Article Title (2.Language):
The purpose of this research was to formulate tasteless complexes of Fexofenadine Hydrochloride with Kyron-134 and to formulate tasteless complex into fast-Dispersible tablets (FDT) for the treatment of allergic rhinitis & chronic idiopathic urticaria. Tasteless Drug resin complexes (DRC) were prepared using combination of Kyron-134 & drug in different ratio(1:3) and evaluated for different factor affecting Drug-Resin Complexation, Complexation time, stirring time, soaking time, temperature, and effect of pH on Fexofenadine Hydrochloride loading on Kyron-134. Fexofenadine Hydrochloride release from FDT is obtained at salivary and gastric pH. Infrared spectroscopy & DSC revealed Complexation of -NH (drug) with Kyron-134. Drug release from FDT in salivary pH was insufficient to impart bitter taste. Complete drug release was observed at gastric pH. The values of pre-compression parameters evaluated, were within prescribed limits and indicated good free flowing properties. The tablets were evaluated for post-compression parameters such as weight variation, hardness, and friability, wetting time, content uniformity, disintegration time and dissolution. The study conclusively demonstrated significant taste masking of API and rapidly dispersible and dissolution. Maximum loading was obtained at drug-resin ratio 1:3, pH 6-7, temperature 60 °C, soaking time 60 min and stirring time 5-6 hr. Formulation D-5 containing Kyron-314 (66.66%) & CSS (33.33%) show optimum result among all formulation. The studies indicate that the formulation was taste masked drug can be formulated in to FDT with view to enhance patient compliance & to obtain faster onset action of the drug which would be advantageous in comparison to the currently available conventional forms. Formulations D-5 was found to be palatable with in vitro disintegration time of 20 s Dissolution studies showed complete release of D-5 within 30 min.