SYRUP FORMULATION WITH ENHANCED STABILITY COMPRISING MONTELUKAST OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ACIDIC STABILIZER, AND METHOD FOR PREPARING THE SAME

摘要

The present invention relates to a syrup formulation comprising Montelukast or a pharmaceutically acceptable salt thereof as a pharmacologically active ingredient and an acidic stabilizer, wherein the Montelukast or the pharmaceutically acceptable salt thereof is comprised in a state of suspension and the pH of the syrup formulation is 3.0-7.5; and to a manufacturing method of the syrup formulation. The Montelukast or the pharmaceutically acceptable salt thereof is comprised in a content of 0.005-10 w/v% with respect to the total amount of the syrup formulation. The acidic stabilizer is comprised in a content of 0.001-0.5 w/v% with respect to the total amount of the syrup formulation. According to the present invention, the syrup formulation has improved storage stability and facilitates dose regulation. In addition, the syrup formulation is conveniently and easily taken due to excellent taste and flavor so the medication compliance of patients can be enhanced. Therefore, the syrup formulation can be practically used for patients suffering from asthma, allergic rhinitis, etc.