JP4255515B2 - 安定化された成長ホルモン処方物およびその製造方法 - Google Patents

安定化された成長ホルモン処方物およびその製造方法 Download PDF

Info

Publication number
JP4255515B2
JP4255515B2 JP52882197A JP52882197A JP4255515B2 JP 4255515 B2 JP4255515 B2 JP 4255515B2 JP 52882197 A JP52882197 A JP 52882197A JP 52882197 A JP52882197 A JP 52882197A JP 4255515 B2 JP4255515 B2 JP 4255515B2
Authority
JP
Japan
Prior art keywords
formulation
hgh
growth hormone
buffer
stabilizers
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 - Lifetime
Application number
JP52882197A
Other languages
English (en)
Japanese (ja)
Other versions
JP2000504696A5 (enExample
JP2000504696A (ja
Inventor
マイケル、ケビン、マクナマーラ
ウィリアム、ネイル、シャーマン
スーザン、アン、シャーマン
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.)
Monash University
Original Assignee
Monash University
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=3792327&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP4255515(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Monash University filed Critical Monash University
Publication of JP2000504696A publication Critical patent/JP2000504696A/ja
Publication of JP2000504696A5 publication Critical patent/JP2000504696A5/ja
Application granted granted Critical
Publication of JP4255515B2 publication Critical patent/JP4255515B2/ja
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Images

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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
    • 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
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
JP52882197A 1996-02-12 1997-02-12 安定化された成長ホルモン処方物およびその製造方法 Expired - Lifetime JP4255515B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
AU8012 1996-02-12
AUPN8012A AUPN801296A0 (en) 1996-02-12 1996-02-12 Stabilised growth hormone formulation and method of preparation thereof
PCT/AU1997/000075 WO1997029767A1 (en) 1996-02-12 1997-02-12 Stabilised growth hormone formulation and method of preparation thereof

Publications (3)

Publication Number Publication Date
JP2000504696A JP2000504696A (ja) 2000-04-18
JP2000504696A5 JP2000504696A5 (enExample) 2004-11-18
JP4255515B2 true JP4255515B2 (ja) 2009-04-15

Family

ID=3792327

Family Applications (1)

Application Number Title Priority Date Filing Date
JP52882197A Expired - Lifetime JP4255515B2 (ja) 1996-02-12 1997-02-12 安定化された成長ホルモン処方物およびその製造方法

Country Status (12)

