Understanding Disintegration and Dissolution for Improved Solid Dose Formulations Development on-demand webinar

Standard dissolution tests are a critical and mandatory part of quality testing for oral dosage form pharmaceutical products. These tests will confirm that not only has a tablet released the desired quantity of Active Pharmaceutical Ingredient (API) into solution, but that it has done it over the required time frame. Yet, while the test result is of critical importance, if a tablet fails there is absolutely no information about what caused the tablet to fail. Was the internal tablet structure incorrect? Did the tablet break up in such a way as to release API into solution incorrectly? Was there an upstream processing problem - in the granulator for example - that resulted in poor tablet properties?

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With the advent of in-process real-time particle characterization tools, such as the FBRM®, it is now possible to use PAT tools in the same dissolution apparatus to track the disintegration, break-up and dissolution of tablets quickly and effectively. The test is simple to carry out and the apparatus freely available. Therefore a range of designed experiments can readily be performed to gain a wealth of data relating tablet properties to API release, formulation and upstream processing.

Webinar Details
During the webinar recent case studies will be presented showing how FBRM® and other PAT in situ tools have been used in dissolution tests to gain valuable formulation and process understanding. The case studies will show how:

Changes in formulation can affect tablet properties such as structural stability and rate of release
The effect of disintegration and diffusion can be studied to understand API release
Tablet properties can be related to upstream process variables during granulation

Armed with this information, a fundamental understanding of what critical quality and processing attributes affect consistent tablet performance can be acquired.