Ternary Pseudo-Triphasic Phase Diagram for Lipid Formulation

Purpose: Lipid-based formulations are frequently studied, they improve oral bioavailability of water-insoluble drugs and constitute 40% of new drugs. A ternary pseudo-phase diagram(TPPD) is a thesaurus tool used to define specific physical compositions of a thermodynamically stable solution. The aim of this study was to construct TPPD of lipid-based formulations and identify optimum composition for drug delivery. Method: The aqueous titration experimental method was used. A lipid and surfactant components were mixed in a fixed ratio. No cosurfactant was used. The mixture was heated at 45°C. Water was used as a titer and was added in increment of 5%-10% to up to 95% of the total mixture. After equilibrium, the mixture was observed for characterization. Data were gathered on a table, showing each increment of water, the amount of each component, and the percentage of each component in the mixture. Data collected were used to build TPPD through excel. Result: Comparing one set of 3 phase diagrams(PDs), the PD(Miglyol-812, TPGS, Water) presents a larger area of clear solution(CS), a very small area of microemulsion, and a small area of emulsion. The PD(Miglyol-812, Tween 80, Water) presents a smaller area of CS, a small area of microemulsion, and a larger area of emulsion. The PD(Miglyol-812, K El, Water) presents a small area of CS, a small area of microemulsion, and a large area of emulsion. Conclusion: All PD built present stable area of emulsion and microemulsion that can be reconstituted for optimum delivery.