PREFORMULATION CHARACTERIZATION, DEVELOPMENTAND EVALUATION OF HARD GELATIN CAPSULES OF DACLATASVIR DIHYDROCHLORIDE

Jeevana Jyothi B.* and Padmaja G.

ABSTRACT

Daclatasvirdihydrochloride (DCLD) is a new drug gained its FDA approval on July 24, 2015 for treatment of hepatitis C.There are no reports on preformulation characters and formulations. Hence present research work was assessment of preformulation characters, development of hard gelatin capsules and in-vitro evaluation. DCLD is hydrophilic with aqueous solubility. XRD indicated amorphous nature. DSC showed melting peak at 273.600C. FTIR revealed amide C=O stretch at 1641.46 cm-1, aromatic C=C bending.at 1726.67 cm-1. Hard gelatin capsules containing 60 mg of DCLD, 320 mg of Lactose and 4mg magnesium stearate evidenced optimum disintegration and drug release.

Keywords: Daclatasvir dihydrochloride, New drug, Preformulation, XRD, DSC, FTIR, hard gelatin capsulesin-vitrodrug release.