Abstract: A nasal delivery device for and method of delivering a substance, preferably comprising oxytocin, non-peptide agonists thereof and antagonists thereof, preferably as one of a liquid, as a suspension or solution, or a powder, to the nasal airway of a subject, preferably the posterior region of the nasal airway, and preferably the upper posterior region of the nasal airway which includes the olfactory bulb and the trigeminal nerve, and preferably in the treatment of neurological conditions and disorders.

Abstract: An implant for insertion into a punctum of a patient comprises a body. The body has a distal end, a proximal end, and an axis therebetween. The distal end of the body is insertable distally through the punctum into the canalicular lumen. The body comprises a therapeutic agent included within an agent matrix drug core. Exposure of the agent matrix to the tear fluid effects an effective therapeutic agent release into the tear fluid over a sustained period. The body has a sheath disposed over the agent matrix to inhibit release of the agent away from the proximal end. The body also has an outer surface configured to engage luminal wall tissues so as to inhibit expulsion when disposed therein. In specific embodiments, the agent matrix comprises a non-bioabsorbable polymer, for example silicone in a non-homogenous mixture with the agent.

Abstract: An implant for insertion through a punctum and into a canalicular lumen of a patient. The implant includes a matrix of material, a therapeutic agent dispersed in the matrix of material, a sheath disposed over a portion of the matrix of material and configured to inhibit the therapeutic agent from being released from the matrix of material into the canalicular lumen and to allow the therapeutic agent to be released from a surface of the matrix of material to a tear film, and a retention structure configured to retain the implant within the canalicular lumen.

Abstract: The invention relates to a regulator for increasing the expression of the p53 protein in hepatocyte cells and/or a regulator for reducing or inhibiting the expression of the p63? protein in hepatocyte cells, for the production of a drug for use in the treatment of non-alcoholic fatty liver disease (NAFLD) and/or non-alcoholic steatohepatitis (NASH).

Abstract: The anesthetic chewing gum includes lidocaine HCL and prilocaine HCL as the anesthetic ingredients, as well as a chewing gum base. The anesthetic chewing gum may also include one or more sweeters, an anti-adherent, a lubricant, an opacifier, a glidant, a flavoring agent, and a flavor enhancer.

Abstract: The instant invention is drawn to a hepatocyte targeted composition comprising insulin associated with a lipid construct comprising an amphipathic lipid and an extended amphipathic lipid that targets the construct to a receptor displayed by an hepatocyte. The composition can comprise a mixture of free insulin and insulin associated with the complex. The composition can be modified to protect insulin and the complex from degradation. The invention also includes methods for the manufacture of the composition and loading insulin into the composition and recycling various components of the composition. Methods of treating individuals inflicted with diabetes.

Abstract: The described invention provides site-specific sustained release microparticulate formulations containing a therapeutic amount of an L-type voltage gated calcium channel inhibitor, a PLGA polymer comprising from 25% to 50% glycolide, and a hyaluronic acid. A therapeutic amount of the formulation is effective to reduce signs or symptoms of delayed cerebral ischemia comprising one or more of a cortical spreading ischemia, a cortical spreading depolarization, a plurality of microthromboemboli, or an angiographic vasospasm after brain injury in a mammal, while reducing the risk of systemic hypotension, cardiac dysfunction, anoxia, and intracranial hypertension.

Abstract: A controlled release pharmaceutical formulation is provided, comprising cyclosporine-loaded microparticles of a bioresorbable polymer comprising poly(D,L-lactide), wherein the mean diameter of the microparticles is in the range 20 ?m to 40 ?m. Also provided are medical uses of the pharmaceutical formulation, in particular in the treatment of uveitis, a process for production of the pharmaceutical formulation and injectable dosage forms, including those formulated for intravitreal injection.

Abstract: A solid pharmaceutical dosage form having drug-loaded particles and methods of making.

