Abstract
Author(s): Ishan Mathurvaishya, Sanket Dharashivkar, Madhuri Gaikwad, Pritam Juvatkar, Akanksha Badgujar
The present study deals with the formulation of an enteric-coated tablet of Divalproex sodium using the polymer Eudragit L 100-55. The core tablet was prepared by non-aqueous granulation technique and seal coated with Hydroxypropyl methylcellulose (HPMC) which acts as a moisture protectant. This seal coated tablet was further enteric coated with Eudragit L 100-55 to dissolve the drug in the intestinal fluid. Three factors and two levels (23 ) factorial design was applied using the design expert software to scrutinize the interaction effects of independent variables namely; quantity of Hydroxypropylcellulose EXF, Croscarmellose sodium, and Corn starch on the parameters like disintegration time and in vitro drug release. ANOVA analysis demonstrated that Hydroxypropylcellulose EXF level and, Croscarmellose sodium level had a significant effect (P ≤ 0.05) on the dependent responses of the core tablet. Further, the optimized batch shows the in vitro result of the enteric-coated tablet is gastro-resistant in acidic media. The comparative study was conducted with the marketed formulation using the (f1) dissimilarity and (f2) similarity factor. A similarity factor (f2) of the optimized batch was higher than 50 and thus, the formulated enteric-coated tablet could be a promising alternative to the conventional dosage form.
