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MX2018013215A - Composicion farmaceutica. - Google Patents

Composicion farmaceutica.

Info

Publication number
MX2018013215A
MX2018013215A MX2018013215A MX2018013215A MX2018013215A MX 2018013215 A MX2018013215 A MX 2018013215A MX 2018013215 A MX2018013215 A MX 2018013215A MX 2018013215 A MX2018013215 A MX 2018013215A MX 2018013215 A MX2018013215 A MX 2018013215A
Authority
MX
Mexico
Prior art keywords
freeze
pharmaceutical compositions
pharmaceutical composition
antibody
drying
Prior art date
Application number
MX2018013215A
Other languages
English (en)
Inventor
Jeffrey Yates Andrew
Ivo MASSANT Jan
Original Assignee
Ucb Biopharma Sprl
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=56320265&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2018013215(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ucb Biopharma Sprl filed Critical Ucb Biopharma Sprl
Publication of MX2018013215A publication Critical patent/MX2018013215A/es

Links

Classifications

    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39566—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against immunoglobulins, e.g. anti-idiotypic antibodies
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • 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
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oncology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

La presente invención se refiere a composiciones farmacéuticas que comprenden un anticuerpo o un fragmento del mismo, adecuadas para el secado por congelación (es decir liofilización). Las composiciones farmacéuticas, que comprenden un anticuerpo o un fragmento de unión al antígeno del mismo; de 1 % a 20 % p/v de sucrosa; un aminoácido o una mezcla de aminoácidos; y un agente tensioactivo, son provistas como composiciones farmacéuticas para el secado por congelación; como composiciones secadas por congelación (es decir liofilizadas) que se pueden reconstituir en un disolvente en el momento del uso o como formulaciones líquidas reconstituidas listas para su administración.
MX2018013215A 2016-05-12 2017-05-11 Composicion farmaceutica. MX2018013215A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1608323.0A GB201608323D0 (en) 2016-05-12 2016-05-12 Pharmaceutical compositions
PCT/EP2017/061261 WO2017194646A1 (en) 2016-05-12 2017-05-11 Pharmaceutical composition

Publications (1)

Publication Number Publication Date
MX2018013215A true MX2018013215A (es) 2019-02-21

Family

ID=56320265

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2018013215A MX2018013215A (es) 2016-05-12 2017-05-11 Composicion farmaceutica.

Country Status (18)

Country Link
US (1) US11407835B2 (es)
EP (1) EP3454899B1 (es)
JP (1) JP7126454B2 (es)
KR (1) KR102436694B1 (es)
CN (1) CN109069643A (es)
AR (1) AR108449A1 (es)
AU (1) AU2017264553A1 (es)
BR (1) BR112018072264A2 (es)
CA (1) CA3022124A1 (es)
CL (1) CL2018003178A1 (es)
CO (1) CO2018011733A2 (es)
EA (1) EA201892446A1 (es)
ES (1) ES2977545T3 (es)
GB (1) GB201608323D0 (es)
IL (1) IL262654A (es)
MX (1) MX2018013215A (es)
SG (1) SG11201809229VA (es)
WO (1) WO2017194646A1 (es)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10668053B2 (en) 2013-05-03 2020-06-02 Selecta Biosciences, Inc. Tolerogenic synthetic nanocarriers to reduce or prevent anaphylaxis in response to a non-allergenic antigen
TWI703158B (zh) 2015-09-18 2020-09-01 美商希佛隆公司 特異性結合tl1a之抗體
EP3558363A1 (en) 2016-12-21 2019-10-30 Amgen Inc. Anti-tnf alpha antibody formulations
HUE072005T2 (hu) 2017-03-11 2025-10-28 Cartesian Therapeutics Inc Gyulladásgátlókkal és immunszupresszánst tartalmazó szintetikus nanohordozókkal történõ kombinált kezeléssel összefüggõ eljárások és készítmények
GB201708655D0 (en) 2017-05-31 2017-07-12 Ucb Biopharma Sprl Cell culture methods
CN112004827A (zh) * 2018-03-23 2020-11-27 艾伯维德国有限责任两合公司 稳定的水性抗tau抗体调配物
PH12021551916A1 (en) 2019-02-18 2022-05-23 Lilly Co Eli Therapeutic antibody formulation.
CA3174988A1 (en) * 2020-03-11 2021-09-16 Selecta Biosciences, Inc. Methods and compositions related to synthetic nanocarriers
CA3184423A1 (en) * 2020-06-29 2022-01-06 Hanall Biopharma Co., Ltd. Formulation for anti-fcrn antibody
JP2024518536A (ja) * 2021-05-12 2024-05-01 アナプティスバイオ インコーポレイティッド 抗体組成物
PE20241936A1 (es) 2021-12-01 2024-09-24 UCB Biopharma SRL Formulaciones que comprenden fab-peg
WO2023224112A1 (ja) * 2022-05-20 2023-11-23 株式会社ダイセル 液状医薬組成物
CA3254741A1 (en) 2022-05-30 2023-12-07 Hanall Biopharma Co., Ltd. ANTI-FCRN ANTIBODY OR ANTIGEN-BINDING FRAGMENT OF FCRN EXHIBITING IMPROVED STABILITY
CN115708810A (zh) * 2022-11-03 2023-02-24 浙江新码生物医药有限公司 含有抗cd70-药物偶联物的冻干组合物、冻干制剂及其制备方法和用途
AU2024232611A1 (en) * 2023-03-08 2025-10-16 Immunovant Sciences Gmbh High concentration protein formulations with polysorbate excipients and methods of making the same
WO2025056011A1 (zh) * 2023-09-13 2025-03-20 正大天晴药业集团股份有限公司 包含抗pd-1抗体和第二抗体的药物组合物

