Solid dispersions having stabilized emulsion particles

A solid dispersion composition obtainable by a method comprising the steps of:

• (a) dissolving compound (1):
• or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable dispersion carrier comprising hydroxypropyl methylcellulose acetate succinate in a solvent comprising dichloromethane/methanol to form a solution;
• (b) combining the solution and an anti-solvent comprising water to form a combination, wherein the anti-solvent comprises a surfactant comprising polyvinyl alcohol;
• (c) mixing the combination to generate an emulsion with a pre-determined mean particle size range;
• (d) removing the solvent from the emulsion to generate the solid dispersion composition, wherein the solid dispersion composition has a predetermined mean particle size range.

An apparatus for conducting a continuous or semi-continuous production of a solid dispersion composition, wherein the apparatus comprises:

• (a) a container (300, 10, 110) comprising a dissolved API/pharmaceutically acceptable dispersion carrier solution in a solvent;
• (b) a container (400, 20, 120) comprising an anti-solvent/surfactant solution;
• (c) a mixing device (320, 28, 128) fluidly connected to the containers of (a) and of (b), and configured to mix the solutions in the containers (a) and (b) to generate an emulsion, wherein the emulsion has a pre-determined mean particle size range;
• (d) at least one solvent removal device (36, 326, 136, 156) fluidically connected to the mixing device (320, 28, 128) wherein the at least one solvent removal device (36, 326, 136, 156) is configured to remove the solvent from the emulsion to produce the solid dispersion composition;
• (e) a decanter or filtration device (342, 206) fluidically connected downstream of the at least one solvent removal device (36, 326, 136, 156) configured to collect the solid dispersion composition, wherein the decanter or filtration device (342, 206) is optionally configured to wash the collected solid dispersion composition with an anti-solvent;
• wherein the apparatus further comprises one or more fluidically connected pumps (404, 304, 24, 14, 124, 114, 324, 34) configured to deliver the solutions of (a) and (b) to the mixing device (320, 28, 128) and/or deliver the emulsion to the at least one solvent removal device (36, 326, 136, 156).