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

Khalid M El-Say, Tarek A Ahmed, Maged F Abdelbary

    Acta Pharmaceutica (Zagreb, Croatia)
    |December 19, 2015
    PubMed

    Insights

    This study developed risperidone oral disintegrating mini-tablets for pediatric use. The optimized formulation ensures uniform dosing, rapid disintegration, and suitable mechanical properties for infants and children.

    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.

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