Formulation and evaluation of ofloxacin aqueous injection

Abstract

Ofloxacin is a synthetic fluoroquinolone broad spectrum anti microbial agent used in the treatment of bacterial infections and it is presently available in the market only as tablet dosage form. It is preferred in the treatment of adults with community acquired pneumonia and acute bacterial exacerbations of chronic bronchitis caused by susceptible organism. The present study was undertaken with an intention to develop a stable and effective parenteral formulation, containing the drug Ofloxacin. Ofloxacin is a light sensitive and water soluble drug but unstable at higher temperature in water. So the effects of various co solvents in the solubility of Ofloxacin have been evaluated. Ofloxacin was tried with co solvents such as PEG-200, Span 20 and Glycerin. The drug was made into injection formulation for administered as a SVP. Various batches of Ofloxacin injection formulation were prepared in order to assess the influence of heat, light, atmospheric oxygen and antioxidant on the stability of the drug and the formulations were also subjected to accelerated stability test. Out of all trials, formulation containing 45% of PEG-200 was found to be more stable and passed all tests satisfactorily.