Abstract: The present invention relates to: a non-surfactant type oil-water (O/W) dispersion composition comprising non-polar solvent droplets in a polar solvent, the transparency of the dispersion composition being 90-100%; a non-surfactant type water-oil (W/O) dispersion composition comprising polar solvent droplets in a non-polar solvent, the transparency of the dispersion composition being 90-100%; and manufacturing methods for both of the compositions.

Abstract: Provided is a pharmaceutical composition comprising a collection of particles, wherein the particles comprise a drug and an ion exchange resin, wherein 90% or more by weight of the particles pass through a mesh screen having openings of 150 ?m, and wherein 90% or more by weight of the particles are retained on a mesh screen having openings of 106 ?m.

Abstract: The present application relates to a method for preparing a pharmaceutical composition, the method comprising providing pharmaceutical compound having a solubility in water of 1 mg/ml or less at 25° C. in a solvent enabling solubilizing the pharmaceutical compound at least partly into the solvent, providing an aqueous dispersion of nanostructured cellulose, and combining the pharmaceutical compound with the aqueous dispersion of nanostructured cellulose in an anti-solvent process to provide nanosized pharmaceutical particles having an average diameter of 50 nm or less, to provide a pharmaceutical composition. The present application also provides pharmaceutical composition, and use of the pharmaceutical composition.

Abstract: Novel microsphere compositions for use in parenteral formulations are provided. The microspheres comprise a biodegradable polymer of a molecular weight greater than 10,000 daltons, an active therapeutic agent, and a cellulose-derived material such as ethyl cellulose, carboxymethyl cellulose, hydroxypropylmethyl cellulose, or sodium carboxymethyl cellulose. The microsphere compositions decreased deviation in mean microsphere diameter, improved drug entrapment, and improved microsphere stability.

Abstract: The present invention discloses a spray drying process characterized by continuous preparation and immediate spray drying of a solution comprising at least one active pharmaceutical ingredient and/or at least one excipient, and at least one solvent. The said active pharmaceutical ingredient(s) and solvent(s) are combined, alone or along with one or more excipients to form a first suspension. Said suspension is continuously fed to an intensifier pump that pushes said suspension through at least one micro-reaction chamber and/or at least one micro-channel where the suspension's solid(s) component(s) is(are) dissolved into said solvent(s) by means of high energy mixing I forced contact at micro, nano and molecular level to form a solution stream. The said solution stream is then immediately and continuously fed to the spray dryer through at least one atomization nozzle, drying said atomized stream to obtain solid particles and collecting said solid particles.

Abstract: Disclosed are a composition and a method for freeze-drying which allow excellent stability, safety, and efficacy to be exhibited at the time of freeze-drying and reconstituting a composition for anionic drug delivery.

Abstract: Antibody formulations and methods useful for prophylaxis or treatment of amyloidosis, including AA amyloidosis and AL amyloidosis.

Abstract: The present invention in general relates to an immediate-release pharmaceutical composition containing ketoprofen lysine salt and mannitol. In particular, the present invention relates to an immediate-release pharmaceutical composition in the form of tablet. The invention also provides a process for manufacturing such composition.

Abstract: The invention relates to a solid oral extended release pharmaceutical dosage form comprising an extended release matrix formulation. The extended release matrix formulation comprises (1) at least one active agent, (2) at least one anionic surfactant, and (3) at least about 40% by weight (based on the weight of the extended release matrix formulation) of at least one polyethylene oxide. In certain embodiments, the molar ratio of the at least one anionic surfactant to the at least one active agent is from about 1:2 to about 10:1.

Abstract: The present disclosure provides oral drug dosage forms comprising: (a) an erodible non-stimulant material admixed with an ADHD non-stimulant; and (b) an erodible stimulant material admixed with an ADHD stimulant, wherein the erodible non-stimulant material admixed with the ADHD non-stimulant is embedded in a substrate material, and wherein upon exposure to gastrointestinal fluid the ADHD non-stimulant is released according to a desired non-stimulant release profile and the ADHD stimulant is released according to a desired stimulant release profile. In some embodiment, the ADHD non-stimulant is released according to a sustained release profile. In some embodiments, the ADHD stimulant is released according to an immediate release profile. The oral drug dosage forms of the present disclosure are useful for the treatment of attention deficit hyperactivity disorder (ADHD). Also provided herein are methods of designing and manufacturing the oral drug dosage forms described herein.

