Media degassing or “de-aeration”, pre-heating to a temperature of 37°C and absolutely precise gravimetric dispensing according to the recommendations and demanded for dissolution testing from the US FDA authorities are standard for the Pharma Test PT-DDS4 media preparation and degasing system. De-aeration is generally recommended to prevent the formation of bubbles on the dosage form surface, which may cause a variation in active dissolution rates, by virtue of surface obscuration.
Test Procedure
Effective media de-aeration is one of the most important requirements for a successful tablet dissolution test. USP reference standard tablets (RST) for PVT tests in particular, react very sensitive to ineffectively de-aerated media. Often the test fails to arrive at the required results for the release, even if all technical parameters of the dissolution bath in use have been checked and passed the tests. A save and efficient way of media de-aeration of un-dissolved oxygen (O²) is offered by the techniques the PT-DDS4 is using.
The prepared media (buffer) is filled by means of vacuum or manually into the storage and heating tank of the instrument. While the media is heated, it is being constantly circulated under vacuum within the tank. Because of this way of operating, the PT-DDS4 provides fully de-aerated and preheated media ready to be dispensed into the USP dissolution vessels. Therefore another huge advantage of media preparation in this way is the time saved during the startup of subsequent dissolution runs, because the media is already at the required testing temperature of 37°C.