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Preformulation studies of ceftriaxone for pediatric non-parenteral administration as an alternative to existing injectable formulations.

hal.structure.identifierRégulations Naturelles et Artificielles [ARNA]
dc.contributor.authorKAUSS, Tina
hal.structure.identifierInstitut de Chimie de la Matière Condensée de Bordeaux [ICMCB]
dc.contributor.authorMARCHIVIE, Mathieu
hal.structure.identifierRégulations Naturelles et Artificielles [ARNA]
dc.contributor.authorPHOEUNG, Thida
hal.structure.identifierRégulations Naturelles et Artificielles [ARNA]
dc.contributor.authorGAUBERT, Alexandra
hal.structure.identifierRégulations Naturelles et Artificielles [ARNA]
dc.contributor.authorDÉSIRÉ, Amélie
hal.structure.identifierRégulations Naturelles et Artificielles [ARNA]
dc.contributor.authorTONELLI, Giovanni
hal.structure.identifierRégulations Naturelles et Artificielles [ARNA]
dc.contributor.authorBOYER, Chantal
hal.structure.identifierRégulations Naturelles et Artificielles [ARNA]
dc.contributor.authorLANGLOIS, Marie-Hélène
hal.structure.identifierGlobal Regulatory Solutions
dc.contributor.authorCARTWRIGHT, Anthony
hal.structure.identifierOrganisation Mondiale de la Santé / World Health Organization Office [OMS / WHO]
dc.contributor.authorGOMES, Melba
hal.structure.identifierMahidol Oxford Tropical Medicine Research Unit
hal.structure.identifierCentre for Tropical Medicine and Global Health [Oxford, UK]
dc.contributor.authorWHITE, Nicholas
hal.structure.identifierRégulations Naturelles et Artificielles [ARNA]
dc.contributor.authorGAUDIN, Karen
dc.date.issued2017-04-20
dc.identifier.issn0928-0987
dc.description.abstractEnCeftriaxone, a third generation cephalosporin, has a wide antibacterial spectrum that has good CNS penetration, which makes it potentially suitable for initial treatment of severe neonatal pediatric infections providing suitable formulation. We evaluated its physicochemical and technical characteristics to assess its potential for development as a non-parenteral dosage form. As ceftriaxone is marked only for injectable use, these data are not available. Using HPLC and Karl Fischer titration, sensitivity of ceftriaxone to water, feasibility and impact of pharmaceutical processes and compatibility with common pharmaceutical excipients were assessed. X-ray diffraction studies gave deeper insight into the mechanisms involved in degradation. Chemometrical analysis of near infrared spectra enabled classification of ceftriaxone powder according to exposure conditions or processes applied. The results showed that ceftriaxone was not highly hygroscopic, could be processed in all climatic zones, but should be packaged protected against humidity. Controlling water presence in formulation was shown critical, as ceftriaxone degraded in the presence of water content above 2.4% w/w. To improve flowability, a critical parameter for dry dosage form development, granulation (wet and dry techniques, providing complete drying and moderate force compaction respectively) was shown feasible. Compression with moderate forces was possible, but grinding and high compression forces significantly affected long term ceftriaxone stability and should be avoided. Based on these results, development of ceftriaxone non-parenteral solid or liquid non-aqueous forms appears feasible.
dc.language.isoen
dc.publisherElsevier
dc.subject.enCeftriaxone
dc.subject.enCompatibility
dc.subject.enNear infrared (NIR) spectroscopy
dc.subject.enNon-parenteral administration
dc.subject.enPharmaceutical process simulation
dc.subject.enStability
dc.subject.enX-ray diffraction (XRD)
dc.title.enPreformulation studies of ceftriaxone for pediatric non-parenteral administration as an alternative to existing injectable formulations.
dc.typeArticle de revue
dc.identifier.doi10.1016/j.ejps.2017.04.010
dc.subject.halChimie/Matériaux
bordeaux.journalEuropean Journal of Pharmaceutical Sciences
bordeaux.page382-392
bordeaux.volume104
bordeaux.peerReviewedoui
hal.identifierhal-01530465
hal.version1
hal.popularnon
hal.audienceInternationale
hal.origin.linkhttps://hal.archives-ouvertes.fr//hal-01530465v1
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