Abstract: Disclosed herein are compositions comprising a drug such as a triptan (e.g. rizatriptan) and/or an NSAID (e.g. meloxicam) in combination with a cyclodextrin and/or a carbonate or a bicarbonate. These compositions may be orally administered, for example, to improve the bioavailability or pharmacokinetics of the drug for the treatment of conditions such as pain.

Abstract: An oral suspension formulation comprising eslicarbazepine acetate and a pharmaceutically acceptable liquid vehicle.

Abstract: The present invention pertains to a drug available for long-term continuous administration for preventing or treating glaucoma or ocular hypertension, said drug showing no decrease in efficacy during long-term administration and exhibiting a stable ocular hypotensive effect. The present invention pertains to a therapeutic agent for glaucoma or ocular hypertension that is to be continuously administered for a long period of time, said drug comprising an Rho kinase inhibitor, more specifically, to a therapeutic agent comprising an Rho kinase inhibitor for treating glaucoma or ocular hypertension in a patient suffering from glaucoma or ocular hypertension who has been administered with a therapeutic agent comprising the Rho kinase inhibitor for treating glaucoma or ocular hypertension continuously over a definite period of time and needs a further enhanced ocular hypotensive effect.

Abstract: A method for the treatment of facial Rosacea and skin erythema using pyrithione zinc aqueous solution of given concentration strength as the sole active ingredient in a topically applied fluid composition in which the pyrithione zinc aqueous solution comprises about 20% to about 30% of the fluid composition by volume, with an inactive moisturized carrier comprising the remainder of the fluid composition by volume.

Abstract: The present invention relates to a polyunsaturated fatty acid composition comprising Omega-3 fatty acids, 17-HDHA and 18-HEPE. The composition can furthermore comprise DPA and/or an acceptable carrier and can be present in a capsule or other suitable dosage unit. The invention also relates to the process of obtaining the composition and methods for using same.

Abstract: Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

Abstract: The invention provides corticosteroids that are chemically modified by covalent attachment of a water-soluble oligomer. A compound of the invention, when administered by any of a number of administration routes, exhibits a reduced biological membrane crossing rate as compared to the biological membrane crossing rate of the corticosteroid not attached to the water-soluble oligomer.

Abstract: The present invention relates to methods of treating or preventing cancer in a subject in need thereof comprising administering a therapeutically effective amount of a compound of the invention.

Abstract: The present disclosure provides, among other things, uses for ursodeoxycholic acid or analogs or conjugates or derivatives thereof, for example for ameliorating the effects of brain disorders, neurodevelopmental disorders, and neuropsychiatric disorders, and compositions relating thereto.

Abstract: The present invention relates to methods of accelerating, promoting or increasing hepatic regeneration, or increasing liver mass in a subject, by using a compound of formula (A): or a pharmaceutically acceptable salt thereof, and wherein R1, R2, R3, R4, R5, R6, m, and n are as described herein.

Abstract: The invention relates to compositions and formulations comprising at least one triterpenoic acid and at least one neutral triterpenoid and uses thereof for treating stroke or trauma and side effects related thereto.

Abstract: Novel methods of treating tumors, including neuroendocrine tumors (NET), such as a catecholamine-secreting tumor (CST), are disclosed. The methods include treating Cushing's syndrome in a Cushing's syndrome patient having a NET, such as a CST. Tumors may be treated with a glucocorticoid receptor (GR) modulator (GRM), such as a GR antagonist (GRA). The novel treatments may treat Cushing's syndrome, may reduce catecholamine production by the tumor, may reduce catecholamine excess, may ameliorate symptoms of catecholamine excess, and may improve the efficacy of ?-adrenergic or ?-adrenergic blockade, somatostatin or somatostatin analog treatment or imaging, or Peptide Receptor Radionuclide Therapy, in patients with a CST. The GRM may reduce the activation of a GR, and may bind to a GR with higher affinity than it binds to a progesterone receptor (PR). In embodiments, the drug may only poorly bind to PR, or may not measurably bind to PR.

