Biphasic vesicles, a novel nanostructured lipid-based delivery system show potential for topical application of interferon alpha (IFN α) for the treatment of human papillomavirus (HPV) infections (anogenital warts). Dermal delivery of IFN α encapsulated in biphasic vesicles (BPV-IFN α), applied topically to the skin, was characterized in a guinea pig model. BPV-IFN α (1g, 2 MIU/g) was topically applied either as a single or multiple treatments on the skin of guinea pigs. As a comparison with currently used regimens, IFN α solution was administered intravenously or intradermally. Skin and serum samples were collected over 96 h, IFN α levels were determined by an antiviral assay, and half-life (t₁/₂) and elimination (k) rates were calculated. Topical BPV-IFN α treatment resulted in maximum skin levels (about 100,000 U/100 cm(2)) of IFN α within 6h and maintained for 72-96 h. Clearance from the skin after intradermal injections was initially fast (t₁/₂ 0.62 h, k 1.1179 h(-1)), followed by a slower steady decrease after 6h. After intravenous and intradermal administration, IFN α was rapidly cleared from the serum, t₁/₂ 0.75 h, k 0.9271 h(-1) and t₁/₂ 1.28 h, k 0.5421 h(-1), respectively, whereas after topical application, IFN α levels remained below 100 U/mL. Topical application of BPV- IFN α resulted in sustained delivery of biologically active IFN α locally into skin with minimal systemic exposure.
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