Abstract: The present invention provides a composition and method of forming an amorphous drug-loaded particle by forming one or more amorphous drug-loaded nanoparticles comprising one or more active agents stabilized by one or more polymers, desolvating the one or more amorphous drug-loaded nanoparticles to form one or more flocculated amorphous drug-loaded nanoparticles, filtering the one or more flocculated amorphous drug-loaded nanoparticles and drying the one or more flocculated amorphous drug-loaded nanoparticles to form amorphous drug-loaded particles.

Abstract: Described herein are intracameral implants including at least one therapeutic agent for treatment of at least one ocular condition. The implants described herein are not anchored to the ocular tissue, but rather are held in place by currents and gravity present in the anterior chamber of an eye. The implants are preferably polymeric, biodegradable and provide sustained release of at least one therapeutic agent to both the trabecular meshwork and associated ocular tissue and the fluids within the anterior chamber of an eye.

Abstract: A thermally stable Vitamin C composition containing montmorillonite, an organic acid containing L-ascorbic acid or a derivative thereof, a divalent cation present within nanolayers of the montmorillonite, wherein the organic acid is combined with the divalent cation within the nanolayers to form an organic acid-montmorillonite chelate.

Abstract: The present invention is directed to a pulsatile ophthalmic peri-corneal drug delivery device. The device includes an annular body and a mechanism for releasing multiple separate and distinct doses of a therapeutic composition over an extended period of time.

Abstract: Granules of racemic sodium ibuprofen dihydrate formed from components specified herein have very desirable properties and can be effectively used in conventional rotary press tableting equipment without operational difficulties often encountered in actual practice. Their preparation by a wet granulation process, the wet granule compositions, formulations adapted for preparation of solid dosage forms utilizing a rotary press, solid dosage forms, and methods of preparing solid dosage forms in a rotary press are also described.

Abstract: A tablet, containing an inner phase, comprising a) a first type of pellets (I) which contain a first active ingredient and which have a coating and/or release the active ingredient in a modified manner, or b) a first type of coated first active ingredient (I), mixed with c) spherical particles (II), and an outer phase containing one or more excipients present in non-granulated form before tableting, selected from disintegrants, lubricants, flow regulators, fillers and binders, wherein the weight of the outer phase makes up not more than 25 percent of the total weight of the tablet.

Abstract: Compounds and related methods as can be used for selective mevalonate pathway inhibitors.

Abstract: This invention features methods for treating diseases associated with mutations in the CFTR gene by administering PPAR agonists, specifically PPAR?, PPAR?, and PPAR? agonists, PPAR inducers, and/or antioxidants. Also disclosed are screening methods for identifying therapeutically useful candidate compounds.

Abstract: An anti-aging composition comprising a skin-beneficial amount of actives identified in Menyanthes trifoliata leaf, wherein the actives are inhibitors of one or more of MMP-1, 2 and 9 and/or scavengers of peroxynitrite. Also disclosed are methods of using such a composition, which include treating the skin for signs of chronological or pre-mature aging.

Abstract: The present invention describes a method for determination of urinary globotriaosylceramide (Gb3) levels in non-Fabry disease cardiac patients. Determination of Gb3 levels provides a screening method for determining cardiac risk and may offer an alternative therapeutic option for cardiac disease management or cardiac disease risk mitigation by lowering Gb3 levels by the use of pharmacological chaperones or other agents.

Abstract: Provided herein are methods and materials for treating pulmonary hypertension (PH) in a subject. Also provided herein is a method of diagnosing whether a has PH by detecting a PH marker. A PKG pulmonary hypertension marker has been identified and may be useful in predicting PH disease progression and assessing a subject's response to PH therapy.

Abstract: The invention provides a solvating system for the removal of biofilms which solvates the extracellular polysaccharide matrix holding it to a surface. The aqueous solvating system comprises water, a metal ion sequestering agent, and a solvating agent for an extracellular polysaccharide matrix, which is gentle enough to be used directly on human tissues, but which may also be used on hard or soft non-tissue surfaces to breakdown, and/or remove biofilms.

