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Abstract

DESIGN AND DEVELOPMENT OF OPHTHALMIC LYOPHILISATE CARRIER SYSTEM FOR CIPROFLOXACIN HYDROCHLORIDE.

Nirav Patel*, Punit Parejiya, Dharmik Mehta, Vivek Vyas, Hetal Patel and Pragna Shelat

ABSTRACT

A major problem in ocular therapeutics is the attainment of optimal drug concentration at the site of action, which is compromised mainly due to precorneal loss resulting in only a small fraction of the drug being ocularly absorbed. The objective of the present study was to develop Ophthalmic Lyophilisate Carrier System (OLCS) of Ciprofoxacin Hydrochloride to overcome the drawbacks of currently available market formulations. Different hydrophilic polymers were screened to select best polymer for imparting satisfactory strength to the system. METHOCEL® E5 was optimized as best polymer for preparing drug-polymer solution having optimal strength. Poly propylene was optimized as a best carrier. Exhaustive preformulation study and drug excipietns compatibility study was performed. The supportive media was sterilized by steam sterilizer. OLCS was finally lyophilized by conventional laboratory freeze dryers. The developed formulation was characterized for various physicochemical parameters. Ocular irritation study of OLCS was performed using a modified het-cam test and assessed by irritation score. The OLCs were charged for the accelerated stability studies as per ICH guidelines (25±2°C/60±5% RH, 40±2°C/75±5% RH) for a period of 6 months. The results of drug excipietns compatibility study and FTIR spectra revealed compatibility of drug with proposed excipietns. The IS score of the OLCS was 0.38 indicating that OLCS does not cause any eye irritancy. The results of all physicochemical parameters were within the acceptable limit for eye application. The results of short term stability study exhibited stable characteristics of the OLCS. In a nutshell, OLCs can be a promising approach for ophthalmic delivery of drug with better bioavailability and minimal loss.

Keywords: Ophthalmic Lyophilisate Carrier System, METHOCEL® E5, Het-Cam Test.


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