Abstract: The present invention provides a method for preparing a pharmaceutical composition containing a quinoline derivative or a salt thereof. Specifically, the invention provides a method for preparing a pharmaceutical composition containing (R,E)-N-(4-(3-chloro-4-(pyridin-2-ylmethoxy)phenylamino)-3-cyano-7-ethoxyquinolin-6-yl)-3-(1-methylpyrrolidin-2-yl)-propeneamide or a pharmaceutically acceptable salt thereof. The method uses a wetting agent containing at least one organic solvent for a wet granulation in a preparation process of the pharmaceutical composition. The pharmaceutical composition prepared using the method has a uniform distribution of grain sizes during the preparation process and a property of rapid and uniform dissolution.

Abstract: The present invention provides a solid preparation wherein variation in weight is suppressed, a solid preparation wherein the active ingredient is stabilized, and a stabilization method thereof. A solid preparation containing (1) an active ingredient, (2) D-mannitol and (3) an alkaline earth metal salt selected from magnesium aluminometasilicate and calcium silicate. A method of stabilizing the active ingredient, including adding an alkaline earth metal salt selected from magnesium aluminometasilicate and calcium silicate.

Abstract: The present disclosure relates to pharmaceutical compositions comprising a gonadotropin-releasing hormone (GnRH) antagonist and methods of preparing and using such compositions. The disclosure also relates to methods of facilitating release of a GnRH antagonist from a pharmaceutical composition.

Abstract: Pharmaceutical compositions of colchicine for once-a-day oral administration are provided. The formulations comprise a sustained-release component and an optional immediate-release component, the compositions of which can be selectively adjusted, respectively, to release the active ingredient along a pre-determined or desired release profile. Methods of treating or preventing cardiovascular disease and/or inflammatory disease in mammalian subjects comprising the administration of the novel formulations disclosed herein are also provided.

Abstract: Provided are pharmaceutical composition particles which are capable of achieving both of masking of an unpalatable taste and improvement in dissolution properties; an orally disintegrating tablet including the pharmaceutical composition particles; and a method for manufacturing the pharmaceutical composition particles. Each of the pharmaceutical composition particles includes: a drug-containing core particle; an intermediate layer containing a gelling swelling substance and coating an outside of the core particle; and an outermost layer containing a water-insoluble substance and coating an outside of the intermediate layer.

Abstract: Among other things, compositions, kits, and methods for epilepsy therapy using a process for treating calcinosis manifested in Neurocysticercosis, Tuberous Sclerosis Complex, and Sturge-Weber Syndrome; an automated platform for real-time diagnosis and treatment of calcinosis comprising a computer-implemented method for using predictive analytics for administering a novel drug, Kamini™, to human patients generated at least in part from information that has been accumulated automatically from on-line resources.

Abstract: The presently disclosed subject matter provides a solid immediate release pharmaceutical multi-particulate dosage form containing at least two different populations of particulates. In certain embodiments, the immediate release pharmaceutical dosage forms contain at least three different populations of multi-particulates. Each population of particulates is designed for a specific function to accomplish the desired combination of abuse deterrence and overdose protection.

Abstract: There are provided a pharmaceutical composition, a preparation method thereof, and an application of same. The pharmaceutical composition includes an active ingredient, a polymer, and a surfactant. The surfactant includes a bile salt. The pharmaceutical composition is prepared as a nanoparticle.

Abstract: Provided herein are use of polymeric excipients, specifically polyvinyl alcohols, optionally in conjunction with sugars, as cryoprotectants to prevent aggregation of PEG-containing particles. Also provided are PEG-containing particles comprising such polymeric excipients.

Abstract: Systems and methods for targeting specific cancer cell subpopulations present in tumor tissue are described. A system can include a first component for specifically targeting cancer stem cells and a second component for specifically targeting differentiated cancer cells. A system can include a drug conjugated to small (e.g., 5-20 nm) nanoparticles, e.g., polyhedral oligomeric silsequioxane nanoparticles. The small nanoparticles can be preferentially taken up by cancer stem cells via macropinocytosis and can release a toxic payload within the cancer stem cells without triggering the efflux pump. A system can include a second component that targets differentiated cancer cells, e.g., a free drug or a drug encapsulated in nanoparticles.

Abstract: Provided are peptide-based nanostructures, as well as diagnostic and therapeutic methods using same.