Abstract: Provided is a slow release composition to promote bone growth, the slow release composition comprising: an oxysterol encapsulated in a biodegradable polymer to control the release of the oxysterol. Methods of making and use are further provided.

Abstract: The invention relates to a multilayer dosage form comprised of: a) a neutral core; b) an inner coating consisting of a methacrylate copolymer; c) an outer coating consisting of a copolymer of which 40 to 95% by weight is composed of radically polymerized C1 to C4 alkyl esters of acrylic acid or of methacrylic acid and of which 5 to 60% by weight is composed of (meth)acrylate monomers having an anionic group in the alkyl radical. The invention is characterized in that the inner coating is essentially comprised of a methacrylate copolymer, of which at least up to 90% by weight consists of (meth)acrylate monomers with neutral radicals, which, in accordance with DIN 53 787, has a minimum film formation temperature of no higher than 30° C., and which contains the pharmaceutical active substance in bound form.

Abstract: Embodiments provide apparatus and methods for delivering solid form medications such as pellets to various locations in the body. One embodiment provides an apparatus for in vivo delivery of medication pellets comprising a housing including a port, a pellet-containing belt disposed in the housing, and a mechanism for transferring the pellets from the belt to a delivery site (DS) outside the housing. Each pellet contains a dose of drug to treat a medical condition. An elongate member is coupled to the housing and includes a lumen for pellet delivery, a proximal end coupled to the port and a distal end positioned at the DS. The pellet can be delivered to the DS at regular intervals or responsive to a detected biological event. Embodiments of the invention are particularly useful for delivering medication to treat a medical condition over an extended period without requiring a patient to take external medication.

Abstract: An improved lyophilized cyclophosphamide solid composition is described. The lyophilized cyclophosphamide solid composition is thermally stable, contains anhydrous cyclophosphamide and mannitol, and is substantially free of cyclophosphamide monohydrate. A method for preparing the lyophilized cyclophosphamide solid composition is also provided.

Abstract: An improved lyophilized cyclophosphamide solid composition is described. The lyophilized cyclophosphamide solid composition is thermally stable, contains anhydrous cyclophosphamide and mannitol, and is substantially free of cyclophosphamide monohydrate. A method for preparing the lyophilized cyclophosphamide solid composition is also provided.

Abstract: This invention relates to a pharmaceutical composition comprising 5-chloro-N4-[2-(dimethylphosphoryl)phenyl]-N2-{2-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}pyrimidine-2,4-diamine as the active pharmaceutical ingredient, and therapeutic uses of the pharmaceutical formulation. In particular, the invention is directed to tablets comprising the pharmaceutical composition, methods of preparing the tablets, and therapeutic uses thereof.

Abstract: Oral dosage forms of bisphosphonates, such as zoledronic acid, in an acid form or a salt form can be used to treat or alleviate pain or related conditions. Zoledronic acid also tends to speed up the conversion of M1-dominant to M2-dominant Modic changes and decrease the volume of M1-dominant Modic changes, which correlate with improvement in symptoms.

Abstract: The present invention provides a composition comprising a mixture of an exogenous ketone body, an exogenous NAD modulator and a methyl donor. Typically, exogenous NAD modulator is an exogenous nicotinamide adenine dinucleotide (NAD) precursor. The present invention also provides a method of using such a composition for treating various clinical conditions, including metabolic disorders and neurocognitive impairments. The compositions of the invention can also be used to improve human performance in various competitive or environmental conditions.

Abstract: The present invention relates to nanoemulsion type synthetic red blood cells having a calcium phosphate coating of controllable thickness, and to a preparation method thereof. According to the present invention, Ca2+ and PO42? coating layers are uniformly and sequentially formed using a layer-by-layer (LBL) coating method while controlling the thicknesses of the coating layers. Thus, the oxygen capacity and oxygen release rate of the synthetic red blood cells can be controlled, and the synthetic red blood cells can be retrieved and reused.

