Abstract

FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILMS OF MONTELUKAST SODIUM

Pranjali R. Tarte., U. T. Jadhao*, Sayyed Asad Ali., G. N. Dhembre., S. T. Thoke and D. A. Rathod

ABSTRACT

This formulation was aimed to deliver the quick onset of action of drug montelukast in the management of allergic condition, so as to enhance patient’s compliance. The mouth dissolving film of montelukast was prepared by solvent casting method. Mouth dissolving film of montelukast was formulated using two different film forming agent HPMC F15 and sodium alginate along with Sodium Strach Glycolate as a superdisintegrant. Total six formulations were developed using varying concentration of film forming agents. FTIR compatibility studies showed that there is no interaction between the excipient and the drug. Prepared mouth dissolving films were subjected to evaluation study like, thickness, weight variation, folding endurance, disintegration time, drug content and % drug release. The thickness and weight variation for all batch formulations were satisfactory andensuring uniform distribution of drug among films. Folding endurance test for all tablets formulations was found satisfactory. Confirming optimum flexibility of prepared films using both film forming agents. Drug content values for all formulation was within pharmacopoeial limit and ensuring uniform drug distribution among the tablets formulations. All batch formulations showed lowest disintegration time, meeting the criteria for mouth dissolving film. Formulation F1 prepared with showed lowest disintegration time as compared with other formulations. The in vitro dissolution profile of all the formulation showed rapid drug release. The optimized formulation of F1 was consider as the best formulation with respect to drug content, disintegration time, folding edurance and in vitro drug release pattern.

Keywords: Montelukast, Folding endurance. Superdisintegrant. Drug content.