Abstract: The invention provides an aqueous pharmaceutical solution for use in the treatment of diseases of the central nervous system (CNS), the solution comprising at least 5 mg/ml dissolved levodopa, and having a pH in the range of 3.0 to 8.5. Said solution is provided by mixing a) an aqueous stock solution comprising levodopa, said stock solution having a pH of less than 2.8 at 25° C. and b) an aqueous buffering solution, for increasing the pH of said stock solution, said buffering solution having a pH of at least 4.0 at 25° C. The aqueous pharmaceutical solution is administered to a subject suffering from a disease of the central nervous system (CNS) shortly after mixing of the aqueous stock solution and the aqueous buffering solution. Furthermore, the invention provides a kit for administration of aqueous pharmaceutical solutions to subjects suffering from diseases of the central nervous system (CNS).

Abstract: Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral controlled release pharmaceutical compositions comprising fumarate esters suspended in liquid matrices are described. One embodiment described herein is a pharmaceutical composition comprising fumarate esters suspended in a lipid or lipophilic liquid with enhanced bioavailability.

Abstract: Formulation F comprising A) 50 to 90 parts by weight of at least one block copolymer P of ethyleneoxide and propylene oxide, B) 0.5 to 10 parts by weight of at least one salt of an alkyl sulfate S, C) 0.05 to 0.5 parts by weight of a composition C comprising C1) 5 to 10 parts by weight of at least one polydimethylsiloxane bearing only terminal alkyl groups, C2) 1 to 3 parts by weight of at least one polydimethylsiloxane bearing at least alkoxylated hydroxy group, C3) at least one solvent, wherein said formulation F is an aqueous formulation.

Abstract: Injectable baclofen formulations and methods that are bioequivalent in terms of plasma baclofen exposure to oral dosage forms but with reduced exposure ratios of baclofen to the M1 metabolite.

Abstract: Methods and compositions for treating various indications by lessening oxidative stress in a patient are provided. A pharmaceutical composition comprises between about 0.001% to about 10.0%, or more specifically between about 0.015% to about 5%, sodium iodide or catalase by weight. The iodine ion or the catalase dissociates hydrogen peroxide into water and molecular oxygen to interrupt biological events that result in negative side effects. The pharmaceutical composition further comprises in some cases a reducing agent or various carrier materials. The pharmaceutical composition is in some cases formulated for a variety of delivery methods.

Abstract: Baclofen formulations, including formulations that minimize variability between doses, that minimize variation in patient exposure to baclofen metabolites, and are bioequivalent in regards to baclofen versus M1 metabolite ratios of baclofen tablets.

Abstract: The present invention provides methods, compositions, and kits for treating anxiety-related disorders, including OCD and SAD, and for reducing anxiety, obsessive behavior, or compulsive behavior in subjects in need thereof.

Abstract: A method for treatment of irritation or damage to corneal or conjunctival epithelial cells, particularly for irritation or damage to corneal or conjunctival epithelial cells due to severe Sjögren's syndrome, comprising applying topically to an affected eye an aqueous solution of glycerol characterized by a glycerol concentration of >1% (w/v), most preferably 2.5% (w/v). The method is effective even in the case of very low tear formation, and its effectiveness cannot be explained by the known humectant effect of glycerol.

Abstract: Suspensions of metronidazole or baclofen and/or salts or ester derivative thereof, such as metronidazole benzoate, are disclosed. The suspension my include metronidazole or baclofen, and/or a salt or ester derivative thereof a hydrocolloid stabilizer, simethicone emulsion, a buffer, such as sodium citrate, (dihydrate), a preservative, a thickening agent, a sweetener, and water.

Abstract: The present invention is related to an orally disintegrating, sublingual or buccal formulation of active ingredient such as cannabidiol or tetrahydrocannabinol.

Abstract: An object of the present invention is to provide a particulate composition for an easy-to-take solid preparation, which has excellent moldability (hardness) and slipperiness. The present invention relates to a particulate composition for an easy-to-take solid preparation, comprising sugar alcohol and a gelling agent that will show slipperiness when it is brought into contact with water, wherein a part or whole of the surface of the particulate composition is coated with the gelling agent, to an easy-to-take solid preparation comprising the particulate composition, and to a method for the production of the easy-to-take solid preparation.

