Fentanyl Patch Adhesive Composition and Skin Permeability
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Solution Overview
Problem
Fentanyl-containing patch preparations face challenges such as complex manufacturing processes, drug crystallization, adhesion issues, and 'sticking-out' problems due to the use of liquid ingredients in pressure-sensitive adhesives, which compromise skin permeability and ease of use.
Innovation Solution
A patch preparation with a backing layer and a drug layer containing a pressure-sensitive adhesive mixture of polyisobutylene and a silicon-containing polymer, with a specific mass ratio, that prevents sticking-out and crystal formation, and enhances skin permeability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If liquid ingredients (solubilizers, transdermal absorption enhancers) are increased in the pressure-sensitive adhesive to enhance drug diffusion and skin permeation, then the skin permeability of the drug is improved, but the cohesive force of the adhesive base is reduced
Solution Approach 1:
The patent changes the chemical composition parameters of the pressure-sensitive adhesive by incorporating specific compounds (isopropyl myristate, oleyl alcohol, cetyl palmitate) in optimized proportions. This allows the adhesive to maintain adequate cohesive force while providing sufficient skin permeability for fentanyl, resolving the contradiction between adhesion strength and drug permeation
Solution Approach 2:
The patent creates a composite pressure-sensitive adhesive system combining polyisobutylene (70-90 parts by mass) with smaller amounts of silicon-containing polymer (5-20 parts by mass) and liquid ingredients (0.1-10 parts by mass). This composite structure maintains the cohesive properties of the base polymer while the added components provide enhanced drug diffusion and skin permeation without compromising adhesive integrity
2Reliability
If a large amount of liquid ingredients is added to the pressure-sensitive adhesive to achieve adequate drug diffusion, then the skin permeation of fentanyl is improved, but the adhesive base becomes too soft and loses its cohesive force
Solution Approach 1:
The patent optimizes the concentration parameters of liquid ingredients in the pressure-sensitive adhesive, limiting them to 0.1-10 parts by mass per 100 parts of polyisobutylene. This parameter control ensures sufficient drug diffusion while preventing excessive softening that would compromise adhesive cohesion
Solution Approach 2:
The silicon-containing polymer acts as an intermediary component that mediates between the polyisobutylene base and the liquid ingredients. It helps maintain the structural integrity and cohesive force of the adhesive base while allowing the liquid ingredients to effectively enhance drug diffusion and skin permeation
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 solution simplifies the manufacturing process, prevents adhesive remnants on the skin, and maintains effective drug absorption and adhesion, ensuring prolonged drug release and improved patient comfort.
Implementation Method 1
to secure a predetermined amount of a drug to be absorbed, it is desirable to mix a transdermal absorption enhancer in a pressure-sensitive adhesive
Implementation Method 2
it is desirable that a drug be dissolved in an adhesive in view of its diffusion and skin permeation
Data Source
Figure 1
AI summary
A patch preparation having a backing layer and a drug layer laminated on the backing layer; wherein the drug layer contains an adhesive containing at least one compound selected from the group consisting of fentanyl and pharmaceutically acceptable salts thereof, polyisobutylene, and a silicon-containing polymer; and a mass ratio of the polyisobutylene and the silicon-containing polymer in the adhesive is 20:1 to 7:3.