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Vaccine adjuvant and microneedle preparation

A technology of microneedle preparation and vaccine adjuvant, applied in the directions of microneedle, antigen/adjuvant combination, needle, etc., can solve the problem of inability to dissolve rapidly, the strength of dissolving microneedle or the adverse effects of solubility, and the inability to tolerate skin puncture. and other problems, to achieve the effect of high immune induction, high strength and high solubility

Pending Publication Date: 2020-02-21
BIOSERENTACH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no description in Patent Document 2 about the adjuvant effect of acid esters other than carboxylic acid esters.
[0009] In the case where water-insoluble, low-solubility, or insufficient stringent substances are contained in the dissolving microneedles, the strength or solubility of the dissolving microneedles may be adversely affected
For example, when the strength of the dissolving microneedle preparation decreases, it may not be able to withstand the puncture into the skin
In addition, when the solubility of the soluble microneedle preparation decreases, there is a possibility that it cannot be quickly dissolved by a small amount of body fluid present in the skin.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Hyaluronic acid (trade name "Hyaluronic Acid FCH-SU", manufactured by Kikkoman Biochemifa Co., Ltd., average molecular weight 5-110,000) 6 mg, polymer dextran (trade name "Dextran 70", manufactured by Meito Sangyo Co., Ltd. , average molecular weight 70,000) 12mg, ovalbumin (trade name "Ovalbumin", manufactured by Sigma-Aldrich, St.Louis, MO, USA) 5mg, add 150 microliters of phosphate buffer solution of pH 7.4, stir, thereby Prepare the first viscous liquid (hydrogel). The viscous liquid is coated on a female mold with 300 inverted conical pores with a depth of about 500 microns and an opening diameter of about 300 microns per square centimeter, filled into the female mold under pressure, and allowed to dry .

[0074] Chondroitin sulfate sodium (trade name "chondroitin sulfate C sodium", manufactured by Nakalai Tesque) 600 mg, dextran sulfate (trade name "dextran sodium sulfate", manufactured by Nakalai Tesque, average molecular weight 5000-6000) 2.4 2.1 mL of phospha...

Embodiment 2

[0080] Sodium chondroitin sulfate (trade name "chondroitin sulfate C sodium", manufactured by Nakalai Tesque Co.) 6 mg, dextran sulfate (trade name "dextran sodium sulfate", manufactured by Nakalai Tesque Co., Ltd., average molecular weight 5000-6000) 24 mg 5 mg of ovalbumin (trade name "Ovalbumin", manufactured by Sigma-Aldrich, St. Louis, MO, USA) and 200 microliters of phosphate buffer solution at pH 7.4 were added to the mixture and stirred to prepare the first viscous solution . The viscous liquid is coated on a female mold having 300 inverted conical pores with a depth of about 500 microns and an opening diameter of about 300 microns per square centimeter, filled into the female mold under pressure, and allowed to dry .

[0081] Chondroitin sulfate sodium (trade name "chondroitin sulfate C sodium", manufactured by Nakalai Tesque Co., Ltd.) 600 mg, polymer dextran (trade name "dextran 70", manufactured by Mingsu Sangyo Co., Ltd., average molecular weight 70,000) 1.2 2.1...

Embodiment 3

[0085] The effectiveness of the transdermal vaccine was evaluated using Wistar male rats with a body weight of about 230 g. The preparations of Example 1 and Comparative Example 1 were applied by puncturing each chip on the shaved rat skin. The administration was set as two times of Day0 (Day 0) and Day14, and the blood collection was set as Day14 and Day28. Using the obtained blood sample, the total antibody titer Ig (G+A+M) was measured.

[0086] Regarding the total antibody titer Ig (G+A+M) after 14 days from the initial administration of the preparation, it was 15.1±2.6×10 in the preparation of Example 1 4 U / mL, in the preparation of Comparative Example 1, it was 3.1±0.7×10 4 U / mL.

[0087]Regarding the total antibody titer Ig (G+A+M) after 28 days from the initial administration of the preparation, it was 310.2±47.3×10 in the preparation of Example 1. 4 U / mL, in the preparation of Comparative Example 1, it was 143.3±35.7×10 4 U / mL.

[0088] In the dissolvable micron...

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Abstract

The present invention addresses the problem of providing a novel vaccine adjuvant. To solve this problem, provided is a vaccine adjuvant comprising dextran sulfate or a derivative thereof.

Description

technical field [0001] The invention relates to a transdermal vaccine and a vaccine adjuvant. Background technique [0002] The world's major vaccine companies use intradermal syringes filled with hollow metal microneedles for influenza vaccine development. However, development will definitely not proceed smoothly due to high back pressure during injection or limited amount of drug solution that can be injected into the skin. [0003] As a transdermal vaccine instead of an intradermal syringe, there is a microneedle preparation. Patent Document 1 describes a dissolving three-layer microneedle preparation for epidermal delivery of vaccine antigens. The dissolving three-layer microneedle preparation of Patent Document 1 is a transdermal vaccine formed by kneading vaccine antigens with the base using a stringy and water-soluble polymer as the base. [0004] The stringiness refers to the property that when a polymer substance is dissolved in a small amount of water, it become...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/39A61K9/00A61K39/00A61K47/36A61M37/00
CPCA61K39/39A61K47/36A61K9/0021A61M2037/0046A61M37/0015A61K2039/55555A61K2039/555A61K2039/55583A61K2039/575A61K9/0019
Inventor 高田宽治
Owner BIOSERENTACH
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