Preparation method and application of HA material for HA soluble microneedle

A soluble, microneedle technology, applied in the directions of microneedles, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. Needs, the hardness of the soluble drug-loaded microneedle tip is not up to standard, and the drying cycle of the finished product is long, so as to achieve the effects of increasing the drug-loading capacity and formability, high drug-loading capacity and drug delivery efficiency, and shortening the drying time.

Pending Publication Date: 2022-02-01
浙江摩达生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, at present, domestic HA microneedles are mostly prepared by centrifugal injection molding, natural sedimentation or vacuum casting. Pure HA is used as a microneedle forming material, and its microneedle formability, hardness, and solubility cannot meet the requirements for production or medicinal use. Therefore, pure HA materials can no longer meet the needs of production and technology development, and further material mixing or physical and chemical modification are required to meet the requirements of production technology research and development applications
Moreover, the preparation of soluble drug-loaded microneedles with HA materials has technical problems such as substandard hardness, low drug loading, and long drying cycle for finished products.

Method used

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  • Preparation method and application of HA material for HA soluble microneedle
  • Preparation method and application of HA material for HA soluble microneedle
  • Preparation method and application of HA material for HA soluble microneedle

Examples

Experimental program
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Effect test

Embodiment 1

[0037] like figure 1 As shown, the HA material preparation method for HA soluble microneedles comprises the following steps:

[0038] S100, set the molecular weight to 10 3 kDa HA mixed with 2-hydroxymethyl-β-cyclodextrin, and stirred in purified water until dissolved; wherein, the mass ratio of HA to 2-hydroxymethyl-β-cyclodextrin is 1 to 100:1 ~100.

[0039] In fact, in this step, in order to improve the poor formability and weak drug loading capacity of pure HA materials, the molecular weight of 10 3 kDa HA and 2-hydroxymethyl-β-cyclodextrin (2-HP-β-CD) were mixed at a mass ratio of 1:5, and stirred in 10 mL of purified water until dissolved, since HA and 2-HP-β -CD is mixed and dissolved in a certain proportion, so that the hydroxyl group of HA in the system and the carboxyl group of cyclodextrin form a relatively stable and firm hydrogen bond, which greatly increases the stability, hardness and toughness of HA, and after the hydrogen bond is formed between the carboxyl...

Embodiment 2

[0048] like figure 2 As shown, in this example, the tip polymer gel and the backing polymer gel obtained in Example 1 are used to prepare a complete blank microneedle patch, including the following steps:

[0049] S000. Slowly insert the male mold of the microneedle into a six-hole plate filled with dimethylsiloxane (PDMS) that has been left to remove air bubbles, and vacuumize for 3 hours to completely remove the tiny air bubbles visible to the naked eye. The plate was dried in a blast drying oven at 70°C for 2 hours, and after cooling to room temperature, the male microneedle mold was removed to obtain the negative microneedle mold;

[0050] The number of microneedle male mold arrays in this step is 15×15 conical metal microneedles (the base diameter of a single needle is 130 μm, the tip diameter is 12 μm, and the needle length is 800 μm), the purpose is to increase the number of microneedle arrays per unit area , and this microneedle male mold can be used precisely becaus...

Embodiment 3

[0055] like image 3 As shown, the preparation of drug-loaded microneedles based on Example 1 and Example 2, that is, the preparation of a complete drug-containing microneedle patch, includes the following steps:

[0056] S000. Slowly insert the male mold of the microneedle into a six-hole plate filled with dimethylsiloxane (PDMS) that has been left to remove air bubbles, and vacuumize for 3 hours to completely remove the tiny air bubbles visible to the naked eye. The plate was dried in a blast drying oven at 70°C for 2 hours, and after cooling to room temperature, the male microneedle mold was removed to obtain the negative microneedle mold;

[0057] S100, using the HA material preparation method for HA soluble microneedles in Example 1 to prepare backing polymer gel and white powder;

[0058] S201. Take the remaining part of the white powder in step S100, mix the indocyanine green model drug with the white powder at a ratio of 2:1 v / w, add purified water to prepare a 15% m / ...

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Abstract

The invention relates to a preparation method and application of an HA material for an HA soluble microneedle. The scheme comprises the steps of uniformly mixing HA with the molecular weight of 103kDa and 2-hydroxymethyl-beta-cyclodextrin, and stirring in purified water until the HA is dissolved; freeze-drying a mixed solution obtained by dissolving, and collecting dried white powder; adding purified water into the white powder to prepare high-concentration polymer preparation gel; placing the high-concentration polymer preparation gel on a four-dimensional rotating instrument, rotating and uniformly mixing until needle point polymer gel is obtained; and taking HA with the molecular weight of 2 * 10 < 2 > kDa, adding water to prepare low-concentration polymer preparation gel, and taking the low-concentration polymer preparation gel as backing polymer gel, wherein the concentration of the low-concentration polymer is lower than that of the high-concentration polymer preparation gel. The invention also provides the microneedle patch prepared by using the method. The mechanical strength of the microneedle can be remarkably improved, the microneedle can adapt to various molds, and high drug loading capacity and drug delivery efficiency can be achieved for lipophilic and hydrophilic drugs.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of HA material used for HA soluble microneedles and its application. Background technique [0002] Microneedle is a new type of transdermal drug delivery method developed in the past 30 years, which is safe, efficient and painless. Microneedles pierce the stratum corneum, the largest barrier for transdermal drug penetration in a minimally invasive way, creating short-term reversible micropores, which allow drugs to penetrate the skin through the micropores and enter the human body to achieve therapeutic effects. The length of the microneedle and the size of the array can be designed according to the site of action and drug loading. Typically, microneedles are transdermal drug delivery devices with a length ranging within 2 mm that enable painless, minimally invasive, highly effective drug delivery and slow disease treatment over time. Si...

Claims

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Application Information

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IPC IPC(8): A61M37/00A61K9/00A61K31/404A61K47/36A61K47/40
CPCA61M37/0015A61K31/404A61K9/0021A61K47/36A61K47/40A61M2037/0053A61M2037/0046
Inventor 高颖纪旭刚
Owner 浙江摩达生物科技有限公司
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