In-Vitro, In-Vivo Evaluation of Floating Tablets of Clarithromycin.

Abstract

The main purpose of this research work was to design and process optimization of oral floating drug delivery system of Clarithromycin floating tablets by using the hydrophilic polymer Hydroxylpropyl methyl cellulose and gas generating agent sodium bicarbonate and citric acid. A 32 randomized full factorial design was used to study. In this design 2 factors were evaluated, each at 3 levels and experimental trials were performed at all 9 possible combinations. The independent and dependent variables are selected for optimization study. The radio-labelled floating tablets were prepared by adding barium sulphate in the optimized formulations for in- vivo radiographic study. The Results of multiple regression analysis indicated that both factors X1 and X2 significantly affected on the dependent parameters. The formulation was optimized on the basis of floating ability and in-vitro drug release. It should be concluded that as the time increases, the swelling index was increased, because weight gain by tablet was increased proportionally with rate of hydration. In-vivo radiographic studies of the optimized formulations were performed using New Zeal Albino rabbits by X-ray imaging technique. The in-vivo X-ray imaging and radiographic studies clearly indicated that the prepared optimized floating tablets were retained in the rabbit stomach over a prolonged period of time and had good in-vivo performance. Radiological evidences suggest that the formulated floating tablets of antibiotics were well floated more than 6 h in rabbit stomach.