Polyethylene Oxide Matrix for Tamper-Resistant Opioid Dosage Forms
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Solution Overview
Problem
Existing pharmaceutical formulations of opioid agonists are vulnerable to tampering and alcohol exposure, leading to unintended rapid drug release and misuse.
Innovation Solution
A solid oral extended release pharmaceutical dosage form using a matrix formulation with high molecular weight polyethylene oxide, which maintains drug release properties when crushed or exposed to alcohol, ensuring resistance to tampering and controlled release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If controlled release opioid agonist formulations are made vulnerable to alcohol extraction, then the opioid can be rapidly released for immediate use, but this enables tampering and misuse by drug abusers
Solution Approach 1:
The patent changes the physical and chemical parameters of the dosage form by incorporating specific excipients and coating materials that alter the matrix structure. These parameter changes create a formulation that maintains controlled release properties while resisting alcohol extraction and crushing, thereby preventing tampering and misuse.
Solution Approach 2:
The patent uses composite materials including opioid agonist, controlled release matrix material, and specific excipients combined in a multi-layer or coated structure. This composite approach creates a dosage form that is both resistant to tampering and maintains reliable controlled release characteristics, preventing both abuser and patient misuse.
2Reliability
If the dosage form is made resistant to crushing, then tampering is prevented, but the tablet structure becomes more complex
Solution Approach 1:
The patent modifies the physical parameters of the tablet by controlling compression forces, binder types, and excipient ratios during manufacturing. These parameter changes enhance crushing resistance without requiring complex multi-layer structures, achieving structural integrity through optimized material properties rather than structural complexity.
Solution Approach 2:
The patent applies different material properties to different regions of the dosage form through coating or layered construction. The outer layer or coating provides enhanced crushing resistance and tamper evidence, while the inner matrix maintains controlled release properties. This local differentiation achieves tamper resistance without complicating the overall structure.
3Reliability
If the dosage form is made resistant to alcohol extraction, then unintended rapid release is prevented, but the formulation becomes more complex
Solution Approach 1:
The patent changes the chemical composition parameters by selecting specific excipients and coating materials that are insoluble or resistant to alcohol extraction. These parameter changes create a formulation barrier that prevents alcohol from extracting the opioid, maintaining controlled release properties without requiring complex multi-component systems.
Solution Approach 2:
The patent introduces an intermediary coating or barrier layer between the opioid matrix and the external environment. This intermediary layer acts as a protective barrier that resists alcohol extraction while allowing controlled release of the opioid through dissolution or erosion mechanisms, preventing tampering without significantly complicating the formulation.
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 formulation provides consistent drug release and resistance to crushing and alcohol extraction, maintaining therapeutic efficacy while deterring misuse.
Implementation Method 1
A solid oral extended release pharmaceutical dosage form using a matrix formulation with high molecular weight polyethylene oxide, which maintains drug release properties when crushed or exposed to alcohol
Data Source
AI summary
The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.