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J Control Release. 2016 Mar 10;225:40-52. doi: 10.1016/j.jconrel.2016.01.027. Epub 2016 Jan 19.

Formulations for microprojection/microneedle vaccine delivery: Structure, strength and release profiles.

Author information

1
The University of Queensland, Delivery of Drugs and Genes Group (D(2)G(2)), Australian Institute for Bioengineering and Nanotechnology, QLD 4072, Australia.
2
The University of Queensland, Delivery of Drugs and Genes Group (D(2)G(2)), Australian Institute for Bioengineering and Nanotechnology, QLD 4072, Australia; ARC Centre of Excellence in Convergent Bio-Nano Science and Technology, The University of Queensland, Australia.
3
University of Sheffield, Department of Chemical & Biological Engineering, ChELSI Institute, Sheffield S1 3JD, England, United Kingdom.
4
The University of Queensland, School of Mechanical and Mining Engineering, QLD 4072, Australia.
5
The University of Queensland, Delivery of Drugs and Genes Group (D(2)G(2)), Australian Institute for Bioengineering and Nanotechnology, QLD 4072, Australia; ARC Centre of Excellence in Convergent Bio-Nano Science and Technology, The University of Queensland, Australia; The University of Queensland, Faculty of Medicine and Biomedical Sciences, Royal Brisbane and Women's Hospital, Herston, Queensland 4006, Australia. Electronic address: m.kendall@uq.edu.au.

Abstract

To develop novel methods for vaccine delivery, the skin is viewed as a high potential target, due to the abundance of immune cells that reside therein. One method, the use of dissolving microneedle technologies, has the potential to achieve this, with a range of formulations now being employed. Within this paper we assemble a range of methods (including FT-FIR using synchrotron radiation, nanoindentation and skin delivery assays) to systematically examine the effect of key bulking agents/excipients - sugars/polyols - on the material form, structure, strength, failure properties, diffusion and dissolution for dissolving microdevices. We investigated concentrations of mannitol, sucrose, trehalose and sorbitol from 1:1 to 30:1 with carboxymethylcellulose (CMC), although mannitol did not form our micro-structures so was discounted early in the study. The other formulations showed a variety of crystalline (sorbitol) and amorphous (sucrose, trehalose) structures, when investigated using Fourier transform far infra-red (FT-FIR) with synchrotron radiation. The crystalline structures had a higher elastic modulus than the amorphous formulations (8-12GPa compared to 0.05-11GPa), with sorbitol formulations showing a bimodal distribution of results including both amorphous and crystalline behaviour. In skin, diffusion properties were similar among all formulations with dissolution occurring within 5s for our small projection array structures (~100μm in length). Overall, slight variations in formulation can significantly change the ability of our projections to perform their required function, making the choice of bulking/vaccine stabilising agents of great importance for these devices.

KEYWORDS:

Drug delivery; Formulation; Microneedles; Skin; Vaccine

PMID:
26795684
DOI:
10.1016/j.jconrel.2016.01.027
[Indexed for MEDLINE]

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