title: Successful application of large microneedle patches by human volunteers.
abstract: We describe, for the first time, the design, production and evaluation of large microneedle patches. Such systems, based on 16 individual microneedle arrays (needle height 600μm), were prepared from aqueous blends of 15% w/w Gantrez®S97 and 7.5% w/w poly(ethyleneglycol) 10,000Da. Ester-based crosslinking was confirmed by FTIR and mechanical strength was good. Insertion depths in a validated skin model were approximately 500μm. Ten human volunteers successfully self-inserted the microneedles of these larger patches in their skin, following appropriate instruction, as confirmed by transepidermal water loss measurements. The mean insertion depth ranged between 300 and 450μm over the area of the large patches. That this was not significantly different to a single unit MN patch self-applied by the same volunteers is encouraging. Microneedle patch sizes much larger than the 1-2cm2will be required if this technology is to be successfully translated to clinic for delivery of drug substances. The work described here suggests that use of such larger patches by patients can be successful, potentially opening up the possibility for a significant expansion of the size of the market for transdermal drug delivery.
authors.affiliation: School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.
authors.forename: Anastasia
authors.initials: A
authors.lastname: Ripolin
authors.affiliation: School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.
authors.forename: James
authors.initials: J
authors.lastname: Quinn
authors.affiliation: School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.
authors.forename: Eneko
authors.initials: E
authors.lastname: Larrañeta
authors.affiliation: School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.
authors.forename: Eva Maria
authors.initials: EM
authors.lastname: Vicente-Perez
authors.affiliation: School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK.
authors.forename: Johanne
authors.initials: J
authors.lastname: Barry
authors.affiliation: School of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7BL, UK. Electronic address: r.donnelly@qub.ac.uk.
authors.forename: Ryan F
authors.initials: RF
authors.lastname: Donnelly
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D016503:Drug Delivery Systems / Q000295:instrumentation* / Q000379:methods; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D020100:Hydrogels / Q000008:administration & dosage / Q000378:metabolism; D008297:Male; D008845:Microinjections / Q000295:instrumentation* / Q000379:methods; D009339:Needles; D012867:Skin / Q000187:drug effects / Q000378:metabolism; D057968:Transdermal Patch; D055815:Young Adult
chemical_list: D020100:Hydrogels
keywords: Clinical translation; Large patches; Microneedles; Self-application