Development and Characterization of Modified Ocular Inserts with Improved Ocular Compatibility Karthikeyan D.1,*, Sonkar S.1, Pandey V.P.2, Kumar J. Nandha1, Sengottuvelu S.1, Bhowmick M.1, Shivakumar T.1 1Nandha College of Pharmacy, Erode-638052, Tamil Nadu, India 2Department of Pharmacy, Faculty of Science and Technology, Annamalai University, Chitambaram, India *Corresponding Author E-mail: karthii69@yahoo.co.in
Abstract The objective of the present work is to develop modified ocular inserts of Indomethacin having a single film instead of tri-film and evaluate its potential for sustained ocular delivery. The advantage of having a single film is that it considerably reduces the thickness and weight of ocular insert as well as is better retained in the cul-de-sac of the eye. The modified ocular insert was prepared by solvent casting method using polymers Eudragit RS 100 (ERS) and Ethyl cellulose (EC). Dichloromethane (DCM) and Dibutyl phthalate (DBP) were used as solvent and plasticizer respectively. The modified ocular inserts were evaluated for drug-excipient interaction, physico-chemical characteristics, stability studies, sterility studies, ocular irritation test, in-vitro and in-vivo release studies. Attenuated total reflectance Fourier Transform Infra-red spectroscopy (ATR-FTIR) was used to study the interaction between drug and excipients, which enable the modified ocular insert to be examined directly without further preparation (in contrast to KBr method). The in-vitro release study of the formulations follow zero order kinetics and revealed that the drug released by super case II kinetics (n>1). The optimized formulation F7, when inserted into the eye of rabbit showed controlled release upto 24 hours. There was a good correlation between in-vitro and in-vivo release data. On the basis of above studies, it can be concluded that the modified ocular insert having a single film provided the desired drug release for 24 hours and remained stable and intact at ambient conditions. Top Keywords Modified ocular inserts, Single film, Atr-Ftir, Super case II kinetics. Top |