Technical Note : Why Is Vibration an Issue for Dissolution Testing ?

INTRODUCTION It has become apparent, in the recent past, that vibration within the tablet dissolution testing environment is a real issue. Although this may not have been too apparent in normal routine dissolution testing, the real impact of vibration has become a focal point as a result of the Prednisone “Calibrator Tablet” tests, which generally have to be performed every six months on each instrument within the testing environment. Prednisone tablets are referred to as “disintegrating” tablets because they break down in the medium very quickly to form a powdered mass in the basket (Apparatus 1) or a fairly well-defined cone under the Paddle (Apparatus 2). The second system validation test is made using Salicylic Acid tablets, which are “non-disintegrating,” so they keep their form throughout the test and slowly dissolve. The Prednisone tablet is 10 mg in active content, and so it has a large percentage of excipients present; in contrast, the Salicylic Acid tablet is made entirely of salicylic acid with no excipients present.