A simple and practical approach for establishing credibility and authenticity of the help and advice provided in the practice of drug dissolution testing

Drug dissolution testing is a well-established analytical technique or test, and is extensively employed for the development and assessment of pharmaceutical products in particular the tablet and capsule. In fact, it would not be an exaggeration in saying that it is the only test which is used for establishing the quality of products. However, it is also a fact that the tests and testers as recommended have never been qualified and validated for their intended purpose. Therefore, tests and testers cannot provide relevant and scientifically valid results regarding the quality of the tested products. This is simply common sense and scientific fact.

Some however, still promote the current practices, through trainings (conference, seminars, and write-ups) as scientific and useful which are not only causing delays and hindrance in addressing the issues at hand, but also create false hope for analysts/scientists that this technique may provide useful and relevant results. Sometimes this training and advice is disguised in different fanciful names or topics such as clinical or bio-relevant, IVIVC, bioavailability/bioequivalence assessment, but underneath it all are flawed dissolution results. Reality remains that it is almost impossible to obtain reproducible and relevant dissolution results for any product using the currently suggested dissolution testers.

A simple and practical approach one could use to assess the credibility or authenticity of promoted claims and expertise is to request if the person (trainer or vendor’s representative) is able to determine dissolution characteristics of a given blinded sample of a product containing a highly soluble drug using an independently developed and validated method (see below). If yes, then certainly it could be a good source for learning, otherwise, one should use caution.

Please use caution and pay attention (link)

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