Abstract: Provided is a method of encapsulation, the method including: providing a first mixture; applying heat to the first mixture until the first mixture reaches a first temperature; providing a second mixture; applying heat to the second mixture until the second mixture reaches a second temperature; mixing the first mixture with the second mixture to obtain a third mixture; providing a fourth mixture; applying heat to the fourth mixture until the fourth mixture reaches a third temperature; mixing the third mixture with the fourth mixture to obtain a fifth mixture.

Abstract: This invention provides novel oral dosage forms comprising a hops extract. The oral dosage forms are capable of activating bitter taste receptors expressed in the gastrointestinal tract. The applications include but are not limited to the use of the oral dosage forms for reducing energy intake and/or appetite in a subject.

Abstract: The present disclosure relates to cholestyramine formulations for targeted delivery to the ileum, its use and its process of manufacture, more particularly scale-up manufacture.

Abstract: A detector assembly includes scintillators configured to generate a light signal in response to an impinging backscatter signal, where the scintillators are arranged in a first pattern, a plurality of first detectors, where each first detector is coupled to a scintillator and configured to receive a first portion of a light signal from that scintillator, and where the first detectors are arranged in a second pattern aligned with the first pattern, a plurality of second detectors, where each second detector is disposed adjacent a scintillator and configured to receive a second portion of the light signal from that scintillator, and where the plurality of second detectors is arranged in a third pattern, and a scintillator collimator including a plurality of openings and configured to selectively receive the backscatter signal, where the detector assembly is configured to provide depth resolution, azimuthal resolution, a defect type, a defect size, or combinations thereof.

Abstract: Described herein are oral liquid pharmaceutical compositions for the oral administration of an aminosalicylate, as well as methods of making such oral liquid pharmaceutical compositions, and therapeutic methods for using them. The oral liquid pharmaceutical compositions comprise extended-release microparticles formulated with an aminosalicylate, wherein the extended-release microparticles are provided with an outer delayed release coating.

Abstract: Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.

Abstract: There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

Abstract: We describe that carotenoids provide a prebiotic effect and can be used to improve the health of the gut microbiome.

Abstract: Apparatus, systems, and methods provide access to the renal pelvis of a kidney to treat renal nerves embedded in tissue surrounding the renal pelvis. Access to the renal pelvis may be via the urinary tract or via minimally invasive incisions through the abdomen and kidney tissue.

Abstract: This invention provides a solubility enhancer for monosodium urate for use in the treatment of gout. The solubility enhancer may be a pharmaceutically acceptable base, a solvent, a lipid, a surfactant, a pharmaceutically acceptable acid, a cyclodextrin, at least one paraben or a combination thereof.

Abstract: The present technology relates to methods of treating SYNGAP1 encephalopathy by transdermally administering an effective amount of cannabidiol (CBD) to the subject, wherein a SYNGAP1 symptom is treated in the subject.

Abstract: A cannabinoid composition for reducing the pathogenic microbial load of a subject. The cannabinoid composition includes purified water, full spectrum hemp extract having a between 30-70% cannabidiol concentration, which is predominately Cannabidiol, 200-800 mg and bioactive amounts of crofelemer and bioactive amounts of organosulfur compounds. Preferably, the Crofelemer is derived from Ajo Sacha paste, which naturally includes bioactive amounts of Crofelemer extracted from the latex of Croton lechleri. The paste is dissolved in the water in a final concentration of 600 mg paste per 60 ml (2 oz) finished product. The organosulfur preferably is derived from Sangre de Grado and added in a standardized aqueous commercial form at a concentration of 0.5 ml per 60 ml of the finished product and an excipient. This yields a cannabinoid composition with detectable and bioactive amounts of Crofelemer and organosulfur compounds. The cannabinoid composition is packaged in an oral dropper bottle.

