BR0308442A - Composições farmacêuticas sólida e lìquida - Google Patents

Composições farmacêuticas sólida e lìquida

Info

Publication number
BR0308442A
BR0308442A BR0308442-6A BR0308442A BR0308442A BR 0308442 A BR0308442 A BR 0308442A BR 0308442 A BR0308442 A BR 0308442A BR 0308442 A BR0308442 A BR 0308442A
Authority
BR
Brazil
Prior art keywords
liquid pharmaceutical
solid
pharmaceutical compositions
pharmaceutical composition
amino acids
Prior art date
Application number
BR0308442-6A
Other languages
English (en)
Inventor
Mary White
Paul Webb
Original Assignee
Sod Conseils Rech Applic
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 Sod Conseils Rech Applic filed Critical Sod Conseils Rech Applic
Publication of BR0308442A publication Critical patent/BR0308442A/pt

Links

Classifications

    • 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
    • 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
    • A61K47/06—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
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

"COMPOSIçõES FARMACêUTICAS SóLIDA E LìQUIDA". A invenção refere-se a uma composição farmacêutica sólida estável compreendendo fator VIII. Uma tal composição está destituída de aminoácidos e compreende: (a) fator VIII; (b) um tensoativo; (c) cloreto de cálcio; (d) sacarose; (e) cloreto de sódio; (f) citrato trissódico; e (g) um tampão destituído de aminoácidos; e possui um pH de 6 a 8 antes da liofilização e após a reconstituição em água para injeção. A invenção também se refere à composição farmacêutica líquida obtenível após a diluição da citada composição farmacêutica sólida estável com água estéril opcionalmente contendo cloreto de sódio.
BR0308442-6A 2002-03-26 2003-03-26 Composições farmacêuticas sólida e lìquida BR0308442A (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0207092.8A GB0207092D0 (en) 2002-03-26 2002-03-26 Stable pharmaceutical composition containing factor VIII
PCT/GB2003/001297 WO2003080108A1 (en) 2002-03-26 2003-03-26 Stable pharmaceutical composition containing factor viii

Publications (1)

Publication Number Publication Date
BR0308442A true BR0308442A (pt) 2005-01-18

Family

ID=9933726

Family Applications (1)

Application Number Title Priority Date Filing Date
BR0308442-6A BR0308442A (pt) 2002-03-26 2003-03-26 Composições farmacêuticas sólida e lìquida

Country Status (27)

Country Link
US (1) US7790680B2 (pt)
EP (2) EP2292216A3 (pt)
JP (4) JP2005530714A (pt)
KR (1) KR20040093482A (pt)
CN (2) CN103006540B (pt)
AR (1) AR039123A1 (pt)
AT (1) ATE477814T1 (pt)
AU (1) AU2003217030B2 (pt)
BR (1) BR0308442A (pt)
CA (1) CA2480226C (pt)
DE (1) DE60333825D1 (pt)
DK (1) DK1490095T3 (pt)
ES (1) ES2350337T3 (pt)
GB (1) GB0207092D0 (pt)
HK (2) HK1080713A1 (pt)
HR (1) HRP20040882B1 (pt)
IL (2) IL163849A0 (pt)
IS (1) IS7458A (pt)
MX (1) MXPA04009275A (pt)
MY (1) MY149831A (pt)
NO (1) NO328450B1 (pt)
NZ (1) NZ535032A (pt)
PL (1) PL208009B1 (pt)
PT (1) PT1490095E (pt)
RU (1) RU2314825C2 (pt)
TW (1) TWI285106B (pt)
WO (1) WO2003080108A1 (pt)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7560107B2 (en) 1996-06-26 2009-07-14 Emory University Modified factor VIII
KR20050083841A (ko) * 2002-10-29 2005-08-26 알자 코포레이션 안정화된 고체상태 폴리펩타이드 입자
US7485291B2 (en) 2003-06-03 2009-02-03 Cell Genesys, Inc. Compositions and methods for generating multiple polypeptides from a single vector using a virus derived peptide cleavage site, and uses thereof
US7498024B2 (en) 2003-06-03 2009-03-03 Cell Genesys, Inc. Compositions and methods for enhanced expression of immunoglobulins from a single vector using a peptide cleavage site
AU2004288854B2 (en) * 2003-11-10 2009-10-01 Arriva-Pharmaceuticals, Inc. Dry recombinant human alpha 1-antitrypsin formulation
SI1750733T1 (sl) * 2004-05-03 2014-03-31 Emory University POSTOPEK DAJANJA PRAĹ IÄŚJEGA fVIII BREZ DOMENE B
KR101710471B1 (ko) * 2008-04-21 2017-02-27 노보 노르디스크 헬스 케어 악티엔게젤샤프트 건조한 트랜스글루타미나제 조성물
EP2113564A1 (en) 2008-05-01 2009-11-04 Arecor Limited Protein formulation
MX2011001624A (es) 2008-08-21 2011-03-28 Octapharma Ag Factor viii y ix humano producido en forma recombinante.
SI2337580T1 (sl) * 2008-09-03 2012-06-29 Octapharma Ag Stabilizirani sestavki za rekombinanto proizveden faktor VIII
AU2009313325B2 (en) * 2008-11-07 2014-05-01 Takeda Pharmaceutical Company Limited Factor VIII formulations
GB0915480D0 (en) * 2009-09-04 2009-10-07 Arecor Ltd Stable formulation of factor viii
CA2816575C (en) 2010-11-05 2019-06-11 Baxter Healthcare S.A. A new variant of antihemophilic factor viii having increased specific activity
ES2926798T3 (es) 2013-03-15 2022-10-28 Bioverativ Therapeutics Inc Formulaciones de polipéptido de factor VIII
RU2015144076A (ru) * 2013-03-15 2017-04-24 БАЙЕР ХелсКер ЛЛСи Композиции рекомбинантного фактора viii
MX2017000862A (es) 2014-08-04 2017-05-01 Csl Ltd Formulacion de factor viii.
JP6781508B2 (ja) * 2014-11-18 2020-11-04 塩野義製薬株式会社 安定化されたペプチド組成物
KR20220029733A (ko) 2019-07-04 2022-03-08 체에스엘 베링 렝나우 아게 응고 인자 viii의 시험관내 안정성을 증가시키기 위한 절단된 폰 빌레브란트 인자 (vwf)
US20220380439A1 (en) 2020-11-09 2022-12-01 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6281327A (ja) * 1985-10-04 1987-04-14 Green Cross Corp:The 人トロンビン製剤の加熱処理方法
JPS6485927A (en) 1987-09-29 1989-03-30 Green Cross Corp Hepatitis b vaccine
US5605884A (en) 1987-10-29 1997-02-25 Rhone-Poulenc Rorer Pharmaceuticals Inc. Factor VIII formulations in high ionic strength media
WO1989009784A1 (en) * 1988-04-08 1989-10-19 Commonwealth Serum Laboratories Commission Production of heat-stable factor viii concentrate
SE465222C5 (sv) 1989-12-15 1998-02-10 Pharmacia & Upjohn Ab Ett rekombinant, humant faktor VIII-derivat och förfarande för dess framställning
IE64738B1 (en) * 1990-03-20 1995-09-06 Akzo Nv Stabilized gonadotropin containing preparations
DE4111393A1 (de) 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
CA2124690C (en) 1992-10-02 2007-09-11 Thomas Osterberg Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
SE9301581D0 (sv) 1993-05-07 1993-05-07 Kabi Pharmacia Ab Protein formulation
SE504074C2 (sv) 1993-07-05 1996-11-04 Pharmacia Ab Proteinberedning för subkutan, intramuskulär eller intradermal administrering
ZA955642B (en) * 1994-07-07 1997-05-06 Ortho Pharma Corp Lyophilized imaging agent formulation
JPH0899999A (ja) * 1994-09-30 1996-04-16 Chemo Sero Therapeut Res Inst α１プロテアーゼインヒビターの製造方法
US6458563B1 (en) * 1996-06-26 2002-10-01 Emory University Modified factor VIII
US5763401A (en) 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
DK2130554T3 (da) * 1999-02-22 2012-12-03 Univ Connecticut Albuminfrie faktor VIII-præparater
AU780415B2 (en) 1999-07-13 2005-03-17 Biovitrum Ab Stable Factor VIII compositions
US6586574B1 (en) * 1999-08-17 2003-07-01 Nn A/S Stabilization of freeze-dried cake
DE60009926T2 (de) * 1999-08-17 2005-04-07 Novo Nordisk Health Care Ag Stabilisierung von gefriergetrocknetem kuchen
US7282562B2 (en) * 1999-08-31 2007-10-16 Genentech, Inc. Compositions and methods for the treatment of immune related diseases

