NO323557B1 - Stabil, rekonstituert formulering og lyofilisert formulering, fremgangsmate for fremstilling av disse, fremstilt artikkel og anvendelse av formuleringene. - Google Patents

Stabil, rekonstituert formulering og lyofilisert formulering, fremgangsmate for fremstilling av disse, fremstilt artikkel og anvendelse av formuleringene.

Info

Publication number
NO323557B1
NO323557B1 NO980335A NO980335A NO323557B1 NO 323557 B1 NO323557 B1 NO 323557B1 NO 980335 A NO980335 A NO 980335A NO 980335 A NO980335 A NO 980335A NO 323557 B1 NO323557 B1 NO 323557B1
Authority
NO
Norway
Prior art keywords
formulation
reconstituted
stable
formulations
preparation
Prior art date
Application number
NO980335A
Other languages
English (en)
Other versions
NO980335L (no
NO980335D0 (no
NO323557B3 (no
Inventor
Steven J Shire
James Andya
Jeffrey L Cleland
Chung C Hsu
Xanthe M Lam
David E Overcashier
Janet Yu-Feng Yang
Sylvia Sau-Yan Wu
Original Assignee
Genentech Inc
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=27056058&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=NO323557(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from US08/615,369 external-priority patent/US6267958B1/en
Application filed by Genentech Inc filed Critical Genentech Inc
Publication of NO980335D0 publication Critical patent/NO980335D0/no
Publication of NO980335L publication Critical patent/NO980335L/no
Publication of NO323557B1 publication Critical patent/NO323557B1/no
Publication of NO323557B3 publication Critical patent/NO323557B3/no

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

Stabil lyofilisert proteinformulering beskrives som kan rekonstitueres med et egnet fortynningsmiddel for å danne en rekonstituert formulering med høy proteinkonsentrasjon som er egnet for subkutan administrering. Anti-IgE- og og anti-HER2-antistofformuleringer har f.eks. blitt fremstilt ved å ftysetørke disse antistoffene i nærvær av en frysetØrkingsbeskytter. Den lyofiliserte blanding som dermed dannes rekonstitueres til en høy proteinkonsentrasjon uten betydelige tap av proteinets stabilitet.
NO19980335A 1995-07-27 1998-01-26 Stabil, rekonstituert formulering og lyofilisert formulering, fremgangsmåte for fremstilling av disse, fremstilt artikkel og anvendelse av formuleringene. NO323557B3 (no)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US50801495A 1995-07-27 1995-07-27
US08/615,369 US6267958B1 (en) 1995-07-27 1996-03-14 Protein formulation
PCT/US1996/012251 WO1997004801A1 (en) 1995-07-27 1996-07-23 Stabile isotonic lyophilized protein formulation

Publications (4)

Publication Number Publication Date
NO980335D0 NO980335D0 (no) 1998-01-26
NO980335L NO980335L (no) 1998-03-26
NO323557B1 true NO323557B1 (no) 2007-06-11
NO323557B3 NO323557B3 (no) 2007-06-11

Family

ID=27056058

Family Applications (2)

Application Number Title Priority Date Filing Date
NO19980335A NO323557B3 (no) 1995-07-27 1998-01-26 Stabil, rekonstituert formulering og lyofilisert formulering, fremgangsmåte for fremstilling av disse, fremstilt artikkel og anvendelse av formuleringene.
NO2007012C NO2007012I1 (no) 1995-07-27 2007-11-05 Trastuzumab eller farmasoytisk akseptable salter derav

Family Applications After (1)

Application Number Title Priority Date Filing Date
NO2007012C NO2007012I1 (no) 1995-07-27 2007-11-05 Trastuzumab eller farmasoytisk akseptable salter derav

Country Status (18)

Country Link
EP (3) EP1516628B1 (no)
JP (7) JPH11510170A (no)
CN (3) CN1151842C (no)
AR (2) AR003969A1 (no)
AU (1) AU716785B2 (no)
BR (1) BR9609743A (no)
CA (2) CA2226575C (no)
DK (2) DK1516628T3 (no)
ES (2) ES2435462T3 (no)
HK (2) HK1117075A1 (no)
IL (1) IL122910A (no)
MX (1) MX9800684A (no)
NO (2) NO323557B3 (no)
NZ (2) NZ500539A (no)
PT (2) PT2275119E (no)
RU (2) RU2497500C2 (no)
SI (2) SI1516628T1 (no)
WO (1) WO1997004801A1 (no)

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