Abstract: Agents useful for the treatment of various metabolic disorders, such as insulin resistance syndrome, diabetes, polycystic ovary syndrome, hyperlipidemia, fatty liver disease, cachexia, obesity, atherosclerosis and arteriosclerosis are disclosed.

Abstract: The present invention provides compositions and methods for noninvasive delivery of therapeutic agents across an intact tympanic membrane. For example, the compositions include a penetration enhancer which increases the flux of a therapeutic agent (e.g., antibiotic) across the tympanic membrane. Such compositions are particularly useful in the treatment of otitis media. Additionally, the composition may include a sustained release agents that, in some embodiments form sustained release reservoirs, in situ, once administered to a patient.

Abstract: The present invention relates to liquid dosage compositions of stable nanoparticulate active agents. The liquid dosage compositions of the invention include osmotically active crystal growth inhibitors that stabilize the nanoparticulate active agents against crystal and particle size growth of the active agent.

Abstract: A pharmaceutical composition comprising an effective amount of a pharmaceutical active and up to about 99.8% wt/wt water soluble protein hydrolysate to total weight of composition is provided. Whey protein hydrolysate is exemplary of a suitable soluble protein hydrolysate. A method for preparing such a composition is also provided.

Abstract: The use of paracetamol and ibuprofen in the preparation of a medicament for treating osteoarthritis or rheumatoid arthritis, wherein the medicament comprises a combination composition having approximately 125 mg to approximately 150 mg ibuprofen and approximately 475 mg to approximately 500 mg paracetamol.

Abstract: [Problem to be Solved] The purpose of present invention is to provide a medicine which has low contamination with a fine-pulverizing medium, is safe and has improved bioavailability. [Solution] A method for producing a composite organic compound powder for medical use is used which comprises: mixing a poorly water-soluble and crystalline organic compound powder, a physiologically acceptable salt, a physiologically acceptable polyol, and a carboxyvinyl polymer and fine-pulverizing the organic compound powder; and removing at least the salt and the polyol during or after fine-pulverizing.

Abstract: Described herein are methods for treating obesity or promoting weight loss using agents that alter pyruvate flux in an adipocyte. Methods are provided for administering an agent or combination of agents to an obese individual to alter the flux of pyruvate in an adipocyte. Also described herein is a method for modifying triglyceride storage in an adipocyte by contacting an adipocyte with an agent or combination of agents that alter pyruvate flux.

Abstract: A sustained release dosage form is comprising a pharmaceutically active agent and pharmaceutically acceptable salts thereof and adapted to release as an erodible solid over a prolonged period of time, wherein the dosage form provides an ascending rate of release of the pharmaceutically active agent for at least about 4 hours. The dosage form is able to deliver high doses of poorly soluble or slowly dissolving active agents. When additional pharmaceutically active agents are present, the agents are released from the dosage form at rates that are proportional to the respective weights of each active agent in the dosage form. Methods of using the dosage forms to treat disease or conditions in human patients are also disclosed.

Abstract: In alternative embodiments, this invention provides compositions and methods for treating cancer or any condition caused by dysfunctional cells, side effects from treatments for cancer or any condition caused by dysfunctional cells, e.g., mucositis therapies (e.g., for oral mucositis; digestive mucositis; esophageal mucositis; intestinal mucositis). In alternative embodiments, the invention provides cytoprotection products that may be used either alone or in combination with other medical therapies such as cancer chemotherapies and radiation therapies.

Abstract: An external preparation that effectively produces the anti-inflammatory analgesic effect of a non-steroidal anti-inflammatory analgesic agent, and reduces skin irritation on the application site of the preparation and has an excellent effect on pain associated with inflammation such as chronic rheumatoid arthritis, osteoarthritis, and also lumbago is provided. The external preparation includes a non-steroidal anti-inflammatory analgesic agent and oxybuprocaine or a pharmaceutically acceptable salt thereof. The external preparation includes the non-steroidal anti-inflammatory analgesic agent at a content of 0.1 to 10 wt % based on the total weight of the formulation and oxybuprocaine or a pharmaceutically acceptable salt thereof at a content of 0.01 to 60 wt % based on the total weight of the formulation.

