In vitro alcohol induced dose dumping studies for Quetiapine fumarate floating drug delivery systems

Abstract

Alcohol dose dumping can occur due to the solubility of the pharmaceutical excipients, the solubility of the drug, and the formulation’s drug release mechanism. Cellulosics are the most commonly used polymers in pharmaceutical controlled release technologies. The ethanol vulnerability of tablets made with HPMC K250, HPMC K750 and HPMC K1500 were investigated with the low soluble drug quetiapine fumarate. Quetiapine fumarate is an antipsychotic drug and it is suitable drug candidate for FDDS due to its solubility in low pH. HPMC K250, HPMC K750 and HPMC K1500 were used as a polymer matrix to control the release of quetiapine fumarate up to 24 hr. The quetiapine floating tablets were prepared by direct compression method. All the tablets were evaluated for the Pre-compression and post Compression Parameter. In-vitro dissolution study was done in Normal Dissolution Media, 0.1N Hcl and also in 10%, 20%, 30% and 40% v/v hydro alcoholic media for up to 24 hrs. All HPMC K250, HPMC K750 and HPMC K1500 preparation did not fail in alcoholic media. From these studies it was concluded that the concern around alcohol dose dumping seems negligible for these polymers.