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dc.contributor.authorTina Kaussen_US
dc.contributor.authorAlexandra Gauberten_US
dc.contributor.authorChantal Boyeren_US
dc.contributor.authorBoubakar B. Baen_US
dc.contributor.authorMuriel Manseen_US
dc.contributor.authorStephane Massipen_US
dc.contributor.authorJean Michel Légeren_US
dc.contributor.authorFawaz Fawazen_US
dc.contributor.authorMartine Lembegeen_US
dc.contributor.authorJean Michel Boironen_US
dc.contributor.authorXavier Lafargeen_US
dc.contributor.authorNiklas Lindegardhen_US
dc.contributor.authorNicholas J. Whiteen_US
dc.contributor.authorPiero Olliaroen_US
dc.contributor.authorPascal Milleten_US
dc.contributor.authorKaren Gaudinen_US
dc.contributor.otherDeveloppements Analytiques et Pharmaceutiques Appliques aux Maladies Negligees et Aux Contrefaconsen_US
dc.contributor.otherUniversite de Bordeauxen_US
dc.contributor.otherEtablissement Francais du Sangen_US
dc.contributor.otherMahidol Universityen_US
dc.contributor.otherNuffield Department of Clinical Medicineen_US
dc.contributor.otherOrganisation Mondiale de la Santeen_US
dc.identifier.citationInternational Journal of Pharmaceutics. Vol.441, No.1-2 (2013), 218-226en_US
dc.description.abstractPharmaceutical development and manufacturing process optimization work was undertaken in order to propose a potential paediatric rectal formulation of azithromycin as an alternative to existing oral or injectable formulations. The target product profile was to be easy-to-use, cheap and stable in tropical conditions, with bioavailability comparable to oral forms, rapidly achieving and maintaining bactericidal concentrations. PEG solid solution suppositories were characterized in vitro using visual, HPLC, DSC, FTIR and XRD analyses. In vitro drug release and in vivo bioavailability were assessed; a study in rabbits compared the bioavailability of the optimized solid solution suppository to rectal solution and intra-venous product (as reference) and to the previous, non-optimized formulation (suspended azithromycin suppository). The bioavailability of azithromycin administered as solid solution suppositories relative to intra-venous was 43%, which compared well to the target of 38% (oral product in humans). The results of 3-month preliminary stability and feasibility studies were consistent with industrial production scale-up. This product has potential both as a classical antibiotic and as a product for use in severely ill children in rural areas. Industrial partners for further development are being sought. © 2012 Elsevier B.V. All rights reserved.en_US
dc.rightsMahidol Universityen_US
dc.subjectPharmacology, Toxicology and Pharmaceuticsen_US
dc.titlePharmaceutical development and optimization of azithromycin suppository for paediatric useen_US
Appears in Collections:Scopus 2011-2015

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