To evaluate the uses of Labskin as an alternative to human or animal experimentation when characterizing in vitro permeation of Ibuprofen (IBU).
- Atatic glass Franz diffusion cells were used to mount Labskin. This was then equilibrated at 32 oC ±1 oC. The receptor phase used PBS. Figure 1.
- Any excess surface water was removed and TEWL measurements were carried out using an AquaFlux AF200 (Biox Systems).
- A test was carried out on infinite dose: 1mL of saturated IBU solution in propylene glycol (PG). After each sample receptor fluid was replaced.
- An addition of finite dose: 3.6 μL of IBU solution (1.5% w/v in 5% PG : 95% isopropyl alcohol) was made to the donor compartment. Fresh PBS replaced the collected 200 μL samples.
- A period of 24 hours was used to conduct all experiments and samples were assayed by UV-HPLC.
- Over the time- course of the experiments TEWL for Labskin remained constant. (Figure 2).
- There was less variability demonstrated for Labskin (Figure 3) than that usually demonstrated by human or porcine skin and other human skin equivalent tissue culture models (Netzlaff, F., et al., European Journal of Pharmaceutics and Biopharmaceutics, 2005. 60: p.167-178)
- Labskin demonstrated flux values for the infinite dose study (Figure 4) that were roughly 1.5 times higher than with human epidermis (Watkinson, R.M., et al., Skin Pharmacology and Physiology, 2009. 22: p. 225-230)
- After application the total amount of IBU permeated across Labskin of 3.6 μL of the formulation was 46.2 μg cm-2 compared to 17 μg cm-2 across human epidermis (Figure 5)
Figure 1. Mounting in the receptor compartment of a Franz diffusion cell & Franz diffusion cell final assembly.
Figure 2. TEWL values measured on Labskin, no formulation control for 24 h infinite () and finite () dose study.
Figure 3. Cumulative amount of ibuprofen permeated from a saturated solution of IBU in PG for 24 h across Labskin at 32 ºC
Figure 4. Steady-state fluxes of ibuprofen through different membranes from saturated solutions in PG (mean ± SD)
Figure 5. Cumulative amount IBU permeated from 95:5:1.47 (IPA:PG:IBU) solution over 24 h across Labskin () and human epidermis () at 32 °C (n=5, Mean ± SD)
Whilst IBU permeated more quickly through Labskin than human skin in vitro, permeability is comparable to porcine ear tissue, which is the closest animal model to human skin.
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