Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 393, Issue 1-2, Pages 55-60Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ijpharm.2010.03.055
Keywords
Ondansetron; Orally disintegrating tablet (ODT); Orodispersible tablet; Bioequivalence; Orodispersible film; Delivery system
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The aim of the research was to assess the bioequivalence between Rapidfilm (R), 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 (R) vs. Zofran (R) Zydis (R) Lingual ODT by GlaxoSmithKline GmbH & Co. KG). Plasma samples were analysed by a validated LC-MS/MS method during a collection period of 24h 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 (R) 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. (c) 2010 Elsevier B.V. All rights reserved.
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