Abstract: A formulation for administration of at least one therapeutic mammalian protein to a mammal or a protein selected from the group, and for enhancing the absorption, distribution and release of the at least one therapeutic mammalian protein in or on the mammal, comprising at least one therapeutic mammalian protein in a micro-emulsion comprising a dispersion of vesicles or microsponges of a fatty acid based component in an aqueous or other pharmacologically acceptable carrier in which nitrous oxide is dissolved, the fatty acid based component comprising at least one long chain fatty acid based substance selected from the group consisting of free fatty acids and derivatives of free fatty acids. A method for effective delivery of at least one therapeutic mammalian protein to a mammal and for enhancing the therapeutic efficacy of such at least one therapeutic mammalian protein, comprising the step of administering the at least one therapeutic mammalian protein to the mammal in such a formulation.

Abstract: Embodiments of the invention relate to particles of active substances, methods for preparing the particles, formulations containing the particles, and metered dose inhalers containing such particles or formulations. In one embodiment, a composition of an aerosol formulation is provided and contains a particulate active substance of non-micronized, solid particles having a mass median aerodynamic diameter of less than 10 ?m suspended in a hydrofluorocarbon fluid vehicle at a concentration within a range from about 0.2% w/v to about 5% w/v. The aerosol formulation exhibits a flocculation volume of about 85% or greater about 1 minute after mixing the particulate active substance and the hydrofluorocarbon fluid vehicle. The particulate active substance contains an alkaloid ergotamine, pharmaceutically acceptable salts thereof, analogs thereof, or derivatives thereof.

Abstract: Provided herein are dry pharmaceutical compositions for transmucosal delivery, comprising spray-dried particles that include pharmaceutically active agent nanoparticles, a binder, and a pharmaceutically acceptable carrier, where the active agent nanoparticles have an average particle size diameter prior to spray-drying of less than about 1 ?m, and wherein up to 10% of the spray-dried particles have a particle size of less than 10 ?m; at least 50% of the spray-dried particles have a particle size of at least about 15 ?m; and at least 90% of the spray-dried particles have a particle size of up to about 55 ?m. Also provided are methods for making such pharmaceutical compositions and therapeutic methods comprising transmucosally administering the compositions, such as intranasally or intravaginally.

Abstract: Compositions and methods for targeted delivery of therapeutic agents, and particularly for mucosal, oral, nasal, or parenteral delivery of therapeutic agents. The compositions comprise carrier particles containing or encapsulating a therapeutic agent or agents, which have been modified on their surface to contain one or more targeting moieties that enable the enhanced uptake and transport of the therapeutic agent via receptor-mediated processes such as endocytosis or transcytosis.

Abstract: Provided herein are methods and compositions for treating a subject who has pulmonary damage or an injury caused by or who is at risk for an injury caused by an anti-vesicant agent. The compositions comprise cacao extracts that include a mixture of epicatechin and one or more epicatechin oligomers and a pharmaceutically acceptable carrier. Also provided are methods for fermenting cacao to enhance epicatechin and antioxidant content.

Abstract: A temperature stable nanoparticle is provided comprising a core, a water soluble polymer and a peptide, the water soluble polymer attached to the core at a first terminus of the water soluble polymer, the peptide attached to a second terminus of the water soluble polymer, the peptide comprising an RGD amino acid sequence, the water soluble polymer of having sufficient length to allow binding of the peptide to glycoprotein lib/Ilia (GPIIb/llla). In one aspect, the nanoparticle has a melting temperature over 35° C. In various aspects, the nanoparticle has a spheroid shape and a diameter of less than 1 micron.

Abstract: The invention provides, inter alia, immunogenic compositions that comprise (a) a first antigen, (b) at least first and second adjuvants, wherein the first adjuvant comprises microparticles and wherein the second adjuvant comprises an imidazoquinoline compound, and (c) a pharmaceutically acceptable excipient, which compositions elicits an immune response when administered to a vertebrate subject. The invention also provides methods of producing immunogenic compositions and methods for using immunogenic compositions (e.g., for treatment), among other benefits.

Abstract: The present invention provides nanoparticle compositions including one or more peptides. The present invention achieves transdermal delivery of such peptides without the need for peptide modification, or for use of chemical or mechanical abrasion or disruption of skin.

