RESUMEN
A novel technology for the delivery of active substances to the skin based on microfibers loaded with dried active substances was developed. The objective of this work was to demonstrate deposition of the active substances on the skin including concurrent cleansing properties of the wipe. As model active substance to measure deposition capacity Niacinamide was used and as parameter to measure cleansing capacities of the wipe squalene uptake was measured. Wipes loaded with niacinamide were used in the face and the forearm of 25 subjects. By means of Raman spectrometry the deposited niacinamide was analyzed before and after application. Wipes used on the face were analyzed for squalene to assess skin cleansing properties and for residual niacinamide. Forearm analysis including placebo and verum on left and right arm respectively was performed to rule out changes of the skin through application of the tissue. Measured amounts of niacinamide from face application demonstrate statistically significant results in the study population. Analysis of the wipes used show a liberation of 28.3% of niacinamide from the wipes and an uptake of 1.7 mg squalene per wipe. Results from forearm application show statistically significant differences (p < 0.05) between placebo and active for the complete study population. Sub group analyses are significant for both gender and ethnicity for face and forearm analysis respectively. Results clearly demonstrate deposition of niacinamide on the skin and the cleansing properties of the wipe. The institutional review board approved this prospective study.
RESUMEN
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.