Fast Disintegrating Film Approach for the Oral Delivery of Zolmitriptan: Formulation, In Vitro and In Vivo Evaluation

Background and Objectives: The objective of the study was to formulate and evaluate fast disintegrating oral film of zolmitriptan. Method: The film was prepared by solvent casting method using different polymers like Lycoat RS720, PVP K-30, and HPC in combination with other excipients. All prepared formulations were evaluated for physico-mechanical properties. Films were also evaluated for % moisture uptake, % moisture content, in vitro drug release studies and in vitro disintegration time. The optimized formulation (L1) was subjected to stability study as per the ICH guidelines at 40 ± 0.5°C/75 ± 5% RH for six months. In vivo studies were conducted on Wistar albino rats and concentration of drug in blood was analysed by HPLC. Various pharmacokinetic parameters for optimized formulation were determined and compared with reference (drug sol.). Results: On the basis of results of physico-mechanical properties and other parameters like in vitro disintegration time, the formulation L1 was selected as optimized formulation. The optimized formulation was found to be stable under the specified storage condition. The value of AUC0128;“t (ng h/ml), AUC0∞ (ng h/ml) Cmax (ng/ml), Tmax (h), Ke (h^-1), and t1/2 (h) of the optimized film formulation was found to be 727.72 ± 23.63, 777.17 ± 31.82, 353.67 ± 9.98, 0.5, 0.253 ± 0.023, and 2.74 ± 0.31 respectively, for the drug sol 559.71 ± 27.52, 585.18 ± 36.53, 280.87 ± 28.98, 0.5, 0.295 ± 0.032, and 2.34 ± 0.35, respectively. Relative bioavailability of optimized film formulation (L1) was 1.33 time than that of drug sol. In vitro-in vivo relationship between percentage drug absorbed and percentage drug released was also established. A moderate type of relationship (R²=0.897) was observed between percentage drug absorbed and percentage drug released. Conclusion: The results of present study showed that fast disintegrating oral film approach is suitable for the delivery of zolmitriptan. This formulation not only increase the bioavailability of drug but also produce the quick action for the migraine patients.