JP2010513309A - ヒト成長ホルモン製剤 - Google Patents

ヒト成長ホルモン製剤 Download PDF

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Publication number
JP2010513309A
JP2010513309A JP2009541592A JP2009541592A JP2010513309A JP 2010513309 A JP2010513309 A JP 2010513309A JP 2009541592 A JP2009541592 A JP 2009541592A JP 2009541592 A JP2009541592 A JP 2009541592A JP 2010513309 A JP2010513309 A JP 2010513309A
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JP
Japan
Prior art keywords
hgh
preparation
crystals
tris
suspension
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2009541592A
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English (en)
Japanese (ja)
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JP2010513309A5 (enExample
Inventor
ウェン−リー チャン，
ローレンス ブッシュ，
セルゲイ ペチノフ，
スジット ケー． バス，
Original Assignee
アルタス ファーマシューティカルズ インコーポレイテッド
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Publication of JP2010513309A publication Critical patent/JP2010513309A/ja
Publication of JP2010513309A5 publication Critical patent/JP2010513309A5/ja
Pending legal-status Critical Current

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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
    • A61K9/0012—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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/27—Growth hormone [GH], i.e. somatotropin
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/645—Polycationic or polyanionic oligopeptides, polypeptides or polyamino acids, e.g. polylysine, polyarginine, polyglutamic acid or peptide TAT
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6921—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a particulate, a powder, an adsorbate, a bead or a sphere
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • 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
    • C07K14/575—Hormones
    • C07K14/61—Growth hormone [GH], i.e. somatotropin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Toxicology (AREA)
  • Biophysics (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Peptides Or Proteins (AREA)
JP2009541592A 2006-12-18 2007-12-13 ヒト成長ホルモン製剤 Pending JP2010513309A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US87060506P 2006-12-18 2006-12-18
PCT/US2007/087417 WO2008076819A2 (en) 2006-12-18 2007-12-13 Human growth hormone formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2015153650A Division JP6106722B2 (ja) 2006-12-18 2015-08-03 ヒト成長ホルモン製剤

Publications (2)

Publication Number Publication Date
JP2010513309A true JP2010513309A (ja) 2010-04-30
JP2010513309A5 JP2010513309A5 (enExample) 2011-01-27

Family

ID=39402753

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2009541592A Pending JP2010513309A (ja) 2006-12-18 2007-12-13 ヒト成長ホルモン製剤
JP2015153650A Expired - Fee Related JP6106722B2 (ja) 2006-12-18 2015-08-03 ヒト成長ホルモン製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2015153650A Expired - Fee Related JP6106722B2 (ja) 2006-12-18 2015-08-03 ヒト成長ホルモン製剤

Country Status (7)

Country Link
US (2) US8071544B2 (enExample)
EP (2) EP2120869A2 (enExample)
JP (2) JP2010513309A (enExample)
AU (1) AU2007333959A1 (enExample)
CA (1) CA2672284C (enExample)
DK (1) DK2486916T3 (enExample)
WO (1) WO2008076819A2 (enExample)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012511009A (ja) * 2008-12-05 2012-05-17 アルコン リサーチ， リミテッド 薬学的懸濁物
JP2014508174A (ja) * 2011-03-15 2014-04-03 バイオジェン・アイデック・インコーポレイテッド 速い用量調節の漸増投与レジメンを用いた、インターフェロンの筋肉内投与に伴うインフルエンザ様症状を軽減するための方法
JPWO2015064591A1 (ja) * 2013-10-28 2017-03-09 テルモ株式会社 タンパク質水性懸濁剤

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10201604530SA (en) 2008-01-22 2016-07-28 Araim Pharmaceuticals Inc Tissue protective peptides and peptide analogs for preventing and treating diseases and disorders associated with tissue damage
WO2010101989A1 (en) 2009-03-03 2010-09-10 Alcon Research, Ltd. PHARMACEUTICAL COMPOSITION FOR DELIVERY OF RECEPTOR TYROSINE KINASE INHIBITING (RTKi) COMPOUNDS TO THE EYE
WO2010115728A2 (en) * 2009-03-30 2010-10-14 F. Hoffmann-La Roche Ag A method for avoiding glass fogging
EP2453874A2 (en) * 2009-07-14 2012-05-23 Biogen Idec MA Inc. Methods for inhibiting yellow color and peroxide formation in a composition
EP2473191B1 (en) * 2009-09-04 2017-08-23 XOMA Technology Ltd. Antibody coformulations
FR2966044B1 (fr) 2010-10-18 2012-11-02 Sanofi Pasteur Procede de conditionnement d'un vaccin contenant un adjuvant d'aluminium
WO2013014196A1 (en) 2011-07-25 2013-01-31 Sandoz Ag Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein
EP2782590A4 (en) * 2011-11-23 2016-08-03 Durect Corp BIODEGRADABLE AND MEDIUM-RADIATED STERILIZED MEDICAMENTAL COMPOSITIONS
EP2949336B1 (en) 2013-01-28 2018-09-05 National University Corporation Kumamoto University Stabilized protein gel preparation
CN105764491A (zh) 2013-12-09 2016-07-13 度瑞公司 药物活性剂复合物、聚合物复合物，以及包括其的组合物和方法
CN113425835B (zh) * 2020-03-23 2024-03-19 常州健益生物制药有限公司 一种生长激素原料药溶液、水针剂及其制备方法
CN112494638B (zh) * 2020-12-22 2023-12-19 深圳科兴药业有限公司 一种人生长激素注射剂组合物及其制备方法