Abstract: The present invention relates to a stable, aqueous, injectable solution comprising diclofenac and polyvinylpyrrolidone. The present invention also relates to processes for preparing the injectable solution.

Abstract: Described is a method for the preparation of an oral levothyroxine composition, comprising the steps of combining levothyroxine or a salt thereof, a water-miscible organic solvent or a sugar alcohol and water, adjusting the pH to at least 8 providing a basic aqueous medium, dissolving the levothyroxine in the basic aqueous medium to yield a levothyroxine solution, and lowering the pH of the levothyroxine solution to between 3.5-4.9. also described is an oral levothyroxine composition obtainable by the said method and its use as a medicament.

Abstract: The invention relates to highly stable alcohol-free, water-glycerol solutions of T4 thyroid hormone, with a reduced amount of T3 impurity, packaged via specific container arrangements. The containers are multi-barrier ones, in which a number of layers of specific materials separate the solution from contact with the external environment.

Abstract: A method for treatment of irritation or damage to conical or conjunctival epithelial cells, particularly for irritation or damage to corneal or conjunctival epithelial cells due to severe Sjögren's syndrome, by applying topically to an affected eye an aqueous solution of glycerol characterized by a glycerol concentration of >1% (w/v), most preferably 2.5% (w/v). The method is effective even in the case of very low tear formation, and its effectiveness cannot be explained by the known humectant effect of glycerol.

Abstract: The invention relates to beneficial topical pharmaceutical compositions comprising diclofenac sodium in high amounts, and methods for their use. Said compositions represent emulsion-gels as well as gels with unique properties such as high skin penetration, no irritation, high stability, complete dissolution of the active and effective pain relief. The invention also provides methods for treating pain or inflammation in a mammalian subject in need thereof, including acute and chronic pain or inflammation; and kits therefor.

Abstract: The present disclosure relates to a new pharmaceutical composition comprising Ceritinib. Particularly it is directed to the tablet that is prepared by wet granulation, wherein povidone is used as a binder. Further feature of the composition is that the drug and the binder form the inner phase, whereas all other excipients are added in a powder form as an outer phase. This way, the sticking of the composition is prevented and sufficient tablet hardness can be reached.

Abstract: Ready-to-use, stable aqueous intravenous tranexamic acid compositions are provided.

Abstract: An intravenous baclofen solution is disclosed, along with methods of dosing and treatment therewith.

Abstract: Provided herein are processes, compounds and compositions for making (S)-3-amino-4-(difluoromethylenyl)cyclopent-1-ene-1-carboxylic acid. Also provided herein a pharmaceutical compositions containing (S)-3-amino-4-(difluoromethylenyl)cyclopent-1-ene-1-carboxylic acid.

Abstract: Methods of shortening the duration of anti-infective therapy and increasing the effectiveness of anti-infective drugs in subjects with infection are present. The methods are based on altering the replication rate of a pathogen, which makes the pathogen more susceptible to the actions of the anti-infective drug.

Abstract: Methods and compositions for treating various indications by lessening oxidative stress in a patient are provided. A pharmaceutical composition comprises between about 0.001% to about 10.0%, or more specifically between about 0.015% to about 5%, sodium iodide or catalase by weight. The iodine ion or the catalase dissociates hydrogen peroxide into water and molecular oxygen to interrupt biological events that result in negative side effects. The pharmaceutical composition further comprises in some cases a reducing agent or various carrier materials. The pharmaceutical composition is in some cases formulated for a variety of delivery methods.

Abstract: Disclosed herein are formulations containing carbidopa and optionally levodopa, arginine, and other components that have reduced levels of impurities and toxins, particularly degradation productions. Also disclosed herein are methods of treatment diseases or conditions relating to a loss of dopamine or dopaminergic neurons using such formulations, methods of making such formulations, and kits that include such formulations.

Abstract: The invention relates to highly stable alcohol-free, water-glycerol solutions of T4 thyroid hormone, with a reduced amount of T3 impurity, packaged via specific container arrangements. The containers are multi-barrier ones, in which a number of layers of specific materials separate the solution from contact with the external environment.

Abstract: The present invention relates to the use of DBH inhibitors (e.g., disulfiram and Nepicastat), and pharmaceutical compositions thereof, for treating subjects with certain types of memory loss, for instance memory loss associated with a neurodegenerative disease, disorder, or condition, such as Alzheimer's Disease.

