FORMULATION AND STATISTICAL OPTIMIZATION OF S-SMEDDS OF NICARDIPINE HYDROCHLORIDE BY USING BBD AND PCA DESIGNAbstract
The study purpose is to further enhance the rate of dissolution for poorly water-soluble drug Nicardipine Hydrochloride by dissolving NH in surfactant, Co-surfactant, and oil; phase diagram was plotted by using oil (Capmul MM C8 EP), surfactant (Labrasol), and co-surfactant (PEG 400) through which a region called microemulsifying region was obtain. The batches were optimized by holding a 3-factor and 3-level Box–Behnken design for knowing the impact of independent and dependent variables. For the selection of dependent responses, the PCA technique was employed for examining significant variables. The Liq-SMEDDS were characterized for % T, zeta potential, emulsification time, particle size, cloud point, drug content, etc. The optimized batch shows an emulsification time of 32.73 sec and particle size as 97.745 nm. In-vitro drug release shows the faster release of drug as 90.37% within 15 min. S-SMEDDS were obtained by using Neusilin as an adsorbent in Optimized formulation. DSC of solid SMEDDS showed no peak indicates that the drug was completely converted into an amorphous form or was present in solubilized form. From SEM, it was revealed that S-SMEDDS appeared as smooth-surfaced, which indicated that the liquid SMEDDS is adsorbed or coated within the pores of Neusilin US2. TEM results showed that globules of all composition formulas were well dispersed and no aggregation of globule was observed.
R. L. Dumpala * and A. Khodakiya
Department of Pharmaceutical Science, Research, Development & Innovation Centre (RDIC), C.U. Shah University, Wadhwan, Surendranagar, Gujarat, India.
09 March 2020
02 September 2020
11 September 2020
01 March 2021