EA038462B1 - Снижение вязкости фармацевтических составов - Google Patents

Снижение вязкости фармацевтических составов Download PDF

Info

Publication number
EA038462B1
EA038462B1 EA201991447A EA201991447A EA038462B1 EA 038462 B1 EA038462 B1 EA 038462B1 EA 201991447 A EA201991447 A EA 201991447A EA 201991447 A EA201991447 A EA 201991447A EA 038462 B1 EA038462 B1 EA 038462B1
Authority
EA
Eurasian Patent Office
Prior art keywords
viscosity
excipient
protein
antibody
acetyl
Prior art date
Application number
EA201991447A
Other languages
English (en)
Russian (ru)
Other versions
EA201991447A1 (ru
Inventor
Кристофер Джеймс Слоуи
Секхар Канапурам
Original Assignee
Эмджен Инк.
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=EA038462(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Эмджен Инк. filed Critical Эмджен Инк.
Publication of EA201991447A1 publication Critical patent/EA201991447A1/ru
Publication of EA038462B1 publication Critical patent/EA038462B1/ru

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
    • 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
    • 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
    • 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
    • A61K9/14—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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Microbiology (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)
EA201991447A 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов EA038462B1 (ru)

Applications Claiming Priority (1)

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

Publications (2)

Publication Number Publication Date
EA201991447A1 EA201991447A1 (ru) 2019-11-29
EA038462B1 true EA038462B1 (ru) 2021-08-31

Family

ID=54427875

Family Applications (3)

Application Number Title Priority Date Filing Date
EA201991447A EA038462B1 (ru) 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов
EA201790787A EA033444B1 (ru) 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов
EA202191513A EA202191513A1 (ru) 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов

Family Applications After (2)

Application Number Title Priority Date Filing Date
EA201790787A EA033444B1 (ru) 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов
EA202191513A EA202191513A1 (ru) 2014-10-23 2015-10-22 Снижение вязкости фармацевтических составов

Country Status (17)

Country Link
US (3) US11813328B2 (enExample)
EP (2) EP3209332B1 (enExample)
JP (3) JP2017531682A (enExample)
KR (1) KR102534017B1 (enExample)
CN (2) CN107206070B (enExample)
AU (2) AU2015335743B2 (enExample)
BR (1) BR112017008125B1 (enExample)
CA (1) CA2964786C (enExample)
CL (2) CL2017000984A1 (enExample)
EA (3) EA038462B1 (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)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2964713T3 (es) 2014-10-23 2024-04-09 Amgen Inc Reducción de la viscosidad de formulaciones farmacéuticas
JP7275027B2 (ja) * 2016-10-06 2023-05-17 アムジェン インコーポレイテッド 粘度低下タンパク質医薬製剤
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
US12103979B2 (en) * 2017-04-28 2024-10-01 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
MA48461A (fr) 2017-04-28 2020-03-04 Amgen Inc Excipients pour réduire la viscosité de formulations d'anticorps et compositions de formulation
US10646569B2 (en) 2017-05-16 2020-05-12 Bhami's Research Laboratory, Pvt. Ltd. High concentration protein formulations with reduced viscosity
IL271245B2 (en) 2017-06-16 2023-10-01 Zealand Pharma As Dosing regimen for administration of glucagon-like peptide analog (GLP-2) 2
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
WO2020008022A1 (en) 2018-07-05 2020-01-09 Bayer Aktiengesellschaft METHOD FOR THE PRODUCTION OF FREEZE-DRIED PELLETS COMPRISING AN ANTI-COAGULATION FACTOR XIa (FXIa) ANTIBODY
MY204234A (en) 2018-08-27 2024-08-16 Regeneron Pharma 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
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
CR20220457A (es) * 2020-02-13 2023-01-09 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
EP4674865A3 (en) * 2021-03-09 2026-03-25 GI Innovation, Inc. Formulation of fusion protein including extracellular domain of alpha subunit of ige fc receptor
CA3214867A1 (en) * 2021-04-09 2022-10-13 Courtney O'DELL Performance-enhancing excipients and methods of reducing viscosity and increasing stability of biologic formulations
TW202600593A (zh) * 2024-02-16 2026-01-01 美商再生元醫藥公司 製造濃縮配製包括蛋白質之藥品物質之方法,以及該方法製造之濃縮配製之藥品物質

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6767892B1 (en) * 1997-11-07 2004-07-27 Chrion Corporation Compositions providing for increased IGF-I solubility
EP1977763A1 (en) * 2005-12-28 2008-10-08 Chugai Seiyaku Kabushiki Kaisha Antibody-containing stabilizing preparation
WO2011104381A2 (en) * 2010-02-26 2011-09-01 Novo Nordisk A/S Stable antibody containing compositions

