MA46466A - Formulations pharmaceutiques de protéines à viscosité réduite - Google Patents

Formulations pharmaceutiques de protéines à viscosité réduite

Info

Publication number
MA46466A
MA46466A MA046466A MA46466A MA46466A MA 46466 A MA46466 A MA 46466A MA 046466 A MA046466 A MA 046466A MA 46466 A MA46466 A MA 46466A MA 46466 A MA46466 A MA 46466A
Authority
MA
Morocco
Prior art keywords
pharmaceutical formulations
reduced viscosity
proteins
viscosity proteins
reduced
Prior art date
Application number
MA046466A
Other languages
English (en)
Inventor
William J Callahan
Twinkle R Christian
Christi L Clogston
Rahul Rajan Kaushik
Nazer Khalaf
Qahera Munaim
Alona Teran
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
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of MA46466A publication Critical patent/MA46466A/fr

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
MA046466A 2016-10-06 2017-10-06 Formulations pharmaceutiques de protéines à viscosité réduite MA46466A (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201662404861P 2016-10-06 2016-10-06

Publications (1)

Publication Number Publication Date
MA46466A true MA46466A (fr) 2019-08-14

Family

ID=60294396

Family Applications (1)

Application Number Title Priority Date Filing Date
MA046466A MA46466A (fr) 2016-10-06 2017-10-06 Formulations pharmaceutiques de protéines à viscosité réduite

Country Status (5)

Country Link
US (1) US11459401B2 (fr)
EP (1) EP3522918A1 (fr)
JP (2) JP7275027B2 (fr)
MA (1) MA46466A (fr)
WO (1) WO2018067987A1 (fr)

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016010927A1 (fr) * 2014-07-14 2016-01-21 Amgen Inc. Formulations d'anticorps cristallins
AU2015335743B2 (en) 2014-10-23 2020-12-24 Amgen Inc. Reducing viscosity of pharmaceutical formulations
US10858422B2 (en) 2016-05-31 2020-12-08 Abcentra, Llc Methods for treating systemic lupus erythematosus with an anti-apolipoprotein B antibody
US10434141B2 (en) 2016-05-31 2019-10-08 Abcentra, Llc Methods for treating systemic lupus erythematosus with an anti-apolipoprotein B antibody
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
US20210031012A1 (en) 2018-01-26 2021-02-04 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with a pde4 inhibitor
CN110464842B (zh) * 2018-05-11 2022-10-14 信达生物制药(苏州)有限公司 包含抗pcsk9抗体的制剂及其用途
WO2019246312A1 (fr) 2018-06-20 2019-12-26 Progenity, Inc. Traitement d'une maladie du tractus gastro-intestinal avec un immunomodulateur
WO2019246273A1 (fr) 2018-06-20 2019-12-26 Progenity, Inc. Traitement d'une maladie du tractus gastro-intestinal avec un jak ou un autre inhibiteur de kinase
EP3810085A1 (fr) 2018-06-20 2021-04-28 Progenity, Inc. Traitement d'une maladie du tractus gastro-intestinal par un inhibiteur de l'intégrine
US20230009902A1 (en) 2018-06-20 2023-01-12 Progenity, Inc. Treatment of a disease or condition in a tissue orginating from the endoderm
EP3810095A1 (fr) 2018-06-20 2021-04-28 Progenity, Inc. Traitement d'une maladie du tractus gastro-intestinal avec un inhibiteur du tnf
US20210363233A1 (en) 2018-06-20 2021-11-25 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an il-12/il-23 inhibitor
WO2020071876A1 (fr) * 2018-10-04 2020-04-09 삼성바이오에피스 주식회사 Trastuzumab à concentration élevée ayant une viscosité réduite ou agent de stabilisation de fragment de liaison à l'antigène associé
CR20210435A (es) 2019-02-18 2021-09-20 Lilly Co Eli Formulación de anticuerpos terapéuticos
WO2020232247A1 (fr) 2019-05-14 2020-11-19 Provention Bio, Inc. Procédés et compositions pour la prévention du diabète de type 1
KR20220047826A (ko) * 2019-08-16 2022-04-19 리제너론 파마슈티칼스 인코포레이티드 고 농도의 항-c5 제형
CN111024863A (zh) * 2019-12-31 2020-04-17 上海博威生物医药有限公司 一种雷莫芦单抗的肽图的测试方法
US12006366B2 (en) 2020-06-11 2024-06-11 Provention Bio, Inc. Methods and compositions for preventing type 1 diabetes
AU2021308997A1 (en) * 2020-07-13 2023-02-02 Merck Patent Gmbh Viscosity reducing excipients and combinations thereof for highly concentrated protein formulations
US20220142992A1 (en) * 2020-11-10 2022-05-12 Medregen, Llc Formulations, methods, kits, and dosage forms

