CY1123657T1 - Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1 - Google Patents

Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1

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Publication number
CY1123657T1
CY1123657T1 CY20201100860T CY201100860T CY1123657T1 CY 1123657 T1 CY1123657 T1 CY 1123657T1 CY 20201100860 T CY20201100860 T CY 20201100860T CY 201100860 T CY201100860 T CY 201100860T CY 1123657 T1 CY1123657 T1 CY 1123657T1
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CY
Cyprus
Prior art keywords
antibody
formulation
relates
certain embodiments
stable
Prior art date
Application number
CY20201100860T
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English (en)
Inventor
Roberto Depaz
Natalie DEJESUS
Jared BEE
Original Assignee
Astrazeneca Ab
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=58052002&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CY1123657(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Astrazeneca Ab filed Critical Astrazeneca Ab
Publication of CY1123657T1 publication Critical patent/CY1123657T1/el

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [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 cytokines, lymphokines, interferons
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
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    • A61P1/14Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
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    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P37/02Immunomodulators
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    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00Preparation of peptides or proteins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/524CH2 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL

Abstract

Η παρούσα εφεύρεση αναφέρεται σε μια σταθερή, χαμηλού ιξώδους φαρμακοτεχνική μορφή αντισώματος, όπου η φαρμακοτεχνική μορφή περιλαμβάνει υψηλή συγκέντρωση ενός αντισώματος αντι-INFAR1. Σε ορισμένες υλοποιήσεις, η εφεύρεση αναφέρεται γενικά σε μια σταθερή φαρμακοτεχνική μορφή αντισώματος που περιλαμβάνει περίπου 100 mg/mL έως περίπου 200 mg/mL αντισώματος ή θραύσματος αυτού που δεσμεύει ειδικά την ανθρώπινη ιντερφερόνη άλφα 1 (INFAR1)• περίπου 20 mM έως περίπου 80 mM λυσίνης ή άλατος αυτής• περίπου 0.02% έως περίπου 0.06% επιφανειοδραστικού μέσου• μη φορτισμένο έκδοχο• και ρυθμιστικό διάλυμα φαρμακοτεχνική ς μορφής. Σε ορισμένες υλοποιήσεις, η εφεύρεση αναφέρεται σε έναν περιέκτη, δοσολογική μορφή ή/και κιτ. Σε ορισμένες υλοποιήσεις, η εφεύρεση αναφέρεται σε μια μέθοδο παρασκευής και χρήσης της σταθερής φαρμακοτεχνικής μορφής αντισώματος.
CY20201100860T 2015-08-19 2020-09-11 Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1 CY1123657T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562207164P 2015-08-19 2015-08-19
PCT/US2016/047506 WO2017031288A1 (en) 2015-08-19 2016-08-18 Stable anti-ifnar1 formulation

Publications (1)

Publication Number Publication Date
CY1123657T1 true CY1123657T1 (el) 2022-03-24

Family

ID=58052002

Family Applications (2)

Application Number Title Priority Date Filing Date
CY20201100860T CY1123657T1 (el) 2015-08-19 2020-09-11 Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1
CY20231100289T CY1126062T1 (el) 2015-08-19 2023-06-20 Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1

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CY20231100289T CY1126062T1 (el) 2015-08-19 2023-06-20 Σταθερη φαρμακοτεχνικη μορφη anti-ifnar1

Country Status (24)

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US (1) US10125195B2 (el)
EP (3) EP3337502B1 (el)
JP (3) JP6720293B2 (el)
KR (3) KR20200119916A (el)
CN (1) CN107921109A (el)
AU (3) AU2016308262C1 (el)
BR (1) BR112018002196A8 (el)
CA (1) CA2995222C (el)
CY (2) CY1123657T1 (el)
DK (2) DK3337502T3 (el)
ES (2) ES2818229T3 (el)
FI (1) FI3769781T3 (el)
HK (1) HK1256195A1 (el)
HR (2) HRP20230463T1 (el)
HU (2) HUE061985T2 (el)
IL (1) IL257279B2 (el)
LT (2) LT3769781T (el)
PL (2) PL3769781T3 (el)
PT (2) PT3337502T (el)
RS (2) RS64263B1 (el)
RU (1) RU2731737C2 (el)
SG (1) SG10202106970XA (el)
SI (2) SI3337502T1 (el)
WO (1) WO2017031288A1 (el)

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LT3337502T (lt) 2020-09-25
SI3769781T1 (sl) 2023-06-30
CA2995222A1 (en) 2017-02-23
SG10202106970XA (en) 2021-07-29
HUE061985T2 (hu) 2023-09-28
PT3337502T (pt) 2020-09-23
HRP20230463T1 (hr) 2023-07-21
KR102168005B1 (ko) 2020-10-21
AU2021257915A1 (en) 2021-11-18
JP7035119B2 (ja) 2022-03-14
ES2818229T3 (es) 2021-04-09
JP6720293B2 (ja) 2020-07-08
EP3337502A1 (en) 2018-06-27
JP2022066345A (ja) 2022-04-28
CY1126062T1 (el) 2023-11-15
US10125195B2 (en) 2018-11-13
KR20180041173A (ko) 2018-04-23
US20170051066A1 (en) 2017-02-23
PT3769781T (pt) 2023-06-19
CN107921109A (zh) 2018-04-17
RU2731737C2 (ru) 2020-09-08
PL3769781T3 (pl) 2023-07-17
RS64263B1 (sr) 2023-07-31
HUE051862T2 (hu) 2021-03-29
AU2020203306B2 (en) 2021-09-09
JP2020158527A (ja) 2020-10-01
SI3337502T1 (sl) 2020-10-30
LT3769781T (lt) 2023-06-12
AU2016308262C1 (en) 2022-04-21
RS60773B1 (sr) 2020-10-30
KR20200119916A (ko) 2020-10-20
BR112018002196A8 (pt) 2021-05-04
JP2018523676A (ja) 2018-08-23
AU2020203306C1 (en) 2022-03-31
AU2016308262B2 (en) 2020-04-30
ES2947488T3 (es) 2023-08-10
PL3337502T3 (pl) 2021-01-11
WO2017031288A1 (en) 2017-02-23
EP3337502A4 (en) 2019-01-23
KR20220127378A (ko) 2022-09-19
RU2018107725A (ru) 2019-09-19
DK3769781T3 (da) 2023-06-19
AU2020203306A1 (en) 2020-06-11
EP3769781A1 (en) 2021-01-27
EP4233892A2 (en) 2023-08-30
IL257279B2 (en) 2023-04-01
HK1256195A1 (zh) 2019-09-13
EP3337502B1 (en) 2020-06-24
BR112018002196A2 (pt) 2019-04-30
RU2018107725A3 (el) 2019-10-02
AU2016308262A1 (en) 2018-03-08
CA2995222C (en) 2021-07-13
FI3769781T3 (fi) 2023-06-07
EP3769781B1 (en) 2023-04-19
IL257279A (en) 2018-03-29
DK3337502T3 (da) 2020-09-14
HRP20201297T1 (hr) 2020-11-27
IL257279B (en) 2022-12-01
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