ES2964713T3 - Reducción de la viscosidad de formulaciones farmacéuticas - Google Patents

Reducción de la viscosidad de formulaciones farmacéuticas Download PDF

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Publication number
ES2964713T3
ES2964713T3 ES21175309T ES21175309T ES2964713T3 ES 2964713 T3 ES2964713 T3 ES 2964713T3 ES 21175309 T ES21175309 T ES 21175309T ES 21175309 T ES21175309 T ES 21175309T ES 2964713 T3 ES2964713 T3 ES 2964713T3
Authority
ES
Spain
Prior art keywords
acetyl
viscosity
excipient
antibody
protein
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.)
Active
Application number
ES21175309T
Other languages
English (en)
Spanish (es)
Inventor
Christopher James Sloey
Sekhar Kanapuram
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.)
Amgen Inc
Original Assignee
Amgen Inc
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=54427875&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2964713(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc filed Critical Amgen Inc
Application granted granted Critical
Publication of ES2964713T3 publication Critical patent/ES2964713T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • 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
    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
ES21175309T 2014-10-23 2015-10-22 Reducción de la viscosidad de formulaciones farmacéuticas Active ES2964713T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201462067637P 2014-10-23 2014-10-23

Publications (1)

Publication Number Publication Date
ES2964713T3 true ES2964713T3 (es) 2024-04-09

Family

ID=54427875

Family Applications (1)

Application Number Title Priority Date Filing Date
ES21175309T Active ES2964713T3 (es) 2014-10-23 2015-10-22 Reducción de la viscosidad de formulaciones farmacéuticas

Country Status (17)

Country Link
US (3) US11813328B2 (enExample)
EP (2) EP3909611B1 (enExample)
JP (3) JP2017531682A (enExample)
KR (1) KR102534017B1 (enExample)
CN (2) CN114569716A (enExample)
AU (2) AU2015335743B2 (enExample)
BR (1) BR112017008125B1 (enExample)
CA (1) CA2964786C (enExample)
CL (2) CL2017000984A1 (enExample)
EA (3) EA202191513A1 (enExample)
ES (1) ES2964713T3 (enExample)
IL (2) IL287947B2 (enExample)
MA (1) MA54716A (enExample)
MX (2) MX388858B (enExample)
SG (1) SG11201703152RA (enExample)
WO (1) WO2016065181A1 (enExample)
ZA (1) ZA201702762B (enExample)

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JP2017531682A (ja) 2014-10-23 2017-10-26 アムジエン・インコーポレーテツド 医薬製剤の粘度低下
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JP7377596B2 (ja) 2017-02-22 2023-11-10 アムジエン・インコーポレーテツド 低粘度、高濃度エボロクマブ製剤及びそれらの製造方法
AU2018258676B2 (en) * 2017-04-28 2024-09-19 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
EP3615065A1 (en) 2017-04-28 2020-03-04 Amgen Inc. Excipients to reduce the viscosity of antibody formulations and formulation compositions
US10646569B2 (en) 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
PE20200678A1 (es) 2017-06-16 2020-06-11 Zealand Pharma As Posologias para la administracion de analogos de peptido de tipo glucagon-2 (glp-2)
EP3685849A4 (en) * 2017-09-22 2021-12-22 Asahi Kasei Pharma Corporation LIQUID PHARMACEUTICAL COMPOSITION CONTAINING TERIPARATIDE WITH EXCELLENT STABILITY
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AU2019297498A1 (en) 2018-07-05 2021-01-21 Bayer Aktiengesellschaft Method for the production of freeze-dried pellets comprising an anti-coagulation factor xia (FXIa) antibody
EP3774841A1 (en) 2018-08-27 2021-02-17 Regeneron Pharmaceuticals, Inc. Use of raman spectroscopy in downstream purification
EP3628683A1 (en) * 2018-09-28 2020-04-01 Zealand Pharma A/S Formulations of glucagon-like-peptide-2 (glp-2) analogues
JP7739182B2 (ja) * 2019-04-23 2025-09-16 アムジエン・インコーポレーテツド 高濃度タンパク質製剤の粘度を低減させるための低分子量ポリビニルピロリドン（ｐｖｐ）の使用
CA3166964A1 (en) * 2020-02-13 2021-08-19 Alexis Lueras Formulations of human anti-tslp antibodies and methods of treating inflammatory disease
KR102746418B1 (ko) * 2020-12-03 2024-12-26 동국대학교 산학협력단 N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물
MX2023010457A (es) * 2021-03-09 2023-09-14 Gi Innovation Inc Formulacion de proteina de fusion que incluye el dominio extracelular de la subunidad alfa del receptor fc de ige.
EP4319795A4 (en) * 2021-04-09 2025-03-05 Avantor Performance Materials, LLC Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations
WO2025175164A1 (en) * 2024-02-16 2025-08-21 Regeneron Pharmaceuticals, Inc. Methods of producing concentrated formulated drug substances comprising proteins, and concentrated formulated drug substance made by the methods

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Also Published As

Publication number Publication date
EA038462B1 (ru) 2021-08-31
WO2016065181A1 (en) 2016-04-28
KR20170071518A (ko) 2017-06-23
EP3209332A1 (en) 2017-08-30
IL251726B (en) 2021-12-01
CN107206070A (zh) 2017-09-26
EP3909611B1 (en) 2023-08-30
JP2020037559A (ja) 2020-03-12
AU2015335743A1 (en) 2017-05-04
CN114569716A (zh) 2022-06-03
JP6965321B2 (ja) 2021-11-10
AU2021200990B2 (en) 2023-02-16
BR112017008125A2 (pt) 2018-06-19
CL2017000984A1 (es) 2018-01-05
AU2015335743B2 (en) 2020-12-24
US11813328B2 (en) 2023-11-14
EP3209332B1 (en) 2021-05-26
JP7411615B2 (ja) 2024-01-11
IL251726A0 (en) 2017-06-29
US20240066124A1 (en) 2024-02-29
MA54716A (fr) 2021-11-17
IL287947A (en) 2022-01-01
KR102534017B1 (ko) 2023-05-19
EA033444B1 (ru) 2019-10-31
US12318447B2 (en) 2025-06-03
US20250345421A1 (en) 2025-11-13
CL2019002190A1 (es) 2019-11-22
BR112017008125B1 (pt) 2023-11-21
ZA201702762B (en) 2022-12-21
IL287947B2 (en) 2024-08-01
JP2017531682A (ja) 2017-10-26
IL287947B1 (en) 2024-04-01
SG11201703152RA (en) 2017-05-30
MX2017005243A (es) 2017-08-18
EA201991447A1 (ru) 2019-11-29
MX2021015789A (es) 2022-01-27
CA2964786A1 (en) 2016-04-28
EP3909611A1 (en) 2021-11-17
AU2021200990A1 (en) 2021-03-11
EA202191513A1 (ru) 2021-11-30
US20170333559A1 (en) 2017-11-23
JP2022009223A (ja) 2022-01-14
CN107206070B (zh) 2022-01-18
CA2964786C (en) 2023-10-17
EA201790787A1 (ru) 2017-08-31
MX388858B (es) 2025-03-20

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