Abstract: The present invention relates generally to a sterile, particulate-free, stable intrathecal baclofen solution with less than 0.5% of 4-(4-chlorophenyl)-2-pyrrolidone, a degradation product. These solutions are stable under a variety of storage conditions and for extended periods of time. Also disclosed are methods for preparing such compositions.

Abstract: A levothyroxine composition includes levothyroxine sodium and mannitol. The composition is a solid. The composition may include from 100 to 500 micrograms levothyroxine sodium and from 1 to 5 milligrams mannitol. The composition may include from 100 to 200 micrograms levothyroxine sodium, and the mass ratio of mannitol to levothyroxine sodium in the composition may be at most 40:1. The composition may include about 500 micrograms levothyroxine sodium, and the mass ratio of mannitol to levothyroxine sodium in the composition may be at most 10:1.

Abstract: Methods and compositions are provided for treating neuropsychiatric disorders such as schizophrenia, depression, attention deficit disorder, mild cognitive impairment, dementia, and bipolar disorder. The methods entail administering to a patient diagnosed as having a neuropsychiatric disorder (e.g., schizophrenia, depression, attention deficit disorder, mild cognitive impairment, dementia bipolar disorder, etc.) or as at risk for a neuropsychiatric disorder a benzoic acid, benzoic acid salt, and/or benzoic acid derivative, and/or a sorbic acid, sorbic acid salt, and/or sorbic acid derivative, in combination with a neuropharmacological agent (e.g., an antipsychotic, an antidepressant, medications for attention deficit and hyperactivity disorder, cognitive impairment, or dementia, etc.) where the benzoic acid, benzoic acid salt, or benzoic acid derivative, and/or a sorbic acid, sorbic acid salt, and/or sorbic acid derivative, is in an amount sufficient to increase the efficacy of the neuropharmacological agent.

Abstract: LXR nuclear receptor agonists have been previously shown to increase cholesterol efflux, raise plasma HDL cholesterol, stimulate cholesterol excretion, and reduce atherosclerotic lesions. However, these agonists have also been associated with the unwanted side effect of hypertriglyeridemia. This hypertriglyeridemia appears to be mediated by the LXR? subtype rather than LXR?, which suggests that LXR?-selective agonists are attractive candidates for modulation of human lipid metabolism. The present application provides novel LXR?-selective ligands that preferably modulate LXR? over LXR?. These ligands may be used to treat a variety of diseases associated with LXR, such as for example lipid metabolism disorders, atherosclerosis, Alzheimer disease, and inflammation.

Abstract: The present disclosure is directed in part to methods of treating fibrosis, e.g., hepatic fibrosis and/or intestinal fibrosis, comprising administering to a patient in need thereof an effective amount of a disclosed compound.

Abstract: Oral non-steroidal anti inflammatory drugs (NSAIDs) are not an effective treatment of Alzheimer's disease, because the brain dose is too low. Nasal delivery of NSAIDs such as ibuprofen, flurbiprofen, indomethacin, diclofenac, or naproxen, which inhibit the enzymes cyclooxygenase-1 (cox-1) and cox-2, are used to prevent and/or treat Alzheimer's disease, a low grade brain inflammation. The large amount of nasal NSAIDs (e.g., ibuprofen, flurbiprofen, indomethacin, diclofenac, or naproxen) that reaches the brain far exceeds that from an oral dose. Low-molecular-weight lipophilic drugs, such as ibuprofen, naproxen, indomethacin, diclofenac, and flurbiprofen, are readily absorbed into the brain by the intranasal route. Alzheimer's starts in the entorhinal cortex, which is closely connected to the olfactory nerves, and spreads anatomically in a defined pattern. Therefore, a nasal NSAID would readily reach the region of the brain where it acts therapeutically.

Abstract: Disclosed herein are methods for treating lactose intolerance, including compounds that may be specific or modulate PPAR? receptors.

Abstract: NK cell licensing predisposes patients to chronic inflammatory disease. Methods and kits to diagnose and treat chronic inflammatory disease based on genetic haplotype and cytokine profile are described herein.

