Abstract

FORMULATION DEVELOPMENT AND CHARACTERIZATION OF SELF NANOEMULSIFYING DRUG DELIVERY SYSTEM OF LERCANIDIPINE

Tejram Basor*, Aditya Tiwari and Dr. Nitendra Sahu

ABSTRACT

A SNEDDS of Lercanidipine was successfully developed with olive oil, Tween 80, and ethanol as the components. The preformulation studies it is observed that lercanidipine is a yellow, odorless powder. Melting point was observed at 198-2000C. max 252 nm was determined. Total 15 different type formulations formed using different concentration of oil and Smix on trial basis. Characterization of selected nanoemulsion formulations were evaluated under various parameters like Droplet size (116 to 388 nm), Poly Dispersity Index (PDI) (0.447 to 0.731) and (%) Drug content (96.43 ± 2.21 to 98.84 ±2.53) all results showed in tables. Prepared SNEDDS formulations were solidified to achieve free flowing properties and found flow rate (4.22 to 5.74), angle of repose (24.43 ± 0.11 to 29.54 ± 2.74) and Carr’s Index (06.90 to 11.11). Also self emulsification time (91 ± 12 to 123 ± 20 sec) was obtained. In-vitro dissolution studies revealed that all formulations were reached the drug release percentage as F-1(94.99), F-2(93.55), F-8(95.52), F-9(96.23), F-11(92.12) and F-12(96.13). All prepared SNEDDS formulations were subjected for diffusion study with cellophane membrane. Cumulative amount of drug released Q (μg/cm2) at different time intervals and steady state flux (Jss, μg/cm2.hr) were obtained. Also permeability coefficient (Kp) are calculated and found F-12 has highest Q value i.e. 1579.45 for cellophane. Accelerated Stability studies for 30 days was performed with optimized batch F-12 for physical examination observed no visible change, % Drug content after stability and before stability were 98.01 and 100.33 respectively. The cumulative amount of drug permeated at 6 hour (Q2.5) and the steady state flux (Jss) for the formulation were found to be 1551.65μg/cm2 and 220.33μg/cm2.hr respectively. No significant changes were observed in the formulation after its stability testing.

Keywords: Self- Nanoemulsifying Drug Delivery System, Lercanidipine, nanoemulsion, olive oil.