Document Detail

Development and evaluation of age-appropriate film-coated tablets of levamisole for paediatric use (2 - 18 years).
MedLine Citation:
PMID:  23289762     Owner:  NLM     Status:  Publisher    
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. Conclusion: The formulated tablets were found to be suitable for children aged 2 - 18 years and to provide good dose accuracy.
Annemarie Rosan Kreeftmeijer-Vegter; Mariska de Meijer; Kim Am Wegman; Cees Kw van Veldhuizen
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-5
Journal Detail:
Title:  Expert opinion on drug delivery     Volume:  -     ISSN:  1744-7593     ISO Abbreviation:  Expert Opin Drug Deliv     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-7     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101228421     Medline TA:  Expert Opin Drug Deliv     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Clinical Research, ACE Pharmaceuticals BV , Zeewolde , The Netherlands.
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