Abstract: A fiber may comprise an electrospun polymer and a pharmaceutical. The pharmaceutical may be dispersed within the electrospun polymer, and may have the form of a crystal, an oil, or a combination thereof. A method of making an electrospun fiber may comprise configuring a receiving surface to receive a polymer fiber, applying a charge to one or more of the receiving surface, a polymer injection system, and a polymer solution ejected from the polymer injection system, and depositing a polymer solution ejected from the polymer injection system onto the receiving surface. The polymer solution may comprise a polymer and a pharmaceutical. A method of treating a disorder in a subject may comprise obtaining such a fiber having an effective amount of a pharmaceutical, applying the fiber to an oral region of the subject, and allowing the fiber to disintegrate, thereby delivering the effective amount of the pharmaceutical to the subject.

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

Abstract: An example of a nitric oxide generating formulation includes an S-nitrosothiol (RSNO) powder, a salt, and an additive. The additive is to control or accelerate a rate of release of nitric oxide (NO) from RSNO after the RSNO powder, the salt, and additive are dissolved into a liquid carrier. The nitric oxide generating formulation may be part of a kit that includes a container for dissolving the components into a liquid carrier. One of the kits may be used to prevent and/or treat sinonasal infections and another of the kits may be used to create antimicrobial lock solutions.

Abstract: Disclosed herein are therapeutic regimens for improving visual function in Retinitis Pigmentosa and other visual disorders associated with an endogenous retinoid deficiency in a subject by administering a therapeutically effective amount of a synthetic retinal derivative, for example a 9- or 11-cis retinyl ester, according to the therapeutic regimen which leads to local recovery of visual functions such as visual fields, visual acuity and retinal sensitivity, among others.

Abstract: Disclosed herein are compounds and compositions thereof which find use in increasing stability of TTR tetramers reducing its tendency to misfold and form aggregates. Also provided herein are methods for using these compounds and compositions for increasing stability of TTR and thereby decreasing aggregate formation by TTR. Also disclosed herein are methods to screen for candidate compounds that increase stability of TTR. Also disclosed herein are heterobifunctional compounds that include a TTR binding compound connected to a targeting moiety via a linker, for use in disrupting PPis of a target protein.

Abstract: Disclosed is a use of a nootkatone in the preparation of medicines for preventing and/or treating depression. The nootkatone has a significant efficacy which is better than that of the existing antidepressant drug Prozac; and it has a wide range of sources and offers more choices for preventing and treating depression.

Abstract: Methods and compositions utilizing 2-aminoindan derivatives collectively represented by Formula I as described and defined in the specification for regulating binge behavior, particularly binge drinking, are disclosed.

Abstract: The present invention relates to compositions of S-enantiomer enriched oxprenolol and their use in treating cancer and treating or preventing, in cancer patients, cachexia, body weight loss, lean body mass loss and adipose tissue loss, and improving quality of life and prolonging survival of cancer patients.

Abstract: The present invention relates to a pharmaceutical oral dosage form comprising both (A) trans-clomiphene or a pharmaceutically acceptable salt thereof and (B) cis-clomiphene or a pharmaceutically acceptable salt thereof, wherein (i) the ratio of (A):(B) in the dosage form is about 70:30; (ii) the amount of (A) in the dosage form is about 12.5 mg or about 25 mg; and (iii) the amount of (B) in the dosage form is less than 15 mg. The pharmaceutical oral dosage form is useful to treat secondary hypogonadism in men and minimize certain antiestrogenic drug side effects such as impaired cognition, hot flashes and bone loss, osteoporosis, and skeletal fractures.

Abstract: The disclosure provides methods and compositions for treating skin conditions. In particular, the disclosure provides compositions comprising metformin either alone or in combination with at least one additional active agent, and methods for treating skin conditions using such compositions.

Abstract: The present invention relates to a pharmaceutical composition/formulation for the prevention of diet induced obesity. More particularly, the invention relates to a composition/formulation comprising a synergistic combination of Oleoylethanolamide (OEA) and other natural ingredients can be used for treatment of obesity and its related disorders associated with fat metabolism like non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD). This can also be helpful in controlling obesity by way of maintaining body weight. The invention also provides various formulations and methods of preparing the same.

