Date of Award

Spring 2013

Document Type

Thesis

Degree Name

Master of Science in Pharmaceutical Engineering - (M.S.)

Department

Chemical, Biological and Pharmaceutical Engineering

First Advisor

Piero M. Armenante

Second Advisor

Laurent Simon

Third Advisor

Gerard Bredael

Abstract

Dissolution testing is routinely conducted in the pharmaceutical industry to provide in vitro drug release information for quality control purposes. The most common dissolution testing system for solid dosage forms is the United States Pharmacopeia (USP) Dissolution Testing Apparatus 2. In this work, a modified Apparatus 2, termed "OPI" System for "off-center paddle impeller," in which the impeller is placed 8 mm off center in the vessel is tested to determine its sensitivity to differentiate between the dissolution profiles of differently formulated and manufactured tablets. Dissolution tests are conducted with both the OPI System and the Standard System using three different brands of aspirin at nine different tablet positions. The OPI system produces dissolution profiles that are highly dependent on the different brands of aspirin used, similarly to those generates in the Standard System. However, the dissolution profiles obtained with the OPI apparatus are found to be largely independent of the tablet location at the vessel bottom, whereas those obtained in the Standard System generates statistically different profiles depending on tablet location. It can be concluded that the newly proposed OPI system can effectively eliminate artifacts generated by random settling of the tablet at the vessel bottom, thus making the test more robust, while at the same time being just as sensitive as the Standard System to actual differences in differently manufactured tablets having intrinsically different dissolution profiles.

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