Abstract: The present invention provides compositions useful in reducing or preventing pain in a subject in need thereof. In one embodiment, the compositions comprise a halogenated volatile compound. The present invention further includes a method of reducing or preventing pain in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a composition of the invention. Dosing regimens contemplated within the invention include one-time administration, continuous administration or periodic administration.

Abstract: The present disclosure relates to a method of inducing apoptosis in a cancer cell by delivery of exogenous Coenzyme Q1O or its metabolites thereof in a pharmaceutically acceptable carrier to effectuate cell contact of endogenous Coenzyme Q1O or its metabolites thereof in addition to but not limited to mevalonic acid and oleic acid to form an intracellular complex. The present disclosure also provides a method of modulating the p53 pathway and Bcl-2 protein family in a manner that restores the apoptotic potential to a cancer cell by delivery of Coenzyme Q1O in a pharmaceutically acceptable carrier. The present disclosure further provides a method to specifically normalize the ratio of pro-apoptotic and anti-apoptotic members of the Bcl-2 gene family in a proportion to re-program a cancer cell to undergo apoptosis.

Abstract: In an embodiment of the invention, a composition for treating a cell population comprises an Affinity Medicant Conjugate (AMC). The medicant moiety can be a toxin including an acylfulvene or a drug moiety. The affinity moiety can be an antibody, a binding protein, a steroid, a lipid, a growth factor, a protein, a peptide or non peptidic. The affinity moiety can be covalently bound to the medicant via a linker. Novel linkers that can be directed to cysteine, arginine or lysine residues based on solution pH allow greater flexibility in preserving and/or generating specific epitopes in the AMC.

Abstract: Provided herein are treatments for reducing pain in dogs. The treatments generally comprise a combination of an opioid compound, such as methadone, and an azole compound, such as fluconazole. The treatments may further comprise an opioid abuse deterrent that advantageously inhibits opioid effects in humans while maintaining desirable analgesic effects in dogs. Additionally, the treatments provided herein avoid the undesirable side effects of prior art opioid treatments for dogs. The treatments may be administered as separate doses or in a single formulation product for improved compliance. The treatments have wide use potential in dogs from perioperative patients to inpatients and outpatients and may be used, for example, for sedation in minor procedures, analgesia, and decreasing temperature in canine patients.

Abstract: The present invention relates generally to compositions and methods for treating neurodegenerative diseases and disorders, particularly ophthalmic diseases and disorders. Provided herein are alkoxyl derivative compounds and pharmaceutical compositions comprising these compounds. The subject compositions are useful for treating and preventing ophthalmic diseases and disorders, including age-related macular degeneration (AMD) and Stargardt's Disease.

Abstract: Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Abstract: Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Abstract: The invention relates to a DPP-IV inhibitor (preferably vildagliptin or a pharmaceutically acceptable salt thereof), and metformin or a pharmaceutically acceptable salt thereof, for use in treating type 2 diabetes. The invention also relates to the use of a DPP-IV inhibitor (preferably vildagliptin or a pharmaceutically acceptable salt thereof), and metformin or a pharmaceutically acceptable salt thereof, in the manufacture of a medicament for treating type 2 diabetes. The invention also relates to a method of treating type 2 diabetes using a DPP-IV inhibitor (preferably vildagliptin or a pharmaceutically acceptable salt thereof), and metformin or a pharmaceutically acceptable salt thereof.

Abstract: The present disclosure relates to an N-(substituted naphthyl-ethyl) substituted amide compound and uses thereof serving as a melatonin receptor agonist and 5-HT2C receptor antagonist, and specifically relates to the compound of formula (I) or a pharmaceutically acceptable salt thereof, a solvate or a mixture of them, and a pharmaceutical composition, where X, R1, and R2 are as defined in the present text.