Abstract: The present invention relates to the use of a compound of Formula (I??) or pharmaceutically acceptable salt or solvate, isomer or prodrug thereof in the manufacturing of a medicament for the treatment and/or prophylaxis of arthritis and pain.

Abstract: Products and methods are disclosed for reducing the production of unwanted odors from the pudendum.

Abstract: The present invention relates to compositions and methods for preventing migraines. The migraine prophylaxis composition is a single dosage form comprising at least one form of elemental magnesium and at least one NSAID. The prophylaxis composition, comprising at least one form of elemental magnesium and a therapeutically effective concentration of acetylsalicylic acid may also provide cardiac protection and prevent cardiovascular diseases.

Abstract: The present invention provides a new pharmaceutical application of a 15,15-difluoroprostaglandin F2? derivative. As a result of intensive studies in order to find a new pharmaceutical application of a 15,15-difluoroprostaglandin F2? derivative, it was found that, in a European Phase III clinical trial for tafluprost, one of the 15,15-difluoroprostaglandin F2? derivatives, with patients with open-angle glaucoma or ocular hypertension, tafluprost has actions of growing eyelashes, making eyelashes thicker, and changing the color thereof, that is, has an effect of promoting the growth of hair (eyelashes). Therefore, a 15,15-difluoroprostaglandin F2? derivative is useful as a hair growth promoting agent, and is expected to be useful as an active ingredient of a preventive or therapeutic agent for a disease associated with hair such as alopecia and a hair care product or a hair cosmetic product for regrowing hair, growing hair, increasing hair density, nourishing hair, or the like.

Abstract: Disclosed herein is method of treating glaucoma or ocular hypertension comprising administering a prostaglandin agonist and a second therapeutically active agent to a mammal in need thereof, wherein said second therapeutically active agent is selected from: ?-Blockers, Adrenergic Agonists, non-selective adrenergic agonists, ?2-selective adrenergic agonists, Carbonic Anhydrase Inhibitors, Cholinergic Agonists, direct acting cholinergic agonists, chlolinesterase inhibitors, Glutamate Antagonists, Ca2+ channel blockers, Prostamides, Prostaglandins, Cannabinoids, and combinations thereof. Compositions and medicaments containing a combination of these two active agents are also disclosed.

Abstract: There is provided novel compounds capable of modulating the G-protein-coupled receptor GPR40, compositions comprising the compounds, and methods for their use for controlling insulin levels in vivo and for the treatment of conditions such as type I1 diabetes, hypertension, ketoacidosis, obesity, glucose intolerance, and hypercholesterolemia and related disorders associated with abnormally high or low plasma lipoprotein, triglyceride or glucose levels.

Abstract: Disclosed are methods of treating subjects having conditions related to angiogenesis including administering an effective amount of a polymeric Nanoparticle form of thyroid hormone agonist, partial agonist or an antagonist thereof, to promote or inhibit angiogenesis in the subject. Compositions of the polymeric forms of thyroid hormone, or thyroid hormone analogs, are also disclosed.

Abstract: Provided herein are compositions and methods of making compositions of ibuprofen in combination with a narcotic analgesic. Specifically provided is a pharmaceutical tablet composition comprising ibuprofen; a narcotic analgesic; colloidal silicon dioxide; a filler selected from the group consisting of microcrystalline cellulose and powdered cellulose; a disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate; a binder consisting of an akylhydroxy methylcellulose; a starch; and a lubricant.

Abstract: The invention provides methods for treating and preventing a neurodegenerative disease associated with aberrant protein aggregation by modulating the expression and/or activity of XBP-1, IRE-1 alpha, and/or EDEM. The present invention also pertains to methods for identifying compounds that modulate the expression and/or activity of XBP-1, 1RE-1 alpha, and/or EDEM. The present invention further provides methods for determining whether a subject is at risk of developing or has developed a neurodegenerative disease associated with aberrant protein aggregation.

