Self-Regulated Release of Active Pharmaceutical Ingredient with Enhanced Abuse Deterrent Features
Legal Citation
Summary of the Inventive Concept
An improved pharmaceutical composition with a modified release profile, featuring a pH-dependent solubility component and a buffering ingredient to retard release of the active pharmaceutical ingredient in excess dosing scenarios, reducing the euphoric effect and risk of overdose.
Background and Problem Solved
The original patent addresses the issue of opioid abuse by proposing a composition with an acid soluble ingredient and a buffering ingredient. However, it has limitations in terms of peak plasma concentration and time to reach peak concentration. The new inventive concept solves this problem by introducing a pH-dependent solubility feature, which slows release of the active pharmaceutical ingredient in excess dosing scenarios, thereby reducing the euphoric effect and risk of overdose.
Detailed Description of the Inventive Concept
The improved pharmaceutical composition consists of a pH-dependent solubility component, an acid soluble ingredient, and a buffering ingredient. The pH-dependent solubility component is designed to retard release of the active pharmaceutical ingredient in excess dosing scenarios, thereby reducing peak plasma concentration and the risk of overdose. The buffering ingredient maintains a predetermined pH range, ensuring a consistent release profile. This modified release profile reduces the euphoric effect associated with opioid abuse, providing an enhanced abuse deterrent feature.
Novelty and Inventive Step
The new claims introduce a pH-dependent solubility feature, which is a novel and non-obvious improvement over the original patent. This feature, in combination with the buffering ingredient, provides a more effective abuse deterrent mechanism, reducing the risk of overdose and addressing a significant limitation of the original patent.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include varying the pH-dependent solubility component's properties, such as its solubility profile or release rate, to optimize the abuse deterrent feature. Additionally, the buffering ingredient's composition or concentration could be modified to further enhance the release profile.
Potential Commercial Applications and Market
The improved pharmaceutical composition has significant commercial potential in the opioid market, particularly in the context of prescription pain management. The enhanced abuse deterrent feature addresses a critical need in the industry, providing a safer and more effective treatment option for patients.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K47/02 |
| A | A61 | A61K9/2009 |
| A | A61 | A61K9/2027 |
| A | A61 | A61K9/2077 |
| A | A61 | A61K31/5517 |
| A | A61 | A61K47/32 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulation design, specifically abuse-deterrent drug delivery systems focusing on controlled release mechanisms for opioid and high-risk pharmaceutical compounds
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical formulation scientist with expertise in drug delivery technologies, polymer chemistry, and pharmacokinetic modification techniques, holding at least a PhD or equivalent industrial experience in pharmaceutical engineering
Obviousness Rationale
A PHOSITA would recognize the PTD's pH-dependent solubility feature as a predictable extension of the source patent's abuse deterrent strategies, leveraging known pharmaceutical engineering techniques to modify drug release profiles and enhance overdose prevention mechanisms. The combination of existing abuse deterrent elements with a pH-modifying component represents an incremental yet obvious improvement within the established technological framework of controlled pharmaceutical release systems.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,629 |
|---|---|
| Title | Methods and compositions for self-regulated release of active pharmaceutical ingredient |
| Assignee(s) | Acurx Pharmaceuticals, Inc. |