Formulation of multiparticulate systems as lyophilised orally disintegrating tablets

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Abstract

The current study aimed to exploit the electrostatic associative interaction between carrageenan and gelatin to optimise a formulation of lyophilised orally disintegrating tablets (ODTs) suitable for multiparticulate delivery. A central composite face centred (CCF) design was applied to study the influence of formulation variables (gelatin, carrageenan and alanine concentrations) on the crucial responses of the formulation (disintegration time, hardness, viscosity and pH). The disintegration time and viscosity were controlled by the associative interaction between gelatin and carrageenan upon hydration which forms a strong complex that increases the viscosity of the stock solution and forms tablet with higher resistant to disintegration in aqueous medium. Therefore, the levels of carrageenan, gelatin and their interaction in the formulation were the significant factors. In terms of hardness, increasing gelatin and alanine concentration was the most effective way to improve tablet hardness. Accordingly, optimum concentrations of these excipients were needed to find the best balance that fulfilled all formulation requirements. The revised model showed high degree of predictability and optimisation reliability and therefore was successful in developing an ODT formulation with optimised properties that were able deliver enteric coated multiparticulates of omeprazole without compromising their functionality.

Details

Original languageEnglish
Pages (from-to)627-634
Number of pages7
JournalEuropean Journal of Pharmaceutics and Biopharmaceutics
Volume79
Issue number3
Early online date13 Jun 2011
DOIs
Publication statusPublished - Nov 2011

    Keywords

  • oral administration, analysis of variance, carrageenan, pharmaceutical chemistry, high pressure liquid chromatography, drug delivery systems, excipients, freeze drying, gelatin, chemical models, omeprazole, solubility, surface properties, enteric-coated tablets, time factors, viscosity

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