Abuse-Deterrent Pharmaceutical Composition Using Precursor Complexes
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
There is a growing need for novel and effective methods to deter the abuse of pharmaceutical products, particularly orally administered drugs that can be tampered with or converted into illicit substances like methamphetamine, as existing formulations are vulnerable to illicit chemical processes.
Innovation Solution
A pharmaceutical composition incorporating a pharmacologically effective amount of a drug susceptible to abuse, combined with triglycerides, hydroxypropylcellulose, polyethylene oxide, and disintegrants like crospovidone, which interferes with the crystallization and extraction of the drug when attempted to be converted, forming complexes in non-polar solvents and reducing the yield of illicitly recovered substances.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a solid dosage form containing a drug susceptible to abuse is made available for oral administration, then the drug can be administered therapeutically, but the dosage form can be crushed, ground, dissolved, or otherwise tampered with to make the active drug available for abuse
Solution Approach 1:
The patent introduces precursor compounds as intermediary substances that require illicit chemical conversion to become active drugs. The dosage form contains precursors (e.g., ephedrine, pseudoephedrine) instead of the directly active drug (e.g., methamphetamine), creating a chemical barrier that deters abuse while maintaining legitimate therapeutic use
Solution Approach 2:
The patent changes the chemical state of the active ingredient from a directly active drug to a precursor compound that requires chemical transformation. This parameter change in molecular structure and reactivity state prevents direct abuse while allowing controlled conversion under legitimate medical supervision
2Ease of manufacture
If a precursor compound is included in a dosage form, then the drug can be converted through chemical synthesis, but the precursor can be extracted and converted into illicit substances through processes like the Shake and Bake Method
Solution Approach 1:
The patent combines multiple components in a composite dosage form: precursor compounds, binders, fillers, and abuse-deterrent agents. This composite structure makes extraction and illicit conversion more difficult while maintaining the ability to undergo controlled chemical synthesis for legitimate purposes
Solution Approach 2:
The patent converts the potential harm of precursor compounds being easily converted into illicit drugs by incorporating them into a controlled dosage form with abuse-deterrent properties. The same chemical synthesis capability that enables illicit conversion is also the basis for controlled, supervised manufacturing of legitimate medications
3Speed
If the dosage form is designed for immediate release, then the drug is quickly available for therapeutic effect, but the drug is also quickly available for extraction and abuse
Solution Approach 1:
The patent uses precursor compounds as intermediaries that release quickly for therapeutic effect but require additional chemical steps for abuse. The rapid release of precursors provides immediate therapeutic benefit while the need for further chemical conversion creates a barrier to abuse
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 composition significantly reduces the chemical conversion and extraction of precursor compounds into abused drugs, making it difficult to recover the illicit substance, thereby deterring abuse and maintaining the integrity of the pharmaceutical form.
Implementation Method 1
a triglyceride... which interferes with the crystallization and extraction of the drug when attempted to be converted, forming complexes in non-polar solvents
Implementation Method 2
hydroxypropylcellulose, polyethylene oxide... interfering with the crystallization and extraction of the drug
Data Source
AI summary
Effective methods and compositions to deter abuse of pharmaceutical products (e.g., orally administered pharmaceutical products) including but not limited to immediate release, sustained or extended release and delayed release formulations for drugs subject to abuse.