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Understanding Dissolution Inconsistency Through In Situ Particle Characterization and Root Cause Analysis

Dissolution and disintegration testing are well established as standard analytical tests used during pharmaceutical development. Yet, if dissolution is inconsistent, what is the root cause? Was the internal tablet or capsule structure inconsistent? Were the particle disintegration and erosion mechanisms inconsistent? Was there an upstream processing inconsistency that resulted in poor tablet properties? With the advent of in-process real-time particle characterization tools, such as FBRM ® , it is now possible to use Process Analytical Technology (PAT) tools within the dissolution apparatus to track the particle disintegration, erosion, and dissolution quickly and effectively. Experiments can easily be performed to map the design space relating real time particle distributions to tablet properties, raw materials, and upstream formulation processing. The root cause of dissolution can often be uncovered by linking in situ particle behavior to change in raw materials, over/under granulation, segregation, or changes in compression force.

Type of Event: On-Demand Webinars
By appointment: Yes
Language: English

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