DK2486916T3 - Formulations of Human Growth Hormone - Google Patents

Formulations of Human Growth Hormone Download PDF

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Publication number
DK2486916T3
DK2486916T3 DK11010051.8T DK11010051T DK2486916T3 DK 2486916 T3 DK2486916 T3 DK 2486916T3 DK 11010051 T DK11010051 T DK 11010051T DK 2486916 T3 DK2486916 T3 DK 2486916T3
Authority
DK
Denmark
Prior art keywords
hgh
crystals
poly
buffer
suspension
Prior art date
Application number
DK11010051.8T
Other languages
Danish (da)
English (en)
Inventor
Lawrence Bush
Sergey Pechenov
Sujit K Basu
Wen-Li Chung
Original Assignee
Ajinomoto Althea 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 Ajinomoto Althea Inc filed Critical Ajinomoto Althea Inc
Application granted granted Critical
Publication of DK2486916T3 publication Critical patent/DK2486916T3/en

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Classifications

    • 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 or needleless injectors

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Endocrinology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (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)
DK11010051.8T 2006-12-18 2007-12-13 Formulations of Human Growth Hormone DK2486916T3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US87060506P 2006-12-18 2006-12-18
EP07869230A EP2120869A2 (en) 2006-12-18 2007-12-13 Human growth hormone formulations

Publications (1)

Publication Number Publication Date
DK2486916T3 true DK2486916T3 (en) 2015-06-15

Family

ID=39402753

Family Applications (1)

Application Number Title Priority Date Filing Date
DK11010051.8T DK2486916T3 (en) 2006-12-18 2007-12-13 Formulations of Human Growth Hormone

Country Status (7)

Country Link
US (2) US8071544B2 (https=)
EP (2) EP2486916B1 (https=)
JP (2) JP2010513309A (https=)
AU (1) AU2007333959A1 (https=)
CA (1) CA2672284C (https=)
DK (1) DK2486916T3 (https=)
WO (1) WO2008076819A2 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009094172A2 (en) 2008-01-22 2009-07-30 Araim Pharmaceuticals, Inc. Tissue protective peptides and peptide analogs for preventing and treating diseases and disorders associated with tissue damage
TW201023912A (en) * 2008-12-05 2010-07-01 Alcon Res Ltd Pharmaceutical suspension
US8912236B2 (en) 2009-03-03 2014-12-16 Alcon Research, Ltd. Pharmaceutical composition for delivery of receptor tyrosine kinase inhibiting (RTKi) compounds to the eye
US20120018338A1 (en) * 2009-03-30 2012-01-26 Hoffman-La Roche Inc. Method for avoiding glass fogging
CA2765220A1 (en) * 2009-07-14 2011-01-20 Biogen Idec Ma Inc. Methods for inhibiting yellow color and peroxide formation in a composition
WO2011028962A1 (en) * 2009-09-04 2011-03-10 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
AU2012229104B2 (en) * 2011-03-15 2017-03-16 Biogen Ma Inc. Method for reducing flu-like symptoms associated with intramuscular administration of interferon using a fast titration escalating dosing regimen
JP6363949B2 (ja) * 2011-07-25 2018-07-25 サンド アクチェンゲゼルシャフト 少なくとも中性塩および生物薬学的タンパク質を含む、水性製剤
US20140294977A1 (en) * 2011-11-23 2014-10-02 Durect Corporation Radiation-Sterilized Biodegradable Drug Delivery Composition
JP6527697B2 (ja) 2013-01-28 2019-06-05 国立大学法人 熊本大学 タンパク質を安定化させたゲル状製剤
JP6444310B2 (ja) * 2013-10-28 2018-12-26 テルモ株式会社 モノクローナル抗体の安定化方法
JP6564369B2 (ja) 2013-12-09 2019-08-21 デュレクト コーポレイション 薬学的活性剤複合体、ポリマー複合体、ならびにこれらを伴う組成物及び方法
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

Family Cites Families (17)

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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.
DK168790D0 (https=) * 1990-07-13 1990-07-13 Novo Nordisk As
DK0618807T3 (da) * 1991-12-20 2003-03-03 Novo Nordisk As Stabiliseret farmaceutisk formulering omfattende human væksthormon og histidin
ES2153385T5 (es) * 1992-07-31 2008-09-01 Genentech, Inc. Composicion acuosa a base de hormona del crecimiento humana.
DE69426292T2 (de) * 1993-02-23 2001-05-17 Genentech, Inc. Stabilisierung von mit organischen lösungsmittel behandelten polypeptiden mit einem hilfsstoff
US5439643A (en) * 1993-11-03 1995-08-08 Liebert; Richard T. Method and apparatus for terminal sterilization
ATE184798T1 (de) * 1994-06-17 1999-10-15 Applied Research Systems Hgh enthaltende pharmazeutische zubereitungen
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
WO2001055360A1 (en) * 2000-01-28 2001-08-02 Infimed Therapeutics, Inc. Slow release protein polymers
NZ554885A (en) 2002-12-31 2009-07-31 Altus Pharmaceuticals Inc Complexes of hgh crystals and protamine polymers
EP2460530A3 (en) * 2002-12-31 2012-08-29 Althea Technologies, Inc. Human growth hormone crystals and methods for preparing them
US20090023629A1 (en) * 2005-12-23 2009-01-22 Altus Pharmaceuticals Inc. Compositions comprising polycation-complexed protein crystals and methods of treatment using them

Also Published As

Publication number Publication date
US8071544B2 (en) 2011-12-06
CA2672284C (en) 2014-08-26
US20100216705A1 (en) 2010-08-26
CA2672284A1 (en) 2008-06-26
WO2008076819A3 (en) 2009-03-26
AU2007333959A1 (en) 2008-06-26
WO2008076819A2 (en) 2008-06-26
EP2486916B1 (en) 2015-04-01
JP6106722B2 (ja) 2017-04-05
JP2015214573A (ja) 2015-12-03
EP2120869A2 (en) 2009-11-25
EP2486916A8 (en) 2013-03-27
US20120088724A1 (en) 2012-04-12
EP2486916A1 (en) 2012-08-15
JP2010513309A (ja) 2010-04-30

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