Cyclic Surfactant Microneedle Formulation Bubble Stability

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Solution Overview

Problem

The production of microneedles using mold-based methods often results in defective products due to air bubbles aggregating and rupturing within the mold, leading to voids and reduced yield rates, especially when incorporating poorly soluble or insoluble active components.

Innovation Solution

A microneedle formulation combining surfactants with cyclic structures and microneedle scaffold materials to enhance bubble stability, improve solubility of active components, and stabilize the production process, thereby reducing defect rates and increasing yield.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If mold-based methods are used for microneedle production, then production efficiency is improved, but air bubbles aggregate and rupture causing voids and defective products

Engineering Contradiction:
Improveproduction efficiencyVSAvoidproduct defect rate
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The patent introduces a surfactant as an intermediary substance in the microneedle formulation. This surfactant acts as a mediator between the hydrophobic air bubbles and the hydrophilic formulation matrix, reducing surface tension and preventing bubble aggregation and rupture during the molding process, thereby eliminating voids and defective products while maintaining production efficiency

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If centrifugation and vacuuming methods are used to eliminate bubbles, then small bubbles are removed, but bubbles are re-introduced during material filling and static drying processes

Engineering Contradiction:
Improvebubble eliminationVSAvoiddefect rate
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The patent applies preliminary action by incorporating the surfactant into the formulation before the molding process. This pre-treatment ensures that the formulation is already protected against bubble aggregation from the outset, preventing the need for repeated bubble elimination steps and avoiding re-introduction of bubbles during subsequent filling and drying operations

Inventive Principle:
Principle #10Preliminary action

3Reliability

If poorly soluble or insoluble active components are added to microneedle formulations, then therapeutic efficacy is improved, but defect rates increase due to bubble aggregation

Engineering Contradiction:
Improvetherapeutic efficacyVSAvoidproduct defect rate
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The surfactant serves as a dual-function intermediary: it not only prevents bubble aggregation to maintain manufacturing quality but also enhances the solubility of poorly soluble active components through micellization, allowing both therapeutic efficacy and manufacturing precision to be improved simultaneously

Inventive Principle:
Principle #24Intermediary (Mediator)

4Quantity of substance

If conventional surfactants are used in microneedle formulations, then solubility of active components is improved, but bubble stability is not enhanced and defect rates remain high

Engineering Contradiction:
Improvesolubility of active componentsVSAvoidbubble stability
Core Design Contradiction:
Quantity of substanceVSManufacturing precision

Solution Approach 1:

The patent applies parameter changes by selecting surfactants with specific molecular characteristics (hydrophilic-lipophilic balance, molecular weight, cyclic structure) that optimize both solubility enhancement and bubble stabilization properties, transforming the formulation parameters to achieve superior performance in both solubility and bubble stability

Inventive Principle:
Principle #35Parameter changes

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 use of surfactants with cyclic structures in the microneedle formulation effectively prevents bubble aggregation and rupture, significantly improving the yield rate and product quality by reducing needle deficiency and unflatness rates.

Implementation Method 1

The present disclosure utilizes a combination of surfactant with cyclic structure with microneedle scaffold material to enhance the stability of bubbles in microneedle formulations

Methodology Applied
Scientific EffectSurfactant: Surfactant

Implementation Method 2

dissolving the aforementioned formulation amount of microneedle scaffold material and surfactant with cyclic structure in deionized water, stirring uniformly

Methodology Applied
Scientific EffectSolvation: Solvation

Data Source

PatentUS20250144011A1Microneedle formulation, microneedle patch, and preparation methods thereof
Publication Date: 2025.05.08 YOUWE ZHUHAI BIOTECH CO LTD
  • US20250144011A1 patent drawing
  • US20250144011A1 patent drawing
  • US20250144011A1 patent drawing

AI summary

The present disclosure discloses a microneedle formulation, a microneedle patch, and preparation methods thereof. The microneedle formulation includes the following components in mass percentage: 15-55% of microneedle scaffold material, 0.05-5% surfactant with cyclic structure, 0-15% of active components, and the remaining being deionized water. The microneedle patch is prepared from the aforementioned microneedle formulation.