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1. CA2524256 - SUSTAINED-RELEASE FINE GRANULAR PREPARATION OF HUMAN GROWTH HORMONE AND PROCESS FOR PRODUCING THE SAME

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Canada
Application Number 2524256
Application Date 15.06.2004
Publication Number 2524256
Publication Date 29.12.2004
Publication Kind A1
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 9/14
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
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
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 AND TECHNOLOGY AGENCY
INDEPENDENT ADMINISTRATIVE INSTITUTION, NATIONAL INSTITUTE FOR MATERIALS SCIENCE
GALENISEARCH, LABORATORIES
Inventors OGAWA, YASUAKI
FUJII, TAKAO
MIYAMOTO, YOKO
NIIMI, JUN
IKOMA, TOSHIYUKI
TANAKA, JUNZOU
Priority Data 2003173410 18.06.2003 JP
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
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.


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