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Rapid separation type soluble microneedle and preparation method thereof

A soluble and separable technology, used in microneedles, medical preparations with inactive ingredients, needles, etc., can solve the problems of prolonging the dissolution rate of the intermediate layer, limited amount of tissue fluid exudation, inaccurate drug dosage, etc., achieving no waste. The effect of secondary injury, efficient drug delivery efficiency, and accelerated dissolution rate

Active Publication Date: 2022-04-01
GUANGZHOU NEWORLD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, this solution still has the problem of low drug delivery efficiency of traditional soluble microneedles. Because the drug is evenly distributed in the microneedle body and the skin is elastic, it is difficult for the needle body to penetrate the skin completely, so it is distributed near the base. The drug is exposed to the skin surface, the short-term self-healing of the skin leads to the closure of the pores caused by the microneedle, and the drug that is not penetrated and the residual drug on the skin surface is lost due to external contact or cannot penetrate into the body, resulting in drug waste and the efficiency of transdermal drug delivery. Decreased, inaccurate doses of drug delivered to the body
And when used on a dry skin surface, the exudation of interstitial fluid in the skin is limited, which may prolong the dissolution rate of the middle layer

Method used

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  • Rapid separation type soluble microneedle and preparation method thereof
  • Rapid separation type soluble microneedle and preparation method thereof
  • Rapid separation type soluble microneedle and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] This embodiment provides a quick-separation soluble microneedle whose support separation layer is hyaluronic acid and sucrose, including a base layer and a needle body, wherein the needle body is composed of a needle tip drug-loaded layer and a support separation layer, and the support separation layer is located at the needle tip Between the drug-loaded layer and the base layer, it is used to connect the needle tip drug-loaded layer and the base layer. The schematic diagram of the structure is as follows figure 1 shown. In this embodiment, the total length of the needle body is 1000 μm; the shape of the drug-loaded layer at the needle tip is a quadrangular pyramid with a height of 450 μm; the shape of the support separation layer is a quadrangular prism with a height of 550 μm; the lengths of the bottom edges are both 250 μm.

[0052] The preparation method comprises the following steps:

[0053] 1) Preparation of needle tip drug-loaded layer solution

[0054] Weigh ...

Embodiment 2

[0064] This embodiment provides a quick-separation soluble microneedle whose supporting separation layer is polyvinylpyrrolidine K17PF and sucrose and a preparation method thereof.

[0065] The microneedle includes a base layer and a needle body, wherein the needle body is composed of a needle point drug-loaded layer and a support separation layer, and the support separation layer is located between the needle point drug-loaded layer and the base layer, and is used for connecting the needle point drug-loaded layer and the base layer. In this embodiment, the total length of the needle body is 1050 μm; the shape of the drug-loaded layer at the needle tip is a square pyramid with a height of 450 μm; the shape of the supporting separation layer is a square prism with a height of 600 μm; the lengths of the bottom edges are all 300 μm.

[0066] The preparation method comprises the following steps:

[0067] 1) Preparation of needle tip drug-loaded layer solution

[0068] Polyvinyl a...

Embodiment 3

[0094] For the soluble microneedles prepared in Example 1 and Comparative Example 1, the separation test of the drug-loaded layer at the needle tip and the base layer was carried out. The specific method is as follows:

[0095]Take an appropriate amount of gelatin and add it to ultrapure water to fully swell for 30 minutes, then transfer it to a 65°C water bath, heat and stir until it is completely dissolved so that its mass fraction is 20%. Pour the dissolved gelatin solution into a petri dish of a suitable size while it is hot, so that the height of the gelatin solution in the petri dish is about 1 cm. When the temperature of the gelatin solution drops to room temperature, a gel with a certain hardness and immobile is formed to start the separation of the microneedle patch. sex test. Cut the gelatin gel into an appropriate size and place it under a microscope, press the microneedles cut into a single row onto the surface of the gelatin gel, observe and record the dissolution...

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Abstract

The invention provides a quick-separation soluble microneedle and a preparation method thereof. The quick-release dissolvable microneedle includes a needle body and a base layer, the needle body includes a support separation layer and a drug-loaded layer on a needle point, and the support separation layer is connected to the base layer. The needle-tip drug-loading layer is made of polymer excipient materials, the supporting separation layer is made of high molecular polymers with polar groups and small molecular sugars, and the base layer is made of high molecular polymer materials. Prepared. By controlling the type, ratio and solid content of the hydrophilic polymer composite supporting the separation layer, adjusting the height and dissolution rate of the support separation layer, the drug-loaded layer at the needle tip can be completely embedded in the skin and can be quickly separated from the substrate. It solves the problems that traditional soluble microneedles cannot completely penetrate into the body and needs to be worn for a long time, resulting in low drug delivery efficiency and skin irritation, and improves the drug delivery efficiency and safety of the microneedle drug delivery system.

Description

technical field [0001] The invention belongs to the field of novel biomedical preparations, in particular to a quick-separation soluble microneedle and a preparation method thereof. Background technique [0002] The transdermal preparation is a preparation that absorbs the drug through the skin and exerts its effect. The drug exerts its effect on the skin locally or in the whole body, avoiding the side effects of the gastrointestinal tract that can be administered orally and the pain of injection. However, due to the obstruction of the stratum corneum of the skin, only a small part of small-molecule drugs can effectively enter the body circulation through the skin to produce curative effects, and most drugs, especially macromolecular drugs, are difficult to pass through the stratum corneum of the skin in a fast and sufficient amount in a passive manner. As the most promising development direction of transdermal drug delivery, microneedle transdermal drug delivery combines th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K47/26A61K47/32A61K47/36A61M37/00
CPCA61K47/26A61K47/32A61K47/36A61M37/0015A61K9/0021A61M2037/0053
Inventor 吴传斌侯嫒琳权桂兰杨蓓蓓潘昕
Owner GUANGZHOU NEWORLD PHARMA CO LTD
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