Abstract: In various embodiments deformable nano-scale vehicles (DNV) are provided that are useful for the delivery of therapeutic agents. In certain embodiments the DNVs are capable of transdermal delivery and can additionally cross the blood-brain barrier.

Abstract: The present invention provides compositions and methods for the treatment of a human patient. The methods and compositions of the present invention include composition for the efficient loading of curcumin, comprising: an amount of a curcuminoid:liposome complex effective to load curcumin into the liposome, wherein the curcuminoids has between 2 to 9 weight percent of the total composition and the curcuminoids are natural or synthetic.

Abstract: Nanolipoprotein particles comprising at least a scaffold protein component and a membrane lipid component and related complexes, compositions, methods and systems are described, in which the membrane lipid component comprises at least one or more membrane forming lipids and one or more cationic lipids.

Abstract: The present invention provides a composition for the treatment of cancer including zwitterionic liposomes consisting essentially of: 50-65 mol % of a phosphatidylcholine lipid, 30-45 mol % of cholesterol, and 2-8 mol % of a PEG-lipid; and cisplatin. Cisplatin is encapsulated in the liposomes in an amount such that the ratio of the total lipid weight to the cisplatin weight is from about 65:1 to about 95:1. Methods for the preparation of liposomal cisplatin and the treatment of cancer are also disclosed.

Abstract: Provided are an active ingredient-containing particle with improved shape retainability. The particle includes a first fraction containing an active ingredient, a second fraction containing a surfactant, and at least one water-soluble polymer selected from the group consisting of a polysaccharide and a polymer having 2-methacryloyloxyethyl phosphorylcholine as a constituent unit.

Abstract: Pharmaceutical compositions of colchicine salicylate, including once-a-day orally administered formulations are provided. Method of treating and/or preventing cardiovascular disease and/or inflammatory disease in mammalian subjects comprising the administration of the novel formulations disclosed herein is also provided.

Abstract: Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.

Abstract: A solid administration form, protected from parenteral abuse and containing at least one viscosity-increasing agent in addition to one or more active substances that have parenteral abuse potential. The agent forms, when a necessary minimum amount of an aqueous liquid is added, on the basis of an extract obtained from the administration form, a preferably injectable gel that remains visually distinct when introduced into another quantity of an aqueous liquid.

Abstract: The present invention relates to a directly compressible composition for the production of tablets which comprise fine-grained polyvinyl alcohols (PVAs) and fine-grained microcrystalline celluloses (MCCs) in a co-mixture. The present invention also relates to the use of this mixture and to a process for the preparation thereof.

Abstract: Controlled release and taste masking compositions containing one or more active principles inglobated in a three-component matrix structure, i.e. a structure formed by successive amphiphilic, lipophilic or inert matrices and finally inglobated or dispersed in hydrophilic matrices. The use of a plurality of systems for the control of the dissolution of the active ingredient modulates the dissolution rate of the active ingredient in aqueous and/or biological fluids, thereby controlling the release kinetics in the gastrointestinal tract.

Abstract: A slow-release orally dissolving capsule has been described, which releases medicaments in the mouth cavity up to 1 hour. The medicaments may have a therapeutic effect in the mouth cavity and a portion of the drug is delivered to stomach. Thus, the medication may have a local action in the oral cavity and/or have a systemic effect. Mainly, the orally dissolving capsule is administered without an aid of water. Also, large capsules such as size “000” can be administered allowing delivery of large amounts (800 to 1600 mg) of medicament. The medicament can be absorbed through mouth cavity to blood stream bypassing hepatic first pass metabolism. In some instances, a drug(s) is incorporated in the capsule shell matrix and no drug composition is filled inside the capsule shell core.

Abstract: A tamperproof dosage form for oral administration comprising a cap and a body each comprising an outer surface and an inner surface, the cap and body being arranged to telescopically engage with each other such that an overlap region is formed between a portion of the outer surface of the body and a portion of the inner surface of the cap, said overlap region comprising an overlap length extending parallel to a centerline of said dosage form, wherein an adhesive substance is comprised throughout at least a portion of the overlap length bonding said cap to said body. The adhesive substance being essentially free of organic solvent.

