Method development practices: Are these achieving their intended purpose?

The purpose of any analytical method development, including for dissolution testing, is to have a method which would describe the unknown property of the material it tests. The main and foremost requirement for method development practices is that one must have a reference material, or a product, of known value of the parameter, or dissolution result. A method will be considered developed when this method will be capable of providing the value of the parameter (dissolution results) of the reference product accurately with an acceptable confidence (variance).

In the case of drug dissolution testing, unfortunately, no such reference product is available with known or accepted dissolution value/result. Thus, in the true sense of the meaning of method development, it is not possible to develop a dissolution method which could be used to determine the unknown dissolution results of a test product.

On the other hand, current practices use the terminology of method development for making the choice of an apparatuses and associated experimental conditions which would reflect the expected or desired behavior of the test product. Another way of saying of this is, the test product becomes its own “reference”.  That is why products often come with their own methodologies. Obviously, it is not the correct and valid understanding and approach of method development, thus requires reconsideration. An obvious outcome of such practices is that the developed method would not allow comparison of drug dissolution (release) characteristics between products. In addition, one would never know the true dissolution rate (characteristics) of any product.

Therefore, in reality, current practices of method development in drug dissolution testing are neither accurate nor serving their intended purpose.

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