Dissolution method development practices – reality

In simple terms current practices of dissolution method development may be described as:

A practice of selecting experimental conditions (e.g. apparatus, rpm, medium) to achieve or observe expected or perceived dissolution characteristics of a product.

The selected methods (i.e. experimental conditions) are then “labelled” differently at one’s own choosing such as the QC-method, bio-relevant method, discriminatory method, etc. There are absolutely no differences in such methods and/or in their development approaches.

It is important to note that one never determines or establishes dissolution characteristics of any product, one just selects experimental conditions to achieve certain desired results. Therefore, one can never determine/establish quality, for QC, or bio-relevance (IVIVC, bio-waiver, product development etc.) for product development purposes. It has all been a serious and unfortunate marketing illusion.

Moreover, all the suggested or recommended apparatuses, e.g. compendial, have never been qualified and/or validated for dissolution testing purposes, for both bio-relevancy and/or manufacturing links. Therefore, dissolution results commonly obtained using these apparatuses, in particular using basket/paddle, are no different or better than those one may obtain using desk-top blenders, shakers, mixers etc. The point being that at present all the dissolution results, and their interpretations, reported have no meaning, use and/or relevance.

Considering the limitations of current practices, a new and very simple approach has been suggested which addresses issues described above. Further information in this regard can be obtained by visiting the site/blog (link).

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