The PVT (Performance Verification Test) which is for all practical purposes is a name change of an old test known as dissolution apparatus calibration. This test has been propagated to provide some sort of assurance about the performance of the drug dissolution apparatuses commonly known as Paddle and Basket. Almost from the beginning, the test has been faced with criticism about its relevance and usefulness. In fact, it is generally considered as a serious economical burden on pharmaceutical manufacturers. To minimize this burden, and a lack of scientific rationale, FDA recently provides an alternate to avoid the PVT.
On the other hand, USP which propagates the use of PVT, and the provider of the tablets used for PVT, has been making tremendous efforts in convincing that the PVT is indeed a useful practice. However, selling this idea appears to be becoming difficult, because generally analysts/scientists consider this as “an effort to maintain the status quo”. This status quo impression appears to have merit, because there has been no experimental evidence provided to address the concerns of the users or to establish the usefulness and relevance of the PVT.
At this stage question remains that if PVT fails (which it often does without any apparent reasons), what experimental evidence are available to reflect that indeed the apparatus was not functioning as expected? Otherwise, why propagate the use of PVT?
On the other hand, lack of evidence with regard usefulness of PVT, gives strength to the reported observations that problems with PVT are in fact reflections of problems of Paddle and Basket apparatuses (poor hydrodynamics, variable and unpredictable results) themselves.
