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1. WO2018135839 - MICROPARTICLE TYPE SUSTAINED-RELEASE INJECTABLE AGENT AND METHOD FOR PRODUCTION THEREFOR

Publication Number WO/2018/135839
Publication Date 26.07.2018
International Application No. PCT/KR2018/000751
International Filing Date 16.01.2018
IPC
A61K 9/00 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
A61K 9/10 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
10Dispersions; Emulsions
A61K 47/56 2017.01
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
51the non-active ingredient being a modifying agent
56the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
A61K 9/16 2006.01
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
CPC
A61K 47/56
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
51the non-active ingredient being a modifying agent
56the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
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 9/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
10Dispersions; Emulsions
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, ; 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
Applicants
  • 한국화학연구원 KOREA RESEARCH INSTITUTE OF CHEMICAL TECHNOLOGY [KR]/[KR]
Inventors
  • 신병철 SHIN, Byung Chul
  • 조선행 CHO, Sun Hang
Agents
  • 특허법인 필앤온지 PHIL & ONZI INT'L PATENT & LAW FIRM
Priority Data
10-2017-000791117.01.2017KR
Publication Language Korean (KO)
Filing Language Korean (KO)
Designated States
Title
(EN) MICROPARTICLE TYPE SUSTAINED-RELEASE INJECTABLE AGENT AND METHOD FOR PRODUCTION THEREFOR
(FR) AGENT INJECTABLE À LIBÉRATION PROLONGÉE DE TYPE MICROPARTICULE ET SON PROCÉDÉ DE PRODUCTION
(KO) 미립구형 서방출 주사제 및 그의 제조방법
Abstract
(EN)
The present invention relates to a biodegradable polymeric microparticle sustained-release preparation carrying micropowders as a drug and a method for producing such a sustained-release preparation. The sustained-release preparation includes a drug-polymer ion composite particle for delaying the release for a long period of time by loading the drug in a biodegradable polymer in the form of a composite with an ionic polymer. In the producing method according to the present invention, drug micropowders and drug-polymer ion composite particles for controlling release are loaded in microparticles made of a biodegradable polymer by using a S/O/W solvent intra extraction evaporation (Solid-in-Oil-in-Water; solvent intra extraction evaporation), and thus it is possible to increase productivity in a simple producing process, to maximize a loading amount and a loading efficiency of the drug in the microparticle, and to inhibit the initial overdose of the drug and to allow the drug to be continuously released over a long period of one month or longer in the body.
(FR)
La présente invention concerne une préparation à libération prolongée de microparticules polymères biodégradables portant des micropoudres à titre de médicament et un procédé de production de ladite préparation à libération prolongée. La préparation à libération prolongée comprend une particule composite de type médicament-ion polymère capable de retarder la libération pendant une longue période de temps par chargement du médicament dans un polymère biodégradable sous la forme d'un composite avec un polymère ionique. Dans le procédé de production selon la présente invention, des micropoudres de médicament et des particules composites de type médicament-ion polymère capables de réguler la libération sont chargées dans des microparticules constituées d'un polymère biodégradable par évaporation/intra-extraction à l'aide d'un solvant S/O/W (solide dans huile dans eau ; évaporation/intra-extraction à l'aide d'un solvant) et permettent ainsi d'accroître la productivité dans un procédé de production simple, de maximiser la quantité de charge et l'efficacité de chargement du médicament dans la microparticule, et d'inhiber la surdose initiale du médicament de façon que le médicament soit libéré en continu sur une longue période d'un mois ou plus dans le corps.
(KO)
본 발명은 약물로서 미세 분말을 담지하는 생분해성 고분자 미립구 서방출 제제 및 이러한 서방출 제제의 제조방법에 관한 것이다. 상기 서방출 제제는 약물이 이온성 고분자와 복합체 형태로 생분해성 고분자에 봉입되어 장기간 동안 방출을 지연시키기 위한 약물-고분자 이온복합체 입자를 포함한다. 본 발명에 따른 제조 방법은 S/O/W 용매 내 추출 증발법(Solid-in-Oil-in-Water; solvent intra extraction evaporation)을 이용하여 약물 미세분말 및 방출 조절용 약물-고분자 이온복합체 입자를 생분해성 고분자로 제조된 미립구에 봉입하는 것으로써 간단한 제조과정으로 생산성을 높일 수 있으며, 미립구 내 약물의 봉입량과 봉입 효율을 극대화하고, 초기 과다방출을 억제하며, 체내에서 약물이 1달 이상 장기간에 걸쳐 지속적으로 방출될 수 있다.
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