Abstract: Novel calcilytic compounds and methods of using them are provided.

Abstract: Method for producing enteric microcapsules without coating, containing diclofenac or one of the salts thereof with satisfactory anti-inflammatory activity and low gastric aggressiveness; and a pharmaceutical composition containing them. The method comprises a) preparing a mixture in water-ethanol with an alginate salt, adding diclofenac or one of the salts thereof previously diluted with a surfactant and sodium bicarbonate; b) adding the previous solution to a solution with a calcium salt; c) resuspending the microcapsules obtained and isolated in an aqueous solution of the alginate salt; and d) isolating, drying and sieving through 1000 and 250 micron meshes the microcapsules obtained; and selecting the fraction comprised between both meshes. The pharmaceutical composition can be an oral composition, tablets, chewable tablets, or a powder for suspension in water.

Abstract: The present invention discloses novel agents and methods for diagnosis and treatment of melanoma. Also disclosed are related arrays, kits, and screening methods.

Abstract: The present invention relates to a method for the treatment of pain and inflammation. In particular, the present invention relates to a method for the treatment of musculo-skeletal and connective tissue pain/inflammations. Further, the invention relates to reducing the incidence and seventy of adverse events resulting from administration of diclofenac. The method comprises administration of a topical pharmaceutical composition of diclofenac or its salts.

Abstract: The present invention is based, in part, on our studies of molecular pathways that include the deubiquitinase CYLD. Accordingly, the present invention features, inter alia, nucleic acid constructs that express CYLD or a biologically active variant thereof (e.g., a variant including the catalytic domain), nucleic acids that inhibit the expression of a negative regulator of CYLD (e.g., PDE4B or LNK2), nucleic acids that modulate the expression of downstream CYLD targets (e.g., Akt, by inhibiting or promoting the expression of the downstream target), compositions including one or more of these types of constructs (e.g., pharmaceutical compositions), kits including one or more of the compositions described herein and instructions for use, screening methods to identify therapeutic agents {e.g., anti-inflammatory agents) that upregulate CYLD, downregulate a negative regulatory of CYLD, or modulate (e.g., inhibit) a downstream CYLD target (e.g.

Abstract: Methods and formulations are provided for treating migraine and other acute pain episodes using diclofenac, and formulations of diclofenac that provide both rapid and sustained relief from acute pain. Methods and formulations are also provided for treating symptoms that often accompany migraine and acute pain such as photophobia, phonophobia, nausea and vomiting.

Abstract: The present invention relates to pharmaceutical formulations for the controlled delivery of threo-3-(3,4-dihydroxyphenyl)serine (threo-DOPS) and derivatives of it. Such formulations can contain an extended or slow release component that maintains therapeutic concentration of threo-DOPS in the blood plasma over a prolonged time period. They can be further combined with an immediate release formulation to produce a product that, when administered to a patient in need thereof, results in substantially steady levels of active drug, eliminating the sharp peaks and troughs in blood plasma drug levels experienced with the existing threo-DOPS formulations.

Abstract: The present invention relates generally to a sterile, particulate-free, stable intrathecal baclofen solution with less than 0.5% 4-(4-chlorophenyl)-2-pyrrolidone, a degradation product. These solutions are stable under a variety of storage conditions and for extended periods of time. Also disclosed are methods for preparing such compositions.

Abstract: The present disclosure generally relates to therapeutic nanoparticles. Exemplary nanoparticles disclosed herein may include about 0.1 to about 40 weight percent of a therapeutic agent and about 10 to about 90 weight percent a diblock poly(lactic) acid-poly(ethylene)glycol copolymer or a diblock poly(lactic)-co-poly(glycolic) acid-poly(ethylene)glycol copolymer, wherein the diblock poly(lactic) acid-poly(ethylene)glycol copolymer comprises poly(lactic) acid having a number average molecule weight of about 30 kDa to about 90 kDa or the diblock poly(lactic)-co-poly(glycolic) acid-poly(ethylene)glycol copolymer comprises poly(lactic)-co-poly(glycolic) acid having a number average molecule weight of about 30 kDa to about 90 kDa.

