385705 QbD in Development of Film Coated Tablets: A Risk Assessment Based Doe Towards a Robust Product and Process

Wednesday, November 19, 2014: 2:25 PM
202 (Hilton Atlanta)
Ganeshkumar Subramanian, Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, NJ

The principles of Quality by Design (QbD) were applied during the formulation development of a film-coated tablet. A risk based approach was used to identify the impact of formulation components and process parameters on the critical quality attributes of the coated tablets. Formulation composition and manufacturing process parameters were defined by carefully constructed design of experiments with focus on impact to critical quality attributes of the final dosage form at release and on shelf-life. The case study will also highlight the integration of process analytical tools (PAT) to monitor in-process material attributes together with parametric controls to ensure a robust and cost effective strategy to transfer and scale-up at the commercial manufacturing site.

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