Ilgaz Akseli, Celgene

Conventional, quality-by-test methods for determining tablet breaking force and disintegration time usually involve destructive tests, which consume significant amount of time, labor and provide limited information. Recent advances in material characterization, statistical analysis and machine learning have provided multiple tools that have the potential to develop nondestructive, fast and accurate approaches in drug product development. In this talk, a methodology to predict the tablet breaking force and disintegration time of tablet formulations using nondestructive and machine learning tools will be presented. The inputs to the model include intrinsic properties of drug formulation as well as extrinsic process variables influencing the tablet during manufacturing. The model has been applied to predict tablet breaking force and disintegration time of tablets using small quantities of API and prototype formulation designs. The novel approach presented in this study is a step forward toward rational design of a robust drug product based on insight into the performance of common materials during formulation and process development. It may also help reduce development time, API usage and facilitate the development of a robust drug product.

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Ilgaz Akseli

Ilgaz Akseli is a Director in the Pharmaceutical Development Department in Celgene, leading the Integrated Materials Engineering and Technology Group. Before joining Celgene, he was the head of Formulation Materials Science and Process Modeling Group in Boehringer Ingelheim. Ilgaz has 14+ years of experience developing variety of oral dosage forms spanning from phase I to phase III to commercialization. Ilgaz serves as an USP Expert Committee Member, General Chapters – Dosage Forms, and he is the working group leader for Materials Science and Predictive Modeling group in the Innovation and Quality in Pharmaceutical Development (IQ) consortium. He has authored 43 refereed journal papers, 87 conference papers & has 2 patents.