Variability of USP Lot P Prednisone Reference Standard Tablets - Pharmaceutical Technology

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Variability of USP Lot P Prednisone Reference Standard Tablets
The authors demonstrate that anecdotal reports of prednisone tablet variability are inaccurate.


Pharmaceutical Technology


In summary, USP Lot P Prednisone RS Tablets are not a major source of variability in dissolution performance verification testing. As is most evident in Figure 1 and Reference 3, results vary considerably between laboratories. We also see results that vary by assembly (see Tables II and III) and by vessels (see Table IV). In part, this is the reason there is a PVT for dissolution. USP continues its efforts to identify sources of variability in dissolution and will update its Dissolution Toolkit to help all dissolution laboratories improve results (5).

Walter W. Hauck, PhD,* is a senior scientific fellow, Gang Deng, PhD, is group leader, Maria J. Glasgow, PhD, is a scientist IV, Mark R. Lidell, PhD, is a chemist III, Pallavi Nithyanandan, PhD, is a chemist III, and Roger L. Williams, MD, is executive vice-president and chief executive officer, at United States Pharmacopeia (USP), 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8390,
Dr. Williams is also a member of Pharmaceutical Technology's Editorial Advisory Board.

*To whom all correspondence should be addressed.

References

1. T. S. Foster et al., "Metrology and USP Dissolution," Pharm. Technol., 32 (3), 186–190 (2008).

2. G. Deng et al., "The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets—Quality Attributes and Experimental Variables Contributing to Dissolution Variance," Pharm. Res., 25 (5), 1100–1109 (2008).

3. M. Glasgow et al., "The USP Performance Verification Test, Part II: Collaborative Study of USP's Lot P Prednisone Tablets," Pharm. Res., 25 (5), 1110–1115 (2008).

4. USP 31–NF 26, Dissolution ‹711›, US Pharmacopeial Convention, Rockville, MD, 2008, pp. 267–274.

5. USP, "Dissolution Toolkit," available at http://www.usp.org/pdf/EN/dissolutionProcedureToolkit2007-10-04.pdf.

6. FDA, CDER, Guidance for Industry: Use of Mechanical Calibration of Dissolution Apparatus 1 and 2—Current Good Manufacturing Practice, Office of Regulatory Affairs, Rockville, MD, 2007.

7. W. W. Hauck et al., "USP Responses to Comments on Stimuli Article, 'Proposed Change to Acceptance Criteria for Dissolution Performance Verification Testing,'" Pharm. Forum., 34 (2), 474–476 (2008).

8. P. Nithyanandan et al., "Evaluation of the Sensitivity of USP Prednisone Tablets to Dissolved Gas in the Dissolution Medium Using USP Apparatus 2," Dissol. Technol., 13 (3), 15–18 (2006).

9. J. Eaton et al., "Perturbation Study of Dissolution Apparatus Variables—A Design of Experiment Approach," Dissol. Technol., 14 (1), 20–26 (2007).

10. M. R. Liddell et al., "Evaluation of Glass Dissolution Vessel Dimensions and Irregularities," Dissol. Technol., 14 (2), 28–33 (2007).

11. W. W. Hauck et al., "Proposed Change to Acceptance Criteria for Dissolution Performance Verification Testing," Pharm Forum., 33 (3), 574–579 (2007).

12. M.R. Liddell et al., "Dissolution Testing Variability: Effect of Using Vessels from Different Commercial Sources," Am. Pharm. Rev., 10 (6), 122–128 (2007).

13. P. Nithyanandan et al., "Dissolution Variability: Comparison of Commercial Dosage Forms with US Pharmacopeia Lot P Prednisone Reference Standard Tablets," AAPS PharmSciTech (2008). In press (DOI 10.1208/s12249-008-9034-z).

14. R. G. Manning et al., "Dissolution Testing and Metrological Measurement of Quality for Solid Oral Dosage Forms," Pharm. Technol., 31 (5), 68–74 (2007).

15. USP 31NF 26: The Dissolution Procedure: Development and Validation ‹1092›, US Pharmacopeial Convention, Rockville, MD, 2008, pp. 573–578.

16. M. Liddell et al., "Reproducibility of the Dissolution Test Methodology Following Relocation of Dissolution Test Equipment," poster presented at AAPS Annual Meeting, San Diego, CA, Nov. 2007.

17. Z. Gao et al., "Gauge Repeatability and Reproducibility for Accessing Variability during Dissolution Testing: A Technical Note," AAPS PharmSciTech., 8, E1–E5 (2007).


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