Dissolving Microneedle Patch

Dissolving microneedle patch is a substrate of polymers that dissolve in vivo blended with active ingredients and molded into the shape of fine needles. The patch form can be placed directly on the skin.

About Dissolving Microneedle

Dissolving microneedles are drawing attention as a next-generation transdermal drug delivery system (DDS), or approach for the controlled distribution of a drug in the body.

Polymers that dissolve in vivo, or a substrate made of such polymers and with active ingredients blended, are molded into the shape of fine needles measuring several tens to hundreds of micrometers in length.
These needles are then processed into a patch to produce a transdermal dosage form. When the patch is placed on the skin, the needles penetrate through the skin’s barrier function and dissolve directly inside the skin, delivering the active ingredients far more efficiently than simple topical application.
The diameter (thickness) of the needle tip is one-tenth or less than the outer diameter of an intradermal injection needle, causing virtually no pain when placed on the skin and making the patch a minimally invasive DDS.

Microneedles in the process of dissolving

Application of Microneedles to Skin Care Cosmetic

Usage examples

At Nissha we engage in product development taking advantage of our core technologies of printing, coating, laminating, molding, and patterning. Using high-precision molding and laminating technologies, we expanded the application of dissolving microneedles to a skin care cosmetic. Needles molded from a substrate of high polymer hyaluronic acid enable delivery of the ingredient directly and efficiently into the skin in a way not possible by liquid application. The product is designed to give the skin moisture and resilience, and improve wrinkles from the inside.
Various skin care effects may be added by blending beauty ingredients into the high polymer hyaluronic acid substrate.

Conceptual illustration of penetration inside the skin

                Conceptual illustration of penetration inside the skin


Anti-wrinkle effects of standard-substrate microneedle patch
(Source: Human efficacy evaluation, February–March 2017)

Production Technology

Nissha’s microneedles are manufactured using our proprietary high-precision molding process.

Features of high-precision molded microneedles
• Optimal needle shapes by compliances with regional regulations
• Strong needles resistant to breakage prior to use
• Consistent molding quality in mass production
• High-density design of 400 or more needles per square centimeter
• Low-temperature drying process to prevent denaturation of the active ingredients

 
 

Dissolving microneedle patch

Hygiene Quality

The production factory located in the premises of Nissha Global Headquarters in Kyoto employs thorough hygiene controls.

Dissolving microneedle patch

• Cleanroom cleanliness: Class 10,000
• Major equipment cleanliness: Class 1,000
• Microbial test record
  Test specifications

Measurement target

General bacterial population (viable bacteria count)

Measured portion

Entire microneedle patch

Measurement method

Membrane filter method
SCDLP agar medium (30ºC, 3 days)

Acceptance criteria

≤50 CFU/patch
  Test record

Test results

0 CFU/patch

Target lot

Total lot of trial and mass-production products
(manufactured January 2015 – March 2018)

Inquiry

Please feel free to contact us.

Cosmetic Manufacturing License number in Japan  :26CZ200065
Quasi-Drug Manufacturing License number in Japan :26DZ200024

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