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KMID : 1142220210160020173
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Regulatory Research on Food, Drug & Cosmetic
2021 Volume.16 No. 2 p.173 ~ p.179
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Study on Development of Performance Evaluation Test Method for Microneedle of Microneedle Combination Product
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Hwang Chul-Jin
Park Chang-Hee
Kim Hee-Jin
Park Ok-Nam
Kim Mi-Ran
Lee Sang-Rea
Kim Su-Dong
Kim Joo-Hee
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Abstract
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The transdermal drug delivery system is emerging as a new drug delivery system that can effectively deliver drugs to patients in a painless method, which is a disadvantage of the existing subcutaneous injection administration method. Among the transdermal drug delivery systems, the microneedle combination product combined with pharmaceuticals prevents pain by creating a passage only in the stratum corneum, avoiding nerve endings due to the fine length of the needle and it has the advantage of effectively delivering the main ingredient of drug through the skin. As the market demand for microneedle combination product increases, many studies are being conducted at domestic and foreign and companies are also actively developing products. In the microneedle combination product, various factors (type of raw material, thickness, diameter, spacing between needles, needle height, needle strength, durability, etc.) of the microneedle can affect the performance of the microneedle that helps the drug absorption, therefore it is necessary to prepare a test method to evaluate the essential performance for the purpose of use of the microneedle to be developed. Since it is required to set performance evaluation test items considering the form, method of use, application period, raw materials, etc. of the product so that the manufacturer's intended purpose of use can be achieved, this study sought to derive an appropriate performance evaluation test method. It is expected to be used for product development approval and review, quality control, and performance evaluation by preparing an analytical performance evaluation information collection for the microneedle combination product developed through this study.
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KEYWORD
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Combination product, Microneedling, Performance Evaluation, Quality Standard, Test Item
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