AR123477A1 - Formulaciones de anticuerpos terapéuticos - Google Patents

Formulaciones de anticuerpos terapéuticos

Info

Publication number
AR123477A1
AR123477A1 ARP210102512A ARP210102512A AR123477A1 AR 123477 A1 AR123477 A1 AR 123477A1 AR P210102512 A ARP210102512 A AR P210102512A AR P210102512 A ARP210102512 A AR P210102512A AR 123477 A1 AR123477 A1 AR 123477A1
Authority
AR
Argentina
Prior art keywords
therapeutic antibody
antibody formulations
lcvr
hcvr
seq
Prior art date
Application number
ARP210102512A
Other languages
English (en)
Inventor
Aaron Paul Markham
Galen Huaiqiu Shi
Justin Cody Thomas
Original Assignee
Lilly Co Eli
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 Lilly Co Eli filed Critical Lilly Co Eli
Publication of AR123477A1 publication Critical patent/AR123477A1/es

Links

Classifications

    • 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
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • 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
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pain & Pain Management (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Formulaciones farmacéuticas estables para anticuerpos terapéuticos anti-IL-23p19 y métodos para usar tales formulaciones farmacéuticas estables. Reivindicación 1: Una formulación farmacéutica que comprende: (i) 50 mg/mL - 150 mg/mL de un anticuerpo contra IL-23p19; (ii) 8 mM - 12 mM de un amortiguador de citrato; (iii) 100 - 200 mM de cloruro de sodio (NaCl); y (iv) de 0,01% p/v a 0,05% p/v de un tensioactivo, en donde el pH de la formulación está entre 5,0 y 6,0, y en donde el anticuerpo anti-IL-23p19 comprende una región variable de cadena ligera (LCVR) y una región variable de cadena pesada (HCVR), la secuencia de aminoácidos del LCVR es SEQ ID Nº 8 y la secuencia de aminoácidos del HCVR es SEQ ID Nº 7.
ARP210102512A 2020-09-10 2021-09-09 Formulaciones de anticuerpos terapéuticos AR123477A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US202063076600P 2020-09-10 2020-09-10

Publications (1)

Publication Number Publication Date
AR123477A1 true AR123477A1 (es) 2022-12-07

Family

ID=78232370

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP210102512A AR123477A1 (es) 2020-09-10 2021-09-09 Formulaciones de anticuerpos terapéuticos

Country Status (19)

Country Link
US (1) US20230322913A1 (es)
EP (1) EP4210749A1 (es)
JP (1) JP2023541249A (es)
KR (1) KR20230066592A (es)
CN (1) CN116437963A (es)
AR (1) AR123477A1 (es)
AU (1) AU2021339759A1 (es)
BR (1) BR112023002984A2 (es)
CA (1) CA3191114A1 (es)
CL (1) CL2023000667A1 (es)
CO (1) CO2023002864A2 (es)
CR (1) CR20230122A (es)
DO (1) DOP2023000048A (es)
EC (1) ECSP23017107A (es)
IL (1) IL301104A (es)
MX (1) MX2023002889A (es)
PE (1) PE20231191A1 (es)
TW (2) TW202224702A (es)
WO (1) WO2022056202A1 (es)

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100531813C (zh) 2003-08-12 2009-08-26 伊莱利利公司 具有实现机械利益的三头螺纹的药物分配装置
BRPI0509269B8 (pt) 2004-03-30 2021-06-22 Lilly Co Eli aparelho de dispensação de medicamento
EP1971366B1 (en) 2005-12-29 2014-07-30 Janssen Biotech, Inc. Human anti-il-23 antibodies, compositions, methods and uses
SI2426144T1 (sl) 2007-02-23 2019-02-28 Merck Sharp & Dohme Corp. Umetno proizvedena anti-IL23P19 antitelesa
JO3244B1 (ar) 2009-10-26 2018-03-08 Amgen Inc بروتينات ربط مستضادات il – 23 البشرية
ES2484266T3 (es) 2010-03-01 2014-08-11 Eli Lilly And Company Dispositivo de inyección automático con mecanismo de retardo incluyendo un elemento de empuje de función doble
EP3456740A1 (en) 2010-11-04 2019-03-20 Boehringer Ingelheim International GmbH Anti-il-23 antibodies
CN104302350B (zh) 2012-03-07 2018-09-07 德卡产品有限公司 输液泵组件
AR094877A1 (es) * 2013-03-08 2015-09-02 Lilly Co Eli Anticuerpos que se unen a il-23
AR102417A1 (es) * 2014-11-05 2017-03-01 Lilly Co Eli Anticuerpos biespecíficos anti-tnf- / anti-il-23
AR112341A1 (es) * 2017-08-02 2019-10-16 Lilly Co Eli ANTICUERPOS BIESPECÍFICOS ANTI-TNF- / ANTI-IL-23 DE IgG
EP3810268A1 (en) * 2018-06-20 2021-04-28 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an il-12/il-23 inhibitor
TWI725532B (zh) * 2018-09-11 2021-04-21 美商美國禮來大藥廠 治療牛皮癬之方法

Also Published As

Publication number Publication date
CL2023000667A1 (es) 2023-09-15
TW202224702A (zh) 2022-07-01
CN116437963A (zh) 2023-07-14
EP4210749A1 (en) 2023-07-19
CR20230122A (es) 2023-04-14
TW202428304A (zh) 2024-07-16
JP2023541249A (ja) 2023-09-29
WO2022056202A1 (en) 2022-03-17
AU2021339759A1 (en) 2023-03-16
MX2023002889A (es) 2023-04-18
IL301104A (en) 2023-05-01
BR112023002984A2 (pt) 2023-04-04
US20230322913A1 (en) 2023-10-12
KR20230066592A (ko) 2023-05-16
ECSP23017107A (es) 2023-04-28
DOP2023000048A (es) 2023-04-30
PE20231191A1 (es) 2023-08-15
CO2023002864A2 (es) 2023-03-27
CA3191114A1 (en) 2022-03-17

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