Release Behavior of Cinacalcet Hydrochloride Using Wet Granulation

Cinacalcet hydrochloride, known as a treatment for a secondary hyperparathyroidism in a chronic renal failure, is a poorly soluble drug with the properties of BCS class IV. To improve poor solubility, in this study, after preparing a wet granule of soluble polymer and poorly soluble drug cinacalcet hydrochloride, tablets were designed by mixing additives by proportion. Chemical changes occurring in the wet granulation process were evaluated using FTIR, and DSC and XRD were performed to confirm that the granules were formed as designed. After this, the release was tested through HPLC in an artificial gastric acid (pH1.2) to confirm that the tablet was properly designed. As a result, it was confirmed that the formation of the wet granules using a soluble polymer was effective for the release of cinacalcet hydrochloride, a poorly soluble drug.