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Multiple dose comparison of a whole 240 mg verapamil sustained-release tablet with two half tablets

✍ Scribed by T. A. Moreland; M. E. T. McMurdo; J. McEwen


Publisher
John Wiley and Sons
Year
1989
Tongue
English
Weight
435 KB
Volume
10
Category
Article
ISSN
0142-2782

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✦ Synopsis


Twelve healthy male volunteers were studied in a balanced crossover comparison of an intact 240 mg verapamil sustained-release tablet (Securon SR, Isoptin Forte Retard) given once daily for 7 days, and the same dose given as two half tablets. One subject was withdrawn because of asymptomatic second degree heart block on day 3 of verapamil treatment. The mean Cmx after dosing with whole tablets, 143 (95 per cent confidence limits 91.6-223) ngml-' was lower than after dosing with half tablets, 160 (107-241) ngml-', but this was not significant (p=0*49). The mean steady-state C,i, values after whole and half tablets were also similar: 222 (12.6-39.4) ngml-' and 22.0 (16.2-29-9) ngml-I, respectively (p=0*96). The mean (2S.D.) tmx, A U G M and t% were not significantly different: whole tablet 3.5 * 1-2 h, 1733 ?: 1125 ng.hm1-' and 10.5 2 3.4 h, respectively, and half tablets 3.62 1.0 h, 17802 1057 ng.h ml-' and 9-62 2.3 h, respectively.

The findings for plasma norverapamil were generally similar to those for the parent drug. This investigation indicates that the formulation is sufficiently robust to retain its sustained-release properties when the tablet is halved.