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Soluble microneedle patch and preparation method thereof

A soluble and microneedle patch technology, applied in the field of medicine, can solve the problems of affecting the treatment effect of soluble microneedles, hindering the speed and degree of drugs, and low drug concentration, so as to improve bioavailability, good bioavailability, increase release and The effect of penetration rate

Pending Publication Date: 2022-04-12
GUANGZHOU NEWORLD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although the use of soluble microneedles breaks through the barrier of the stratum corneum of the skin, the macromolecular drug has a strong binding force with the subcutaneous tissue. At the same time, the large molecular weight of the macromolecular drug also hinders the speed and degree of the drug entering the blood circulation, eventually leading to the actual entry into the blood. Less drug concentration circulates, compromising therapeutic efficacy of soluble microneedle transdermal delivery

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0103] Embodiment 1 A kind of dissolvable microneedle patch

[0104] The drug of this dissolvable microneedle patch is exenatide, the polymer skeleton material in the needle tip is selected from hyaluronic acid, the penetration enhancer is sodium deoxycholate, arginine or HS-15, and the stabilizer is selected from Trehalose. The mass ratio of exenatide, hyaluronic acid, penetration enhancer, and trehalose is 1:5:3:1, and the total amount of exenatide, hyaluronic acid, penetration enhancer, and trehalose is 100%. The polymer skeleton material in the substrate is selected from PVP K90.

[0105] Tartaric acid was used as a penetration enhancer to prepare a dissolvable microneedle patch with other components as above.

Embodiment 2

[0106] Embodiment 2 A kind of dissolvable microneedle patch

[0107] The drug of the soluble microneedle patch is liraglutide, the polymer skeleton material in the needle tip is selected from dextran, the penetration enhancer is sodium deoxycholate, aspartic acid or HS-15, and the stabilizer is glucose. The mass ratio of liraglutide, dextran, penetration enhancer, and glucose is 1:4.5:4:0.5, and the total amount of liraglutide, dextran, penetration enhancer, and glucose is 100%. The polymer skeleton material in the substrate is selected from PVP K90.

[0108] Using retinoic acid as a penetration enhancer, a dissolvable microneedle patch with other ingredients as above was prepared.

Embodiment 3

[0109] Embodiment 3 A kind of dissolvable microneedle patch

[0110] The drug of this soluble microneedle patch is albiglutide, the polymer skeleton material in the needle tip is selected from hyaluronic acid, and the penetration enhancer is selected from one of sodium deoxycholate, lysine and HS-15 , the stabilizer is selected from trehalose. The mass ratio of albiglutide, hyaluronic acid, penetration enhancer and trehalose is 0.5:4:5:0.5, and the total amount of albiglutide, hyaluronic acid, penetration enhancer and trehalose is 100%. The polymer skeleton material in the substrate is selected from PVP K90.

[0111] Using citric acid as a penetration enhancer, a dissolvable microneedle patch with other components as above was prepared.

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Abstract

The invention relates to a soluble microneedle patch and a preparation method thereof. The soluble microneedle patch comprises a substrate and a needle body on the substrate, the needle body comprises the following components: a high-molecular polymer framework material, polypeptide or protein drugs, a penetration enhancer and a stabilizer; the substrate comprises the high-molecular polymer framework material; the penetration enhancer is at least one of 15-hydroxystearic acid polyethylene glycol ester, Tween 80, deoxycholate, nicotinamide and amino acid. The microneedle patch is used for delivering polypeptide or protein drugs, the intradermal release and permeation speed of the polypeptide or protein drugs is obviously improved, the concentration of the polypeptide or protein drugs entering blood circulation is obviously increased, and the in-vivo bioavailability of the polypeptide or protein drugs after being delivered and administered through the microneedle is improved.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a dissolvable microneedle patch and a preparation method thereof. Background technique [0002] At present, more and more protein and peptide drugs such as peptides, proteins, hormones, nucleic acids, vaccines and monoclonal antibodies play an important therapeutic role in clinical practice. Such substances have large molecular weight and complex spatial configuration, and are easily denatured by the influence of temperature, acid, and alkali; their activity mainly comes from their spatial structure and amino acid sequence, so the prerequisite for the drug to exert its efficacy is to ensure the stability of the structure. This type of drug has a single route of administration, and oral administration is one of the most commonly used methods for traditional chemical drug delivery. Due to the existence of the first-pass effect in the gastrointestinal tract and liver, it is very easy to degr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M37/00
CPCA61M37/00
Inventor 吴传斌陈航平李峰冯地桑杨蓓蓓赵志明
Owner GUANGZHOU NEWORLD PHARMA CO LTD
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