Sa. Qureshi et Ij. Mcgilveray, Typical variability in drug dissolution testing: study with USP and FDA calibrator tablets and a marketed drug (glibenclamide) product, EUR J PH SC, 7(3), 1999, pp. 249-258
To evaluate variability in drug dissolution testing 28 laboratories analyze
d USP calibrators, US FDA prednisone tablets and a marketed glibenclamide t
ablet product. The experiments were conducted using paddle and basket metho
ds at 50 (calibrators) and 75 (glibenclamide) rpm. The media employed were
deaerated by equilibrating at 37 degrees C for 24 h and by the USP recommen
ded method. The 95% CI values for percent drug release for the USP calibrat
or tablets were similar to the reported tolerances for the USP Acceptance R
anges; however, individual results from 15 of 28 laboratories suggest that
the apparatus would not comply with the USP Apparatus Suitability Criteria.
For FDA prednisone calibrator tablets, percent drug release using equilibr
ated medium was different (P=0.003) than by the USP recommended method. For
the glibenclamide tablet results, a CV of 14-37% was observed, depending u
pon the sampling time and the type of apparatus employed. The results indic
ate that failure to meet the USP Dissolution Apparatus Suitability Test may
not truly mean that the apparatus is 'out of compliance'. Due to the high
variability in dissolution testing, in many cases the impact of formulation
or manufacturing changes on drug release characteristics may not be observ
ed, in particular with multi-point profiles. (C) 1999 Published by Elsevier
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