Development, evaluation and optimization of solid self emulsifying drug delivery system (S-sedds) of lercanidipine hydrochloride

The objective of the study is to formulate Solid Self Emulsifying Drug Delivery System (SEDDS) for improvement of solubility and dissolution of poorly water-soluble drug Lercanidipine Hydrochloride which has very less water solubility (0.000165mg/mL) and absolute bioavailability of 10%. The Liquid Self Emulsifying Drug Delivery System concentrate was prepared using different oils, surfactants and cosurfactants which were screened based on saturation solubility studies. The SEDDS prepared using oil like peppermint oil, surfactant as propylene glycol, cosurfactant as PEG 400 showed very good self-emulsification property. The prepared SEDDS were subjected for evaluation of various parameters like self-emulsification property, FTIR studies, DSC studies, viscosity, globule size determination, zeta potential determination, robustness to dilution, thermodynamic stability studies. Liquid SEDDS showed good emulsification with globule size 357.2 nm and PDI 0.491. The optimized SEDDS formulation with 20% peppermint oil, 7% propylene glycol surfactant, 63% PEG 400 cosurfactant and 10% drug was used for the preparation of Solid SEDDS following physical adsorbent technique using Avicel PH 101 as an inert solid adsorbent in 1:4 ratio. The prepared solid SEDDS with free-flowing property were compressed as tablets and evaluated for hardness, friability, drug content, disintegration and dissolution studies. The results of our study conclude that the Avicel PH 101 can be used for the preparation of solid SEDDS to improve the solubility and dissolution of poorly water-soluble drug Lercanidipine Hydrochloride.