ES2182899T3 - Formulacion farmaceutica para la administracion subcutanea, intramuscular o intradermica de factor viii. - Google Patents

Formulacion farmaceutica para la administracion subcutanea, intramuscular o intradermica de factor viii.

Info

Publication number
ES2182899T3
ES2182899T3 ES95914669T ES95914669T ES2182899T3 ES 2182899 T3 ES2182899 T3 ES 2182899T3 ES 95914669 T ES95914669 T ES 95914669T ES 95914669 T ES95914669 T ES 95914669T ES 2182899 T3 ES2182899 T3 ES 2182899T3
Authority
ES
Spain
Prior art keywords
factor viii
subcutaneous
intramuscular
intradermal administration
pharmaceutical formulation
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
ES95914669T
Other languages
English (en)
Inventor
Jack Spira
Lars Widlund
Thomas Osterberg
Brita Sjostrom
Marianne Mikaelsson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Swedish Orphan Biovitrum AB
Original Assignee
Biovitrum AB
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=26662019&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2182899(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from SE9401105A external-priority patent/SE9401105D0/
Priority claimed from SE9500036A external-priority patent/SE9500036D0/xx
Application filed by Biovitrum AB filed Critical Biovitrum AB
Application granted granted Critical
Publication of ES2182899T3 publication Critical patent/ES2182899T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor 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)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Landscapes

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

Abstract

LA PRESENTE INVENCION SE REFIERE A UNA FORMULACION PARA LA ADMINISTRACION SUBCUTANEA, INTRAMUSCULAR O INTRADERMICA QUE INCLUYE FACTOR VIII O IX DE COAGULACION Y EL USO DE LOS MISMOS PARA LA FABRICACION DE UN MEDICAMENTO PARA TRATAR LA HEMOFILIA AO B. LA FORMULACION INCLUYE FACTOR VIII O IX DE COAGULACION CON UNA ACTIVIDAD DE AL MENOS 200 IU/ML Y UN ADITIVO QUE AUMENTA LA BIODISPONIBILIDAD DEL FACTOR VIII O IX. LAS PRUEBAS CON FACTOR VIII PROPORCIONA UN NIVEL TERAPEUTICO DE FACTOR VIII ACTIVO EN LA CIRCULACION SANGUINEA DURANTE UN PERIODO DE TIEMPO SORPRENDENTEMENTE LARGO DESPUES DE LA ADMINISTRACION SUBCUTANEA, INTRAMUSCULAR O INTRADERMICA. EL FACTOR VIII ES ADECUADAMENTE UN FACTOR VIII RECOMBINANTE ALTAMENTE PURIFICADO, Y PREFERIBLEMENTE UN DERIVADO DE ANULACION DEL MISMO , QUE PUEDE UTILIZARSE PARA LA FABRICACION DE UN MEDICAMENTO PARA LA ADMINISTRACION SUBCUTANEA.
ES95914669T 1994-03-31 1995-03-31 Formulacion farmaceutica para la administracion subcutanea, intramuscular o intradermica de factor viii. Expired - Lifetime ES2182899T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9401105A SE9401105D0 (sv) 1993-07-05 1994-03-31 Formulation
SE9500036A SE9500036D0 (sv) 1995-01-05 1995-01-05 Formulation

Publications (1)

Publication Number Publication Date
ES2182899T3 true ES2182899T3 (es) 2003-03-16

Family

ID=26662019

Family Applications (1)

Application Number Title Priority Date Filing Date
ES95914669T Expired - Lifetime ES2182899T3 (es) 1994-03-31 1995-03-31 Formulacion farmaceutica para la administracion subcutanea, intramuscular o intradermica de factor viii.

Country Status (19)

Country Link
US (1) US5925739A (es)
EP (1) EP0772452B1 (es)
JP (1) JP3939750B2 (es)
AT (1) ATE222770T1 (es)
AU (1) AU690666B2 (es)
BR (1) BRPI9507227B8 (es)
CA (1) CA2186126C (es)
DE (1) DE69527966T2 (es)
DK (1) DK0772452T3 (es)
ES (1) ES2182899T3 (es)
FI (1) FI118171B (es)
HU (1) HU223314B1 (es)
IL (2) IL113010A0 (es)
NO (1) NO321139B1 (es)
NZ (1) NZ283499A (es)
PL (1) PL180282B1 (es)
PT (1) PT772452E (es)
TW (1) TW400234B (es)
WO (1) WO1995026750A1 (es)

