EFFECT OF pH OF ENTERIC POLYER ON DISSOLUTION PROFILE OF DULOXETINE HCl DELAYED RELEASE PELLETS AT VARIOUS pH RANGESAbstract
The main objective of the present study is to evaluate the effect of pH of enteric polymer [methacrylic acid ethyl acrylate copolymer dispersion (Eudragit L30 D-55)], on dissolution profile of Duloxetine HCl delayed release formulation with the Tlag of 2hrs. The said formulation was formulated using fluidized bed process in three separate layers, the drug layer, the barrier layer and the enteric layer, were coated on sugar spheres. The enteric coated pellets were top coated using a film coating material, filled in hard gelatin capsules. Eudragit L30-D55 is used as such and neutralized to different pH (pH 4.00, pH 4.25, pH 4.50, pH 4.75, pH 5.00 and pH 5.25), coated on barrier coated pellets. The formulation coated by using enteric polymer neutralized to pH 4.75 shows the maximum extent of dissolution (91.8%) in 0.1N HCl for 2 hrs followed by pH 5.5 phosphate buffer at 120mins.
Raja Subburayalu*, Janakiraman Kunchithapatham and Ramkumar Pillppan
Department of Pharmacy, Annamalai University, Annamalai Nagar, Chidambaram, Tamil Nadu, India
05 May, 2013
16 June, 2013
25 August, 2013
01 September, 2013