Response to a recent query: Scientifically all dissolution results obtained using currently recommended apparatuses would be null and void and non-GMP compliant!


Hello sir.. How r U? I want to know about Dissolution. If my product (Solid oral dosage form) is not available in any pharmacopoeia for dissolution than how can I select dissolution media, apparatus, RPM etc.??? how to develop dissolution method? its depend on solubility of drug or absorption of drug? Please sir help me about this topic. Thank you,

My response:

Thanks for asking the question and your interest in my expertise. Please note that as it stands, considering what is available in literature including from US Pharmacopeia (e.g. General Chapters <711> and <1092>) and available guidance documents such as (from FDA, Health Canada and Europe), it is NOT possible to develop a dissolution method or select relevant experimental conditions to conduct a dissolution test. People do promote such practices, however, the fact remains that one cannot determine dissolution characteristics of any product using the currently suggested apparatuses and method. One of the main reasons to this effect is that currently suggested dissolution testers are not qualified/validated for dissolution testing purposes (e.g. see here). Therefore, any results obtained using such testers, in particular paddle/basket, would be null and void and GMP non-compliant.

On the other hand, considering the limitations of the current practices, I have proposed a slightly modified dissolution tester using a new stirring element known as Crescent-shape spindle, which provides a simpler and scientifically valid approach for conducting dissolution tests (1, 2). In this case, you would not need to develop a dissolution method at all, and dissolution tests can be conducted using a very simple set of experimental conditions. If you require more details in using Crescent-shape spindle, let me know, I will be happy to help.

Best of luck!

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