PL3148510T3 - Ciekła kompozycja farmaceutyczna - Google Patents

Ciekła kompozycja farmaceutyczna

Info

Publication number
PL3148510T3
PL3148510T3 PL15724974T PL15724974T PL3148510T3 PL 3148510 T3 PL3148510 T3 PL 3148510T3 PL 15724974 T PL15724974 T PL 15724974T PL 15724974 T PL15724974 T PL 15724974T PL 3148510 T3 PL3148510 T3 PL 3148510T3
Authority
PL
Poland
Prior art keywords
pharmaceutical composition
liquid pharmaceutical
liquid
composition
pharmaceutical
Prior art date
Application number
PL15724974T
Other languages
English (en)
Polish (pl)
Inventor
Gianluca Rinaldi
Silvia Fratarcangeli
Alessandra Del Rio
Original Assignee
Fresenius Kabi Deutschland Gmbh
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=50774705&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PL3148510(T3) "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 filed Critical Fresenius Kabi Deutschland Gmbh
Publication of PL3148510T3 publication Critical patent/PL3148510T3/pl

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
    • 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
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/14—Decongestants or antiallergics
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Transplantation (AREA)
  • Hematology (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Ophthalmology & Optometry (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
PL15724974T 2014-05-23 2015-05-15 Ciekła kompozycja farmaceutyczna PL3148510T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14169754.0A EP2946766B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition
PCT/EP2015/060817 WO2015177058A1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition
EP15724974.9A EP3148510B1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition

Publications (1)

Publication Number Publication Date
PL3148510T3 true PL3148510T3 (pl) 2018-11-30

Family

ID=50774705

Family Applications (1)

Application Number Title Priority Date Filing Date
PL15724974T PL3148510T3 (pl) 2014-05-23 2015-05-15 Ciekła kompozycja farmaceutyczna

Country Status (21)

Country Link
US (5) US10493152B2 (enExample)
EP (6) EP2946766B1 (enExample)
JP (3) JP2017516847A (enExample)
CN (2) CN108785670A (enExample)
AU (4) AU2015263246B2 (enExample)
CA (2) CA3050875A1 (enExample)
CY (1) CY1120488T1 (enExample)
DE (2) DE25179059T1 (enExample)
DK (3) DK3148510T3 (enExample)
ES (5) ES2572919T3 (enExample)
HK (1) HK1257026A1 (enExample)
HR (1) HRP20181226T1 (enExample)
HU (1) HUE040097T2 (enExample)
IL (1) IL249117B2 (enExample)
LT (1) LT3148510T (enExample)
PL (1) PL3148510T3 (enExample)
PT (1) PT3148510T (enExample)
RS (1) RS57772B1 (enExample)
SI (1) SI3148510T1 (enExample)
SM (1) SMT201800413T1 (enExample)
WO (1) WO2015177058A1 (enExample)

Families Citing this family (12)

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EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
PL2946765T3 (pl) 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
EP3824906A1 (en) 2016-12-21 2021-05-26 Amgen Inc. Anti-tnf alpha antibody formulations
EP3459527B1 (en) * 2017-09-20 2022-11-23 Tillotts Pharma Ag Method for preparing a solid dosage form comprising antibodies by wet granulation, extrusion and spheronization
RU2020131642A (ru) * 2018-03-29 2022-04-29 Эйрвэй Терапьютикс, Инк. Способы и композиции, содержащие сурфактантный белок d (sp-d)
MX2020010031A (es) 2018-03-29 2021-01-08 Airway Therapeutics Inc Sistemas y metodos para caracterizar oligomeros de proteina surfactante d (sp-d).
WO2020138517A1 (ko) * 2018-12-24 2020-07-02 삼성바이오에피스 주식회사 항-TNFα 항체를 포함하는 약제학적 조성물
AU2020207124A1 (en) * 2019-01-11 2021-07-29 Samsung Bioepis Co., Ltd. Pharmaceutical composition comprising antibody, device comprising same, and use thereof
CN113727730A (zh) * 2019-03-18 2021-11-30 阿尔沃科技Hf公司 高浓度TNFα抗体的含水制剂
CN115429751B (zh) * 2022-09-21 2023-11-17 景泽生物医药(合肥)股份有限公司 一种人重组卵泡刺激素注射剂及其制备方法
WO2025038671A2 (en) * 2023-08-15 2025-02-20 Amgen Inc. Acidic buffered intravenous solution stabilizers for use in methods of treatment

