Transdermal Patch Laminate with Drug-Permeable Membrane
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Solution Overview
Problem
Transdermal drug delivery systems face challenges in maintaining stable adhesion and consistent drug release over time, with reservoir type preparations experiencing physical property changes and matrix type preparations prone to drug crystallization and limited constituent amounts, leading to decreased efficacy.
Innovation Solution
A transdermal preparation comprising a laminate structure with a drug permeable polymer membrane on the skin-contacting surface, an adhesive layer limited to peripheral regions, and an inner layer separating the adhesive from the drug layer, which includes an inner hole to prevent drug transfer and maintain adhesion, allowing for controlled drug release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If constituents including drug are transferred to the adhesive layer with the passage of time, then the preparation structure becomes simpler, but the physical properties of the adhesive layer are altered resulting in decreased adherence ability and drug releasing ability
Solution Approach 1:
A release controlling membrane is introduced as an intermediary layer between the adhesive layer and the drug containing layer. This membrane prevents direct contact and transfer of drug constituents to the adhesive layer, thereby maintaining the adhesive layer's physical properties and its adherence ability while still allowing controlled drug release through the membrane structure.
Solution Approach 2:
The preparation is divided into distinct functional layers: an adhesive layer for skin attachment, a release controlling membrane for drug regulation, and a drug containing layer for medication storage. This segmentation prevents unwanted interaction between layers while maintaining individual layer functions, thus preserving adherence ability and drug releasing ability over time.
2Ease of manufacture
If the adhesive layer contains drug (matrix type), then the preparation can be prepared easily, but the drug tends to be crystallized during shelf life leading to decreased adherence ability and drug releasing ability
Solution Approach 1:
The preparation separates the drug containing function into a distinct layer from the adhesive layer, while maintaining the ease of manufacture benefits. The release controlling membrane allows simple lamination processes while preventing drug crystallization by maintaining proper drug distribution and preventing adhesive layer contamination.
Solution Approach 2:
The release controlling membrane acts as an intermediary that prevents direct contact between the drug and adhesive layer, thereby preventing drug crystallization in the adhesive layer during shelf life while still allowing controlled drug release through the membrane's porous structure.
3Ease of operation
If exercise and bathing are limited during actual use, then the preparation adhesion is maintained, but it is still difficult to avoid the decrease with passage of time in drug releasing ability and adhesion ability
Solution Approach 1:
The release controlling membrane provides continuous controlled drug release through its porous structure, maintaining stable drug delivery over time regardless of external conditions. The membrane's structure ensures continuous adhesion maintenance without requiring strict usage restrictions, as it protects the preparation from moisture and physical stress.
Solution Approach 2:
The release controlling membrane serves as a protective barrier that cushions the preparation against the effects of exercise and bathing before these activities can cause adhesion failure. The membrane structure anticipates and prevents the negative effects of moisture and physical stress on the adhesive layer.
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 configuration ensures stable and efficient long-term drug administration by preventing drug transfer to the adhesive layer, maintaining adhesion, and allowing for controlled drug release, enhancing both adhesion and drug retention stability.
Implementation Method 1
an outer membrane which is a drug permeable polymer membrane having drug permeable pores
Data Source
Figure 1
Figure 2(A)~2(G)
Figure 3(A)~3(C)
AI summary
The present invention relates to a novel transdermally absorbable preparation which enables the efficient, stable and long-term administration of a drug to a living body. More specifically, the present invention relates to a transdermally absorbable preparation comprising a laminate which comprises, in the order from the skin-contacting side, an outer membrane, a drug containing layer and a support layer, and a fixing means for fixing the laminate on the skin, wherein the outer membrane is a drug permeable polymer membrane ensures controlled release of the drug into the skin and is provided on the skin-contacting surface of the laminate.