Fentanyl Transdermal Adhesive Matrix Design
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Solution Overview
Problem
Current transdermal fentanyl delivery systems, such as reservoir and matrix patches, often require high drug content and are bulky, expensive, and prone to leakage, with FDA concerns over potential drug abuse and inefficiencies in drug delivery profiles.
Innovation Solution
A transdermal drug delivery device featuring an adhesive composition with a copolymer comprising at least 50% C4 to C10 alkyl acrylate units and skin permeation enhancers, which is substantially free of undissolved fentanyl, providing a more efficient delivery profile matching or exceeding that of existing systems with lower drug content.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reservoir type devices with liquid fentanyl are used, then continuous systemic delivery of fentanyl is achieved, but the devices become larger, bulkier, and more expensive with potential leakage issues
Solution Approach 1:
The patent uses a thin film adhesive matrix containing fentanyl dissolved in the adhesive itself, eliminating the need for a bulky liquid reservoir while maintaining continuous delivery through the adhesive's controlled release properties
Solution Approach 2:
The invention extracts the liquid reservoir component entirely and replaces it with a solid adhesive matrix that delivers fentanyl through controlled diffusion and permeation, reducing device volume while maintaining delivery function
2Productivity
If high fentanyl content is used in adhesive patches, then delivery efficiency is improved, but manufacturing costs increase and FDA concerns over drug abuse arise
Solution Approach 1:
The patent optimizes the adhesive composition parameters including copolymer type (C4-C10 alkyl acrylate), skin permeation enhancer concentration (5-25%), and fentanyl content (3-7.5%) to achieve efficient delivery without requiring excessive drug amounts, thereby reducing costs and addressing FDA concerns
3Quantity of substance
If undissolved fentanyl is present in the adhesive composition, then drug content is increased, but the adhesive composition becomes less stable and may cause leakage
Solution Approach 1:
The patent specifies precise parameter ranges including fentanyl content (3-7.5% by weight) and skin permeation enhancer amounts (5-25% by weight) to ensure complete dissolution of fentanyl in the adhesive matrix, maintaining composition stability while achieving effective delivery
Solution Approach 2:
The patent uses skin permeation enhancers as intermediary substances that facilitate fentanyl dissolution and transport through the adhesive matrix, ensuring complete dissolution and preventing undissolved drug crystals that would compromise stability
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 device achieves efficient fentanyl delivery, maintaining therapeutic levels with lower fentanyl content, reducing costs and avoiding FDA concerns, while providing a stable and effective transdermal delivery comparable to or exceeding commercial products.
Implementation Method 1
The adhesive composition further includes a skin permeation enhancer in a range from 5 percent to 25 percent by weight, based on the total weight of the adhesive composition
Data Source
AI summary
A transdermal drug delivery device includes a backing and an adhesive composition disposed on the backing. The adhesive composition includes a copolymer having at least 50 percent by weight C4 to C10 alkyl acrylate units, based on the total weight of the copolymer, and one or more second monomer units selected from the group consisting of vinyl acetate, acrylamide, ethyl acrylate, methyl acrylate, and N-vinyl-2-pyrrolidone. The C4 to C10 alkyl acrylate and the one or more second monomer units together make up at least 98 percent by weight of the copolymer. The adhesive composition further includes a skin permeation enhancer in a range from 5 percent to 25 percent by weight, based on the total weight of the adhesion composition, and fentanyl. The adhesive composition is substantially free of undissolved fentanyl. A method of treating a mammal including placing the transdermal drug delivery device on the mammal's skin is also disclosed.