Abstract: Provided is a drug sustained-release agent including a carbon material (porous carbon material) which has an inverse opal structure. The drug sustained-release agent includes a porous carbon material which has spherical pores having an average diameter of 1×10?9 to 1×10?5 m and arrayed three-dimensionally and which has a surface area of 3×102 m2/g. Or, the drug sustained-release agent includes a porous carbon material in which pores are arrayed in an arrangement corresponding to a crystal structure on a macroscopic basis. Or, the drug sustained-release agent includes a porous carbon material in which pores are arrayed at a surface thereof in an arrangement corresponding to the (111) plane orientation of a face-centered cubic structure on a macroscopic basis.

Abstract: The invention relates to a tablet capable of being chewed or disintegrated in the oral cavity, which comprises a pharmaceutically active ingredient, and a matrix comprising directly compressible dextrose monohydrate and sucralose, said tablet being substantially fat free and said matrix being substantially free of non-saccharide, water soluble polymeric binders.

Abstract: The present invention discloses 4-nerolidylcatechol and its derivatives isolated from South American/Amazon plants (Pothomorphe species) and their potential use as therapeutical agent for treatment of malarial symptoms, including malarial patients resistant to traditional drugs. The present invention also discloses a method for producing 4-nerolidylcatechol and their derivatives.

Abstract: The present invention is directed to a pharmaceutically acceptable taste masking liquid excipient base for administration of a relatively large amount of unpleasant tasting medicines. More particularly, the enhanced sweetness and taste masking effect are produced by the addition of sucralose to the excipient base with maintenance of a pH from about 2 to about 5. The invention is further directed to medicinal compositions comprising such a liquid excipient base and unpleasant tasting medicines. Still further, the invention is directed to a method for taste masking unpleasant tasting medicines through their incorporation into the claimed liquid excipient bases.

Abstract: A sustained release dosage form is comprising a pharmaceutically active agent and pharmaceutically acceptable salts thereof and adapted to release as an erodible solid over a prolonged period of time, wherein the dosage form provides an ascending rate of release of the pharmaceutically active agent for at least about 4 hours. The dosage form is able to deliver high doses of poorly soluble or slowly dissolving active agents. When additional pharmaceutically active agents are present, the agents are released from the dosage form at rates that are proportional to the respective weights of each active agent in the dosage form. Methods of using the dosage forms to treat disease or conditions in human patients are also disclosed.

Abstract: The present invention relates to compounds of Formula I as shown below, wherein the definitions of A, R1 R2, R3, R4, R5, R6, R7, and R8 are provided in the specification. Compounds of Formula I are useful for the treatment of diseases associated with ?-secretase activity, including Alzheimer's disease.

Abstract: A pharmaceutical implant may include a pharmaceutical and at least one excipient, and may be configured to be implanted in a body of a patient. The at least one excipient may dissolve after implantation of the pharmaceutical implant in the body of the patient and release the pharmaceutical. In some examples, the pharmaceutical implant includes at least two pharmaceuticals. The at least one excipient may be selected to provide a desired release profile of the pharmaceutical. For example, the pharmaceutical implant may be configured to dissolve and release the pharmaceutical over a length of time between about one day and about 30 days. In some examples, the pharmaceutical implant may be implanted in the body of the patient proximate to an implantable medical device.

Abstract: The present invention relates to an oral pharmaceutical suspension comprising paracetamol and ibuprofen. The invention also relates to a method of treating perioperative or postoperative pain by administering to a subject a therapeutically effective amount of oral pharmaceutical suspension comprising paracetamol and Ibuprofen.

Abstract: The invention provides dosage forms for the delivery of one or more non-steroidal anti-inflammatory drugs to equines. The dosage forms are palatable, desirable, and easy to administer with little or no mess or waste. The dosage form can be a cookie that includes one or more grain products, one or more protein products, one or more flavoring agents, or a combination thereof. The dosage form also includes a therapeutically effective amount of one or more non-steroidal anti-inflammatory drugs, for example, for the treatment of joint deterioration, swelling and inflammation, founder, fever, laminitis, or a combination thereof. The drug can be phenylbutazone or firocoxib and the dosage unit can be conveniently hand-fed to the horse.

