Self-Regulated Release of Active Pharmaceutical Ingredient with Enhanced Abuse Deterrent Features

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.

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.

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.

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 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.

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.