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6660843B1 (en) 1998-10-23 2003-12-09 Amgen Inc. Modified peptides as therapeutic agents
RS51829B (sr) 2001-08-23 2012-02-29 Genmab A/S. Ljudska antitela specifična za interleukin 15 (il-15)
JP4869064B2 (ja) 2003-04-04 2012-02-01 ジェネンテック, インコーポレイテッド 高濃度抗体及びタンパク質製剤
DE602005026998D1 (de) * 2005-01-14 2011-04-28 Camurus Ab Somatostatin-analog-formulierungen
AU2007249349B2 (en) 2006-05-11 2012-03-08 Isis Pharmaceuticals, Inc. 5'-Modified bicyclic nucleic acid analogs
US20130072665A1 (en) 2007-08-23 2013-03-21 Simon Mark Jackson Antigen binding proteins to proprotein convertase subtilisin kexin type 9 (pcsk9)
JOP20080381B1 (ar) 2007-08-23 2023-03-28 Amgen Inc بروتينات مرتبطة بمولدات مضادات تتفاعل مع بروبروتين كونفيرتاز سيتيليزين ككسين من النوع 9 (pcsk9)
WO2009131740A2 (fr) 2008-04-23 2009-10-29 Amgen Inc. Variants neutralisants de la proprotéine convertase subtilisine/kexine de type 9 (pcsk9) et ses applications
TWI516501B (zh) 2008-09-12 2016-01-11 禮納特神經系統科學公司 Pcsk9拮抗劑類
CA2743789C (fr) * 2008-11-16 2017-10-31 Board Of Regents, The Univesity Of Texas System Suspensions hautement concentrees de faible viscosite
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).
WO2011053783A2 (fr) 2009-10-30 2011-05-05 Merck Sharp & Dohme Corp. Antagonistes et variants ax213 et ax132 pcsk9
KR101614983B1 (ko) 2009-11-17 2016-04-22 입센 파마 에스.에이.에스 Hgh 및 rhigf―1의 조합물을 위한 제제
US20110223208A1 (en) * 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
EP2683362A4 (fr) * 2011-03-10 2014-09-17 Univ Texas Dispersions de nanoparticules de protéines
JOP20200043A1 (ar) 2011-05-10 2017-06-16 Amgen Inc طرق معالجة أو منع الاضطرابات المختصة بالكوليسترول
AR087305A1 (es) * 2011-07-28 2014-03-12 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-pcsk9, metodo de preparacion y kit
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
SG10201709555SA (en) 2012-05-18 2017-12-28 Genentech Inc High-concentration monoclonal antibody formulations
US20160074515A1 (en) * 2014-06-20 2016-03-17 Reform Biologics, Llc Viscosity-reducing excipient compounds for protein formulations
CA2956991A1 (fr) * 2014-08-06 2016-02-11 Rinat Neuroscience Corp. Methodes destinees a reduire le cholesterol ldl
EP3197492A1 (fr) * 2014-09-23 2017-08-02 Pfizer Inc Traitement avec des anticorps anti-pcsk9
AU2015335743B2 (en) * 2014-10-23 2020-12-24 Amgen Inc. Reducing viscosity of pharmaceutical formulations

Also Published As

Publication number Publication date
US20200024363A1 (en) 2020-01-23
JP2023054369A (ja) 2023-04-13
JP2019530703A (ja) 2019-10-24
EP3522918A1 (fr) 2019-08-14
US11459401B2 (en) 2022-10-04
WO2018067987A1 (fr) 2018-04-12
JP7275027B2 (ja) 2023-05-17

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