Abstract: Nimesulide is a unique non- steroidal anti-inflammatory drug that acts specifically on cyclo-oxygenase-2 and does not affect cyclo-oxygenase-1. Hence, it exerts its anti-inflammatory action characteristics of non- steroidal anti-inflammatory drug but shows a marked increase in gastric tolerability and minimal incidences of renal dysfunction. Due to its additional action of inhibiting respiratory burst of phagocytosing neutrophils it is also well tolerated by asthmatic patients. Hence, it is one of the most commonly prescribed non- steroidal anti-inflammatory drugs for the treatment of various inflammatory conditions such as tonsillitis, pharyngitis, stomatitis, rheumatoid arthritis, osteoarthritis, low back pain. A variety of Nimesulide preparations are available in the market in the form of tablets and syrup for oral administration and gels for topical application.
Like many non- steroidal anti-inflammatory drug, nimesulide is insoluble in water. The very poor aqueous solubility and wettability of the drug give rise to difficulties in the pharmaceutical formulation of oral or parenteral solutions and may lead to a variable bioavailability. The present work investigates the solubility enhancement and hence bioavailability of the drug. Solubility of drug can be increased by variety of contemporary methods such as hydrotropic solubilization, solid dispersions. Hence in the present investigation to enhance the solubility of nimesulide using hydrotropes such as sodium benzoate, sodium-o-hydroxy benzoate, and sodium-p-hydroxy benzoate. Hydrotropy used to increase in solubility in water of various substances due to the presence of large amount of additives. The feasibility of preparing injection was examined, and suitable batches with good solubility profile were selected and parenteral dosage form was formulated. Investigations related to chemical interaction were done by Fourier transmission infrared spectroscopy and by High performance liquid chromatography. Finally the short-term physical and chemical stability study was conducted.
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