The significant changes in release pattern are further confirmed by low F2 values. The similarity factor F2, as defined by the US Food and Drug Administration, is a logarithmic reciprocal square-root transformation of one plus the
mean squared (i.e., the average sum of squares) differences of drug percent dissolved between the test and reference products
(5). Table I compares the F2 values for all dissolutions in alcoholic beverages with those in water. The results clearly indicate the effect of alcoholic
beverages on in vitro drug release.
Table I: F2 values of dissolution data.
The authors concluded that the release of the instant-release formulations was faster in Kingfisher Strong beer, Mild beer,
rum, and 40% alcohol than it was in water. The difference may be attributable to the volume of the alcoholic beverages, rather
than to their strength. The drug release of the sustained-release formulations was faster in 40% alcohol and in rum than it
was in water. The authors concluded that the consumption of alcoholic beverages should be avoided during treatment with sustained-release
formulations of metformin and diclofenac to prevent dose dumping.
Anagha Joshi* is a doctoral student at Bharati Vidyapeeth University's Poona College of Pharmacy and assistant professor of pharmaceutical
chemistry at Indira College of Pharmacy, Pune, Maharashtra, India, email@example.com
. Shivajirao S. Kadam is vice-chancellor of Bharati Vidyapeeth University Pune, Maharashtra,India, and Aatmaram P. Pawar is a professor of pharmaceutics at Bharati Vidyapeeth University Pune, Maharashtra, India.
*To whom all correspondence should be addressed.
Submitted: Feb. 13, 2010. Accepted: Apr. 5, 2010.
1. L.A. Bennett et al., Alcohol Health Res. World 22 (4), 243–252 (1998).
2. R.J. Meyer and A.S. Hussain, Proceedings of FDA's Advisory Committee For Pharmaceutical Science meeting (Rockville, MD,
2005), p. 2.
3. Indian Pharmacopoeia (Controller of Publications, New Delhi, India, 2007), p. 1020.
4. Goodman and Gilman's The Pharmacological Basis of Therapeutics, J.G. Hardman, L.E. Limbird, and A.G. Gilman, Eds. (McGraw-Hill, New York, 10th ed., 2001), pp. 644–646.
5. M.C. Gohel and M.K. Panchal, Dissol. Technol. 9 (1), 1–5 (2002).