A common and frequent response to a number of different queries regarding choices in apparatuses, media, or other experimental conditions, is that the changes and choices must be validated. The responses are as varied as the number of respondents and their views. This leaves people usually even more confused than before asking the question. The reason for this confusion is that one cannot validate an apparatus or method using current practices of dissolution testing. Therefore, in good faith, most respondents suggest what it may be, not what it is or should be because no one knows what it is and what is expected.
The question may only be answered if one has a procedure or lead to a procedure, as to how an apparatus was validated to start with. For example, how was it established that paddle/basket is indeed validated apparatuses? How was this shown that paddle/basket apparatuses are suitable for their purpose (QC, discriminatory, IVIVC etc.)? If we have that procedure, we may follow the procedure to establish the validity of other secondary steps (changes, alteration, improvements, etc.). However, as we, to our knowledge, do not have that initial procedure that was used to establish the validity of paddle/basket, we cannot perform a secondary validation.
Thus, it should be kept in mind that current validation practices in this respect are more like rituals/traditions than based on facts from experimental science.
It is hoped that this will help and simplify your future dissolution work and validation steps.