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DE4430205A1 (de) * 1994-08-26 1996-02-29 Behringwerke Ag Zusammensetzungen, die als Gegenmittel für Blut-Antikoagulanzien geeignet sind und deren Verwendung
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SE9502285D0 (sv) 1995-06-22 1995-06-22 Pharmacia Ab Improvements related to injections
US5770700A (en) * 1996-01-25 1998-06-23 Genetics Institute, Inc. Liquid factor IX formulations
DE69733664T3 (de) * 1996-04-19 2011-04-14 Grifols Inc. (n.d. Ges.d.Staates Delaware), Los Angeles Verfahren zur INaktivierung von Viren und Lyophilisierung von Blutproteinen
US7560107B2 (en) * 1996-06-26 2009-07-14 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
US6310183B1 (en) * 1997-09-10 2001-10-30 Novo Nordisk A/S Coagulation factor VIIa composition
WO2001082943A2 (en) 2000-05-03 2001-11-08 Novo Nordisk A/S Subcutaneous administration of coagulation factor vii
US20050032690A1 (en) * 1997-09-10 2005-02-10 Rojkjaer Lisa Payne Factor VII polypeptides for preventing formation of inhibitors in subjects with haemophilia
US7786070B2 (en) 1997-09-10 2010-08-31 Novo Nordisk Healthcare A/G Subcutaneous administration of coagulation factor VII
EP2921180B1 (en) 1999-02-22 2019-08-14 University of Connecticut Albumin-free factor VIII formulations
US8465468B1 (en) 2000-06-29 2013-06-18 Becton, Dickinson And Company Intradermal delivery of substances
US20020156453A1 (en) * 1999-10-14 2002-10-24 Pettis Ronald J. Method and device for reducing therapeutic dosage
JP4663837B2 (ja) * 1999-12-24 2011-04-06 一般財団法人化学及血清療法研究所 第▲viii▼因子を主成分とする血小板減少に伴う出血疾患の予防・治療用医薬組成物
US20020123093A1 (en) 2000-04-06 2002-09-05 Zannis Vassilis I. Compounds and methods for lowering cholesterol levels without inducing hypertrigylceridemia
RU2185158C2 (ru) * 2000-06-14 2002-07-20 Нижегородский государственный научно-исследовательский институт травматологии и ортопедии Способ анестезиологического пособия при операциях на тазобедренном суставе
RU2163140C1 (ru) * 2000-07-05 2001-02-20 Гематологический научный центр РАМН Концентрат фактора ix системы свертывания крови и способ его получения
KR20040065278A (ko) * 2001-12-21 2004-07-21 노보 노르디스크 에이/에스 변경된 인자 ⅶ 폴리펩티드의 액체 조성물
AU2002351756A1 (en) * 2001-12-21 2003-07-15 Novo Nordisk Health Care Ag Liquid composition of factor vii polypeptides
US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
PT1517698E (pt) 2002-06-21 2014-11-19 Novo Nordisk Healthcare Ag Composições sólidas estabilizadas de polipéptidos do fator viia
RU2005132164A (ru) * 2003-03-18 2006-06-10 Ново Нордиск Хелт Кэр Аг (Ch) Жидкие, водные фармацевтические композиции полипептидов фактора vii
US7897734B2 (en) * 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
EP2055189A1 (en) 2003-04-09 2009-05-06 Neose Technologies, Inc. Glycopegylation methods and proteins/peptides produced by the methods
CA2465004A1 (en) * 2003-05-19 2004-11-19 National Institute For Biological Standards And Control Composition
KR20060015574A (ko) * 2003-05-23 2006-02-17 노보 노르디스크 헬스 케어 악티엔게젤샤프트 용액 중 단백질 안정화
WO2004112828A1 (en) * 2003-06-25 2004-12-29 Novo Nordisk Health Care Ag Liquid composition of factor vii polypeptides
EP1644030B1 (en) * 2003-07-01 2009-10-28 Novo Nordisk Health Care AG Liquid, aqueous pharmaceutical composition of factor vii polypeptides
WO2005012484A2 (en) 2003-07-25 2005-02-10 Neose Technologies, Inc. Antibody-toxin conjugates
ES2574581T3 (es) * 2003-08-14 2016-06-20 Novo Nordisk Health Care Ag Composición farmacéutica líquida acuosa de polipéptidos de tipo Factor VII
ES2229931B1 (es) * 2003-10-03 2006-01-16 Grifols, S.A. Composicion liquida bilogicamente estable de fviii, de fvw o del complejo fviii/fvw humanos.
US20080305992A1 (en) 2003-11-24 2008-12-11 Neose Technologies, Inc. Glycopegylated erythropoietin
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Also Published As

Publication number Publication date
FI963871A0 (fi) 1996-09-27
BR9507227A (pt) 1997-09-09
JP3939750B2 (ja) 2007-07-04
EP0772452B1 (en) 2002-08-28
IL113010A0 (en) 1995-10-31
NO321139B1 (no) 2006-03-27
MX9604455A (es) 1997-07-31
HU223314B1 (hu) 2004-05-28
NO964081D0 (no) 1996-09-27
PL316618A1 (en) 1997-01-20
WO1995026750A1 (en) 1995-10-12
PL180282B1 (pl) 2001-01-31
NZ283499A (en) 1997-08-22
FI963871L (fi) 1996-09-27
ATE222770T1 (de) 2002-09-15
CA2186126C (en) 2007-11-20
NO964081L (no) 1996-11-29
DK0772452T3 (da) 2003-01-06
DE69527966D1 (de) 2002-10-02
AU2156095A (en) 1995-10-23
IL113010A (en) 1999-10-28
FI118171B (fi) 2007-08-15
CA2186126A1 (en) 1995-10-12
HUT74918A (en) 1997-03-28
AU690666B2 (en) 1998-04-30
US5925739A (en) 1999-07-20
DE69527966T2 (de) 2003-05-28
PT772452E (pt) 2003-01-31
BRPI9507227B8 (pt) 2015-12-08
TW400234B (en) 2000-08-01
JPH10501522A (ja) 1998-02-10
EP0772452A1 (en) 1997-05-14
HU9602693D0 (en) 1996-11-28

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