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Introduction There is only a brief mention in the USP of vibration requirements,consisting of the statement,“No part of the assembly, including the environment in which the assembly is placed,contributes significant motion,agitation, or vibration beyond that due to the smoothly rotating stirring element.”Vibration is a complicated concept that can result in the addition of energy to a system. The addition of energy from an external source can alter the results of a dissolution evaluation. Such an alteration is an unacceptable source of error that must be minimized. It can be minimized by eliminating all external sources so that only the tester machinery is left as a potential vibration source that is external to the drug delivery system under evaluation. Vibration is defined as “a periodic motion of particles of an elastic body or medium in alternately opposite directions from the position of equilibrium when that equilibrium has been disturbed.” The energy (vibration) causing this movement is an interrelated function involving acceleration, velocity,displacement,and frequency (which can occur in three dimensions and can be designated z,x,and y). For the purpose of discussion,a frame of reference must be established. Using the vessel plate as a starting point,the x-axis will begin at the front left edge and go toward the back of the plate. This leaves the left-to-right vector as the y-axis and the up-and-down vector as the z-axis (Figure 1). As a measure of vibration,displacement is often reported, since it is this relative motion that can be sensed by placing a hand on the tester. This is a measure of the up-and-down (in the z axis) motion of the item of interest, in this instance,a dissolution tester. How often this up-and-down motion occurs is of equal importance,and this is the frequency. To measure one without the other does not provide sufficient information concerning the overall vibration. Vibrations of the same displacement but with differing frequency would not input the same amount of energy into a system over a given period of time. Frequency can be estimated based on eq 1.

Vibration Measurements on Dissolution Systems and Effects on Dissolution of Prednisone Tablets RS