(720a) Using a Focused Beam Reflectance Measurement (FBRM) Probe to Characterize Tablet Disintegration Behavior As a Function of Drug Product Processing Conditions
- Conference: AIChE Annual Meeting
- Year: 2017
- Proceeding: 2017 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
Thursday, November 2, 2017 - 12:30pm-12:52pm
Immersion of an FBRM probe in the media of a modified USP dissolution vessel enables the tracking of both particle count and size as disintegration progresses. We demonstrate how differences in upstream tablet processing steps are manifest in differences in micro scale disintegration behavior, and how FBRM-based analytics can provide insights absent from the traditional USP-based disintegration assessment. Specifically, in a roller compaction QbD assessment, granule density differences are traceable in FBRM particle size data on final tablet disintegration. Process ranges for roller compaction can be tied to specific physical properties such as granule sizes during disintegration, and help set operating ranges. Infrared and Raman techniques can be employed in parallel, monitoring active as it dissolves, and interrogating the physical form of residual solid material during the process. The resulting approach offers a more detailed analysis of initial phenomena tied to tablet disintegration, providing a deeper understanding of the relationships between material properties, processing conditions, and formulation performance.