Dissolution Testing of Prednisone and Salicylic Acid Calibrator Tablets At Different Tablet Locations

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
2011 AIChE Annual Meeting
AIChE Annual Meeting
October 19, 2011 - 8:00pm

Dissolution testing is routinely carried out in the pharmaceutical industry to determine the rate of dissolution of solid dosage forms. This test is one of the several tests that pharmaceutical companies typically conduct on oral dosage formulations (e.g., tablets) to determine compliance. The USP Dissolution Testing Apparatus 2 is the most common of the apparatuses listed in the USP. However, it has been shown previously that the dissolution profile of a tablet undergoing dissolution in the USP Dissolution Apparatus 2 can be affected by the tablet location in the apparatus.

In this work, the dissolution rates of both non-disintegrating tablets (salicylic acid) and disintegrating tablets (Prednisone) were experimentally determined for many different tablet locations, both centered on the vessel bottom and off-center. The location of the tablet was experimentally varied in very small increments in order to determine the exact location where a transition in the dissolution profile occurred. It was found that in a small region (2-4 mm in radius) centered around the vessel centerline just below the impeller the dissolution profiles were similar to those observed with a centered tablet. However, outside this region the dissolution profiles were found to be significantly different, as indicated by the values of the Similarity Factor f1 and the Difference Factor f2. These finding are consistent with previous hydrodynamic investigations that showed the existence of a poorly mixed zone below the USP Apparatus 2 impeller. The results of this work can guide the practitioner on when to accept dissolution testing results based on tablet location.

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