Development and Evaluation of Fast Dissolving Tablets of Quetiapine Fumarate using 3^2 Full Factorial Design

Author(s)

Patel, J. V., Patel, K. N., Patel, K. D., Patel, K. N., Nayak, B. S.

Author's Affiliation

Abstract

The purpose of this study was to develop Fast Dissolving Tablets of Quetiapine Fumarate. Quetiapine Fumarate is an atypical anti-psychotic drug, used for depressive episodes, acute manic episodes associated with bipolar Ι disorder at a short time. Initially the inclusion complex between Quetiapine Fumarate and β-Cyclodextrin (β-CD) was prepared by kneading method. FTIR and DSC of Quetiapine Fumarate and it combination with Excipients shows no change in peak of absorbance and melting point. Fast Dissolving Tablets containing Quetiapine Fumarate were prepared by direct compression method using various superdisintegrants like sodium starch glycolate, croscarmellose sodium and crosspovidone in three different concentrations i.e. 4, 6, 8 mg. A 3² full factorial design was applied to systematically optimize the drug disintegration time. The concentration of Croscarmellose Sodium (X₁) and concentration of Crospovidone (X₂) were selected as independent variables. The disintegration time (Y₁), wetting time (Y₂) and %CDR (Y₃) were selected as dependent variables. The prepared tablets were evaluated for hardness, friability, disintegration time, wetting time and In-vitro drug release. The results indicated that concentration of croscarmellose Sodium (X₁) and concentration of crosspovidone (X₂) significantly affected the disintegration time (Y₁), wetting time (Y₂) and %CDR (Y₃). Regression analysis and numerical optimization were performed to identify the best formulation. Formulation F10 prepared with Croscarmellose Sodium (5 %) & Crospovidone (5 %) was found to be the best formulation with disintegration time 11 sec, wetting time 14 sec and % drug release in 20 min 99.89%.

Keywords

Fast Dissolving Tablet, β-Cyclodextrin, Quetiapine Fumarate, Inclusion complex, Superdisintegrants, 3² Full Factorial Design

Cite This Article

Patel, J. V., Patel, K. N., Patel, K. D., Patel, K. N., & Nayak, B. S. (2014). Development and Evaluation of Fast Dissolving Tablets of Quetiapine Fumarate using 3*2 Full Factorial Design. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(2), 281-297.