MX351659B - Formulaciones de anticuerpos en suspension, no acuosas, con viscosidad reducida y concentracion alta. - Google Patents

Formulaciones de anticuerpos en suspension, no acuosas, con viscosidad reducida y concentracion alta.

Info

Publication number
MX351659B
MX351659B MX2013010335A MX2013010335A MX351659B MX 351659 B MX351659 B MX 351659B MX 2013010335 A MX2013010335 A MX 2013010335A MX 2013010335 A MX2013010335 A MX 2013010335A MX 351659 B MX351659 B MX 351659B
Authority
MX
Mexico
Prior art keywords
antibodies
high concentration
reduced viscosity
suspension formulations
aqueous high
Prior art date
Application number
MX2013010335A
Other languages
English (en)
Other versions
MX2013010335A (es
Inventor
Kui Liu
Weiguo Dai
Beth Hill
Carl Mieczkowski
Original Assignee
Janssen Biotech 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 Janssen Biotech Inc filed Critical Janssen Biotech Inc
Publication of MX2013010335A publication Critical patent/MX2013010335A/es
Publication of MX351659B publication Critical patent/MX351659B/es

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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • A61K38/38—Albumins
    • 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
    • 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
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K47/44—Oils, 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
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies

Abstract

La presente invención se refiere a una formulación en suspensión no acuosa de concentración alta, caracterizada porque comprende: a. un vehículo que comprende un agente hidrófobo y un agente reductor de viscosidad, en donde el agente hidrófobo es aceite de sésamo y el agente reductor de viscosidad es oleato de etilo; y b. un anticuerpo formulado con un excipiente, en donde el anticuerpo es un anticuerpo anti-TNFa que comprende una región variable de cadena ligera (VL) de SEQ ID NO: 6 y una región variable de cadena pesada (VH) de SEQ ID Nos: 1 o 2, o una VL de SEQ ID NO: 7 y una VH de SEQ ID Nos: 3, 4 o 5.
MX2013010335A 2011-03-09 2011-09-30 Formulaciones de anticuerpos en suspension, no acuosas, con viscosidad reducida y concentracion alta. MX351659B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/043,925 US20110223208A1 (en) 2010-03-09 2011-03-09 Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
PCT/US2011/054257 WO2012121754A1 (en) 2011-03-09 2011-09-30 Non-aqueous high concentration reduced viscosity suspension formulations of antibodies

Publications (2)

Publication Number Publication Date
MX2013010335A MX2013010335A (es) 2013-10-03
MX351659B true MX351659B (es) 2017-10-23

Family

ID=46798862

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2013010335A MX351659B (es) 2011-03-09 2011-09-30 Formulaciones de anticuerpos en suspension, no acuosas, con viscosidad reducida y concentracion alta.

Country Status (16)

Country Link
US (1) US20110223208A1 (es)
EP (1) EP2683403B1 (es)
JP (1) JP5881748B2 (es)
KR (1) KR101949707B1 (es)
CN (1) CN103402540A (es)
AU (1) AU2011361700B2 (es)
BR (1) BR112013023006A8 (es)
CA (1) CA2829367A1 (es)
EA (1) EA201391298A1 (es)
ES (1) ES2743687T3 (es)
IL (1) IL228211B (es)
MX (1) MX351659B (es)
SG (1) SG193278A1 (es)
UA (1) UA114289C2 (es)
WO (1) WO2012121754A1 (es)
ZA (2) ZA201307513B (es)

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Also Published As

Publication number Publication date
WO2012121754A1 (en) 2012-09-13
SG193278A1 (en) 2013-10-30
BR112013023006A2 (pt) 2016-12-06
EP2683403A4 (en) 2014-10-08
KR101949707B1 (ko) 2019-02-19
KR20140145942A (ko) 2014-12-24
CA2829367A1 (en) 2012-09-13
AU2011361700B2 (en) 2017-06-22
IL228211B (en) 2018-04-30
EP2683403B1 (en) 2019-06-19
CN103402540A (zh) 2013-11-20
BR112013023006A8 (pt) 2017-12-19
MX2013010335A (es) 2013-10-03
ZA201600811B (en) 2016-11-30
ZA201307513B (en) 2018-12-19
UA114289C2 (uk) 2017-05-25
JP5881748B2 (ja) 2016-03-09
EA201391298A1 (ru) 2014-02-28
AU2011361700A1 (en) 2013-09-19
US20110223208A1 (en) 2011-09-15
EP2683403A1 (en) 2014-01-15
ES2743687T3 (es) 2020-02-20
JP2014510077A (ja) 2014-04-24

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