European Journal of Biomedical and Pharmaceutical Sciences

IN VITRO RELEASE STUDIES OF DEVELOPED TADALAFIL MOUTH DISSOLVING TABLETS

Shahul Hameed K. M.*, Arun Kumar M. and Dhanapal C. K.

ABSTRACT

For industrially manufactured pharmaceutical dosage forms, product quality tests and performance tests are required to ascertain the quality of the final product. Current compendial requirements specify a disintegration and/or a dissolution test to check the quality of oral solid dosage forms. The release rate of Mouth dissolving tablets of selected drug tadalafil was determined using USP dissolution testing apparatus II (Electro lab, India). The dissolution testing was performed using 900ml of phosphate buffer pH 6.8 at 37±0.5°C temperature and speed 50 rpm. Sample of 05ml was withdrawn at 02 minutes interval of time upto 20 minutes. The drug releases from these tablets were found to increase with increase in the concentration of disintegrant used in the formulation. Thus, it can be concluded that in vitro release of drugs is a direct function of its solubility in the dissolution medium. When plotted according to Peppas equation, formulation F6 for tadalafil showed good linearity (r2=0.988), with a slope (n) value of 0.364 respectively. This probably indicates that the drug release of tadalafil is by Non-Fickian diffusion, when the tablet enters an in vitro dissolution medium, drug particles initially pass into solution from the surface (immediate release). The in vitro drug release profiles were plotted according to zero order, first order, Higuchi and Peppas equations to understand the mechanism of drug release and to compare the differences in the release profile of various batches of tadalafil tablets.

Keywords: Tadalafil, Higuchi and Peppas.