Feasibility study for intraepidermal delivery of proteins using a solid microneedle array

Item Type:	Article
Title:	Feasibility study for intraepidermal delivery of proteins using a solid microneedle array
Creators Name:	Witting, M. and Obst, K. and Pietzsch, M. and Friess, W. and Hedtrich, S.
Abstract:	Solid microneedles (MN) are a promising tool for dermal drug delivery. Particular focus lies on the field of vaccination due to pain-free, safe, hygienic and patient compliant antigen deposition. Diverse coating techniques and formulations have been developed to preserve vaccine activity and to enable targeted drug deposition in the skin. Process and long-term storage stability of coated MN, however, have not yet been studied in detail. Hence, a feasibility study was conducted determining the appropriate needle length (300 μm) for local intraepidermal protein delivery. Moreover, a protein-stabilizing coating formulation was developed. Coating of the MN resulted in protein concentrations between 10 and 23 μg, 90% of the bioactivity of the model protein asparaginase was maintained for 3 months. Skin experiments verified the intraepidermal deposition of 68.0 ± 11.7% of the coated model protein after single application. Slightly increased interleukin 8 levels right after MN insertion indicated minor skin irritation due to the mechanical piercing stress. Thus, specifically highlighting protein stabilization during storage, we demonstrated that selective intraepidermal deposition of proteins or peptides’ using solid MN is a feasible approach.
Keywords:	Solid Microneedle Array, Proteins, Coating Formulation, Protein Stability, Human Reconstructed Skin, Skin Irritation, Animals, Swine
Source:	International Journal of Pharmaceutics
ISSN:	0378-5173
Publisher:	Elsevier
Volume:	486
Number:	1-2
Page Range:	52-58
Date:	30 May 2015
Official Publication:	https://doi.org/10.1016/j.ijpharm.2015.03.046
PubMed:	View item in PubMed

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