Abstract: A method of treating a bacterial infection in a subject in need thereof includes administering to the subject therapeutically effective amounts of at least one ?-lactam antibiotic and at least one triazolylmethyl boronic acid.

Abstract: The present invention provides compositions and formulations capable of maintaining or promoting the growth of certain strains of Lactobacilli spp. The compositions and formulations generally comprise only a single therapeutic agent selected from the group consisting of isomaltulose, maltitol, pullulan, maltotriose, 2-deoxy-D-ribose, 1-kestose and erlose. The single therapeutic agent is the sole source of carbon for bacterium when administered to a user. Despite comprising only a single therapeutic agent the compositions have been shown to promote the growth and maintenance of beneficial lactobacilli and to effectively inhibit the growth of pathogens associated with urogenital infections. As such administration of the compositions maintain a healthy microflora balance in the urogenital area.

Abstract: The inventive subject matter provides compositions and methods for reducing serum levels of at least one biomarker associated with a lipid or liver-related condition. Preferred compositions include a set of actives that consists essentially of at least two saccharides selected from galacturonic acid, galactose, arabinose, rhamnose, glucose, xylose, and mannose.

Abstract: The present disclosure relates to methods of extending the lifespan of a subject or treating, suppressing, inhibiting or delaying the onset of an age-related condition or disorder, such as cancer, in a subject. The methods comprise administering to the subject an effective amount of (i) a compound that sustains pharmacological activation of xenobiotic metabolism, (ii) a cardiac glycoside, (iii) a chelator, (iv) inulin, (v) D-valine, or any combination thereof. In a further aspect, the present disclosure relates to a method of identifying clinical candidates by performing a high throughput screening in mammals of test compounds which have great structural and/or functional diversity.

Abstract: The disclosure provides an oral antiviral supplement composition comprising a lysine, an ascorbic compound, a flavonoid glycoside, a threonine, and a pyridoxine. The disclosure also provides a method of reducing viral replication in a cell comprising treating a virus-infected cell with a composition of the disclosure. The disclosure further provides a method for the treatment and prophylaxis of a viral infection in a patient comprising administering a composition of the disclosure.

Abstract: The invention provides medicaments comprising an oenothein, including oral formulations to treat inflammation or to treat hormone balance in perimenopausal, menopausal and postmenopausal women. The oenothein for use in such formulations such as oenothein A or oenothein B maybe purified from natural sources, such as Epilobium.

Abstract: Foods or meals high in available carbohydrate such as sucrose or starch increase postprandial blood glucose concentrations. According to Node et al. (Cardiovascular diabetology, 8, 23 (2009)), repeated high post-prandial plasma glucose “spikes” are associated with an increased risk of developing type II diabetes. Unregulated glycemic excursions are undesirable, and any reduction or “blunting” of the post-prandial glucose concentration in blood is potentially beneficial. This invention relates to an edible composition for delay of intestinal glucose uptake through synergistic inhibition of both active sodium glucose co-transporter 1 (SGLT1) and passive glucose transporter 2 (GLUT2) leading to flattening or blunting of the post-prandial glucose peak.

Abstract: The present disclosure relates to composition comprising Trigofoenoside, Vitexin, Iso-vitexin, Vitexin-2-o-rhamnoside Vicenin-1 and fiber, optionally along with pharmaceutically acceptable excipient(s) and method(s) of preparing said composition. The present disclosure also relates to methods of managing various conditions such as, but not limited to, Hypoxia, Pulmonary Hypertension, Pulmonary Fibrosis and Sinusitis using the said composition.

Abstract: Provided herein are pharmaceutically acceptable compositions containing macrolide antibiotics, in particular azithromycin and tulathromycin. In particular, compositions containing azithromycin or tulathromycin with low toxicity, especially for administration to canines, are provided herein.

