Acetic acid as processing aid in spray drying for basic drugs

A method for preparing a spray dried solid dispersion of an active agent, which is an organic Bronstedt base, comprising:

• a. combining an active agent, a dispersion polymer, acetic acid, and a solvent to form a spray solution, wherein
• i. the solvent comprises a C1-3 alkanol,
• the amount of the C1-3 alkanol in the solvent is at least 50 wt %, with the wt % being based on the weight of the solvent;
• ii. the active agent is in its free base form when combined with the acetic acid and the solvent to form the spray solution, and, in its free base form, has a basic pKa of 4 or greater, and the active agent has a solubility of 40 mg/mL or less in the solvent, and
• iii. the spray solution is not a supersaturated solution of the active agent in the solvent and the acetic acid;
• and
• b. spray drying the spray solution to form a spray-dried solid dispersion comprising the active agent and the dispersion polymer,
• wherein the spray solution has only one liquid phase.