Acceptance of uncoated mini-tablets in young children: results from a prospective exploratory cross-over study

Area of Science:

• Pediatric pharmacology
• Drug delivery systems
• Swallowing physiology

Background:

• Liquid formulations are common in pediatric drug therapy but can present challenges.
• Mini-tablets offer a potential alternative dosage form for children.
• Limited data exists on the acceptance and swallowing ability of very young children with mini-tablets.

Purpose of the Study:

• To evaluate the acceptance of uncoated, drug-free mini-tablets (2 mm diameter) in children aged 0.5-6 years.
• To assess the ability of these children to swallow the mini-tablets.
• To compare the acceptance of mini-tablets with a standard liquid formulation (glucose syrup).

Main Methods:

• Prospective, open-label, randomized, two-way cross-over pilot study.
• 60 children (0.5-6 years) received either mini-tablets with a beverage or glucose syrup, followed by the alternative.
• Visual assessment of deglutition using predefined criteria for both dosage forms.

Main Results:

• Contrary to hypothesis, mini-tablet acceptance was higher than or equal to liquid formulation acceptance.
• Children aged 6-12 months could swallow mini-tablets and accepted them well, sometimes better than syrup.
• Acceptance rates for mini-tablets across all age groups were unexpectedly high, with some younger children chewing before swallowing.

Conclusions:

• Uncoated mini-tablets are a viable and well-accepted alternative to liquid formulations for pediatric patients.
• Mini-tablets can potentially be introduced earlier in pediatric drug therapy than previously thought.
• This dosage form shows significant promise for improving medication adherence and administration in young children.