title: Development and evaluation of age-appropriate film-coated tablets of levamisole for paediatric use (2 - 18 years).
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  The formulated tablets were found to be suitable for children aged 2 - 18 years and to provide good dose accuracy.
authors.affiliation: Clinical Research, ACE Pharmaceuticals BV, Zeewolde, The Netherlands.
authors.forename: Annemarie Rosan
authors.initials: AR
authors.lastname: Kreeftmeijer-Vegter
authors.forename: Mariska
authors.initials: M
authors.lastname: de Meijer
authors.forename: Kim A M
authors.initials: KA
authors.lastname: Wegman
authors.forename: Cees K W
authors.initials: CK
authors.lastname: van Veldhuizen
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000737:chemistry*; D000284:Administration, Oral; D000293:Adolescent; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D003679:Deglutition; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004339:Drug Compounding; D004341:Drug Evaluation; D006801:Humans; D007978:Levamisole / Q000008:administration & dosage* / Q000737:chemistry*; D009404:Nephrotic Syndrome / Q000188:drug therapy*; D013607:Tablets; D013608:Tablets, Enteric-Coated; D055697:Taste Perception
chemical_list: D000276:Adjuvants, Immunologic; D003692:Delayed-Action Preparations; D013607:Tablets; D013608:Tablets, Enteric-Coated; D007978:Levamisole