Ann Dermatol.  2013 Feb;25(1):46-53. 10.5021/ad.2013.25.1.46.

Safety Evaluation of Stamp Type Digital Microneedle Devices in Hairless Mice

• Park KY
• Jang WS
• Lim YY
• Ahn JH
• Lee SJ
• Kim CW
• Kim SE
• Kim BJ
• Kim MN

• KMID: 2265970
• DOI: http://doi.org/10.5021/ad.2013.25.1.46

Abstract

BACKGROUND
Microneedles provide a minimally invasive means to transport molecules into the skin. A number of specific strategies have been employed to use microneedles for transdermal delivery.
OBJECTIVE
The purpose of this study was to investigate the safety of two new digital microneedle devices (Digital Hand(R) and Digital Pro(R); Bomtech Electronics Co., Ltd., Seoul, Korea) for the perforation of skin in skin-hairless-1 mice. This device replaces conventional needles and is designed specifically for intradermal delivery.
METHODS
We used two newly developed digital microneedle devices to perforate the skin of skin-hairless-1 mice. We conducted a comparative study of the two digital microneedle devices and DTS(R) (Disk type-microneedle Therapy System; DTS lab., Seoul, Korea). To evaluate skin stability, we performed visual and dermatoscopic inspections, measurements of transepidermal water loss, and biopsies.
RESULTS
The two novel digital microneedle devices did not induce significant abnormalities of the skin on visual or dermatoscopic inspection, regardless of needle size (0.25~2.0 mm). No significant histopathological changes, such as inflammatory cell infiltration, desquamation of the stratum corneum, or disruption of the basal layer, were observed. The digital microneedle devices and microneedle therapy system produced similar results on measures of skin stability.
CONCLUSION
These two novel digital microneedle devices are safe transdermal drug delivery systems.

Keyword

Digital; Mesotherapy; Safety; Water loss

MeSH Terms

Animals
Drug Delivery Systems
Electronics
Electrons
Mesotherapy
Mice
Mice, Hairless
Needles
Pyridines
Skin
Thiazoles
Water Loss, Insensible
Pyridines
Thiazoles
Water Loss, Insensible

Figure

• 

  Fig. 1 Pictures of Digital Hand® and Digital Pro® (motorized microneedle devices, Bomtech Electronics Co.) showing (A) Digital Hand®; (B) Digital Pro®; and (C) a magnified picture of the microneedle portion of Digital Hand® and Digital Pro®. Therefore, when a doctor places them in contact with the patient's skin, the microneedles are automatically inserted into the skin.

• 

  Fig. 2 Number of needlings per unit area (2×2 cm) using paper clay: (A) 12 pores at a time for Digital Hand® and Digital Pro® (Bomtech Electronics Co.) versus (B) 135 pores per rolling of DTS® (Disk type-microneedle Therapy System; DTS lab.).

• 

  Fig. 3 Comparison of novel 1.5 mm digital microneedle devices (Digital Hand® and Digital Pro®, Bomtech Electronics Co., Ltd.) and 1.5 mm DTS® (DTS Lab.) using (A) dermatoscopic inspection, (B) histopathological examination, and (C) transepidermal water loss (TEWL) measurements.

• 

  Fig. 4 Comparison of different needle sizes (no application, 0.25 mm, 0.5 mm, 1.0 mm, 1.5 mm, or 2.0 mm) using (A) dermatoscopic inspection, (B) biopsy for Digital Hand® (Bomtech Electronics Co., Ltd.), and (C) transepidermal water loss (TEWL).

• 

  Fig. 5 Comparison of different needle sizes (no application, 0.25 mm, 0.5 mm, 1.0 mm, 1.5 mm, or 2.0 mm) using (A) dermatoscopic inspection, (B) biopsy for Digital Pro® (Bomtech Electronics Co., Ltd.), and (C) transepidermal water loss (TEWL).

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