Novel risperidone orally disintegrating minitablets for pediatric use: patient acceptance and dose adjustment

OBJECTIVE: Risperidone is a potent psychotropic agent has been approved for symptomatic treatment of irritability in children and adolescents with autism spectrum disorders. However, its bitter taste and dose adjustment of liquid dosage forms are a main hurdle for patient acceptance. SIGNIFICANCE: Thus, this recent study investigate the formulation of taste masked risperidone orally disintegration minitablets (ODMT) as a way of enhancing patient acceptance. METHODS: Taste masked risperidone hydrogenated castor oil or Cetyl alcohol based granules were prepared using a simple melt granulation technique in different drug to lipid ratios; drug release, bitterness score of the prepared granular formulations were evaluated. DSC was also performed to detect the possible drug lipid interaction. The selected lipid-based granules were further compressed into ODMT formulations. Bitterness score was assessed by gustatory sensation test and results were compared to marketed liquid formulations of risperidone. RESULTS: All the prepared ODMT formulations showed high content uniformity, with minimum dose fluctuation compared to marketed oral liquid preparations. CONCLUSION: In conclusion, risperidone lipid-based granules could be formulated in different ratios by simple techniques and commonly used excipients into taste masked risperidone ODMT with accurate and flexible doses suitable for pediatric use with high taste preference and acceptability