Abstract: This invention relates to nano-, micro-, and macro-encapsulation methods and constructs, including single and multi-compartment particles and capsules, and methods of release.

Abstract: A method for making clear hard vegetarian gelatin free two piece capsules by creating the first phase of the biphasic system using seaweed extract, gellan gum, metallic element, maltol extract, seaweed extract and water. A filler is created for the first phase of the biphasic network by blending water, galactomannan extract, and cellulose. The filler is then mixed into the system forming a biphasic system, a first pin is then dripped into the blend and then a second pin is then dripped into the blend. Blowing hot air on the dipped pins, which then blows away water on the outer surface of the dipped pins to bond and lock moisture to the cellulose. A large diameter capsule piece is removed from the first pin and a small diameter capsule piece is removed from the second pin, wherein each capsule piece has an outer surface which is mechanically and dimensionally stable.

Abstract: A pharmaceutical composition comprising an effective amount of a pharmaceutical active and up to about 99.8% wt/wt water soluble protein hydrolysate to total weight of composition is provided. Whey protein hydrolysate is exemplary of a suitable soluble protein hydrolysate. A method for preparing such a composition is also provided.

Abstract: The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Amlodipine, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component (a) of 60% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component (b) of 50% or more after 20 minutes, and 70% or more after 30 minutes at pH 2, said pharmaceutical oral fixed dose combination being bioequivalent, or close to reaching bioequivalence, to a free dose combination of Aliskiren and Amlodipine.

Abstract: The disclosure generally relates to a method of producing a handleable wafer of medicament powder (for example, aspirin powder) by utilizing a restraining envelope of fine water-soluble fibers, which are, upon use, quickly dissolved by bodily fluids. Such wafer would quickly provide sublingual or buccal cavity medications without significant excipients. Additional applications for such a wafer is in the prompt provision of a variety of medicaments to selected moist areas, such as, surgery or trauma sites, such as, a wound dressing.

Abstract: This disclosure relates to pharmaceutical compositions comprising bazedoxifene and an antioxidant such as vitamin E, vitamin E TPGS, propyl gallate, citric acid, or BHA/BHT, substantially free of ascorbic acid, as well as methods of making such compositions. Also provided are methods of enhancing dissolution stability and/or enhancing bioavailability of bazedoxifene in a formulation containing an antioxidant, and methods of reducing interactions of at least one of bazedoxifene and hydroxymethyl cellulose with at least one of ascorbic acid and one or more degradant products of ascorbic acid in such compositions.

Abstract: An apparatus for manufacturing a medication comprising an ejector unit adapted for ejecting a predefined amount of a drug having a liquid component to a solid carrier substrate. The ejector unit comprises a capillary and a tubular piezoelectric actuator surrounding at least a part of the capillary. The apparatus further comprises a control unit adapted for applying an electric signal to the piezoelectric actuator which, in response to the electric signal, is adapted to generate a compressional wave in the capillary for ejecting the predefined amount of the drug via an orifice of the capillary. Moreover, a method of manufacturing a medication is provided, the method comprising ejecting a predefined amount of a drug having a liquid component to a solid carrier substrate. Furthermore, a medication is provided comprising a solid carrier substrate, and a predefined amount of a drug ejected with a liquid component to the solid carrier substrate by an ejector unit.

Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

Abstract: A particle and a method of manufacturing a particle that includes a complex, a paramagnetic entity, and a silica layer that encapsulates the paramagnetic entity and the complex. The dielectric layer of the particle encapsulates the complex and the paramagnetic entity such that at least a portion of an outer surface of the complex is covered by the paramagnetic entity. In addition, the particle may or may not include a fluorescent entity encapsulated within the dielectric layer. Also, the particle may or may not include a targeting entity covalently bonded to the silica layer.

Abstract: Disclosed herein are pharmaceutical compositions comprising wet granulated bile acid sequestrants having the general Formula I shown, and their process of preparation. The present invention also discloses process for preparation of Colesevelam hydrochloride, an antilipemic agent.

