Formulation Development and Evaluation of Divalproex Sodium Extended-release Tablets

Abstract

There are two important parameters for a control release formulation. Primarily, it should be available in the form of a single-dose formulation. It should be given to the patient per day or few days a week during the treatment of patients suffering from diseases like arthritis, angina and diabetes. The second important characteristic of such formulation is that they release the active molecule at the site of action. This will reduce the chances and the level of the side effects of the drug. Among the available such type of dosage form, sustained-release formulations (SR) give the most promising and desirable results. In the SR dosage form, the drug release profile is controlled by the pharmaceutical engineering in the core matrix of tablet. In this study, SR oral tablet of divalproex sodium was manufactured by varying the quantity of drug release-controlling polymers like metolose 65 SH and metolose 90 SH. In the formulations, these polymers were used in different proportions and evaluated their impact on the physical and chemical characteristics of the finished drug product. The results of all formulations were as per the requirement of standard pharmacopoeial monograph. However, drug dissolution results of two formulations viz. DF9 and DF16 were observed to be optimum and excellent among all batches.