Development of an Age-Appropriate Mini Orally Disintegrating Carvedilol Tablet with Paediatric Biopharmaceutical Considerations

Owing to considerable differences observed in anatomy and physiology between paediatric subsets, it has been well established that children respond drugs differently compared adults. Furthermore, from a formulation perspective, there is distinct challenge develop dosage form capable of safely, accurately, reliably delivering the dose across whole population. Orally disintegrating mini-tablets (ODMT) have widely considered as an age-appropriate option possess ability for adequate flexibility, avoids swallowing difficulties, exhibits superior stability due its solid state. Within this study, two strengths (0.5 mg 2 mg) carvedilol ODMT formulations were developed using excipient composition load appropriate use. The demonstrated mechanical strength (>20 N) fast disintegration times (<30 s). Dissolution profiles robust comparable marketed conventional tablet various parts gastrointestinal (GI) tract both fed fasted state, signifying efficacy, quality, performance. As such, study show potential address need ‘age-appropriate’ carvedilol, highlighted by European Medicines Agency (EMA) Inventory Needs Paediatric Medicine.