Abstract: A novel composition comprising a tablet, comprising a highly soluble active pharmaceutical ingredient, which is then coated with a coating. The core is preferably a tablet. The coating preferably comprises any type of suitable extended release polymer, with the proviso that the polymer does not comprise an enteric polymer.

Abstract: Nitric oxide releasing compositions, which comprise nanoparticles having an exterior surface comprising solid amorphous silica, the exterior surface having nitrosothiol-containing groups attached thereto, the nanoparticles being dispersible in an aqueous system, devices including the compositions, and methods of making and using the compositions and devices are disclosed.

Abstract: A jettable solution includes an oil, the oil being one of a naturally occurring oil, an edible oil, or a removable oil, an edible surfactant, an edible aqueous solution, and a pharmaceutical solubilized into the naturally occurring oil, in which the naturally occurring oil, the pharmaceutical, the surfactant, and the aqueous solution form a microemulsion.

Abstract: The invention provides a pharmaceutical composition for oral drug delivery comprising a solid dosage form containing an effective amount of a therapeutic agent, a permeation enhancer and a pharmaceutically acceptable excipient and a bioadhesive layer containing a bioadhesive polymer, and optionally comprising an impermeable or semi-permeable layer having an opening capable of directing a unidirectional release of the therapeutic agent and the permeation enhancer from the solid dosage form. Methods of making and using the present pharmaceutical composition are also provided.

Abstract: A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and can include a second therapeutic agent and a second excipient. The first and second therapeutic agents have different dissolution rates during balloon inflation and therefore provide a coating that is tunable.

Abstract: An adhesive patch for attaching to the skin for medical, cosmetic, and/or orthopedic purposes. The patch is formed with a film that includes a carrier material, which is provided with a therapeutically effective coating on both sides.

Abstract: A dosage form comprising a tablet core containing at least one active ingredient and having at least one modified release coating that partially surrounds the tablet core is disclosed. The tablet core is preferably in the form of a compressed core wherein the at least one modified release coating is provided on a position of the exterior surface of the compressed core using dipping technology. The invention also relates to a method of manufacturing the dosage form and a method of treatment using the dosage form.

Abstract: An oral dosage form comprising, (i) an erodable core, which core comprises a pharmaceutically active weak base or a pharmaceutically acceptable salt or solvate thereof; and (ii) an erodable coating surrounding said core, which coating comprises one or more openings extending substantially completely through said coating but not penetrating said core and communicating from the environment of use to said core; characterised in that release of the pharmaceutically active weak base or a pharmaceutically acceptable salt or solvate thereof from the dosage form occurs through the said opening(s) by the erosion of said erodable core and through erosion of said erodable coating under pre-determined pH conditions; a process for preparing such a dosage form and the use of such a dosage form in medicine.

Abstract: A system for delivery of a beneficial agent in the form of a viscous liquid or paste allows holes in a medical device to be loaded in a single step process. The loading of a beneficial agent in a paste form also provides the ability to deliver large and potentially sensitive molecules including proteins, enzymes, antibodies, antisense, ribozymes, gene/vector constructs, and cells including endothelial cells.

Abstract: Described are transdermal drug delivery systems for the transdermal administration of testosterone, comprising a polymer matrix and testosterone. Methods of making and using such systems also are described.

Abstract: Magnetically responsive therapeutic carriers comprise nanoparticles including single-domain nanoparticles comprising magnetite and having an average particle size ranging between 1 and 50 nanometers, clusters of the single-domain nanoparticles, the clusters having an average cluster size ranging between 5 and 1000 nanometers, and mixtures of the two. The single-domain nanoparticles are encapsulated with a silica coating. A silane coupling agent is bonded to the silica coating and has a specific pendant functional group capable of selectively binding with the therapeutic. Preferably, the bond between the specific pendant functional group and the therapeutic is a covalent bond. The movement of magnetically responsive nanoparticle therapeutic constructs, with concentration and extravasation/endocytosis at a target site, such as cancerous tumors, uses a controllable magnetic field generator adapted to move the therapeutic constructs in three dimensions, and is enhanced using a repetitively-varying magnetic field.

