Abstract: Self-regulating, osmotic, floating gastroretentive compositions that provide extended release, delayed release, and/or delayed extended release of active pharmaceutical agents, as well as, optionally, immediate release of the same or a different active pharmaceutical agent, are provided here. The gastroretentive compositions of the disclosure comprise a swellable, extended release, multilayer core comprising a push layer and a pull layer; a water-insoluble permeable elastic membrane surrounding the multilayer core; and an orifice (e.g., a laser-drilled orifice, a manually drilled orifice) on the pull-layer side of the dosage form. The gastric retention of the composition is controlled by rapid floating of the composition and expansion of the membrane.

Abstract: Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.

Abstract: Self-regulating, osmotic, floating gastroretentive compositions that provide extended release, delayed release, and/or delayed extended release of active pharmaceutical agents, as well as. optionally, immediate release of the same or a different active pharmaceutical agent, are provided here. The gastroretentive compositions of the disclosure comprise a swellable, extended release, multilayer core comprising a push layer and a pull layer; a water-insoluble permeable elastic membrane surrounding the multilayer core; and an orifice (e.g., a laser-drilled orifice, a manually drilled orifice) on the pull-layer side of the dosage form. The gastric retention of the composition is controlled by rapid floating of the composition and expansion of the membrane. The rapid swelling of the composition to a size greater than the size of the pyloric sphincter is due to the presence of an osmogen.

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: Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.

Abstract: Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.

Abstract: Extended release pyridostigmine dosage forms, suitable for maintaining stable plasma concentrations with reduced or minimized initial burst release/dose dumping of pyridostigmine, are provided. The dosage forms include matrix tablets, gastroretentive tablets, and pellets, the latter being suitable for dosing in capsules, tablets, and sachets, as well as for sprinkling on foodstuffs. The disclosure also provides methods for improving patient compliance by administering once-a-day extended release pyridostigmine bromide dosage forms that provide a superior controlled drug release.

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: Disclosed are methods of making oral pharmaceutical compositions that contain substantially crush-resistant drug-containing microparticles. The microparticles may contain an active pharmaceutical agent, a polymer and a plasticizer. The microparticles may be uncoated (so as to impart an immediate release profile) or coated so as to impart an extended-release (ER), delayed release (DR) or delayed-extended release (DER) profile. One or more of the populations of microparticles may be coated with a taste-masking composition. The methods may produce oral compositions such as orally disintegrating tablets that contain one or more these types of microparticles in order to further customize the release profile. Also disclosed are the oral compositions, per se, and methods of using same for their intended purposes.

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 methods of making oral pharmaceutical compositions that contain substantially crush resistant drug containing microparticles. The microparticles may contain an active pharmaceutical agent, a polymer and a plasticizer. The microparticles may be un-coated (so as to impart an immediate release profile) or coated so as to impart an extended release (ER), delayed release (DR) or delayed extended release (DER) profile. One or more of the populations of microparticles may be coated with a taste masking composition. The methods may produce oral compositions such as orally disintegrating tablets that contain one or more these types of microparticles in order to further customize the release profile. Also disclosed are the oral compositions, per se, and methods of using same for their intended purposes.

Abstract: In some aspects of the present invention is a formulation comprising a solid dispersion or intimate mixture of a poorly water soluble drug and an ionic polymer surprisingly exhibiting fast disintegration of tablet.

Abstract: The presently disclosed subject matter provides 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: In some aspects of the present invention is a formulation comprising a solid dispersion or intimate mixture of a poorly water soluble drug and an ionic polymer surprisingly exhibiting fast disintegration of tablet.

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: Embodiments of the disclosure relate generally to formulations, methods of treatment, kits, and dosage forms for treating inflammatory disorders, including atopic dermatitis, or cancer, the formulations comprising an active pharmaceutical ingredient. The formulation provided comprises granules, wherein the granules comprise: micronized active ingredient; one or more granulation binders; one or more fillers; one or more disintegrants; and one or more antioxidants. In one embodiment, the methods of treatment include orally administering the active ingredient to a subject suffering from atopic dermatitis, where the active ingredient is in an amount of about 20 mg to about 80 mg.

Abstract: The present technology relates to an extended-release solid oral pharmaceutical composition, comprising a cured blend of a melt-extruded first component and a second component, wherein the melt-extruded first component comprises a therapeutically effective amount of an opioid or a pharmaceutically acceptable salt thereof, at least one PEO polymer, and a stabilizing agent; and the second component comprises at least one PEO polymer and an oxidative stabilizing agent. The extended-release pharmaceutical compositions of the present technology provide crush-resistant and abuse-deterrent formulations featuring enhanced heat stability, resistance to drug segregation, and resistance to alcohol-induced dose dumping.

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.