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1. WO2008075762 - SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME

Publication Number WO/2008/075762
Publication Date 26.06.2008
International Application No. PCT/JP2007/074617
International Filing Date 17.12.2007
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 31/55 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
55having seven-membered rings, e.g. azelastine, pentylenetetrazole
CPC
A61K 31/55
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
55having seven-membered rings, e.g. azelastine, pentylenetetrazole
A61K 38/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
A61K 38/08
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
08Peptides having 5 to 11 amino acids
A61K 38/095
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
08Peptides having 5 to 11 amino acids
095Oxytocins; Vasopressins; Related peptides
A61K 47/6925
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
50the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
69the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
6921the form being a particulate, a powder, an adsorbate, a bead or a sphere
6925the form being a microcapsule, nanocapsule, microbubble or nanobubble
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
Applicants
  • TAKEDA PHARMACEUTICAL COMPANY LIMITED [JP]/[JP] (AllExceptUS)
  • FUTO, Tomomichi [JP]/[JP] (UsOnly)
  • SAITO, Kazuhiro [JP]/[JP] (UsOnly)
  • HOSHINO, Tetsuo [JP]/[JP] (UsOnly)
  • HORI, Masuhisa [JP]/[JP] (UsOnly)
Inventors
  • FUTO, Tomomichi
  • SAITO, Kazuhiro
  • HOSHINO, Tetsuo
  • HORI, Masuhisa
Agents
  • TANAKA, Mitsuo
Priority Data
60/875,36418.12.2006US
60/917,40111.05.2007US
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME
(FR) COMPOSITION À LIBÉRATION PROLONGÉE ET PROCÉDÉ DE PRODUCTION CORRESPONDANT
Abstract
(EN) Sustained-release compositions wherein a water-soluble physiologically active peptide is substantially uniformly dispersed in a microcapsule comprised of a lactic acid polymer or a salt thereof, and the physiologically active substance is contained in an amount of 15 to 35 wt/wt% to the total microcapsules and weight-average molecular weight (Mw) of the lactic acid polymer is about 11,000 to about 27,000, which is characterized by having a high content of the physiologically active substance, and suppression of the initial excessive release within one day after the administration and a stable drug sustained-release over a long period of time, and method for producing the same.
(FR) La présente invention se rapporte à des compositions à libération prolongée comprenant un peptide physiologiquement actif hydrosoluble dispersé de manière sensiblement uniforme dans une microcapsule composée d'un polymère d'acide lactique ou d'un sel de celui-ci, la substance physiologiquement active étant présente en une quantité comprise entre 15 et 35% poids/poids par rapport au poids total des microcapsules, le poids moléculaire moyen en poids (Mw) du polymère d'acide lactique étant compris entre 11000 et 27000 environ. Ces compositions se caractérisent par une forte teneur en substance physiologiquement active, par la suppression de la libération excessive initiale dans le jour suivant l'administration et par une libération prolongée stable de médicament sur une longue période. Cette invention concerne également un procédé de production correspondant.
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