Abstract: A method for the treatment or prevention of a cardiovascular event in a subject with atherosclerotic vascular disease comprising the step of: b) administering a therapeutically effective amount of a compound of formula (I), a known colchicine derivative and/or a salt thereof wherein: R1, R2, R3, R4, R9, R10, R11 and R12 independently represent hydrogen, C1-4 alkyl, C2-4 alkenyl, C3-6 cycloalkyl, halogen, C1-4 haloalkyl, nitro, amino, C2-4 acylamino, C1-4 alkyl or dialkylamino, hydroxyl, C1-4 alkoxy, C1-4 alkylthio, a group of the formula —SO2N(Rx)2 or SO2Rx where Rx is C1-4 alkyl, C1-4 acyloxy, or optionally substituted phenyl, optionally substituted phenoxy; R7 and R8 independently represent hydrogen, C1-4 alkyl or C1-4 acyl; and R5?, R5?, R6? and R6? independently represent hydrogen, C1-4 alkyl, C2-4 alkenyl, C3-6 cycloalkyl, halogen, C1-4 haloalkyl, nitro, amino, C2-4 acylamino, hydroxyl, C1-4 alkoxy or C1-4 alkylthio a group of the formula —SO2N(Rx)2 or SO2Rx where Rx is C1-4 alkyl, C1-4 acylo

Abstract: An oral pharmaceutical dosage form that comprises both acetaminophen and a glutathione replenishing agent, such as N-acetylcysteine. This allows co-administering the glutathione replenishing agent along with acetaminophen, which may be beneficial in rapidly counteracting the toxic effects of acetaminophen overdose. The oral dosage form could be in the form of a tablet or capsule. The dosage form may be designed to compartmentally separate the glutathione replenishing agent from having chemical interaction with the acetaminophen. The dosage form may be designed to mask the taste or smell of the glutathione replenishing agent.

Abstract: The presently disclosed subject matter provides methods, compositions, and kits for the treatment of cancer using a combination treatment comprising a locally administered chemotherapy and an immunotherapeutic agent. The presently disclosed subject matter also provides methods of promoting the combination treatment and instructing a patient to receive the combination treatment are also provided, as well immunotherapeutic, non-immunosuppressive compositions comprising the combination treatment, and methods of using the immunotherapeutic, non-immunosuppressive compositions for treating cancer.

Abstract: The present invention provides oral solutions containing sotalol hydrochloride which advantageously avoid swallowing while providing with improved stability. The present invention also relates to methods of using the oral solutions for treatment of diseases and disorders, such as delay in reoccurrence of atrial fibrillation/atrial flutter and/or ventricular arrhythmias.

Abstract: The invention relates to a compound which is effective in inhibiting the function of the TRPM4 ion channel and the use of such compound in treating or preventing a neurodegenerative disease, such as Multiple Sclerosis, Parkinson's disease, Alzheimer's disease, or amyotrophic lateral sclerosis, in a subject. The invention also provides a pharmaceutical composition comprising a TRPM4 inhibitory compound. The invention further relates to in vitro methods for identifying pharmaceutically active compounds that are useful for treating or preventing a neurodegenerative disease.

Abstract: Provided herein are methods for administering dichlorphenamide, or a pharmaceutically acceptable salt thereof, to a subject in need thereof, wherein the subject is also being administered an organic anion transporter-1 (OAT1) substrate to treat an associated disease or disorder. The method comprises administering to the subject a therapeutically effective amount of dichlorphenamide, or a pharmaceutically acceptable salt thereof, and monitoring the subject for signs and symptoms of toxicity and clinical response associated with the OAT1 substrate.

Abstract: The present invention relates to decontaminating compositions and methods for producing and using the same. The compositions may comprise a peracid, a hydroperoxide, and a peroxyacid.

Abstract: The present invention provides a composition comprising HMB. Methods of administering HMB to an animal are also described. HMB is administered to decrease joint instability, increase joint stability, decrease joint stiffness, improve joint function, improve joint health, improve balanced movement and improve skeletal joint stability during muscle movement. HMB is administered to increase muscle strength and/or muscle mass in a side of the body contralateral to joint inflammation, joint damage, and/or joint injury.

Abstract: A method is described for providing acute symptomatic relief to a subject with Parkinson's Disease (PD) or other CNS disorders resulting from dopamine deficiency in the brain comprising administering to said subject an amount of a ketogenic material sufficient to produce a ketosis in the subject sufficient to provide therapeutic benefit in such neurological disorders. Preferred materials produce a ketosis is such that the total concentration of acetoacetate and (R)-3-hydroxybutyrate in the blood of the subject is raised to between 0.1 and 30 mM.