Abstract: A method for a slow-release of drugs from orally dissolving capsule has been described. It releases medicaments in the mouth cavity up to 1 hour. The medicaments may have a therapeutic effect in the mouth cavity and a portion of the drug is delivered to stomach. Thus, the medication may have a local action in the oral cavity and/or have a systemic effect. Mainly, the orally dissolving capsule is administered without an aid of water. Also, large capsules such as size “000” can be administered allowing delivery of large amounts (800 to 1600 mg) of medicament. The medicament can be absorbed through mouth cavity (oral transmucosal absorption) to blood stream bypassing hepatic first pass metabolism. In some instances, a drug(s) is incorporated in the ODC empty shell matrix and no drug composition is filled inside the capsule shell core.

Abstract: The disclosure relates to compositions and methods for the preparation, manufacture and therapeutic use of combinations of immunomodulatory polynucleotides (e.g., mRNAs) encoding an immune response primer polypeptide (e.g., an interleukin 23 (IL-23) polypeptide or an interleukin 36? (IL-36-gamma) polypeptide), and an immune response co-stimulatory signal polypeptide (e.g., an OX40L polypeptide).

Abstract: Provided is a nanoparticle comprising a pH-responsive polymer, a pH-insensitive polymer and a payload molecule. The nanoparticle can act as a system for delivery of the payload that releases the payload in a pH sensitive manner.

Abstract: Cationic polymers are provided for delivering anionic active agents, preferably in the form or nanoparticles and other nanostructures. The polymer can be a polycation homopolymer or a copolymer containing a polycation block. The polycations and polycation containing polymers can contain dicarboxylic acid ester units and units of (?-amino acid)-?,?-alkylene diester units. The nanoparticles can contain high loadings of anionic active agents, with sustained release of the active agents. Methods of making the polycations and polycation containing polymers are provided. Methods of making the nanoparticles and formulating them for administration to an individual in need thereof are also provided.

Abstract: Disclosed is a transdermal preparation, comprising sequentially-stacked layers of a backing layer, a barrier layer, a drug adhesive layer and a release layer, wherein the drug adhesive layer contains a drug selected from the group consisting of fentanyl, an analogue thereof and a pharmaceutically-acceptable salt thereof, a skin permeation enhancer of the drug, and a polyacrylate adhesive, which shows a high skin permeation with a low drug dosage, equivalent to one with high drug dosage, by increasing the skin permeation rate of drug.

Abstract: The invention relates to a silyl-containing polymer that is used, together with a tackifying resin to form an adhesive composition capable of storing and delivering drugs to the skin of a user. Typically the composition is formed into a patch which shows excellent adhesion to the skin even when drugs and other additives are dissolved into the composition.

Abstract: The present invention relates to a purgative composition for cleansing an intestinal tract and, specifically, to a purgative composition for cleansing an intestinal tract, the composition containing 40-60 g of polyethylene glycol, 10-28 g of sorbitol, and 1-10 mg of sodium picosulfate, on the basis of 100 ml of the composition, or 40-60 g of polyethylene glycol, 10-28 g of sorbitol, and 1-15 mg of bisacodyl, on the basis of 100 ml of the composition. The purgative composition according to the present invention has higher drug compliance while showing an excellent intestinal tract cleansing rate. In addition, the purgative composition exhibits a sufficient intestinal tract cleansing effect even when taken together with a small amount of water, thereby relieving the suffering that a patient must take a large amount of medicine when taking a purgative.

Abstract: A composition comprising a pharmaceutically effective amount of zeaxanthin or its derivative for use in treating a malignant tumor and a method of using a pharmaceutically effective amount of zeaxanthin or its derivative either alone or together with one or more pharmaceutical agents for treating a malignant tumor. The tumor may be, but is not limited to breast cancer, cervix cancer, colon cancer, cutaneous melanoma, cutaneous squamous carcinoma, hepatocellular carcinoma, lung cancer, osteosarcoma, prostate cancer, and uveal melanoma. The pharmaceutically effective amount of zeaxanthin is generally above about 0.5 mg/kg/d to about 20 mg/kg/d.

