1. 14T0900
Comparative Dissolution of Over the Counter (OTC) Acetaminophen
“Fast-Release Quick Gels ” Versus Standard Acetaminophen Tablets.
G. Abernathy, D. Choi, C. Colwell, K. Powell, R. Webb, J.R. Dunbar
South College School of Pharmacy, Knoxville, TN
PURPOSE
METHOD
RESULTS
One of the many acetaminophen products
available OTC, is a 500 mg gelcap formulation
distributed by a major U.S. pharmacy chain that
carries the label descriptor, “Fast-Release Quick
Gels ”. It is reasonable to expect that this
labeling could lead the consumer to infer that this
product is superior to a standard immediate-
release tablet with regard to onset of pain-
relieving action, and overall efficacy. This study
was undertaken to determine the dissolution
profile of these “Fast-Release Quick Gels ”
compared to the standard immediate release
caplet formulation distributed by the same
pharmacy chain; and whether any differences
might be significant enough to justify a
consumer’s assumption that it would be a “faster-
acting” pain-relieving product.
CONCLUSION
REFERENCE &
Acknowledgement
Despite carrying the label
statement, “Fast-Release Quick
Gels ”, the OTC acetaminophen
gelcap formulation, sold by a major
U.S. pharmacy chain, does not
demonstrate a superior rate of
dissolution relative to the their
standard OTC acetaminophen
caplet. While the “Fast-Release”
label designation may be
consistent with the generally
accepted dissolution performance
characteristic of “immediate
release”, the labeling, “Fast-
Release Quick Gels ”, can imply
to the consumer a superior rate of
dissolution than standard
acetaminophen tablets, which was
not demonstrated in this study.
There was no difference in dissolution profiles between the 500 mg acetaminophen gelcaps (“Fast-Release Quick Gels ”)
and the 500 mg acetaminophen caplets when using any common, identical test conditions. Both products exhibited slower
dissolution at 30 vs 50 rpm in both phosphate and SGF media, but still exhibited no difference in dissolution of
acetaminophen between products.
Acetaminophen, 500 mg gelcaps (“Fast-Release
Quick Gels ”) and 500 mg caplets were
purchased from one of the local chain
pharmacies. Dissolution of these products was
tested according to the USP monograph for
acetaminophen tablets using 900mL phosphate
buffer, pH 5.8 @ 37 C; USP 2 apparatus with 50
rpm paddle speed. These products were also
tested by substituting 900mL simulated gastric
fluid w/o enzymes (SGF), pH 1.2 (USP) as the
dissolution media, as well as using both media at
lower paddle speed (30 rpm) to determine if these
varying dissolution conditions might be more or
less discriminating between the two products than
the USP monograph. Dissolution samples taken
at 5, 10, 20, and 30 minutes were analyzed for
acetaminophen concentrations using the
reversed-phase HPLC method described for the
“Assay”, in the USP monograph for
acetaminophen tablets.
1. United States Pharmacopeia
(USP) 39 - National Formulary
(NF) 34. May 1, 2016.
The authors wish to acknowledge
the support of South College
School of Pharmacy for their
continued support of student
research.