OPTIMIZATION AND IN-VIVO EVALUATION OF OCULAR FILMS OF AN ANTI-INFLAMMATORY AGENTAbstract
The present study focuses on the treatment of ocular inflammation with objectives of reducing the frequency of administration, obtaining controlled release and greater therapeutic efficacy of drug (Keterolac tromethamine) using ocular films. Various combinations were designed for different batches of ocular films as per factorial design study with 0.5 % w/v concentration by solvent evaporation method containing different combination of polymers such as HPMC K100M, ethyl cellulose, Carbopol 934 and PVP K30. The folding endurance and thickness of the films were in the range of 44±1.1to 92±1.8 and 4.5±0.6 to 6.8±0.3, respectively for different formulations. Surface pH was evaluated in the range of 6.6 to 7.2 for optimized formulations. % moisture absorption and % moisture loss were evaluated in the range of 1.17±1.1 to 6.72±1.5 and 0.58±0.9 to 1.23±0.9 respectively. No microbial growth was observed in any formulation during sterility testing by direct inoculation method. The drug release for prepared formulations of different batch codes PAH, PBE, PCP, PDC, PEEH & PFEC was found to be 93.3±1.1, 54.2±0.9, 92.3±1.2, 96.1±1.5, 97.7±0.9 & 93.5±1.1% respectively upto 12 hours. Ocular films of batch code PEEH was optimized for maximum drug release (97.7±0.9). The anti-inflammatory effect was noted periodically (0.5 hr to 06 hrs) after administration of sterile formulation in the treated eyes vs. control eyes of each rabbit. The optimized batch PEEH of ocular inserts reduced the inflammation completely upto 4 hrs in a single dose.