A pharmacokinetic comparison of the modified release capsule and a plain tablet formulation of mebeverine.
This study was conducted to compare the pharmacokinetic properties of the modified release 200 mg capsule of mebeverine and the plain 135 mg tablet of mebeverine after single and multiple doses in 12 healthy subjects in a randomised, crossover design. Single doses were given on days 1 and 7 and multiple doses (200 mg b.i.d. for the capsule and 135 mg t.i.d. for the tablet) on days 2-6 of the study. The 200 mg modified release capsule of mebeverine has extended release properties, as indicated by a lower Cmax, a later tmax and a longer elimination half-life than the plain tablet, while the bioavailability is optimal. No significant accumulation occurs after multiple doses of either formulation. The twice-daily dosage regimen of the 200 mg modified release capsule is a good alternative to the three times daily dosage regimen of the 135 mg plain tablet, because the reduced daily intake is likely to benefit patient compliance.
Winsemius
A
A
Department of Clinical Pharmacology, Solvay Pharmaceuticals, Weesp, The Netherlands.
Meuwsen
I M
IM
Boon
C
C
van der Laan
A
A
Brekle
A
A
de Vries
M
M
D000328:Adult; D002214:Capsules; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D010276:Parasympatholytics / Q000008:administration & dosage / Q000493:pharmacokinetics*; D010349:Patient Compliance; D010627:Phenethylamines / Q000008:administration & dosage / Q000493:pharmacokinetics*; D013608:Tablets, Enteric-Coated / Q000008:administration & dosage
D002214:Capsules; D003692:Delayed-Action Preparations; D010276:Parasympatholytics; D010627:Phenethylamines; D013608:Tablets, Enteric-Coated; C005096:mebeverine