Abstract: A pharmaceutical composition in the form of a combination tablet is described. The tablet has a rapidly absorbed component that enters the circulation by traversing the buccal mucosa, oral mucosa and combinations thereof, and a more slowly absorbed component that is swallowed. The therapeutic agent in the swallowed portion is absorbed across the gastric mucosa. The combination tablet may be modified, by varying the specific combinations of excipients, fillers, and the like to effect distinct release rates. In addition, the rapid and slow components may have identical or different therapeutic agents depending on the application to a specific medical condition. One embodiment of the combination tablet includes a prostaglandin inhibitor in the rapidly absorbed component in order to mitigate the side effects of immediate release niacin that is in the slow absorbing component.

Abstract: The present invention relates to oral controlled-release formulations of 5-(pyridinyl)-2(1H)-pyridinone compounds and their use in the treatment of a subject with heart failure, a stage, class or manifestation of heart failure, or at risk of developing or exhibiting symptoms of heart failure. The formulations of the invention release the compounds in the range of between 0.1 ?g/kg body weight/minute and 20 ?g/kg body weight/minute.

Abstract: The present invention is directed to compositions and methods of delivery of CoQ-10 solubilized in monoterpenes. Use of monoterpenes as dissolving agents, greatly effects the ability to incorporate greater amounts of bioactive CoQ-10 in formulations, such as soft gel capsules.

Abstract: A composition is described that includes lipid microcapsules and at least one dispersed active principle. A method is also described for preparing the composition. Also described, is the use of the composition in the treatment of dermatological diseases.

Abstract: The present disclosure relates to orally available stabilized supplement-containing articles (e.g., softgels). The stabilized supplement may be a probiotic, and may contain a stabilizing component derived from chocolate. The present disclosure also relates to methods of making such stabilized articles.

Abstract: Intact, bacterially-derived minicells can safely introduce therapeutically effective amounts of plasmid-free functional nucleic acid to target mammalian cells. To this end, functional nucleic acid can be packaged into intact minicells directly, without resort to expression constructs, the expression machinery of the host cell, harsh chemicals or electroporation.

Abstract: Provided herein are methods of inhibiting proliferation of one or more tumor cells comprising contacting the one or more tumor cells with a composition comprising one or more epigenetic drugs that inhibit one or more epigenetic mechanisms of the tumor cells, wherein the one or more epigenetic drugs are encapsulated in a nanogel. The invention is also directed to methods of treating a tumor, metastasis of a tumor or a combination thereof in an individual in need thereof. The invention is also directed to a method of sequentially delivering one or more epigenetic drugs that alter one or more epigenetic mechanisms of a tumor cell and one or more chemotherapeutic drugs to an individual that has a tumor. Compositions which comprise one or more epigenetic drugs that alter one or more epigenetic mechanisms of a tumor cell, wherein the one or more epigenetic drugs are encapsulated in a nanogel.

Abstract: The present disclosure includes compositions and methods of making a nanoparticle composition comprising a phospholipids core comprising one or more lipids and one or more active agents, and at least one layer of one or more polymers on the surface of the phospholipids core; more specifically, the disclosure relates to the use of capecitabine (N4-pentyloxycarbonyl-5-deoxy-5-fluoro-cytidine, CAP) within such a lipid-polymer nanoparticle formulation for optimizing pharmaceutical properties of capecitabine for the treatment of cancer.

Abstract: The present invention relates to a novel multilayered assembly for the prolonged delayed and controlled diffusion of an active agent or a drug, in particular into an aqueous medium. In particular, the present invention relates to a nano-sized drug delivery structure comprising at least one support material; one multilayered structure overlaying and/or surrounding at least partially said support material and comprising at least two layers of oppositely charged materials; and one drug active agent conjugated by means of a disulphide bond on one or more negatively charged material(s) of one or more inner layer(s) of the said multilayered structure. Such a nano-sized drug delivery structure is more particularly useful for the manufacture of pharmaceutical compositions, for example intended to be used in cancer therapy. Internalization of the drug nanostructures into cancer cells, retardation of diffusion of the active drug, activity and specific targeting of the drug nanostructures were tested.

Abstract: The present disclosure generally relates to nanoparticles comprising an endo-lysosomal escape agent, a nucleic acid, and a polymer. Other aspects include methods of making and using such nanoparticles.

Abstract: The present invention relates to a method for preparing nanoparticle of active ingredient using lipid as lubricant in milling process, and more specifically, it relates to a method for preparing active ingredient into nanoparticle, which can be properly used in drugs, cosmetics, functional foods, etc., by pulverizing a mixture comprising the active ingredient and a lipid as a lubricant, and a biocompatible polymer having a glass transition temperature of 80° C. or higher by roll mill, and then removing the lipid used as a lubricant therefrom by using supercritical fluid.

