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

Area of Science:

• Pharmaceutical Sciences
• Paediatric Drug Delivery
• Formulation Development

Background:

• Children exhibit unique physiological and anatomical differences impacting drug response compared to adults.
• Developing safe, accurate, and reliable paediatric dosage forms presents significant formulation challenges.
• Orally disintegrating mini-tablets (ODMT) offer dose flexibility and ease of administration for paediatric populations.

Purpose of the Study:

• To develop and characterize two strengths (0.5 mg and 2 mg) of carvedilol ODMT formulations suitable for paediatric use.
• To evaluate the mechanical strength, disintegration time, and dissolution profiles of the developed ODMT formulations.
• To assess the potential of these ODMT formulations to meet the European Medicines Agency's (EMA) identified needs for paediatric carvedilol.

Main Methods:

• Development of carvedilol ODMT using paediatric-appropriate excipients and excipient load.
• Assessment of mechanical strength (crushing strength) and disintegration time.
• In vitro dissolution testing across simulated gastrointestinal tract conditions (fed and fasted states).

Main Results:

• Carvedilol ODMT formulations exhibited adequate mechanical strength (>20 N) and rapid disintegration (<30 s).
• Dissolution profiles were robust and comparable to conventional carvedilol tablets in both fed and fasted states.
• The developed formulations demonstrated consistent performance, indicating appropriate quality and efficacy.

Conclusions:

• Paediatric-appropriate carvedilol ODMT formulations were successfully developed.
• The ODMT formulations show potential for safe, accurate, and effective drug delivery in children.
• These formulations address a key need for age-appropriate carvedilol medicines identified by the EMA.