European Journal of Biomedical and Pharmaceutical Sciences

FORMULATION AND EVALUATION OF MOUTH DISPERSIBLE TABLETS OF SIMVASTATIN USING NOVEL EXCIPIENTS

Alaa F. Abouzeid*, Ebtessam A. Essa and Esmat E. Zin Eldin

ABSTRACT

Introduction: Novel excipients are necessary for the development of modern and advanced drug delivery systems. Soluplus® is a newly introduced hydrophilic polymer specially designed for hot melt extrusion technique, Objectives: The aim of this work was to study the potential of using Soluplus® in enhancing dissolution rate of simvastatin (SIM), a poorly water soluble drug. The goal was extended to develop and evaluate orodispersible tablets (ODT). Methods: The drug and polymer were dissolved in ethanol in absence and presence of Aerosil 200 as solid carrier. Simultaneous precipitation was achieved by evaporation of the solvent. In addition, the drug and polymer were subjected to ethanol assisted wet co-grinding. The optimized formulation was used to prepare ODT tablets using Pharmaburst® 500 and Ludiflash® as new ODT fillers. Results: Co-precipitated products showed significant improvement in drug dissolution compared to raw SIM. Presence of Aerosil further improved dissolution parameters. Solid state characterization indicated drug-polymer compatibility and reduction in crystalline nature of SIM. Co-precipitation was superior to kneading technique. The optimized co-precipitated formula was successively used to prepare ODT. Based on the quality control studies, tablets prepared using Pharmaburst® 500 were better to those prepared using Ludiflash® concerning dissolution parameters. Conclusion: The study introduced Soluplus® as promising dissolution enhancer with Pharmaburst® 500 as new filler for tablet manufacture.

Keywords: Soluplus®, simvastatin, oral dispersible tablets, kneading, Pharmaburst® 500.