Enhanced Abuse-Deterrent Pharmaceutical Compositions with pH-Dependent Solubility Features

Publication ID: 24-11857629_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Abuse-Deterrent Pharmaceutical Compositions with pH-Dependent Solubility Features,” Published Technical Disclosure No. 24-11857629_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857629_0006_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,629.

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

SectionClassGroup
A A61 A61K47/02
A A61 A61K9/2009
A A61 A61K9/2027
A A61 A61K9/2077
A A61 A61K31/5517
A A61 A61K47/32

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

Source Patent Element
Buffering ingredient to retard pharmaceutical ingredient release
PTD Variation
Adding pH-dependent solubility features to modulate gastric environment interactions
Obviousness Reasoning
Predictable modification using known polymer and excipient technologies to enhance existing abuse-deterrent mechanisms
Source Patent Element
Composition designed to suppress peak plasma concentration
PTD Variation
Incorporating additional pH modifying features to further control drug absorption
Obviousness Reasoning
Logical extension of existing abuse-deterrent strategies using well-understood pharmaceutical engineering principles
Source Patent Element
Pharmaceutical composition for drugs with narrow therapeutic index
PTD Variation
Introducing polymeric and lipid-based solubility control mechanisms
Obviousness Reasoning
Routine optimization using known pharmaceutical formulation techniques to enhance drug delivery safety
Source Patent Element
Method of reducing drug absorption when exceeding therapeutic dosage
PTD Variation
Implementing advanced pH-dependent release blocking strategies
Obviousness Reasoning
Predictable application of known pharmaceutical engineering approaches to improve existing abuse-deterrent technologies
Source Patent Element
Composition comprising acid-soluble ingredients
PTD Variation
Expanding solubility control through sophisticated environmental interaction mechanisms
Obviousness Reasoning
Logical progression of existing pharmaceutical formulation strategies using finite set of known modification techniques
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857629, the present publication demonstrates that the claimed pharmaceutical composition variations would have been obvious to a person having ordinary skill in the art at the time of invention. The incremental modifications to abuse-deterrent drug delivery systems represent predictable applications of known pharmaceutical engineering principles, thereby rendering subsequent claims obvious and anticipatable as a matter of law.

Original Patent Information

Patent NumberUS 11,857,629
TitleMethods and compositions for self-regulated release of active pharmaceutical ingredient
Assignee(s)Acurx Pharmaceuticals, Inc.