Worth repeating it: Drug and/or product dependent dissolution tests are scientifically invalid. They do not provide dissolution characteristics of products even for QC purposes.

It is important to note that drug dissolution tests are conducted for products (tablets/capsules) and not for drugs (APIs). Therefore, it is not accurate to use or develop drug-specific experimental conditions as commonly reported.

On the other hand, drug dissolution characteristics are mostly dependent on the formulation and manufacturing attributes of a product i.e. a dissolution test is conducted to evaluate the impact of formulation and manufacturing. Therefore, for determining dissolution characteristics of a product, the test must be independent of the formulation and manufacturing characteristics of the product under consideration. This means that one is required to use a pre-established dissolution test independent of the product under consideration. Developing a dissolution test for a product, which is being developed, and then using it to show its own dissolution characteristics, as currently done, is obviously a scientifically invalid practice.

Furthermore, it is to be noted that dissolution medium and other experimental conditions are linked to the physiology of the human GI tract, which remains constant, and also drug and product independent. Therefore, if one uses drug/product dependent experimental conditions, then this will make a dissolution test bio irrelevant and product evaluation pretty much useless, even for QC purposes. The following link may be of further help in this regard (link).

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