| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 2503856 | International Journal of Pharmaceutics | 2010 | 6 Pages |
The aim of the research was to assess the bioequivalence between Rapidfilm®, a new patented delivery system, versus the traditional orodispersible tablet (ODT).A randomized, two-way, single dose, crossover, bioequivalence study was conducted in 24 fasting, healthy volunteers with two formulations of ondansetron (Ondansetron Rapidfilm® vs. Zofran® Zydis® Lingual ODT by GlaxoSmithKline GmbH & Co. KG).Plasma samples were analysed by a validated LC–MS/MS method during a collection period of 24 h post-dosing. The analysis of variance (ANOVA) on the targeted pharmacokinetic parameters did not show any significant difference between the two formulations and 90% confidence intervals (CIs) fell within the common acceptance range of 80–125%, satisfying the bioequivalence criteria. These results allow Rapidfilm® to claim the same panel of indications of the conventional immediate release oral solid dosage forms, but offering several advantages also over the ODT: it can result in higher patient convenience for several applications.
