor viii formulations with low sugar-glycine

Also Published As

Publication number Publication date
CN106456720A (zh) 2017-02-22
AU2015240354A1 (en) 2016-11-17
US20170080059A1 (en) 2017-03-23
JP2017509658A (ja) 2017-04-06
US9855319B2 (en) 2018-01-02
WO2015149144A3 (en) 2016-03-10
KR20160146763A (ko) 2016-12-21
EP3125925A2 (en) 2017-02-08
CA2944183A1 (en) 2015-10-08
EP3125925A4 (en) 2017-12-06
WO2015149144A2 (en) 2015-10-08
CL2016002493A1 (es) 2017-07-07

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