(164a) Influencing API Particle Formation Using Ultrasound

Control of physical properties of API particles is an important aspect of pharmaceutical product development owing to their impact on the stability and ease of formulation. These desired physical attributes are often achieved through controlled crystallization of the API particles. Ultrasonic sound provides a means of inducing nucleation and crystal growth without direct seeding of the supersaturated solution, thus potentially simplifying the crystallization process. In this work, we present the effect of ultrasound on the nucleation behavior of an API. The effectiveness of sonication as a tool for inducing nucleation of API crystals, and for manipulating their size and aspect ratio, is discussed. These results give us a basis for assessing the feasibility of implementing ultrasonic crystallization at manufacturing scale.