SK CHEMICALS CO., LTD.; LTD.;SK CHEMICALS CO.;에스케이케미칼주식회사
发明人:
IM, JONG SEOB,임종섭,HWANG, YONG YOUN,황용연,YOUN, WON NO,윤원노,PARK, YEO JIN,박여진,KIM, HYE MIN,김혜민,OH, JOON GYO,오준교,KIM, HUN TAEK,김훈택,LEE, BONG YONG,이봉용
申请号：
KR1020130010369
公开号：
KR1020130098902A
申请日:
2013.01.30
申请国别(地区):
KR
年份:
2013
代理人:
摘要：
PURPOSE: A transdermal formulation is provided to enable long-term release of donepezil in a constant rate and to prevent dose dumping. CONSTITUTION: A transdermal formulation comprises a support layer, a drug-containing matrix layer, an adhesion layer, and a release layer. The drug-containing matrix contains donepezil or a pharmaceutically acceptable salt thereof as an active ingredient, polyvinylpyrrolidone, and an acryl-based adhesive. The adhesion layer contains the acryl-based adhesive. A method for manufacturing the transdermal formulation comprises the steps of: dissolving the acryl-based adhesive in a solution containing donepezil or the pharmaceutical salt and polyvinylpyrrolidone； applying the prepared solution on a film and drying the applied solution to form a drug-containing matrix layer； and forming the adhesion layer containing the acryl-based adhesive on the drug-containing matrix layer. [Reference numerals] (AA) Example 3-1 5 cm2； (BB) Example 3-1 10 cm2； (CC) Comparative example 1본 발명은 도네페질을 특정 중합체를 사용하여 완전히 용해시켜 점착제와 함께 제제화한 약물-함유 매트릭스층 및 점착층을 갖는 이중층 구조의 경피흡수제제(예를 들어, 패치(patch) 형태의 경피흡수제제) 및 그의 제조방법을 제공한다. 본 발명에 따른 경피흡수제제는 제제내에서 도네페질의 석출을 나타내지 않으면서, 장시간 동안 균일한 속도로 도네페질을 방출할 수 있을 뿐만 아니라, 단일층 구조의 경피흡수제제에서 발생하는 방출 과다(release dumping) 현상을 방지할 수 있다.
