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Microneedle preparation and method for producing the microneedle preparation

A technology of microneedle preparation and manufacturing method, which can be applied to microneedles, needles, pharmaceutical formulations, etc., can solve the problems of reduced transdermal absorption, insufficient needle formation, easy bending and lifting, etc. Excellent compliance effect

Active Publication Date: 2016-10-05
LION CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, even in this method, when the microneedle preparation is taken out from the mold, the tips of the needles may be chipped and the formation of the needles may be insufficient.
[0008] In addition, the base material containing hyaluronic acid is easy to bend and warp after drying
Once the base material is bent, it is difficult to penetrate the skin completely by the needle, and the transdermal absorbability decreases

Method used

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  • Microneedle preparation and method for producing the microneedle preparation
  • Microneedle preparation and method for producing the microneedle preparation
  • Microneedle preparation and method for producing the microneedle preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment A1～A9

[0250] [Examples A1-A9, Comparative Examples A1-A6]

[0251] As a mold for producing microneedle preparations, a conical container with a bottom diameter of 0.5 mm and a height of 0.65 mm is used as a container in a shape complementary to a needle with a tip angle of 33 degrees, and a total of 10 containers in the horizontal and vertical directions are formed at intervals of 1.0 mm. Mold for 100 containers. In addition, the tip angle of a needle whose tip is not sharp is an angle at which an extension line extending above both sides of the needle intersects in a front view. All the above-mentioned molds were made of 100% silicone resin (two-component RTV rubber KE-17: Shin-Etsu Silicone (Shin-Etsu Silicone)).

[0252] As shown in Table 2 and Table 3, a composition in which each component was uniformly dissolved or dispersed was obtained. About (A) component, 10 mass % aqueous solution was prepared and mixed. In a mold heated to 80° C., about 0.5 g of the above composition w...

Embodiment B1

[0304] As a mold for the production of microneedle preparations, a container with a bottom diameter of 0.5 mm and a height of 0.65 mm, which has a shape complementary to a conical needle with a tip diameter of 0.04 mm, is used, and 10 containers are formed at intervals of 1.0 mm in length and width, and a total of 100 containers are formed. mold for containers. The material of the above-mentioned mold, including the base material and the surface in contact with the needle, was all 100% polysiloxane (two-component RTV rubber KE-17: Shin-Etsu polysiloxane).

[0305] A liquid composition in which the components (other than water) shown in Table 4 were dissolved in water was prepared. Next, use a constant temperature bath to heat the mold to 80°C (temperature T A ), the mold was taken out from the constant temperature bath, and about 1 g of the above-mentioned liquid composition was quickly filled in the mold. The liquid composition before filling was normal temperature (25 degr...

Embodiment B2～B27

[0307] [Examples B2-B27, Comparative Examples B1-B15]

[0308] In addition to changing the composition of the liquid composition filled into the mould, the temperature T of the mould, as shown in Tables 4 to 8 A and the drying temperature T B Other than that, a microneedle preparation was produced in the same manner as in Example B1.

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Abstract

A microneedle preparation having a substrate difficult to bend and good compliance for skin curve surfaces, and allowing easy needle puncturing into skin, and a method of preparing the microneedle preparation capable of stably forming needles are provided. The microneedle preparation (11) provided with the substrate (112) and a plurality of needles (114) protruding from one side surface of the substrate (112), and comprising an (A) component and a (B) component is provided, wherein the (A) component is more than one selected from a group consisting of hyaluronic acid and hyaluronates, the (B) component is a glycerol adhering part (110), and the mass ratio A / B of the (A) component to the (B) component is 1-5. In addition, the method of preparing the microneedle preparation by dissolving a preparation into a water soluble solvent to form a liquid composition, filling a mold the temperature TA of which meets a conditions that the TA is not less than 50 DEG C with the composition, and drying in an environment the temperature TB of which is lower than the TA to form the adhering part is also provided.

Description

technical field [0001] The invention relates to a microneedle preparation and a manufacturing method of the microneedle preparation. Background technique [0002] Microneedle preparations (also referred to as dissolving microneedle preparations) are known as preparations for administering physiologically active ingredients such as anti-inflammatory and analgesic drugs or blood flow-increasing drugs into the human body. The microneedle preparation includes a sheet-like base material on which a plurality of needles are formed on one side and a bonding portion containing a physiologically active component. When the microneedle preparation is attached to the skin, the base material and the needles dissolve, and the physiologically active ingredients contained therein are absorbed transdermally. [0003] As a microneedle preparation, for example, a microneedle preparation having a base material containing hyaluronic acid and a sticking portion having needles is exemplified (Pate...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/70A61K47/36A61K47/10A61M37/00
CPCA61K47/10A61K47/36A61M37/0015A61K9/0021A61M2037/0053A61M2037/0046
Inventor 矢野傑小嶋博臣石川聪之丸山美由纪
Owner LION CORP