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: Aspects of the disclosure include methods for treating hyperhidrosis in a subject with a composition including a muscarinic antagonist and a muscarinic agonist. In practicing methods according to certain embodiments, a therapeutically effective amount of a composition including a muscarinic antagonist or a pharmaceutically acceptable salt thereof and a muscarinic agonist or a pharmaceutically acceptable salt thereof is administered to a subject and is sufficient to reduce hyperhidrosis in the subject and to reduce a dry mouth side effect of the muscarinic antagonist. Compositions for practicing the subject methods are also described as well as dose units containing one or more of the subject compositions.

Abstract: The present invention provides capsules having a shell of material that comprises an assembly of a protein, and the capsule is optionally provided with a network of material within the shell that is an assembly of the protein. The assembly of the protein is obtained or obtainable by the aggregation of the protein, optionally together with another protein. The assembly is a non-covalent assembly of a protein.

Abstract: A pharmaceutical composition for use in treatment or prevention of disorders caused by ischemia contains a mitochondrial damage inhibitor, an anti-inflammatory agent, and a biocompatible particle that encloses both or each of the above mitochondrial damage inhibitor and the above anti-inflammatory agent. The above-mentioned biocompatible particle may be a poly(lactic-co-glycolic acid) copolymer having a number mean particle size of 2.5 to 1000 nm or a polyethylene glycol modification thereof.

Abstract: Particles comprising a branched polymer and either a block copolymer or a linear dendritic hybrid represent a category of useful materials. They may be used in for example drug delivery applications. They may be prepared by a method comprising the steps of: dissolving the branched polymer and block copolymer or linear dendritic hybrid, and optionally other component(s), in a solvent to form a solution; adding said solution to a different liquid; and removing said solvent to form a dispersion of co-precipitated particles.

Abstract: Provided are methods of treating a cancer (such as lung cancer, breast cancer, pancreatic cancer, etc.) in an individual in need thereof, comprising administering to the individual a) an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and an albumin (such as human serum albumin), and b) an effective amount of ABT-263.

Abstract: Nanoparticulate carrier formulations are useful to solubilize, deliver, and target hydrophobic drugs for treating diseases including cancer and bacterial infections. The formulations contain amphiphilic peptides having a hydrophobic portion and a positively charged hydrophilic portion. The peptides self-associate at nonacidic pH to form mi-celles with a spherical nanoparticle morphology. The hydrophobic core of the nano-particles encapsulates hydrophobic drugs, including antitumor agents, increasing their solubility in water and allowing them to be targeted, for example, to cancer cells. The positively charged surface of the nanoparticles, together with an optional targeting moiety such as an RGD peptide, allows the nanoparticles to bind selectively to mammalian cells and bacterial cells, including cancer cells that overexpress integrin receptors.

Abstract: The invention in suitable embodiments is directed to using a purified, clathrin light chain protein for purposes of drug development, enablement, activity, and/or delivery. In one aspect, a man-made, configurable clathrin light chain composition, formed in whole or in part from isolated, synthetic and or recombinant amino acid residues comprising in whole or in part one or more of a protein sequence, forms one or more type of multifunction nanoscale bio-nanoparticle, such as a biomedical platform, bio-molecular platform, and the like, and using such bio-nanoparticle platforms for development, enablement, and delivery of drugs.

Abstract: Disclosure provides a formulation of curcuminoid with essential oil of turmeric to enhance the bioavailability of curcumin and to augment the biological activity of curcumin, wherein curcumin is the main constituent of curcuminoid and wherein Ar-turmerone is the main constituent of the essential oil of turmeric. An application of curcuminoid with essential oil of turmeric to enhance the bioavailability of curcumin for oral supplementation against a variety of diseases and method of doing the same is provided.

Abstract: A novel pulsatile drug delivery system composition, methods of administration, method of treating disease condition and methods of making the same are provided. Novel pulsatile drug delivery systems provide adjustable lag time of release of drug from dosage form before administration. Novel pulsatile drug delivery systems provide administration of dosage form after modifying lag time of drug release while patient miss the administration of dosage form at particular time.

Abstract: Inhalation solutions for administration of beta 2-agonists or combinations of muscarinic antagonists and beta 2-agonists for the treatment of breathing disorders, such as COPD, are provided. The inhalation solutions are administered by nebulization, particularly with a high efficiency nebulizer.

Abstract: This invention provides: 1) a method of treating androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; 2) a method of preventing androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; 3) a method of suppressing or inhibiting androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer; and 4) a method of reducing the risk of developing androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), and/or hot flashes in a male subject suffering from prostate cancer, by administering to the subject a pharmaceutical composition comprising cis-clomiphene or a pharmaceutically acceptable salt thereof.

