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

Annemarie Kreeftmeijer - Vegter, Mariska de Meijer, Kim A M Wegman, Cees K W van Veldhuizen

Research output: Contribution to journalArticleAcademicpeer-review


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.

Original languageEnglish
Pages (from-to)293-300
Number of pages8
JournalExpert Opinion on Drug Delivery
Issue number3
Publication statusPublished - 2013


  • Adjuvants, Immunologic
  • Administration, Oral
  • Adolescent
  • Chemistry, Pharmaceutical
  • Child
  • Child, Preschool
  • Deglutition
  • Delayed-Action Preparations
  • Double-Blind Method
  • Drug Compounding
  • Drug Evaluation
  • Humans
  • Levamisole
  • Nephrotic Syndrome
  • Tablets
  • Tablets, Enteric-Coated
  • Taste Perception


Dive into the research topics of 'Development and evaluation of age-appropriate film-coated tablets of levamisole for paediatric use (2 - 18 years)'. Together they form a unique fingerprint.

Cite this