FILM FOR ORAL CAVITY ADMINISTRATION CONTAINING MONTELUKAST OR ITS PHARMACEUTICALLY ACCEPTABLE SALT

摘要

PURPOSE: An oral disintegrating film (ODF) containing montelukast or a pharmaceutically acceptable salt thereof, preferably montelukast sodium, is provided to improve montelukast stability. CONSTITUTION: A montelukast ODF contains ODF or a pharmaceutically acceptable salt thereof, a polymer which is a film forming agent, and a plasticizer. The loss on drying of the film is 1-8 wt%. A method for manufacturing the montelukast ODF comprises the steps of: preparing a liquid composition containing dissolved or dispersed montelukast ODF or a pharmaceutically acceptable salt thereof, the polymer, and the plasticizer; applying the liquid composition for forming a film; and drying the film.