Development of Enteric Coated Sustained Release Matrix Tablets of Sertraline Hydrochloride.

ABSTRACT

The aim of the present investigation is to develop enteric coated sustained release matrix tablets of Sertraline hydrochloride (STH) using HPMC K4M and Carbopol-971 as drug release retardants and cellulose acetate phthalate (CAP) as an enteric coat polymer. The tablets were prepared by direct compression process and evaluated for various physico-chemical/mechanical parameters. Among the two release retardants, HPMC K4M was selected based on controlling the STH release during dissolution. The effect of different fillers like microcrystalline cellulose (MCC), di calcium phosphate (DCP), spray dried lactose with maize starch (SDL) and pre gelatinized starch (PGS), on STH release was also studied. The percent of STH released at the end of dissolution with different fillers is in the order of SDL > MCC > DCP > PGS. The tablets containing 15% w/w of HPMC K4M & MCC as filler with 5% coating weight gain (1% v/v glycerine in 5%w/v CAP solution) gave a STH release of less than 10% in 0.1N HCl (pH 1.2) for 2 h and a sustained release of STH over a period of 12 h (99.17±0.54%) in pH 6.8 phosphate buffer and fulfilled the regulatory requirements. The dissolution data was also evaluated for drug release kinetics and mechanisms.