(355a) Particle Engineering of Amorphous API Via Co-Processing for Enhanced Physical Properties
AIChE Annual Meeting
2023
2023 AIChE Annual Meeting
Pharmaceutical Discovery, Development and Manufacturing Forum
Advancements in Drug Substance Processing and Material Science
Thursday, November 9, 2023 - 8:00am to 8:21am
Recently, more APIs has been found to be inherently amorphous due to their flexible or bulky structures that prevent them to form crystalline structures and render them with poor physical properties such as particle size uniformity, flowability and processibility. It also poses significant challenges in terms of drug substance isolation and formulation.
In this presentation, various co-processing strategies have been explored and compared to improve the physical property of an inherently amorphous API. The co-processed API gives uniform particle size distribution, enhanced flowability, which ultimately simplify the drug product manufacturing. The dissolution profile is also compared with the ones prepared from conventional spray drying. In addition, the process feasibility and scalability have also been studied. Various process analytical tools (PAT), such as in situ IR, in situ Raman, and real time imaging tools, are also applied during the co-processing to gain process understandings and used for process optimization.