Patent ID: 7871642

Claim:
A method of preparing a pharmaceutical formulation of a lipophilic pharmaceutical active agent in the form of an oil-in-water nanodispersion, which comprises (α) preparing a nanodispersion prephase by mixing (a) 0.1 to 30% by weight of a phospholipid, (b) 1 to 50% by weight of a polyoxyethylene coemulsifier selected from the group consisting of polyethoxylated fatty alcohols, polyethoxylated fatty acids, polyethoxylated vitamin E derivatives, polyethoxylated lanoline and lanoline derivatives, and polyethoxylated fatty acid glycerides, (c) a lipophilic component comprising a natural or synthetic or a partially synthetic C 4 -C 18 triglyceride, and (d) 3 to 30% by weight of ethanol, until a homogeneous clear liquid is obtained, and (β) adding the liquid obtained in step (α) to a water phase, where component (c) used in step (α), or the water phase in step (β), or both, additionally contain a lipophilic pharmaceutically active agent, where the total weight of lipophilic pharmaceutically active agent and C 4 -C 18 triglyceride of component (c) ranges from 20 to 70% by weight, and where percentages relate to sum of the weight of the components (a), (b), (c), (d) and the lipophilic pharmaceutically active agent.