Abstract: The invention relates to an improved process for preparing a new medicament formulation of the active substance dabigatran etexilate of formula I in the form of the methanesulphonic acid salt thereof, and this new medicament formulation as such.

Abstract: Electrospray methods and systems for coating of objects (e.g., medical devices such as a stent structure) with an open matrix coating. The open matrix coating is formed by electrospray using one or more nozzle structures each having at least an inner and outer opening. A first flow of a liquid spray composition is provided to the inner opening and a second flow of a liquid diluent composition is provided to the outer opening (e.g., the liquid diluent composition including at least one solvent, such as a composition having a dielectric constant equal to or greater than 10).

Abstract: A polymeric hollow nanoshell or nanosphere for release of an agent is described, wherein the hollow nanosphere comprises at least one biodegradable polymer, characterised in that the polymer is cross-linked. The biodegradable mono-disperse nanospheres described are suitable for use as carriers of biomolecules, therapeutic agents and/or imaging agents.

Abstract: The present invention relates to pharmaceutical solid dosage forms for oral administration comprising a tri-substituted glycerol compound or a pharmaceutically acceptable salt thereof. The invention also relates to a corresponding method for preparing such dosage forms as well as to their use as medicaments for the treatment of cancer and immune diseases.

Abstract: The invention relates to a pharmaceutical composition of a humidity-sensitive core comprising an active ingredient or pharmaceutically acceptable salt thereof; a coating over the core, the coating containing a cationic polymer; and an additional coating over the cationic polymer-containing coating, with the additional coating including an acidifying agent. Also, methods for preparing such compositions wherein a cationic polymer containing coating is applied over a humidity-sensitive core that contains the active ingredient or pharmaceutically acceptable salt thereof; and then an additional coating is applied over the cationic polymer containing coating.

Abstract: Multifunctional “smart” nanostructures are disclosed that include fluorescein isothiocyanate (FITC)-encapsulated SiO2 core-shell particles with a nanoscale ZnO finishing layer, wherein an outer ZnO layer is formed on the SiO2-FITC core. These ˜200 nm sized particles showed promise toward cell imaging and cellular uptake studies using the bacterium Escherichia coli and Jurkat cancer cells, respectively. The FITC encapsulated ZnO particles demonstrated excellent selectivity in preferentially killing Jurkat cancer cells with minimal toxicity to normal primary immune cells (18% and 75% viability remaining, respectively, after exposure to 60 ?g/mL) and inhibited the growth of both gram-positive and gram-negative bacteria at concentrations ?250-500 ?g/mL (for Staphylococcus aureus and Escherichia coli, respectively).

Abstract: A method of making active pharmaceutical ingredient particles with surface-modified nanoparticles deposited on the particles' surfaces, the method comprising: providing a plurality of media particles having surfaces with the surface-modified nanoparticles deposited on the surfaces; mixing the plurality of media particles with the active ingredient particles, both of which are in dry form, to provide active ingredient particles having surfaces with the surface-modified nanoparticles deposited on the surfaces; and separating the plurality of media particles from the active ingredient particles having surfaces with the surface-modified nanoparticles deposited on the surfaces is disclosed.

Abstract: Gastric retentive dosage forms for both immediate and extended release of phenylephrine are described which allow once- or twice-daily dosing. Methods of treatment using the dosage forms and methods of making the dosage forms are also described.

Abstract: The invention features the use of a matrix consisting of low molecular weight components for use as a self-eliminating coating for implantable medical devices. The matrix coatings can be used to enhance biocompatibility and to control the local delivery of biologically active agents.

Abstract: A pharmaceutical composition for oral administration comprising a core and a film coating on the core that exhibits enhanced disintegration characteristics is disclosed. The film coating comprises a film forming polymer, an organic solvent, a super-disintegrant and, optionally, an acid labile material.

Abstract: The present invention relates to a process using ultrasonic cutting for the preparation of an oral delivery device comprising a core which includes a pharmaceutically active agent covered by an outer coating which includes one or more openings communicating from the exterior of the device toward the core.