Abstract: The present invention relates to methods and compositions for improved drug bioavailability and disease treatment, including treatment of diseases related to hormone modulation or CNS function. In certain embodiments, the instant invention provides methods for hormone modulation or improving CNS function, comprising administering to a subject in need thereof a composition comprising one or more hydrogel particles, wherein the one or more hydrogel particles are non-toxic and incorporate at least one active agent, wherein the one or more hydrogel particles release the active agent in a time-controlled and sustained manner in vivo.

Abstract: Provided herein are methods for treating certain conditions, including diabetes, obesity, and other metabolic diseases, disorders or conditions by administrating a composition comprising a biguanide or related heterocyclic compound, e.g., metformin. Also provided herein are biguanide or related heterocyclic compound compositions, and methods for the preparation thereof for use in the methods of the present invention. Also provided herein are compositions comprising metformin and salts thereof and methods of use.

Abstract: According to the invention there is provided N,N-bis-2-mercaptoethyl isophthalamide, or a pharmaceutically acceptable salt or derivative thereof, for use in the therapeutic treatment of a neurodegenerative disorder, such as Alzheimer's disease, Parkinson's disease, Huntington's disease and/or amyotrophic lateral sclerosis.

Abstract: A method for treating a tau-associated disease is disclosed, which comprises the step of administering a pharmaceutical composition to a subject in need. Particularly, a method for treating Alzheimer's disease is disclosed, which comprises the step of administering a pharmaceutical composition to a subject in need.

Abstract: A packaged acetaminophen injection solution preparation comprises an oxygen-impermeable packaging container and an acetaminophen injection solution preparation including acetaminophen aqueous solution of pH 4 to 8 containing acetaminophen as an active ingredient and a sealed oxygen-permeable container filling the acetaminophen aqueous solution. The acetaminophen injection solution preparation is sterilized by moist heat sterilization. The oxygen-impermeable packaging container encloses the acetaminophen injection solution preparation and is sealed. The packaged acetaminophen injection solution preparation has an oxygen scavenger to absorb oxygen within the oxygen-impermeable packaging container.

Abstract: The present invention relates to method of treatment of hepatitis C using bufexamac or a derivative thereof. The methods of the present invention can be used in patients with hepatitis C administering bufexamac or a derivative thereof in combination with one or more anti-hepatitis C drugs.

Abstract: The present invention concerns compounds, compositions containing these compounds, and methods of using these compounds and compositions as inhibitors of Stat3 signaling, Stat3 dimerization, Stat3-DNA binding, Stat5-DNA binding, and/or aberrant cell growth in vitro or in vivo, e.g., as anti-cancer agents for treatment of cancer, such as breast cancer. The compounds of the invention include, but are not limited to, NSC 74859 (S3I-201), NSC 42067, NSC 59263, NSC 75912, NSC 11421, NSC 91529, NSC 263435, and pharmaceutically acceptable salts and analogs of the foregoing. Other non-malignant diseases characterized by proliferation of cells that may be treated using the compounds of the invention, but are not limited to, cirrhosis of the liver; graft rejection; restenosis; and disorders characterized by a proliferation of T cells such as autoimmune diseases, e.g., type 1 diabetes, lupus and multiple sclerosis.

Abstract: Provided are compositions comprising beta-alanylhistidine peptides and/or beta-alanines, and methods for administering these peptides and amino acids. In one aspect, the compositions and methods cause an increase in the blood plasma concentrations of beta-alanine and/or creatine.

Abstract: The treatment options for treating blast-induced and noise-induced traumatic brain injury and tinnitus are limited. Thus, the current invention provides methods for treating traumatic brain injury and tinnitus. The methods involve administering a pharmaceutically effective amount of a composition comprising 2,4-disulfonyl ?-phenyl tertiary butyl nitrone and N-acetylcysteine (NAC).

Abstract: The invention relates to trans carotenoid salt compounds, methods for making them, methods for solubilizing them and uses thereof. These compounds are useful in improving diffusivity of oxygen between red blood cells and body tissues in mammals including humans.

Abstract: The present disclosure describes how all-retinoic acid (ATRA) binds and inhibits Pin1 activity and induces degradation of the activated Pin1 monomer selectively in cancer cells. Identification of the binding mechanism of ATRA with Pin1 confirm ATRA binding specificity to Pin1 residues in the PPIase active site, thus demonstrating that drug-induced Pin1 ablation has potent anticancer activity, such as in acute promyelocytic leukemia (APL), by inducing PML-RARa degradation, as well as against other types of cancer and diseases that are associated with Pin1 overexpression, such as aggressive triple negative breast cancer, lupus, asthma, cocaine addiction, among others, due to their unique ability to simultaneously block numerous cancer-driving pathways, with relatively lower toxicity. The present disclosure also provides a rationale for developing sustained released ATRA-containing formulations.

