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1. WO2004112827 - SUSTAINED-RELEASE FINE GRANULAR PREPARATION OF HUMAN GROWTH HORMONE AND PROCESS FOR PRODUCING THE SAME

Publication Number WO/2004/112827
Publication Date 29.12.2004
International Application No. PCT/JP2004/008344
International Filing Date 15.06.2004
IPC
A61K 9/16 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
16Agglomerates; Granulates; Microbeadlets
A61K 38/27 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
27Growth hormone (Somatotropin)
CPC
A61K 38/27
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
27Growth hormone [GH] (Somatotropin)
A61K 9/0019
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
A61K 9/1611
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1605Excipients; Inactive ingredients
1611Inorganic compounds
A61K 9/1694
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1682Processes
1694resulting in granules or microspheres of the matrix type containing more than 5% of excipient
A61K 9/19
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
19lyophilised ; , i.e. freeze-dried, solutions or dispersions
A61P 43/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
43Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Applicants
  • 独立行政法人 科学技術振興機構 JAPAN SCIENCE AND TECHNOLOGY AGENCY [JP]/[JP] (AllExceptUS)
  • 独立行政法人物質・材料研究機構 INDEPENDENT ADMINISTRATIVE INSTITUTION, NATIONAL INSTITUTE FOR MATERIALS SCIENCE [JP]/[JP] (AllExceptUS)
  • GALENISEARCH, LABORATORIES [JP]/[JP] (AllExceptUS)
  • 小川 泰亮 OGAWA, Yasuaki [JP]/[JP] (UsOnly)
  • 藤井 隆雄 FUJII, Takao [JP]/[JP] (UsOnly)
  • 宮本 陽子 MIYAMOTO, Yoko [JP]/[JP] (UsOnly)
  • 新美 純 NIIMI, Jun [JP]/[JP] (UsOnly)
  • 生駒 俊之 IKOMA, Toshiyuki [JP]/[JP] (UsOnly)
  • 田中 順三 TANAKA, Junzo [JP]/[JP] (UsOnly)
Inventors
  • 小川 泰亮 OGAWA, Yasuaki
  • 藤井 隆雄 FUJII, Takao
  • 宮本 陽子 MIYAMOTO, Yoko
  • 新美 純 NIIMI, Jun
  • 生駒 俊之 IKOMA, Toshiyuki
  • 田中 順三 TANAKA, Junzo
Agents
  • 高橋 剛 TAKAHASHI, Takeshi
Priority Data
2003-17341018.06.2003JP
Publication Language Japanese (ja)
Filing Language Japanese (JA)
Designated States
Title
(EN) SUSTAINED-RELEASE FINE GRANULAR PREPARATION OF HUMAN GROWTH HORMONE AND PROCESS FOR PRODUCING THE SAME
(FR) PREPARATION GRANULAIRE FINE A LIBERATION PROLONGEE D'HORMONE DE CROISSANCE HUMAINE ET PROCEDE DE PRODUCTION CORRESPONDANT
(JA) ヒト成長ホルモンの徐放性微粒子製剤およびその製造方法
Abstract
(EN) It is intended to provide a sustained release fine granular preparation of human growth hormone having both of biodegradability and sustained-release performance with the use of an organic solvent in a minimized amount, ensuring the release of human growth hormone over 3 days or longer, showing regulated initial burst release, being able to have human growth hormone at a content of 10% or more, allowing the quantitative adsorption/encapsulation of sustained-release fine granules of human growth hormone up to 20%, and having favorable dispersion and needle penetration properties, and a process for producing the same. This preparation comprises a porous apatite derivative, human growth hormone and a water-soluble divalent metal compound.
(FR) L'invention vise à mettre au point une préparation granulaire fine à libération prolongée, ayant à la fois des propriétés de biodégradabilité et de libération prolongée, à l'aide d'un solvant organique, dans une quantité minimisée, assurant la libération de l'hormone de croissance humaine pendant 3 jours ou davantage, indiquant une libération en rafale initiale régulée, en mesure de comprendre une teneur d'au moins 10 % d'hormone de croissance humaine, permettant l'adsorption/l'encapsulation quantitative de fins granulés à libération prolongée d'hormone de croissance, à concurrence de 20 % et présentant des propriétés de dispersion et de pénétration d'aiguille favorables. L'invention concerne également un procédé de préparation correspondant. Cette préparation comprend un dérivatif d'apatite poreux, l'hormone de croissance humaine et un composé métallique bivalent soluble dans l'eau.
(JA) 有機溶媒の使用を極力避けて生体内分解性および徐放性能を併せもち、3日間以上にわたりヒト成長ホルモンが徐放され、初期バースト放出が抑制され、ヒト成長ホルモン含有率も10% 以上とすることができ、ヒト成長ホルモンを定量的に最大20%まで吸着封入することができ、かつ分散性、通針性も良好であるヒト成長ホルモンの徐放性微粒子製剤及びその製造方法を提供することにある。多孔性アパタイト誘導体、ヒト成長ホルモンおよび水溶性2価金属化合物からなること。
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US2006258575This application is not viewable in PATENTSCOPE because the national phase entry has not been published yet or the national entry is issued from a country that does not share data with WIPO or there is a formatting issue or an unavailability of the application.
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