Formulation and Evaluation of Levofloxacin and Betamethasone Ophthalmic Emulgel.

OBJECTIVE

Drug delivery to ocular tissues is challenging due to rapid removal of instilled drug due to low resident time in ocular tissues. The aim of the study was to formulate an ophthalmic emulgel that delivers two drugs (betamethasone sodium phosphate [BSP] and levofloxacin). The new combination will allow the simultaneous administration and extended release of the two drugs which potentially improve resident time in ocular tissues, patient compliance, and adherence to treatment.

MATERIALS AND METHODS

Formulations containing different gelling agents at different concentrations were prepared to choose the optimum combination regarding physical properties and release. The emulgel formulations F1, F2, F3, and F4 were made using gelling agent 1% and 2% xanthan gum, 1% carbopole 934, and 2% methyl cellulose, respectively. F5 was formulated using 2% methyl cellulose with double the amount of poloxamer 188 as emulsifying agent. All the formulations were examined regarding their physical appearance, pH, viscosity, drug content, and drug release. The optimum formula was also examined for antibacterial activity.

RESULTS

The results demonstrated that F5 was the optimum formulation having a proper physical characteristics and release profile of both drugs, 96% and 90% for BSP and levofloxacin, respectively, compared to other formulations and commercial eye drops.

CONCLUSION

Simultaneous and extended release of the two drugs was achieved using one formulation of emulgel. The ability to deliver hydrophilic and hydrophobic drug through the same formulation without the need to use two drops will improve patient compliance and hence patient adherence to treatment.