Supersaturated Gas Transdermal Delivery Device for Large Therapeutic Agents
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Solution Overview
Problem
Existing transdermal drug delivery systems face challenges in administering therapeutic agents with molecular weights greater than 500 Daltons and those with low or high partition coefficients, often causing patient discomfort and limited to small daily dosages.
Innovation Solution
A transdermal delivery device using a vapor-producing assembly that administers a supersaturated amount of dissolved gas through the skin via sweat gland pores, comprising a pressure cylinder, permeation valve, and fluid chamber, which regulates gas pressure and temperature to facilitate non-invasive delivery of therapeutic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If passive transdermal delivery systems are used, then lipophilic therapeutic agents can be delivered, but therapeutic agents with molecular weight greater than 500 Daltons or with very low or high partition coefficients cannot be effectively administered
Solution Approach 1:
The invention changes the physical state of the therapeutic agent from solid or liquid to vapor phase, enabling molecules of various sizes and partition coefficients to be delivered transdermally. The vaporization process converts the agent into a gas that can penetrate skin through sweat glands, bypassing the limitations of passive diffusion that restrict delivery to only lipophilic agents with molecular weight under 500 Daltons.
Solution Approach 2:
The invention replaces the passive diffusion mechanism with an active vaporization and inhalation system. Instead of relying on concentration gradients and lipophilic properties for skin penetration, the system uses thermal energy to vaporize the agent and delivers it through the respiratory system, which has much higher absorption capacity and is not limited by molecular weight or partition coefficient constraints.
2Productivity
If active transdermal delivery systems such as microneedles, iontophoresis, or sonophoresis are used, then therapeutic agent transport across skin is increased, but patient discomfort and device complexity increase
Solution Approach 1:
The invention replaces mechanical penetration methods (microneedles, microdermabrasion) and electrical methods (iontophoresis, electroporation) with a thermal vaporization system. The therapeutic agent is heated to vaporize it, and the vapor is delivered through the respiratory system, completely avoiding mechanical or electrical stimulation of the skin that causes patient discomfort.
Solution Approach 2:
The invention introduces vapor as an intermediary medium between the therapeutic agent and the body. Instead of directly applying the agent to the skin where it must overcome skin barrier resistance, the agent is converted to vapor and inhaled, using the respiratory system as a more efficient and comfortable absorption pathway.
3Stability of the object's composition
If conventional transdermal patches are used, then controlled and constant administration of therapeutic agent is achieved, but delivery is limited to small molecular weight drugs with very small daily dosages
Solution Approach 1:
The invention changes the delivery route from transdermal to respiratory by vaporizing the therapeutic agent. The respiratory system can absorb much larger quantities of substance compared to transdermal delivery, while the controlled vaporization rate and inhalation pattern maintain steady plasma levels. This enables delivery of high daily dosages that were impossible with conventional patches.
4Reliability
If transdermal delivery is used, then bioavailability is increased by avoiding gastrointestinal absorption and hepatic first pass metabolism, but difficulty in administering therapeutic agents with molecular weight greater than 500 Daltons occurs
Solution Approach 1:
The invention uses vapor as an intermediary to bypass skin barrier limitations. By converting the therapeutic agent to vapor phase and delivering it through the respiratory system, the system maintains high bioavailability (avoiding first-pass metabolism) while simultaneously enabling delivery of agents with any molecular weight, as respiratory absorption is not constrained by the 500 Dalton limit that applies to transdermal delivery.
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
Enables efficient delivery of therapeutic agents across the skin, avoiding patient discomfort and overcoming molecular weight limitations, providing controlled and continuous administration.
Implementation Method 1
A method of producing a substance comprising a supersaturated amount of dissolved gas comprises the steps of placing a substance into an air-tight container; and exposing the substance to gas, wherein upon exposure, the gas dissolves into the substance in an amount greater than the substance could dissolve at 25° C. and 1 atm.
Implementation Method 2
The vapor producing assembly vaporizes the supersaturated liquid to produce vapor that comprises liquid particles including a supersaturated amount of a dissolved therapeutic agent
Implementation Method 3
a vapor comprising liquid particles including a supersaturated amount of a dissolved therapeutic agent that enters the circulatory system via the sweat gland pore and duct system
Data Source
AI summary
The present specification disclosed a noninvasive transdermal delivery device that relates generally to a handheld mechanical apparatus for noninvasive transdermal administration of gas, small to large water-soluble (hydrophilic) pharmaceutical agents, vitamins, and other therapeutic agents. Components of such delivery devices, methods of producing a substance comprising a supersaturated amount of a dissolved gas, as well as, methods of administering a therapeutic agent using such delivery devices and methods of treating a disease or condition using such delivery devices are also disclosed.