The aim of this study was to prepare amoxicillin tri-hydrate (AMXT) granules in the form of single dose (125mg) sachet for pediatric use. A 33 full factorial design to select the best disintigrant, diluent and lubricant, followed by a 23 factorial design for the selection of the optimum excipient concentration as well as the most appropriate techniques for the preparation of drug granules were performed. Finally a complexation study using ßCD (β-cyclodextrin) or HPßCD (Hydroxy propyl β-cyclodextrin) was done. The best formulae obtained from the factorial design, based on the flow ability properties (Angle repose), saturated solubility study and release after 5 minutes from the prepared granules were further investigated after complexation with CD (cyclodextrins). Results showed that optimized amoxicillin tri-hydrate 125 mg sachet in the formation with the composition: 44%Avicel PH101, 1%Mg.Staerate, 5%Ac.Di.Sol and 1:3 AMXT: HPßCD complexation using freeze drying showed an increased solubility and stability of amoxicillin tri-hydrate and thus can be used as a single dose sachet dosage form replacing the currently available drug suspension for pediatric use.
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