Abstract: Apparatus and methods for inserting a medicament into a body cavity are described. The apparatus comprises an elongate tube with a plunger rod therein. The plunger rod has at least one projection which cooperatively interacts or engages with at least one discontinuity on the inside of the elongate tube so that proximal movement of the plunger rod with respect to the elongate tube expels the medicament into the body cavity.

Abstract: The present disclosure is directed to floating gastroretentive dosage forms with prolonged gastric residence time. The disclosure also provides rapidly expanding sustained release or combined immediate release and sustained release formulations comprising drugs that require targeted release in the proximal gastrointestinal tract for maximum therapeutic benefit. The rapidly expanding floating gastroretentive dosage forms comprise a permeable elastic membrane providing desired characteristics for drug release and mechanical strength to maintain tablet integrity.

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: 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: 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.

Abstract: Apparatus and methods for inserting a medicament into a body cavity are described. The apparatus comprises an elongate tube with a plunger rod therein. The plunger rod has at least one projection which cooperatively interacts or engages with at least one discontinuity on the inside of the elongate tube so that proximal movement of the plunger rod with respect to the elongate tube expels the medicament into the body cavity.

Abstract: Apparatus and methods for inserting a medicament into a body cavity are described. The apparatus comprises an elongate tube with a plunger rod therein. The plunger rod has at least one projection which cooperatively interacts or engages with at least one discontinuity on the inside of the elongate tube so that proximal movement of the plunger rod with respect to the elongate tube expels the medicament into the body cavity.

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: 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: Apparatus and methods for inserting a medicament into a body cavity are described. The apparatus comprises an elongate tube with a plunger rod therein. The plunger rod has at least one projection which cooperatively interacts or engages with at least one discontinuity on the inside of the elongate tube so that proximal movement of the plunger rod with respect to the elongate tube expels the medicament into the body cavity.

Abstract: Apparatus and methods for inserting a medicament into a body cavity are described. The apparatus comprises an elongate tube with a plunger rod therein. The plunger rod has at least one projection which cooperatively interacts or engages with at least one discontinuity on the inside of the elongate tube so that proximal movement of the plunger rod with respect to the elongate tube expels the medicament into the body cavity.

Abstract: The present disclosure pertains to pharmaceutical formulation comprising low aqueous solubility drug, a solubilizer, and optionally at least one pharmaceutically acceptable excipient that form dispersions when exposed to an aqueous environment.

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: Disclosed are abuse resistant oral pharmaceutical compositions that reduce the likelihood of improper administration of drugs that are susceptible to abuse. The oral pharmaceutical formulations contain abuse deterrent agents that cause discomfort to the user when administered in an improper manner and make the extraction of an active ingredient more difficult. Methods of making and using the compositions are also disclosed.

Abstract: The present disclosure pertains to pharmaceutical formulation comprising low aqueous solubility drug, a solubilizer, and optionally at least one pharmaceutically acceptable excipient that form dispersions when exposed to an aqueous environment.