Carbetocin drug product and process for preparing same

A carbetocin drug product comprising carbetocin or a pharmaceutically acceptable salt thereof with increased resistance to aggregation, wherein the concentration of carbetocin is about 10 mg/mL to about 70 mg/mL and the carbetocin drug product is substantially free of aggregate-forming solids, the carbetocin drug product prepared by a process comprising:

• (a) dissolving carbetocin or a pharmaceutically acceptable salt thereof and one or more excipients chosen from a surface active agent, solubilizer, tonicity enhancer, an agent to adjust the pH, and combinations thereof to form an aqueous solution;
• (b) agitating the aqueous solution from step (a) for a time period of hours to form aggregate-forming solids;
• (c) removing the formed aggregate-forming solids from the agitated solution to form a post-agitation solution;
• and
• (d) adding the post-agitation solution to a container to form a final drug product;
• wherein the carbetocin drug product has increased resistance to aggregation when tested with shaking stress compared to an aqueous solution of carbetocin that has not been treated according to steps (b) and (c).