Premium
Multiple dose comparison of a whole 240 mg verapamil sustained‐release tablet with two half tablets
Author(s) -
Moreland T. A.,
McMurdo M. E. T.,
McEwen J.
Publication year - 1989
Publication title -
biopharmaceutics and drug disposition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.419
H-Index - 58
eISSN - 1099-081X
pISSN - 0142-2782
DOI - 10.1002/bdd.2510100309
Subject(s) - verapamil , pharmacology , pharmacokinetics , chemistry , medicine , chromatography , calcium
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 One subject was withdrawn because of asymptomatic second degree heart block on day 3 of verapamil treatment.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 C max after dosing with whole tablets, 143 (95 per cent confidence limits 91·6–223) ngml −1 was lower than after dosing with half tablets, 160 (107–241) ngml −1 , but this was not significant ( p =0·49). The mean steady‐state C min values after whole and half tablets were also similar: 22·2 (12·6–39·4) ngml −1 and 22·0 (16·2–29·9) ngml −1 , respectively ( p =0·96). The mean (± S.D.) t max , AUC 0–24 and t 1/2 were not significantly different: whole tablet 3·5 ± 1·2h, 1733 ± 1125 ng.h ml −1 and 10·5 ± 3·4h, respectively, and half tablets 3·6 ± 1·0h, 1780 ± 1057 ng.h ml −1 and 9·6 ± 2·3h, 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.