JP2010530846A - 高温で安定なペプチド製剤 - Google Patents

高温で安定なペプチド製剤 Download PDF

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Publication number
JP2010530846A
JP2010530846A JP2010510365A JP2010510365A JP2010530846A JP 2010530846 A JP2010530846 A JP 2010530846A JP 2010510365 A JP2010510365 A JP 2010510365A JP 2010510365 A JP2010510365 A JP 2010510365A JP 2010530846 A JP2010530846 A JP 2010530846A
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peptide
formulation
lyophilized
reconstituted
lyophilized mixture
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Japanese (ja)
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JP2010530846A5 (cg-RX-API-DMAC7.html
Inventor
デニス チェン
ルッセル ウェイン ブラッチャー
バイオン チャン
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アコロジックス インコーポレイティッド
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Publication of JP2010530846A5 publication Critical patent/JP2010530846A5/ja
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • A61K47/26Carbohydrates, 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
    • 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
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • C07K14/4701Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals not used
    • C07K14/4702Regulators; Modulating activity
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Marine Sciences & Fisheries (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2010510365A 2007-06-01 2008-05-29 高温で安定なペプチド製剤 Pending JP2010530846A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US94155607P 2007-06-01 2007-06-01
US96908007P 2007-08-30 2007-08-30
PCT/US2008/006898 WO2008150479A2 (en) 2007-06-01 2008-05-29 High temperature stable peptide formulation

Publications (2)

Publication Number Publication Date
JP2010530846A true JP2010530846A (ja) 2010-09-16
JP2010530846A5 JP2010530846A5 (cg-RX-API-DMAC7.html) 2012-07-19

Family

ID=40094334

Family Applications (1)

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JP2010510365A Pending JP2010530846A (ja) 2007-06-01 2008-05-29 高温で安定なペプチド製剤

Country Status (7)

Country Link
US (1) US7879805B2 (cg-RX-API-DMAC7.html)
EP (1) EP2150537A4 (cg-RX-API-DMAC7.html)
JP (1) JP2010530846A (cg-RX-API-DMAC7.html)
AU (1) AU2008260483A1 (cg-RX-API-DMAC7.html)
CA (1) CA2687246A1 (cg-RX-API-DMAC7.html)
MX (1) MX2009012964A (cg-RX-API-DMAC7.html)
WO (1) WO2008150479A2 (cg-RX-API-DMAC7.html)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013213031A (ja) * 2012-03-09 2013-10-17 Fujiyakuhin Co Ltd ペプチドを含む医薬組成物
JP2014004327A (ja) * 2012-05-31 2014-01-16 Yoshinori Kuboki チタン−タンパク質複合体、生体インプラントおよび細胞培養基材
JP2017517517A (ja) * 2014-05-28 2017-06-29 ノノ インコーポレイテッド Tat−NR2B9cの塩化物塩
JP2023511786A (ja) * 2020-03-31 2023-03-22 株式会社スリー・ディー・マトリックス 照射による自己組織化ペプチドの滅菌

