Design and Evaluation of Gatifloxacin Ocular Films for Sustained Release

Gatifloxacin ocular films were prepared by solvent casting method using hydroxy propyl methyl cellulose, methyl cellulose, sodium carboxy methyl cellulose and gelatin in different concentrations using glycerin as plasticizer. The physicochemical parameters of the ocular films were evaluated. The compatibility of the drug in the formulations was confirmed by IR studies. In vitro diffusion studies and mechanism of drug release was identified. The formulation F₄ and F₈ shows a maximum cumulative percentage drug release of 96.15% and 97.34% at the end of 12^th h respectively. The drug release decreases in all the formulations as the concentration of polymer increases. The release of drug from the films has followed first-order kinetics and non-fickian in nature with diffusion controlled mechanism. The formulation F₄ and F₈ were subjected to UV-irradiation and in vivo drug release studies on rabbits. A high correlation coefficient was found between in vitro and in vivo release rate studies. No significant change in the drug content and physical features was observed during storage at 30±2°C/65±5% RH and 40±2°C/75±5% RH for three months. The data demonstrated that hydroxy propyl methyl cellulose and methyl cellulose in the concentration of 4.5% w/v was suitable for developing sustained release ocular films of gatifloxacin.