Intestinal Microneedle Structure Using Swelling for Oral Biologic Delivery
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Solution Overview
Problem
Current oral delivery methods for biologic macromolecular drugs face significant barriers such as denaturation, mucus layer blockage, and absorption by intestinal epithelial cells, leading to low bioavailability and patient discomfort, while existing microneedle technologies suffer from biosafety issues, inconsistent delivery success, and poor retention.
Innovation Solution
A microneedle drug delivery apparatus utilizing a swellable mechanism and natural peristaltic behavior to penetrate the intestinal wall, employing biodegradable materials and a barbed structure for improved retention, without external fields or rigid driving units.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If penetration enhancers are used to promote drug absorption, then absorption efficiency is improved, but biosafety deteriorates due to disruption of intestinal epithelial cells
Solution Approach 1:
The patent replaces chemical penetration enhancers with a mechanical microneedle system that physically penetrates the intestinal wall. The microneedles create micro-channels through the intestinal wall using mechanical force, allowing drugs to pass through without chemically disrupting the epithelial cells, thus maintaining biosafety while achieving effective drug delivery
Solution Approach 2:
The patent changes the delivery parameter from chemical interaction to physical penetration. By using microneedles with specific dimensions (length, diameter, sharpness) to mechanically penetrate the intestinal wall, the system achieves drug delivery without the harmful chemical effects of penetration enhancers, resolving the contradiction between absorption efficiency and biosafety
2Productivity
If microneedles are used to penetrate intestinal wall, then drug delivery effectiveness is improved, but retention consistency deteriorates due to intestinal peristalsis
Solution Approach 1:
The patent designs microneedles with dynamic retention mechanisms including barbed structures and expansion capabilities. The microneedles can expand or engage with the intestinal wall tissue to maintain stable positioning despite peristaltic movements, ensuring consistent drug delivery while preserving delivery effectiveness
Solution Approach 2:
The patent incorporates retention enhancement features in the microneedle design before insertion, such as barbed structures or expandable segments. These features are prepared in advance to engage with the intestinal wall tissue, providing cushioning against peristaltic forces and ensuring consistent retention throughout the drug delivery process
3Force
If rigid driving units are used to propel microneedles, then penetration force is improved, but biosafety deteriorates due to non-degradable materials
Solution Approach 1:
The patent changes the material parameter of the microneedle system from rigid non-degradable materials to flexible biodegradable materials. The microneedles are designed with appropriate mechanical properties (flexibility, strength, degradation rate) to achieve sufficient penetration force while being safely degraded by the body, thus resolving the contradiction between penetration force and biosafety
Solution Approach 2:
The patent employs composite material structures for the microneedles, combining biodegradable polymers with appropriate mechanical properties. These composite materials provide sufficient penetration force through optimized structural design while ensuring biocompatibility and safe degradation in the body, eliminating the need for rigid non-degradable driving units
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
Enhances drug bioavailability by physically overcoming physiological barriers with high safety and patient compliance, ensuring consistent delivery and retention in the intestinal wall.
Implementation Method 1
a swellable mechanism and natural peristaltic behavior to penetrate the intestinal wall
Implementation Method 2
utilizing a swellable mechanism and natural peristaltic behavior to penetrate the intestinal wall
Data Source
AI summary
The present application relates to the technical field of drug delivery, and particularly, to a microneedle drug delivery apparatus and a preparation method thereof. The apparatus includes: a substrate; an array of microneedles loaded on the substrate; and a liquid-absorbing swellable material wrapped by the substrate to form a closed sandwich structure. This microneedle drug delivery apparatus allows microneedles to penetrate an intestinal wall using a mild water-absorbing swellable mechanism and natural peristaltic behavior of a gastrointestinal tract, to complete drug delivery. It penetrates a physiological barrier of oral delivery and absorption of biologic drugs by physical means, improving oral bioavailability of biologic drugs. Also, all materials used are biodegradable soft materials, with high safety.