Abstract: Compositions that facilitate the delivery of an active agent or an active agent carrier wherein the compositions are capable of penetrating the stratum corneum (SC) and/or the cellular membranes of viable cells are provided. In some embodiments, the compositions include a peptide, an active agent, and a carrier that includes the active agent, wherein the peptide has an amino acid sequence set forth in any of SEQ ID NOs: 1-18; the peptide is associated with and/or conjugated to the active agent, the carrier, or both; the carrier is selected from the group consisting of a micelle, a liposome, an ethosome, and combinations thereof; and the composition is capable of penetrating a stratum corneum (SC) layer when contacted therewith or penetrating a cell when contacted therewith, and optionally wherein the composition further includes one or more free peptides having an amino acid sequence set forth in any of SEQ ID NOs: 1-18.

Abstract: Methods for preparing dry powders having hydrophobic and hydrophilic components comprise combining solutions of the components and spray drying them simultaneously in a spray dryer. The hydrophilic and hydrophobic component are separately dissolved in separate solvents and directed simultaneously through a nozzle, usually a coaxial nozzle, into the spray dryer. The method provides dry powders having relatively uniform characteristics.

Abstract: A method for treating or preventing disorders, diseases, and symptom of reflux, that is laryngopharyngeal reflux (LPR), in the laryngopharynx caused by pepsin comprises orally administering to the laryngopharynx of a patient an effective amount of cellulose powder. A method for treating or preventing damage to the lining membranes of at least some of the aerodigestive tract, the damage caused by pepsin, comprises coating at least some of the lining membranes with an effective amount of a cellulose powder. Upon inhalation of the powder, the powder coats the lining membranes. Upon coating the lining membranes, the powder becomes a gel. The gel prevents the pepsin from binding with the lining membranes, thereby preventing damage caused by pepsin in laryngopharyngeal reflux or in extra-esophageal reflux.

Abstract: This invention relates to a solid drug formulation comprising granulates containing• a therapeutically active compound of the formula (I) or a geometric isomer, a stereoisomer, a pharmaceutically acceptable salt, an ester thereof or a metabolite thereof, in combination with one or more intra-granular excipients.

Abstract: The present invention provides three-dimensional, nanoscale delivery systems, particularly well adapted for delivery of nucleic acids and/or nucleic acid associated entities.

Abstract: The present invention provides colloidally stable dispersions of nanoparticles comprising beta-lactoglobulin and a polysaccharide which are transparent when diluted in aqueous media. In particular these colloidally stable dispersions of nanoparticles are useful as delivery vehicles of hydrophobic nutraceuticals and fat-soluble vitamins, for enrichment of food products, especially of transparent beverages and other non-fat or low fat foods and drinks. The present invention further provides methods for the preparation of said colloidally stable dispersions.

Abstract: Embodiments of the present invention provide pharmaceutical compositions in unit dosage form that comprise a therapeutically effective amount of levothyroxine sodium; an antioxidant in an amount sufficient to stabilize the levothyroxine sodium against oxidation; an amount of an alditol sufficient to stabilize the levothyroxine sodium; and at least two excipients selected from a filler, a binder, and a lubricant. Such compositions are free of added monosaccharide, disaccharide, and an oligosaccharide and are storage stable.

Abstract: The invention relates to a method for the production of carrier pellets for pharmaceutical active substances. Likewise, the invention relates to such carrier pellets and also to pharmaceutical formulations containing these. The carrier pellets according to the invention are used for transporting and releasing pharmaceutical active substances, in particular in the human body.

Abstract: Microparticles and nanoparticles and compositions thereof are provided. The microparticles and nanoparticles and compositions may be used for the treatment of musculoskeletal disease, such as osteoarthritis and injury.

Abstract: Alveolar macrophages contribute to host defenses against influenza. Enhancing their function contributed to protection against influenza and other acute lethal pulmonary infections. Wild-type mice and Tg mice expressing GM-CSF in the lung were infected with influenza virus, and lung pathology, weight loss and mortality were measured. GM-CSF was also administered to lungs of wild-type mice that were infected with influenza virus. All Tg mice expressing GM-CSF in the lungs survived with greatly reduced weight loss and lung injury and histologic evidence of a rapid host inflammatory response that controlled infection vs. wild-type mice not expressing GM-CSF in the lungs. This resistance to influenza was abrogated by elimination of alveolar phagocytes, but not by depletion of T cells, B cells or neutrophils. Tg mice had far more alveolar macrophages than wild-type mice and were more resistant to influenza-induced apoptosis. Delivery of intranasal GM-CSF to wild-type mice also conferred influenza resistance.

