Challenges with dissolution testing and quality assessment for commercial feverfew products

Abstract

The purpose of this study was to develop a suitable dissolution test for feverfew products and to investigate the parthenolide content, disintegration, and dissolution performance of several marketed feverfew products. Parthenolide content was determined by a validated HPLC method. Disintegration was tested according to the USP requirements for botanical dosage forms. A suitable dissolution test method was developed to study the dissolution performance of feverfew products. Parthenolide content varied from 0 to 0.23% among the feverfew products tested. The average disintegration times of these products were significantly different (p < 0.005) and varied from 5 to 11 min. All products containing measurable parthenolide exhibited more than 85% dissolution of parthenolide content in 1 h; however, these products exhibited substantially different dissolution profiles. In the first 10 min, one product released more than 80%, but dissolution from the two other products could not be detected at all during that time. Although not currently required by USP, dissolution testing of formulated products can be a useful tool to evaluate the quality of feverfew finished products. Patients should be cautious when changing from one brand to another because of such differences in actual parthenolide content and release performance. Manufacturers should commit to proper quality control procedures to ensure that label claims for content and dose are accurate and realistic.