The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets—Quality Attributes and Experimental Variables Contributing to Dissolution Variance
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Beyond instrumental qualification, proficiency testing is not usually a prerequisite for many analytical procedures, given reliance on a manufacturer’s assay validation coupled with regulatory review and inspection. Given the special features of the dissolution procedure, proficiency testing was put in place initially by pharmaceutical manufacturers and carried on by USP. Proficiency testing is designed to help ensure that execution of a dissolution procedure for solid oral dosage forms adequately supports administrative and legal decisions so that measurements made at different times, by different analysts, or with different methods can be confidently compared. USP has applied metrological principles to aid practitioners in carrying out the dissolution procedure alone and in collaborative studies to facilitate understanding potential sources of variability.
Materials and Methods
The present study aimed to identify key dissolution variables associated with USP Lot P Prednisone Tablets in conjunction with the USP Performance Verification Test (PVT). Using five dissolution test assemblies from different manufacturers, at least four of six analysts determined percents prednisone dissolved on dissolution Apparatus 1 (basket) and Apparatus 2 (paddle) on each assembly. Six replicate experiments were performed on each analyst–assembly combination with a set of six to eight tablets in each experiment.
Results and Conclusions
Statistical analysis demonstrated that dissolution test assemblies were the largest factor contributing to dissolution variability. Inherent tablet variability was low, and USP Lot P Prednisone Tablets did not contribute importantly to dissolution variability. Contributions from analyst and analytical procedure also were estimated to be low.
- USP, USP 30–NF 25, Dissolution <711>, United States Pharmacopeial Convention, Inc., Rockville, MD, 2001, pp. 277–282.
- W. W. Hauck, T. Foster, E. Sheinin, T. L. Cecil, W. Brown, M. Marques, and R. L. Williams. Oral dosage form performance tests: new dissolution approaches. Pharm. Res 22:182–187 (2005). CrossRef
- FDA, Center for Drug Evaluation and Research. Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. (2000). www.fda.gov/cder/guidance/3618fnl.pdf. Accessed October 19, 2007.
- WHO. 2005. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. Geneva, Switzerland: WHO. (2005). www.who.int/medicines/services/expertcommittees/pharmprep/QAS04_093Rev4_final.pdf. Accessed October 19, 2007.
- M. Glasgow, S. Dressman, W. Brown, T. Foster, S. Schuber S, R. G. Manning, S. Z. Wahab, R. L. Williams, and W. W. Hauck W. W. The USP performance verification test, part II: collaborative study of USP’s Lot P Prednisone Tablets. DOI 10.1007/s11095-007-9482-2 (2008).
- NIST. Guidance on federal conformity assessment activities. Fed. Regist. 65:48894–48902 (2000).
- FDA. Guidance for industry: text on validation of analytical procedures. (1995). www.fda.gov/cder/guidance/ichq2a.pdf. Accessed October 19, 2007.
- ISO. ISO 5725 1-6: Accuracy (Trueness and Precision) of Measurement Methods and Results. ISO, Geneva, Switzerland, 1994.
- ISO. ISO/IEC Guide 43-1: Proficiency Testing by Interlaboratory Comparisons. ISO, Geneva, Switzerland, 1997.
- J. Dressman, and J. Kramer. Pharmaceutical Dissolution Testing. Taylor & Francis, Boca Raton, FL, 2005.
- R. Hanson, and V. Gray. Handbook of Dissolution Testing, 3rd ed. Dissolution Technologies, Hockessin, DE, 2004.
- J. Eaton, G. Deng, W. W. Hauck, W. Brown, R. G. Manning, and S. Wahab. Perturbation study of dissolution apparatus variables—a design of experiment approach. Dissolution Technol. 14:20–26 (2007).
- M. R. Liddell, G. Deng, W. W. Hauck, W. Brown, S. Wahab, and R. G. Manning. Evaluation of glass dissolution vessel dimensions and irregularities. Dissolution Technol. 14:28–33 (2007).
- S. A. Qureshi, and I. J. McGilveray. Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product. Eur. J. Pharm. Sci. 7:249–258 (1999). CrossRef
- S. A. Qureshi, and J. Shabnam. Cause of high variability in drug dissolution testing and its impact on setting tolerances. Eur. J. Pharm. Sci. 12:271–276 (2001). CrossRef
- Z. Gao, T. W. Moore, A. P. Smith, W. H. Doub, and B. J. Westenberger. Studies of variability in dissolution testing with USP apparatus 2. J. Pharm. Sci. 96:1794–1801 (2007). CrossRef
- J. L. Baxter, J. Kukura, and F. J. Muzzio. Hydrodynamics-induced variability in the USP Apparatus 2 dissolution test. Int. J. Pharm. 292:17–29 (2005). CrossRef
- J. Kukura, J. L. Baxter, and F. J. Muzzio. Shear distribution and variability in the USP apparatus 2 under turbulent conditions. Int. J. Pharm. 279:9–17 (2004). CrossRef
- USP. The USP performance test: mechanical calibration vs. a periodic performance verification test with reference standard tablets (calibrators) [and links therein]. www.usp.org/USPNF/notices/calibratorsPublicStatement.html. Accessed October 19, 2007.
- R. Hanson. Comments on mechanical and chemical calibration by an instrument manufacturer. Dissolution Technol. 14:7(2007).
- The USP Performance Verification Test, Part I: USP Lot P Prednisone Tablets—Quality Attributes and Experimental Variables Contributing to Dissolution Variance
Volume 25, Issue 5 , pp 1100-1109
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- performance verification
- performance verification test
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- United States Pharmacopeia
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- Author Affiliations
- 1. United States Pharmacopeia, Rockville, Maryland, 20852, USA
- 2. Department of Health and Human Services, Washington, District of Columbia, 20201, USA
- 3. US Pharmacopeia, Department of Reference Materials Development, 12601 Twinbrook Parkway, Rockville, Maryland, 20852, USA