Formulation Development of Modafinil Sprinkle Dosage Form: Study on the Effect of Food on Dosage

Sprinkles, drug-containing pellets or granules that can be mixed with soft food before administration, may be administered either directly in the mouth, or mixed with a spoonful of cold or room temperature soft foods. In this study, attempts were made to develop a new oral sprinkle formulation for modafinil in granular form. In order to increase the oral bioavailability and taste masking to food taken along with the drug, modafinil-hydroxypropyl-beta-cyclodextrin complexes were prepared and evaluated. A molar ratio of 1:5 was optimized. In vitro drug-release studies showed a maximum drug release rate of 93%. In-use analysis study also showed that the drug release was more than 90% within 45 minutes. The formulation was found to be stable for 3 months under accelerated conditions.