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710c

Characterizing In-Situ Particle Disintegration Mechanisms to Correlate Formulation Conditions to Tablet Dissolution Profiles

Des O'Grady1, Eric Dycus1, Eric J. Hukkanen1, and Jeff Seely2. (1) Particle Systems Characterization, METTLER TOLEDO, Redmond, WA 98052, (2) Distek, North Brunswick, NJ 08902-4905

USP tablet dissolution testing is well established as the standard analytical test in the pharmaceutical industry. Yet dissolution testing often fails to detect the root cause of dissolution inconsistency. As the role of dissolution moves toward enabling quality by design and screening product development, one requires a more mechanistic understanding to why tablets release API with varying kinetics. The application of in-situ particle monitoring technology, Lasentec FBRM is demonstrated to track a series of tablet disintegration and dissolution profiles. By understanding the mechanism for particle disintegration and dissolution, one can correlate release inconsistencies to the upstream source (ie changes in raw materials, granulation, segregation, or tableting). One can use this information to quickly screen formulation development conditions to build quality into the formulation design and achieve a repeatable target release profile.


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