NEW YORK (Reuters Health) - By the time they're 4 years old, most children can swallow 3 millimeter "minitablets," and even younger children can often be taught to swallow the pills without chewing them first, British investigators report.

Although oral medicine for children is usually administered as liquids, "the development of minitablets would require fewer and less-problematic excipients, in smaller quantities," the researchers explain. The excipient is an inactive ingredient added to a drug dilute it or to give it form and consistency. Other advantages of dry formulations would be improved drug stability and the potential for developing sustained-release products.

Because there are few age-appropriate drug formulations for young children, regulatory agencies in the U.S. and Europe encourage pharmaceutical companies to increase the number of clinically tested medicines for children in age-appropriate dosage forms and doses, the researchers note in their report, published in the journal Pediatrics.

To see if minipills might be an option for pediatric use, Dr. Alastair G. Sutcliffe at University College London and colleagues studied 100 children, ages 2 to 5, who were taught how to swallow a 3-mm diameter placebo tablet by "drinking lots of water until the tablet was in the tummy," without chewing them first.

The ability to swallow a minitablet increased with age, from 45 percent of 2-year-olds, to 53 percent, 76 percent, and 87 percent of 3-, 4-, and 5-year-olds, respectively. None of the children choked or aspirated the pill.

The findings suggest that minitablets can be used as a new formulation for preschool children. The next step, Sutcliffe's group points out, will be to assess "the long-term acceptability of and compliance with minitablets for children, in comparison with other available dosage forms."

SOURCE: Pediatrics, February 2009.

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