Abstract: Active principle-based coated particle, in which both the core and the coating contain active principle, includes a core which contains a first active principle while the coating contains a second active principle, which is different in nature.

Abstract: A sugar-coated agent that includes a core, a film layer that mainly includes a film component, the outer surface of the core being coated with the film layer, a sugar coating layer that mainly includes a sugar coating component, the outside of the film layer being coated with the sugar coating layer, and a middle layer that includes a film component and a sugar coating component and is provided between the film layer and the sugar coating layer, wherein within the middle layer, the concentration of the sugar coating component at the interface between the middle layer and the sugar coating layer is higher than the concentration of the sugar coating component at the interface between the middle layer and the film layer.

Abstract: The present invention provides a method and composition for loading one or more drugs in a solution onto one or more ion exchange resin particles to form a drug-loaded resin particle. The drug-loaded resin particle is separated from the solution and dried before recombining the drug-loaded resin particle with the solution to load more drugs onto the drug-loaded resin particle from the solution.

Abstract: A method for producing an agent depot for mechanical connection to a surface of an endovascular implantable body, comprising a) providing one or more polymers; b) providing one or more agents; and c) producing an agent depot from said polymers and said agents, the agent depot being mechanically connectable to the surface of the body using force action or adhesive.

Abstract: A compressed chewing gum tablet includes at least one compressed chewing gum module, the at least one compressed chewing gum module including a compressed particulate chewing gum composition, which compressed particulate chewing gum composition includes compressed chewing gum particles containing gum base. The content of gum base is at least 5% by weight of the tablet, the chewing gum tablet is provided with a film coating, and the film coating includes liquid flavoring.

Abstract: A capsule dusting system is designed to expose capsules to a dusting agent in a controlled manner. The system incorporates a tumbling basket positioned within an enclosure. The tumbling basket is loaded with capsules and is rotatably connected to a drive shaft. A dust injection system meters the dusting agent into the dust injection system. The dust injection system may include a dusting injector that translates between two positions. At one position, the dusting injector is loaded with dusting agent by a powder supply system. At the other position, the dusting injector is positioned to inject the dusting agent into the tumbling basket. A gas is fluidly connected to the dusting injector to cause the dusting agent to disperse into the tumbling basket. The enclosure contains the dusting agent within the system to reduce the environmental, health, and safety hazards associated with airborne particulates.

Abstract: Powder drug compositions exhibiting improved flow properties are manufactured by spraying a suspension of surface-modified nanoparticles having an average particle size diameter of less than 100 nm in a dryable liquid carrier onto particles of a powder ingredient of a drug composition. The liquid carrier is rapidly dried so as to leave the nanoparticles on the powder. Other ingredients of the powder drug composition can also be added.

Abstract: The present invention provides preparation methods of protein nanoparticles for in vivo delivery of pharmacologically active agents, wherein said methods are to encase pharmaceutically active agents into proteins or peptides to form nanoparticles by unfolding the protein, and subsequently refolding or assembling the protein to produce a pharmacologically active agent encased within a protein nanoparticle.

Abstract: The invention relates to a solid oral pharmaceutical composition combining ketorolac and B-complex consisting of inter alia thiamin, pyridoxine and cyanocobalamin (vitamins B1, B6 and B12 respectively) and/or the pharmaceutically acceptable salts thereof, as well as pharmaceutically acceptable excipients and/or vehicles. The invention also relates to the method for producing the composition and to the use of said composition having a synergistic therapeutic activity, indicated for the treatment of moderate to severe pain or neuralgias in different locations.

Abstract: Therapeutic compositions containing therapeutic agents and poly(beta-amino esters) or polymers thereof are described. These tertiary amine-containing polymers are preferably biodegradable and biocompatible. Nanoparticles and microparticles containing polymer/therapeutic agent complexes are also described.

