Enhanced Abuse-Deterrent Pharmaceutical Compositions with pH-Dependent Solubility Features
Legal Citation
Summary of the Inventive Concept
The inventive concept relates to improved pharmaceutical compositions that incorporate pH-dependent solubility features and buffering ingredients to self-regulate the release of active pharmaceutical ingredients, thereby reducing the potential for abuse and overdose.
Background and Problem Solved
The original patent disclosed methods and compositions for self-regulated release of active pharmaceutical ingredients, but had limitations in terms of peak plasma concentration and release timing. The new inventive concept addresses these limitations by incorporating pH-dependent solubility features and buffering ingredients to modify the gastric environment and retard release of the active pharmaceutical ingredient when ingested in excess.
Detailed Description of the Inventive Concept
The enhanced abuse-deterrent pharmaceutical compositions comprise a pH-dependent solubility feature, which slows or blocks the release of the active pharmaceutical ingredient in response to excessive doses. The compositions also include a buffering ingredient that modifies the gastric environment to further regulate the release of the active pharmaceutical ingredient. This results in a safer and more efficient delivery of the active pharmaceutical ingredient, reducing the potential for abuse and overdose.
Novelty and Inventive Step
The new inventive concept introduces the use of pH-dependent solubility features and buffering ingredients to self-regulate the release of active pharmaceutical ingredients, providing a significant improvement over the original patent. The combination of these features enables a more controlled and safer delivery of the active pharmaceutical ingredient, reducing the potential for abuse and overdose.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept could include the use of different pH-dependent solubility features, such as polymers or lipids, or the incorporation of additional ingredients to further modify the gastric environment. Variations of the inventive concept could also include the use of different buffering ingredients or the optimization of the composition for specific active pharmaceutical ingredients.
Potential Commercial Applications and Market
The inventive concept has significant commercial potential in the pharmaceutical industry, particularly in the development of abuse-deterrent formulations for opioids and other drugs with narrow therapeutic indices. The market for such formulations is substantial, driven by the need to address the growing problem of drug abuse and overdose.
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 ingredients
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 that the PTD's pH-dependent solubility features represent a predictable extension of the source patent's abuse-deterrent composition framework. The disclosed variations leverage known pharmaceutical engineering techniques to modify drug release characteristics through controlled environmental interactions. The incremental modifications to buffering and solubility mechanisms represent standard design optimization strategies within pharmaceutical formulation development.
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. |