KIM, Hyung Seo,김형서,CHO, Jung Hyun,조정현,KIM, Jin Cheul,김진철,KIM, Yong Il,김용일,PARK, Jae Hyun,박재현,WOO, Jong Soo,우종수
申请号：
KRKR2017/007586
公开号：
WO2018/012931A1
申请日:
2017.07.14
申请国别(地区):
KR
年份:
2018
代理人:
摘要：
The present invention relates to an oral pharmaceutical preparation containing a tamsulosin hydrochloride-containing extended release pellet containing tamsulosin hydrochloride and a pharmaceutically acceptable additive, wherein the extended release pellet comprises particles having a particle size of approximately 0.50-0.85 mm in an amount of approximately 50-100 wt% and particles of approximately 0.50 mm or less in an amount of less than approximately 15 wt%. The oral pharmaceutical preparation of the present invention exhibits low tamsulosin hydrochloride dissolution deviation and a constant amount in products, thereby having high production reproducibility for products so as to facilitate quality assurance for the preparation.La présente invention concerne une préparation pharmaceutique orale composé d'une pastille, à libération prolongée, avec du chlorhydrate de tamsulosine contenant du chlorhydrate de tamsulosine et un additif pharmaceutique. La pastille à libération prolongée comprend 50 à 100 % de particules de 0,50 à 0,85 mm et moins de 15% de particules de 0,50 mm ou moins. Cette préparation a une faible déviation de dissolution de chlorhydrate de tamsulosine et une quantité constante de produits, ce qui permet d'obtenir une reproductibilité de production élevée pour les produits et de faciliter la qualité de la préparation.본 발명은 탐수로신 염산염 및 약제학적으로 허용 가능한 첨가제를 함유하는, 탐수로신 염산염 함유 서방성 펠렛을 포함하는 경구용 약제학적 제제로서, 상기 서방성 펠렛은 입도가 약 0.50mm 내지 0.85mm인 입자를 약 50 내지 100 중량%, 약 0.50mm 이하인 입자를 약 15 중량% 미만의 비율로 포함하는, 경구용 약제학적 제제에 관한 것이다. 본 발명의 경구용 약제학적 제제는 제품간에 탐수로신 염산염의 용출 편차가 적고, 함량이 일정하게 나타나므로, 제품의 생산 재현성이 높아 제제의 품질 확보에 용이하다.
