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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/32749
Title: Pharmaceutical development and optimization of azithromycin suppository for paediatric use
Authors: Tina Kauss
Alexandra Gaubert
Chantal Boyer
Boubakar B. Ba
Muriel Manse
Stephane Massip
Jean Michel Léger
Fawaz Fawaz
Martine Lembege
Jean Michel Boiron
Xavier Lafarge
Niklas Lindegardh
Nicholas J. White
Piero Olliaro
Pascal Millet
Karen Gaudin
Developpements Analytiques et Pharmaceutiques Appliques aux Maladies Negligees et Aux Contrefacons
Universite de Bordeaux
Etablissement Francais du Sang
Mahidol University
Nuffield Department of Clinical Medicine
Organisation Mondiale de la Sante
Keywords: Pharmacology, Toxicology and Pharmaceutics
Issue Date: 30-Jan-2013
Citation: International Journal of Pharmaceutics. Vol.441, No.1-2 (2013), 218-226
Abstract: Pharmaceutical 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.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84872827650&origin=inward
http://repository.li.mahidol.ac.th/dspace/handle/123456789/32749
ISSN: 18733476
03785173
Appears in Collections:Scopus 2011-2015

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