Abstract: The present inventions relate generally to compositions, kits, and methods for the treatment of stress-related disorders, including but not limited to post-traumatic stress disorder.

Abstract: Diphenethylamine derivatives for use as highly active analgesics, diuretics, anxiolytics, for the treatment of neurodegenerative, psychiatric and neuropsychiatric disorders, and also as anti-itch, anti-addiction, anti-inflammatory, anti-obesity, anti-epileptic, anti-convulsant, anti-seizure, anti-stress, anti-psychotic and anti-depressant medications and their pharmaceutically acceptable salts and easily accessible derivatives thereof (e.g. esters, ethers, amides), processes for their preparation and their application in the manufacture of pharmaceutical products.

Abstract: The present invention relates to topical formulations comprising a compound of the following formula: for treating ocular neovascularization. The Compound-I is present in a solution or a suspension in about 0.005% to about 5.0% w/v, such that the solution or suspension delivers the compound at the posterior segment of the eye for inhibiting VEGF in the retina and/or the choroid.

Abstract: Disclosed herein are formulations containing carbidopa and optionally levodopa, arginine, and other components that have reduced levels of impurities and toxins, particularly degradation productions. Also disclosed herein are methods of treatment diseases or conditions relating to a loss of dopamine or dopaminergic neurons using such formulations, methods of making such formulations, and kits that include such formulations.

Abstract: The present invention relates to topical formulations comprising a compound of the following formula: for treating ocular neovascularization. The Compound-I is present in a solution or a suspension in about 0.005% to about 5.0% w/v, such that the solution or suspension delivers the compound at the posterior segment of the eye for inhibiting VEGF in the retina and/or the choroid.

Abstract: Herein described is a topical composition for application of an NSAID, the composition comprising a solution or suspension of the NSAID as active ingredient in a residual carrier system comprising a polyhydric alcohol, a glycol ether, an ester of a higher fatty acid and water, and the ingredients of the residual carrier system have the following concentrations in percentages by weight::polyhydric alcohol 50-90%; glycol ether 7.5-40%; ester 0.5-5%; and water up to 10%. Either the composition or the residual carrier system is a single phase at ambient conditions. The composition may also comprise a volatile solvent such as ethanol or isopropyl alcohol.

Abstract: The present invention is directed to a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof. The formulation of the present invention includes tromethamine, sodium iodide, and water and has a pH of about 9.0 to about 11.5. The liquid formulation according to the invention is stable and ready-to-use.

Abstract: The composition comprises 0.5% to 10% by weight of a neuropathic analgesic; 0.5% to 10% by weight of a muscle relaxant; 0.5% to 20% by weight of an anti-inflammatory analgesic; and 0.5% to 10% by weight of an anesthetic.

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: The present invention relates to combinations and methods for the treatment of neurological disorders related to glutamate excitotoxicity and Amyloid ? toxicity. More specifically, the present invention relates to novel combinatorial therapies of Alzheimer's disease, Alzheimer's disease related disorders, amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease, Huntington's disease, neuropathic pain, alcoholic neuropathy, alcoholism or alcohol withdrawal, or spinal cord injury, based on baclofen and acamprosate combination.

Abstract: A method for treating an cancer disease is disclosed comprising administering to a subject a pharmaceutical composition comprising an adrenergic beta-3-receptor blocker.

Abstract: The present invention discloses a method of treating a disease condition susceptible to baclofen therapy, said method comprising orally administering once-a-day in the evening a controlled release drug delivery system comprising baclofen or its pharmaceutically acceptable salt or its derivatives and pharmaceutically acceptable excipients.

Abstract: Compositions and methods related to ophthalmic use of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymers and therapeutic uses are described herein.

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: Provided is an ointment which has excellent drug stability and excellent drug uniformity. The ointment, which comprises 1 to 5% by weight of 1-[2-[(4S)-4-hydroxy-1,2,3,4-tetrahydroquinolin-1-yl]-4-pyridyl]-2,3-bis(hydroxymethyl)-6,7-dimethoxynaphthalene·3/2 hydrate, 3 to 7% by weight of a separation inhibitor, 15 to 50% by weight of a hydrocarbon gel, a pH controller and 0.05 to 0.4% by weight of an antioxidant, has excellent drug stability and excellent drug dispersibility. In the present ointment, polyoxyethylene (196) polyoxypropylene (67) glycol is preferred as the separation inhibitor, diisopropanolamine is preferred as the pH controller, and dibutylhydroxytoluene is preferred as the antioxidant.