Abstract: The present application discloses compositions and methods useful for controlling blood glucose and insulin resistance during the acute stress response. It is shown that Atglistatin can attenuate glucose excursions and insulin resistance arising from surgical procedures. It is further disclosed herein that Atglistatin is useful for inhibiting and preventing hyperglycemia and insulin resistance in many acute stress conditions, including, but not limited to, surgery, trauma/hemorrhage, burns, sepsis, myocardial infarction, and stroke.

Abstract: The present invention relates generally to methods and compositions for gene therapy and immunotherapy that activate gamma delta T-cells, and in particular, can be used in the treatment of various cancers and infectious diseases.

Abstract: The present disclosure relates to compositions and methods for treating cancers using antisense (AS) nucleic acids directed against Insulin-like Growth Factor 1 Receptor (IGF-1R). The AS may be administered to the patients systemically, or may be used to produce an autologous cancer cell vaccine. In embodiments, the AS are provided in an implantable irradiated biodiffusion chamber comprising tumor cells and an effective amount of the AS. The chambers are irradiated and implanted in the abdomen of subjects and stimulate an immune response that attacks tumors distally. The compositions and methods disclosed herein may be used to treat many different kinds of cancer, for example glioblastoma.

Abstract: Aspects of the invention provide compositions for use in the treatment galectin-dependent diseases. In particular, compositions comprising a selectively depolymerized, branched galactoarabino-rhamnogalacturonate whose backbone is predominantly comprised of 1,4-linked galacturonic acid (GalA) moieties, with a lesser backbone composition of alternating 1,4-linked GalA and 1,2-linked rhamnose (Rha), which in-turn is linked to any number of side chains, including predominantly 1,4-b-D-galactose (Gal) and 1,5-a-L-arabinose (Ara) residues.

Abstract: A skin care composition is disclosed comprising at least one exopolysaccharide (EPS) originating from a microbial mat, the EPS being in a concentration of about 0.001% w/w to about 1.5% w/w of the composition. Uses and methods of use thereof. In specific embodiments, the EPSs are derived from microorganisms isolated from microbial mats found in French Polynesia. The composition is useful in reducing signs of skin aging and environmental damage by altering skin cell metabolism and improving hydration.

Abstract: The disclosure features methods of reducing or inhibiting an anti-drug antibody response in a subject, as well as methods of reducing or inhibiting unwanted immune cell activation in a subject to be treated with a messenger RNA (mRNA), comprising administering to the subject a mRNA, e.g., a chemically modified messenger RNA (mmRNA), encoding a polypeptide of interest, wherein the mRNA comprises at least one microRNA (miR) binding site for a miR expressed in immune cells, such as miR-126 binding site and/or miR-142 binding site, such that an anti-drug antibody response to the polypeptide or interest, or unwanted immune cell activation (e.g., B cell activation, cytokine secretion), is reduced or inhibited in the subject. The disclosure further provides therapeutic treatment regimens designed to reduce or inhibit AD A or unwanted immune cell activation (e.g., B cell activation, cytokine secretion) in a subject being treated with mRNA-based therapeutics.

Abstract: Disclosed herein are antisense compounds and methods for decreasing apo(a) to treat, prevent, or ameliorate diseases, disorders or conditions related to apo(a) or Lp(a). Certain diseases, disorders or conditions related to apo(a) or Lp(a) include inflammatory, cardiovascular and/or metabolic diseases, disorders or conditions. The antisense compounds disclosed herein can be used to treat such diseases, disorders or conditions in an individual in need thereof.

Abstract: The present invention provides an anticancer agent to be used as a single agent. More specifically, the present invention provides an anticancer agent containing complexes that contain (a) an oligodeoxynucleotide containing a humanized K-type CpG oligodeoxynucleotide and polydeoxyadenylic acid, the polydeoxyadenylic acid being located on the 3? side of the humanized K-type CpG oligodeoxynucleotide, and (b) ?-1,3-glucan. The present invention is preferably characterized in that the anticancer agent is administered without a cancer antigen.

