CA2672284C - Human growth hormone formulations - Google Patents

Human growth hormone formulations Download PDF

Info

Publication number
CA2672284C
CA2672284C CA2672284A CA2672284A CA2672284C CA 2672284 C CA2672284 C CA 2672284C CA 2672284 A CA2672284 A CA 2672284A CA 2672284 A CA2672284 A CA 2672284A CA 2672284 C CA2672284 C CA 2672284C
Authority
CA
Canada
Prior art keywords
hgh
crystals
poly
suspension
buffer
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.)
Expired - Fee Related
Application number
CA2672284A
Other languages
English (en)
French (fr)
Other versions
CA2672284A1 (en
Inventor
Wen-Li Chung
Lawrence Bush
Sergey Pechenov
Sujit K. Basu
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ajinomoto Althea Inc
Original Assignee
Althea Technologies 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 Althea Technologies Inc filed Critical Althea Technologies Inc
Publication of CA2672284A1 publication Critical patent/CA2672284A1/en
Application granted granted Critical
Publication of CA2672284C publication Critical patent/CA2672284C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Biochemistry (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)
CA2672284A 2006-12-18 2007-12-13 Human growth hormone formulations Expired - Fee Related CA2672284C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US87060506P 2006-12-18 2006-12-18
US60/870,605 2006-12-18
PCT/US2007/087417 WO2008076819A2 (en) 2006-12-18 2007-12-13 Human growth hormone formulations

Publications (2)

Publication Number Publication Date
CA2672284A1 CA2672284A1 (en) 2008-06-26
CA2672284C true CA2672284C (en) 2014-08-26

Family

ID=39402753

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2672284A Expired - Fee Related CA2672284C (en) 2006-12-18 2007-12-13 Human growth hormone formulations

Country Status (7)

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

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
CN102361632A (zh) * 2009-03-30 2012-02-22 弗·哈夫曼-拉罗切有限公司 避免玻璃雾化的方法
WO2011008770A2 (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
CA2846786C (en) 2011-03-15 2022-05-17 Biogen Idec Inc. Method for reducing flu-like symptoms associated with intramuscular administration of interferon using a fast titration escalating dosing regimen
WO2013014196A1 (en) 2011-07-25 2013-01-31 Sandoz Ag Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein
TW201334791A (zh) * 2011-11-23 2013-09-01 杜瑞克公司 輻射滅菌之可生物降解之藥物遞送組合物
WO2014115882A1 (ja) 2013-01-28 2014-07-31 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
EP3064213B1 (en) * 2013-10-28 2026-08-19 Terumo Kabushiki Kaisha Protein aqueous suspension
WO2015088990A1 (en) 2013-12-09 2015-06-18 Durect Corporation Pharmaceutically active agent complexes, polymer complexes, and compositions and methods involving the same
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)

* 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.
DK168790D0 (enExample) * 1990-07-13 1990-07-13 Novo Nordisk As
DE10399015I1 (de) * 1991-12-20 2012-05-03 Novo Nordisk As Stabilisierte pharmazeutische formulierung, die wachstumshormon und histidin enthält
DK0955062T3 (da) * 1992-07-31 2007-09-17 Genentech Inc Vandig formulering indeholdende humant væksthormon
DK0686045T3 (da) * 1993-02-23 2001-03-05 Genentech Inc Stabilisering af med organisk opløsningsmiddel behandlede polypeptider med et hjælpestof
US5439643A (en) * 1993-11-03 1995-08-08 Liebert; Richard T. Method and apparatus for terminal sterilization
DE69420872T2 (de) * 1994-06-17 2000-01-13 Applied Research Systems Ars Holding N.V., Curacao 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
EP1255823A4 (en) * 2000-01-28 2007-10-31 Azopax Therapeutics Llc PROTEIN POLYMERS WITH SLOW RELEASE
DK1581251T3 (da) 2002-12-31 2016-06-27 Althea Tech Inc Krystaller af humant væksthormon og fremgangsmåder til fremstilling deraf
KR20050094832A (ko) 2002-12-31 2005-09-28 알투스 파마슈티컬스 인코포레이티드 단백질 결정과 이온성 중합체를 함유하는 복합체
EP1976551A4 (en) * 2005-12-23 2009-12-30 Altus Pharmaceuticals Inc COMPOSITIONS COMPRISING COMPLEX PROTEIN CRYSTALS BY POLYCATIONS AND PROCESSING METHOD THEREOF

Also Published As

Publication number Publication date
DK2486916T3 (en) 2015-06-15
JP2010513309A (ja) 2010-04-30
EP2486916A1 (en) 2012-08-15
JP2015214573A (ja) 2015-12-03
WO2008076819A3 (en) 2009-03-26
JP6106722B2 (ja) 2017-04-05
WO2008076819A2 (en) 2008-06-26
EP2486916A8 (en) 2013-03-27
CA2672284A1 (en) 2008-06-26
AU2007333959A1 (en) 2008-06-26
US20100216705A1 (en) 2010-08-26
US8071544B2 (en) 2011-12-06
EP2486916B1 (en) 2015-04-01
EP2120869A2 (en) 2009-11-25
US20120088724A1 (en) 2012-04-12

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Effective date: 20201214