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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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q&more – the networking platform for quality excellence in lab and process

The q&more concept is to increase the visibility of recent research and innovative solutions, and support the exchange of knowledge. In the broad spectrum of subjects covered, the focus is on achieving maximum quality in highly innovative sectors. As a modern knowledge platform, q&more offers market participants one-of-a-kind networking opportunities. Cutting-edge research is presented by authors of international repute. Attractively presented in a high-quality context, and published in German and English, the original articles introduce new concepts and highlight unconventional solution strategies.

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