Family Cites Families (46)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5078997A (en) 1988-07-13 1992-01-07 Cetus Corporation Pharmaceutical composition for interleukin-2 containing physiologically compatible stabilizers
US5955448A (en) 1994-08-19 1999-09-21 Quadrant Holdings Cambridge Limited Method for stabilization of biological substances during drying and subsequent storage and compositions thereof
EP1028748B1 (en) * 1997-11-07 2003-05-02 Chiron Corporation Compositions providing for increased igf-i solubility
US6660843B1 (en) 1998-10-23 2003-12-09 Amgen Inc. Modified peptides as therapeutic agents
US6159485A (en) * 1999-01-08 2000-12-12 Yugenic Limited Partnership N-acetyl aldosamines, n-acetylamino acids and related n-acetyl compounds and their topical use
WO2001074397A1 (fr) 2000-03-31 2001-10-11 Kirin Beer Kabushiki Kaisha Preparation en poudre destinee a etre administree par les muqueuses comprenant un medicament de forme polymere et presentant une stabilite de conservation amelioree
PT1343518E (pt) 2000-11-07 2009-08-03 Novartis Vaccines & Diagnostic Composições de interferão estabilizadas
KR100911951B1 (ko) 2001-08-23 2009-08-13 젠맵 에이/에스 인터루킨 15 (il-15)에 대하여 특이적인 인간 항체
CA2476934C (en) 2002-02-27 2009-06-16 Immunex Corporation Stabilized tnfr-fc composition comprising arginine
AU2003293543A1 (en) 2002-12-13 2004-07-09 Abgenix, Inc. System and method for stabilizing antibodies with histidine
JP2006516636A (ja) 2003-01-30 2006-07-06 メディミューン,インコーポレーテッド 抗インテグリンαvβ3抗体製剤及びその用途
PT1610820E (pt) * 2003-04-04 2010-12-16 Novartis Ag Formulações de elevada concentração de anticorpos e proteínas
US8084032B2 (en) 2004-01-21 2011-12-27 Ajinomoto Co., Inc. Purification method which prevents denaturation of an antibody
US20060051347A1 (en) 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
WO2006081171A1 (en) 2005-01-24 2006-08-03 Amgen Inc. Humanized anti-amyloid antibody
US8003108B2 (en) 2005-05-03 2011-08-23 Amgen Inc. Sclerostin epitopes
US7592429B2 (en) 2005-05-03 2009-09-22 Ucb Sa Sclerostin-binding antibody
CN101426527A (zh) * 2006-02-03 2009-05-06 米迪缪尼有限公司 蛋白质制剂
GB0603683D0 (en) 2006-02-23 2006-04-05 Novartis Ag Organic compounds
CA2651453C (en) 2006-05-11 2014-10-14 Isis Pharmaceuticals, Inc. 5'-modified bicyclic nucleic acid analogs
AR064333A1 (es) 2006-12-14 2009-04-01 Schering Corp Anticuerpo anti-tslp de diseno
KR20100034015A (ko) 2007-06-20 2010-03-31 아이알엠 엘엘씨 알레르기 질환 치료를 위한 방법 및 조성물
JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
US7982016B2 (en) 2007-09-10 2011-07-19 Amgen Inc. Antigen binding proteins capable of binding thymic stromal lymphopoietin
US8420081B2 (en) * 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
SG2013054218A (en) * 2008-01-15 2014-10-30 Abbott Gmbh & Co Kg Powdered protein compositions and methods of making same
TWI445716B (zh) 2008-09-12 2014-07-21 Rinat Neuroscience Corp Pcsk9拮抗劑類
JO3672B1 (ar) 2008-12-15 2020-08-27 Regeneron Pharma أجسام مضادة بشرية عالية التفاعل الكيماوي بالنسبة لإنزيم سبتيليسين كنفرتيز بروبروتين / كيكسين نوع 9 (pcsk9).
JP2011067202A (ja) 2009-08-31 2011-04-07 Sanyo Chem Ind Ltd タンパク質水溶液の安定化剤、この安定化剤を含有するタンパク質水溶液及びタンパク質の安定化方法
RU2558821C2 (ru) * 2009-11-17 2015-08-10 Ипсен Фарма С.А.С. ЛЕКАРСТВЕННАЯ ФОРМА ДЛЯ КОМБИНАЦИИ hGH И rhIGF-1
DK2531218T3 (en) 2010-02-04 2019-04-01 Csl Behring Ag immunoglobulin
US20130171128A1 (en) * 2010-03-02 2013-07-04 Amgen Inc. Reducing viscosity of pharmaceutical formulations
BR112012027828A2 (pt) 2010-05-03 2016-08-09 Genentech Inc composição de matéria, artigo de fabricação e método de redução da viscosidade de uma formulação contendo proteína e de preparação de uma formulação aquosa contendo proteína
UY33679A (es) 2010-10-22 2012-03-30 Esbatech Anticuerpos estables y solubles
JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
JP6176849B2 (ja) 2011-07-19 2017-08-09 中外製薬株式会社 アルギニンアミドまたはその類似化合物を含む安定なタンパク質含有製剤
AU2012328524B2 (en) * 2011-10-28 2017-05-18 Excelse Bio, Inc. Protein formulations containing amino acids
EA039663B1 (ru) 2012-05-03 2022-02-24 Амген Инк. Применение антитела против pcsk9 для снижения сывороточного холестерина лпнп и лечения связанных с холестерином расстройств
EP2863951A1 (en) 2012-06-12 2015-04-29 Boehringer Ingelheim International GmbH Pharmaceutical formulation for a therapeutic antibody
US20150004174A1 (en) 2013-06-28 2015-01-01 Amgen Inc. Methods for treating homozygous familial hypercholesterolemia
TWI694836B (zh) 2014-05-16 2020-06-01 英商葛蘭素史克智慧財產管理有限公司 抗體調配物
ES2964713T3 (es) 2014-10-23 2024-04-09 Amgen Inc Reducción de la viscosidad de formulaciones farmacéuticas
CN121371151A (zh) 2014-12-03 2026-01-23 瑞士杰特贝林生物制品有限公司 具有增加的稳定性的包含免疫球蛋白的药物产品
IL307684B2 (en) 2016-09-29 2025-04-01 Amgen Inc Low viscosity antigen binding proteins and methods for preparing them
JP7275027B2 (ja) 2016-10-06 2023-05-17 アムジェン インコーポレイテッド 粘度低下タンパク質医薬製剤
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

