Methods for the preparation of a pharmaceutical-vesicle formulation and associated products and uses

A pharmaceutical vesicle formulation comprises: (a) a vesicle comprising monopalmitoyl glycerol, cholesterol and dicetyl phosphate; (b)a pharmaceutical agent, and (c) a pharmaceutically acceptable carrier. A method for the preparation of the formulation comprises: (a) heating the monopalmitoyl glycerol, cholesterol and dicetyl phosphate at a temperature in the range of 50°C to 150°C; (b) dissolving the pharmaceutical agent in the pharmaceutically acceptable carrier mixture at a range of 30°C to 99°C; (c) adding the pharmaceutical agent carrier mixture to the vesicle components; and (d) processing the formulation mixture whereby the pharmaceutical agent is entrapped within a plurality of vesicles. The formulation is reconstituted in a known quantity of the pharmaceutical agent dissolved in a pharmaceutically acceptable carrier to provide a biphasic pharmaceutical-vesicle formulation. Preferably, the monpalmitoyl glycerol, cholesterol and dicetyl phosphate are provided in a 5:4:1 molar ratio respectively. The vesicles may carry an agent for the prevention or treatment of infection by bacteria such as Burkoholderia pseudomallei and Francisella tularensis, and viruses such as Venezuelan Equine Encephalitis Virus (VEEV). The vesicles may be non-ionic surfactant vesicles (NISVs).