JP6707469B2 - アセチル化スカベンジャーを含むTat−NR2B9cの凍結乾燥製剤 - Google Patents

アセチル化スカベンジャーを含むTat−NR2B9cの凍結乾燥製剤 Download PDF

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Publication number
JP6707469B2
JP6707469B2 JP2016569613A JP2016569613A JP6707469B2 JP 6707469 B2 JP6707469 B2 JP 6707469B2 JP 2016569613 A JP2016569613 A JP 2016569613A JP 2016569613 A JP2016569613 A JP 2016569613A JP 6707469 B2 JP6707469 B2 JP 6707469B2
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Prior art keywords
tat
nr2b9c
concentration
formulation
trehalose
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Japanese (ja)
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JP2017521370A5 (enExample
JP2017521370A (ja
Inventor
ジョナサン デイヴィッド ガーマン,
ジョナサン デイヴィッド ガーマン,
フリーダー ホフマン,
フリーダー ホフマン,
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ノノ インコーポレイテッド
ノノ インコーポレイテッド
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    • 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
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/10—Peptides having 12 to 20 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/005—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from viruses
    • C07K14/08—RNA viruses
    • C07K14/15—Retroviridae, e.g. bovine leukaemia virus, feline leukaemia virus human T-cell leukaemia-lymphoma virus
    • C07K14/155—Lentiviridae, e.g. human immunodeficiency virus [HIV], visna-maedi virus or equine infectious anaemia virus
    • C07K14/16—HIV-1 ; HIV-2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70571—Receptors; Cell surface antigens; Cell surface determinants for neuromediators, e.g. serotonin receptor, dopamine receptor
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/10—Fusion polypeptide containing a localisation/targetting motif containing a tag for extracellular membrane crossing, e.g. TAT or VP22

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Virology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Toxicology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • AIDS & HIV (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Neurosurgery (AREA)
JP2016569613A 2014-05-28 2015-05-28 アセチル化スカベンジャーを含むTat−NR2B9cの凍結乾燥製剤 Expired - Fee Related JP6707469B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462004144P 2014-05-28 2014-05-28
US62/004,144 2014-05-28
PCT/IB2015/053996 WO2015181757A1 (en) 2014-05-28 2015-05-28 Lyophilized formulation of tat-nr2b9c with acetylation scavenger

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2020087977A Division JP2020143116A (ja) 2014-05-28 2020-05-20 アセチル化スカベンジャーを含むTat−NR2B9cの凍結乾燥製剤

Publications (3)

Publication Number Publication Date
JP2017521370A JP2017521370A (ja) 2017-08-03
JP2017521370A5 JP2017521370A5 (enExample) 2018-06-21
JP6707469B2 true JP6707469B2 (ja) 2020-06-10

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Family Applications (2)

Application Number Title Priority Date Filing Date
JP2016569613A Expired - Fee Related JP6707469B2 (ja) 2014-05-28 2015-05-28 アセチル化スカベンジャーを含むTat−NR2B9cの凍結乾燥製剤
JP2020087977A Pending JP2020143116A (ja) 2014-05-28 2020-05-20 アセチル化スカベンジャーを含むTat−NR2B9cの凍結乾燥製剤

Family Applications After (1)

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JP2020087977A Pending JP2020143116A (ja) 2014-05-28 2020-05-20 アセチル化スカベンジャーを含むTat−NR2B9cの凍結乾燥製剤

Country Status (5)

Country Link
US (3) US10206878B2 (enExample)
EP (1) EP3148568A4 (enExample)
JP (2) JP6707469B2 (enExample)
CA (1) CA2950392A1 (enExample)
WO (1) WO2015181757A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10251935B2 (en) * 2012-11-28 2019-04-09 Nono Inc. Lyophilized formulation comprising tat-NR2B9C, histidine and trehalose
CA2950392A1 (en) 2014-05-28 2015-12-03 Nono Inc. Lyophilized formulation of tat-nr2b9c with acetylation scavenger
UA123820C2 (uk) * 2014-05-28 2021-06-09 Ноно Інк. Хлоридна сіль пептиду tat-nr2b9c
DK4553432T3 (da) 2023-11-08 2026-06-29 Bachem Holding Ag Tørrepose og tørresystem
CN122122428A (zh) 2023-11-08 2026-05-29 巴克姆股份公司 干燥袋和干燥系统

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009525986A (ja) * 2006-02-03 2009-07-16 メディミューン,エルエルシー タンパク質製剤
CA2647111A1 (en) * 2006-03-28 2007-10-04 F. Hoffmann-La Roche Ag Anti-igf-1r human monoclonal antibody formulation
EP1884521A1 (en) * 2006-07-31 2008-02-06 Xigen S.A. Fusion peptide for inhibiting interaction of neuronal NMDA receptor (NMDAR) and NMDAR interacting proteins
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
CN102413839A (zh) * 2009-03-06 2012-04-11 医学免疫有限责任公司 人源化抗cd19抗体制剂
WO2011017070A1 (en) 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
PL3721904T3 (pl) * 2009-11-20 2022-01-31 Biocon Limited Formulacje przeciwciała t1h
WO2011134979A2 (en) * 2010-04-27 2011-11-03 Scil Technology Gmbh Stable mia/cd-rap formulation
US9629892B2 (en) 2010-08-12 2017-04-25 Nono Inc. Treatment of penetrative injury to the brain
KR102374576B1 (ko) * 2011-05-17 2022-03-15 솔리제닉스, 인크. 열안정성 백신 조성물 및 그의 제조방법
UY34105A (es) * 2011-06-03 2012-07-31 Lg Life Sciences Ltd Formulación líquida estable de etanercept
US10251935B2 (en) 2012-11-28 2019-04-09 Nono Inc. Lyophilized formulation comprising tat-NR2B9C, histidine and trehalose
TR201905787T4 (tr) 2012-11-28 2019-05-21 Nono Inc Liyofilize TAT-NR2B9C formülasyonu.
UA123820C2 (uk) 2014-05-28 2021-06-09 Ноно Інк. Хлоридна сіль пептиду tat-nr2b9c
CA2950392A1 (en) 2014-05-28 2015-12-03 Nono Inc. Lyophilized formulation of tat-nr2b9c with acetylation scavenger

Also Published As

Publication number Publication date
EP3148568A4 (en) 2018-01-17
JP2020143116A (ja) 2020-09-10
US10206878B2 (en) 2019-02-19
WO2015181757A1 (en) 2015-12-03
US20190231693A1 (en) 2019-08-01
US20170112769A1 (en) 2017-04-27
EP3148568A1 (en) 2017-04-05
US20220096383A1 (en) 2022-03-31
CA2950392A1 (en) 2015-12-03
JP2017521370A (ja) 2017-08-03

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