CN106535935A - 液体药物组合物 - Google Patents

液体药物组合物 Download PDF

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Publication number
CN106535935A
CN106535935A CN201580039972.4A CN201580039972A CN106535935A CN 106535935 A CN106535935 A CN 106535935A CN 201580039972 A CN201580039972 A CN 201580039972A CN 106535935 A CN106535935 A CN 106535935A
Authority
CN
China
Prior art keywords
suitably
adalimumab
liquid pharmaceutical
composition
pharmaceutical composition
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
CN201580039972.4A
Other languages
English (en)
Chinese (zh)
Inventor
G·里纳尔迪
S·弗拉塔坎杰里
里奥 A·德尔
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Ares Trading SA
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=CN106535935(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ares Trading SA filed Critical Ares Trading SA
Priority to CN202010856565.5A priority Critical patent/CN111939257A/zh
Publication of CN106535935A publication Critical patent/CN106535935A/zh
Pending legal-status Critical Current

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)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Genetics & Genomics (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Hydrogenated Pyridines (AREA)
CN201580039972.4A 2014-05-23 2015-05-15 液体药物组合物 Pending CN106535935A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202010856565.5A CN111939257A (zh) 2014-05-23 2015-05-15 液体药物组合物

Applications Claiming Priority (3)

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN202010856565.5A Division CN111939257A (zh) 2014-05-23 2015-05-15 液体药物组合物

Publications (1)

Publication Number Publication Date
CN106535935A true CN106535935A (zh) 2017-03-22

Family

ID=50774706

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201580039972.4A Pending CN106535935A (zh) 2014-05-23 2015-05-15 液体药物组合物
CN202010856565.5A Pending CN111939257A (zh) 2014-05-23 2015-05-15 液体药物组合物

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN202010856565.5A Pending CN111939257A (zh) 2014-05-23 2015-05-15 液体药物组合物

Country Status (19)

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

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110831621A (zh) * 2017-04-18 2020-02-21 雷迪博士实验室有限公司 稳定的液体药物组合物
CN117257936A (zh) * 2023-10-30 2023-12-22 海正生物制药有限公司 一种阿达木单抗组合物
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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ES2572919T3 (es) 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
PT2946765T (pt) 2014-05-23 2016-11-10 Ares Trading Sa Composição farmacêutica líquida
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
WO2017177160A1 (en) 2016-04-07 2017-10-12 Nevakar Llc Formulation for use in a method of treatment of pain
WO2018119142A1 (en) 2016-12-21 2018-06-28 Amgen Inc. Anti-tnf alpha antibody formulations
WO2019070641A1 (en) * 2017-10-03 2019-04-11 Nevakar Inc. COMBINATIONS OF ACETAMINOPHENE-PRÉGABALINE AND METHODS OF TREATING PAIN
MX2017016884A (es) * 2017-12-19 2019-06-20 Probiomed S A De C V Formulacion farmaceutica estable de una proteina anti-tnfa.
WO2020023310A1 (en) * 2018-07-20 2020-01-30 Williams Eva Compositions of fcrn antibodies and methods of use thereof
CN113518783A (zh) 2018-07-20 2021-10-19 动量制药公司 FcRn抗体组合物
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
EP4598575A1 (en) * 2022-10-07 2025-08-13 Annexon, Inc. Formulations for anti-c1q antibodies

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WO2013164837A1 (en) * 2012-03-07 2013-11-07 Cadila Healthcare Limited Pharmaceutical formulations of tnf-alpha antibodies

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Publication number Priority date Publication date Assignee Title
WO2009073569A2 (en) * 2007-11-30 2009-06-11 Abbott Laboratories Protein formulations and methods of making same
WO2013164837A1 (en) * 2012-03-07 2013-11-07 Cadila Healthcare Limited Pharmaceutical formulations of tnf-alpha antibodies

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110831621A (zh) * 2017-04-18 2020-02-21 雷迪博士实验室有限公司 稳定的液体药物组合物
CN117257936A (zh) * 2023-10-30 2023-12-22 海正生物制药有限公司 一种阿达木单抗组合物
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

Also Published As

Publication number Publication date
DK3145488T3 (da) 2020-08-10
CN111939257A (zh) 2020-11-17
SI3145488T1 (sl) 2020-10-30
EP2946767A1 (en) 2015-11-25
AU2020204269A1 (en) 2020-07-16
JP2022174082A (ja) 2022-11-22
CY1124493T1 (el) 2022-03-24
HK1231391A1 (zh) 2017-12-22
RS60801B1 (sr) 2020-10-30
IL277241A (en) 2020-10-29
SMT202000479T1 (it) 2020-11-10
DK202000038Y3 (da) 2020-07-10
EP2946767B1 (en) 2016-10-05
ES2607489T3 (es) 2017-03-31
JP2021107399A (ja) 2021-07-29
DK202000038U1 (da) 2020-05-18
EP3939566A1 (en) 2022-01-19
PT3145488T (pt) 2020-09-01
EP3145488B1 (en) 2020-07-22
JP2017516848A (ja) 2017-06-22
AU2020204269B2 (en) 2020-09-17
LT3145488T (lt) 2020-11-25
IL249116B (en) 2020-09-30
EP3741358A1 (en) 2020-11-25
AU2020286276A1 (en) 2021-01-14
US20200155677A1 (en) 2020-05-21
DK202000030U1 (da) 2020-04-28
HUE050779T2 (hu) 2021-01-28
CA2948746A1 (en) 2015-11-26
ES2815598T3 (es) 2021-03-30
US10426833B2 (en) 2019-10-01
AU2020286276B2 (en) 2023-06-01
EP3145488A1 (en) 2017-03-29
WO2015177059A1 (en) 2015-11-26
IL249116A0 (en) 2017-01-31
HRP20201242T1 (hr) 2020-11-13
AU2015263247A1 (en) 2016-12-01
CA2948746C (en) 2021-01-12
IL277241B (en) 2022-08-01
CA3104940A1 (en) 2015-11-26
DK202000030Y3 (da) 2020-05-26
US20170182162A1 (en) 2017-06-29

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