Abstract: The present invention relates to a bioabsorbable sheet or film, composed of a composition containing phosphorylated pullulan. The bioabsorbable sheet or film of the present invention can be suitably used in the medical fields, for example, as medical adhesives to be patched to a biotissue such as organs and blood vessels during surgical operations.

Abstract: Bacteria-responsive core-shell nanofibers and a process for the preparation thereof are described. The nanofibers release of an antibacterial agent in response to the presence of bacteria. The core of the nanofiber comprises a biocompatible polymer together with an antibacterial agent such as a quaternary ammonium compound, for example benzyl dimethyl tetradecyl ammonium chloride (BTAC). Surrounding the core is shell comprised of a bacterially degradable polymer, which is susceptible to break-down by bacterial enzymes such as lipase, or to acidic pH conditions. The shell may comprise, for example, polycaprolactone (PCL) and poly(ethylene succinate) (PES).

Abstract: Provided is a transdermal formulation including a transdermal absorption enhancer including an aliphatic hydrocarbon derivative and a pyrrolidone derivative; and a benzene diamine derivative for preventing or treating dementia, Alzheimer's disease, and hair loss.

Abstract: Casein particles, such as micelles or clusters thereof having encapsulated therein hydrophobic and/or water insoluble therapeutically active agents such as hydrophobic chemotherapeutic agents, which are otherwise administered parenterally, are disclosed. Pharmaceutical compositions containing the casein particles and uses thereof in the treatment of cancer and other conditions treatable by the encapsulated therapeutically active agent are also disclosed. Further disclosed are processes of preparing the casein particles. The disclosed casein particles are useful for orally delivering the therapeutically active encapsulated therein and can further be used for controllably releasing the agents in the gastrointestinal tract.

Abstract: The present invention provides compositions and methods of their use in treating muscular dystrophy and other disorders.

Abstract: The present disclosure relates to the use of cannabidiol (CBD) for the treatment of atonic seizures. In particular the CBD appears particularly effective in reducing atonic seizures in patients suffering with etiologies that include: Lennox-Gastaut Syndrome; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Aicardi syndrome; CDKL5 and Dup15q in comparison to other seizure types. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).

Abstract: A composition for lowering blood pressure comprising an effective amount of a carotenoid selected from among a group consisting of lycopene, phytofluene, phytoene, astaxanthin and cathaxanthin or mixtures thereof. Further disclosed is a method for lowering blood pressure.

Abstract: A method of increasing an average time between seizures in a human patient diagnosed with Dravet syndrome, comprising administering to the patient a therapeutically effective dose of fenfluramine or a pharmaceutically acceptable salt, base, acid or amine thereof, and repeating the administering over a period of days until the patient exhibits an increase from baseline in average time between convulsive seizures of 6 hours, days weeks or more.

Abstract: A method of reducing a particular type of seizure in a human patient diagnosed with Dravet syndrome, by administering to the patient a therapeutically effective dose of fenfluramine or a pharmaceutically acceptable salt, base, acid or amine thereof, and repeating the administering over a period of days until the patient exhibits a reduction from baseline in seizures of a particular type. The reduction may be of one, two or three specific types of seizures.

Abstract: A method of reducing dosing of a concomitant medication in a human patient diagnosed with Dravet syndrome, by administering to the patient a therapeutically effective dose of fenfluramine or a pharmaceutically acceptable salt, base, acid or amine thereof, and repeating the administering over a period of days while reducing the dose of one or more concomitant anti-seizure or anti-epileptic drugs (AEDs) from baseline and thereby decreasing the amount of medication given to the patient while reducing adverse side effects. Pharmaceutical compositions and formulations for use in practicing the subject methods are also provided.

Abstract: Provided herein is a method of treating a selected patient population, wherein the patient population is selected based on a determination that the patients have previously been non-responsive when treated with cannabidiol. In some embodiments, the method comprises selecting the patient based on a previously failed treatment with cannabidiol, based on lack of efficacy or tolerability. Pharmaceutical compositions and formulations for use in practicing the subject methods are also provided. The method comprises identifying a population of patients diagnosed with Dravet syndrome who were found previously to have been non-responsive when treated with cannabidiol.

Abstract: Provided herein is a method of treating a selected patient population, wherein the patient population is selected based on a determination that the patients have previously been non-responsive when treated with stiripentol. In some embodiments, the method comprises selecting the patient based on a previously failed treatment with stiripentol, based on lack of efficacy or tolerability. Pharmaceutical compositions and formulations for use in practicing the subject methods are also provided. The method comprises identifying a population of patients diagnosed with Dravet syndrome who were found previously to have been non-responsive when treated with stiripentol.

