IL277241B - Liquid pharmaceutical composition - Google Patents

Liquid pharmaceutical composition

Info

Publication number
IL277241B
IL277241B IL277241A IL27724120A IL277241B IL 277241 B IL277241 B IL 277241B IL 277241 A IL277241 A IL 277241A IL 27724120 A IL27724120 A IL 27724120A IL 277241 B IL277241 B IL 277241B
Authority
IL
Israel
Prior art keywords
pharmaceutical composition
suitably
adalimumab
composition
liquid pharmaceutical
Prior art date
Application number
IL277241A
Other languages
English (en)
Hebrew (he)
Other versions
IL277241A (en
Inventor
Gianluca Rinaldi
Silvia Fratarcangeli
Rio Alessandra Del
Original Assignee
Fresenius Kabi Deutschland Gmbh
Gianluca Rinaldi
Silvia Fratarcangeli
Rio Alessandra Del
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50774706&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=IL277241(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Fresenius Kabi Deutschland Gmbh, Gianluca Rinaldi, Silvia Fratarcangeli, Rio Alessandra Del filed Critical Fresenius Kabi Deutschland Gmbh
Publication of IL277241A publication Critical patent/IL277241A/en
Publication of IL277241B publication Critical patent/IL277241B/en

Links

Classifications

    • 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
    • A61K47/06Organic 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
    • A61K47/26Carbohydrates, 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
    • 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
    • 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
    • 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
    • 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
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • 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
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Hydrogenated Pyridines (AREA)
IL277241A 2014-05-23 2015-05-15 Liquid pharmaceutical composition IL277241B (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14169755.7A EP2946767B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition
PCT/EP2015/060818 WO2015177059A1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition

Publications (2)

Publication Number Publication Date
IL277241A IL277241A (en) 2020-10-29
IL277241B true IL277241B (en) 2022-08-01

Family

ID=50774706

Family Applications (2)

Application Number Title Priority Date Filing Date
IL277241A IL277241B (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition
IL249116A IL249116B (en) 2014-05-23 2016-11-22 A liquid pharmaceutical preparation

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL249116A IL249116B (en) 2014-05-23 2016-11-22 A liquid pharmaceutical preparation

Country Status (19)

Country Link
US (2) US10426833B2 (enExample)
EP (4) EP2946767B1 (enExample)
JP (3) JP2017516848A (enExample)
CN (2) CN106535935A (enExample)
AU (3) AU2015263247A1 (enExample)
CA (2) CA3104940A1 (enExample)
CY (1) CY1124493T1 (enExample)
DK (3) DK3145488T3 (enExample)
ES (2) ES2607489T3 (enExample)
HK (1) HK1231391A1 (enExample)
HR (1) HRP20201242T1 (enExample)
HU (1) HUE050779T2 (enExample)
IL (2) IL277241B (enExample)
LT (1) LT3145488T (enExample)
PT (1) PT3145488T (enExample)
RS (1) RS60801B1 (enExample)
SI (1) SI3145488T1 (enExample)
SM (1) SMT202000479T1 (enExample)
WO (1) WO2015177059A1 (enExample)

Families Citing this family (13)

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ES2572919T3 (es) 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
PL2946765T3 (pl) * 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
CN105543204A (zh) * 2015-12-30 2016-05-04 海口奇力制药股份有限公司 一种组合物及其应用、含有该组合物的稳定剂
US10052296B2 (en) 2016-04-07 2018-08-21 Nevakar Inc. Formulations for treating pain
US20200087390A1 (en) 2016-12-21 2020-03-19 Amgen Inc. Anti-tnf alpha antibody formulations
US11639391B2 (en) * 2017-04-18 2023-05-02 Dr. Reddy's Laboratories Limited Stable liquid pharmaceutical composition
JP7249670B2 (ja) * 2017-10-03 2023-03-31 ネヴァカー インジェクテーブルズ インコーポレイテッド アセトアミノフェン-プレガバリン組み合わせ及び疼痛を処置する方法
MX2017016884A (es) * 2017-12-19 2019-06-20 Probiomed S A De C V Formulacion farmaceutica estable de una proteina anti-tnfa.
UA130214C2 (uk) 2018-07-20 2025-12-24 Момента Фармасьютикалз, Інк. Фармацевтична композиція антитіл проти fcrn
US20210299255A1 (en) * 2018-07-20 2021-09-30 Momenta Pharmaceuticals, Inc. Compositions of fcrn antibodies and methods of use thereof
CN113134081A (zh) * 2020-01-20 2021-07-20 上海君实生物医药科技股份有限公司 抗btla抗体药物组合物及其用途
CN119907685A (zh) * 2022-10-07 2025-04-29 安尼艾克松股份有限公司 用于抗c1q抗体的制剂
CN117257936B (zh) * 2023-10-30 2026-05-01 杭州博之锐生物制药有限公司 一种阿达木单抗组合物

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US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
AU2004229335C1 (en) 2003-04-04 2010-06-17 Genentech, Inc. High concentration antibody and protein formulations
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ES2572919T3 (es) * 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
PL2946765T3 (pl) * 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna

Also Published As

Publication number Publication date
HRP20201242T1 (hr) 2020-11-13
EP3741358A1 (en) 2020-11-25
HK1231391A1 (zh) 2017-12-22
AU2020286276A1 (en) 2021-01-14
WO2015177059A1 (en) 2015-11-26
DK202000038U1 (da) 2020-05-18
LT3145488T (lt) 2020-11-25
US20170182162A1 (en) 2017-06-29
EP3939566A1 (en) 2022-01-19
AU2020286276B2 (en) 2023-06-01
DK202000038Y3 (da) 2020-07-10
RS60801B1 (sr) 2020-10-30
EP2946767A1 (en) 2015-11-25
ES2607489T3 (es) 2017-03-31
AU2020204269B2 (en) 2020-09-17
US10426833B2 (en) 2019-10-01
JP2022174082A (ja) 2022-11-22
SI3145488T1 (sl) 2020-10-30
IL249116A0 (en) 2017-01-31
IL277241A (en) 2020-10-29
DK202000030Y3 (da) 2020-05-26
DK202000030U1 (da) 2020-04-28
CA3104940A1 (en) 2015-11-26
CN111939257A (zh) 2020-11-17
HUE050779T2 (hu) 2021-01-28
SMT202000479T1 (it) 2020-11-10
AU2020204269A1 (en) 2020-07-16
EP3145488A1 (en) 2017-03-29
AU2015263247A1 (en) 2016-12-01
CA2948746A1 (en) 2015-11-26
EP3145488B1 (en) 2020-07-22
IL249116B (en) 2020-09-30
JP2017516848A (ja) 2017-06-22
CY1124493T1 (el) 2022-03-24
EP2946767B1 (en) 2016-10-05
CA2948746C (en) 2021-01-12
PT3145488T (pt) 2020-09-01
DK3145488T3 (da) 2020-08-10
US20200155677A1 (en) 2020-05-21
JP2021107399A (ja) 2021-07-29
ES2815598T3 (es) 2021-03-30
CN106535935A (zh) 2017-03-22

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