Effect of Green and Black Tea on the Dissolution Profile of Amlodipine Tablets

Abstract

Background: Amlodipine, a dihydropyridine calcium channel blocker, is widely recognized as an effective and well-tolerated medication for the management of hypertension. Tea is the second most consumed liquid after water. Black and green tea are products made from the leaf and bud of Camellia sinensis. The study aimed to determine the effect of black and green tea on the in vitro dissolution profile of amlodipine tablets. Materials and Methods: An in vitro dissolution interaction study of amlodipine tablets was carried out in the presence and absence of black and green tea at pH 1.2 and 6.8 using USP Apparatus 2 at a constant temperature of 37 ± 0.5 ºC and a rotating speed of 50 revolutions per minute. A total of 24 teabags of black and green tea from the same batch were used and sampling was done at 5, 10, 15, 30, 45, and 60 minutes. Analysis of amlodipine was done using High-performance liquid chromatography (HPLC). Results: The study showed that at pH 1.2 amlodipine release was not significantly affected by green or black tea. The percentage release conformed with tolerance specifications in monographs. At pH 6.8, however, amlodipine release decreased significantly in the presence of tea (p=0.02). Using the similarity factor (f2) dissolution profiles were dissimilar (11,43). The degree of amlodipine inhibition at pH 6.8 was 11.5 and 55.3 % for black and green tea respectively. Conclusion: Coadministration of black or green tea with amlodipine tablets could alter the release of amlodipine which may influence therapy outcomes.