Characterization and release behavior of sibtramine HCL tablet with the additives

In this study, sibutramine HCl, appetite suppressants were prepared into tablet type with additives such as lactose monohydrate, microcrystalline cellulose(MCC), and PVP K-25 to effective oral administration. We used the polyplasdone XL-10 as disintegrant. We compared the in vitro release behavior of sibutramine from the tablets according to additives with commercial drug, Reductil. The change of structure and crystallinity of tablet by additives were characterized by fourier-transform infrared spectroscopy(FT-IR) and differential scanning calorime-ter(DSC). FT-IR and DSC results demonstrates that structure of drug was changed and crystallinity of drug was decreased according to additives. The dissolution rate of sibutramine HCl from tablet greatly increased in simulated gastric fluid(pH 1.2) and simulated intestinal fluid(pH 6.8) in case of adding lactose monohydrate and PVP K-HR Jeon, DW Kwon, BS Lee, et al., Composition containing sibutramine free base and manufacturing method thereof, Korea Patent, 10-0627687 (2006).