Dissolving Microstructure Array for Stable Vaccine Skin Delivery
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Solution Overview
Problem
Existing microneedle arrays for transdermal drug delivery face challenges in providing stable formulation and effective administration of active agents without causing discomfort or chemical instability, particularly with the formation of subcutaneous nodules due to insoluble aluminum adjuvants.
Innovation Solution
A method of manufacturing microstructure arrays involving a liquid formulation of vaccine, insoluble particulate adjuvant, and hydrophilic polymer in an aqueous buffer, followed by dispensing, pressurization, and drying in a mold, resulting in a biocompatible and water-soluble matrix that dissolves upon penetration to deliver the vaccine and adjuvant without forming nodules.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If insoluble aluminum adjuvants are used in vaccine formulation, then immune response is enhanced, but subcutaneous nodules are formed causing discomfort
Solution Approach 1:
The patent changes the physical state of the adjuvant from insoluble (aluminum salts) to soluble by using water-soluble polymers. This parameter change maintains the adjuvant's ability to enhance immune response while eliminating the harmful nodule formation associated with insoluble materials.
Solution Approach 2:
The patent converts the harmful effect of insoluble adjuvants (nodule formation) into a beneficial outcome by using water-soluble polymers that provide adjuvant activity without the harmful side effects. The soluble polymers dissolve in subcutaneous fluid, providing sustained release without nodule formation.
2Ease of operation
If microneedle arrays are made disposable to eliminate sterilization needs, then ease of operation is improved, but manufacturing cost increases
Solution Approach 1:
The patent employs disposable microneedle arrays that are inexpensive enough to be discarded after single use. This eliminates the need for sterilization and controlled storage, greatly simplifying operation and distribution, particularly in resource-limited settings.
Solution Approach 2:
The microneedle arrays use composite structures combining biodegradable polymers with vaccine formulations. This allows the arrays to be manufactured at low cost using simple processes while maintaining effectiveness, making disposable use economically viable.
3Ease of operation
If traditional liquid-based needle methods are used, then ease of administration is maintained, but chemical instability and discomfort increase
Solution Approach 1:
The patent transitions the vaccine formulation from liquid state to solid state by incorporating it into microneedle arrays. This phase transition stabilizes the formulation, eliminating chemical degradation issues associated with liquid storage while maintaining ease of administration through painless microneedle application.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The method ensures stable delivery of therapeutically effective amounts of active agents with reduced discomfort and nodule formation, enhancing immune response while maintaining formulation stability during manufacturing, storage, and administration.
Implementation Method 1
a biocompatible and water-soluble matrix that dissolves upon penetration to deliver the vaccine and adjuvant
Implementation Method 2
drying the formulation present in the mold
Data Source
AI summary
Provided herein is a microstructure array comprising a plurality of dissolving microstructures such as microprojections attached to a base. The plurality of microstructures comprise an active agent in a biocompatible and water-soluble matrix, where the water-soluble matrix preferably comprises a polysaccharide polymer and a sugar alcohol, and the base typically comprises a non-water soluble matrix. The plurality of microstructures, upon penetration of the subject's skin, undergo dissolution to deliver the active agent. Also provided are related microstructure formulations, in dried and liquid form, methods for preparing the above-described microstructure arrays, and methods for administering an active agent by application of a microstructure array as provided herein to a subject's skin, among other features.