Abstract: Systems and methods provide sugar alcohol to heat stressed ruminants to improve performance. During periods of high temperature or humidity, heat stressed ruminants may exhibit decreased dry matter intake, and in response, an effective amount of sugar alcohol such as sorbitol may be provided in the ruminant diet to cause performance to increase, which may include increased milk yield, improved feed efficiency or both compared to heat stressed dairy cattle without sugar alcohol in the diet.

Abstract: A method of treating a disease state or condition in mammals other than humans via topical brainstem afferent stimulation therapy via the administration of a cannabinoid drug(s) to the back of the neck region and/or spine to provide regional neuro-affective therapy is disclosed. In certain preferred embodiments, the cannabinoid drug(s) are not psychoactive or substantially not psychoactive. In certain embodiments, the cannabinoid drug(s) are incorporated into a pharmaceutically acceptable topical carrier, e.g., a cream or mousse. In certain preferred embodiments, the cannabinoid drug(s) comprises cannabidiol.

Abstract: Provided are methods for using S-alkylisothiouronium derivatives, including S-ethylisothiouronium diethylphosphate, to alleviate, prevent and/or reduce a sequela of intra-dialytic hypotension.

Abstract: Provided herein are methods of treating glaucoma in a patient, comprising: obtaining a biological sample from the patient; testing the biological sample for presence of a mutation in Kir6.2 protein or KCNJ11 gene; and provided that the biological sample tests positive for the presence of a mutation in Kir6.2 protein or KCNJ11 gene, administering to the patient a therapeutically effective amount of a composition comprising tolbutamide or a physiologically equivalent salt or solvate thereof and a pharmaceutically acceptable carrier. Also provided herein are methods of maintaining and/or improving eye health in a subject, comprising: administering to the patient a therapeutically effective amount of a composition comprising tolbutamide or a physiologically equivalent salt or solvate thereof, and a pharmaceutically acceptable carrier.

Abstract: A method for the treatment and/or reduction of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is disclosed. The method uses active amino-aryl-benzamide compounds and methods for the preparation thereof.

Abstract: The present specification provides methods of treating nervous system disorders with a thyroid hormone neutral dose of a RXR agonist to promote remyelination or neuroprotection or both and thereby maintain or regenerate healthy axons and neurons.

Abstract: The present disclosure generally relates to methods for treating temporomandibular joint disorders. More particularly, the disclosure pertains to topical compositions and methods of applying the topical compositions to reduce pain and symptoms associated with temporomandibular joint disorders. The method may include applying an external composition to a head or neck area and applying an intraoral composition to an intraoral area. The external composition and the intraoral composition may include an anti-inflammatory and a muscle relaxant. The disclosed compositions and methods alleviated facial pain, preauricular pain, jaw pain, neck pain, upper-back pain, and headache.

Abstract: Methods for treating central nervous system (CNS) disorders or attenuating pain with a lithium benzoate compound.

Abstract: Methods and formulations of modified release amino acids are provided for the treatment or management of diseases defined by impaired amino acid metabolism, with improved pharmacokinetics, metabolism and utilization.

Abstract: Provided herein are novel isotretinoin formulations that provide an enhanced targeted dermal delivery system for the drug isotretinoin with improved thermodynamic activity using no to a small level of ethanol relative to existing isotretinoin gel products, and methods for treatment of ichthyosis and other skin conditions using the same.

Abstract: The present invention relates to pharmaceutical composition comprising dimethyl fumarate; an enzyme modulator or a permeation enhancer or both; and one or more pharmaceutically acceptable excipients. It further relates to a pulsatile release pharmaceutical composition comprising dimethyl fumarate and one or more pharmaceutically acceptable excipients. The compositions of the present invention are administered at a lower dose as compared to the recommended daily dose of Tecfidera®. Further, the compositions of the present invention are resistant to dose dumping in the presence of alcohol.

