Formulation Development and Evaluation of Self Nanoemulsifying Drug Delivery System of Selected Drugs

Abstract

newlineBCS Class-II drugs have poor oral bioavailability due to its limited aqueous solubility. Lercanidipine HCl, an antihypertensive orally administered drug belongs to a group of medicines called Calcium Channel Blockers of the third generation as well as Cinacalcet HCl, a calcimimetic orally administered drug with poor aqueous solubility were selected as drug candidates for the research work. In this study, an attempt was made to develop a self nanoemulsifying drug delivery system (SNEDDS) to enhance oral bioavailability of selected drugs. Received complimentary samples of selected drugs were subjected for identification and compatibility study by FTIR. Based on solubility in different solvents and their combinations, oil, surfactant, and co-surfactant were identified for both drugs separately. SNEDDS were prepared using a pseudo-ternary phase diagram method. Various parameters like dispersion time, globule size and drug release etc. were screened for 32 full factorial design. The optimized formulations of selected drugs were evaluated by various parameters like globule size, polydispersity index, zeta potential, drug content and in-vitro drug release study. Optimized formulations were subjected to accelerated stability study according to ICH guidelines. In vitro drug release study was also carried out to compare optimized SNEDDS with the available marketed conventional tablet. The results of the present study revealed the prospective use of SNEDDS of poorly water-soluble drug like Lercanidipine HCl and and Cinacalcet HCl.quot