Soluble microneedle vaccine patch and preparation method thereof

A soluble, vaccine technology, applied in sheet delivery, pharmaceutical formulations, medical preparations with inactive ingredients, etc., can solve the problems of unsuitable large-scale use, impact, and the microneedle tip is not sharp enough, and achieve sustainable and efficient utilization, The effect of enhancing immune response and enhancing the effect of adjuvant

Active Publication Date: 2014-09-10
BEIJING CAS MICRONEEDLE TECH LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, among the commonly used soluble microneedle production methods, the centrifugation method is inconvenient to operate and is not suitable for large-scale use; the method of vacuum production of microneedles is inconvenient to produce microneedles that are only loaded with drugs on part of the needle tip; The gas in the micropores cannot be completely removed, resulting in the microneedle tip not being sharp enough, which affects practical application

Method used

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  • Soluble microneedle vaccine patch and preparation method thereof
  • Soluble microneedle vaccine patch and preparation method thereof
  • Soluble microneedle vaccine patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] (1) Preparation of reverse mold: relying on a master mold with 36 (6×6 rows) tetrahedral microneedle bodies with a height of about 650 microns and a bottom diameter of about 250 microns on the surface (such as figure 2 shown), take a mixture of 10 grams of pre-polymerized polydimethylsiloxane and 1 gram of crosslinking agent and cover it on the master mold, and place it at a temperature of 80 ° C for about 30 minutes to obtain a surface with the same The shape and number of microneedle needles on the master mold are suitable for the reverse mold of the required number of pinholes; the surface of the reverse mold contains 36 (6×6 rows) with a depth of about 650 microns and a diameter of the bottom end Pinholes about 250 microns square (such as image 3 shown); the cone angle of the pinhole is 35 degrees;

[0065] (2) Hollow cationic liposome nanoparticles loaded with trypan blue and CpG OND (hollow cationic liposome nanoparticles can be prepared according to the method...

Embodiment 2

[0076] (1) adopt the reverse mold of embodiment 1;

[0077] (2) The hollow cationic liposome nanoparticles loaded with trypan blue and CpG OND (adjuvant) shown in Table 4 (hollow cationic liposome nanoparticles can be prepared according to the method of Comparative Example 3, and The loading method can also be added according to the method of Comparative Example 3) into the 5% HA aqueous solution by weight to obtain three needle preparation solutions respectively, in which the hollow cationic liposomes loaded with trypan blue and CpG OND The weight percentages of the needle body preparation liquid of nanoparticles are 0.1% (the particle diameter of the hollow cationic liposome nanoparticle is 10 nanometers), 20% (the particle diameter of the hollow cationic liposome nanoparticle is 200 nanometers) ), 50% (the particle size of the hollow cationic liposome nanoparticle is 1 micron); then the obtained 3 needle preparation solutions are respectively covered on the 3 surfaces obtai...

Embodiment 3

[0098] A mixture of HBSAg and CpG OND (the weight ratio of HBSAg and CpG OND is 1:2) was substituted for HBSAg in Comparative Example 3, and the drug-loaded hollow cationic nanoparticles described in Comparative Example 3 were used to produce simultaneously loaded Hollow cationic liposome nanoparticles of HBSAg and CpG OND (Lip-HBSAg-CpG OND), the weight ratio of hollow cationic liposome nanoparticles:HBSAg:CpG OND is 5:1:2.

[0099] Add Lip-HBSAg-CpG OND to 5% HA aqueous solution by weight to obtain a needle body preparation solution, wherein the total weight percentage of Lip-HBSAg-CpG OND in the needle body preparation solution is 4% . Except that the above-mentioned needle preparation solution prepared in this example was substituted for the needle preparation solution in Comparative Example 1, the same method and backing preparation solution as in Comparative Example 1 were used to prepare a soluble microneedle vaccine patch. A dissolvable microneedle vaccine patch conta...

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Abstract

The invention belongs to a transdermal delivery soluble microneedle patch, and especially relates to a soluble microneedle vaccine patch and a preparation method thereof. The soluble microneedle vaccine patch is composed of a soluble microneedle substrate containing no target drug, and a soluble microneedle body containing the target drug; the target drug of a vaccine and the adjuvant suitable for the vaccine is loaded at the front end of the soluble microneedle body, the vaccine and the adjuvant suitable for the vaccine are loaded on nanoparticles, and the nanoparticles are uniformly distributed at the front end of the soluble microneedle body; and the matrix material of the soluble microneedle vaccine patch is a biocompatible water-soluble polymer material. The soluble microneedle body of the soluble microneedle vaccine patch suitable for vaccine transcutaneous immunization has enough hardness and can effectively penetrate the stratum corneum of skin surface, and the front end of the needle body entering the skin can realize fast dissolving and release of the target drug stored in the front end of the needle body.

Description

technical field [0001] The invention belongs to a soluble microneedle vaccine patch for transdermal administration, in particular to a soluble microneedle vaccine patch suitable for transdermal administration of vaccines made of a biocompatible water-soluble polymer material and its preparation method. Background technique [0002] At present, most clinical therapeutic drugs and vaccines are administered by injection. Although injection has the advantages of rapidity, low cost and being applicable to various types of drugs, it must be operated by skilled nurses and is not suitable for self-administration by patients. At the same time, injection methods also have the risk of various infectious diseases caused by repeated use of needles. Transdermal drug delivery overcomes the above-mentioned shortcomings and has attracted more and more attention because of its fast and simple drug delivery method. [0003] For vaccines, the skin contains a large number of professional anti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K47/32A61K47/36A61K47/34A61K39/39A61K39/29A61K39/09A61K39/12A61P31/00A61P31/20A61P31/04A61P31/14A61J3/00
CPCY02A50/30
Inventor 高云华郭雷
Owner BEIJING CAS MICRONEEDLE TECH LTD
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