Formulation and in-vitro characterization of erythromycin ocular inserts

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Erythromycin has antibacterial activity and especially useful in the treatment of superficial infections involving conjunctivitis and/or cornea caused by organisms. Sustained drug therapies have more advantages than conventional. In the present study, an attempt was made to formulate sustained drug delivery system for Erythromycin in matrix type the formulations for Erythromycin containing 10%, 12%, and 14% w/v of Gelatin & Hydroxy propyl methylcellulose, and 14% , 16%, and 18% w/v for Ethyl cellulose were prepared by solvent casting method and evaluated for their average weight variation, thickness, drug content, in-vitro drug release and stability studies. An increase in average weight and thickness is due to an increase in polymer concentration. IR spectral studies were performed to confirm the interaction of drug with excipients. IR spectrum revealed that there is no incompatibility and no drug-polymer interactions. In vitro drug release studies were performed by vial method. Gelatin F09, HPMC F15 and EC F21 exhibited maximum average weight 16.66 ± 0.02, 10.81 ± 0.01 & 21.40 ± 0.01 mg respectively and thickness of 0.29 ± 0.01, 0.33± 0.06 and 0.43± 0.02mm respectively. The drug content was found to be 94.48, 92.87 & 90.26% respectively. The in-vitro drug release studies showed that increase in polymer content decreases the drug release from ocular inserts. Formulations containing 16 % and 18% w/v of EC showed sustained and almost complete drug release and dissolved 86.99% and 85.00 % over 14hours period was selected as an ideal formulation. The dissolution data of above formulation were subjected to first order, Higuchi’s and peppa’s equations. The linearity and slope indicates that the release of erythromycin from the films might have followed Peppa’s double log plot and non Fickian characteristics. Drug release from the ocular insert by diffusion controlled mechanism. Stability studies conducted for F20 formulation. The formulation showed satisfactory physical stability at 25oC and 40oC at 60% and 75% RH respectively. The physical appearance had not changed considerably. It can be concluded that formulation containing EC 18 % w/v has achieved the objectives of increased contact time, prolonged release, decreased frequency of administration and thus may improve the patient compliance.