Abstract: Nutritional supplement, feed formulation and methods to improve the efficiency of meat production of a bovine animal, using ethyl ferulate as a nutritional supplement; where the administration of ethyl ferulate at bovine animal, is premixed with an excipient food grade, feed formulation, balanced food, concentrated food, and the like. The ethyl ferulate administration is daily during the final stage of fattening bovine animal, wherein the final stage of fattening is 20 to 40 last days.

Abstract: Described are stability-enhancing formulations of drugs that are sensitive to moisture. The formulations comprise co-granulates containing a moisture-sensitive drug and an excipient selected from fructose, xylitol, maltitol, and mixtures thereof. Also described are methods of producing a pharmaceutical tablet. The method comprises forming a blend of a moisture-sensitive drug and a first excipient selected from fructose, xylitol, maltitol, and mixtures thereof; spraying the blend with water to produce granules; drying and milling the granules; mixing a second excipient with the granules; and compressing into tablets.

Abstract: Kits, compositions and methods are provided which comprise a nutritional composition and an adjuvant composition. The nutritional composition comprises vitamin A, vitamin C, vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9, vitamin B12, iron, iodine, magnesium, zinc, copper, a source of omega-3 fatty acids and one or more pharmaceutically-acceptable carriers. The adjuvant composition is formulated to mitigate at least one undesired side effect associated with the administering of the first composition to the patient. The first composition may comprise at least about 90 mg of iron. The iron may be provided in the form of a polysaccharide iron complex. The adjuvant composition may comprise fiber or a laxative to mitigate the undesired side effects of the relatively high iron content of the nutritional composition.

Abstract: Acne lesions, whether of inflammatory and/or non-inflammatory type, are simultaneously or sequentially treated and their number reduced, via daily topical regimen, with the combination or association of adapalene or pharmaceutically acceptable salt thereof and benzoyl peroxide (BPO).

Abstract: The present invention relates to water dispersible mini-tablets of Enalapril or a pharmaceutically acceptable salt thereof for use in the treatment of hypertension in a pediatric formulation. The pediatric formulation is defined as 0 to 18 years of age. The present invention also provides a method of manufacturing of such dosage form.

Abstract: The present invention is directed to a composition for treating alopecia containing minoxidil, cyclosporine A and a compound that binds FK506 binding protein 4 suitable for administration to humans. The present invention is further directed to treating alopecia in humans by administering a composition of the invention.

Abstract: In alternative embodiments, provided are therapeutic combinations, pharmaceutical compositions, formulations, kits and devices for treating, preventing or ameliorating a tumor or a cancer, and methods and uses for treating, preventing or ameliorating a tumor or a cancer. In alternative embodiments, provided are therapeutic combinations, pharmaceutical compositions, formulations, kits and devices comprising: a beta adrenergic receptor antagonist (a “beta blocker”) such as propranolol; a non-steroidal anti-inflammatory drug (a NSAID) such as etodolac; and, a sorafenib or NEXAVAR™ or equivalent thereof. In alternative embodiments, the therapeutic combinations further comprise an anti-cancer or anti-tumor antibody, a cytokine, and/or an additional chemotherapeutic agent.

Abstract: A high dose rapidly dispersing three-dimensionally printed dosage form comprising a high dose of water soluble drug in a porous matrix that disperses in water within a period of less than about 15 seconds is disclosed. Also disclosed are methods of preparing the dosage form and of treating a condition, disease or disorder that is therapeutically responsive to the drug.

Abstract: The present invention relates to pharmaceutical dosage forms for oral administration comprising the drug substance 4-[(5R)-6,7-dihydro-5H-pyrrolo[1,2-c]imidazol-5-yl]-3-fluorobenzonitrile or any pharmaceutically acceptable salt thereof and to processes of making said solid pharmaceutical dosage forms.

Abstract: The invention belongs to the chemical and pharmaceutical industry, including the creation of a new medicinal agent intended to treat sexual disorders, and can be used in the biochemistry, physiology and medicine.

Abstract: Provided are small molecule inhibitors of ubiquitin specific protease 1 (USP1) activity and methods for their use in treating and characterizing cancers. The small molecule USP1 inhibitors of the invention are particularly useful in the treatment of cancers that are resistant to DNA cross-linking agents.

Abstract: The present invention provides a three-dimensionally printed porous dosage composition and a method of producing the same.

