Comparison of Three Dissolution Devices for Evaluating Drug Release

Abstract

The dissolution studies are usually conducted on “official” USP dissolution devices or “non-official” dissolution devices like the Rotating Bottle Apparatus. The recent introduction of the Bio-Dis® Tester exacerbates a difficult situation : no comparative dissolution studies have been done regarding the results for a drug and/or dosage form using these three different instruments. The purpose of this investigation was to evaluate and compare three dissolution devices - USP XXI Dissolution Apparatus II, Rotating Bottle Apparatus, and Bio-Dis® Tester -taking into account pertinent factors that can affect dissolution. Dissolution profiles were obtained for two drugs - theophylline and phenylpropanolamine HCI. Three dosage forms of each drug were evaluated at different agitation intensities using two different dissolution media (simulated gastric fluid and simulated intestinal fluid) on all three dissolution devices. Various advantages/limitations for each device were observed depending on the drug, dosage form, agitation speed and dissolution medium.