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Shvoong Home>Medicine & Health>Optimization Studies on Design and Evaluation of Orodispersible Pediatric Formulation of Indometha Review

Optimization Studies on Design and Evaluation of Orodispersible Pediatric Formulation of Indometha

Article Review   by:anilbetty     Original Authors: Anil Philip; Kamla Pathak
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Orodispersible tablets of indomethacin were developed using a combined approach of subliming agent and superdisintegrant addition. The tablets were made by non-aqueous wet granulation technique with superdisintegrant incorporated both intragranularly and extragranularly. A 23 factorial design was used to investigate the effects amount of subliming agents, camphor and ammonium bicarbonate and taste masking and soothening hydrophilic agent mannitol as independent variables and disintegration time and crushing strength as dependent responses. The subliming agents were removed by subjecting the tablets to volatilization at 500C for 8hours. The volatilization time was optimized by conducting solid-state kinetic studies of optimized formulations. The results suggested that for obtaining an orodispersible tablet higher levels of camphor and mannitol and a lower percentage of ammonium bicarbonate is required. A checkpoint batch was also prepared to validate the experimental design. Optimized orodispersible tablets were evaluated for wetting time, water absorption ratio, porosity and in vitro and in vivo disintegration tests. Surface morphology of the prepared orodispersible tablets was investigated by SEM and kinetic digital images were recorded to study the disintegration process of prepared orodispersible tablets. Stability studies carried out as per ICH Q1 A guidelines suggested the formulations to be stable for the tested time period of six months. DSC studies exhibited physiochemical compatibility between indomethacin and various excipients used in the tablet formulation.
Published: June 03, 2007   
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