A novel scalable manufacturing process for the production of hydrogel-forming microneedle arrays

Rebecca E.M Lutton,Eneko Larrañeta,Mary-Carmel Kearney,Peter Boyd,A.David Woolfson,Ryan F Donnelly

doi:10.1016/j.ijpharm.2015.08.049

Rebecca E.M Lutton, Eneko Larrañeta + Show 4 more

Open Access

https://doi.org/10.1016/j.ijpharm.2015.08.049

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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%.

Highlights

The microneedle arrays (MN) arrays produced using this novel method was compared with centrifugation, the traditional method of producing aqueous hydrogel-forming MN arrays
Both types of MN arrays can be successfully inserted in a skin simulant
Microneedle arrays (MN) are minimally-invasive devices that painlessly by-pass the stratum corneum, the principal skin barrier to topically-applied drugs, and as such are intended for drug delivery and biosensing (Donnelly et al, 2012; Singh et al, 2010a, b)

Summary

Introduction

Microneedle arrays (MN) are minimally-invasive devices that painlessly by-pass the stratum corneum, the principal skin barrier to topically-applied drugs, and as such are intended for drug delivery and biosensing (Donnelly et al, 2012; Singh et al, 2010a, b) They consist of a plurality of micro-projections, generally ranging from 25 to 2000 mm in height, which are attached to a base support (Donnelly et al, 2010a,b; Gittard et al, 2013). MN can be prepared using a wide variety of geometries, having a great impact on their performance (Gomaa et al, 2010; Olatunji et al, 2013)

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