Microneedle Array for Intradermal Hepatitis Vaccine Delivery

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Solution Overview

Problem

The natural impermeability of the stratum corneum skin layer poses a barrier for intradermal application of hepatitis vaccines, making it difficult for pharmaceutical agents to penetrate effectively, which is a challenge for achieving successful immunization against hepatitis B.

Innovation Solution

A microneedle array formulation comprising polyvinylpyrrolidone (PVP) and HBsAg is used to facilitate intradermal application, where the microneedles penetrate the skin, allowing for the delivery of the hepatitis vaccine directly into the dermis, potentially eliminating the need for adjuvants and ensuring effective antibody generation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional injection methods are used for hepatitis vaccination, then effective immunization can be achieved, but the application process is invasive and requires trained personnel

Engineering Contradiction:
Improveease of vaccination applicationVSAvoidcomplexity of vaccination system
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The vaccine formulation is segmented into multiple microneedle arrays, each containing multiple microneedles that can be applied simultaneously to the skin. This segmentation allows the complex vaccination process to be divided into simple, repeatable applications that are easier to administer while maintaining effectiveness

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Polyvinylpyrrolidone (PVP) serves as an intermediary substance that enables the HBsAg vaccine antigen to be delivered through microneedles. The PVP forms a matrix that holds the antigen and facilitates its release into the dermis upon skin penetration, bridging the gap between the solid microneedle structure and the liquid vaccine delivery requirement

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of manufacture

If the stratum corneum barrier is intact, then skin protection is maintained, but intradermal delivery of vaccine antigens is prevented

Engineering Contradiction:
Improveease of intradermal vaccine deliveryVSAvoidskin barrier impermeability
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The microneedle array provides localized penetration through the stratum corneum at specific points, creating temporary channels for vaccine delivery. The local quality of the skin barrier is altered only at the microneedle contact points, allowing intradermal delivery without compromising the overall integrity and protective function of the skin barrier

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The microneedles physically alter the parameter of skin permeability by creating micro-channels through the stratum corneum. This temporary parameter change allows vaccine antigens to pass through the normally impermeable barrier and reach the dermis, after which the channels close and the barrier function is restored

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS12168053B2Microneedle system for applying a hepatitis vaccine
Publication Date: 2024.12.17 LTS LOHMANN THERAPIE SYST AG
  • US12168053B2 patent drawing

AI summary

The present invention relates to a microneedle system (MNS for short) for the intradermal application of a hepatitis vaccine, namely the antigen HBsAg.