title: A novel scalable manufacturing process for the production of hydrogel-forming microneedle arrays.
abstract: A novel manufacturing process for fabricating microneedle arrays (MN) has been designed and evaluated. The prototype is able to successfully produce 14×14 MN arrays and is easily capable of scale-up, enabling the transition from laboratory to industry and subsequent commercialisation. The method requires the custom design of metal MN master templates to produce silicone MN moulds using an injection moulding process. The MN arrays produced using this novel method was compared with centrifugation, the traditional method of producing aqueous hydrogel-forming MN arrays. The results proved that there was negligible difference between either methods, with each producing MN arrays with comparable quality. Both types of MN arrays can be successfully inserted in a skin simulant. In both cases the insertion depth was approximately 60% of the needle length and the height reduction after insertion was in both cases approximately 3%.
authors: School of Pharmacy, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors: Rebecca E M
authors: RE
authors: Lutton
authors: School of Pharmacy, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors: Eneko
authors: E
authors: Larrañeta
authors: School of Pharmacy, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors: Mary-Carmel
authors: MC
authors: Kearney
authors: School of Pharmacy, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors: Peter
authors: P
authors: Boyd
authors: School of Pharmacy, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom.
authors: A David
authors: AD
authors: Woolfson
authors: School of Pharmacy, Queens University Belfast, 97 Lisburn Road, Belfast BT9 7BL, United Kingdom. Electronic address: r.donnelly@qub.ac.uk.
authors: Ryan F
authors: RF
authors: Donnelly
mesh_terms: D016503:Drug Delivery Systems / Q000295:instrumentation*; D020100:Hydrogels / Q000138:chemical synthesis* / Q000737:chemistry; D009339:Needles; D012828:Silicones; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D020100:Hydrogels; D012828:Silicones
keywords: Commercialisation; Drug delivery; Injection moulding; Manufacture; Microneedle; Scalable