Dissolving Microneedle Patches for Dermal Vaccination

Leone, Marialucrezia; Mönkäre, Juha; Bouwstra, Joke A.; Kersten, Gideon

doi:10.1007/s11095-017-2223-2

Cited by 159 publications

(117 citation statements)

References 110 publications

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“…The most common indication of conventional microneedle systems is in vaccine administration [11,12]. In such cases, only a small number of applications would be necessary to achieve the desired immunological effect.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the clinical impact of repeat application of hydrogel-forming microneedle array patches

Al-Kasasbeh

Brady

Courtenay

et al. 2020

Drug Deliv. and Transl. Res.

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Hydrogel-forming microneedle array patches (MAPs) have been proposed as viable clinical tools for patient monitoring purposes, providing an alternative to traditional methods of sample acquisition, such as venepuncture and intradermal sampling. They are also undergoing investigation in the management of non-melanoma skin cancers. In contrast to drug or vaccine delivery, when only a small number of MAP applications would be required, hydrogel MAPs utilised for sampling purposes or for tumour eradication would necessitate regular, repeat applications. Therefore, the current study was designed to address one of the key translational aspects of MAP development, namely patient safety. We demonstrate, for the first time in human volunteers, that repeat MAP application and wear does not lead to prolonged skin reactions or prolonged disruption of skin barrier function. Importantly, concentrations of specific systemic biomarkers of inflammation (C-reactive protein (CRP); tumour necrosis factor-α (TNF-α)); infection (interleukin-1β (IL-1β); allergy (immunoglobulin E (IgE)) and immunity (immunoglobulin G (IgG)) were all recorded over the course of this fixed study period. No biomarker concentrations above the normal, documented adult ranges were recorded over the course of the study, indicating that no systemic reactions had been initiated in volunteers. Building upon the results of this study, which serve to highlight the safety of our hydrogel MAP, we are actively working towards CE marking of our MAP technology as a medical device.

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Section: Introductionmentioning

confidence: 99%

Evaluation of the clinical impact of repeat application of hydrogel-forming microneedle array patches

Al-Kasasbeh

Brady

Courtenay

et al. 2020

Drug Deliv. and Transl. Res.

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“…As such, it can be expected that MNs will need to be sterilized for any clinical application. Though no specific guidelines currently exist, due to the novelty of MN‐based technologies, based on FDA guidelines for medical devices which are in direct contact with lymphatic tissues, the endotoxin content in MNs should be < 20 EU per device . While fully aseptic preparation would ensure sterility, this could dramatically increase manufacturing costs, thereby generating interest in terminal sterilization methods, including heat and irradiation.…”

Section: Translational Considerationsmentioning

confidence: 99%

“…Though no specific guidelines currently exist, due to the novelty of MN-based technologies, based on FDA guidelines for medical devices which are in direct contact with lymphatic tissues, the endotoxin content in MNs should be < 20 EU per device. [122] While fully aseptic preparation would ensure sterility, this could dramatically increase manufacturing costs, thereby generating interest in terminal sterilization methods, including heat and irradiation. Heat-sterilization would likely be suitable for some MNs, including solid metal and silicon arrays, but would be incompatible with dissolving polymer, hydrogel, or complex hollow MNs devices.…”

Section: Translational Considerationsmentioning

confidence: 99%

Advances in the Design of Transdermal Microneedles for Diagnostic and Monitoring Applications

Babity

Roohnikan

Brambilla

2018

Small

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Due to their intrinsic advantages over classical hypodermic needles, microneedles have received much attention over the last two decades and will likely soon appear in clinics. Although the vast majority of research is focused on designing microneedles for the painless delivery of drugs, their applications for diagnostic purposes have also provided promising results. In this paper, the main advances in the field of microneedles for diagnostic and patient monitoring purposes are introduced and critically discussed.

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“…MNs may be fabricated from various materials including metal, silicon, carbohydrates, or FDA-approved biocompatible polymers and their mode of action is dependent upon the fabrication method [61]. In general, these materials should be biocompatible, have low toxicity, sufficient strength/toughness and be cost-effective [62]. Solid MNs are most often used in a two-step procedure, whereby the MN patch is firstly applied to the skin surface, temporarily disrupting its natural permeability barrier, prior to the 21 application of either a patch or topical formulation.…”

Section: Microneedle Arrays Circumvent Skin Barrier Functions and Facmentioning

confidence: 99%

Microneedle arrays for vaccine delivery: the possibilities, challenges and use of nanoparticles as a combinatorial approach for enhanced vaccine immunogenicity

Rodgers

Cordeiro

Kissenpfennig

et al. 2018

Expert Opinion on Drug Delivery

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Vaccination is one of the greatest breakthroughs of modern preventative medicine. Despite this, there remain problems surrounding delivery, efficacy and compliance. Thus, there is a pressing need to develop cost-effective vaccine delivery systems that could expand the use of vaccines, particularly within developing countries. Microneedle (MN) arrays, given their ease of use, painlessness and ability to target skin antigen presenting cells, provide an attractive platform for improved vaccine delivery and efficacy. Studies have demonstrated enhanced immunogenicity with the use of MN in comparison to conventional needle. More recently, dissolving MN have been used for efficient delivery of nanoparticles (NP), as a means to enhance antigen immunogenicity. Areas covered: This review introduces the fields of MN technology and nanotechnology, highlighting the recent advances which have been made with these two technologies combined for enhanced vaccine delivery and efficacy. Some key questions that remain to be addressed for adoption of MN in a clinical setting are also evaluated. Expert opinion: MN-mediated vaccine delivery holds potential for expanding access to vaccines, with individuals in developing countries likely to be the principal beneficiaries. The combinatorial approach of utilizing MN coupled with NP, provides opportunities to enhance the immunogenicity of vaccine antigens.

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Dissolving Microneedle Patches for Dermal Vaccination

Cited by 159 publications

References 110 publications

Evaluation of the clinical impact of repeat application of hydrogel-forming microneedle array patches

Evaluation of the clinical impact of repeat application of hydrogel-forming microneedle array patches

Advances in the Design of Transdermal Microneedles for Diagnostic and Monitoring Applications

Microneedle arrays for vaccine delivery: the possibilities, challenges and use of nanoparticles as a combinatorial approach for enhanced vaccine immunogenicity

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