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: Disclosed herein are compositions that include for example the arginine salt of carbidopa, and methods for treating neurological or movement diseases or disorders such as restless leg syndrome, Parkinson's disease, secondary parkinsonism, Huntington's disease, Parkinson's like syndrome, PSP, MSA, ALS, Shy-Drager syndrome and conditions resulting from brain injury including carbon monoxide or manganese intoxication, using substantially continuous administration of carbidopa or salt thereof together with administration of levodopa.

Abstract: Pharmaceutical ocular compositions include levodopa, an antioxidant and an aqueous carrier. A wide selection of antioxidants can be included in the compositions, such as ascorbic acid, phenolic acids, sorbic acid, sodium bisulfite, sodium metabisulfite, acetyl cysteine, sodium thiosulfate, ethylene diamine tetraacetic acid, sodium nitrite, ascorbyl stearate, ascorbyl palmitate, alpha-thioglycerol, erythorbic acid, cysteine hydrochloride, citric acid, tocopherol or vitamin E, tocopherol acetate, dibutylhydroxytoluene, soybean lecithin, sodium thioglycolate, butylhydroxyanisole, propyl gallate, uric acid, melatonin, and thiourea, as well as salts and combinations of these antioxidants.

Abstract: Provided are methods of increasing metabolic maturation of an immature hepatocyte, by contacting an immature hepatocyte which expresses alpha-fetoprotein (AFP) and albumin with an effective amount of a fatty acid or a small molecule selected from the group consisting of: an amphipathic carboxylic acid Thiazolidinedione (TZD), WY-14643 (Pirinixic Acid), GW409544, GW6471, Leukotriene B4, GW 7647, Perfluorooctanesulfonic Acid, Perfluorooctanoic Acid, CP-775146, CP-865520, UNII-999KY5ZIGB, and Gemfibrozil. Also provided are isolated hepatocytes and uses thereof.

Abstract: The present specification provides methods of treating a muscular disorder with a combination of a RXR agonist and a thyroid hormone.

Abstract: The present patent application relates to novel polyunsaturated fatty acid salt (PUFA salts) solid formulations.

Abstract: The present invention provides a composition for improving lymphatic circulation, which contains a component selected from at least one highly unsaturated fatty acid, salt thereof, and ester thereof as an active ingredient. The present invention also provides a composition for improving lymphatic circulation, which contains as active ingredients a triglyceride comprising the at least one highly unsaturated fatty acid as a constituent fatty acid and a triglyceride comprising the at least one middle chain fatty acid as a constituent fatty acid. The present invention also provides a composition for improving lymphatic circulation, which contains as an active ingredient a triglyceride comprising the at least one highly unsaturated fatty acid and the at least one middle chain fatty acid as constituent fatty acids.

Abstract: An agent for preventing or ameliorating nocturia, containing rosmarinic acid or a salt thereof as an active ingredient.

Abstract: Novel active compositions having antimicrobial and anti-inflammatory activity are described, the activity provided by an active component prepared in a suspension, the active component being at least a single chain fatty acid having a carbon length of 12, or between 12 and no more than 18. The fatty acid may be esterified and/or ethylated or methylated. As an antimicrobial the active component has activity against one or more microorganisms including Staphylococcus spp., Streptococcus spp., Mycobacterium spp., Clostridium spp., and Candida spp., with an MIC as low as 0.0018 ?g/ml. As an anti-inflammatory, it is at least as or is more effective than cyclosporine in preventing T-cell proliferation in response to a trigger, such as stimulation by the one or more microorganisms. The active component is more active when combined with a phospholipid (e.g., lecithin, phosphatidylcholine) and caused to form liposomal nanoparticles. It is also more active when caused to form coated liposomal nanoparticles.

Abstract: The present invention relates to a method for treating or preventing obesity in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of certain carbamate compounds. The invention further relates to methods for reducing body weight and/or reducing food intake in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of certain carbamate compounds.