Abstract: A sample can be collected from an enclosed container by opening a sample collection valve and drawing the sample from the enclosed container. After delivery of the sample out of a fluid flow path, a sanitizing fluid can be directed along the fluid flow path to sanitize the fluid flow path.

Abstract: A secondary drying process is disclosed for removing residual solvent from drug-containing particles that have been formed by solvent-based processes, the secondary drying process utilizing a combination of vacuum, agitation, and a stripping gas.

Abstract: The process comprises delivering a spray solution comprising at least one solute in a solvent to a spray-drying apparatus, using a flash nozzle to atomize the spray solution into droplets within the spray-drying apparatus to remove at least a portion of the solvent from the droplets to form a plurality of particles, and collecting the particles. The spray solution is directed to a heat exchanger, thereby increasing the temperature of the spray solution to a temperature T2, wherein T2 is greater than T1. The flash nozzle comprises a central tube through which the spray solution is delivered and an outer tube through which a sweep gas is delivered. The central tube may have a first outer diameter at an inlet and a second outer diameter at an outlet, wherein the first outer diameter is greater than the second outer diameter.

Abstract: A sample can be collected from an enclosed container, such as an aseptic bioreactor or chemical environment, using the disclosed sampling modules and manifold, providing consistent or substantially consistent sampling procedures for obtaining samples of a desired quality, while reducing the risk of contamination. The samples can be directed to appropriate analytical devices for analysis.

Abstract: A pharmaceutical composition comprises nanoparticles comprising a poorly water soluble drug, a poorly aqueous soluble non-ionizable polymer, and an amine-functionalized methacrylate copolymer.

Abstract: Disclosed are compositions including a solid dispersion comprising a dispersion polymer, a basic low-water solubility active, and an anionic counterion, as well as methods of making and using the compositions.

Abstract: High loading immediate release dosage forms containing at least 30 wt % of a solid drug dispersion, at least 5 wt % of a disintegrant and a porosigen are disclosed that exhibit excellent strength and aqueous solubility.

Abstract: A spray-drying apparatus includes a drying chamber that has a first end, a second end, and at least one side wall extending between the first and second ends to define an interior of the drying chamber having a center axis. A nozzle can be positioned at the first end of the drying chamber and be configured to atomize liquid and spray the atomized liquid into the interior of the drying chamber at a maximum spray pattern angle relative to the center axis. A ratio of the length between the first end and second end to a maximum width between opposing internal surfaces of the interior of the drying chamber can be at least 5 to 1.

Abstract: A spray-drying apparatus includes a drying chamber that has a first end, a second end, and at least one side wall extending between the first and second ends to define an interior of the drying chamber having a center axis. A nozzle can be positioned at the first end of the drying chamber and be configured to atomize liquid and spray the atomized liquid into the interior of the drying chamber at a maximum spray pattern angle relative to the center axis. A heating device can be provided to heat the liquid prior to introduction into the drying chamber.

Abstract: An exemplary method comprises providing a spray-dried dispersion comprising particles, the particles comprising an active agent and a polymer, the dispersion particles having an average particle diameter of less than 50 ?m. An ordered mixture is formed by high-shear mixing the dispersion with a powdered glidant, wherein the average particle diameter of the glidant is less than or equal to one fifth the average particle diameter of the dispersion after high-shear mixing. The dosage forms are formed by at least one of directly compressing the ordered mixture to form a tablet and encapsulating the ordered mixture to form a capsule.

Abstract: A spray-drying apparatus includes a drying chamber that has a first end, a second end, and at least one side wall extending between the first and second ends to define an interior of the drying chamber having a center axis. A nozzle can be positioned at the first end of the drying chamber and be configured to atomize liquid and spray the atomized liquid into the interior of the drying chamber at a maximum spray pattern angle relative to the center axis. A heating device can be provided to heat the liquid prior to introduction into the drying chamber.

Abstract: Methods and compositions for maintaining an active agent in an intra-articular space are disclosed. Methods of delivering the compositions to an intra-articular space and methods of making the compositions also are disclosed. The compositions comprise an active agent and a polymer comprising at least one cationic group. A fluid including the composition may be injected into an intra-articular space in a human or animal whereby the composition associates with endogenous material in the intra-articular space. In some embodiments, the fluid further comprises a poorly aqueous soluble polymer.

Abstract: A spray-drying apparatus includes a drying chamber that has a first end, a second end, and at least one side wall extending between the first and second ends to define an interior of the drying chamber having a center axis. A nozzle can be positioned at the first end of the drying chamber and be configured to atomize liquid and spray the atomized liquid into the interior of the drying chamber at a maximum spray pattern angle relative to the center axis. A ratio of the length between the first end and second end to a maximum width between opposing internal surfaces of the interior of the drying chamber can be at least 5 to 1.

Abstract: A drug in a solubility-improved form is combined with a concentration-enhancing polymer in a sufficient amount so that the combination provides substantially enhanced drug concentration in a use environment relative to a control comprising the same amount of the same solubility-improved form of drug without the concentration-enhancing polymer.

Abstract: Solid dry powder compositions comprising active agents and dextran polymer derivatives comprising an ester-linked amine-containing substituent and an alkyl ester substituent are disclosed, as are methods for making such compositions.

Abstract: A controlled release dosage form has a coated core with the core comprising a drug-containing composition and a water-swellable composition, each occupying separate regions within the core. The drug-containing composition comprises a low-solubility drug and a drug-entraining agent. The coating around the core is water-permeable, water-insoluble and has at least one delivery port therethrough. A variety of formulations having specific drug release profiles are disclosed.

Abstract: A pharmaceutical composition comprises a solid adsorbate comprising a drug adsorbed onto a substrate and a lipophilic microphase-forming material. The solid adsorbate may also be co-administered with a lipophilic microphase-forming material to an in vivo use environment. The compositions of the present invention enhance the concentration of drug in a use environment.

Abstract: A drug in a solubility-improved form is combined with a concentration-enhancing polymer in a sufficient amount so that the combination provides substantially enhanced drug concentration in a use environment relative to a control comprising the same amount of the same solubility-improved form of drug without the concentration-enhancing polymer.

Abstract: A pharmaceutical composition comprises nanoparticles comprising a poorly water-soluble drug, a poorly aqueous soluble non-ionizable cellulosic polymer, and a poorly aqueous soluble polymeric amphiphilic non-ionizable block copolymer.

Abstract: Solid compositions of low-solubility drugs and poloxamers that provide concentration enhancement when administered to an aqueous environment of use are disclosed.