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Bioavailability of hydrochlorothiazide from isomalt-based moulded tablets.

International journal of pharmaceutics (2002-09-25)
F Ndindayino, C Vervaet, G Van den Mooter, J P Remon
RÉSUMÉ

The bioavailability of hydrochlorothiazide (HCT) from moulded isomalt-based tablets was evaluated after oral administration of 50 mg HCT to healthy volunteers as an oral moulded tablet and as a lozenge, in comparison with a conventional tablet formulation (Dichlotride 50 mg). Moulded tablets had a high relative bioavailability (F(rel)) as the pharmacokinetic parameters (C(max), t(max), t(1/2), AUC(0-->24 h)) determined from HCT plasma concentration versus time profiles were not significantly different (P>0.05; two-way ANOVA) in comparison with the conventional tablet. The relative bioavailability of the moulded tablet administered as a lozenge and as an oral tablet was 106.2+/-30.9% and 89.4+/-25.9%, respectively, in relation to the conventional tablet formulation. Direct moulding of isomalt tablets proved to be a suitable technique to administer a poorly soluble drug either as a conventional tablet or as a lozenge.

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Isomalt, United States Pharmacopeia (USP) Reference Standard
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Isomalt, European Pharmacopoeia (EP) Reference Standard
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