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

Abstract

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 One subject was withdrawn because of asymptomatic second degree heart block on day 3 of verapamil treatment.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 Cmax after dosing with whole tablets, 143 (95 per cent confidence limits 91.6-223) ng ml-1 was lower than after dosing with half tablets, 160 (107-241) ng ml-1, but this was not significant (p = 0.49). The mean steady-state Cmin values after whole and half tablets were also similar: 22.2 (12.6-39.4) ng ml-1 and 22.0 (16.2-29.9) ng ml-1, respectively (p = 0.96). The mean (+/- S.D.) tmax, AUC0-24 and t 1/2 were not significantly different: whole tablet 3.5 +/- 1.2 h, 1733 +/- 1125 ng.h ml-1 and 10.5 +/- 3.4 h, respectively, and half tablets 3.6 +/- 1.0 h, 1780 +/- 1057 ng.h ml-1 and 9.6 +/- 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.

• Authors: T A Moreland, M E McMurdo, J McEwen
• Journal: Biopharmaceutics & drug disposition (Biopharm Drug Dispos) 1989 May-Jun Vol. 10 Issue 3 Pg. 311-9 ISSN: 0142-2782 [Print] England
• PMID: 2720134 (Publication Type: Clinical Trial, Comparative Study, Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Delayed-Action Preparations
• Tablets
• norverapamil
• Verapamil

Topics

• Adult
• Delayed-Action Preparations
• Electrocardiography
• Humans
• Male
• Tablets
• Verapamil (administration & dosage, analogs & derivatives, blood, pharmacokinetics, pharmacology)