COMPARISON OF 3 DISSOLUTION DEVICES FOR EVALUATING DRUG-RELEASE

The dissolution studies are usually conducted on ''official'' USP diss olution devices or ''non-official'' dissolution devices like the Rotat ing Bottle Apparatus. The recent introduction of the Bio-Dis(R) Tester exacerbates a difficult situation no comparative dissolution studies have been done regarding the results for a drug and/or dosage form usi ng these three different instruments. The purpose of this investigatio n was to evaluate and compare three dissolution devices - USP XXI Diss olution Apparatus II, Rotating Bottle Apparatus, and Bio-Dis(R) Tester - taking into account pertinent factors that can affect dissolution. Dissolution profiles were obtained for two drugs - theophylline and ph enylpropanolamine HCl. Three dosage forms of each drug were evaluated at different agitation intensities using two different dissolution med ia (simulated gastric fluid and simulated intestinal fluid) on all thr ee dissolution devices. Various advantages/limitations for each device were observed depending on the drug, dosage form, agitation speed and dissolution medium.