Reliability and Reproducibility of Vertical Diffusion Cells for Determining Release Rates from Semisolid Dosage Forms |
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Authors: | Walter W Hauck Vinod P Shah Steven W Shaw Clarence T Ueda |
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Affiliation: | (1) US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Maryland 20852, USA;(2) Hanson Research, Chatsworth, California 91311, USA;(3) University of Nebraska College of Pharmacy, Omaha, Nebraska 68114, USA |
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Abstract: | Purpose USP has formed Advisory Panels to ensure the integrity of laboratory procedures for non-oral routes of administration and
expects that the panels will recommend performance tests (performance qualification, PQ) for these dosage forms as well as
performance verification tests (PVT) for those PQ tests. An integral part of PQ is PVT, in which a standard formulation is
first tested in a metrologically sound collaborative study to set acceptance criteria. Individual laboratories can then test
the performance of their product by comparing their results to those obtained from the USP collaborative study. These studies
are guided by metrological principles, e.g., those of the International Organization for Standardization (ISO) 43-1, which
succinctly states that “one of the main uses of proficiency testing schemes is to assess laboratories’ ability to perform
tests competently.”
Materials and methods Four laboratories conducted two collaborative studies to determine the reliability and reproducibility—understood in metrological
terms—of release rates from semisolid dosage forms using the vertical diffusion cell (VDC).
Results The experiments reported here from the second study found that the major contributor to variability is the interlaboratory
component that may include intermediate precision considerations other than analyst. Because all laboratories used the same
model equipment, one might expect that the observed reproducibility CV was lower than if the laboratories used different models
or equipment made by different manufacturers. Also, more variability was observed with the creams than the other dosage forms.
Conclusions The results from the preliminary collaborative study found inconsistency among the laboratories. After operator training,
the results from the second study were more consistent, suggesting the initial results were associated with variations among
the laboratories in performing the methods and procedures and conducting the protocols. Those results emphasize that although
the in vitro release procedure is simple and reproducible, training is needed. The data presented suggest that testing of in vitro release by VDCs should be considered as a PVT for topical semisolid dosage forms. Thus, a standard semisolid product is needed,
along with a means for setting acceptance criteria. The SUPAC-SS Guidance may be helpful in the latter regard. |
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Keywords: | Franz Cell performance qualification performance verification test semisolid dosage forms |
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