CA2964786C - Reducing the viscosity of pharmaceutical formulations with n-acetyl amino acids - Google Patents

Reducing the viscosity of pharmaceutical formulations with n-acetyl amino acids Download PDF

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Publication number
CA2964786C
CA2964786C CA2964786A CA2964786A CA2964786C CA 2964786 C CA2964786 C CA 2964786C CA 2964786 A CA2964786 A CA 2964786A CA 2964786 A CA2964786 A CA 2964786A CA 2964786 C CA2964786 C CA 2964786C
Authority
CA
Canada
Prior art keywords
antibody
excipient
acetyl
viscosity
concentration
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
CA2964786A
Other languages
English (en)
French (fr)
Other versions
CA2964786A1 (en
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=CA2964786(C) "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
Publication of CA2964786A1 publication Critical patent/CA2964786A1/en
Application granted granted Critical
Publication of CA2964786C publication Critical patent/CA2964786C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (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)
CA2964786A 2014-10-23 2015-10-22 Reducing the viscosity of pharmaceutical formulations with n-acetyl amino acids Active CA2964786C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462067637P 2014-10-23 2014-10-23
US62/067,637 2014-10-23
PCT/US2015/056972 WO2016065181A1 (en) 2014-10-23 2015-10-22 Reducing viscosity of pharmaceutical formulations

Publications (2)

Publication Number Publication Date
CA2964786A1 CA2964786A1 (en) 2016-04-28
CA2964786C true CA2964786C (en) 2023-10-17

Family

ID=54427875

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2964786A Active CA2964786C (en) 2014-10-23 2015-10-22 Reducing the viscosity of pharmaceutical formulations with n-acetyl amino acids

Country Status (17)

Country Link
US (3) US11813328B2 (https=)
EP (2) EP3209332B1 (https=)
JP (3) JP2017531682A (https=)
KR (1) KR102534017B1 (https=)
CN (2) CN107206070B (https=)
AU (2) AU2015335743B2 (https=)
BR (1) BR112017008125B1 (https=)
CA (1) CA2964786C (https=)
CL (2) CL2017000984A1 (https=)
EA (3) EA038462B1 (https=)
ES (1) ES2964713T3 (https=)
IL (2) IL287947B2 (https=)
MA (1) MA54716A (https=)
MX (2) MX388858B (https=)
SG (1) SG11201703152RA (https=)
WO (1) WO2016065181A1 (https=)
ZA (1) ZA201702762B (https=)

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WO2016065181A1 (en) 2014-10-23 2016-04-28 Amgen Inc. Reducing viscosity of pharmaceutical formulations
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WO2018201064A1 (en) 2017-04-28 2018-11-01 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
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US20200289621A1 (en) * 2017-09-22 2020-09-17 Asahi Kasei Pharma Corporation Teriparatide-containing liquid pharmaceutical composition having excellent stability
WO2019106206A1 (en) 2017-12-01 2019-06-06 Fyb 202 Project Gmbh Stable, low viscosity, high concentration liquid formulations of an anti-il-12/23p40 antibody
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EP3628683A1 (en) * 2018-09-28 2020-04-01 Zealand Pharma A/S Formulations of glucagon-like-peptide-2 (glp-2) analogues
CN113660927A (zh) * 2019-04-23 2021-11-16 安进公司 使用低分子量聚乙烯吡咯烷酮（pvp）降低高浓度蛋白质配制品的黏度
MX2022010012A (es) * 2020-02-13 2022-09-07 Amgen Inc Formulaciones de anticuerpos anti-tslp humanos y métodos de tratamiento de una enfermedad inflamatoria.
KR102746418B1 (ko) * 2020-12-03 2024-12-26 동국대학교 산학협력단 N-아세틸-l-아르기닌을 포함하는 단백질 응집 억제용 조성물
JP2024509937A (ja) * 2021-03-09 2024-03-05 ジーアイ・イノベイション・インコーポレイテッド Ｉｇｅ ｆｃ受容体のアルファサブユニットの細胞外ドメインを含む融合タンパク質の製剤
WO2022217021A1 (en) * 2021-04-09 2022-10-13 Avantor Performance Materials, Llc Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations
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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

Also Published As

Publication number Publication date
AU2015335743A1 (en) 2017-05-04
CA2964786A1 (en) 2016-04-28
IL251726A0 (en) 2017-06-29
IL251726B (en) 2021-12-01
CN114569716A (zh) 2022-06-03
JP2017531682A (ja) 2017-10-26
IL287947A (en) 2022-01-01
EA202191513A1 (ru) 2021-11-30
ZA201702762B (en) 2022-12-21
AU2015335743B2 (en) 2020-12-24
US20240066124A1 (en) 2024-02-29
JP2020037559A (ja) 2020-03-12
IL287947B2 (en) 2024-08-01
MX2017005243A (es) 2017-08-18
US12318447B2 (en) 2025-06-03
CN107206070B (zh) 2022-01-18
KR102534017B1 (ko) 2023-05-19
US20170333559A1 (en) 2017-11-23
US11813328B2 (en) 2023-11-14
WO2016065181A1 (en) 2016-04-28
AU2021200990A1 (en) 2021-03-11
MA54716A (fr) 2021-11-17
EA201790787A1 (ru) 2017-08-31
JP2022009223A (ja) 2022-01-14
BR112017008125A2 (pt) 2018-06-19
ES2964713T3 (es) 2024-04-09
EP3909611B1 (en) 2023-08-30
BR112017008125B1 (pt) 2023-11-21
KR20170071518A (ko) 2017-06-23
JP6965321B2 (ja) 2021-11-10
IL287947B1 (en) 2024-04-01
EP3209332B1 (en) 2021-05-26
AU2021200990B2 (en) 2023-02-16
EA201991447A1 (ru) 2019-11-29
CL2019002190A1 (es) 2019-11-22
SG11201703152RA (en) 2017-05-30
EA033444B1 (ru) 2019-10-31
JP7411615B2 (ja) 2024-01-11
EA038462B1 (ru) 2021-08-31
MX2021015789A (es) 2022-01-27
CL2017000984A1 (es) 2018-01-05
US20250345421A1 (en) 2025-11-13
EP3909611A1 (en) 2021-11-17
MX388858B (es) 2025-03-20
CN107206070A (zh) 2017-09-26
EP3209332A1 (en) 2017-08-30

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