Abstract: Disclosed are solid oral pharmaceutical compositions that that are intended to provide protection against overdose and tampering, as well as abuse deterrence. The compositions contain a plurality of granules or multi-particulates. A first population of multi particulates contains an API or drug susceptible to abuse, a polymer matrix, and an outer coating that contains a cationic pH dependent polymer. These multi particulates also contain a plasticizer and a surfactant. A second population of multi particulates contains a viscosity building polymer and an alkaline buffering agent. Compositions may further include a disintegrant, and/or additional viscosity building polymers and/or alkaline buffering agents and/or ion exchange polymers. Also disclosed are the methods of making and using the compositions.

Abstract: A pharmaceutical composition and method of producing supersaturated stabilized nanoparticles of poorly soluble drugs having average sizes less than 1 ?m, or less than 800 nm, or less than 500 nm, comprising at least one pharmaceutically active ingredient, a hydrophilic polymer, a water-soluble surfactant, and subsequently stabilized by ionic polymers.

Abstract: The presently disclosed subject matter provides a solid, immediate release, pharmaceutical multi-particulate dosage form containing at least one population of Opioid Particulates comprising one or more opioids; at least one population of Naloxone Particulates; and a population of Triggering Particulates. Each population of particulates is designed for a specific function to accomplish the desired combination of abuse deterrence and overdose protection.

Abstract: The presently disclosed subject matter provides solid, oral, extended release, pharmaceutical particulate and multi-particulate dosage forms with abuse deterrent and overdose protection features/characteristics comprising at least one or two populations of particulates. In certain embodiments, the first population of particulates comprises a therapeutically effective amount of at least one opioid embedded in a polymer matrix, a primary functional coat layer (FC 1), a secondary functional coat 2 coat layer (FC 2), and an over coat; wherein FC 1 comprises a nonionic water-insoluble polymer and, optionally, at least one of a cationic polymer, a nonionic water-soluble polymer, and a water-soluble plasticizer; FC 2 comprises a cationic polymer and, optionally, a nonionic water-insoluble polymer; and the over coat comprises a nonionic water-soluble polymer. The second population of particulates comprises an alkaline agent and, optionally, a pH-stabilizing agent.

Abstract: Disclosed are pharmaceutical compositions, e.g., in the form of tablets, containing a therapeutically effective amount of an HIV protease inhibitor, e.g., ritonavir, a pharmaceutically acceptable aqueous-soluble polymer, and an erosion-enhancing agent having a particle size distribution in the range of about 1 ?m to about 350 ?m, wherein the composition is free or substantially free of surfactant. Methods of making the compositions, and methods of using them to treat HIV infection, are also provided.

Abstract: The presently disclosed subject matter provides a solid immediate release pharmaceutical particulate dosage form containing one population of particulates, and/or a solid immediate release pharmaceutical multi-particulate dosage form containing at least two different populations of particulates. In certain embodiments, the immediate release pharmaceutical dosage forms contain at least three different populations of multi-particulates. Each population of particulates is designed for a specific function to accomplish the desired combination of abuse deterrence and overdose protection.

Abstract: Disclosed are pharmaceutical compositions, e.g., in the form of tablets, containing a therapeutically effective amount of an HIV protease inhibitor, e.g., ritonavir, a pharmaceutically acceptable aqueous-soluble polymer, and an erosion-enhancing agent having a particle size distribution in the range of about 1 ?m to about 350 ?m, wherein the composition is substantially free or free of surfactant. Methods of making the compositions, and methods of using them to treat HIV infection are also provided.

Abstract: Disclosed are pharmaceutical compositions, e.g., in the form of tablets, containing a therapeutically effective amount of an HIV protease inhibitor, e.g., ritonavir, a pharmaceutically acceptable aqueous-soluble polymer, and an erosion-enhancing agent having a particle size distribution in the range of about 1 ?m to about 350 ?m, wherein the composition is substantially free or free of surfactant. Methods of making the compositions, and methods of using them to treat HIV infection are also provided.

Abstract: A pharmaceutical composition and method of producing supersaturated stabilized nanoparticles of poorly soluble drugs having average sizes less than 1 ?m, or less than 800 nm, or less than 500 nm, comprising at least one pharmaceutically active ingredient, a hydrophilic polymer, a water-soluble surfactant, and subsequently stabilized by ionic polymers.