title: Bioavailability of hydrochlorothiazide from isomalt-based moulded tablets.
abstract: 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.
authors.affiliation: Laboratory of Pharmaceutical Technology, Ghent University, Harelbekestraat 72, Belgium.
authors.forename: F
authors.initials: F
authors.lastname: Ndindayino
authors.forename: C
authors.initials: C
authors.lastname: Vervaet
authors.forename: G
authors.initials: G
authors.lastname: Van den Mooter
authors.forename: J P
authors.initials: JP
authors.lastname: Remon
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D019540:Area Under Curve; D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D018592:Cross-Over Studies; D004187:Disaccharides / Q000737:chemistry; D005079:Excipients / Q000737:chemistry; D006207:Half-Life; D006801:Humans; D006852:Hydrochlorothiazide / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics*; D066298:In Vitro Techniques; D008297:Male; D008875:Middle Aged; D012995:Solubility; D013402:Sugar Alcohols / Q000737:chemistry; D013607:Tablets
chemical_list: D004187:Disaccharides; D005079:Excipients; D013402:Sugar Alcohols; D013607:Tablets; D006852:Hydrochlorothiazide; C016640:Palatinit