Favorable acceptance of mini-tablets compared with syrup: a randomized controlled trial in infants and preschool...

Area of Science:

• Pediatric pharmacology and drug delivery systems.
• Clinical acceptability and tolerability of pharmaceutical formulations.

Background:

• Syrup formulations are common for pediatric medication but can present challenges in administration and acceptability.
• Alternative dosage forms are needed to improve medication adherence and ease of use in young children.

Purpose of the Study:

• To evaluate the acceptability and swallowing capability of 2 mm mini-tablets compared to syrup in pediatric patients.
• To assess the safety and tolerability of mini-tablets and syrup in children aged 6 months to 5 years.

Main Methods:

• An open-label, randomized cross-over study involved 306 pediatric patients aged 6 months to 5 years.
• Participants were divided into 6 age groups, with comparisons made between uncoated/coated mini-tablets and 3 mL syrup.
• Acceptability, swallowing capability, and adverse events were recorded for each formulation.

Main Results:

• Uncoated mini-tablets demonstrated superior acceptability compared to syrup in the overall patient population (14.8% difference, P < .0001).
• Swallowing capability was significantly higher for uncoated mini-tablets versus syrup (12.3% difference, P = .0008).
• All formulations were well-tolerated, with minimal coughing reported for coated mini-tablets and none for syrup or uncoated mini-tablets.

Conclusions:

• 2 mm mini-tablets represent a valuable and more acceptable alternative to syrup for pediatric patients aged 6 months to 6 years.
• The findings support the consideration of mini-tablets by regulatory bodies like the Food and Drug Administration and European Medicine Agency for future guidelines and drug approvals.