It is quite often asked which approach should one choose and why, i.e., is there a reason for the preference for one over the other?
Such a question has two components; (1) scientific or logical (2) required standards. Generally, the required standards component is based on the first one, i.e. science and logic. Unfortunately, in case of the current practices of dissolution testing, scientific principles are completely absent from the standardization. That is why there is so much difficulty, along with the associated frustrations.
I provide suggestions based on underlying scientific principles, which often do not fit well with the current practices, because, as I stated above, the current practices lack scientific reasoning and logic. People say that both MQ and PVT are good and valid, which is correct, and an analyst can choose either. However, the next question is, which one is better and why. That is where the difficulty is. If one likes to know which one is better, then one has to know the reason behind conducting these tests to start with, which will help in deciding and rationalizing the preferred one.
So, the question is why are these MQ and PVT done? The answer is, to establish that the apparatuses are fit for their intended purpose, i.e. apparatuses can be used to evaluate dissolution characteristics of a product for human use. The next question is, or at least should be, that if one meets the requirements of MQ/PVT, will the apparatuses be considered fit for the evaluation of the product for human use. The answer is clearly no, because both MQ/PVT lack the critical link between apparatuses and the evaluation of dissolution characteristics of a drug product (please use the link to read the article for further discussion). Therefore, in general, MQ and PVT are not useful practices and requirements, and are unnecessary burdens on the pharmaceutical industry.
Now if the testing (MQ/PVT) lacks any real benefit, but has to be performed to meet the requirement, then, I would prefer the MQ. The MQ takes the responsibility away from the analysts and transfers it to the vendors of the dissolution testers. They can provide certification that the testers meet the specifications, which they usually provide when one purchases an apparatus and may provide later as well. In addition, the beauty of MQ is that no one can question that an apparatus does not work/perform as expected, because there is no way to prove that it does not work, as performance of the apparatuses is not associated with the MQ requirements. So, my dear analysts, go with the MQ and say good bye to the PVT and its so called “best practices”.