Abstract: Administration of low molecular weight (10,000-20,000 Daltons, or lower) pectins, particularly modified citrus pectins (MCP), like PectaSol-C reduces galectins-3 levels in vivo. Reduction of galectin-3 levels by MCP inhibits inflammation, inhibits fibrosis formation in organs and tissues, and inhibits cancer formation, progression, transformation and metastases. The reduction in circulating, serum and cellular galectin-3, inherently resulting from the administration of MCP, provides benefit over a spectrum of biological conditions, as evidenced by in vivo trials.

Abstract: Administration of low molecular weight (10,000-20,000 Daltons, or lower) pectins, particularly modified citrus pectins (MCP), like PectaSol-C reduces galectins-3 levels in vivo. Reduction of galectin-3 levels by MCP inhibits inflammation, inhibits fibrosis formation in organs and tissues, and inhibits cancer formation, progression, transformation and metastases. The reduction in circulating, serum and cellular galectin-3, inherently resulting from the administration of MCP, provides benefit over a spectrum of biological conditions, as evidenced by in vivo trials.

Abstract: The invention relates to a long chain inulin for influencing the immune response against a pathogen. The invention also relates to a combination comprising a long chain inulin and a vaccine for influencing the immune response against a pathogen, wherein the long chain inulin is orally administrated.

Abstract: The present invention provides non-anticoagulant sulfated or sulfonated polysaccharides (NASPs), which accelerate the blood clotting process. Also provided are pharmaceutical formulations comprising a NASP of the invention in conjunction with a pharmaceutically acceptable excipient and, in various embodiments, these formulations are unit dosage formulations. The invention provides a NASP formulation, which is orally bioavailable. Also provided are methods for utilizing the compounds and formulations of the invention to promote blood clotting in vivo as therapeutic and prophylactic agents and in vitro as an aid to studies of the blood clotting process.

Abstract: Described herein are compositions for purging the GI tract of a subject together with methods of manufacture of said compositions. In various embodiments, compositions for purging the GI tract of a subject may comprise USP food ingredients and USP/NF grade chemicals mixed together to form homogeneous edible mixtures. Methods of manufacture of formulations for delivery laxatives may comprise a temperature controlled process.

Abstract: Provided are therapeutic formulations and methods of use thereof.

Abstract: Provided herein are methods for maintaining physiological levels of nitrite in a subject undergoing hemodialysis. Also provided herein are methods of administering pharmaceutically acceptable sodium nitrite to a subject undergoing hemodialysis.

Abstract: Provided herein are pharmaceutically acceptable sodium nitrite and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-volatile organic carbon in a sodium nitrite-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium nitrite. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium nitrite.

Abstract: Provided herein are methods for maintaining physiological levels of thiosulfate in a subject undergoing hemodialysis. Also provided herein are methods of administering pharmaceutically acceptable sodium thiosulfate to a subject undergoing hemodialysis.

Abstract: A composition including a hydrate form of magnesium oxide, denoted as MgO.(H2O)n, at a concentration ranging from 1 to 100 weight percent (wt %), where n is any value from 0.1 to 2. The composition may further include MgO at a concentration ranging from 0 to 99 wt %; or Mg(OH)2, at a concentration ranging from 0 to 99 wt %; or Mg(OH)2 at a concentration ranging from 0 to 99 wt %, and MgO, at a concentration ranging from 0 to 99 wt %.

Abstract: In one embodiment, the present invention provides a composition, wherein the composition is a porous scaffold, wherein the pores of the scaffold are from 2 to 500 microns, the composition comprising: a) a cross-linkable protein selected from the group consisting of collagen and gelatin; b) a cross-linker which induces cross-linking of the cross-linkable protein; and c) a liquid.

Abstract: Region-specific extracellular matrix (ECM) biomaterials are provided. Such materials include acellular scaffolds, sponges, solutions, and hydrogels suitable for stem cell culture.