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 for the intended purpose thus cannot provide relevant dissolution methods and/or results for any product. Furthermore developing a discriminating dissolution test, often promoted and suggested as 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 developed a relevant and/or appropriate dissolution test at present, thus one cannot develop discriminating test as well.

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 one (with crescent-shape spindle), then there is a possibility of conducting 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 be helpful in exploring the topic further (link).

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