Abstract: Injectable compositions having improved injectability. The injectable compositions include microparticles suspended in an aqueous injection vehicle having a viscosity of at least 20 cp at 20° C. The increased viscosity of the injection vehicle that constitutes the fluid phase of the suspension significantly reduces in vivo injectability failures. The injectable compositions can be made by mixing dry microparticles with an aqueous injection vehicle to form a suspension, and then mixing the suspension with a viscosity enhancing agent to increase the viscosity of the fluid phase of the suspension to the desired level for improved injectability.

Abstract: The present invention is related to a biodegradable carrier with adjustable zeta potentials and particle sizes, a method for making the same, and a pharmaceutical composition comprising the same. In such a method, a first solution comprising a first biodegradable macromolecule is prepared, and a second solution comprising a second biodegradable macromolecule is also prepared according to a desired zeta potential of a biodegradable carrier and further added into the first solution to form a mixture solution. The biodegradable carrier with the desired zeta potentials is formed by the attraction force between the different electric properties. Then, the mole number of the first biodegradable macromolecule and the second biodegradable macromolecule in the mixture solution are proportionally adjusted according to a desired particle size of the biodegradable carrier. Therefore, the zeta potential and the particle size of the biodegradable carrier are adjustable artificially.

Abstract: The invention discloses pharmaceutical compositions in liquid form comprising a peptide with the amino acid sequence KLKL5KLK and an oligodeoxynucleotide with the nucleic acid sequence (dIdC)13 and wherein the peptide and the oligodeoxynucleotide are present as sterile-filterable nanoparticles in the composition, thereby forming a suspension, characterized in that the mean particle size of the solid particles is less than 1 ?m.

Abstract: The embodiment of the invention is a virus-like particle vector, a process for the manufacture thereof, use of the virus-like particle vector and a pharmaceutical composition, which contains the virus-like particle vector. The vector is intended for the delivery of therapeutic agents into specific mammalian tissues, especially low molecular weight agents, in particular low molecular weight anti-cancer drugs into cancer tissues. More specifically, the invention relates to the virus-like particle vector, which constitutes an adenoviral dodecahedron with the therapeutic substance encapsulated or covalently linked.

Abstract: This document provides methods and materials related to treating cancer (e.g., skin cancer). For example, methods and materials relating to the use of a composition containing albumin-containing nanoparticle/antibody complexes (e.g., Abraxane®/anti-VEGF polypeptide antibody complexes) to treat cancer (e.g., skin cancer) are provided.

Abstract: An inhalable medicament is provided, in particular a new solid-state form of tiotropium bromide. The medicament can be in the form of solid amorphous particles containing an intimate admixture of tiotropium bromide together with a pharmaceutically acceptable co-solid having a glass transition temperature of at least ?50° C., such as a sugar and/or sugar alcohol.

Abstract: The present invention provides combination therapy methods of treating a proliferative disease (such as cancer) comprising a first therapy comprising administering to an individual an effective amount of a taxane in a nanoparticle composition, and a second therapy which may include the administration of an effective amount of at least one other agent that modifies the epigenetics in a cell.

Abstract: There is presently provided a suspension of immiscible particles in a solution, wherein the particles comprise an agglomeration of a bioactive agent, for example an anti-cancer agent; and a plurality of conjugates of a hyaluronic acid and a flavonoid, for example a catechin-based flavonoid, wherein the particles are on average from about 15 nm to about 300 nm in diameter and wherein the bioactive agent is releasably retained in the particles by the flavonoid. The suspension is useful for the delivery of the bioactive agent to cells, including cancer cells. There are also provided a therapeutic formulation comprising the suspension, as well as methods for using the suspension and therapeutic formulation, including for delivery of a bioactive agent to a cell and for treating a disease, including cancer.

Abstract: Pharmaceutical compositions are provided comprising an active agent and a dextran polymer derivative. The compositions include from 0.01 to 99 wt % of an active agent and from 1 to 99.99 wt % of a dextran polymer derivative. The dextran polymer derivative is selected from dextran acetate, dextran propionate, dextran succinate, dextran acetate propionate, dextran acetate succinate, dextran propionate succinate, dextran acetate propionate succinate, and mixtures thereof.

