DEVELOPMENT AND EVALUATION OF LAPATINIB DITOSYLATE SELF-NANO-EMULSIFYING DRUG DELIVERY SYSTEMS

The main objective of the study is to develop gelucire 44/14 based lapatinib ditosylate (LPT) SNEDDS for the improvement of solubility and drug release. Pseudo tertiary phase diagram constructed for varying oil, surfactant, and co-surfactant combinations. Fifteen LPT SNEDDS formulations were prepared with anticipated component ratios (gelucire 44/14, peceol, and capmul MCM) based on monophasic region are subjected to thermodynamic physical stability test. Formulations that cleared stability tests were evaluated for % transmission, drug content, and in-vitro drug release analysis. The optimized formulation analyzed for particle size and zeta potential, followed by FTIR and SEM analysis. Formulation F13 with a maximum drug release of 98.96% in 60 min higher than 38.90±3.25% of pure drug is considered an optimized formulation. The average particle size and zeta potential of the F13 were 72.5 nm and -13.4 mV, respectively. The FTIR and SEM studies do not indicate any drug excipient interaction and confirm uniform drug distribution. The formulation subjected to accelerated stability study is proved to be stable over a period of six months. The results suggested that LPT SNEDDS formulations are an encouraging alternative for improved solubility and drug release of LPT.