Family Cites Families (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003009817A2 (en) * 2001-07-25 2003-02-06 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
CA2545603A1 (en) * 2003-11-12 2005-05-26 Biogen Idec Ma Inc. Neonatal fc receptor (fcrn)-binding polypeptide variants, dimeric fc binding proteins and methods related thereto
CN101124245A (zh) * 2003-11-12 2008-02-13 比奥根艾迪克Ma公司 新生儿Fc受体(FcRn)-结合多肽变体、二聚体Fc结合蛋白及其相关方法
US9283260B2 (en) 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
CN101489587B (zh) * 2006-05-12 2015-05-27 伯哈拉特生物技术国际有限公司 一种可用作疫苗的组合物
AR070316A1 (es) 2008-02-07 2010-03-31 Merck & Co Inc Antagonistas de pcsk9 (proproteina subtilisina-kexina tipo 9)
AR070315A1 (es) * 2008-02-07 2010-03-31 Merck & Co Inc Anticuerpos 1b20 antagonistas de pcsk9
KR20120027031A (ko) * 2009-06-18 2012-03-20 와이어쓰 엘엘씨 소형 모듈 면역제약용 동결건조 제제
US9072668B2 (en) 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
US8788028B2 (en) 2010-07-28 2014-07-22 Medtronic, Inc. Parasympathetic stimulation to enhance tachyarrhythmia detection
WO2012076670A2 (en) 2010-12-10 2012-06-14 Novartis Ag Antibody formulation
SI2691112T1 (en) * 2011-03-31 2018-07-31 Merck Sharp & Dohme Corp. STABILITY FORMULATION PROTITELES FOR HUMAN PROGRAMMED DEPRESSOR RECEPTOR PD-1 AND RELATED HEALTH
JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
EP4527855A3 (en) 2012-03-26 2025-06-11 Sanofi Stable igg4 based binding agent formulations
US9592289B2 (en) * 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
GB201208370D0 (en) 2012-05-14 2012-06-27 Ucb Pharma Sa Antibodies
US8613919B1 (en) 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
WO2014093206A1 (en) 2012-12-13 2014-06-19 Merck Sharp & Dohme Corp. Lyophilized spherical pellets of anti-il-23 antibodies
US20150225479A1 (en) 2014-02-12 2015-08-13 Sanofi Anti-IL-4/Anti-IL-13 Bispecific Antibody/Polyglutamate Formulations
MX2017004975A (es) 2014-10-18 2017-06-30 Pfizer Composiciones de anticuerpos anti-il-7r.
GB201508180D0 (en) 2015-05-13 2015-06-24 Ucb Biopharma Sprl Antibodies

Also Published As

Publication number Publication date
AR108449A1 (es) 2018-08-22
RU2018141591A (ru) 2020-06-15
RU2018141591A3 (es) 2021-01-13
EA201892446A1 (ru) 2019-04-30
BR112018072264A2 (pt) 2019-02-12
AU2017264553A1 (en) 2018-12-13
US11407835B2 (en) 2022-08-09
EP3454899C0 (en) 2024-03-20
IL262654A (en) 2018-12-31
CO2018011733A2 (es) 2019-02-08
JP7126454B2 (ja) 2022-08-26
KR102436694B1 (ko) 2022-08-25
GB201608323D0 (en) 2016-06-29
CA3022124A1 (en) 2017-11-16
SG11201809229VA (en) 2018-11-29
JP2019514998A (ja) 2019-06-06
ES2977545T3 (es) 2024-08-26
EP3454899A1 (en) 2019-03-20
KR20190008320A (ko) 2019-01-23
CL2018003178A1 (es) 2019-02-01
WO2017194646A1 (en) 2017-11-16
US20200048346A1 (en) 2020-02-13
EP3454899B1 (en) 2024-03-20
CN109069643A (zh) 2018-12-21

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