Abstract: A method for loading a molecule into a porous substrate. The molecule has the formula wherein R* is a hydrophobic species and R** is a hydrophilic species which is mixed with mesoporous substrate and allowed to contact liquid carbon dioxide for a sufficient period of time to allow the molecule to load into the pores of the mesoporous substrate.

Abstract: A porous silicon implant impregnated with a beneficial substance, such as a micromineral required for healthy physiology, is implanted subcutaneously and is entirely corroded away over the following months/year to release the micromineral in a controlled manner. In a second embodiment the implant may have a large number of holes which contain beneficial substance and which are closed by bio-errordable doors of different thickness so as to stagger the release of the beneficial substance over time as the doors are breached.

Abstract: The present invention concerns preferably surfactant-free solid pharmaceutical formulations comprising, as an active ingredient, at least one of irbesartan and pharmaceutically acceptable salts thereof, and at least one disintegrant. Preferably, the active ingredient comprises irbesartan hydrochloride. Also, the present invention is directed to a process for the manufacture of such formulations, including a wet granulation process (A) and a direct granulation process (B).

Abstract: Now is provided a new sustained release drug preparation comprising such an inclusion complex of a medical compound with dichroa febrifuga alkone derivative (DFAD), which sustains or retards the dissolution and release of the DFAD at a controlled rate from the inclusion complex and hence from the drug preparation containing the DFAD, so as to maintain the concentration of the DFAD in blood at an effective level for prolonged time.

Abstract: Disclosed is a thermorod for active drug release capable of actively releasing drugs according to temperature and a method of manufacturing the same. The method for manufacturing a thermorod for active drug release that generates heat by means of eddy current loss and hysteresis loss in an induced magnetic field comprises: processing the thermorod into a certain shape; preparing a mixed-drug specimen by mixing a drug with a high molecular compound acting as a support of the drug; and forming a mixed-drug layer on the surface of the thermorod by using the mixed-drug specimen. Also, the thermorod for active drug release manufactured by the method is provided. Therefore, the method and thermorod prepared by the method may be useful to effectively perform the drug administration and anti-cancer drug treatment of affected parts since they may be used to perform local hyperthermia at 36.5° C. or above and to actively control the active drug release and delivery according to temperature as well.

Abstract: A sequestering subunit comprising an aversive agent and a blocking agent, wherein the blocking agent substantially prevents release of the aversive agent from the sequestering subunit in the gastrointestinal tract for a time period that is greater than 24 hours; a composition comprising a sequestering subunit in releasable form, wherein, optionally, the mechanical fragility of the sequestering subunit is the same as the mechanical fragility of the therapeutic agent in releasable form; a capsule or tablet comprising a sequestering subunit and a therapeutic agent; and a method of preventing abuse of a therapeutic agent.

Abstract: The present invention provides a tablet having improved dissolution property, which comprises (+)-3-{1-[3-(trifluoromethoxy)benzyl]piperidin-4-yl}-4-phenyl-3,4-dihydro-2(1H)-quinazolinone or a pharmaceutically acceptable salt thereof as an active component, and a production method thereof. A film-coated tablet obtained by mixing granulated particles obtained by granulating a mixture containing (a) the aforementioned active component, (b) one or more kinds of fillers selected from lactose, D-mannitol, erythritol and crystalline cellulose, (c) a cellulose-based disintegrant and (d) a water-soluble binder with a later powder containing (e) one or more kinds of fillers selected from lactose, D-mannitol and crystalline cellulose and/or (f) a cellulose-based disintegrant, forming the mixture, and applying film coating.

Abstract: A method of producing a dried formulation for an active substance such as a drug compound is described. The method involves dispersing a discontinuous phase (e.g. an oil-based or lipidic medium) comprising the active substance into a continuous phase (e.g. water) so as to form a two-phase liquid system comprising droplets of said discontinuous phase, allowing nanoparticles to congregate at the phase interface at the surface of the droplets such that at least one layer of nanoparticles coat the droplets and thereby provide sufficient structural integrity to the droplets to enable the subsequent removal of the continuous phase, and thereafter removing the continuous phase from the nanoparticle-coated droplets to produce a dried formulation.