Formulation Development and Evaluation of Orodispersible Tablets of Quetiapine Fumarate by Sublimation Method

Abstract

The objective of present study was to formulate directly compressible orodispersible tablets of quetiapine fumarate by sublimation method with a view to enhance patient compliance. A full 32 factorial design was used to investigate the effect of two variables viz., concentration of Indion 414 and camphor. Indion 414 (3-5 % w/w) was used as superdisintegrant and camphor (5-15 % w/w) as subliming agent. The tablets were evaluated for thickness, weight variation, hardness, friability, content uniformity, wetting time, porosity, in vitro disintegration time and in vitro drug release. In vitro dissolution profile revealed faster and maximum drug from formulation F3. SEM study show formation of pores on tablet surface after sublimation of the sublimating agent, thus providing a sufficiently porous structure. This permitted the selection of a batch of tablets with desired disintegration time and improved dissolution rate after oral administration. The F3 batch containing the Indion 414 (5%) and Camphor (5%) w/w of total formulation weight had shown good the disintegration time of 18.66 seconds and with improved dissolution rate and desirable friability. Further studies will be required to evaluate the performance of dosage form in vivo and In Vitro In vivo Correlation. Keywords : Orodispersible tablet, factorial design, Indion 414, sublimation, quetiapine fumarate