Tamper-Resistant Oral Formulation Using Heat-Labile Gel Matrix
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Solution Overview
Problem
Existing pharmaceutical formulations are susceptible to tampering and abuse, particularly for opioid analgesics, which can lead to unintended routes of administration and increased overdose risk.
Innovation Solution
A solid oral dosage form comprising a heat-labile gelling agent, thermal stabilizer, and optionally a pH-modifying agent, which forms a viscous solution upon tampering, inhibiting extraction and absorption through mechanisms like parenteral or nasal routes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a solid oral dosage form contains a drug susceptible to abuse (e.g., opioid analgesic), then the dosage form provides pain relief, but the dosage form becomes susceptible to tampering and abuse
Solution Approach 1:
The dosage form incorporates a gelling agent that proactively prevents abuse by forming a viscous gel matrix upon contact with liquids, which physically blocks extraction and administration by unintended routes before tampering can occur
Solution Approach 2:
The formulation changes its physical state parameters by incorporating a gelling agent that alters the texture and viscosity of the dosage form when exposed to liquids, transforming it from a crushable solid to a viscous gel that resists extraction
2Speed
If the dosage form is crushed to liberate drug for illicit use, then immediate availability of active agent is achieved, but the formulation's controlled release property is compromised
Solution Approach 1:
The gelling agent forms a protective gel matrix that prevents crushing and disintegration of the dosage form, thereby maintaining controlled release properties while blocking immediate drug availability through unintended routes
3Reliability
If a gelling agent is included to prevent parenteral and nasal administration, then abuse is deterred, but the dosage form's manufacturability and dosing precision become more difficult
Solution Approach 1:
The gelling agent is incorporated in controlled amounts during manufacturing to achieve the desired gel formation properties, allowing standard manufacturing processes to be used while still providing abuse deterrence through viscosity changes
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 significantly reduces abuse potential by maintaining high viscosity and preventing drug recovery, thereby deterring illicit use and overdose.
Implementation Method 1
a heat-labile gelling agent; a thermal stabilizer; and a drug susceptible to abuse
Implementation Method 2
forms a viscous solution upon tampering, inhibiting extraction and absorption
Implementation Method 3
a heat-labile gelling agent; a thermal stabilizer
Implementation Method 4
optionally a pH-modifying agent
Data Source
AI summary
Disclosed in certain embodiments is a solid oral dosage form comprising a heat-labile gelling agent; a thermal stabilizer; and a drug susceptible to abuse.