Country Link
US (1) US6593296B1 (enExample)
EP (1) EP0889733B1 (enExample)
JP (1) JP4255515B2 (enExample)
CN (1) CN1132626C (enExample)
AT (1) ATE340587T1 (enExample)
AU (1) AUPN801296A0 (enExample)
CA (1) CA2246501C (enExample)
DE (1) DE69736739T2 (enExample)
DK (1) DK0889733T3 (enExample)
RU (1) RU2191029C2 (enExample)
TR (1) TR199801558T2 (enExample)
WO (1) WO1997029767A1 (enExample)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6277410B1 (en) * 1992-10-08 2001-08-21 Supratek Pharma Inc. Copolymer compositions for oral delivery
CA2378949C (en) * 1999-07-12 2015-03-31 Grandis Biotech Gmbh Growth hormone formulations
AT408721B (de) * 1999-10-01 2002-02-25 Cistem Biotechnologies Gmbh Pharmazeutische zusammensetzung enthaltend ein antigen
KR20080011353A (ko) 2000-02-24 2008-02-01 몬산토 테크놀로지 엘엘씨 소마토트로핀의 지속적인 방출을 위한 비수성 주사제제들
AU2001271491A1 (en) 2000-06-26 2002-01-08 Monsanto Technology Llc Non-aqueous surfactant-containing formulations for extended release of somatotropin
US6664234B1 (en) 2000-06-30 2003-12-16 Monsanto Technology Llc Non-aqueous injectable formulation preparation with pH adjusted for extended release of somatotropin
GB2371227A (en) * 2001-01-10 2002-07-24 Grandis Biotech Gmbh Crystallisation - resistant aqueous growth hormone formulations
JP4610154B2 (ja) * 2002-05-30 2011-01-12 大塚製薬株式会社 注射用製剤
CN101659701B (zh) * 2002-12-31 2019-03-26 阿尔特斯制药公司 人生长激素晶体和制备它们的方法
JP4949828B2 (ja) * 2003-03-18 2012-06-13 アレス トレーディング ソシエテ アノニム 溶液中での成長ホルモンの安定化
JP2007506683A (ja) * 2003-09-25 2007-03-22 カンジェーン コーポレイション ヒト成長ホルモン剤およびその調整方法と使用方法
US8338374B2 (en) 2003-12-23 2012-12-25 Pharmacia Corporation Stable growth hormone liquid formulation
UA89781C2 (uk) * 2004-04-07 2010-03-10 Арес Трейдінг С.А. Рідкий склад гормона росту
DE602005009856D1 (de) 2004-11-09 2008-10-30 Ares Trading Sa Verfahren zur reinigung von fsh
DK1917276T3 (en) 2005-08-26 2018-05-07 Ares Trading Sa Process for Preparation of Glycosylated Interferon Beta
AU2006323925B2 (en) 2005-12-09 2012-08-02 Ares Trading S.A. Method for purifying FSH or a FSH mutant
CN105363022A (zh) * 2006-07-06 2016-03-02 株式会社大熊 稳定的人生长激素液体制剂
PT2049148T (pt) * 2006-07-06 2016-12-30 Daewoong Co Ltd Formulação líquida estável da hormona do crescimento humana
US10391062B2 (en) 2008-04-21 2019-08-27 Novo Nordisk Healthcare Ag Dry transglutaminase composition
US20140194356A1 (en) * 2011-07-25 2014-07-10 Sandoz Ag Aqueous formulation comprising at least a neutral salt and a biopharmaceutical protein
US10064951B2 (en) * 2012-03-30 2018-09-04 Hanmi Science Co., Ltd. Liquid formulation of highly concentrated long-acting human growth hormone conjugate
BR112016006455A2 (pt) * 2013-09-27 2017-08-01 Hanmi Pharm Ind Co Ltd ?formulação de conjugado de hormônio de crescimento humano de ação prolongada?

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB131864A (enExample)
DE3325223A1 (de) * 1983-07-13 1985-01-24 Hoechst Ag, 6230 Frankfurt Gegen denaturierung bestaendige, waessrige proteinloesungen, verfahren zu ihrer herstellung und ihre verwendung
BR8603586A (pt) * 1985-07-30 1987-03-10 Int Minerals & Chem Corp Processo para manter a fluidez de um homonio;processo para efetuar a promocao de crescimento em animais e formulacao promotora de crescimento
IT1222395B (it) * 1987-07-30 1990-09-05 Pierrel Spa Composizione farmaceutica per somministrazione intranasale comprendente l'ormone ghrh,un agonista colinergico e/o un sale biliare
ATE82506T1 (de) 1987-08-21 1992-12-15 Imcera Group Inc Stabilisierung von wachstumshormonen.
US5096885A (en) 1988-04-15 1992-03-17 Genentech, Inc. Human growth hormone formulation
GB8822857D0 (en) * 1988-09-29 1988-11-02 Patralan Ltd Pharmaceutical formulations
EP0374120A3 (en) * 1988-12-13 1991-07-31 Monsanto Company Comosition for controlled release of polypeptides
US5013714A (en) * 1988-12-15 1991-05-07 Lindstrom Richard L Viscoelastic solution
US4994439A (en) * 1989-01-19 1991-02-19 California Biotechnology Inc. Transmembrane formulations for drug administration
US5182258A (en) * 1989-03-20 1993-01-26 Orbon Corporation Systemic delivery of polypeptides through the eye
US5126324A (en) * 1990-06-07 1992-06-30 Genentech, Inc. Method of enhancing growth in patients using combination therapy
US5210017A (en) * 1990-11-19 1993-05-11 Genentech, Inc. Ligand-mediated immunofunctional hormone binding protein assay method
DK204791D0 (da) * 1991-12-20 1991-12-20 Novo Nordisk As Hidtil ukendt farmaceutisk praeparat
SE9201073D0 (sv) 1992-04-03 1992-04-03 Kabi Pharmacia Ab Protein formulation
MD1699F2 (ro) * 1992-07-31 2001-07-31 Genentech, Inc. Compoziţie apoasă a hormonului somatotrop uman şi procedeu de prevenire a denaturării ei
WO1994007510A1 (en) * 1992-10-02 1994-04-14 Kabi Pharmacia Ab Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
JP3698721B2 (ja) * 1993-02-23 2005-09-21 ジェネンテク・インコーポレイテッド 有機溶媒を用いて処理したポリペプチドの賦形剤安定化
CA2176927C (en) * 1993-11-17 2010-03-23 Seang H. Yiv Transparent liquid for encapsulated drug delivery

