STABLE PHARMACEUTICAL FORMULATION FOR ORAL ADMINISTRATION COMPRISING LEVOCETIRIZINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND MONTELUKAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF
KWON, TAEK KWAN,KIM, DONG HO,KIM, KYEONG SOO,KIM, YONG IL,PARK, JAE HYUN,WOO, JONG SOO
申请号：
SG11201403811V
公开号：
SG11201403811VA
申请日:
2013.01.04
申请国别(地区):
SG
年份:
2014
代理人:
摘要：
PURPOSE: A stable pharmaceutical agent is provided to efficiently retrain the formation of a flexible material when stored for long term in a state filled in a hard capsule, thereby having excellent stability.CONSTITUTION: A stable pharmaceutical agent comprises a first particle part including a levo cetrizine or a pharmaceutically acceptable salt and organic acid and a second particle part including montelukast or a pharmaceutically acceptable salt thereof. A manufacturing method of a capsule comprises a step mixing a leveo cetrizine or a pharmaceutically acceptable salt, a pharmaceutically acceptable additive, and the organic acid, forming a capsule with the same, and mixing 40-1parts by weight of the organic acid with regard to 100 parts by weight of the levo cetrizine a step of mixing the montelukast or a pharmaceutically acceptable salt thereof with the pharmaceutically acceptable additive and forming a capsule with the same and a step of filling the hard capsule with the levo cetrizine and the montelukast.COPYRIGHT KIPO 2013[Reference numerals] (AA) Comparison example 1 (B1) Comparison example 2 (B2) Comparison example 3 (B3) Comparison example 4 (B4) Comparison example 5 (B5) Comparison example 6 (B6) Comparison example 7 (CC) Flexible material F (DD) Total flexible material본 발명은 1) 레보세티리진 또는 이의 약학적으로 허용가능한 염 및 유기산을 포함하는 제 1 입자부 및 2) 몬테루카스트 또는 이의 약학적으로 허용가능한 염을 포함하는 제 2 입자부를 포함하는 알레르기성 비염 또는 천식의 예방 또는 치료용 경구투여용 약학 제제를 제공한다. 본 발명에 따른 약학 제제는 제1입자부에 안정화제로서 유기산을 함유함으로써 레보세티리진 뿐만 아니라 몬테루카스트의 유연물질의 형성을 효과적으로 억제시킬 수 있어 우수한 안정성을 가진다.
