Abstract

Purpose: To develop orodispersible tablets (ODTs) of fexofenadine hydrochloride using three different superdisintegrants in various ratios and to compare their disintegration properties.Methods: Direct compression technique was used for the preparation of ODTs. Mannitol and Avicel CE-15 (microcrystalline cellulose and guar gum) were used as direct compression diluents. The disintegration time of tablets using each polymer (superdisintegrant) was evaluated as well as othertablet properties including weight fluctuation, hardness, friability, wetting time and water absorption ratio.Results: Satisfactory values were obtained for all the evaluated parameters. As the polymer concentration increased, there was a decrease in disintegration time. A comparison of the three different polymers used revealed that CCM3 formulated with 12 % croscarmellose sodium and 14.66 % lactose had the least disintegration time of 32.33 ± 3.23 s. In vitro release studies showed that the maximum drug release of 94.38 ± 0.12 % in 25 min was obtained for ODT tablets containing croscarmellose sodium (CCM3).Conclusion: The orodispersible tablets had quick disintegrating property which was achieved using superdisintegrants. Thus, superdisintegrants improve the disintegration efficiency of orodispersible fexofenadine tablets at low concentrations, when compared to traditional disintegrants.
 Keywords: Croscarmellose sodium, Direct compression, Fexofenadine, Orodispersible tablets

Highlights

  • According to FDA, a fast dissolving tablet (FDT) is “a solid dosage form containing medicinal substances which disintegrates rapidly, usually within seconds, when placed upon the tongue” [1]

  • FDTs disintegrate within seconds or slightly higher [2]

  • Orodispersible tablets (ODTs) may be formulated as liquids to facilitate intake and overcome the problems associated with swallowing the solid tablets

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Summary

Introduction

According to FDA, a fast dissolving tablet (FDT) is “a solid dosage form containing medicinal substances which disintegrates rapidly, usually within seconds, when placed upon the tongue” [1]. FDTs disintegrate within seconds or slightly higher [2]. Fast dissolving tablets (FDTs) are much useful for young, elderly and handicapped or bed-confined patients, as well as individuals with unremitting nausea, and those without access to portable to water [3,4,5]. Advances in tableting technology have led to introduction of superdisintegrants which, at low concentrations, enhance the disintegration

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