Abstract: A composition of matter comprising non-cellular particles, which comprise a lysosomal enzyme and/or a small molecule which increases an amount and/or activity of a lysosomal enzyme.

Abstract: Disclosed are spherical particles of clopidogrel bisulfate and a pharmaceutical composition containing the same. The spherical particles can be used for preparing a tablet having sufficient hardness through direct compression, by improving unformulable properties of clopidogrel bisulfate such as compressibility, flowability and strong surface electrostatic charges, reduce a problem in compressing tablets such as weight variation, sticking, etc., and the risk of form conversion, and improve physiochemical stability. Therefore, the spherical particles of the present invention may be used as therapeutics for arteriosclerosis, stroke, myocardial infarction and atherosclerosis.

Abstract: The present invention relates to a process for stabilizing an adjuvant containing vaccine composition, an adjuvanted vaccine composition in dry form and in particular a process for stabilizing an influenza vaccine composition, particularly an adjuvanted influenza vaccine composition in dry form.

Abstract: Microparticle formulations are produced by contacting an aqueous solution of a protein or other active agent with an organic solvent, a counterion and a scavenging agent, and chilling the solution. The microparticles are useful for preparing stable, uniform pharmaceuticals of predetermined defined dimensions.

Abstract: The present invention provides a method for performing a biological test under conditions in which an artificially prepared cell pattern with initial position coordinates that can be determined is three-dimensionally cultured within a gelled matrix. The present invention relates to a biological test method that comprises testing a biological indicator with reference to at least one selected from the group consisting of cell proliferation, cell movement, and cell differentiation in a cell pattern substantially embedded in gel. The present invention also relates to a kit for the biological test method.

Abstract: Disclosed are high density lipoprotein-nucleic acid particles, wherein the particles include (a) an apolipoprotein; (b) a nucleic acid component comprising a therapeutic nucleic acid segment; and (c) a polypeptide comprising a positively charged region, wherein the positively-charged region of the polypeptide associates with the nucleic acid component. Also disclosed are pharmaceutical compositions that include a) an apolipoprotein; (b) a nucleic acid component comprising a therapeutic nucleic acid segment; and (c) a polypeptide comprising a positively charged region. Methods that concern the particles and pharmaceutical compositions of the present invention are also set forth, as well as kits.

Abstract: The present invention relates to a method for preparation of heparin silver, to use of heparin silver in manufacture of medicine for treating burns and/or scalds, to a method of using heparin silver to treat burns and/or scalds, and to a topical preparation containing heparin silver for treating burns and/or scalds. The heparin silver product prepared according to the method of the present invention has a high purity and less impurity. The animal test proved that the medicine made by using heparin silver exhibited effects of accelerating wound healing and reducing scar formation.

Abstract: The invention relates to anti-TNFR1 polypeptides and antibody single variable domains (dAbs) that are resistant to degradation by a protease, as well as antagonists comprising these. The polypeptides, dAbs and antagonists are useful for as therapeutics and/or prophylactics that are likely to encounter proteases when administered to a patient, for example for pulmonary administration, oral administration, delivery to the lung and delivery to the GI tract of a patient, as well as for treating inflammatory disease, such as arthritis or COPD.

Abstract: The invention relates to solid compositions that may be suitable for administering a therapeutic agent to a subject. The invention also relates to methods of making such solid compositions. The invention further relates to methods of treating a disease, condition, or disorder by administering to a subject such solid compositions.

Abstract: A method for treating or preventing disorders, diseases, and symptom of reflux, that is laryngopharyngeal reflux (LPR), in the laryngopharynx caused by pepsin comprises orally administering to the laryngopharynx of a patient an effective amount of cellulose powder. A method for treating or preventing damage to the lining membranes of at least some of the aerodigestive tract, the damage caused by pepsin, comprises coating at least some of the lining membranes with an effective amount of a cellulose powder. Upon inhalation of the powder, the powder coats the lining membranes. Upon coating the lining membranes, the powder becomes a gel. The gel prevents the pepsin from binding with the lining membranes, thereby preventing damage caused by pepsin in laryngopharyngeal reflux or in extra-esophageal reflux.

Abstract: The present invention is concerned with novel pharmaceutical compositions of itraconazole which can be administered to a mammal suffering from a fungal infection, whereby a single such dosage form can be administered once daily, and in addition at any time of the day independently of the food taken in by said mammal. These novel compositions comprise particles obtainable by melt-extruding a mixture comprising itraconazole and an appropriate water-soluble polymer and subsequently milling said melt-extruded mixture.

