Orally disintegrating dosages, or immediate disintegrating dosages, need to undergo USP disintegration testing. These products often cause difficult because of how rapidly they dissolve.
All disintegrators require the media to be agitated during the pre-heating phase of a test. This is to ensure the media in the disintegration beaker is equilibrated and evenly distributed throughout the beaker. The agitation is generally performed using the disintegration basket. This causes problems when using an orally or quickly disintegrating product, because the moment the product comes in contact with the wet disintegration basket, it begins to dissolve. This in turn affects the disintegration results.
To avoid these problems, Distek recommends the use of an agitation only disintegration basket (fig. A). By using an agitation basket during the pre-heating phase of your disintegration test, accelerated media heating can be obtained allowing the dosage to be placed into a dry USP disintegration basket while the disintegrator is pre-heating. In doing so, one can effectively conform to USP disintegration recommendations as noted in Chapters, 701 and 2040.
Upon completion of the media pre-heating, the wet agitation basket can be replaced with disintegration testing basket (fig. B) which contains your actual dosage form.