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1. EP1640019 - SUSTAINED-RELEASE FINE GRANULAR PREPARATION OF HUMAN GROWTH HORMONE AND PROCESS FOR PRODUCING THE SAME

Office
European Patent Office
Application Number 04745898
Application Date 15.06.2004
Publication Number 1640019
Publication Date 29.03.2006
Publication Kind B1
IPC
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 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 9/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
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 9/16
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 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
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 5/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
5Drugs for disorders of the endocrine system
Applicants INDP ADMINISTRATIVE INST NIMS
Inventors OGAWA YASUAKI
FUJII TAKAO
MIYAMOTO YOKO
NIIMI JUN
IKOMA TOSHIYUKI
TANAKA JUNZO
Designated States
Priority Data 2003173410 18.06.2003 JP
Title
(DE) FEINKÖRNIGE ZUBEREITUNG DES HUMANEN WACHSTUMSHORMONS MTI VERZÖGERTER FREISETZUNG UND HERSTELLUNGSVERFAHREN DAFÜR
(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) Provided is a sustained-release microparticle preparation of a human growth hormone which combines biodegradability with sustained-release performance while avoiding the use of an organic solvent as much as possible, allows the sustained-release of a human growth hormone over 3 days or more and reduction in the initial burst release, can contain a human growth hormone at 10% or more, can quantitatively adsorb and encapsulate a human growth hormone at up to 20%, and has excellent dispersion and needle penetration properties. A process for producing the sustained-release microparticle preparation of a human growth hormone is also provided. The sustained-release microparticle preparation comprises a porous apatite derivative, a 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.
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