Explore the application of mixed solvency technique in the injection formulation of poorly soluble drugs

Abstract

In the pharmaceutical industry that on average more than 40% of newly discovered drug candidates are poorly water-soluble. The objective of present research is to explore the application of mixed solvency technique in the injection formulation of poorly soluble drugs and to reduce concentration of individual solubilizers (used for solubility enhancement) to minimize the toxic effects of solubilizers. In the present work poorly soluble drugs Ofloxacin are selected as model drugs. 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. Various batches of Ofloxacin injection formulation were prepared evaluates for Color, Clarity Test, Leakage Test, Viscosity Determination, pH Determination, Drug content Determination, Stability Study. 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.