Abstract: Methods for improving the gastrointestinal tolerability of biguanide compounds and for treating metabolic disorders and/or inducing weight loss in patients in need thereof, particularly in individuals having a contraindication for treatment with biguanide compounds, are provided comprising administering delayed release formulations of such biguanide compounds, including metformin, targeted to the small intestine.

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: The present invention relates to noninvasive microbiome analyses of Barrett's esophagus (BE) patients in which changes in the relative abundance of certain bacteria indicate a disease likelihood or pathogenic state. Additional aspects of the present invention relate to manipulating the microbiome to treat or prevent BE and related conditions. Embodiments also include monitoring for development of disease or monitoring treatment for prevention or elimination of disease states.

Abstract: Provided are compositions and methods comprising a FOXO inhibitor for increasing proliferation of Lgr5+ cochlear cells, and related methods of treating hearing loss.

Abstract: This invention relates to compositions and methods for cleaning, disinfection, and sterilization of hard, soft, and porous surfaces, equipment, human skin, tissues, food and vegetable surfaces, and other media which are contaminated with microorganisms such as bacteria, viruses, yeast, and molds. Particularly relevant is the microbial environment whereby bacterial communities can generate three-dimensional polymicrobial Extracellular Polymeric Substances, or EPS, biofilm communities supported by an aggregation of microorganisms growing on a substrate layer, substantially degrading the antimicrobial performance of typical cleaners, disinfectants, and sterilizers. There is great need for a composition that will reliably eradicate microorganisms across a broad spectrum, particularly polymicrobial EPS communities shrouded by self-generated biofilm layer. Such a composition is disclosed herein.

Abstract: The present invention provides novel fused bicyclic alkylene linked imidodicarbonimidic diamides. In particular, described herein are N-[2-(indol-3-yl)alkylene]-linked imidodicarbonimidic diamides and N-[2-(pyrrolopyridin-3-yl)alkylene]-linked imidodicarbonimidic diamides (compound of formula (I) or formula (II)), and uses therefor. The compounds of the present invention are believed to be organic cation transporter selective compounds, useful for the treatment of diseases and conditions caused by reduced activity of 5? adenosine monophosphate-activated protein kinase (AMPK).

Abstract: The present invention provides a method of treatment of inflammatory disorder of the eye, said method comprising administering into the eye of a person in need thereof, an aqueous solution comprising difluprednate as the sole active ingredient at a concentration of 0.02% to 0.04% weight by volume in an aqueous vehicle, wherein the solution is free of oil and wherein the solution is administered twice-a-day. The present invention also provides an ophthalmic solution comprising a. therapeutically effective concentration of difluprednate, a crystal growth inhibitor and pharmaceutically acceptable amounts of a solubilizer comprising a mixture of i. quaternary ammonium compound and ii. polyethoxylated castor oil, b. in an aqueous vehicle. wherein the crystal growth inhibitor is polyvinyl alcohol or its derivatives.

Abstract: Described herein, are personal care compositions comprising an effective amount of an antibacterial component selected from chloroxylenol (PCMX) and o-cymene-5-on (IPMP); phenoxyethanol; piroctone olamine; and a surfactant. Methods of making and using these compositions are also described.

Abstract: The present invention provides an ophthalmic solution comprising a. therapeutically effective concentration of difluprednate, a crystal growth inhibitor and pharmaceutically acceptable amounts of a solubilizer comprising a mixture of i. quaternary ammonium compound and ii. polyethoxylated castor oil, b. in an aqueous vehicle. wherein the crystal growth inhibitor is polyvinyl alcohol or its derivatives. Also, the present invention provides a method of treatment of inflammatory disorder of the eye, said method comprising administering into the eye of a person in need thereof, an aqueous solution comprising difluprednate as the sole active ingredient at a concentration of 0.02% to 0.04% weight by volume in an aqueous vehicle, wherein the solution is free of oil and wherein the solution is administered twice-a-day.

Abstract: Anti-microbial compositions for cleaning and sanitizing skin are disclosed. The anti-microbial compositions preferably comprises at least one quaternary ammonium chloride active and results in low irritation cleansing and sanitizing products that allow more frequent application.

Abstract: Provided herein are methods for treating subjects having conditions related to adrenocortical activity and/or excessive steroid production. In particular, provided herein are methods for treating subjects having conditions related to adrenocortical activity and/or excessive steroid production through administration of at least one of the following agents: 1) an agent capable of inhibiting cholesterol efflux related to ABCA1 and/or ABCG1; 2) an agent capable of inhibiting MDR1 related cortisol secretion and/or MDR1 P-glycoprotein multiple drug transporter activity; and 3) an agent capable of inhibiting mitochondrial activity.

Abstract: The subject invention provides materials methods for reducing infections in subjects. The materials methods utilize chlorhexidine, which has been found to be surprisingly non-toxic. The lack of toxicity facilitates the use of chlorhexidine in contexts that were not previously thought to be possible.

Abstract: The subject invention provides materials and methods for reducing ocular infections in subjects. The materials and methods utilize chlorhexidine, which has been found to be unexpectedly non-toxic to humans and other animals in low concentrations. The lack of toxicity facilitates the use of chlorhexidine in contexts that were not previously thought possible.

