STABLE PHARMACEUTICAL FORMULATION FOR ORAL ADMINISTRATION COMPRISING LEVOCETIRIZINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND MONTELUKAST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF

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. [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 material