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ATE239041T1 (de) 1996-02-09 2003-05-15 Basf Ag Humane antikörper welche an humanen tnfalpha binden
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
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KR20110097772A (ko) 2008-11-17 2011-08-31 제넨테크, 인크. 생리적 조건하에 거대분자의 응집을 감소시키는 방법 및 제제
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CA2944330A1 (en) 2014-04-02 2015-10-08 Intas Pharmaceuticals Limited Liquid pharmaceutical composition of adalimumab
EP2946766B1 (en) * 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
EP2946767B1 (en) 2014-05-23 2016-10-05 Ares Trading S.A. Liquid pharmaceutical composition
PL2946765T3 (pl) 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
EP3411401A1 (en) * 2016-02-03 2018-12-12 Oncobiologics, Inc. Buffer formulations for enhanced antibody stability
US10980881B2 (en) 2017-01-11 2021-04-20 Celltrion Inc. Stable liquid formula having an anti-TNFalpha antibody, acetate buffer and glycine
US20230115267A1 (en) 2020-03-13 2023-04-13 Samsung Bioepis Co., Ltd. Pharmaceutical liquid composition having increased stability

Also Published As

Publication number Publication date
ES3053508T2 (en) 2026-01-22
EP4249060A3 (en) 2024-01-03
CA2947487A1 (en) 2015-11-26
US12109267B2 (en) 2024-10-08
EP3659582B1 (en) 2023-08-16
AU2015263246A1 (en) 2016-11-17
EP2946766B1 (en) 2016-03-02
EP3403646A1 (en) 2018-11-21
US11752208B2 (en) 2023-09-12
PT3148510T (pt) 2018-09-28
DK3148510T3 (en) 2018-07-16
CN108785670A (zh) 2018-11-13
AU2022203863A1 (en) 2022-06-23
EP3148510B1 (en) 2018-06-27
SI3148510T1 (sl) 2018-10-30
DE23189888T1 (de) 2024-03-21
DK201800070Y4 (da) 2018-12-13
EP4585614A3 (en) 2025-10-29
AU2020201090B2 (en) 2022-03-10
US20230338527A1 (en) 2023-10-26
ES2928738T3 (es) 2022-11-22
LT3148510T (lt) 2018-10-10
CY1120488T1 (el) 2019-07-10
US11752209B2 (en) 2023-09-12
IL249117B1 (en) 2024-07-01
AU2020201090A1 (en) 2020-03-05
CA2947487C (en) 2019-09-24
IL249117A0 (en) 2017-01-31
CN106659781A (zh) 2017-05-10
CA3050875A1 (en) 2015-11-26
AU2018222887A1 (en) 2018-09-13
DK201800070U1 (da) 2018-09-18
ES2572919T3 (es) 2016-06-03
HUE040097T2 (hu) 2019-02-28
IL249117B2 (en) 2024-11-01
DE25179059T1 (de) 2025-08-28
EP3148510A1 (en) 2017-04-05
US10772961B2 (en) 2020-09-15
US20230061801A1 (en) 2023-03-02
DK201800070Y8 (da) 2019-07-09
ES2955316T3 (es) 2023-11-30
RS57772B1 (sr) 2018-12-31
EP4585614A2 (en) 2025-07-16
EP3659582A1 (en) 2020-06-03
JP2020033361A (ja) 2020-03-05
DK201800071Y4 (da) 2018-12-13
DK201800071U1 (da) 2018-12-05
EP4249060A2 (en) 2023-09-27
JP2022003091A (ja) 2022-01-11
AU2015263246B2 (en) 2018-06-21
JP6962984B2 (ja) 2021-11-05
US10493152B2 (en) 2019-12-03
US20200085948A1 (en) 2020-03-19
SMT201800413T1 (it) 2018-11-09
JP2017516847A (ja) 2017-06-22
ES2683194T3 (es) 2018-09-25
AU2018222887B2 (en) 2020-02-27
EP3403646B1 (en) 2022-09-28
HK1257026A1 (zh) 2019-10-11
US20210023215A1 (en) 2021-01-28
US20170189527A1 (en) 2017-07-06
HRP20181226T1 (hr) 2018-10-19
EP2946766A1 (en) 2015-11-25
WO2015177058A1 (en) 2015-11-26

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