Families Citing this family (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2677045C (en) 2007-01-31 2016-10-18 Dana-Farber Cancer Institute, Inc. Stabilized p53 peptides and uses thereof
KR20160061439A (ko) 2007-03-28 2016-05-31 프레지던트 앤드 펠로우즈 오브 하바드 칼리지 스티칭된 폴리펩티드
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
CN104398471A (zh) * 2008-11-28 2015-03-11 Abbvie公司 稳定的抗体组合物和用于稳定其的方法
CN104490767A (zh) * 2009-05-04 2015-04-08 艾伯维生物技术有限公司 人抗TNF-α抗体的稳定高蛋白质浓度制剂
CA2781666C (en) * 2009-11-23 2017-02-21 Cubist Pharmaceuticals, Inc. Lipopeptide compositions and related methods
ES2543795T3 (es) 2010-03-31 2015-08-21 Stabilitech Ltd. Estabilización de partículas virales
DK2552478T3 (en) 2010-03-31 2017-03-27 Stabilitech Ltd EXCIPIENTS FOR STABILIZING VIRUS PARTICLES
WO2011121305A2 (en) 2010-03-31 2011-10-06 Stabilitech Ltd. Method for preserving alum adjuvants and alum-adjuvanted vaccines
MX355543B (es) 2010-08-13 2018-04-20 Aileron Therapeutics Inc Star Macrociclos peptidomiméticos.
TWI606840B (zh) 2010-11-11 2017-12-01 艾伯維生物技術有限責任公司 具有增進高濃度之抗-TNFα抗體之液體調配物
CN102488886B (zh) * 2011-09-26 2014-03-26 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
CN103386117B (zh) * 2011-09-26 2015-09-30 上海天伟生物制药有限公司 一种低杂质含量的卡泊芬净制剂及其制备方法和用途
GB201117233D0 (en) 2011-10-05 2011-11-16 Stabilitech Ltd Stabilisation of polypeptides
RU2639523C2 (ru) 2011-10-18 2017-12-21 Эйлерон Терапьютикс, Инк. Пептидомиметические макроциклы и их применение
EP2773364A1 (en) * 2011-11-02 2014-09-10 The University of Chicago Stable pharmaceutical formulations of growth factor peptides
JP6450191B2 (ja) 2012-02-15 2019-01-09 エイルロン セラピューティクス,インコーポレイテッド ペプチドミメティック大環状化合物
HK1205454A1 (en) 2012-02-15 2015-12-18 Aileron Therapeutics, Inc. Triazole-crosslinked and thioether-crosslinked peptidomimetic macrocycles
EP2698162A1 (en) * 2012-08-15 2014-02-19 Credentis AG Method for producing a composition for treating a tooth lesion
US9604919B2 (en) 2012-11-01 2017-03-28 Aileron Therapeutics, Inc. Disubstituted amino acids and methods of preparation and use thereof
US10251935B2 (en) * 2012-11-28 2019-04-09 Nono Inc. Lyophilized formulation comprising tat-NR2B9C, histidine and trehalose
GB201406569D0 (en) 2014-04-11 2014-05-28 Stabilitech Ltd Vaccine compositions
WO2016049355A1 (en) * 2014-09-24 2016-03-31 Aileron Therapeutics, Inc. Peptidomimetic macrocycles and formulations thereof
SG11201702223UA (en) 2014-09-24 2017-04-27 Aileron Therapeutics Inc Peptidomimetic macrocycles and uses thereof
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
EP3294318A4 (en) 2015-03-20 2019-04-03 Aileron Therapeutics, Inc. PEPTIDOMIMETIC MACROCYCLES AND USES THEREOF
JP2018528217A (ja) 2015-09-10 2018-09-27 エルロン・セラピューティクス・インコーポレイテッドAileron Therapeutics,Inc. Mcl−1のモジュレーターとしてのペプチド模倣大環状分子
GB2562241B (en) 2017-05-08 2022-04-06 Stabilitech Biopharma Ltd Vaccine compositions
CN109528761A (zh) * 2018-12-20 2019-03-29 江西润泽药业有限公司 制备钠钾钙镁葡萄糖注射液的方法
JP2023517926A (ja) 2020-03-12 2023-04-27 バクスター・インターナショナル・インコーポレイテッド ソルビトールとマンニトールの組み合わせを含むダプトマイシン製剤
KR102869156B1 (ko) * 2021-03-29 2025-10-15 (주)아모레퍼시픽 콜라겐 펩티드 안정화용 조성물 및 이를 포함하는 식품

