Systematic Error Associated with Apparatus 2 of the USP Dissolution Test II: Effects of Deviations in Vessel Curvature from That of a Sphere

Evaluation of Glass Dissolution Vessel Dimensions and Irregularities

“…The shape of the inner surface of glass dissolution vessels has been shown to have an impact on the results of dissolution experiments with disintegrating USP Prednisone Reference Standard Tablets (4,5). For dissolution vessels having a nominal capacity of 1 L, the specifications found in USP General Chapter Dissolution <711> include those for the inner diameter (98-106 mm) and the height (160-210 mm) of the dissolution vessel (6).…”

Overview of Dissolution Instrument Qualification, Including Common Pitfalls

“…An awareness of some of the most frequent causes can aid in your investigation (5)(6)(7)(8)(11)(12)(13). In our experience, some of the most frequent causes are deaeration of the medium, vessel geometry, vibration, and sampling procedures, which are described below.…”

Developing Discriminatory Drug Dissolution Tests and Profiles: Some Thoughts for Consideration on the Concept and Its Interpretation

“…There are reports in the literature that indicate that an improved and comparable in vitro-in vivo environment may be obtained if stirring and mixing behaviour relates better to the physiological environment (17)(18)(19)(20)(21). Therefore,if one creates a more appropriate and relevant mixing and stirring environment in vitro, dissolution testing may be more appropriate (i.e.,one should be able to test multiple products using the same experimental condition as in vivo dictates).…”