title: Hydrogel-forming microneedles increase in volume during swelling in skin, but skin barrier function recovery is unaffected.
abstract: We describe, for the first time, quantification of in-skin swelling and fluid uptake by hydrogel-forming microneedle (MN) arrays and skin barrier recovery in human volunteers. Such MN arrays, prepared from aqueous blends of hydrolyzed poly(methylvinylether/maleic anhydride) (15%, w/w) and the cross-linker poly(ethyleneglycol) 10,000 Da (7.5%, w/w), were inserted into the skin of human volunteers (n = 15) to depths of approximately 300 μm by gentle hand pressure. The MN arrays swelled in skin, taking up skin interstitial fluid, such that their mass had increased by approximately 30% after 6 h in skin. Importantly, however, skin barrier function recovered within 24 h after MN removal, regardless of how long the MN had been in skin or how much their volume had increased with swelling. Further research on closure of MN-induced micropores is required because transepidermal water loss measurements suggested micropore closure, whereas optical coherence tomography indicated that MN-induced micropores had not closed over, even 24 h after MN had been removed. There were no complaints of skin reactions, adverse events, or strong views against MN use by any of the volunteers. Only some minor erythema was noted after patch removal, although this always resolved within 48 h, and no adverse events were present on follow-up.
authors.affiliation: School of Pharmacy, Queen's University Belfast, Belfast, BT9 7BL, UK.
authors.forename: Ryan F
authors.initials: RF
authors.lastname: Donnelly
authors.forename: Karen
authors.initials: K
authors.lastname: Mooney
authors.forename: Maelíosa T C
authors.initials: MT
authors.lastname: McCrudden
authors.forename: Eva M
authors.initials: EM
authors.lastname: Vicente-Pérez
authors.forename: Luc
authors.initials: L
authors.lastname: Belaid
authors.forename: Patricia
authors.initials: P
authors.lastname: González-Vázquez
authors.forename: James C
authors.initials: JC
authors.lastname: McElnay
authors.forename: A David
authors.initials: AD
authors.lastname: Woolfson
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D004867:Equipment Design / Q000295:instrumentation* / Q000379:methods; D005260:Female; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000008:administration & dosage* / Q000737:chemistry*; D008297:Male; D008845:Microinjections / Q000295:instrumentation* / Q000379:methods; D008875:Middle Aged; D009339:Needles; D011108:Polymers / Q000008:administration & dosage / Q000737:chemistry; D020127:Recovery of Function; D012867:Skin / Q000187:drug effects*; D055815:Young Adult
chemical_list: D011108:Polymers; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate
keywords: OCT; diffusion; hydrogel; microneedle; micropore; percutaneous; skin; skin barrier; transdermal