Formulation and Evaluation of Extended Release Tablet of Divalproex Sodium

Author(s)

Lakhani, K.M., Shah, S.V., Patel, K.N., Patel, B.A., Patel, P.A.

Author's Affiliation

Abstract

In the present work, an attempt was made to design an oral Extended release matrix tablet of Divalproex sodium and to optimize the drug release profile using 3² full factorial design. Tablets were prepared by direct compression method using HPMC K100M and Eudragit L100 as matrix forming polymers. Tablets were evaluated for various physicochemical parameters like Hardness, Thickness, Friability, Weight variation test, Content Uniformity and In vitro drug release. All the formulations complied with pharmacopoeial standards. A 3² full factorial design for 2 factors at 3 levels each was employed to systematically optimize drug release profile. HPMC K100M and Eudragit L100 were taken as the independent variables. The dependent variables selected were % of drug released in 3 hrs, % of drug released in 12 hrs. In vitro drug release study showed that batch F8 (HPMC K100M-15%, Eudragit L100-10%) was found to be optimized as it had almost identical dissolution profile with marketed product. The formulated tablets exhibited Non–fickian drug release kinetics approaching Zero–order as the value of release rate exponent (n) varied between 0.6024 and 0.7354, resulting in regulated and complete release until 24 hrs. The polymer HPMC K100M and Eudragit L100 had significant effect on the drug release from the tablets (P<0.05). Validation of optimization study performed using confirmatory run indicated very high degree of prognostic ability to 3² full factorial design. Stability study of optimized batch F8 was conducted at accelerated conditions for one month and it was found to be stable.

Keywords

Extended release tablet, Divalproex sodium, HPMC K100M, Eudragit L100

Cite This Article

Lakhani, K.M., Shah, S.V., Patel, K.N., Patel, B.A., Patel, P.A. (2012). Formulation and Evaluation of Extended Release Tablet of Divalproex Sodium, International Journal for Pharmaceutical Research Scholars (IJPRS),  1(2), 122-135.