Rapidfilm: an innovative pharmaceutical form designed to improve patient compliance.
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.
Reiner
Valentina
V
APR Applied Pharma Research SA, via Corti 5, CH-6828 Balerna, Switzerland.
Giarratana
Nadia
N
Monti
Nunzia Ceppi
NC
Breitenbach
Armin
A
Klaffenbach
Peter
P
D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D000932:Antiemetics / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D002853:Chromatography, Liquid; D018592:Cross-Over Studies; D004304:Dosage Forms; D004337:Drug Carriers; D004339:Drug Compounding; D005260:Female; D006801:Humans; D008297:Male; D017294:Ondansetron / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D010349:Patient Compliance; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000737:chemistry / Q000493:pharmacokinetics*; D053719:Tandem Mass Spectrometry; D013810:Therapeutic Equivalency
D000932:Antiemetics; D004304:Dosage Forms; D004337:Drug Carriers; D012702:Serotonin Antagonists; D017294:Ondansetron