Abstract

FORMULATION AND EVALUATION OF PULSATILE DRUG DELIVERY SYSTEM OF NICORANDIL

*Patel Vidhi R., Vipul P. Patel, Mehul Patel, Tejal Soni, B. N. Suhagia

ABSTRACT

The present study was aimed at preparing a new time dependent pulsed release system containing „Tablet-in-Capsule‟ for the programmed release of Nicorandil for the treatment of angina pectoris. The core tablets were prepared using wet granulation with suitable superdisintegrant agents. Eudragit S100 and Eudragit L100 were used as pH dependent polymers for coating the core tablet which were filled in to the capsule. The ratio of Eudragit S100 and Eudragit L100 and the coating level was optimized using 32 full factorial designs. Dissolution characterisation of „Tablet-in-Capsule‟ device in media with different pH 1.2, 5.5, 6.8 and pH 7.4 revealed that drug release in colon could be modulated by optimizing the concentration of Eudragit L100 and Eudragit S100 (1:2). The results of study showed that, lag time prior to drug release was highly affected by the coating level. The dissolution data revealed that the level of coating and the ratio of polymers are very important to achieve an optimum formulation. The In- vitro release from optimized formulation was found to be independent of paddle speed. Stability study of the optimized formulation indicates no significant difference in release profile after a period of one month.

Keywords: Nicorandil, Tablet in capsule, Pulsatile drug delivery, Circadian rhythm, Colon- specific systems.