Abstract: A method for treating a disease characterized by excessive lipofuscin accumulation in the retina of a mammal afflicted therewith comprising administering to the mammal an effective amount of a transthyretin (TTR) ligand.

Abstract: Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.

Abstract: The present invention relates to alkyl derivatives, processes for preparing them, pharmaceutical compositions containing them and their use as pharmaceuticals as modulators of sphingosine-1-phosphate receptors.

Abstract: Formulation of long-acting and controlled release preparations of 2-[(3-chlorophenyl)amino] phenylacetic acid (23CPPA) are disclosed. Long-acting preparations comprise a slow-release formulation coated onto a pharmaceutical composition containing 23CPPA, protect against gastric irritation, slow 23CPPA absorption, extend release of 23CPPA, protect against excessively high 23CPPA blood concentrations, and prolong maintenance of blood concentrations of 23CPPA after administration. Controlled release formulations comprise (a) a core element which is a compressed tablet containing a therapeutic dose of 23CPPA and an amount of a solubility modulating substance that controls the release of said 23CPPA in order to provide a therapeutic level over a period of about 24 hours; and (b) on the outer surface of the core element, a sufficient amount of an enteric coating that causes the 23CPPA to release at a rate that permits the use of once-a-day dosing to maintain steady state therapeutic levels of 23CPPA.

Abstract: The present invention relates to aryl derivatives, processes for preparing them, pharmaceutical compositions containing them and their use as pharmaceuticals as modulators of sphingosine-1-phosphate receptors

Abstract: Anthranilic acid derivatives are used to inhibit the formation of advanced glycation end products to reduce complications in diabetes.

Abstract: The present invention is a screening assay for identifying inhibitors of Pseudomonas aeruginosa CFTR Inhibitory Factor as well as compounds identified by the screening assay for use in compositions and methods for ameliorating or treating a respiratory disease such as cystic fibrosis or secondary infection thereof.

Abstract: The present invention relates to compounds comprising the general formula (I), in which R1 and R2 which may be identical or different, are selected from the group comprising —H or a linear or branched alkyl group having from 1 to 6 carbon atoms or together form an aromatic or aliphatic ring with 5 or 6 atoms, Y and Z, which may be identical pr different, are selected from the group comprising —H, OH, COOH, —OR3, —CH(OR3)COOH, in which R3 is selected from H, phenyl, benzyl, CF3 or CF2CF3, vinyl, allyl, and a linear or branched alkyl group having from 1 to 6 carbon atoms.

Abstract: Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.

Abstract: The present invention provides a prophylactic or therapeutic agent for giant cell tumors occurring in a bone and soft tissue or for chondrosarcoma, which comprises a non-steroidal anti-inflammatory agent or thiazolidine derivative as an active ingredient, and the like

Abstract: Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.

Abstract: The present invention relates to aryl oxy derivatives, processes for preparing them, pharmaceutical compositions containing them and their use as pharmaceuticals as modulators of sphingosine-1-phosphate receptors.

Abstract: Provided are kits containing a base composition and an active pharmaceutical ingredient for transdermal delivery of active pharmaceutical ingredients. Examples of active pharmaceutical ingredients include amitriptyline, baclofen, cyclobenzaprine HCl, ibuprofen, lidocaine HCl, naproxen and tramadol, ketoprofen, diclofenac, phenylbutazone, mefenamic acid, flubiprofen, piroxicam, guaifenasin, prilocaine, bupivicaine, tetracaine, nifedipine, verapamil, orphenadrine, imipramine, ketamine, gabapentin, carbamazepine, menthol, capsaicin, clonidine, dexamethasone, dextromethorphan, testosterone, progesterone, and estrogens.

Abstract: A process for producing a pharmaceutical suspension that comprises an active pharmaceutical ingredient (“API”) having low solubility, the process comprises: (a) preparing a first solution comprising a carboxy-containing vinyl polymer and a solvent; and (b) adding a compound of the API to said first solution under conditions of high-shear mixing for a time from about 5 minutes to about 5 hours, said compound being soluble in said solvent, thereby producing a suspension of particles of said API in a composition comprising said carboxy-containing vinyl polymer; wherein a concentration of said API in said suspension is higher than a solubility of said API in said solvent. The present invention also provides a suspension produced by such process.

