FORMULATION AND EVALUATION OF SOLID-SELF NANO EMULSIFYING DRUG DELIVERY SYSTEM OF FAMOTIDINE

The main objective of the study was to formulate and evaluate solid self nano emulsifying drug delivery systems (SNEDDS) of famotidine (BCS class-IV drug), a histamine receptor antagonist used in case of ulcers, Zollinger-ellison syndrome. Liquid SNEDDS was formulated using oils like oleic acid, arachis oil, surfactants like Tween 20, Tween 80, etc., and co-surfactants like Transcutol-P, polyethylene glycol. Based on solubility studies, oleic acid (15mg/ml), Tween 20 (38.41mg/ml) & Transcutol-P (2.593mg/ml) were further studied by phase titration method using different ratios of oil: s-mix (surfactant: co-surfactant) from 1:9 to 9:1 with pseudo-ternary phase diagrams. FTIR spectra indicated drug excipient compatibility. Further evaluation studies, namely thermodynamic stability studies, robustness to dilution, self-emulsification time, dispersibility test, drug content, and in-vitro drug dissolution tests, formed the basis for optimization of liquid SNEDDS formulation. In-vitro drug release of F1 (97.15±0.02% in 90 min) and F19 (100.23±0.1% in 60 min) was significantly higher when compared to the pure drug (18.41±0.01% in 90 min). The droplet size of F19 (ratio of 3 (oil): 1 (s-mix), smix ratio (2:8)) was found to be 102nm, PdI 0.365 and zeta potential of -12.2mV. Formulations F1 & F19 were converted to Solid-SNEDDS by adsorption onto Neusilin US2 carrier. The Solid F19 capsule formulation has shown ex-vivo permeation of (96.98±0.1%) when compared to the pure drug (44±0.08%) in 120 min.  XRD and DSC studies confirmed the conversion of the crystalline drug to its amorphous form. The surface morphology of solid F19 was studied. Hence, solid-SNEDDS enhanced the solubility and permeation of the drug.