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1. JP2005008545 - HUMAN GROWTH HORMONE SUSTAINED RELEASE FINE PARTICLE PREPARATION AND METHOD FOR PRODUCING THE SAME

Office
Japan
Application Number 2003173410
Application Date 18.06.2003
Publication Number 2005008545
Publication Date 13.01.2005
Grant Number 3915001
Grant Date 16.02.2007
Publication Kind B2
IPC
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 (Somatotropin)
A61K 9/52
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
48Preparations in capsules, e.g. of gelatin, of chocolate
52Sustained or differential release type
A61K 47/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
02Inorganic compounds
A61K 47/04
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
02Inorganic compounds
04Non-metals; Compounds thereof
A61P 5/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
5Drugs for disorders of the endocrine system
10of the posterior pituitary hormones, e.g. oxytocin, ADH
CPC
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
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)
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 JAPAN SCIENCE & TECHNOLOGY AGENCY
国立研究開発法人科学技術振興機構
OGAWA TAIRYO
ガレニサーチ株式会社
FUJII TAKAO
国立研究開発法人物質・材料研究機構
MIYAMOTO YOKO
NIIMI JUN
NATIONAL INSTITUTE FOR MATERIALS SCIENCE
Inventors OGAWA TAIRYO
小川 泰亮
IKOMA TOSHIYUKI
生駒 俊之
FUJII TAKAO
藤井 隆雄
MIYAMOTO YOKO
宮本 陽子
NIIMI JUN
新美 純
TANAKA JUNZO
田中 順三
Agents 高橋 剛
高橋 雅和
Title
(EN) HUMAN GROWTH HORMONE SUSTAINED RELEASE FINE PARTICLE PREPARATION AND METHOD FOR PRODUCING THE SAME
(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)

PROBLEM TO BE SOLVED: To provide a human growth hormone sustained release fine particle preparation which can avoid the employment of an organic solvent to the utmost, has both biodegradability and sustained release performance, sustains the release of the human growth hormone for three or more days, inhibits an initial burst release, can enhance the content of the human growth hormone to 10 % or more, can quantitatively adsorb and encapsulate the human growth hormone up to 20%, and has good dispersibility and needle passableness, and to provide a method for producing the same.

SOLUTION: This human growth hormone sustained release fine particle preparation is characterized by comprising a porous apatite derivative, the human growth hormone and a water-soluble divalent metal compound. The method for producing the human growth hormone sustained release fine particle preparation is characterized by stirring and dispersing fine porous apatite derivative particles in water containing the human growth hormone to infiltrate the aqueous solution in the porous apatite derivative, adding an aqueous solution containing the water-soluble divalent metal compound to infiltrate the water-soluble divalent metal compound in the porous apatite derivative, adding additives such as a stabilizer, and then lyophilizing or vacuum-drying the mixture.

COPYRIGHT: (C)2005,JPO&NCIPI


(JA)

【課題】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。
【解決手段】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。多孔性アパタイト誘導体の微粒子をヒト成長ホルモン含有の水中に撹拌・分散し、水溶液が該多孔性アパタイト誘導体中に浸潤した後、水溶性2価金属化合物を含む水溶液を添加し、水溶性2価金属化合物を該多孔性アパタイト誘導体中に浸潤させ、その後、安定剤などの添加物を加えて凍結または真空乾燥させることによって製造されること。
【選択図】 なし


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