BRPI1010707A2 - composição farmacêutica, processo para o preparo da mesma, processo para o preparo de uma formulação injetável e formulação injetável - Google Patents

composição farmacêutica, processo para o preparo da mesma, processo para o preparo de uma formulação injetável e formulação injetável

Info

Publication number
BRPI1010707A2
BRPI1010707A2 BRPI1010707A BRPI1010707A BRPI1010707A2 BR PI1010707 A2 BRPI1010707 A2 BR PI1010707A2 BR PI1010707 A BRPI1010707 A BR PI1010707A BR PI1010707 A BRPI1010707 A BR PI1010707A BR PI1010707 A2 BRPI1010707 A2 BR PI1010707A2
Authority
BR
Brazil
Prior art keywords
preparing
injectable formulation
pharmaceutical composition
injectable
formulation
Prior art date
Application number
BRPI1010707A
Other languages
English (en)
Portuguese (pt)
Inventor
Annie Bardat
Cornelius Pompe
Original Assignee
Lfb Biotechnologies
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 Lfb Biotechnologies filed Critical Lfb Biotechnologies
Publication of BRPI1010707A2 publication Critical patent/BRPI1010707A2/pt

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)
    • 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
    • A61K47/08—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
    • 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
    • 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
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/6437—Coagulation factor VIIa (3.4.21.21)
    • 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)
    • C12Y304/21021—Coagulation factor VIIa (3.4.21.21)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
BRPI1010707A 2009-06-26 2010-06-18 composição farmacêutica, processo para o preparo da mesma, processo para o preparo de uma formulação injetável e formulação injetável BRPI1010707A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0954390A FR2947181B1 (fr) 2009-06-26 2009-06-26 Composition de facteur vii
PCT/FR2010/051229 WO2010149907A1 (fr) 2009-06-26 2010-06-18 Composition de facteur vii

Publications (1)

Publication Number Publication Date
BRPI1010707A2 true BRPI1010707A2 (pt) 2016-03-15

Family

ID=41620211

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI1010707A BRPI1010707A2 (pt) 2009-06-26 2010-06-18 composição farmacêutica, processo para o preparo da mesma, processo para o preparo de uma formulação injetável e formulação injetável

Country Status (17)

Country Link
US (3) US9029316B2 (enExample)
EP (2) EP2445516B1 (enExample)
JP (3) JP5706888B2 (enExample)
KR (1) KR101468115B1 (enExample)
CN (2) CN105106943A (enExample)
AR (1) AR077234A1 (enExample)
AU (1) AU2010264369B2 (enExample)
BR (1) BRPI1010707A2 (enExample)
CA (1) CA2764779C (enExample)
DK (2) DK2985033T6 (enExample)
ES (2) ES2550269T3 (enExample)
FR (2) FR2947181B1 (enExample)
IL (1) IL216872A (enExample)
NL (1) NL301213I2 (enExample)
PL (2) PL2985033T3 (enExample)
TR (1) TR201906145T4 (enExample)
WO (1) WO2010149907A1 (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2004294403A1 (en) 2003-12-01 2005-06-16 Novo Nordisk Health Care Ag Nanofiltration of factor VII solutions to remove virus
FR2947181B1 (fr) * 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii
US12203113B2 (en) 2009-07-09 2025-01-21 Opko Biologics Ltd. Long-acting coagulation factors and methods of producing same
AU2011350895B2 (en) 2010-12-30 2015-05-28 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Glycols as pathogen inactivating agents
EP2687595B1 (en) * 2012-07-19 2018-05-30 Laboratoire Français du Fractionnement et des Biotechnologies Method for purifying transgenic factor VII
FR3006591B1 (fr) 2013-06-11 2016-05-06 Lab Francais Du Fractionnement Composition de facteur vii presentant un point isoelectrique substantiellement homogene
US20180169297A1 (en) 2015-06-12 2018-06-21 Laboratoire Français Du Fractionnement Et Des Biotechnologies Injectable composition of factor vii and fillers
FR3038517B1 (fr) 2015-07-06 2020-02-28 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Utilisation de fragments fc modifies en immunotherapie
EP4303228B1 (en) 2016-07-11 2026-05-27 OPKO Biologics Ltd. Long-acting coagulation factor vii and methods of producing same
FR3082427B1 (fr) 2018-06-14 2020-09-25 Lab Francais Du Fractionnement Combinaison de facteur vii et d'un anticorps bispecifique anti-facteurs ix et x
EP3833381B1 (en) 2019-08-15 2022-08-03 Catalyst Biosciences, Inc. Modified factor vii polypeptides for subcutaneous administration
CN117860874B (zh) * 2024-03-12 2024-07-02 正大天晴药业集团南京顺欣制药有限公司 重组人凝血因子VIIa的药物组合物

