UA114289C2 - Неводні концентровані суспензійні композиції зі зниженою в'язкістю на основі антитіл - Google Patents

Неводні концентровані суспензійні композиції зі зниженою в'язкістю на основі антитіл

Info

Publication number
UA114289C2
UA114289C2 UAA201311856A UAA201311856A UA114289C2 UA 114289 C2 UA114289 C2 UA 114289C2 UA A201311856 A UAA201311856 A UA A201311856A UA A201311856 A UAA201311856 A UA A201311856A UA 114289 C2 UA114289 C2 UA 114289C2
Authority
UA
Ukraine
Prior art keywords
antibodies
reduced viscosity
concentrated suspension
suspension compositions
aqueous concentrated
Prior art date
Application number
UAA201311856A
Other languages
English (en)
Inventor
Вейго Дай
Вэйго Дай
Бет Хілл
Бэт Хилл
Куй ЛЮ
Карл Мечковскі
Карл Мечковски
Original Assignee
Янссен Байотек, Інк.
Янссен Байотек, Инк.
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 Янссен Байотек, Інк., Янссен Байотек, Инк. filed Critical Янссен Байотек, Інк.
Publication of UA114289C2 publication Critical patent/UA114289C2/uk

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

Даний винахід стосується неводної суспензійної композиції високої концентрації, що складається з: a) несучого середовища, що містить кунжутну олію як гідрофобний засіб і етилолеат як засіб, який знижує в'язкість; і b) антитіла в суміші з ексципієнтом, де антитілом є антитіло проти ФНО-α, яке містить варіабельну ділянку легкого ланцюга (VL) з SEQ ID NO: 7 (VH) і варіабельну ділянку важкого ланцюга з SEQ ID NO: 4.
UAA201311856A 2011-03-09 2011-09-30 Неводні концентровані суспензійні композиції зі зниженою в'язкістю на основі антитіл UA114289C2 (uk)

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 (1)

Publication Number Publication Date
UA114289C2 true UA114289C2 (uk) 2017-05-25

Family

ID=46798862

Family Applications (1)

Application Number Title Priority Date Filing Date
UAA201311856A UA114289C2 (uk) 2011-03-09 2011-09-30 Неводні концентровані суспензійні композиції зі зниженою в'язкістю на основі антитіл

Country Status (16)

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

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Also Published As

Publication number Publication date
BR112013023006A2 (pt) 2016-12-06
JP5881748B2 (ja) 2016-03-09
AU2011361700A1 (en) 2013-09-19
ZA201307513B (en) 2018-12-19
KR20140145942A (ko) 2014-12-24
MX2013010335A (es) 2013-10-03
ES2743687T3 (es) 2020-02-20
MX351659B (es) 2017-10-23
CA2829367A1 (en) 2012-09-13
CN103402540A (zh) 2013-11-20
EA201391298A1 (ru) 2014-02-28
EP2683403A4 (en) 2014-10-08
EP2683403A1 (en) 2014-01-15
KR101949707B1 (ko) 2019-02-19
WO2012121754A1 (en) 2012-09-13
US20110223208A1 (en) 2011-09-15
EP2683403B1 (en) 2019-06-19
BR112013023006A8 (pt) 2017-12-19
AU2011361700B2 (en) 2017-06-22
IL228211B (en) 2018-04-30
ZA201600811B (en) 2016-11-30
SG193278A1 (en) 2013-10-30
JP2014510077A (ja) 2014-04-24

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