Tamper-Resistant Transdermal Dosage Form with Solvent-Sensitive Barrier
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Solution Overview
Problem
Existing transdermal dosage forms are vulnerable to misuse and tampering, particularly when exposed to solvents like water, alcohol, or ether, as they do not effectively prevent the extraction and abuse of active pharmaceutical agents.
Innovation Solution
A transdermal dosage form design featuring a polymeric active agent component with channels and an adverse agent component separated by a barrier that dissolves or becomes permeable in solvents, ensuring the adverse agent is released along with the active agent during tampering, thereby blunting biological effects or causing unpleasant reactions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a transdermal dosage form contains only an active agent, then the therapeutic efficacy is maintained, but the dosage form becomes vulnerable to tampering and misuse
Solution Approach 1:
The dosage form is divided into separate functional components: an active agent-containing component and an adverse agent-containing component, with the adverse agent positioned distally from the active agent. This segmentation allows the active agent to maintain therapeutic efficacy while the separate adverse agent component provides tamper resistance without compromising the delivery function.
Solution Approach 2:
A barrier is introduced as an intermediary component between the active agent component and the adverse agent component. This barrier controls the interaction between the two components, allowing the adverse agent to be released only under tampering conditions (when solvent penetrates the barrier) while preventing premature interaction during normal use.
2Reliability
If a barrier is used to separate active agent and adverse agent, then tamper resistance is improved, but the barrier must be impermeable to both active agent and adverse agent
Solution Approach 1:
The barrier's permeability properties are changed based on the chemical environment. The barrier is designed to be impermeable to both active agent and adverse agent under normal storage conditions, but becomes permeable or dissolves when exposed to specific solvents (water, alcohol, ether), allowing the adverse agent to be released during tampering attempts.
Solution Approach 2:
The barrier is constructed from materials that combine specific properties: it must be sufficiently impermeable to contain both agents during normal use, yet susceptible to degradation or dissolution by common solvents. This may involve using composite materials or specifically engineered polymers that exhibit solvent-dependent permeability changes.
3Object-affected harmful factors
If the adverse agent is released upon solvent exposure, then tampering is deterred, but the active agent may also be extracted and lost
Solution Approach 1:
The extraction process that would normally result in loss of active agent is converted into a beneficial tamper-resistance mechanism. When a solvent penetrates the barrier, it triggers the release of the adverse agent, which then counteracts the extracted active agent's effects. The solvent exposure that would normally cause loss is instead harnessed to activate the protective adverse agent.
Solution Approach 2:
The adverse agent is pre-positioned in the dosage form, ready to counteract the active agent before any abuse can occur. Upon solvent exposure, the adverse agent is released to immediately neutralize the extracted active agent's effects, preventing the harmful consequences of tampering.
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 design effectively deters tampering and misuse by ensuring the adverse agent is extracted with the active agent, either in vitro or in vivo, thereby preventing abuse and maintaining therapeutic efficacy while minimizing unintended diffusion during normal use.
Implementation Method 1
The barrier at least partially dissolves in the presence of and/or is permeable to many solvents, such as water, ethanol, ether, and mixtures thereof
Implementation Method 2
The barrier at least partially dissolves in the presence of and/or is permeable to many solvents, such as water, ethanol, ether, and mixtures thereof
Implementation Method 3
the barrier is impermeable to diffusion of the active agent and the adverse agent in the absence of a suitable solvent
Implementation Method 4
The dosage form comprises at least one channel passing between the skin-contacting surface and the reservoir component
Data Source
AI summary
The invention comprises a transdermal dosage form comprising an active agent component comprising an active agent and an adverse agent component comprising an adverse agent, wherein the active agent component defines at least one channel extending substantially there through.