Abstract

FORMULATION AND EVALUATION OF SODIUM CROMOGLYCATE OCUSERTS

P. Nagadivya*, V.R.M. Gupta, P. Vagdevi, S. Naveen Kumar, V. Sreemouni and V. Sandeep Kumar

ABSTRACT

Objective: The present work describes the formulation and evaluation of Sodium Cromoglycate ocuserts using different polymers to increase the residence time of the drug in the cul-de-sac of the eye. Methods: Aqueous solutions of varying concentrations of different polymers were prepared and evaluated in order to identify the compositions suitable for use as Ocuserts. Solvent casting technique was used to formulate Sodium Cromoglycate ocuserts using polymers carbopol 940, Sodium Alginate and Hydroxypropyl Methylcellulose (K4M), at different concentrations. The promising formulations were evaluated for visual examination, thickness, drug content, folding endurance, percent moisture absorption, in-vitro studies, ocular irritation, and stability. Results: The in vitro diffusion studies gave the cumulative percent drug release which was found to be 80%. The uniformity of the weights of the films indicates good distribution of the drug, in polymer and plasticizer. The formulations did not produce any irritation when placed in the cul de sac since they were not thick enough to produce irritation. The results of drug content were found to be satisfactory. The percent moisture absorption study revealed that formulation F5 (4.20 ± 0.05) showed high moisture loss due to less hindrance offered by carbopol. Conclusion: The ocuserts resulted in increased drug residence time and the drug release was in controlled manner comparative to the marketed formulation.

Keywords: Ocuserts, Sodium Cromoglycate, Sodium Alginate, Carbopol 940, HPMC K4M, folding endurance, in vitro diffusion.