Abstract: The present disclosure generally provides complexes including a pharmaceutically active agent and a functionalized polymer, wherein the functionalized polymer includes repeat units, the repeat units including ionizable repeat units having at least one ionizable side group and/or ionizable end group, a plurality of the at least one ionizable groups forming non-covalent bonds with the pharmaceutically active agent. Polymers which may be used to form such complexes as well as methods of making and using the complexes and related compositions are also provided.

Abstract: The present disclosure generally provides complexes including a pharmaceutically active agent and a functionalized polymer, wherein the functionalized polymer includes repeat units, the repeat units including ionizable repeat units having at least one ionizable side group and/or ionizable end group, a plurality of the at least one ionizable groups forming non-covalent bonds with the pharmaceutically active agent. Polymers which may be used to form such complexes as well as methods of making and using the complexes and related compositions are also provided.

Abstract: The present disclosure provides long-acting formulations of tenofovir alafenamide, methods of making the same and methods of using the same.

Abstract: A composition includes a salt; a polymer; and an antioxidant. A dispenser includes a flexible container having a closed end and an opposed open end; an osmotically-effective solute composition encapsulating at least a portion of the container, the solute composition including antioxidant in an amount of at least 0.5 wt %, based on weight of the solute composition; a semipermeable membrane encapsulating the osmotically-effective solute composition; a cap having a sealing surface adapted for sealing engagement with the open end of the container; and a port extending from an interior of the container and through the cap. Also disclosed are methods of making and using the composition and osmotic pumps.

Abstract: The present disclosure provides a biodegradable drug delivery composition including a vehicle and an insoluble component comprising beneficial agent dispersed in the vehicle. In some cases, the composition includes sucrose acetate isobutyrate, biodegradable polymer, hydrophobic solvent, and a complex comprising a counterion and beneficial agent, such as protein, peptide, nucleic acid, or small molecular weight compound. Also provided, are kits including the biodegradable drug delivery composition or components thereof, as well as methods of making and using the biodegradable drug delivery composition.

Abstract: The present disclosure generally provides complexes including a pharmaceutically active agent and a functionalized polymer, wherein the functionalized polymer includes repeat units, the repeat units including ionizable repeat units having at least one ionizable side group and/or ionizable end group, a plurality of the at least one ionizable groups forming non-covalent bonds with the pharmaceutically active agent. Polymers which may be used to form such complexes as well as methods of making and using the complexes and related compositions are also provided.

Abstract: The invention pertains to methods that include administering to a subject a transoral dosage form comprising a pharmaceutical carrier and sufentanil, and maintaining a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test. Related dosage forms are also disclosed. Also disclosed are transoral dosage forms and related methods, wherein a transoral dosage form may comprise: (1) about 5 to about 1000 micrograms of sufentanil; (2) about 50 micrograms to about 100 milligrams of naloxone; and (3) acidifying material in an amount sufficient to provide a mean pH ranging from about 3.5 to about 5.

Abstract: The present disclosure generally provides complexes including a pharmaceutically active agent and a functionalized polymer, wherein the functionalized polymer includes repeat units, the repeat units including ionizable repeat units having at least one ionizable side group and/or ionizable end group, a plurality of the at least one ionizable groups forming non-covalent bonds with the pharmaceutically active agent. Polymers which may be used to form such complexes as well as methods of making and using the complexes and related compositions are also provided.

Abstract: The present disclosure provides dosage forms designed to deliver active pharmaceutical ingredients (APIs) in a controlled release manner. For instance, the present disclosure includes dosage forms with adequate time of onset of action and reduced lag times in the fed state. Such dosage forms find use in a variety of conditions where a rapid onset of action is desired followed by an extended release phase for the active agent, for example in the treatment of ADHD, pain or anxiety. In some cases, the dosage form includes a drug composition including a pharmacologically active agent, a barrier layer covering at least a portion of the drug composition, and a drug layer covering at least a portion of the barrier layer, wherein the drug layer includes the pharmacologically active agent. Related methods of making and administering the disclosed dosage forms are also provided.

Abstract: Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.

Abstract: The invention pertains to methods that include administering to a subject a transoral dosage form comprising a pharmaceutical carrier and sufentanil, and maintaining a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test. Related dosage forms are also disclosed. Also disclosed are transoral dosage forms and related methods, wherein a transoral dosage form may comprise: (1) about 5 to about 1000 micrograms of sufentanil; (2) about 50 micrograms to about 100 milligrams of naloxone; and (3) acidifying material in an amount sufficient to provide a mean pH ranging from about 3.5 to about 5.

Abstract: A composition includes a salt; a polymer; and an antioxidant. A dispenser includes a flexible container having a closed end and an opposed open end; an osmotically-effective solute composition encapsulating at least a portion of the container, the solute composition including antioxidant in an amount of at least 0.5 wt %, based on weight of the solute composition; a semipermeable membrane encapsulating the osmotically-effective solute composition; a cap having a sealing surface adapted for sealing engagement with the open end of the container; and a port extending from an interior of the container and through the cap. Also disclosed are methods of making and using the composition and osmotic pumps.

Abstract: Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.

Abstract: Novel compositions, formulations and dosage forms comprising stabilized micronized opioid particles are disclosed. Exemplary opioids include oxycodone, oxymorphone, hydrocodone, and hydromorphone, including as free bases or as salts. Stabilized micronized opioid particles having a DV90 particle size distribution of less and or equal to 10? or less than or equal to 20? are disclosed. Methods for micronizing an opioid to provide stabilized micronized opioid particles are also disclosed.

Abstract: The present disclosure provides compositions (e.g., extended release compositions) which exhibit a desirable pharmacokinetic profile of an active agent while providing reduced dissolution sample variability, e.g., in the form of reduced inter-capsule variability and/or a reduction in storage-time dependent change in mean release of the active agent from the composition. Related methods of making and administering the disclosed compositions are also provided.

Abstract: The present disclosure is directed to a method of making a composition by combining a vehicle, e.g., a single phase vehicle, and an insoluble component comprising a beneficial agent, and sterilizing the composition using ionizing radiation prior to use, wherein the beneficial agent is stable following exposure to a sterilizing dose of ionizing radiation. Related compositions and methods are provided.

Abstract: Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.

Abstract: The present disclosure provides compositions (e.g., extended release compositions) which exhibit a desirable pharmacokinetic profile of an active agent while providing reduced dissolution sample variability, e.g., in the form of reduced inter-capsule variability and/or a reduction in storage-time dependent change in mean release of the active agent from the composition. Related methods of making and administering the disclosed compositions are also provided.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Abstract: The present disclosure generally provides complexes including a pharmaceutically active agent and a functionalized polymer, wherein the functionalized polymer includes repeat units, the repeat units including ionizable repeat units having at least one ionizable side group and/or ionizable end group, a plurality of the at least one ionizable groups forming non-covalent bonds with the pharmaceutically active agent. Polymers which may be used to form such complexes as well as methods of making and using the complexes and related compositions are also provided.