Abstract: Disclosed are stable compositions comprising povidone-iodine and a steroid, and methods of making and using such compositions. Also disclosed herein are stable compositions comprising povidone-iodine and an NSAID, and methods of making and using such compositions.

Abstract: The present invention relates to pharmaceutical formulations comprising tranexamic acid, kits thereof, and methods for treating bleeding by local administration.

Abstract: The present invention relates to the use of compounds for the treatment or prevention of pain in mammals, in particularly in human beings, and also to a process for preparing these compounds.

Abstract: The present invention is directed to a pharmaceutical composition containing a unit dose of a diclofenac compound effective to induce analgesia; and a beta-cyclodextrin compound; wherein the dose of the diclofenac compound is less than 75 mg, e.g., from about 18.75 mg to about 37.5 mg. The present invention is also directed to methods of treating a subject in need of analgesia with the pharmaceutical compositions of the invention.

Abstract: Topical compositions are disclosed that are useful for delivering a therapeutic level of an NSAID to a target within a subject having a local inflammatory disorder. A composition of the present invention comprises a Drug and a solvent system, wherein the solvent system comprises at least two solvent alcohols and wherein the solvent system is present in an amount sufficient to solubilize the Drug, the solvent system is a low alkanol system, and the composition is a single phase composition. Exemplary solvent systems are those for which one of the at least two solvent alcohols is polyethylene glycol, glycerin, butylene glycol, dipropylene glycol, propylene glycol, ethanol, isopropanol, or a derivative thereof. Optionally the local inflammatory disorder is pseudofolliculitis barbae, dermatitis, psoriasis, wounds, or sunburn.

Abstract: An object of the present invention is to provide an antitumor aqueous solution and an anticancer agent, both of which can kill cancer cells while having virtually no effects on normal cells, and to provide methods for producing the antitumor aqueous solution and the anticancer agent. The method of the invention for producing an antitumor aqueous solution for killing cancer cells includes an aqueous solution preparation step of preparing an aqueous solution through addition, to water, of a solute containing at least one of disodium hydrogen phosphate (Na2HPO4), sodium hydrogen carbonate (NaHCO3), L-glutamine, L-histidine, and L-tyrosine disodium dihydrate (L-tyrosine.2Na.2H2O); and a plasma irradiation step of irradiating the aqueous solution with atmospheric pressure plasma generated in a plasma generation region by means of a plasma generator.

Abstract: The disclosure provides a method of treating a mammal afflicted with an age-related disorder, comprising administering to the mammal a combination of liver X receptor (LXR) modulator and estrogen receptor (ER) modulator, in an amount effective to treat the mammal. Further disclosed are the LXR modulators and ER modulators used in the combination therapy.

Abstract: The present invention discloses novel agents and methods for diagnosis and treatment of melanoma. Also disclosed are related arrays, kits, and screening methods.

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 one or more of a monosaccharide, a disaccharide, and an oligosaccharide sufficient to stabilize the levothyroxine sodium; and two or more of a filler, a binder, and a lubricant.

Abstract: An aqueous liquid preparation of the present invention containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid or its pharmacologically acceptable salt or a hydrate thereof, an alkyl aryl polyether alcohol type polymer such as tyloxapol, or a polyethylene glycol fatty acid ester such as polyethylene glycol monostearate is stable. Since even in the case where a preservative is incorporated into said aqueous liquid preparation, the preservative exhibits a sufficient preservative effect for a long time, said aqueous liquid preparation in the form of an eye drop is useful for the treatment of blepharitis, conjunctivitis, scleritis, and postoperative inflammation. Also, the aqueous liquid preparation of the present invention in the form of a nasal drop is useful for the treatment of allergic rhinitis and inflammatory rhinitis (e.g. chronic rhinitis, hypertrophic rhinitis, nasal polyp, etc.).

