FLOATING DOSAGE FORMS - AN IN-VIVO STUDY DEMONSTRATING PROLONGED GASTRIC RETENTION

Citation
L. Whitehead et al., FLOATING DOSAGE FORMS - AN IN-VIVO STUDY DEMONSTRATING PROLONGED GASTRIC RETENTION, Journal of controlled release, 55(1), 1998, pp. 3-12
Citations number
19
Categorie Soggetti
Pharmacology & Pharmacy",Chemistry
ISSN journal
01683659
Volume
55
Issue
1
Year of publication
1998
Pages
3 - 12
Database
ISI
SICI code
0168-3659(1998)55:1<3:FDF-AI>2.0.ZU;2-0
Abstract
Gastroretentive dosage forms have potential for use as controlled-rele ase drug delivery systems. The use of floating dosage forms (FDFs) is one method to achieve prolonged gastric residence times (GRTs), provid ing opportunity for both local and systemic drug action. Multiple-unit systems avoid the 'all-or-nothing' gastric emptying nature of single- unit systems. A freeze-dried calcium alginate multiple-unit FDF has be en developed which demonstrated favourable in vitro floating character istics. The aim of this study was to investigate the in vivo behaviour of this system compared to a multiple-unit non-floating dosage form m anufactured from identical material. The study was performed in seven healthy volunteers, who swallowed the radiolabelled formulations after a standard breakfast. Transit was monitored by gamma-scintigraphy and subjects were maintained in the fed state. Prolonged GRTs of over 5.5 h were achieved in all subjects for the floating formulations, which remained high up in the stomach for the whole of the test period. In c ontrast, the non-floating beads displayed short GRTs, with a mean onse t emptying time of 1 h. The results of this study suggest that, in the fed state, this FDF has potential for sustained drug delivery for eit her local or systemic purposes. (C) 1998 Elsevier Science B.V.