Abstract: The present invention relates to novel compounds and pharmaceutical compositions thereof which may be useful in the treatment and/or prevention of various conditions. The present invention also provides methods of preparing such compounds and compositions, and methods of using the same.

Abstract: A pharmaceutical compositions comprising: (a) a carbapenem antibacterial agent selected from imipenem, meropenem, ertapenem, doripenem or a pharmaceutically acceptable derivative thereof, and (b) a compound of Formula (I), or a stereoisomer or a pharmaceutical acceptable derivative thereof, are disclosed.

Abstract: The invention relates to pyridine-3,5-bis-thiocyanates which are new active substances for the treatment and prevention of retroviral infections and secondary diseases thereof, in particular HIV infections and AIDS, from the group of deubiquitinase inhibitors. Administration of the compounds of the invention increases the immunogenicity of viral proteins and thus the antiviral response.

Abstract: The present invention relates to 5-fluoro-N-(pyridin-2-yl)pyridin-2-amine derivatives containing a sulfoximine group of general formula (I) as described and defined herein, and methods for their preparation, their use for the treatment and/or prophylaxis of disorders, in particular of hyper-proliferative disorders and/or virally induced infectious diseases and/or of cardiovascular diseases. The invention further relates to intermediate compounds useful in the preparation of said compounds of general formula (I).

Abstract: This invention is directed to compounds and salts that are generally useful as agents to treat an infection with Dirofilaria immitis. This invention also is directed to treatments comprising the administration of the compounds and salts to animals in need of the treatments.

Abstract: Drug tablets that include a prolonged-release core and an immediate-release layer or shell are prepared with a thin barrier layer of drug-free polymer between the prolonged-release and immediate-release portions of the tablet. The barrier layer is penetrable by gastrointestinal fluid, thereby providing full access of the gastrointestinal fluid to the prolonged-release core, but remains intact during the application of the immediate-release layer, substantially reducing or eliminating any penetration of the immediate-release drug into the prolonged-release portion.

Abstract: Methods for modulating GSK-3 activity and methods for treating a GSK-3-mediated disorder in a subject in need thereof. The methods include contacting a cell expressing GSK-3 with or administering to the subject in need a therapeutically effective amount of one or more compounds of General Formula (I) or General Formula (II): or pharmaceutically-acceptable salts or solvates thereof.

Abstract: Pharmaceutical compositions of metabotropic glutamate 5 receptor (mGlu5) antagonists or a pharmacologically acceptable salt thereof are disclosed. The compositions contain the therapeutic active compound with non-ionic polymer and ionic polymer, binder and fillers in either matrix pellet, matrix tablet or coated pellets. The compositions provide a pH-independent in vitro release profile with NMT 70% in one hour, NMT 85% in 4 hour, and NLT 80% in 8 hours. The compositions are useful for the treatment of CNS disorders, such as Treatment-Resistant Depression (TRD) and Fragile X Syndrome.

Abstract: The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.

Abstract: Methods of treating a human suffering from or susceptible to C3 glomerulopathy comprising administering to the human an effective amount of a C5aR antagonist are provided.

Abstract: The present invention provides methods and compositions for enhancing efficacy of anti-hormone treatment, or for preventing cancer relapse or progression following treatment. The invention also provides methods for re-sensitizing or sensitizing treatment resistant cancer cells or patients with treatment-refractory cancer cells to continuing or starting anti-hormone treatment. Further provided in the invention are methods for prognosis or diagnosis of anti-hormone treatment effect or likelihood of cancer relapse or metastasis following anti-hormone treatment.

Abstract: Disclosed herein are methods of treating subjects suffering from estrogen receptor positive cancer of the brain by administering a selective estrogen receptor degrader (SERM). Also disclosed are methods of treating a cancer that is resistant to an estrogen receptor modulator by administering a SERM.

Abstract: Compositions comprising crystalline apixaban particles having a D90 equal to or less than 89 ?m, and a pharmaceutically acceptable carrier, are substantially bioequivalent and can be used to for the treatment and/or prophylaxis of thromboembolic disorders.

Abstract: Compositions comprising crystalline apixaban particles having a D90 equal to or less than 89 ?m, and a pharmaceutically acceptable carrier, are substantially bioequivalent and can be used to for the treatment and/or prophylaxis of thromboembolic disorders.

Abstract: The present invention relates to a Factor Xa inhibitor dosage form comprising apixaban in a solubility-improved form wherein the dosage form provides controlled release of apixaban and methods for preventing or treating venous thromboembolisms, deep vein thrombosis and acute coronary syndrome with said dosage form.