American Journal of Advanced Drug Delivery www.ajadd.co.uk American Journal of Advanced Drug Delivery www.ajadd.co.uk Original Article Effect of Combination of Methocel K4M, K15M And K100M on the In Vitro Release of Aripiprazole from Controlled Release Tablets Using Full Factorial Design of Experiments Vinay Umesh Rao*, E. Sangeetha, M. Sudhakar Malla Reddy College of Pharmacy, Secunderabad, India ABSTRACT The effect of three different viscosity grades on the in vitro dissolution profile of Aripiprazole controlled release tablets was studied. The study was carried out using full factorial design of experiments. The release rate of 5 to 6 mg%/ hour was targeted and the effect of the polymers on drug release over 24 hours was evaluated at the total polymer level between 30% and 45%. The DOE experiments have shown that when the combination of polymer is used, the total polymer concentration should be in a narrow range of 32.4% w/w to 37.5% w/w in order to achieve the target dissolution profile. Keywords: Aripiprazole, Once a week formulation, Design of Experiments (DOE), Release rate kinetics INTRODUCTION Aripiprazole 1-3 is a newer generation atypical anti psychotic drug belonging to the chemical class of benzoxazole derivative. It is available in different dosage forms in the strength of 10 mg, 20 mg, and 40 mg tablets, orally disintegrating tablets and long acting parental depot preparations. The aim of the present work was to study the effect of three viscosity grades of HPMC polymers on the release rate kinetics of oral controlled release matrix type formulation of Aripiprazole. The target dissolution profile (Table 1) for a 24 hour release preparation was fixed between 5 to 6 % per hour and the effect of three levels of each of the three polymers was evaluated by measuring the in vitro dissolution in 0.1N HCl using a 3 3 full factorial design of experiments 4 . Aripiprazole is a typical BCS Class II drug with a strong blood level dependent adverse effect profile. The aim of the sustained release formulation 5 was to reduce the adverse effect intensity by bringing the drug slowly into the blood stream and at the same time to prolong the effect. The pharmacokinetics and pharmacodynamic profiles of the drug indicates that it is available for action at the receptor site for a Date of Receipt- 31/05/2013 Date of Revision- 06/06/2013 Date of Acceptance- 10/06/2013 Address for Correspondence Malla Reddy College of Pharmacy, Secunderabad, India E-mail: vinayrao68@gmail.com