Also Published As

Publication number Publication date
MXPA04009275A (es) 2005-01-25
CA2480226C (en) 2012-09-18
EP2292216A3 (en) 2011-05-11
AU2003217030B2 (en) 2008-12-04
CN1642570A (zh) 2005-07-20
US7790680B2 (en) 2010-09-07
AU2003217030A1 (en) 2003-10-08
EP1490095B1 (en) 2010-08-18
TW200304827A (en) 2003-10-16
CN1642570B (zh) 2013-01-09
MY149831A (en) 2013-10-31
JP2015143245A (ja) 2015-08-06
GB0207092D0 (en) 2002-05-08
EP2292216A2 (en) 2011-03-09
KR20040093482A (ko) 2004-11-05
JP5770775B2 (ja) 2015-08-26
JP2011079862A (ja) 2011-04-21
US20050256038A1 (en) 2005-11-17
HK1183446A1 (en) 2013-12-27
AR039123A1 (es) 2005-02-09
HRP20040882B1 (hr) 2013-02-28
EP1490095A1 (en) 2004-12-29
ES2350337T3 (es) 2011-01-21
CA2480226A1 (en) 2003-10-02
PT1490095E (pt) 2010-10-21
CN103006540A (zh) 2013-04-03
IL163849A0 (en) 2005-12-18
IS7458A (is) 2004-09-17
JP2005530714A (ja) 2005-10-13
IL163849A (en) 2010-12-30
ATE477814T1 (de) 2010-09-15
NO328450B1 (no) 2010-02-22
WO2003080108A1 (en) 2003-10-02
NZ535032A (en) 2006-03-31
PL372414A1 (en) 2005-07-25
JP2013147508A (ja) 2013-08-01
RU2004131556A (ru) 2005-08-20
TWI285106B (en) 2007-08-11
HRP20040882A2 (en) 2004-12-31
NO20044305L (no) 2004-10-11
PL208009B1 (pl) 2011-03-31
DE60333825D1 (de) 2010-09-30
DK1490095T3 (da) 2010-11-08
HK1080713A1 (en) 2006-05-04
CN103006540B (zh) 2015-09-16
RU2314825C2 (ru) 2008-01-20

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B25D Requested change of name of applicant approved

Owner name: IPSEN PHARMA S.A.S. (FR)

B25G Requested change of headquarter approved

Owner name: IPSEN PHARMA S.A.S. (FR)

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B25A Requested transfer of rights approved

Owner name: BAXTER INTERNATIONAL INC. (US) ; BAXTER HEALTHCARE

B25A Requested transfer of rights approved

Owner name: BAXALTA INCORPORATED (US) ; BAXALTA GMBH (CH)

B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements