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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (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) CN102458455B (enExample)
AR (1) AR077234A1 (enExample)
AU (1) AU2010264369B2 (enExample)
BR (1) BRPI1010707A2 (enExample)
CA (1) CA2764779C (enExample)
DK (2) DK2985033T6 (enExample)
ES (2) ES2725449T7 (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
PL1711513T3 (pl) 2003-12-01 2014-12-31 Novo Nordisk Healthcare Ag Nanofiltracja roztworów czynnika vii w celu usunięcia wirusów
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
PH12013501365A1 (en) 2010-12-30 2013-09-16 Laboratoire Francais Du Fractionnment 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
TW202444744A (zh) * 2016-07-11 2024-11-16 以色列商歐科生物製品有限公司 長效型凝血因子及其生產方法
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
CN114728044A (zh) 2019-08-15 2022-07-08 介控生化科技公司 用于皮下施用和按需求治疗的经修饰的因子vii多肽
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
JP2874751B2 (ja) 1986-04-09 1999-03-24 ジェンザイム・コーポレーション 希望する蛋白質をミルク中へ分泌する遺伝子移植動物
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
WO2001012653A1 (en) * 1999-08-17 2001-02-22 Novo Nordisk A/S Stabilisation of freeze-dried cake
AU2001254624A1 (en) * 2000-05-03 2001-11-12 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
PL207018B1 (pl) 2002-06-21 2010-10-29 Novo Nordisk Helth Care Ag Kompozycja farmaceutyczna, sposób przygotowania stabilnego polipeptydu czynnika VII i zastosowanie polipeptydu czynnika VII
WO2004111242A1 (en) * 2003-06-19 2004-12-23 Maxygen Holdings Ltd. FACTOR VII OR VIIa GLA DOMAIN VARIANTS
FR2857267B1 (fr) * 2003-07-09 2006-03-10 Lab Francais Du Fractionnement Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.
RU2388460C2 (ru) * 2003-08-14 2010-05-10 Ново Нордиск Хелс Кеа Аг Жидкая водная фармацевтическая композиция, содержащая полипептид фактора vii
JP2008531525A (ja) * 2005-02-24 2008-08-14 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 Ｖｉｉ因子ポリペプチド製剤を安定化する化合物
KR101364003B1 (ko) * 2005-04-28 2014-02-21 노보 노르디스크 헬스 케어 악티엔게젤샤프트 활성화된 제ｖｉｉ 인자 폴리펩타이드를 포함하는 밀폐용기와 이의 제조방법 및, 키트와 키트의 사용방법
EP1919498A2 (en) * 2005-08-26 2008-05-14 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"
WO2008113589A1 (en) * 2007-03-20 2008-09-25 Csl Behring Gmbh Methods for industrial scale production of therapeutic complement factor h preparations from human plasma
CN104887620A (zh) * 2007-05-02 2015-09-09 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
JP2012530770A (ja) 2012-12-06
US20120087908A1 (en) 2012-04-12
KR101468115B1 (ko) 2014-12-03
ES2725449T3 (es) 2019-09-24
JP2015134795A (ja) 2015-07-27
EP2985033B1 (fr) 2019-03-20
CN102458455A (zh) 2012-05-16
CA2764779C (fr) 2015-09-29
CN105106943A (zh) 2015-12-02
FR23C1001I2 (fr) 2025-03-28
AR077234A1 (es) 2011-08-10
US9968662B2 (en) 2018-05-15
JP5706888B2 (ja) 2015-04-22
EP2445516B1 (fr) 2015-08-12
US9358275B2 (en) 2016-06-07
US20150216951A1 (en) 2015-08-06
WO2010149907A1 (fr) 2010-12-29
IL216872A (en) 2017-07-31
EP2985033A1 (fr) 2016-02-17
EP2985033B3 (fr) 2022-10-26
FR2947181A1 (fr) 2010-12-31
FR2947181B1 (fr) 2012-05-04
AU2010264369A1 (en) 2012-01-19
AU2010264369B2 (en) 2013-06-27
KR20120047918A (ko) 2012-05-14
CN102458455B (zh) 2015-04-08
PL2985033T3 (pl) 2019-08-30
DK2985033T6 (da) 2022-11-07
FR23C1001I1 (fr) 2023-03-10
ES2550269T3 (es) 2015-11-05
US9029316B2 (en) 2015-05-12
EP2445516A1 (fr) 2012-05-02
TR201906145T4 (tr) 2019-05-21
NL301213I1 (enExample) 2023-01-18
NL301213I2 (nl) 2023-12-14
DK2985033T3 (da) 2019-06-17
CA2764779A1 (fr) 2010-12-29
JP2017081978A (ja) 2017-05-18
PL2445516T3 (pl) 2015-12-31
DK2445516T3 (en) 2015-10-19
US20160271233A1 (en) 2016-09-22
IL216872A0 (en) 2012-02-29
ES2725449T7 (es) 2022-12-20

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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