DESIGNING AND EVALUATION OF FLURBIPROFEN SODIUM SUPPOSITORIES

Abstract

Objective: The present investigation was aimed to develop Flurbiprofen Sodium suppositories by using different suppository bases with a view to avoid loss of drug by first pass effect and to minimize toxic effects, thereby producing safe and effective dosage form which will improve the solubility and absorbability of poorly soluble drug.

Methods: Fusion method was used for the preparation of suppositories. Pre formulation studies of the drug was done by determining its physical appearance, melting point, IR spectrum, UV spectrum and solubility studies of Flurbiprofen sodium were carried out in different Solvents.

Results: Melting point of Flurbiprofen sodium was found to be in the range 114 °C-117 °C. UV spectrum of Flurbiprofen sodium in ethanol at pH7.4 was determined at 273 nm. Calibration curve of Flurbiprofen sodium in pH 6.4 phosphate buffer were constructed in the concentration range of 0-20 μg/ml. The prepared suppositories of each batch was evaluated for their physio-chemical properties like weight variation, Hardness, Friability, length and width, melting point, breaking strength, disintegration test, content uniformity, in vitro drug release and stability studies. The prepared suppositories were smooth and fine in texture with mechanical strength (hardness) i.e. can tolerate less than 5.0 kg. The friability was found to be within acceptable limits (less than 1%).

Conclusion: Suppositories were successfully formulated and evaluated. The type of base employed for the preparation of suppositories influenced the release of the drug during the dissolution studies. They can be arranged in order of release rate as-PEG 4000>PEG 6000>Cocoa butter. The use of Sodium lauryl sulphate also influenced the release rate of the drug and the release rate patterns of all formulations.