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, by its nature dissolution testing using currently suggested apparatuses, in particular paddle/basket, provide only highly variable, unpredictable and irrelevant results.

In case you do not get expected or desired results, please keep testing until you get the desirable results, which in essence is the pharmacopeial approach of continued testing (S1 to S3) with 6 units, followed by 6 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 could continue this repetitive testing.

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

Comments are closed.

Crescent-Shaped Spindle

Now Available
Click here

Archives
Links

PharmacoMechanics