Formulation and Evaluation of Solid Dispersion Based Pediatric Jellies of Risperidone

The oral route is preferred for drug delivery in pediatrics due to its advantages in terms of patient adherence and ease of administration. Risperidone (RIS) is an atypical antipsychotic drug used to manage various psychiatric conditions in children. However, RIS has low aqueous solubility, necessitating the development of an appropriate dosage form to improve its solubility and bioavailability.

This study aimed to formulate and evaluate risperidone chewable jellies as a pediatric dosage form to enhance patient compliance and optimize drug efficacy.

Solid dispersions of risperidone were prepared using polyvinylpyrrolidone (PVP K30) as a carrier. Four different drug-to-carrier ratios (1:1, 1:2, 1:3, and 1:5) were used, and the formulations were characterized for drug content, production yield, solubility, dissolution, Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and powder X-ray diffraction (PXRD).

The solubility of risperidone was enhanced with increasing amounts of PVP K30, with the optimum drug-to-polymer ratio of 1:5. The selected formulation showed a 25-fold increase in solubility compared to pure risperidone. FTIR, DSC, PXRD, and SEM analyses confirmed the successful formation of solid dispersions and the amorphous nature of the drug.

The selected formulation exhibited improved solubility, suggesting enhanced bioavailability. These chewable jellies have the potential to enhance pediatric patient compliance and serve as a convenient dosage form for the effective management of psychiatric conditions in children.