Abstract: Short chain fatty acids (SCFAs) and glycerol esters of SCFAs not previously used for that purpose are provided for use as a medicament for treating, preventing or counteracting microbial infections in animals, including humans, by stimulating the innate antimicrobial peptide defense system. Preferred compounds include phenyl substituted short chain fatty acids (SCFAs) derivatives and. Also provided are methods and compositions for treating, preventing or counteracting microbial infections, including bacterial, viral, fungal, and parasitic infections, by administration of medicaments comprising a secretagogue-effective amount of the compounds of the invention.

Abstract: The present invention provides compositions for extended release of an active ingredient, comprising a lipid-saturated matrix formed from a biodegradable polymer. The present invention also provides methods of producing the matrix compositions and methods for using the matrix compositions to provide controlled release of an active ingredient in the body of a subject in need thereof.

Abstract: Calpains target junctional components that normally seal the epithelium, forming tight junctions. This selective targeting by calpains facilitates the transmigration of leukocytes across the epithelium and into tissue spaces where they can cause inflammation. The present disclosure provides methods of using calpain inhibitors to prevent epithelial junction reorganization such that leukocyte transmigration is inhibited and accordingly, inflammation reduced or prevented. These methods can at least be used to reduce respiratory inflammation by preventing leukocyte accumulation in pulmonary airways.

Abstract: The present specification provides drug delivery platforms useful for the controlled release of a compound over time in an individual.

Abstract: Polymer surfaces coated with organometallic layers, wherein the organometallic layers and polymer surfaces have functional groups that react to bond the organometallic layer to the polymer surface with organometallic functional groups remaining unreacted for the subsequent covalent attachment of organic overlayers. Coating methods and coated articles are also disclosed.

Abstract: The present invention provides compositions of a natural cytokine mixture (NCM) for treating a cellular immunodeficiency characterized by T lymphocytopenia, one or more dendritic cell functional defects such as those associated with lymph node sinus histiocytosis, and/or one or more monocyte functional defects such as those associated with a negative skin test to NCM. The invention includes methods of treating these cellular immunodeficiencies using the NCM of the invention. The compositions and methods are useful in the treatment of diseases associated with cellular immunodeficiencies such as cancer. Also provided are compositions and methods for reversing tumor-induced immune suppression comprising a chemical inhibitor and a non-steroidal anti-inflammatory drug (NSAID). The invention also provides a diagnostic skin test comprising NCM for predicting treatment outcome in cancer patients.

Abstract: The invention relates to high drug load formulations containing (R)-2-(2-fluoro-4-biphenylyl)propionic acid as an active pharmaceutical ingredient.

Abstract: The invention provides novel compounds of formula (I), wherein: R1 is a radical derived from one of the known ring systems; R2 is a phenyl radical optionally substituted; Xn represents a birradical selected from the group consisting of: —(CH2)1-4—, (C2-C4)-alkenyl, (C2-C4)alkynyl, —S—(CH2)1-3—#, and —(CH2)1-3—O—#; wherein the symbol # indicates the position at which Xn is attached to R1; Yn is a birradical selected from the group consisting of: —(CH2)2-4—, —S—(CH2)1-3#, and —O—(CH2)1-3—#; wherein the symbol # indicates the position at which Yn is attached to R2; and R3 is a radical selected from the group consisting of: —OR4. The compounds of formula (I) are useful in the treatment of cancer.

Abstract: Disclosed are compounds of formula: that inhibiting GPBP activity, making them useful as therapeutics in antibody-mediated disorders, drug-resistant cancer, inflammation, protein misfolding and ER stress-mediated disorders, and aberrant apoptosis.

Abstract: Disclosed is a novel transdermally absorbable preparation which enables the efficient, stable and long-term administration of a drug to a living body. More specifically, the transdermally absorbable preparation comprises: a laminate comprising an outer film, a drug-containing layer and a support layer laminated in this order from the side to be contacted with the skin; and a fixing means for fixing the laminate on the skin. In the transdermally absorbable preparation, the outer film is a drug-permeable polymer film that can control the release of the drug into the skin and is provided as a surface of the laminate which is to be contact with the skin.