Abstract: An antimicrobial composition is provided that includes from about 0.1 to about 2 wt. % of a cationic antimicrobial agent selected from the group consisting of lauric arginate and benzalkonium chloride, based upon the total weight of the antimicrobial composition; from about 1 to about 10 wt. % of two or more nonionic surfactants selected from the group consisting of glucoside alkyl ethers and poloxamers, based upon a total weight of the antimicrobial composition; from about 0.1 to about 5 wt.

Abstract: The invention provides a HYA derivative having superior physiological functions intrinsic to HYA and permitting easy ingestion and easy handling, and use thereof. In particular, the invention relates to an alkyl ester of 10-hydroxy-cis-12-octadecenoic acid, or an optical isomer thereof, or ester of 10-hydroxy-cis-12-octadecenoic acid with dihydric alkanol or an optical isomer thereof, and a composition (edible fat or oil, food, medicament, cosmetic etc.) containing same.

Abstract: Pharmaceutical formulations containing busulfan and cyclodextrin are described. The formulation can include busulfan and cyclodextrin in a clear aqueous solution. A process for preparing the busulfan formulation and method of using the formulation are also described.

Abstract: Described herein is a method for treating a central nervous system disorder, said method comprising steps of first transnasally administering to or immediately adjacent the sphenopalatine ganglion a first pharmaceutical agent that effectively enhances permeability of the blood-brain barrier; and thereafter administering a second pharmaceutical agent with known efficacious value for action upon central nervous system tissue. The central nervous system disorder may be related directly to the brain or to other central nervous system tissues and cells.

Abstract: The present invention relates to methods for preventing or treating acute or chronic heart failure and for reducing the risk of cardiovascular death, hospitalization for heart failure and other conditions in patients with preserved or reduced ejection fraction by administering empagliflozin to the patient.

Abstract: Disclosed are methods of favouring epithelial wound healing in a subject. Wounds suitable for this method include wounds located on the skin or in a cornea The methods comprise contacting a wound with an activator of an AKT pathway and/or an inhibitor of the MAPK pathway such as CREB inhibitors. Preferred compounds include SC-79, C646, curcumin, platelet-derived growth factor, 4?chloro-3-hydroxy-2-naphthanilide and fumonisin B. A model for wound healing is also disclosed. The model can be used to identify test compounds that are AKT activators or inhibitors of MAPK pathway, which are suitable to favoring epithelial wound healing.

Abstract: A new indication for the Warfarin family of drugs is described. In patients suffering from chronic periodontitis, continued systemic medication with Warfarin causes a significant reduction in their chronic periodontitis, including reduction in the frequency and severity of gingival inflammation occurrences, and significant decrease in the buildup of dental plaque and tartar. Delivery of Warfarin or its analogs directly to the oral fluid using toothpaste, mouthwash, chewing gum, dental floss, toothbrush, pill, and other forms are described to reduce chronic periodontitis, dental plaque, and dental tartar.

Abstract: Provided herein are compounds of the formula (I), as well as pharmaceutically acceptable salts thereof, wherein the substituents are as those disclosed in the specification. These compounds, and the pharmaceutical compositions containing them, are useful for the treatment or prevention of mGluR5 mediated disorders, such as acute and/or chronic neurological disorders, cognitive disorders and memory deficits, as well as acute and chronic pain.

Abstract: This technology relates generally to compounds and methods for stimulating neurogenesis (e.g., post-natal neurogenesis, including post-natal hippocampal and hypothalamic neurogenesis) and/or protecting neuronal cell from cell death. Various compounds are disclosed herein. In vivo activity tests suggest that these compounds may have therapeutic benefits in neuropsychiatric and/or neurodegenerative diseases such as schizophrenia, major depression, bipolar disorder, normal aging, epilepsy, traumatic brain injury, post-traumatic stress disorder, Parkinson's disease, Alzheimer's disease, Down syndrome, spinocerebellar ataxia, amyotrophic lateral sclerosis, Huntington's disease, stroke, radiation therapy, chronic stress, abuse of a neuro-active drug, retinal degeneration, spinal cord injury, peripheral nerve injury, physiological weight loss associated with various conditions, as well as cognitive decline associated with normal aging, chemotherapy, and the like.