Abstract: A method of treating symptoms of a subtype of epilepsy, e.g., Dravet syndrome, in a patient diagnosed with a subtype of epilepsy, by administering to the patient an effective dose of a fenfluramine formulation in combination with a ketogenic diet over a period of time sufficient to reduce or completely eliminate seizures in the patient. Also provided are compositions and kits finding use in practicing embodiments of the methods.

Abstract: Disclosed herein are methods of improving cognitive function in a patient as measured by, for example, improvement in score on a validated scale that measures cognitive function, such as the Behavior Rating Inventory of Executive Function (BRIEF), by administering the test to a patient and obtaining a pre-treatment test score, treating the patient with fenfluramine or its pharmaceutically acceptable salt, and after treatment, re-administering the test of cognitive function to the patient and obtaining a post-treatment score, to allow observation of an improvement in the test score. In some embodiments, the patient is also being treated for the symptoms of epilepsy.

Abstract: S1P receptor modulators or agonists are administered following a dosage regimen whereby during the initial days of treatment the daily dosage is lower than the standard daily dosage.

Abstract: The present disclosure relates to inhibitors of mitochondrial function. Methods of screening compounds for mitochondrial inhibition are disclosed. Also described are methods of using mitochondrial inhibitors called mitoriboscins—mitochondrial-based therapeutic compounds having anti-cancer and antibiotic properties—to prevent or treat cancer, bacterial infections, and pathogenic yeast, as well as methods of using mitochondrial inhibitors to provide anti-aging benefits. Specific mitoriboscin compounds and groups of mitoriboscins are also disclosed.

Abstract: An aquaporin 4 function promotor contains a compound represented by Formula (1) or (2) or a pharmaceutically acceptable salt thereof, as an active ingredient. (In the formula, n11 represents an integer of 1 to 10, and R21 represents one selected from the group consisting of an alkyl group having 1 to 10 carbon atoms, an alicyclic heterocyclic group, an aromatic hydrocarbon group, and an aromatic heterocyclic group.

Abstract: Compositions of pro-chelator compounds are described herein. The pro-chelators may be activated in reducing conditions, such as in the intracellular space, so as to sequester metals such as iron. The pro-chelators may be used to target malignant cells or in the treatment in a condition associated with metal ion disregulation.

Abstract: Methods of treating Alzheimer's disease and other neurodegenerative and/or neurocognitive and/or neurodevelopmental diseases are described. The methods comprise the administration of compounds that modulate an activity of cell division control protein 42 (Cdc42), such as the interaction between Cdc42 and intersectin (ITSN). Exemplary modulator compounds include thioureas, disulfonamides of fused aromatic systems (e.g., benzofuran), and acyl hydrazones, among others. Some of the modulator compounds act as activators of Cdc42, while others act as inhibitors. In some cases, the modulator compound has dual functionality and the ability of the modulator compound to act as an inhibitor or activator depends on whether or not Cdc42 is already activated in a particular disease stage or biological environment by an upstream activating signal of Cdc42.

Abstract: The present specification discloses pharmaceutical compositions, methods of preparing such pharmaceutical compositions, and methods and uses of treating a chronic inflammation and/or an inflammatory disease in an individual using such pharmaceutical compositions.

Abstract: Various embodiments of this invention are directed to pharmaceutical compositions and methods for treating disease. The compositions of such embodiments include dicarboxylic acid compounds containing electron withdrawing groups, alkyl esters of dicarboxylic acids containing electron withdrawing groups, or compounds of Formulae I to X. The methods of various embodiments include administering an effective amount of any of these pharmaceutical compositions to a patient in need of treatment.

Abstract: Eflornithine is an agent that can be used to treat glioma, especially glioma of WHO Grade II or Grade III such as anaplastic glioma. Eflornithine can suppress or prevent mutations in glioma which can cause the glioma to progress to a higher grade. Compositions and methods can include eflornithine or a derivative or analog of eflornithine, together with other agents such as conventional anti-neoplastic agents for treatment of glioma, inhibitors of polyamine transport, polyamine analogs, or S-adenosylmethionine decarboxylase inhibitors.

Abstract: It is provided a catechol-O-methyltransferase (COMT) inhibitor for use in the prevention and/or treatment of transthyretin-associated amyloidosis. It is also provided a catechol-O-methyltransferase (COMT) inhibitor for use in the prevention and/or treatment of transthyretin-associated amyloidosis in combination therapy with another COMT inhibitor, a benzoxazole derivative, iododiflunisal, diflunisal, resveratrol, tauroursodeoxycholic acid, doxocycline, or epigallocatechin-3-gallate.

