Ternary mixture formulations

A process for making a free-flowing powder pharmaceutical formulation comprising the steps of:

• (a) dissolving a phospholipid component, a poorly water-soluble drug substance component, and a surfactant component in a water partially miscible or water non-miscible solvent or combination of partially miscible or water non-miscible solvents to form a first solution;
• (b) dissolving a solubilizing aid component in water to form a second solution;
• (c) adding a water-miscible solvent to the second solution to form a third solution;
• (d) combining the first solution and with the third solution to form a clear homogenous solution;
• and
• (e) producing a free flowing powder comprising a homogenous solid dispersion consisting of the phospholipid component, the poorly water-soluble drug substance component, the surfactant component, and the solubilizing aid component by spray drying the clear homogenous solution, precipitating the clear homogenous solution, or coating the clear homogenous solution onto a surface of an inert substrate;
• wherein the phospholipid component comprises soy phosphatidyl choline, egg phosphatidyl choline, dimyristoyl-phosphocholine, dimyristoyl-phosphoglycerol, distearoyl-phosphatidylcholine, distearoyl-phosphatidylglycerol, dipalmitoyl-phosphocholine, or a combination thereof;
• wherein the solubilizing aid component comprises lactose, polydextrose, a cyclodextrin, an amino alkyl methacrylate copolymers, or a combination thereof;
• and
• wherein in the free flowing powder, the phospholipid component, the poorly water-soluble drug substance component, the surfactant component, and the solubilizing aid component are present in weight/weight ratios of (1.5−2):1:(0.5−1):(5.8−10), respectively.