Formulation and Evaluation of Delayed Release Pellets of Duloxetine HCl

Author(s)

Gohel, D.K., Jain, A.J., Patel, K.N., Patel, B.A., Patel, P.A.

Author's Affiliation

Abstract

Duloxetine HCl is an Anti-Depressant drug belonging to the class of Dual Monoamine Reuptake inhibitor. Duloxetine HCl is a potent inhibitor of neuronal serotonin and nor-epinephrine reuptake. Duloxetine hydrochloride is acid labile drug so Duloxetine hydrochloride enteric coated pellets were formulated using fluidized bed process and different enteric coating polymers. Three separate layers, the drug layer, the barrier layer and the enteric layer, were coated on to the inert core pellets. The pellets were optimized with the acid resistance and drug release in simulated intestinal fluid as the process parameters. Various other properties, such as bulk and tapped density, Hausner’s ratio, abrasion resistance, yield of pellets, moisture content, and particle size distribution were also studied in the optimized pellets. The concentration of the enteric polymer played a vital role in acid resistance, while the type of enteric polymer affected the drug release in simulated intestinal fluid. In both cases, it was determined that binder polymer concentration was not affected much. The comparisons between the optimized pellets and innovator formulation yielded Similarity (f2) and Dis-similarity (f1) values within a range of 72 and 4 respectively. One month stability studies, conducted at accelerated conditions showed optimized pellets to be stable. So the optimized formula can be utilized to perform scale up trials. It is also expected to be bioequivalent to the innovator product.

Keywords

Duloxetine, Pellet, Enteric polymer, Barrier layer, Similarity factor, Dissimilarity factor, Bio equivalent, Innovator

Cite This Article

Gohel, D.K., Jain, A.J., Patel, K.N., Patel, B.A., Patel, P.A. (2012). Formulation and Evaluation of Delayed Release Pellets of Duloxetine HCl, International Journal for Pharmaceutical Research Scholars (IJPRS), 1(2), 421-436.