Lyophilized NLC of Cinacalcet HCl: Physics of Tablet Compression and Biopharmaceutical Characterization

Abstract: Background: Cinacalcet Hydrochloride (CINH) is a BCS class IV drug. It mainly used for the treatment of chronic renal disease and parathyroid cancer. exhibits poor oral bioavailability less than 25%. The main objective to improve stability CINH by formulating lyophilized Nanostructure Lipid Carrier (NLC) into tablet dosage form. Materials Methods: In this research, Glycerylmonostearate (GMS), labrasol, tween 20 were excipients selected formulation NLC. Hot high speed homogenization ultra-sonication method was NLC CINH. using three different cryoprotectants at concentrations. Physics compressions study conducted powders. pharmacokinetic determine improvement in cytotoxicity performed MTT assay know cell viability. Results: exhibited drug entrapment efficiency content with particle size 200nm. compression showed containing 15%w/v mannitol plastic deformation. Pharmacokinetic 5 folds increase Lyophilized (LNLC3) comparison aqueous suspension Minimum viability determined as 94% which indicates safety incubated formulations. Conclusion: has potential loading, stability, desirable tableting parameters making tablet. Keywords: Compactibility, Cryoprotectant, Crystalinity, Bioavailability Cytotoxicity.