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GR860984B (en) 1985-04-17 1986-08-18 Zymogenetics Inc Expression of factor vii and ix activities in mammalian cells
DE3751873T2 (de) 1986-04-09 1997-02-13 Genzyme Corp Genetisch transformierte Tiere, die ein gewünschtes Protein in Milch absondern
JP3543144B2 (ja) * 1995-03-11 2004-07-14 国際試薬株式会社 臨床検査用製剤
DE19538687A1 (de) * 1995-10-17 1997-04-24 Boehringer Mannheim Gmbh Stabile pharmazeutische Darreichungsformen enthaltend Parathormon
ATE264340T1 (de) * 1999-08-17 2004-04-15 Novo Nordisk Healthcare Ag Stabilisierung von gefriergetrocknetem kuchen
WO2001083725A1 (en) * 2000-05-03 2001-11-08 Novo Nordisk A/S Human coagulation factor vii variants
JP2005526004A (ja) * 2001-11-09 2005-09-02 ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト 第ｖｉｉ因子ポリペプチドおよびトラネキサム酸を含む薬学的組成物
CN101912601B (zh) 2002-06-21 2012-08-29 诺和诺德医疗保健公司 因子vii多肽的稳定化固体组合物
JP4915918B2 (ja) * 2003-06-19 2012-04-11 バイエル ヘルスケア エルエルシー 第ＶＩＩ因子または第ＶＩＩａ因子のＧｌａドメイン変種
FR2857267B1 (fr) * 2003-07-09 2006-03-10 Lab Francais Du Fractionnement Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.
EP1656158B1 (en) * 2003-08-14 2016-03-09 Novo Nordisk Health Care AG Liquid, aqueous pharmaceutical composition of factor vii polypeptides
US20090041747A1 (en) * 2005-02-24 2009-02-12 Novo Nordisk Health Care Ag Compounds for Stabilizing Factor VII Polypeptide Formulations
JP2008539208A (ja) * 2005-04-28 2008-11-13 ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト 活性化型のｖｉｉ因子ポリペプチドを含んでいる閉鎖容器、調製する方法、並びにキットおよび前記キットを使用する方法
US20090017007A1 (en) * 2005-08-26 2009-01-15 Maxygen Holdings Ltd. Liquid factor vii composition
FR2894831B1 (fr) * 2005-12-16 2008-02-15 Lab Francais Du Fractionnement Colle biologique exempte de thrombine et son utilisation comme medicament.
WO2008078189A2 (en) * 2006-12-20 2008-07-03 Bayer Healthcare Llc Factor vii and viia compositions
FR2910786B1 (fr) 2006-12-29 2017-08-11 Laboratoire Francais Du Fractionnement Et Des Biotechnologies (Lfb) "procede d'extraction d'une proteine presente dans du lait"
ES2595059T3 (es) * 2007-03-20 2016-12-27 Csl Behring Gmbh Métodos para la producción a escala industrial de preparados terapéuticos del Factor H del complemento a partir de plasma humano
CN101674805A (zh) * 2007-05-02 2010-03-17 诺沃-诺迪斯克保健股份有限公司 包括芳香族防腐剂和抗氧化剂的高浓度因子ⅶ多肽制剂
FR2947181B1 (fr) * 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii

Also Published As

Publication number Publication date
PL2445516T3 (pl) 2015-12-31
US20120087908A1 (en) 2012-04-12
WO2010149907A1 (fr) 2010-12-29
EP2985033B3 (fr) 2022-10-26
CA2764779C (fr) 2015-09-29
US20160271233A1 (en) 2016-09-22
KR20120047918A (ko) 2012-05-14
CN102458455A (zh) 2012-05-16
CN105106943A (zh) 2015-12-02
DK2985033T3 (da) 2019-06-17
JP2012530770A (ja) 2012-12-06
AU2010264369B2 (en) 2013-06-27
IL216872A0 (en) 2012-02-29
AR077234A1 (es) 2011-08-10
US9358275B2 (en) 2016-06-07
AU2010264369A1 (en) 2012-01-19
FR23C1001I2 (fr) 2025-03-28
IL216872A (en) 2017-07-31
US9968662B2 (en) 2018-05-15
EP2445516B1 (fr) 2015-08-12
CN102458455B (zh) 2015-04-08
NL301213I2 (nl) 2023-12-14
US9029316B2 (en) 2015-05-12
TR201906145T4 (tr) 2019-05-21
FR2947181B1 (fr) 2012-05-04
CA2764779A1 (fr) 2010-12-29
ES2550269T3 (es) 2015-11-05
EP2445516A1 (fr) 2012-05-02
US20150216951A1 (en) 2015-08-06
EP2985033A1 (fr) 2016-02-17
EP2985033B1 (fr) 2019-03-20
JP2017081978A (ja) 2017-05-18
FR2947181A1 (fr) 2010-12-31
ES2725449T3 (es) 2019-09-24
PL2985033T3 (pl) 2019-08-30
ES2725449T7 (es) 2022-12-20
NL301213I1 (enExample) 2023-01-18
DK2985033T6 (da) 2022-11-07
FR23C1001I1 (fr) 2023-03-10
JP5706888B2 (ja) 2015-04-22
JP2015134795A (ja) 2015-07-27
KR101468115B1 (ko) 2014-12-03
DK2445516T3 (en) 2015-10-19

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Legal Events

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B08E Application fees: payment of additional fee required [chapter 8.5 patent gazette]

Free format text: COMPLEMENTAR A RETRIBUICAO DA(S) 6A. ANUIDADE(S), DE ACORDO COM TABELA VIGENTE, REFERENTE A(S) GUIA(S) DE RECOLHIMENTO 22150832473-0.

B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 6A ANUIDADE (COMPLEMENTACAO).

B08H Application fees: decision cancelled [chapter 8.8 patent gazette]
B08G Application fees: restoration [chapter 8.7 patent gazette]
B25C Requirement related to requested transfer of rights

Owner name: LFB BIOTECHNOLOGIES (FR)

B25A Requested transfer of rights approved

Owner name: LABORATOIRE FRANCAIS DU FRACTIONNEMENT ET DES BIOT

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements