FORMULATION AND EVALUATION OF FAST DISSOLVING ORAL FILMS OF ZOLMITRIPTAN BY NATURAL POLYMERS

The purpose of the present investigation was to formulate Fast Dissolving Oral Films of Zolmitriptan for the treatment of acute migraine attack. Films were prepared by solvent casting method using Natural Polymers Xanthan gum, Guar Gum, Sodium Alginate, Aloe vera Powder as the film forming polymer and PEG-400 as the plasticizer. Vanillin was used as taste masking agent in the formulations. Sodium Alginate has excellent film forming capacity with rapid hydration power which leads to rapid disintegration of film upon contact with saliva. The concentrations of the polymers a nd plasticizer were selected as independent variables. Eight formulations were prepared. The thickness, folding Endurance, disintegration time, % drug released and drug content were selected as dependent variables. The optimized formulation, F6 was found s uperior than remaining 7 batches. Among all the formulations, F6 has shown maximum drug release of 99. 1±0.05% within 8 min and a very low disintegration time of 8.33±0.57sec due to super -disintegrant Sodium Starch Glycolate. Hence the films made of 2%w/v of Sodium Alginate and PEG-400 showed excellent film forming property with rapid drug release profile. FT -IR studies revealed that there was no physico-chemical interaction between polymer and drug. Stability studies revealed that optimized formulation was stable as the % drug release at the end of 3 rd month was 99.1%. The observed independent variables were found to be most satisfactory formulation which demonstrates the feasibility of the optimization procedure in successful development of fast dissolving oral film containing Zolmitriptan by using Sodium Alginate, PEG-400 and Vanillin as key excipients.