Ion Exchanger Abuse Deterrent Oral Compositions
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Solution Overview
Problem
There is a need for abuse-deterrent oral pharmaceutical compositions that prevent overingestion and misuse of prescription medications, particularly opioids, by controlling the release of active pharmaceutical ingredients and impeding their absorption into systemic circulation.
Innovation Solution
An oral pharmaceutical composition comprising a release modifier, a flowability enhancer, an ion exchanger, and active pharmaceutical ingredients, where a portion of the API is bound to the ion exchanger, forming an abuse-deterrent elastic semi-solid composition that absorbs and impedes the release of the API upon ingestion, thereby controlling its absorption into the systemic circulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If the API is released rapidly for immediate therapeutic effect, then the onset of action is fast, but the risk of overingestion and abuse increases
Solution Approach 1:
The ion exchanger is pre-loaded with API in the dosage form, creating a reservoir that will release the drug over time. This preliminary preparation ensures that even if the dosage form is tampered with, the API cannot be rapidly extracted or released, thereby preventing abuse while still allowing controlled release for therapeutic effect
Solution Approach 2:
The ion exchanger acts as an intermediary between the API and the gastrointestinal tract. It binds the API and controls its release rate, mediating the interaction between the drug and the body. This intermediary mechanism prevents both rapid absorption (abuse) and ensures sustained release (therapeutic effect)
2Reliability
If a high dose of API is administered to ensure adequate pain relief, then the therapeutic efficacy is improved, but the potential for abuse and overdose increases
Solution Approach 1:
The dosage form provides dynamic control of API release through the ion exchanger mechanism. The release rate adapts to physiological conditions in the gastrointestinal tract, providing sufficient drug levels for pain relief while automatically limiting the maximum rate of absorption, thereby reducing abuse potential even at higher prescribed doses
3Object-affected harmful factors
If the composition is designed for controlled release to prevent abuse, then the risk of overingestion is reduced, but the complexity of the formulation increases
Solution Approach 1:
The invention controls the release rate by changing the parameters of the ion exchanger (type, capacity, particle size) rather than designing complex multi-layer structures or mechanical barriers. This parameter-based approach achieves abuse-deterrent properties through straightforward formulation adjustments, minimizing complexity while maintaining effectiveness
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 achieves a controlled release of the API, delaying its absorption and reducing the risk of overingestion by maintaining a stable plasma concentration, thereby mitigating the risk of abuse and providing effective pain management.
Implementation Method 1
a portion of the API is bound to the ion exchanger... the ion exchanger adsorbs a quantity of the API and impedes its release into the subject's systemic circulation
Data Source
AI summary
Described herein are abuse deterrent oral pharmaceutical compositions, methods for making the same, and methods of treatment using such compositions. In particular, oral pharmaceutical compositions that mitigate the risk of overingestion of one or more active pharmaceutical ingredients are described.