Impact-Insertion Applicator Improves Reliability of Skin Penetration by Solid Microneedle Arrays

Maaden, Koen van der; Şekerdağ, Emine; Jiskoot, Wim; Bouwstra, Joke A.

doi:10.1208/s12248-014-9606-7

Cited by 56 publications

(40 citation statements)

References 18 publications

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“…Compared to failure forces measured in prior studies of microneedles, this yield point is comparable to some and significantly lower than others, although direct comparison is difficult because microneedle mechanical strength depends on microneedle geometry, composition and other factors. 30,33,34,36,39,49 From a practical standpoint, however, microneedles only need to be strong enough to perform their function of penetrating skin, which the microneedles in this study were able to do.…”

Section: Mechanical Characterization Of Microneedlesmentioning

confidence: 94%

“…12,29 Insertion of shorter microneedles can be performed at a high velocity that allows skin penetration to occur on a timescale faster than the mechanical relaxation time of the skin. [30][31][32] Failure of microneedles due to the compressive forces present during insertion into skin has been studied experimentally and modeled. [33][34][35][36][37][38] These studies show that microneedles can be designed to insert into skin at forces substantially lower than those associated with microneedle fracture.…”

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confidence: 99%

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Hepatitis B vaccination using a dissolvable microneedle patch is immunogenic in mice and rhesus macaques

Kodani

Choi

et al. 2018

Bioengineering & Transla Med

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Chronic Hepatitis B virus infection remains a major global public health problem, accounting for about 887,000 deaths in 2015. Perinatal and early childhood infections are strongly associated with developing chronic hepatitis B. Adding a birth dose of the hepatitis B vaccine (HepB BD) to routine childhood vaccination can prevent over 85% of these infections. However, HepB BD coverage remains low in many global regions, with shortages of birth attendants trained to vaccinate and limited HepB BD supply at birth. To address the challenges, we developed coated metal microneedle patches (cMNPs) and dissolvable microneedle patches (dMNPs) that deliver adjuvant‐free hepatitis B vaccine to the skin in a simple‐to‐administer manner. The dMNP contains micron‐scale, solid needles encapsulating vaccine antigen and dissolve in the skin, generating no sharps waste. We delivered HepB BD via cMNP to BALB/c mice and via dMNP to both mice and rhesus macaques. Both cMNP and dMNP were immunogenic, generating hepatitis B surface antibody levels similar to human seroprotection. Biomechanical analysis showed that at high forces the microneedles failed mechanically by yielding but microneedles partially blunted by axial compression were still able to penetrate skin. Overall, this study indicates that with further development, dMNPs could offer a method of vaccination to increase HepB BD access and reduce needle waste in developing countries.

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Section: Mechanical Characterization Of Microneedlesmentioning

confidence: 94%

mentioning

confidence: 99%

Hepatitis B vaccination using a dissolvable microneedle patch is immunogenic in mice and rhesus macaques

Kodani

Choi

et al. 2018

Bioengineering & Transla Med

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show abstract

“…Aqueous formulations are primarily taken up by Langerhans cells in the superficial layers of the mucosal epithelium, while alternative DC populations that may be more immunogenic like interstitial DCs and plasmacytoid DCs reside deeper in the tissue at the mucosa/submucosa interface or in the submucosa (Figure ) . In studies of dermal vaccination, significantly different serum IgG titers have been generated from microneedle arrays with different needle geometry and interneedle spacing that deliver agents at different depths in the skin . Given these promising results in dermal tissue, there is a strong rationale to evaluate the effect of microneedle design parameters such as shape, dimension, and interneedle spacing on penetration of different oral mucosal tissues and the resulting immune responses.…”

Section: Microneedles Have Broad Capabilities That Could Improve Oralmentioning

confidence: 99%

Microneedle‐Mediated Vaccine Delivery to the Oral Mucosa

Creighton

Woodrow

2018

Adv Healthcare Materials

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The oral mucosa is a minimally invasive and immunologically rich site that is underutilized for vaccination due to physiological and immunological barriers. To develop effective oral mucosal vaccines, key questions regarding vaccine residence time, uptake, adjuvant formulation, dose, and delivery location must be answered. However, currently available dosage forms are insufficient to address all these questions. An ideal oral mucosal vaccine delivery system would improve both residence time and epithelial permeation while enabling efficient delivery of physicochemically diverse vaccine formulations. Microneedles have demonstrated these capabilities for dermal vaccine delivery. Additionally, microneedles enable precise control over delivery properties like depth, uniformity, and dosing, making them an ideal tool to study oral mucosal vaccination. Select studies have demonstrated the feasibility of microneedle‐mediated oral mucosal vaccination, but they have only begun to explore the broad functionality of microneedles. This review describes the physiological and immunological challenges related to oral mucosal vaccine delivery and provides specific examples of how microneedles can be used to address these challenges. It summarizes and compares the few existing oral mucosal microneedle vaccine studies and offers a perspective for the future of the field.

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“…The earliest reports indicated that volunteers were able to reliably insert relatively longer MNs (> 550 µm) by hand, while shorter ones (≈ 300 µm) required the use of a spring‐loaded applicator . Further studies have appeared to confirm that while manual pressure is sufficient to insert most MNs, better reproducibility is achieved using applicators . Despite their reliability, the inclusion of an applicator device with each MN array could greatly increase the cost of commercial translation.…”

Section: Translational Considerationsmentioning

confidence: 99%

“…[124,125] Further studies have appeared to confirm that while manual pressure is sufficient to insert most MNs, better reproducibility is achieved using applicators. [126,127] Despite their reliability, the inclusion of an applicator device with each MN array could greatly increase the cost of commercial translation. To overcome this issue, novel methods have been explored for improving the reproducibility of the manual insertion of MNs, notably through the inclusion of a pressure-sensitive film on the back of each MN array.…”

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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Impact-Insertion Applicator Improves Reliability of Skin Penetration by Solid Microneedle Arrays

Cited by 56 publications

References 18 publications

Hepatitis B vaccination using a dissolvable microneedle patch is immunogenic in mice and rhesus macaques

Hepatitis B vaccination using a dissolvable microneedle patch is immunogenic in mice and rhesus macaques

Microneedle‐Mediated Vaccine Delivery to the Oral Mucosa

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

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