In Vivo Reflectance Confocal Microscopy Evaluation of Microneedle Patch Penetration Depth

November 2023 | Volume 22 | Issue 11 | 1107 | Copyright © November 2023


Published online October 21, 2023

doi:10.36849/JDD.6994

Samantha Fong BAa,b, Emaan Mahmood BAb,c, Bianca Sanabria MAa,b, Samantha Ouellette MDa,b, Babar K. Rao MDa,b,d

aRutgers Robert Wood Johnson Medical School, Piscataway, NJ
bRao Dermatology, Atlantic Highlands, NJ
cUniversity of Louisville School of Medicine, Louisville, KY
dWeill Cornell Medical College, New York, NY

Abstract
Background: Firstly, confirm penetration of the skin's most exclusive layer, the stratum corneum (SC), by commercially available microneedle patches using reflectance confocal microscopy (RCM). Secondly, determine the deepest layer of the skin penetrated by the microneedle patches.
Materials and Methods: In this proof-of-concept study, 3 commercially available dissolving microneedle patches with different active ingredients were included in this study. RCM images of the cheek were taken prior to patch application at 4 different layers of the skin: stratum corneum, stratum spinosum-granulosum, dermal-epidermal junction, and papillary dermis. Patches were then applied to the cheeks of participants according to manufacturer guidelines. Immediately after removal, the same area and layers were imaged using RCM and assessed for features of penetration.
Results: Micropores were visualized in RCM images of skin layers post-application of all patches when compared with imaging before application. Characteristics of penetration included uniformly sized, shaped, and spaced well-defined circular areas, which are the created micropores. All 3 patches penetrated the SC to the level of the papillary dermis.
Conclusion: This study confirms that the dissolving microneedle patches penetrate the most exclusive layer of the skin, the SC, down to the level of the papillary dermis as visualized through RCM. Confirming penetration with RCM shows the potential of these patches to be used for medication transmission. While future studies are needed to assess the efficacy of microneedle patches applied for their advertised skin conditions, confirming the penetration of the microneedle technology through RCM is a significant first step in this process.

J Drugs Dermatol. 2023;22(11):1107-1110     doi:10.36849/JDD.6994

INTRODUCTION

Skin is a promising route for drug delivery as it is direct and noninvasive, and avoids the limitations of absorption through the gastrointestinal system.1 Absorption of medication applied to the skin is known as transdermal drug delivery (TDD). However, TDD is limited due to the skin’s barrier-like properties; the most superficial layer of the epidermis, the stratum corneum (SC), greatly limits drug absorption. Drugs with high molecular weights (MW) and multiple hydrogen bonding groups, amongst other factors, have difficulty penetrating this layer.2 

However, the layers of the skin below the SC carry out most drug-related actions, including drug binding, metabolism, and transport.3 Thus, methods of improving penetration of the skin are commonly studied. One method that continues to be used today is injection via a hypodermic needle. It can deliver drugs deeper and more directly into the skin, including drugs with a wider range in MW and structure. However, this method is limited by the need for training, proper needle disposal, and variable patient compliance due to pain and the fear of needles.4 Due to the effectiveness of the hypodermic needle, efforts to identify a new TDD method that conserved the general structure but reduced the size to minimize pain led to the development of microneedles.

Microneedles (MN) have been found to successfully deliver a wide range of drugs painlessly. They create micropores which act as channels for drugs housed in or coated on the needles and can penetrate areas rich in blood and lymph vessels.5 There are 5 classifications of microneedles: solid, hollow, coated, dissolving, and hydrogel-forming, each having its own advantages and disadvantages. This has led to ongoing research