Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF BILAYER TABLETS FOR EFFECTIVE TREATMENT OF ULCER

Ram Krishna Pandey*, Rahul Sharma and Dr. Jagdish Chandra Rathi

.

Abstract

The objective of the present study was to develop bi-layer tablets of Esomeprazole and Levosulpiride, a highly potent drug with short halflife that are characterized by initial burst drug release in the stomach and comply with the release requirements of sustained-release products. Each of the proposed bi-layer tablets is composed of an immediate-release layer of Levosulpiride and a sustained-release layer of esomeprazole. Bi-layer tablets of Esomeprazole and Levosulpiride were prepared using direct compression method. The granules of different formulations were evaluated with respect to bulk density, tapped density, compressibility index, and drug content. Dissolution study data of Levosulpiride SR tablets demonstrated that increased concentration of HPMC K4 and K15 lead to the decreased release of Levosulpiride. Taking into consideration of above results optimized formulation IF6 of Instant release layer (Esomeprazole) and optimized formulation of F6 (Levosulpiride) for control release used for formulation of Bi-layer tablet. Esomeprazole and Levosulpiride bilayer tablet has a promising potential as an alternative to the conventional dosage form. This new dosage form has commercial marketing potency as no such delivery systems are presently available in market.

Keywords: Esomeprazole, Levosulpiride, Bilayer tablets, formulation development, Evaluation.