Abstract: Disclosed herein are methods of treating a malignant adrenocortical tumor, including a locally advanced and metastatic adrenocortical carcinoma. In some examples, methods of treating a malignant adrenocortical tumor include administering an effective amount of niclosamide alone or in combination with other therapeutic agents to a subject in need thereof, thereby treating the malignant adrenocortical tumor.

Abstract: The present application provides that synthetic retinoid compounds are useful in methods of treating bacterial infections, such as a bacterial infection caused by S. aureus, methicillin-resistant S. aureus (MRSA), vancomycin-resistant S. aureus (VRSA), E. faecalis, E. faecium, B. subtilis, and B. anthracis. The present application also provides a tricyclic fluoroquinolone compound, Z3060, useful in methods of treating bacterial infections, such as Sa bacterial infection caused by S. aureus, methicillin-resistant S. aureus (MRSA), vancomycin-resistant S. aureus (VRSA), E. spp., K. pneumoniae, P. aeruginosa, A. baumannii, E. faecium, and E. faecalis. Also provided herein is a gold compound, auranofin, useful in treating bacterial and fungal infections, such as a fungal infection caused by C. albicans, C. parapsilosis, C. tropicalis, C. glabrata, and C. neoformans.

Abstract: The present invention relates to oxaloacetate compounds that activate AMP-activated protein kinase (AMPK), including the preparation of the compounds, compositions containing the compounds, preserving said compounds and the use of the compounds in the prevention or treatment of disorders such as diabetes, metabolic syndrome, obesity, cardiovascular disease, Alzheimer's disease, and cancer.

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: The present disclosure provides compositions and methods for preventing and treating dyskinesia, such as drug-induced dyskinesia in patients of Parkinson's disease. The compositions, preferably in a sustained release formulation, include L-DOPA, carbidopa, and ranitidine wherein the weight ratio of L-DOPA to carbidopa is in the range of about 1:(0.2-0.3), or include L-DOPA, benserazide, and ranitidine, wherein the weight ratio of L-DOPA to benserazide is in the range of about 1:(0.4-0.6).

Abstract: Some aspects of the invention provide for essential fatty acids which are substituted in specific positions to slow down oxidative damage by Reactive Oxygen Species (ROS), and to suppress the rate of consequent formation of reactive products, for the purpose of preventing or reducing the damage associated with oxidative stress associated diseases such as neurological diseases and age-related macular degeneration (AMD).

Abstract: The present invention is directed toward fatty acid-based particles, and methods of making such particles. The particles can be associated with an additional, therapeutic agent. Also provided herein is a method of forming fatty acid particles, comprising associating a cross-linked, fatty acid-derived biomaterial with a cryogenic liquid; and fragmenting the bio material/cryogenic liquid composition, such that fatty acid particles are formed. The particles can be used for a variety of therapeutic applications.

Abstract: In various embodiments, the present invention provides methods of treating and/or preventing cardiovascular-related disease and, in particular, a method of reducing or preventing HDL oxidation in a subject, the method comprising administering to the subject a pharmaceutical composition comprising eicosapentaenoic acid or a derivative thereof.

Abstract: The present invention discloses an application of neuraminidase and inhibitors thereof in myocardial ischemia and myocardial infarction, provides a correlation between neuraminidase and myocardial ischemic damage to prove the myocardial ischemic damage can be alleviated by inhibiting the activity of neuraminidase, and to prove the neuraminidase can be used as a target for screening drugs for preventing, alleviating and/or treating myocardial ischemic damage. The present invention also demonstrates the alleviating effect of neuraminidase inhibitors on myocardial ischemic damage. Neuraminidase inhibitors improves myocardial ischemic damage by reducing the level of neuraminidase. The present invention further provides a pharmaceutical preparation comprising neuraminidase inhibitor(s) and pharmaceutically acceptable carrier(s), the pharmaceutical preparation can be used for reducing the level of neuraminidase, thus improving myocardial ischemic damage.

Abstract: The invention relates to the field of retinoid X receptor (RXR) signaling and a novel vitamin A pathway called Vitamin A5 pathway. Compounds which are useful to provide (R)-9-cis-13,14-dihydroretinoic acid, an endogenous RXR ligand, are claimed as well as their uses and method for preparation thereof. The compounds of the invention are useful for pharmaceutical and nutritional uses.

