Silicone-Based Butorphanol Patch Adhesive Layer
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Solution Overview
Problem
Current butorphanol-containing patches lack sufficient quickness in efficacy development, characterized by long lag times and maximum skin permeation rate reach times, and suffer from unstable skin permeability and drug utilization rates due to volatilization or inflow of aqueous components.
Innovation Solution
A butorphanol-containing patch with an adhesive layer comprising 3 to 5% butorphanol or its pharmaceutically acceptable salt by mass, 65 to 85% silicone-based adhesive base by mass, and a mass per unit area of 40 to 80 g/m², which significantly accelerates efficacy development by shortening lag time and maximizing skin permeation rate.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If a cataplasm containing aqueous ointment is used to increase initial release rate, then the initial release rate is improved, but the skin permeability and utilization rate of the drug become unstable due to volatilization or inflow of aqueous component
Solution Approach 1:
The patent changes the physical-chemical parameters of the adhesive base from aqueous-based to silicone-based. This parameter change eliminates the volatilization and inflow issues of aqueous components while maintaining the ability to provide rapid drug release. The silicone-based adhesive base has different physical properties that prevent water loss and contamination, thereby stabilizing skin permeability and drug utilization rate.
Solution Approach 2:
The patent uses a composite adhesive layer comprising silicone-based adhesive base combined with specific additives (polyvinylpyrrolidone, absorption enhancers, etc.). This composite material structure provides both rapid drug release capability and stability in skin permeability, resolving the contradiction between initial release rate and permeability stability.
2Quantity of substance
If the mass per unit area of the adhesive layer is reduced to decrease drug content, then the drug content is reduced, but the skin permeation rate and utilization rate decrease
Solution Approach 1:
The patent changes the adhesive base from conventional to silicone-based, which has superior drug permeation properties. This parameter change allows the patch to maintain high skin permeation rate even with reduced drug content, as the silicone-based adhesive base enhances drug diffusion through the skin more effectively than conventional adhesives.
Solution Approach 2:
The patent uses absorption enhancers and penetration promoters as auxiliary substances that copy or enhance the permeation function. These additives work synergistically with the silicone-based adhesive base to maintain skin permeation rate even when the drug content is reduced, effectively compensating for the lower quantity of active substance.
3Loss of time
If the lag time is shortened to accelerate efficacy development, then the efficacy development speed is improved, but the maximum skin permeation rate reach time increases
Solution Approach 1:
The patent changes the adhesive base composition to silicone-based with specific additives that enhance rapid drug release. This parameter change simultaneously shortens lag time and achieves maximum skin permeation rate reach time, as the silicone-based adhesive base facilitates both rapid initial release and quick attainment of maximum permeation rate.
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 patch achieves a sufficiently short lag time and maximum skin permeation rate reach time, enhancing drug skin permeability and utilization rate while maintaining stability, even with reduced drug content.
Implementation Method 1
butorphanol as a drug for transdermal absorption preparations
Implementation Method 2
excellent in drug skin permeability (skin permeation rate and skin permeation amount of the drug)
Data Source
AI summary
A patch comprising: a backing layer; and an adhesive layer, wherein the adhesive layer contains at least one drug selected from the group consisting of butorphanol and pharmaceutically acceptable salts thereof and a silicone-based adhesive base, and a mass per unit area of the adhesive layer is 30 to 90 g/m2.