Design and Characterization of Phase Transition System of Zolmitriptan Hydrochloride for Nasal Drug Delivery System
Vedanshu Malviya, V Ladhake, K Gajbiye, J Satao, Mukund Tawar
Abstract
The aim of the present study was to formulate a nasal gel of zolmitriptan, a migraine drug to overcome the limitations of nasal cavity like low residence time. The in-situ gel forming nasal drug delivery system was prepared from polymers that exhibit phase transition (Sol-Gel) and pseudo plastic behavior to minimize interference within the mucociliary clearance. In the present study the interaction study was carried out and it was found that FT-IR study shows that there was no interaction between the drug and the various polymers. In the present study, phase-transition system was used for the nasal gel of zolmitriptan, which was formed by using various polymers like sodium alginate, HPMC k4m, and chitosan hydrochloride by phase transition state. The formulation FF1-FF9 was prepared for various evaluation parameters. The results shows that pH in the range of 7.03 to 7.23, percent drug content 97.33 to 98.6, gellation time 7.95 to 9.71 minutes, gellation temperature 39 to 47 oC, viscosity before gel formation 70 to 85 (Cps), viscosity after gel formation 70.33 to 85.66 (Cps), mucoadhesive time 6.91 to 9.68 minutes, mucoadhesive strength 26.76 to 32.56 dynes/cm2, and % cumulative drug release 7.68 to 97.22. From these results, it was found that FF9 was the optimized formulation. The kinetics study shows the best fit model was peppas model. From the stability studies, it was found that the prepared formulation shows no significant changes from which it was concluded that the prepared formulations were stable under various conditions. It was concluded that phase transition system nasal gel formulation FF9 containing sodium alginate and HPMC K4M, which could be most promising, phase transition system gel formulation for zolmitriptan. Based on the results, it was concluded that the prepared phase transition system of zolmitriptan might prove to be potential candidate for safe and effective drug release study over an extended period of time, which can reduce dosing frequency.