Abstract: The present invention provides compositions and methods for the delivery of therapeutic agents to cells. In particular, these include novel cationic lipids and nucleic acid-lipid particles that provide efficient encapsulation of nucleic acids and efficient delivery of the encapsulated nucleic acid in vivo. The compositions of the present invention are highly potent, thereby allowing effective know-down of a specific target protein at relatively low doses. In addition, the compositions and methods of the present invention are less toxic and provide a greater therapeutic index compared to compositions and methods previously known in the art.

Abstract: This application relates to compositions comprising shortened fibers of poly-N-acetylglucosamine and/or a derivative thereof (“sNAG nanofibers”) and the use of such compositions in the treatment of disease.

Abstract: The present invention provides for methods of preparing silk nanoparticles and microparticles, methods of encapsulating an active agent into the silk nano- and microparticles and compositions comprising these silk particles.

Abstract: A dispersible powder composition comprises aminoglycoside for delivery to the lungs. The composition is effective to provide a therapeutically effective therapy via administration of less than 6 respirable unit doses by inhalation, wherein each unit dose comprises a volume of 0.30 to 0.95 mL.

Abstract: This invention relates to crosslinked protein nanoparticles and a method for producing the same. The method comprises the preparation and nanonization (i.e., size reduction to the nanoscale) of protein nanoparticle precursor materials—i.e., crosslinked proteins of the micron or greater size—via mechanical or hydrodynamic shear, mechanical crushing, sonic cavitation and/or hydrodynamic cavitation.

Abstract: A process for preparing polymeric composite particles includes the steps of preparing an oil phase containing a biodegradable polymer and a water phase containing a hydrophilic compound or nanoparticle and emulsifying the oil phase in the water phase to form emulsions. Then solvent is removed from the emulsions to prepare the particles in the form of capsules and spheres in sizes from 0.01 ?m (10 nm) to 50 ?m.

Abstract: Disclosed herein is an active pellet. The active pellet includes a body and interspaces. The body includes an active ingredient ranging from 50 to 100 wt %, free of chemical additives.

Abstract: The present invention provides for silk fibroin-based compositions comprising one or more antibiotic agents for prevention or treatment of microbial contamination, methods of making antibiotic-containing silk scaffold, methods of stabilizing antibiotics in silk scaffolds, and methods for preventing or treating microbial contamination using the antibiotic-containing compositions. Various methods may be used to embed the antibiotic(s) into the silk fibroin-based compositions. The antibiotic-containing compositions of the invention are particular useful for stabilizing antibiotics, preventing bacterial infections, and for medical implants, tissue engineering, drug delivery systems, or other pharmaceutical or medical applications.

Abstract: The present invention relates to novel microparticles formed of amphiphilic polyamino acids which transport active principle(s), AP(s), in particular protein and peptide active principle(s), and to novel modified-release pharmaceutical formulations comprising said AP microparticles. Microparticles of amphiphilic polyamino acid (PO) may include at least one AP (associated noncovalently) which spontaneously form a colloidal suspension of nanoparticles in water, at pH 7.0, under isotonic conditions. The microparticles may be obtained by atomization of a solution or colloidal suspension of PO comprising at least one AP, may have a size of between 0.5 and 100 microns, and may be dispersible in colloidal suspension.

Abstract: The present invention provides a film composition effective for correcting irregularities on the skin surface, which has stretchability and flexibility as a result of crosslinkable protein microparticles in the film composition being crosslinked by transglutaminase, as well as superior air permeability and moisture evaporation properties as a result of forming a film with the crosslinkable protein microparticles.

Abstract: Microparticle formulations of a sialidase fusion protein are produced by contacting an aqueous solution of a protein or other active agent with an organic solvent, a counterion and a scavenging agent, and chilling the solution. The microparticles are useful for preparing stable, uniform pharmaceuticals of predetermined defined dimensions.

Abstract: The present invention generally relates to treatment of iron-related conditions with iron carbohydrate complexes. One aspect of the invention is a method of treatment of iron-related conditions with a single unit dosage of at least about 0.6 grams of elemental iron via an iron carbohydrate complex. The method generally employs iron carbohydrate complexes with nearly neutral pH, physiological osmolarity, and stable and non-immunogenic carbohydrate components so as to rapidly administer high single unit doses of iron intravenously to patients in need thereof.