Formulation, Optimization and Evaluation of SMEDDS of Norfloxacin for Treatment of Ocular Infection

Abstract

In the modern pharmaceutical and clinical fields, ocular therapy has been shown to be the most appealing and practical method of drug application since ancient times. A successful public health care system must overcome several pharmacokinetic and pharmacodynamic challenges, including the overwhelming need for dose-optimization techniques to lower toxic effects, increase drug efficacy in a given formulation, and reduce dosing frequency. The majority of formulations currently on the market still suggest ocular therapy. The present research aimed to formulate, optimize and evaluate SMEDDS of Norfloxacin for treatment of ocular infection which produced sustained in-vitro drug release and supposed to elicit enhanced bioavailability. The drug excipient compatibility was determined by FTIR studies which was further confirmed by TLC studies. Conclusively Norfloxacin was found to be compatible with various excipients incorporated in preparation of SMEDDS formulation. Different physicochemical parameters of prepared SMEDDS were determined; droplet size range (91-182nm), Zeta potential (-0.11)-(-25.07) mV, pH (7.4), viscosity (26.5-35.3cPs) and drug content (91.61–99.96%). All SMEDDS were found thermostable and no phase separation was observed upon centrifugation stress testing. The in-vitro drug release results revealed that % drug release ranged between 72.019% - 94.101% in pH 7.4 phosphate buffer and 95.072%-71.022& in STF at the end of 24 hrs. On the basis of evaluation parameters, formulation B1 was considered as optimized batch. The results obtained with optimized batch were droplet size (91nm), zeta potential (-25.07) & the percentage drug release was found to be 94.101% and 95.072% in pH 7.4 phosphate buffer and STF respectively. Stability study was performed with the optimized formulation (MEF) as per the ICH guideline and the outcomes indicated that formulations was stable and thus complied with dose conformity criterion. All above data satisfactory complied with the characteristic requirements for the formulation of SMEDDS of Norfloxacin for ocular delivery.