Abstract: 
The purpose of this research work was to prepare the buccoadhesive bilayered tablet of simvastatin for the treatment of hypercholesterolemia, by using the mucoadhesive polymers such as carbopol (CP), hydroxy propyl methyl cellulose (HPMC) and polyvinylpyrrolidone (PVP) in different concentration. Ethyl cellulose is used in backing layer because of its water impermeable nature. Tablets were prepared by direct compression method. The first layer which adheres to mucosa was obtained by direct compression of mucoadhesive polymers and drug. The second layer containing water impermeable agent was compressed on the first layer. Tablets were subjected for physicochemical characterization tests such as FTIR, DSC, hardness, weight variation, friability, mucoadhesive strength, in vitro drug release study, in vitro drug permeation, and stability in human saliva. The FTIR and DSC analysis of drug, polymers, physical mixture and formulation indicated that the compatibility of drug with excipients. Tablets were found to be satisfactory when evaluated for weight variation, thickness, hardness and friability. The surface pH of all the tablets was close to neutral pH. The bilayered tablets containing a higher proportion of CP showed good mucoadhesive strength. The buccal tablets were found to be stable when tested for 8 h in natural human saliva. The present study concludes that mucoadhesive buccal devices of simvastatin can be a good way to bypass the extensive hepatic first pass metabolism and to improve the bioavailability of simvastatin.

Keywords: Bilayer Tablets, Buccal Delivery, Simvastatin, In Vitro Release.