Abstract

FORMULATION AND EVALUATION OF BILAYER ENTERIC COATED TABLETS OF PANTOPRAZOLE AND LEVOSULPIRIDE (SR)

Aslam Khan*, Devika Tripathi, Mukesh Dhiman, Semimul Akhtar

Abstract

The Experiment relates to formulation and development of oral pharmaceutical bilayer enteric-coated tablet of Pantoprazole and Levosulpiride(SR) for administration of therapeutically and prophylactically effective amount of Antipsychotic and proton pump inhibitor drug substance to resist the gastric fluids and obtained both a relatively fast or quick onset of therapeutic effect and maintenance of a therapeutically active plasma concentration for relatively long period of time up to 12hrs. Drug excipient compatibility study by FTIR analysis. Physical mixtures of drug and excipients kept for stability study at 40±2ºC & 75±5% relative humidity for 30 days in stability chamber. By Compare FTIR Peaks of Levosulpiride with peaks of Levosulpiride with excipient and Pantoprazole with peaks of Pantoprazole with excipient there was no significant change observed in the peaks and The FTIR analysis shows the characteristics peaks of API conclude that drug and excipient are compatible with each other.Second stage of formulation development is formulation of immediate release layer and sustained release layer for prepration of bilayer tablet. Formulate immediate release layer and sustained release layer individually by dry granulation and wet granulation method. Both Layers passes the Precompression tests and Formulation of Enteric-coating using Procoat ECM Aqua(Aw1001), HPMC (E-15), Titanium dioxide, PEG-6000 and solvent. It can be concluded from the obtained results that as the concentration of Methocel K100LV increases, The percentage drug release of Levosulpiride decreases.

Keywords: Bilayer enteric-coating, Levosulpiride, Pantoprazole and Methocel K100LV.