Abstract: The invention provides formulations comprising a protein in combination with a compound that prevents oxidation of the protein. The invention also provides methods for making such formulations and methods of using such formulations. The invention further provides methods of screening for compounds that prevent oxidation of a protein in a protein composition and methods of preventing oxidation of a protein in a formulation.

Abstract: Methods of treating immune reconstitution inflammatory syndrome (IRIS) in immunodeficient patients, including HIV patients, using PDE4 modulators are described.

Abstract: Methods that include determining levels of melatonin pathway agents (melatonin, L-tryptophan, 5-hydroxytryptophan (5-HTP), serotonin, N-acetylserotonin (NAS), and melatonin receptor 1A (MT1)) in Hypoxic-ischemic brain injury in both newborns (HIE) and adults (stroke), and in ALS, and optionally administering these agents to treat these conditions.

Abstract: Provided a complex of formula is [3-((1S, 3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl) propionate-(S)-3?-methyl-2?-(pentanoyl {2?-(tetrazol-5-ylate) biphenyl-4?-ylmethyl}amino) butyrate]6.XCa2+.YNa+.ZH2O, wherein X=1-3, Y=12-16, Z=9-18, and 2X+Y=18, and represented by formula (I). Also disclosed are the method of preparing the complex and the method of treating chronic heart disease using a medicament comprising the complex.

Abstract: This invention provides compositions and methods for restoring proper folding and function of Cystic Fibrosis Transmembrane Conductance Regulator mutant with in-flame-deletion of phenylalanine 508 (AF508 CFTR). The invention also provides methods for identifying novel agents capable of restoring proper folding and function of ?P508 CFTR. The invention additionally provides methods for treating cystic fibrosis.

Abstract: The present invention relates to the use of a composition for preparing a medicament for the treatment of amyotrophic lateral sclerosis and associated disorders. The composition comprises 3-methyl-1-phenyl-2-pyrazoline-5-one or pharmaceutically acceptable salts thereof and borneol. The medicament is a drug used for delaying the occurrence time of amyotrophic lateral sclerosis and extending the survival time, and for improving memory function defect of amyotrophic lateral sclerosis.

Abstract: The present invention relates to novel liquid compositions and formulations containing a thioureylene compound, a polysaccharide and a liquid vehicle. The compositions and formulations of the invention are useful for dealing with diseases and conditions associated with abnormally high thyroid hormone levels in mammals, such as humans and cats.

Abstract: A combination therapy for the treatment of cancers refractory to anti-androgen therapy; particularly prostate cancer. The combination therapy includes a pharmaceutically effective amount of enzalutamide, bicalutamide, and/or abiraterone combination with ranolazine, perhexiline, and/or etomoxir. The invention also includes methods for treating cancer. The method can include the steps of administering to the subject a pharmaceutically effective amount of an anti-androgen drug in combination with a pharmaceutically effective amount of a drug that block or reduces lipid metabolism. The cancer can be prostate cancer. In a beneficial embodiment the prostate cancer is unresponsive or has a reduced responsiveness to anti-androgen treatment. The pharmaceutically effective amount of an anti-androgen drug can enzalutamide and abiraterone. It can also be combinations, analogs and derivatives of enzalutamide and/or abiraterone.

Abstract: The disclosure relates to ophthalmic pharmaceutical compositions comprising pilocarpine or a pharmaceutically acceptable salt. Aspects of the disclosure further relate to uses and preparations of ophthalmic pharmaceutical compositions comprising pilocarpine or a pharmaceutically acceptable salt, for correcting presbyopia and other ocular conditions in a subject.

Abstract: The present invention relates to methods of treating demodicosis by administering an isoxazoline compound of formula (I)