MX2009003635A - Formulaciones de anticuerpos estables. - Google Patents

Formulaciones de anticuerpos estables.

Info

Publication number
MX2009003635A
MX2009003635A MX2009003635A MX2009003635A MX2009003635A MX 2009003635 A MX2009003635 A MX 2009003635A MX 2009003635 A MX2009003635 A MX 2009003635A MX 2009003635 A MX2009003635 A MX 2009003635A MX 2009003635 A MX2009003635 A MX 2009003635A
Authority
MX
Mexico
Prior art keywords
antibody
acid buffer
polyol
sugar
buffer
Prior art date
Application number
MX2009003635A
Other languages
English (en)
Inventor
Douglas Rehder
Masazumi Matsumura
Arnold Mcauley
Original Assignee
Amgen 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
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of MX2009003635A publication Critical patent/MX2009003635A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K47/26—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
    • A61K9/14—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
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man

Abstract

La invención proporciona una formulación que incluye un regulador de pH de ácido acético, un regulador de pH de ácido glutámico o un regulador de pH de ácido succínico con un pH de aproximadamente 4.5-7.0, al menos un excipiente que comprende un azúcar o un poliol y una cantidad efectiva de un anticuerpo terapéutico. El regulador de pH puede incluir una sal de acetato, glutamato o succinato y el azúcar o poliol puede incluir glicerol, sucrosa, trehalosa o sorbitol. El anticuerpo terapéutico puede incluir un anticuerpo humano, un anticuerpo humanizado, un anticuerpo quimérico o un fragmento funcional de los mismos.
MX2009003635A 2006-10-06 2007-10-05 Formulaciones de anticuerpos estables. MX2009003635A (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US85036206P 2006-10-06 2006-10-06
US85097006P 2006-10-10 2006-10-10
PCT/US2007/021477 WO2008045373A2 (en) 2006-10-06 2007-10-05 Stable antibody formulations

Publications (1)

Publication Number Publication Date
MX2009003635A true MX2009003635A (es) 2009-04-22

Family

ID=39283396

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2009003635A MX2009003635A (es) 2006-10-06 2007-10-05 Formulaciones de anticuerpos estables.

Country Status (12)

Country Link
US (1) US20080112953A1 (es)
EP (1) EP2081553B1 (es)
JP (1) JP5631591B2 (es)
AR (1) AR063150A1 (es)
AU (1) AU2007307107B2 (es)
CA (1) CA2665567C (es)
CL (1) CL2007002880A1 (es)
ES (1) ES2827180T3 (es)
MX (1) MX2009003635A (es)
PE (1) PE20081179A1 (es)
TW (1) TW200831129A (es)
WO (1) WO2008045373A2 (es)

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Also Published As

Publication number Publication date
TW200831129A (en) 2008-08-01
JP2010505852A (ja) 2010-02-25
JP5631591B2 (ja) 2014-11-26
AU2007307107B2 (en) 2011-11-03
US20080112953A1 (en) 2008-05-15
WO2008045373A3 (en) 2008-10-16
CA2665567A1 (en) 2008-04-17
AR063150A1 (es) 2008-12-30
AU2007307107A1 (en) 2008-04-17
WO2008045373A2 (en) 2008-04-17
CL2007002880A1 (es) 2008-05-09
PE20081179A1 (es) 2008-09-29
EP2081553A2 (en) 2009-07-29
EP2081553B1 (en) 2020-08-12
ES2827180T3 (es) 2021-05-20
CA2665567C (en) 2012-07-03

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