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992000998A1 (en) * 1990-07-13 1992-01-23 Novo Nordisk A/S Growth hormone crystals and a process for production of these gh-crystals
WO1993012812A1 (en) * 1991-12-20 1993-07-08 Novo Nordisk A/S A stabilized pharmaceutical formulation comprising growth hormone and histidine
JP2006512416A (ja) * 2002-12-31 2006-04-13 アルタス ファーマシューティカルズ インコーポレイテッド ヒト成長ホルモンの結晶およびその調製方法

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4342832A (en) 1979-07-05 1982-08-03 Genentech, Inc. Method of constructing a replicable cloning vehicle having quasi-synthetic genes
US5618697A (en) 1982-12-10 1997-04-08 Novo Nordisk A/S Process for preparing a desired protein
NL9000634A (nl) * 1990-03-20 1991-10-16 Catharina Ziekenhuis Stichting Suspensie-injectiepreparaat op waterbasis, werkwijze voor de bereiding daarvan en toepassing van dit preparaat voor pijnbestrijding.
ES2153385T5 (es) * 1992-07-31 2008-09-01 Genentech, Inc. Composicion acuosa a base de hormona del crecimiento humana.
CZ296649B6 (cs) * 1993-02-23 2006-05-17 Genentech, Inc. Zpusob výroby stabilizovaného polypeptidového prostredku zahrnující stabilizování polypeptidu protidenaturaci organickými rozpoustedly, jeho príprava a prostredek pro regulované uvolnování polypeptidu
US5439643A (en) * 1993-11-03 1995-08-08 Liebert; Richard T. Method and apparatus for terminal sterilization
JP3829991B2 (ja) * 1994-06-17 2006-10-04 アプライド リサーチ システムズ エーアールエス ホールディング ナームロゼ ベノートスハップ Ｈｇｈ含有医薬組成物
US7276251B2 (en) * 1997-04-01 2007-10-02 Lg Life Sciences, Ltd., Inc. Sustained-release composition of drugs encapsulated in microparticles of hyaluronic acid
US20020077461A1 (en) * 1996-04-24 2002-06-20 Soren Bjorn Pharmaceutical formulation
US6541606B2 (en) * 1997-12-31 2003-04-01 Altus Biologics Inc. Stabilized protein crystals formulations containing them and methods of making them
US7582311B1 (en) * 1999-10-15 2009-09-01 Genentech, Inc. Injection vehicle for polymer-based formulations
CN1606620A (zh) * 2000-01-28 2005-04-13 因菲米德治疗有限公司 缓慢释放的蛋白质聚合物
BR0317896A (pt) 2002-12-31 2005-12-06 Altus Pharmaceuticals Inc Complexos de cristais de proteìna e polìmeros iÈnicos
US20090023629A1 (en) * 2005-12-23 2009-01-22 Altus Pharmaceuticals Inc. Compositions comprising polycation-complexed protein crystals and methods of treatment using them

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992000998A1 (en) * 1990-07-13 1992-01-23 Novo Nordisk A/S Growth hormone crystals and a process for production of these gh-crystals
WO1993012812A1 (en) * 1991-12-20 1993-07-08 Novo Nordisk A/S A stabilized pharmaceutical formulation comprising growth hormone and histidine
JP2006512416A (ja) * 2002-12-31 2006-04-13 アルタス ファーマシューティカルズ インコーポレイテッド ヒト成長ホルモンの結晶およびその調製方法

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012511009A (ja) * 2008-12-05 2012-05-17 アルコン リサーチ， リミテッド 薬学的懸濁物
JP2014508174A (ja) * 2011-03-15 2014-04-03 バイオジェン・アイデック・インコーポレイテッド 速い用量調節の漸増投与レジメンを用いた、インターフェロンの筋肉内投与に伴うインフルエンザ様症状を軽減するための方法
JP2018030847A (ja) * 2011-03-15 2018-03-01 バイオジェン・エムエイ・インコーポレイテッドＢｉｏｇｅｎ ＭＡ Ｉｎｃ． 速い用量調節の漸増投与レジメンを用いた、インターフェロンの筋肉内投与に伴うインフルエンザ様症状を軽減するための方法
US10500254B2 (en) 2011-03-15 2019-12-10 Biogen Ma Inc. Method for reducing flu-like symptoms associated with intramuscular administration of interferon using a fast titration escalating dosing regimen
JPWO2015064591A1 (ja) * 2013-10-28 2017-03-09 テルモ株式会社 タンパク質水性懸濁剤

Also Published As

Publication number Publication date
EP2486916B1 (en) 2015-04-01
US20100216705A1 (en) 2010-08-26
AU2007333959A1 (en) 2008-06-26
CA2672284A1 (en) 2008-06-26
US8071544B2 (en) 2011-12-06
DK2486916T3 (en) 2015-06-15
JP6106722B2 (ja) 2017-04-05
EP2486916A1 (en) 2012-08-15
WO2008076819A3 (en) 2009-03-26
US20120088724A1 (en) 2012-04-12
EP2486916A8 (en) 2013-03-27
WO2008076819A2 (en) 2008-06-26
CA2672284C (en) 2014-08-26
EP2120869A2 (en) 2009-11-25
JP2015214573A (ja) 2015-12-03

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