Drug dissolution testing – a useful and practical suggestion!

Please do not spend too much time thinking or discussing dissolution results, as currently suggested testers and experimental conditions have no scientific basis. In addition, dissolution testing using currently suggested apparatuses, particularly paddle/basket, provides only highly variable, unpredictable, and irrelevant results.

If you do not get the expected or desired results, please keep testing until you get the desired results, which is the pharmacopeial approach of continued testing (S1 to S3) with six units, followed by six more units, and then by 12 units. You will be in a tough situation if you do not meet the test at S3. After that, you might have to make up some clever suggestion/reason to get over this situation so that you can continue this repetitive testing.

In the end, if you have a choice, document that the suggested testers are non-GMP (non-validated/non-qualified). Thus, their use was not further explored. No one can challenge this! Instead, use a more scientifically relevant tester, e.g., see here.

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