Abstract: Provided herein are small-molecule compounds and combinations thereof that enhance the synthesis of animal endogenous genus host defense peptides, which display potent antimicrobial and immunomodulatory activities. They thus represent alternatives to antibiotics for disease control and prevention for use in animals and humans. Examples of the small molecule compounds include histone deacetylase inhibitors, mono- and disaccharide sugars, cyclic adenosine monophosphate (cAMP) signaling agonists, and cyclooxygenase -2 (COX-2) inhibitors. Synergistic combinations include short-chain fatty acids, their chemical analogs or histone deacetylase inhibitors with other fatty acids, sugars, cAMP signaling agonists, and/or COX-2 inhibitors.

Abstract: The present disclosure provides compositions comprising eicosapentaenoic acid or a derivative thereof, and methods of treating or preventing bone loss using same.

Abstract: Described herein are pharmaceutical compositions adapted for the parenteral administration of macrolide antibiotics, such as triazole-containing and fluoroketolide antibiotics. Also described herein are methods for their use in the treatment of bacterial, protozoal, and other infections.

Abstract: Therapy for influenza using a combination of a neuraminidase inhibitor, a macrolide antibiotic, and a non-steroidal anti-inflammatory drug has been found to provide improved clinical outcomes and reduced incidence of viral quasispecies compared to conventional treatment with neuraminidase inhibitors alone. Effective treatment schedules are also provided. The drug combination can be used in concert with a proton-pump inhibitor and/or an additional antibacterial antibiotic.

Abstract: The present application relates to compounded compositions, methods of making compounded compositions, and methods of using compounded compositions. For example, disclosed herein are compounded compositions and methods of making compounded compositions comprising one or more anti-infective agents such as mupirocin.

Abstract: The present invention provides safe and effective topical compositions for the treatment of psoriasis and alleviation and prevention of frequent recurrence of psoriasis symptoms as well as treatment of seborrheic dermatitis. The compositions comprise therapeutically effective amounts of salicylic acid, zinc oxide, bisabolol, at least one pharmaceutically acceptable carrier selected from the group comprising white petrolatum, lanolin, propylene glycol, and combinations thereof, herbal oils selected from the group comprising Salvia Hispanica seed oil, evening primrose oil, grape seed oil, Nigella seed oil, Silybum Marianum oil, Prunus Amygdalus Dulcis (sweet almond) oil, borage oil, Lavendula Angustifolia (lavender) oil, Cannabis sativa seed oil and mixtures thereof and other pharmaceutically acceptable ingredients. Unlike many topical compositions for the treatment of these skin afflictions, the compositions of the instant invention do not contain steroids (like cortisone) or coal tar.

Abstract: The present invention relates to the use of mixtures of vitamin E and polyunsaturated fatty acids (PUFAs) as agents for the prevention, control and/or treatment of conditions associated with excessive fat accumulation in the liver which is not caused by alcohol abuse. This includes prevention, control and/or treatment of non-alcoholic steatosis in the liver—known as non-alcoholic fatty liver disease (NAFLD)—and/or non-alcoholic steatohepatitis (NASH) in a subject in need thereof. In particular, the present invention relates to the use of such compounds comprising vitamin E acetate and DHA EE as active ingredients in the manufacture of medicaments for the prevention, control and/or treatment of conditions related to NAFLD.

Abstract: Provided herein is a method of treating, preventing, or alleviating one or more symptoms of pancreatic cancer in a subject, comprising administering to the subject therapeutically effective amounts of (i) vitamin C, or a pharmaceutically acceptable salt, solvate, or hydrate thereof, and (ii) a vitamin K compound, or a single enantiomer, a mixture of enantiomers, or a mixture of diastereomers thereof, or a pharmaceutically acceptable salt, solvate, hydrate, or prodrug thereof.

Abstract: The present invention relates to siponimod (BAF312) for use in the treatment of an autoimmune disease, wherein an immediate release dosage form is administered once daily to a patient as maintenance regimen and wherein the patient has experienced a specific titration regimen with siponimod beforehand.