Developing a discriminating dissolution test – a wasteful practice!

Response to a recent query

I am sorry I cannot be of help because, in my view, based on 30 years of research experience, as stated frequently, currently recommended and used dissolution testers  (USP Paddle/Basket) are non-validated testers. Hence, they cannot provide any product’s relevant dissolution methods and/or results. Furthermore, developing a discriminating dissolution test, often promoted and suggested as a regulatory/pharmacopeial requirement, is a scientifically flawed or invalid concept. A properly developed dissolution test by default becomes a discriminating test; however, as one cannot develop a relevant and/or appropriate dissolution test at present, thus one cannot develop a discriminating test.

On the other hand, if you like to work with some modified version of a dissolution tester, developed in-house or as I have suggested (with a crescent-shape spindle),. Then, there is a possibility of conducting an appropriate and relevant dissolution test, which will act as a discriminating test too. I will be happy to discuss this approach in further detail if you like to explore this further.

In the meantime, the following blog article may help explore the topic further (link).

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