Formulation and Evaluation of Fast Dissolving Tablets of Doxazosin Mesylate

The objective of this research was to formulate fast dissolving tablets of Doxazosin mesylate that disintegrate in the oral cavity upon contact with saliva and there by improve therapeutic efficacy. Doxazosin mesylate is used for the treatment of the signs and symptoms of benign Prostatic Hyperplasia. Fast dissolving tablets of Doxazosin mesylate were prepared by direct compression method using superdisintegrant addition method, by using sublimation method and effervescent method. Thirty two formulations were prepared and evaluated for hardness, thickness, friability, weight variation, drug content, in vitro disintegration time, in vitro dispersion time, wetting time, water absorption ratio and in vitro dissolution studies.

FTIR and DSC studies revealed that there was no chemical interaction between the drug and the excipients. Formulation S8 was found to be the best on the basis of wetting time, in vitro disintegration time and in vitro drug release. The formulation S8 containing camphor (8%) as subliming agent was found to be the optimized combinations. Stability studies were carried out at 25°C±2°C/60%±5% RH and 40°C±2°C/75%±5% RH for formulation S8 for 60 days. The results of stability studies indicated no significant changes with respect to physicochemical properties, in vitro disintegration time, wetting time and in vitro drug release.