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)
  • 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)
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 (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)

* 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 (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
DK2486916T3 (en) 2015-06-15
US8071544B2 (en) 2011-12-06
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

Similar Documents

Publication Publication Date Title
CA2672284C (en) Human growth hormone formulations
AU2003238862B9 (en) Formulations for amylin agonist peptides
JP6522711B2 (ja) Ｆｓｈの安定化
JP2004523589A (ja) 改善された安定性を有するいかなる量の亜鉛も含有しないかまたはほんの少量の亜鉛しか含有しないインスリン製剤
JP2002524514A (ja) タンパク質製剤
EP2563809B1 (en) Stable aqueous mia/cd-rap formulations
CN1665541A (zh) 含甘氨酸的高浓度人生长激素液体制剂
KR20110086583A (ko) 제8 인자 제형
IL229977A (en) Freeze-dried preparations containing 18 fgf
WO2002067989A1 (en) Crystallisation-resistant aqueous growth hormone formulations
JP2023166014A (ja) コラーゲン７組成物及びそれを用いる方法
JP2001524090A (ja) ペプチド、タンパク質および核酸を投与するための安定製剤形態
EA010626B1 (ru) Жидкий состав гормона роста
HK1174558A (en) Human growth hormone formulations
HK1174558B (en) Human growth hormone formulations
US20090023629A1 (en) Compositions comprising polycation-complexed protein crystals and methods of treatment using them
HK1061521B (en) Insulin preparations, which do not contain any zinc or only a small quantity of zinc and which have an improved stability
HK1194689A (en) Freeze-dried formulations of fgf-18

Legal Events

Date Code Title Description
EEER Examination request
MKLA Lapsed

Effective date: 20201214