𝗪𝗲𝗲𝗸𝗹𝘆 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 #5 📢

Scientific evidence for acceptability of minitablets in pediatrics: Part II

🔍 Scope and Motivation: Klingmann et al. (2013) evaluated the acceptability of 2 mm solid dosage forms (minitablets) as an alternative administration modality to syrup in young children. 👶

📋 Methodology: 306 pediatric patients aged between 6 months to 5 years of age (51 children represented in each of the 6 age groups) were recruited. An open, randomized cross-over study was conducted to compare the acceptability and swallowability of 2 mm minitablets versus 3 mL syrup.

💡 Key Findings: All pharmaceutical formulations were well tolerated. The overall acceptability of minitablets was seen to be superior over syrup. The level of capability for children to swallow the dosage form was also higher for minitablets.

✅ Conclusions: Minitablets showed higher acceptability over syrup and were seen as a valuable alternative for drug administration in children. The study also suggested FDA/EMA apply the data generated for future updates in guidelines, best practices, and pediatric drug approval processes.

📚 Reference:
Klingmann et al. Favorable acceptance of mini-tablets compared with syrup: a randomized controlled trial in infants and preschool children. J Pediatr. 2013 Dec;163(6):1728-1732. doi: 10.1016/j.jpeds.2013.07.014.