Seriously, it is not science. Please, stop promoting it as science!

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Inspections and quality of pharmaceutical products and/or manufacturing processes – dilemma!

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A recent query!

Question:

How i can enhance Pioglitazone Hydrochloride dissolution profile results in combination with metformin HCl tablet ????

My response:

It is a common question/issue i.e. people ask that they do not observe expected or desired drug dissolution characteristics of a product, but faster or slower. The simple and direct answer to such a question should be to change/adjust the product formulation/manufacturing attributes accordingly. In fact, that should be the only option or advice provided. Often as one does not know the formulation (usually not disclosed), thus it is impossible for anyone to provide any useful advice in this regard.

On the other hand, at present, formulators have been convinced and/or trained to seek changes or adjustments in the dissolution method itself to obtain the characteristics they like to see. Such a practice of dissolution method adjustments are commonly promoted as science and method development practices. I call this as “Fashionable Nonsense”, as this practice is neither scientifically valid nor of any practical use (link). So please avoid such a practice.

To address such a problem/question, I would ask how you would know that your dissolution observations/results are correct. Is your method capable of providing accurate and/or valid dissolution results? That is, is the method you used has been validated to determine dissolution characteristics of a product? The answer is NO, i.e., none of the testers/methods, as recommended at present, are qualified and/or validated for dissolution testing. Thus, one cannot determine dissolution characteristics of any product (link). The dissolution results what you are seeing are simply an illusion, not actual or true dissolution characteristics of the product. Therefore, it is not possible to address the problem using currently recommended testers/methods. This is hard to believe but it is a scientific fact.

Considering this background, I have suggested a modified stirrer, known as crescent-shape spindle, based tester which addresses the issues and provide far better dissolution testing and product characterization. You may read the details about it here. If you require further information, I will be happy explain it further.
Best of luck!

Scientifically speaking!

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Fashionable Nonsense

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Crescent-Shaped Spindle

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