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09512267A (ja) * 1994-04-26 1997-12-09 ジェネティックス・インスティテュート・インコーポレイテッド 因子ix用処方
JPH1067679A (ja) * 1996-07-12 1998-03-10 Bayer Corp 低い糖含量を有する安定化されたアルブミン−フリーの組換え第viii因子調製物
JP2000504327A (ja) * 1996-01-25 2000-04-11 ジェネテイックス・インスティテュート・インコーポレイテッド 高度に濃縮された、凍結乾燥された、および液体の、因子▲ix▼処方
JP2003055257A (ja) * 2001-08-10 2003-02-26 Nihon Pharmaceutical Co Ltd 安定な血液凝固第xiii因子製剤
JP2004532791A (ja) * 2000-06-28 2004-10-28 バイエル・コーポレーシヨン 安定化させたインターロイキン2

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6685940B2 (en) * 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
AUPO871997A0 (en) 1997-08-25 1997-09-18 Csl Limited Dried biologically or therapeutically active preparations
GB9930882D0 (en) * 1999-12-30 2000-02-23 Nps Allelix Corp GLP-2 formulations
US20030186891A1 (en) 2002-02-08 2003-10-02 Toshio Okano Compositions and methods for treatment of vitamin D deficiency
AU2003268380A1 (en) * 2002-10-04 2004-05-04 Elan Pharma International Limited Gamma irradiation of solid nanoparticulate active agents
US20060008415A1 (en) * 2004-06-25 2006-01-12 Protein Design Labs, Inc. Stable liquid and lyophilized formulation of proteins
WO2006023665A2 (en) * 2004-08-17 2006-03-02 Regeneron Pharmaceuticals, Inc. Il-1 antagonist formulations

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09512267A (ja) * 1994-04-26 1997-12-09 ジェネティックス・インスティテュート・インコーポレイテッド 因子ix用処方
JP2000504327A (ja) * 1996-01-25 2000-04-11 ジェネテイックス・インスティテュート・インコーポレイテッド 高度に濃縮された、凍結乾燥された、および液体の、因子▲ix▼処方
JPH1067679A (ja) * 1996-07-12 1998-03-10 Bayer Corp 低い糖含量を有する安定化されたアルブミン−フリーの組換え第viii因子調製物
JP2004532791A (ja) * 2000-06-28 2004-10-28 バイエル・コーポレーシヨン 安定化させたインターロイキン2
JP2003055257A (ja) * 2001-08-10 2003-02-26 Nihon Pharmaceutical Co Ltd 安定な血液凝固第xiii因子製剤

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013213031A (ja) * 2012-03-09 2013-10-17 Fujiyakuhin Co Ltd ペプチドを含む医薬組成物
JP2014004327A (ja) * 2012-05-31 2014-01-16 Yoshinori Kuboki チタン−タンパク質複合体、生体インプラントおよび細胞培養基材
JP2017517517A (ja) * 2014-05-28 2017-06-29 ノノ インコーポレイテッド Tat−NR2B9cの塩化物塩
JP2023511786A (ja) * 2020-03-31 2023-03-22 株式会社スリー・ディー・マトリックス 照射による自己組織化ペプチドの滅菌
JP7335025B2 (ja) 2020-03-31 2023-08-29 株式会社スリー・ディー・マトリックス 照射による自己組織化ペプチドの滅菌
JP2023126409A (ja) * 2020-03-31 2023-09-07 株式会社スリー・ディー・マトリックス 照射による自己組織化ペプチドの滅菌
JP7482564B2 (ja) 2020-03-31 2024-05-14 株式会社スリー・ディー・マトリックス 照射による自己組織化ペプチドの滅菌

Also Published As

Publication number Publication date
AU2008260483A1 (en) 2008-12-11
EP2150537A4 (en) 2010-09-22
WO2008150479A2 (en) 2008-12-11
CA2687246A1 (en) 2008-12-11
US7879805B2 (en) 2011-02-01
EP2150537A2 (en) 2010-02-10
US20090054331A1 (en) 2009-02-26
WO2008150479A3 (en) 2009-02-19
MX2009012964A (es) 2010-01-14

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