It appears so.
In principle a dissolution test is conducted to assess the quality of a drug product based on its in vitro drug release (dissolution) characteristics. However, in recent years it has clearly been shown, based on experimental as well as computer simulation studies, that the tests, in particular using paddle and basket apparatuses, are not capable of providing relevant and reproducible results. Thus, test results do not reflect the true quality of the products.
Another disturbing aspect in this regard is a concern that most of the tests, i.e., experimental conditions, employed are product dependent. With the use of product dependent experimental conditions it is not possible to establish whether the results, thus, the product quality (good or bad) is a reflection of the product or the use of a particular set of experimental conditions. An analyst, at will, can make a product look good or bad (acceptable/unacceptable) or a product of either slow or fast release type by adjusting the experimental conditions appropriately.
Therefore, current practices of dissolution testing appear to be practices aimed at meeting the regulatory requirements rather than assessing the quality of drug products.
It has further been shown that if the artifacts of the paddle and basket apparatuses are adequately addressed, where apparatuses are able to provide efficient product-medium interaction, a dissolution test can be made a useful analytical tool as intended. For a further detailed discussion on this topic please see the publication.
