Risperidone oral disintegrating mini-tablets: A robust-product for pediatrics.

Area of Science:

• Pharmaceutical Technology
• Formulation Development
• Pediatric Drug Delivery

Background:

• Pediatric patients require age-appropriate drug formulations for improved adherence and efficacy.
• Risperidone is an antipsychotic medication often prescribed for children, necessitating suitable dosage forms.

Purpose of the Study:

• To develop and evaluate risperidone oral disintegrating mini-tablets (OD-mini-tablets) for pediatric use.
• To optimize formulation parameters using a Box-Behnken design for dosage form uniformity and quality.

Main Methods:

• A Box-Behnken experimental design was utilized to optimize critical excipient variables.
• Fourier-transform infrared spectroscopy (FTIR) assessed drug-excipient compatibility.
• Pre- and post-compression characteristics, disintegration times in simulated salivary fluid and skimmed milk were evaluated.

Main Results:

• No significant interactions were observed between risperidone and excipients via FTIR.
• The optimized OD-mini-tablet formulation exhibited robust mechanical properties (crushing strength of 5 kN, low friability).
• Rapid disintegration times were achieved: 8.4 seconds in simulated salivary fluid and 53.7 seconds in skimmed milk.

Conclusions:

• The developed risperidone OD-mini-tablet formulation is suitable for pediatric use.
• The formulation offers uniform and precise dosing with desirable mechanical and disintegration characteristics.
• This age-appropriate dosage form can enhance medication adherence and therapeutic outcomes in pediatric patients.