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6767892B1 (en) * 1997-11-07 2004-07-27 Chrion Corporation Compositions providing for increased IGF-I solubility
EP1977763A1 (en) * 2005-12-28 2008-10-08 Chugai Seiyaku Kabushiki Kaisha Antibody-containing stabilizing preparation
WO2011104381A2 (en) * 2010-02-26 2011-09-01 Novo Nordisk A/S Stable antibody containing compositions

Also Published As

Publication number Publication date
US12318447B2 (en) 2025-06-03
CA2964786A1 (en) 2016-04-28
EP3909611B1 (en) 2023-08-30
US20170333559A1 (en) 2017-11-23
ZA201702762B (en) 2022-12-21
JP7411615B2 (ja) 2024-01-11
BR112017008125B1 (pt) 2023-11-21
US11813328B2 (en) 2023-11-14
EP3209332A1 (en) 2017-08-30
IL287947A (en) 2022-01-01
MA54716A (fr) 2021-11-17
AU2015335743B2 (en) 2020-12-24
US20250345421A1 (en) 2025-11-13
JP2020037559A (ja) 2020-03-12
JP2017531682A (ja) 2017-10-26
EA201790787A1 (ru) 2017-08-31
MX2017005243A (es) 2017-08-18
BR112017008125A2 (pt) 2018-06-19
CN114569716A (zh) 2022-06-03
CN107206070B (zh) 2022-01-18
SG11201703152RA (en) 2017-05-30
AU2015335743A1 (en) 2017-05-04
JP6965321B2 (ja) 2021-11-10
EP3209332B1 (en) 2021-05-26
CL2019002190A1 (es) 2019-11-22
IL251726A0 (en) 2017-06-29
MX388858B (es) 2025-03-20
IL287947B2 (en) 2024-08-01
KR20170071518A (ko) 2017-06-23
US20240066124A1 (en) 2024-02-29
CA2964786C (en) 2023-10-17
EP3909611A1 (en) 2021-11-17
CL2017000984A1 (es) 2018-01-05
KR102534017B1 (ko) 2023-05-19
AU2021200990A1 (en) 2021-03-11
JP2022009223A (ja) 2022-01-14
IL287947B1 (en) 2024-04-01
WO2016065181A1 (en) 2016-04-28
AU2021200990B2 (en) 2023-02-16
EA201991447A1 (ru) 2019-11-29
CN107206070A (zh) 2017-09-26
ES2964713T3 (es) 2024-04-09
MX2021015789A (es) 2022-01-27
IL251726B (en) 2021-12-01
EA202191513A1 (ru) 2021-11-30
EA033444B1 (ru) 2019-10-31

Similar Documents

Publication Publication Date Title
US12318447B2 (en) Lyophilized powder configured for reconstitution as a liquid pharmaceutical formulation with reduced viscosity and method of preparing thereof
US20200276313A1 (en) Pharmaceutical Formulations
US20130171128A1 (en) Reducing viscosity of pharmaceutical formulations
WO2022192310A1 (en) Drug delivery device, subassembly for drug delivery device, syringe holder, and method of assembly
EA052596B1 (ru) Снижение вязкости фармацевтических составов
HK1242572B (en) Reducing viscosity of pharmaceutical formulations