Abstract: Provided herein are compositions and methods for reducing blood glucose in a subject.

Abstract: The present invention relates to a method of treating MS in a human patient in need of such treatment and comprises administering to said patient a combination therapy in a single oral dosage form (e.g. a tablet or capsule) of dim ethyifurrta rate and one agent selected from teriflunomide (or its prodrug leflunomide), fingolimod and laquinimod. This combination is more effective than the single agents alone and/or has reduced side effects and better tolerability than the single agents alone and/or can be given in a reduced frequency. Moreover, the present invention is directed to a pharmaceutical composition suitable for the oral treatment of multiple sclerosis consisting of dimethylfumarate and one agent selected from teriflunomide, fingolimod and laquinimod as active ingredients and one or more pharmaceutically acceptable excipients.

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

Abstract: The present invention concerns methods for treating and preventing endothelial dysfunction and related disorders, including, for example, pulmonary arterial hypertension, using bardoxolone methyl or analogs thereof.

Abstract: Substituted hexitol derivatives such as dianhydrogalactitol are useful in the treatment of various neoplastic pathologies. Said pathologies include glioblastoma multiforme, non-small-cell lung carcinoma (NSCLC), ovarian cancer, and leptomeningeal carcinomatosis. The anti-neoplastic activity of dianhydrogalactitol is demonstrated to be due to its activity as an alkylating agent that creates N7 methylation and inter-strand DNA crosslinks. The hexitol derivatives may be used alone or in combination with other anti-neoplastic agents.

Abstract: Pharmaceutical compositions and dosage forms of dimethyl fumarate containing low levels of certain impurities are disclosed.

Abstract: The invention relates to enhanced tulathromycin for use in the treatment, metaphylaxis or prevention of a microbial infection, characterized in that a compound of formula (I) is used in combination with tulathromycin at a weight ratio compound of formula (I):microbial agent of 8:1 to 1:10, and in that the microbial infection is induced in particular by a strain A pathogen in which the concentration of compound (I) satisfies the following equation: [C]<[MIC]/x, where [C] is the concentration according to the invention of compound (I) to be used in strain A, [MIC] is the minimum inhibitory concentration measured for compound (I) alone in strain A, and x is at least 100, advantageously at least 1000, more advantageously between 2000 and 10,000, or even greater than 50,000.

Abstract: The invention provides compositions and methods for treating inflammatory condition of the gastrointestinal (GI) tract, specifically those related to Inflammatory Bowel Disease (IDB). Compositions according to the invention due to their specific content of cannabinoids and methods comprising specific modes of administration thereof are particularly applicable to the treatment of the two major IDBs, Crohn's disease and colitis.

Abstract: The present invention primarily relates to the use of Homoeriodictyol (HED) or a salt thereof or a mixture of HED and one or more salts thereof or a mixture of several salts thereof for reducing the gastric acid secretion-stimulating effect of N-Acetyl-4-aminophenol (Paracetamol).

Abstract: This application is in the field of medicinal chemistry and relates to ultrapure ajulemic acid, its synthesis, pharmaceutical compositions and methods of use thereof for the treatment and/or prevention of inflammation, pain, and fibrotic diseases including scleroderma, systemic sclerosis, scleroderma-like disorders, sine scleroderma, liver cirrhosis, interstitial pulmonary fibrosis, idiopathic pulmonary fibrosis, Dupuytren's contracture, keloids, chronic kidney disease, chronic graft rejection, and other scarring-wound healing abnormalities, post-operative adhesions, and reactive fibrosis.

Abstract: Provided herein are formulations that can contain an effective amount of a PKC? inhibitor. Also provided herein are methods of inhibiting a PKC? in a subject in need thereof, that can include the step of administering an effective amount of a compound that is capable of inhibiting a PKC?.

Abstract: Methods for preventing or treating subjects having cancer based on the identification of pharmaceutical agents that target cancer stem cells (CSCs) have been identified. These methods include administering to the subject an effective amount of a COX2 inhibitor and an effective amount of a YAP1 inhibitor. In addition, methods of enhancing chemotherapeutic responses in cancer patients have been discovered and are described herein.

Abstract: This invention relates to a novel dosage regimen for administration of 3-[5-amino-4-(3-cyanobenzoyl)-pyrazol-1-yl]-N-cyclopropyl-4-methylbenzamide or a pharmaceutically acceptable derivative thereof, namely in the treatment of acute exacerbations of inflammatory conditions.

Abstract: The present invention relates to solid oral pharmaceutical compositions comprising Deferasirox or a pharmaceutical acceptable salt thereof and one or more pharmaceutically acceptable excipients and process for preparation thereof.