Spray-drying process

A spray-drying process, comprising:

• (a) forming a feed suspension in a tank at a temperature T1, the feed suspension comprising an active agent, a matrix material, and an organic solvent, wherein the active agent is suspended in the organic solvent, and wherein the organic solvent is methanol, ethanol, n-propanol, isopropanol, butanol, acetone, methyl ethyl ketone, methyl isobutyl ketone, ethyl acetate, propyl acetate, tetrahydrofuran, acetonitrile, methylene chloride, toluene, 1,1,1-trichloroethane, or any mixture thereof, and contains less than 10 wt % water;
• (b) flowing the feed suspension from the tank through a flow-through heat exchanger located downstream of and separate from the tank and upstream of a spray drying apparatus, the flow-through heat exchanger comprising a feed suspension inlet and a spray solution outlet to form a spray solution, wherein the feed suspension entering the feed suspension inlet is at the temperature T1, wherein the temperature T1 is below the ambient-pressure boiling point of the organic solvent and the matrix material is dissolved in the organic solvent at the temperature T1, and the spray solution at the spray solution outlet is at a temperature T2 and at a pressure that is greater than the vapor pressure of the organic solvent at the temperature T2, such that the active agent and the matrix material are soluble in the organic solvent at the temperature T2, wherein T2>T1,
• (c) directing the spray solution to the spray-drying apparatus via a nozzle positioned proximate the spray solution outlet of the flow-through heat exchanger, wherein the spray solution is delivered to the nozzle at a temperature T3, wherein the temperature T3 is less than or equal to the temperature T2;
• and
• (d) atomizing the spray solution into droplets within the spray-drying apparatus through the nozzle to remove at least a portion of the organic solvent from the droplets to form a plurality of particles having an average diameter ranging from 0.5 μm to 500 μm, wherein the particles comprise a homogeneous solid amorphous dispersion of the active agent and the matrix material,
• wherein the spray solution is at the temperature T2 for less than 5 minutes.