A stable hydrocortisone nanosuspension for improved dissolution: Preparation,characterization and in vitro evaluation

Drug nanosuspensions have gained tremendous attraction as a platform in drug delivery. in the present work,a nanosuspension was prepared by a wet milling approach in order to increase saturation solubility and dissolution of the water insoluble drug,hydrocortisone. size of the generated particeles was 290 nm ± 9 nm having a zeta potential of -1.9 mv ± 0.6 mv. nanosized particles were found to have a rod shape with a narrow particle size distribution (pdi =0.17). results of differential scanning calorimetry and x-ray diffraction analyses revealed minor modifications of crystallinity of hydrocortisone following the milling process. solubility of hydrocortisone was enhanced by nanonization to 875μg/ml ±2.5,an almost 2.9-fold compared to the raw hydrocortisone. moreover,the nanosuspension formulation substabtially enhanced the dissolution rate of hydrocortisone where >97% of the hydrocortisone was dissolved within 10 minutes opposed to 22.3% for the raw 50% for the raw hydrocortisone and the commercial tablet,respectively. the bioavailability study resulted in auc 0-9h for hc nanosuspensions (31.50±2.50),which is significantly (p<0.05) higher compared to the auc 0-9h (14.85±3.25) resulted for hc solution. the nanosuspension was physically stable at room temperature for 24 months.