Nh. Anderson et al., AN EVALUATION OF FIT FACTORS AND DISSOLUTION EFFICIENCY FOR THE COMPARISON OF IN-VITRO DISSOLUTION PROFILES, Journal of pharmaceutical and biomedical analysis, 17(4-5), 1998, pp. 811-822
Dissolution efficiency (D.E.), the area under a dissolution curve betw
een defined time points, and the lit factors (f(1) and f(2)) have been
compared for the characterisation of dissolution profiles, using data
from three batches of a product in nine different packs stored under
two conditions. The factors f(1) and f(2) offer ease of calculation an
d a simple measure of similarity between pairs of dissolution profiles
. This is well suited to the qualitative determination of 'similarity'
as required by the FDA's SUPAC Guide. However, they do not provide in
formation on individual batches, including their consistency. In contr
ast, D.E. does provide such information and is well-suited to making q
uantitative comparisons amongst batches. Because D.E. has a simple phy
sical meaning, it is easier to interpret D.E. data than corresponding
f(1) and f(2) results. The confidence limits in D.E. values provide a
useful measure of the variability in batch dissolution and allow the s
tatistical significance of difference in D.E. between pairs of batches
to be determined. Both the above measures lead to the same conclusion
s regarding the similarity in protective power amongst the nine packs
under test and to the value of added desiccant in maintaining the diss
olution profile of the product when stored under high humidity conditi
ons. It is concluded that D.E. offers a suitable alternative to the si
ngle point dissolution measurement for QC of immediate release product
s. (C) 1998 Elsevier Science B.V. All rights reserved.