Evaluation of the Sensitivity of USP Prednisone Tablets to Dissolved Gas in the Dissolution Medium Using USP Apparatus 2

Perturbation Study of Dissolution Apparatus Variables—A Design of Experiment Approach

“…This has led USP to conduct a comprehensive set of studies to examine potential assembly deviations that contribute to this variability. This study is one of a series of reports of these investigations (3)(4)(5)(6). Based on these studies, USP may change statements in <711> and allied documents to assist manufacturers in improving the USP Performance test when the dissolution procedure is chosen.…”

“…Because this was a screening study, we did not examine exhaustively the effects of each variable but rather attempted to identify which variables were the most essential to control in order to achieve accurate and reproducible dissolution results. Previous research has focused on assembly variables such as dissolved gas, vessel centering, vibration, vessel tilt, paddle height, rotation speed, base plate levelness, shaft wobble, temperature, vessel shape, belt tension, and shaft verticality (3,(7)(8)(9)(10)(11)(12). Building on these earlier studies, we attempted a more systematic approach that included an assessment of combination effects from two or more concurrently perturbed variables.…”

Establishing Acceptance Limits for Dissolution Performance Verification of USP Apparatus 1 and 2 Using USP Prednisone Tablets Reference Standard Lot Q0H398

“…Because of the similarities in formulation, manufacturing process, and dissolution behavior of lots Q0 and P1, Q0 tablets are expected to be as sensitive to the operational parameters as P1 (2,5,6,(9)(10)(11). We see the similarity of the two Lots in Figure 3, where the data are similar, and in Table 3, where we see that the acceptance limits are similar.…”

“…PVT with USP Prednisone Tablets RS, in conjunction with mechanical calibration, is a valuable tool in maintaining proper dissolution apparatus performance (7,8). PVT helps ensure that appropriate measures are taken to control the following sources of significant variability in dissolution testing: dissolved gasses, vibration, vessel dimensions, analyst, and analytical procedure (9)(10)(11)(12). The PVT also addresses sources of variability that are unknown (4).…”

Dissolution Variability: Comparison of Commercial Dosage Forms with US Pharmacopeia Lot P Prednisone Reference Standard Tablets—A Technical Note

“…Beyond these cGMP approaches, USP's physical tablets support proficiency testing, thus leading to USP's new term Performance Verification Test (PVT) for the term apparatus suitability in <711> (10,11). USP has extensively studied the quality attributes of USP Lot P Prednisone RS Tablets and their sensitivity to selected variables of the dissolution test procedure using apparatus 1 and 2 (12)(13)(14).…”