Cause of high variability in drug dissolution testing and its impact on setting tolerances.

摘要: Considering a variable mixing/stirring and flow pattern in drug dissolution vessel as likely source of high variability results, experiments were conducted using USP paddle apparatus by placing (aligned to the walls) metal strip (1.7 mm thick×6.4 wide) vessel. The forces undisintegrated tablet settle about 3 away from centre, facilitates spread disintegrated material diminishes cone formation at bottom To assess impact this altered environment vessel, but still maintaining dimensions within required specifications, release characteristics evaluated for products having different formulation/manufacturing attributes. Tests with calibrator tablets (USP prednisone salicylic acid FDA proposed NCDA No. 2 tablets) two commercially available (250 mg amoxicillin capsules 5 glibenclamide tablets). Except product, all gave significantly (P<0.01) higher results vessels containing than without. extent increased varied product i.e. was smallest (14.4%) largest (88.4%). Based on obtained study, it is concluded that employing current apparatuses, many cases will provide lower anticipated which may not be reflective characteristics. Test-to-test variability, or between laboratories, can also very depending settling position once dropped and/or due slight aberration walls altering Thus, testing require wider tolerances useful comparison batch-to-batch interlaboratory results.