Abstract: A method of treating a subject for Parkinson's disease comprises administering said subject a phenylisopropylamine in an amount effective to treat said Parkinson's disease. In some embodiments the method is used to treat at least a motor symptom of Parkinson's disease; in some embodiments the method is used to treat at least a non-motor symptom of Parkinson's disease.

Abstract: Provided herein are methods of stabilizing thyroid hormone, preventing a thyroid hormone from being oxidized, producing a formulation of thyroid hormone having a uniform potency, and reducing the exposure of a thyroid hormone to oxygen, light, moisture, or high temperature. Such methods comprise coating said thyroid hormone to provide a solid form comprising thyroid hormone coated with a coating material. Also provided are pharmaceutical compositions comprising a solid form of a thyroid hormone, wherein said solid form comprises thyroid hormone coated with a coating material. The invention also provides pharmaceutical compositions produced by the methods. Unit dosage forms and batches comprising such pharmaceutical compositions are also provided.

Abstract: The present invention relates to new dihydroxyphenyl modulators of neurotransmitter levels, pharmaceutical compositions thereof, and methods of use thereof.

Abstract: An aqueous liquid preparation of the present invention containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid or its pharmacologically acceptable salt or a hydrate thereof, an alkyl aryl polyether alcohol type polymer such as tyloxapol, or a polyethylene glycol fatty acid ester such as polyethylene glycol monostearate is stable. Since even in the case where a preservative is incorporated into said aqueous liquid preparation, the preservative exhibits a sufficient preservative effect for a long time, said aqueous liquid preparation in the form of an eye drop is useful for the treatment of blepharitis, conjunctivitis, scleritis, and postoperative inflammation. Also, the aqueous liquid preparation of the present invention in the form of a nasal drop is useful for the treatment of allergic rhinitis and inflammatory rhinitis (e.g. chronic rhinitis, hypertrophic rhinitis, nasal polyp, etc.).

Abstract: A gastroretentive drug formulation for the sustained release of an active agent in the gastrointestinal tract comprises an internal layer or compartment comprising an active agent and one or more pharmaceutical excipients, of which at least one is a polymer and two membranes forming together an envelope around the inner membrane, each membrane comprising at least one polymeric combination of an enteric polymer which is not soluble in gastric juice, and an hydrophilic swelling polymer, and at least one plasticizer.

Abstract: The present invention provides a gel formulation comprising diclofenac sodium which has superior transdermal flux properties, which may be used for the topical treatment of pain, such as in osteoarthritis.

Abstract: To provide a therapeutic agent and a diagnostic agent for mitochondrial dysfunction brain diseases including cerebral infarction as a representative. A therapeutic agent for a mitochondrial dysfunction brain disease, which comprises (A) ?-aminolevulinic acid represented by the formula (1), a derivative thereof, or a salt thereof and (B) an iron compound in combination. R2R1NCH2COCH2CH2COR3??(1) wherein R1 and R2 each independently represents a hydrogen atom, an alkyl group, an acyl group, an alkoxycarbonyl group, an aryl group, or an aralkyl group; and R3 represents a hydroxy group, an alkoxy group, an acyloxy group, an alkoxycarbonyloxy group, an aryloxy group, an aralkyloxy group, or an amino group.

Abstract: A medicant composition is provided. The composition includes a film layer and a powder matrix layer. The powder matrix layer includes a medicant. The powder matrix layer is applied to the film layer by admixing particulate to form a powder matrix and by then applying the powder matrix to the film layer by any desired method. The composition of the powder matrix is varied to alter the dissolution rate of the medicant, the adhesion of the medicant composition, and other physical properties of the powder matrix. The powder matrix layer can be cured.

Abstract: An antimicrobial solution for disinfecting instruments in an automatic sterilization device, the solution comprising: a peracid reaction product formed in situ from combining a liquid acetyl donor with a solid source of peroxide, wherein the in situ reaction takes place in the sterilization device, along with a containment and delivery ampule for use in an automatic sterilization device, and methods for disinfecting a medical instrument employing the inventive antibacterial solution.