Objectives: 1.) To develop and characterize an optimal formulation of oil-in-water nano-emulsions of trifluoperazine for parenteral delivery. 2.) To perform short term stability testing of the optimal formulation and monitor the potency using high performance chromatography (HPLC).
Materials and Methods: Emulsions containing soybean oil, water, trifluoperazine hcl as an amphiphilic drug, phospholipon 90 and Tween 80 as surfactant blend were prepared using the Thin-layer hydration method. Z-average, polydispersity index, zeta potential of emulsions were determined. A fully randomized 2X2X2X2X2 statistical design was developed using JMP software. Optimal formulation was selected based on desirable properties of low z-average and polydispersity index, and high zeta potential. Stability of optimal formulation was determined using HPLC analysis and based on ICH specifications.
Results: Z-average of optimal formulation was 72.9nm with zeta potential value of 25.59 mV and polydispersity index 0.2. After storage for 3 months, z-average values were below 200nm indicating optimal formulation was not physically degraded. Drug content analysis showed chemical degradation due to reduction of potency.
Conclusions: Trifluoperazine nano-emulsions formulations had acceptable values of low z-average, low polydispersity index and high zeta potential and were physically stable but not chemically stable over 3 months
