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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Prior art keywords
peptide
formulation
lyophilized
reconstituted
lyophilized mixture
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English (en)
Japanese (ja)
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JP2010530846A5 (enExample
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
Original Assignee
アコロジックス インコーポレイティッド
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Publication of JP2010530846A publication Critical patent/JP2010530846A/ja
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 (enExample) 2012-07-19

Family

ID=40094334

Family Applications (1)

Application Number Title Priority Date Filing Date
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 (enExample)
EP (1) EP2150537A4 (enExample)
JP (1) JP2010530846A (enExample)
AU (1) AU2008260483A1 (enExample)
CA (1) CA2687246A1 (enExample)
MX (1) MX2009012964A (enExample)
WO (1) WO2008150479A2 (enExample)

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

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PL2118123T3 (pl) 2007-01-31 2016-06-30 Dana Farber Cancer Inst Inc Stabilizowane peptydy p53 i ich zastosowania
JP5631201B2 (ja) 2007-03-28 2014-11-26 プレジデント アンド フェローズ オブ ハーバード カレッジ ステッチングされたポリペプチド
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
MX2011005672A (es) * 2008-11-28 2011-06-20 Abbott Lab Composiciones de anticuerpo estables y metodos para estabilizar a las mismas.
NZ595694A (en) * 2009-05-04 2013-09-27 Abbvie Biotechnology Ltd Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
PT2504353T (pt) 2009-11-23 2018-10-18 Cubist Pharmaceuticals Llc Composições de lipopéptido e métodos relacionados
JP5869553B2 (ja) 2010-03-31 2016-02-24 スタビリテック リミテッド ウイルス粒子、ポリペプチド又は生体材料を安定化させる添加剤
JP5960120B2 (ja) 2010-03-31 2016-08-02 スタビリテック リミテッド ウイルス粒子の安定化
GB2499480A (en) * 2010-03-31 2013-08-21 Stabilitech Ltd Method for preserving alum adjuvants and alum-adjuvanted vaccines
KR102104762B1 (ko) 2010-08-13 2020-04-24 에일러론 테라퓨틱스 인코포레이티드 펩티도미메틱 거대고리
CN103458926B (zh) 2010-11-11 2016-10-26 艾伯维生物技术有限公司 改进的高浓度抗TNF α 抗体液体制剂
CN102488889B (zh) * 2011-09-26 2014-01-22 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
CN103315969B (zh) * 2011-09-26 2016-05-18 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
EP2768518A4 (en) 2011-10-18 2015-05-27 Aileron Therapeutics Inc PEPTIDOMIMETIC MACROCYCLES
EP2773364A1 (en) * 2011-11-02 2014-09-10 The University of Chicago Stable pharmaceutical formulations of growth factor peptides
RU2642299C2 (ru) 2012-02-15 2018-01-24 Эйлерон Терапьютикс, Инк. P53 пептидомиметические макроциклы
CA2864120A1 (en) 2012-02-15 2013-08-22 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
BR112015009470A2 (pt) 2012-11-01 2019-12-17 Aileron Therapeutics Inc aminoácidos dissubstituídos e seus métodos de preparação e uso
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
CN107106642B (zh) * 2014-09-24 2021-02-26 艾瑞朗医疗公司 拟肽大环化合物及其制剂
EP3197478A4 (en) 2014-09-24 2018-05-30 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
JP2018516844A (ja) 2015-03-20 2018-06-28 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. ペプチド模倣大環状分子およびその使用
EP3347372A4 (en) 2015-09-10 2019-09-04 Aileron Therapeutics, Inc. PEPTIDOMIMETIC MACROCYCLES AS MODULATORS OF MCL-1
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
CN115243675A (zh) 2020-03-12 2022-10-25 巴克斯特国际公司 含有山梨糖醇和甘露糖醇的组合的达托霉素制剂
KR102869156B1 (ko) * 2021-03-29 2025-10-15 (주)아모레퍼시픽 콜라겐 펩티드 안정화용 조성물 및 이를 포함하는 식품

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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

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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
CA2473182A1 (en) * 2002-02-08 2003-08-14 Acologix, Inc. Compositions and methods for treatment of vitamin d deficiency
US20040105778A1 (en) * 2002-10-04 2004-06-03 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
AU2005277357B2 (en) * 2004-08-17 2011-08-04 Regeneron Pharmaceuticals, Inc. IL-1 antagonist formulations

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

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