Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF DULOXETIN HYDROCHLORIDE DELAYED RELEASE CAPSULES

Neelam Chakravarthi*, Suryakanta Swain and Manohar Babu S.

Abstract

The present project was carried out to formulate and evaluate duloxetine hydrochloride delayed release capsules. The formulation process was carried out in FBP by suspension layering technique. Duloxetine hydrochloride is an acid labile drug, degraded at acidic pH of stomach. To bypass the stomach, the formulation has to delay the release and give the release in proximal small intestine. This can be achieved by enteric coating. The work was carried out to delay the release of duloxetine hydrochloride by using enteric polymer. The study includes preformulation of drug and excipients, formulation and evaluation, release kinetics and stability studies of capsules. Enteric coating was given to duloxetine hydrochloride pellets by using different enteric polymers. A combination of Hydroxyl propyl methyl cellulose phthalate (HPMCP) HP55 and Hydroxyl propyl methyl cellulose phthalate (HPMCP) HP50 in 6:4 ratio was optimized for enteric coating. Enteric coating was optimized by comparing release profile with that of the innovator. Enteric coated formulations were evaluated for assay, acid resistance and dissolution. F12 enteric coated pellets were found to be optimized and were evaluated and the results were found to be more similar with the innovator.

Keywords: Duloxetine hydrochloride, Delayed release capsules, Acid labile drug, Enteric coating.