Oral self emulsifying powder of lercanidipine hydrochloride: Formulation and evaluation

The current investigation was aimed to improve the solubility of poorly soluble lercanidipine hydrochloride as self emulsifying powder (SEP). Liquid SEDDS of LCH was formulated with Capmul MCM L8 as oil, Tween (R) 80 as surfactant and PEG 400 as co surfactant after screening various vehicles. The prepared formulations were evaluated for self emulsifying ability and phase diagram was constructed to optimize the system. These systems were further characterized for globule size, effect of pH and robustness to dilution, cloud point, thermodynamic stability, surface morphology and drug release. The system was robust to different pH media and dilution volumes. The optimized system possessed a mean globule size of 169 ± 06 nm and cloud point of 76 °C. The self emulsifying powder was prepared by adsorbing the liquid SEDDS on to neusilin as carrier. The SEP formulated was free flowing with similar emulsification characteristics as that of liquid SEDDS. The X-ray diffraction, Differential Scanning Calorimetric studies of SEP revealed transformation of crystalline structure of LCH because of its molecularly dissolved state in the liquid SEDDS. This was further confirmed by scanning electron microscopy. High dissolution efficiency value of SEP compared with pure drug indicated the increase in dissolution characteristics of LCH in SEP.