Microneedle Array Molding for Scalable Pharmaceutical Quality
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Solution Overview
Problem
Existing methods for producing microneedle arrays face challenges in ensuring pharmaceutical quality and scalability, particularly in large-scale production, and there is a need for a method that can produce high numbers of microneedle arrays with consistent quality.
Innovation Solution
A method involving a mold with tapered recesses that allows for sequential or simultaneous introduction of multiple components into the receptacles, which are then joined and solidified to form microneedles, with the option of using a carrier plate for support, enabling efficient production of microneedle arrays with active ingredients or excipients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional filling methods are used to produce microneedle arrays, then production can be maintained at current levels, but pharmaceutical quality consistency and scalability to high volumes cannot be ensured
Solution Approach 1:
The mold is divided into multiple identical recesses (at least two) with individual feed openings, allowing parallel production of multiple microneedle arrays simultaneously. This segmentation enables scaling from single-unit to high-volume production while maintaining consistent quality through repeated standardized structures.
Solution Approach 2:
The feed openings are pre-positioned at optimized locations within each recess to enable controlled filling sequences. Components are introduced in predetermined sequences (first component then second component, or simultaneously) to ensure proper distribution and avoid air bubbles before final solidification, guaranteeing pharmaceutical quality.
2Manufacturing precision
If multiple components are introduced sequentially into receptacles, then pharmaceutical quality and component distribution can be controlled, but production time increases
Solution Approach 1:
The filling process uses periodic action with defined sequences: first component is introduced through feed openings, then second component is introduced either simultaneously to different receptacles or subsequently. This structured periodic filling ensures proper component distribution while minimizing total cycle time through optimized timing.
Solution Approach 2:
Different receptacles can receive different component sequences independently. Some receptacles receive simultaneous filling while others receive sequential filling, allowing optimization of component distribution for different microneedle array types without constraining the entire production batch to a single slow sequence.
3Ease of manufacture
If feed openings are located at the tip surface, then component introduction is simplified, but air bubbles may form and compromise quality
Solution Approach 1:
The first component is introduced through feed openings at the tip surface as a preliminary action to occupy the lower portion of each recess first. This preliminary placement creates a foundation that prevents air bubble formation during subsequent second component filling from the base surface, while maintaining the simplicity of tip-surface feed opening access.
Solution Approach 2:
The first component acts as an intermediary material that fills the space between the feed opening and the eventual final fill level. This intermediary layer prevents air entrapment by providing a pathway for air to escape during subsequent filling operations, thereby eliminating air bubbles while keeping feed openings at the convenient tip surface location.
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
This approach ensures high-quality, scalable production of microneedle arrays with consistent pharmaceutical properties, allowing for precise delivery of active ingredients through rigid and break-resistant needles that penetrate the skin effectively.
Implementation Method 1
The first component and the further component have solidified, the microneedle array with the fillings solidified into needles is removed from the mold
Data Source
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AI summary
The invention relates to: a method for producing microneedle arrays in a mold which has a plurality of receptacles that taper from an upper base surface to a lower tip surface; a device for producing microneedle arrays by means of such a method, the device comprising a mold; and a microneedle array comprising at least two needles that taper from a needle connection cross-section to a smallest end surface. A first component is fed into at least two receptacles through a feed opening that is spaced apart from the base surface. Said receptacles are filled with an additional component from above the feed opening. The fillings of at least said two receptacles, which fillings are formed of the first component and the additional component, are connected to one another above the base surfaces. Furthermore, after the first component and the additional component have solidified, the microneedle array comprising the fillings that have solidified to form needles is removed from the mold. By means of the present invention, sufficient pharmaceutical quality is ensured in large-scale production of microneedle arrays, thus allowing for a large quantity of microneedle arrays.