Published Paper Details:

Introduction: Pre-formulation studies are the initial step in the development of dosage forms of any drug substance. It confirms that there are no significant barriers to the compound's development as a marketed drug. Objective: The main objective of this research work was to conduct a pre-formulation analysis of risperidone an antipsychotic medicine in order to produce a stable, robust including therapeutically effective system. Methods: Risperidone was analyzed to determine its flow characteristic by angle of repose, carr's index, bulk density, tapped density etc. Solubility was also determined in various pH-varying solvents and its purity was determined by FTIR and absorption maxima. Standard calibration curve was developed to aid in further analytical research studies. At last drug-excipients compatibility studies were performed. Results: Risperidone has good flow and compressibility properties (BD 0.562 g/ml, TD 0.714 g/ml, Angle of Repose (?) 24.68, Carr's index 12.39%, Hauser's ratio 1.12). Solubility of drug was found to decrease with increase in pH. The purity of drug was confirmed by infrared spectrum which showed characteristics peaks and by UV spectroscopy which exhibited maxima at 280 nm. The standard curve obtained was linear with correlation coefficient (R2 =0.997) and equation y = 0.026 +0.0028. There were no drug excipient interactions which was clear as no visual changes in drug samples were observed with respect to discoloration, liquefaction and odor. Conclusion: The powder blend under consideration was pure Risperidone which had good flow property suggesting use of granulation technique during tablet manufacturing and it was stable with selected excipient at reported ratio at 40oC / 75 % RH for 4 weeks.