Development and evaluation of age-appropriate film-coated tablets of levamisole for paediatric use (2 - 18 years).

OBJECTIVES

To develop an oral solid dosage form of levamisole suitable for the paediatric population in terms of dose accuracy, palatability, stability and ease of administration.

METHODS

Small undividable tablets (Ø5 - 8 mm) in four different strengths were manufactured to allow for flexible and accurate dosing. In vitro dissolution testing was used to determine drug release in different media. The bitter taste of levamisole was masked using a film-coat and assessed in healthy volunteers. Suitability and acceptability of the tablets were evaluated in 100 patients with nephrotic syndrome aged 2 - 18 years participating in a double blind, placebo-controlled, randomised trial.

RESULTS

All tablet strengths showed good taste-masking characteristics and similar, pH independent, dissolution profiles. Successful taste masking was achieved without affecting the dissolution rate. In a total of 100 paediatric patients, more than 20,000 levamisole tablets were swallowed without any difficulties, choking or aspiration.

CONCLUSION

The formulated tablets were found to be suitable for children aged 2 - 18 years and to provide good dose accuracy.