Ocular delivery systems of pefloxacin mesylate.

Ocular films of pefloxacin mesylate were prepared with the objectives of reducing the frequency of administration, to improve patient compliance, obtaining controlled release and greater therapeutic efficacy in the treatment of eye infections such as conjunctivitis, keratitis, kerato conjunctivitis, corneal ulcers etc. Polymers such as HPC, HPMC, PVP and PVA were used in different ratios to prepare the ocular films. They were evaluated for drug content which varied from 96-104%. Those which consisted of flexible and transparent films were subjected to in vitro release studies. The formulations which prolonged the release for eight hours were selected. The average weight and thickness of these were found to be 38.92-49.71 mg and 31.68-46.08 microns, respectively. The intactness of the formulations was confirmed by IR and TLC studies. In vivo studies carried out in the eyes of rabbits showed controlled release upto 8-9 h. There was a good correlation between the in vitro and in vivo data (r = 0.97-0.995). A minimum of 1 Mrad was found to be necessary for the sterilization of ocular films by gamma radiation. They were found to be stable at temperatures below 45 degrees C.