Formulation of Modified Release Pellets of Montelukast Sodium

Abstract

The present study was carried out with an aim of preparing modified release pellets of the antiasthma drug montelukast sodium. The patients suffering from chronic asthma many a times suffer from exacerbations during the early morning hours i.e. around 4am to 6 am. Thus the need to take an immediate release medication arises during early morning hours which is not quiet feasible for the patients. The delivery of the drug at this time can be made possible by the use of modified release formulation of montelukast sodium which when taken at the bed time would release the drug as a pulsed delivery without the need of the patient to wake up. The montelukast sodium pellets prepared by extrusion-spheronization were coated with release retarding polymer ethyl cellulose using the Wurster method. The ethyl cellulose coating helped in lag time increase due to prolonged water uptake time. The increase in the coating level increased the lag time sufficiently that might release the drug during the early morning hours. Thus a modified release pellets dosage form to prevent the early morning asthma attacks and exacerbations was developed successfully.