Correlation of physicochemical property and the dissolution behavior of ingredients of an antihypertensive combination tablet

We have studied possible differences of bioavailability between single-drugs and antihypertensive combination tablets of amlodipine besylate. The elution behaviors of four kinds of combination tablets were investigated using the dissolution test, and the formulation properties were studied using 3DX analysis with high-resolution X-ray and hardness measurements. The two components in combination tablets could be analyzed within 4 min using ultra-high-performance liquid chromatography (UHPLC). In the four combination tablets used in this study, elution behaviors of amlodipine besylate were the same as that of the single-drug. In 3DX analysis of these tablets, it was possible to observe the thickness of the coating and the particle size distribution. The data obtained in the present study are of use from clinical sites because there is seldom any information about comparisons of single-drug with a combination tablet.