Abstract: A parenteral formulation of esmolol hydrochloride for use in the treatment of a patient suffering from tachycardia comprising a lyophilized powder consisting of pure esmolol hydrochloride, wherein said powder is reconstituted to obtain a ready-to-use i.v. solution of esmolol hydrochloride at a concentration of 20-100 mg/mL, and said i.v. solution is directly administered to the patient, and further a method of producing a ready-to-use i.v. solution of esmolol hydrochloride by reconstituting a lyophilized powder consisting of pure esmolol hydrochloride with a solvent, characterized in that said solvent is an i.v. solvent devoid of alcohol or a buffer excipient, in an amount necessary to obtain a ready-to-use i.v. solution at a concentration of 20-100 mg/mL, and the ready-to-use i.v.

Abstract: The present disclosure provides topical compositions of rofecoxib and methods of making said compositions. The present disclosure also provides methods of using topical compositions of rofecoxib to treat inflammation.

Abstract: Disclosed is an extended-release lacosamide preparation which can be taken once a day. Also disclosed is a method for treating a subject with epilepsy including administering the extended-release lacosamide preparation once a day.

Abstract: The present invention relates generally to a composition comprising apigenin, phenylethylamine, nicotinamide mononucleotide and/or nicotinamide riboside, and resveratrol, anthocyanin, and/or pterostilbene and piceatannol. The composition may be provided in the form of a beverage, jell packet, mixable powder, or the like. Alternatively, the composition may be microencapsulated and selectively added to a consumable substance, such as a fluid, jell, or the like. The composition may be used to increase the consumer's levels of energy, alertness, and activate the body's natural chemical that prevent anxiety and depression. Furthermore, the inclusion of apigenin provides additional benefits, namely, inhibiting the increase of proteins such as CD38 that would otherwise affect the levels of NAD+ in the body that help with cellular aging.

Abstract: Provided are novel prodrugs of treprostinil, as well as methods of making and methods of using these prodrugs.

Abstract: The present invention provides a novel compound of formula I, its derivatives, pharmaceutically acceptable salts thereof, and pharmaceutical compositions thereof. Compounds of the present invention are useful for modulating GSK3 level (e.g., GSK3 (e.g., GSK3a/GSK3b or GSK3P) or CK1) hence, activity.

Abstract: Disclosed are methods for using guanfacine, an analog or derivative of guanfacine, or a pharmaceutically acceptable salt thereof, to reduce the virulence of a bacterial pathogen. When treating a patient, the method generally involves administering to the patient a therapeutically effective dose of guanfacine, an analog or derivative of guanfacine, or a pharmaceutically acceptable salt thereof. An alternative method involves contacting the bacterial pathogen with guanfacine, an analog or derivative of guanfacine, or a pharmaceutically acceptable salt thereof.

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: Thyroid hormone oral dosage forms and methods of making and using the thyroid hormone oral dosage forms are disclosed.

Abstract: Thyroid hormone oral dosage forms and methods of making and using the thyroid hormone oral dosage forms are disclosed.

Abstract: The present invention relates to stable, aqueous, parenteral solutions comprising diclofenac and polyvinylpyrrolidone, wherein the solutions are for parenteral (subcutaneous, intravenous and/or intramuscular) administration.

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

Abstract: Compounds and methods of scavenging bifunctional electrophiles and reducing the occurrence of lysyl-levuglandin adducts in a subject in need thereof by administering a levuglandin adduct formation inhibiting amount of a compound of the following formula: wherein the variables are defined herein.

Abstract: Adhesives for use on user-to-mask interfaces of a respiratory mask and methods of preparing the same are provided. The adhesive includes greater than or equal to about 1 wt. % to less than or equal to about 15 wt. % of one or more glycerides; greater than or equal to about 0.50 wt. % to less than or equal to about 5 wt. % of one or more polyacrylates; greater than or equal to about 1 wt. % to less than or equal to about 10 wt. % of one or more polyethers; greater than or equal to about 25 wt. % to less than or equal to about 45 wt. % of one or more N-vinylpyrrolidone polymers; and a balance of water. The method includes forming a first aqueous mixture, forming a second aqueous mixture, and admixing the first aqueous mixture and the second aqueous mixture to form a substantially homogeneous mixture that defines the adhesive.

Abstract: A method and a system for producing a change in a medium. The method places in a vicinity of the medium an energy modulation agent. The method applies an initiation energy to the medium. The initiation energy interacts with the energy modulation agent to directly or indirectly produce the change in the medium. The energy modulation agent has a normal predominant emission of radiation in a first wavelength range outside of a second wavelength range (WR2) known to produce the change, but under exposure to the applied initiation energy produces the change. The system includes an initiation energy source configured to apply an initiation energy to the medium to activate the energy modulation agent.

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 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: 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: 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.