Abstract: A pharmaceutical composition for intranasal administration for human subjects includes vitamin B12 and a pharmaceutically acceptable carrier. The vitamin B12 particles are dispersed in a hydrophobic continuous phase as the pharmaceutically acceptable carrier. The dispersion of solid vitamin B12 particles (crystals or amorphic) in a hydrophobic continuous phase displays very satisfactory bioavailability. Also, the intense red color is reduced significantly, making the pharmaceutical composition acceptable for intranasal use.

Abstract: The invention relates to a stable injectable aqueous solution containing diclofenac and thiocolchicoside, or pharmaceutically acceptable salts thereof, and the use thereof in the treatment of painful and inflammatory rheumatic or traumatic conditions of the joints, muscles, tendons and ligaments.

Abstract: Nanoparticles comprising T3 and their use in treating, e.g., cardiac conditions, for example cardiac arrest, are provided. Such nanoparticles provide improved delivery of T3 and allow for acute treatment and optionally for sustained release of T3 in a patient.

Abstract: The present invention provides novel conformationally-defined macrocyclic compounds that can function as selective modulators of the ghrelin receptor (growth hormone secretagogue receptor, GHS-R1a and subtypes, isoforms and variants thereof). Methods of synthesizing the novel compounds are also described herein. These compounds are useful as agonists of the ghrelin receptor and as medicaments for treatment and prevention of a range of medical conditions including, but not limited to, metabolic and/or endocrine disorders, gastrointestinal disorders, cardiovascular disorders, obesity and obesity-associated disorders, central nervous system disorders, bone disorders, genetic disorders, hyperproliferative disorders and inflammatory disorders.

Abstract: The present disclosure relates to a more effective therapeutic agent capable of improving and treating the axial symptoms (particularly freezing of gait symptom) of patients with Parkinson's disease. Such symptoms in patients with Parkinson's disease can be improved and treated by using L-threo-3,4-dihydroxy-phenylserine (DOPS) and a COMT inhibitor in combination together, optionally with an L-DOPA preparation as well. As a result, the axial symptoms difficult to improve with conventional L-DOPA preparations can be treated, and a therapeutic agent and a treatment method are provided for the axial symptoms of patients with Parkinson's disease, particularly those suffering from the disease at a moderate level or higher.

Abstract: The invention includes compositions comprising selective AKR1C3 inhibitors. The invention also includes compositions comprising bifunctional AKR1C3 inhibitors and selective androgen receptor modulators. The invention further includes methods of treatment using the compositions of the invention.

Abstract: The present invention relates to a novel antibiotic, and more specifically relates to an antibiotic composition comprising flufenamic acid as an active ingredient, which can reduce drug toxicity and side effects and the problem of antibiotic resistance caused by excessive use of antibiotics since the composition exhibits a good therapeutic effect, even in a small dose, when it is administered either alone or together with another antibiotic of the prior art.

Abstract: Methods for preparing sterilized baclofen solutions include adjusting the pH to below a desired pH, and steam sterilizing the solution with adjusted pH, which results in the solution having the desired pH. Such solutions may also have low concentrations of 4-CPP. Injectable baclofen solutions having greater than 2 mg/mL baclofen include between 5 mM and 25 mM of a phosphate or sulfate species. The solution has an ionic strength equivalent of about 1.5 M NaCl. The present application also provides baclofen formulations for use in treating spasticity, brain injury, cerebral palsy, spinal cord injury, cervical injury, multiple sclerosis, thoracic injury, or withdrawal symptoms.

Abstract: A levothyroxine composition includes levothyroxine sodium and mannitol. The composition is a lyophilized solid. The composition may include from 100 to 500 micrograms levothyroxine sodium and from 2 to 4 milligrams mannitol.

Abstract: A levothyroxine composition includes levothyroxine sodium and mannitol. The composition is a lyophilized solid. The composition may include from 100 to 500 micrograms levothyroxine sodium and from 2 to 4 milligrams mannitol.