Also Published As

Publication number Publication date
CN1214633A (zh) 1999-04-21
AUPN801296A0 (en) 1996-03-07
CN1132626C (zh) 2003-12-31
US6593296B1 (en) 2003-07-15
ATE340587T1 (de) 2006-10-15
RU2191029C2 (ru) 2002-10-20
CA2246501C (en) 2012-07-10
DE69736739T2 (de) 2007-08-16
CA2246501A1 (en) 1997-08-21
HK1017851A1 (en) 1999-12-03
TR199801558T2 (xx) 1998-11-23
WO1997029767A1 (en) 1997-08-21
DE69736739D1 (de) 2006-11-09
EP0889733B1 (en) 2006-09-27
EP0889733A4 (en) 1999-11-03
EP0889733A1 (en) 1999-01-13
JP2000504696A (ja) 2000-04-18
DK0889733T3 (da) 2007-01-29

Similar Documents

Publication Publication Date Title
EP0889733B1 (en) Stabilised growth hormone formulation and method of preparation thereof
RU2236250C2 (ru) Фармацевтическая композиция, содержащая гормон роста, аминокислоту и неионогенный детергент
CA2139358C (en) Human growth hormone aqueous formulation
JP6143827B2 (ja) ｈＧＨとｒｈＩＧＦ−１の組合せのための配合物
EP1180368B1 (en) Freeze dried hgf preparations
PT1397155E (pt) Formulação de libertação sustentada
US6150331A (en) Human growth hormone-containing aqueous pharmaceutical composition
US8841252B2 (en) Pharmaceutical formulation
JPH10507182A (ja) 成長ホルモンおよびイソロイシンを含んでなる医薬製剤
JPH10507181A (ja) 成長ホルモンおよびバリンを含んでなる医薬製剤
JP2003504346A (ja) 成長ホルモン製剤
US20060074011A1 (en) Compositions providing for increased IGF-I solubility
JPH10507183A (ja) 成長ホルモンおよびロイシンを含んでなる医薬製剤
AU716747B2 (en) Stabilised growth hormone formulation and method of preparation thereof
US20090298768A1 (en) Stable liquid formulation of human growth hormone
US20030162711A1 (en) Pharmaceutical formulation
JP2001522814A (ja) 増大されたｉｇｆ−ｉ溶解性を提供する組成物
HK1017851B (en) Stabilised growth hormone formulation and method of preparation thereof
JP2007506683A (ja) ヒト成長ホルモン剤およびその調整方法と使用方法
JPH10511963A (ja) 成長ホルモン及びＬｙｓ−Ｘを含む安定化医薬製剤

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20040130

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20040130

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20070206

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20070507

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20070531

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20070625

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20090106

A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20090128

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20120206

Year of fee payment: 3

R150 Certificate of patent or registration of utility model

Free format text: JAPANESE INTERMEDIATE CODE: R150

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20120206

Year of fee payment: 3

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20120206

Year of fee payment: 3

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20120206

Year of fee payment: 3

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20120206

Year of fee payment: 3

RD02 Notification of acceptance of power of attorney

Free format text: JAPANESE INTERMEDIATE CODE: R3D02

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20120206

Year of fee payment: 3

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20130206

Year of fee payment: 4

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20130206

Year of fee payment: 4

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20130206

Year of fee payment: 4

R157 Certificate of patent or utility model (correction)

Free format text: JAPANESE INTERMEDIATE CODE: R157

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20130206

Year of fee payment: 4

FPAY Renewal fee payment (event date is renewal date of database)

Free format text: PAYMENT UNTIL: 20140206

Year of fee payment: 5

RVTR Cancellation due to determination of trial for invalidation