Abstract: The invention provides compositions and methods for the treatment of presbyopia. In a preferred embodiment correction of presbyopia occurs without reduction in distance vision acuity. The compositions of the invention preferably contain a muscarinic agonist and a cycloplegic agent.

Abstract: A method for using metformin and sodium butyrate in combination to treat a cancer patient with K-ras mutation is disclosed. When administering the pharmaceutical composition to a cancer patient, Metformin and sodium butyrate offer cooperatively therapeutic efficacy. The present invention also discloses a pharmaceutical composition and a pharmaceutical kit containing both aforementioned. The application of the method, the pharmaceutical composition and the pharmaceutical kit of the present invention are advantageous for improving the treatment effect to cancer patients with K-ras mutation.

Abstract: The invention provides compositions and methods for the treatment of presbyopia. The compositions preferably comprise aceclidine and a cycloplegic agent. The compositions optionally contain a surfactant, a viscosity enhancer, an osmolarity modifier and a preservative.

Abstract: Provided is a novel medicament capable of reducing the side effects of metformin or a pharmaceutically acceptable salt thereof and useful as an anti-malignant tumor agent, in which metformin or a pharmaceutically acceptable salt thereof and dihydroquercetin or a pharmaceutically acceptable salt thereof are combined.

Abstract: The subject invention provides materials methods for reducing infections in subjects. The materials methods utilize chlorhexidine, which has been found to be surprisingly non-toxic. The lack of toxicity facilitates the use of chlorhexidine in contexts that were not previously thought to be possible.

Abstract: A topical composition containing an adenosine monophosphate protein kinase (AMPK) activator and methods of administering the AMPK activator for treating acute pain or preventing the development of chronic pain in a subject. The AMPK activator is resveratrol. A second AMPK activator may also be used. The second AMPK activator is metformin. The topical composition may be administered as a gel, ointment, cream, lotion, suspension, liquid, or transdermal patch.

Abstract: The invention relates to the compositions of formula I or its pharmaceutical acceptable polymorphs, solvates, enantiomers, stereoisomers and hydrates thereof. The pharmaceutical compositions comprises a salt of metformin and the methods for treating or preventing metabolic syndrome, prediabetes and diabetes may be formulated for oral, buccal, rectal, topical, transdermal, transmucosal, intravenous, parenteral administration, syrup, or injection. Such compositions may be used to treatment of diabetes mellitus, obesity, lipid disorders, hypertriglyceridemia, hyperglycemia, hyperinsulinemia and insulin resistance.

Abstract: The present invention relates to topical bioadhesive formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein at least one bioactive agent is dissolved or dispersed in the low viscosity mixture and wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The invention additionally relates to a method of delivery of an active agent comprising administration of a preformulation of the invention, a method of treatment comprising administration of a preformulation of the invention and the use of a preformulation of the invention in a method for the manufacture of a medicament.

Abstract: The invention relates to a wound dressing which is particularly suitable for therapeutically dressing wounds. Said wound dressing comprises at least one wound covering layer and at least one sorbent based on an activated carbon which has a biocidal and/or biostatic, in particular antimicrobial effect and/or finish.

Abstract: The present invention relates to methods and compositions for rendering a surface resistant to bio-film formation by a combination of an alkanediol and an antimicrobial agent (and, optionally, an organic hydroxy acid). The invention provides for compositions which may be used to render surfaces bio-film resistant, articles having bio-film resistant surfaces, and methods for their preparation. The present invention may be advantageously applied to medical articles as well as articles used in non-medical contexts, such as child care or food preparation.

Abstract: Fibrous antimicrobial materials for use in structures and barrier applications, such as face masks and wound dressings, have been developed from antimicrobial polymeric materials. The fibrous antimicrobial materials also are particularly suitable for use in air and water filtration. The antimicrobial polymeric materials are prepared from solid solutions of antimicrobial bisguanide compounds blended with certain thermoplastic polymers. The antimicrobial polymeric materials may be extruded into fibers or used in the particulate form for preparation of the nonwoven antimicrobial materials. The antimicrobial bisguanide compound, such as chlorhexidine, are distributed at the molecular level within at least one thermoplastic polymer, such as a polyolefin in which the antimicrobial bisguanide compound is soluble, to form a miscible blend. Methods for their formation and use also are provided.

Abstract: A pharmaceutical composition for use in oral medication for the treatment of diabetes mellitus can include an antacid agent with an enteric coating, which permits the antacid agent to be delivered in the small intestine where it reduces acidity thereby causing a lowering of blood sugar levels. The pharmaceutical composition can be packaged in various tablet forms, including standard tablets and multiple pellet tablets. The pharmaceutical composition can further include a composition for treatment of diabetes, such as metformin, in enteric or non-enteric formulations. The pharmaceutical composition can further include an enteric-coated gastric acid secretion inhibitor. Also disclosed are methods for the treatment of diabetes mellitus, using the pharmaceutical composition and its variants.

Abstract: The invention relates to an antimicrobial composition comprising chlorhexidine and pentane-1,5-diol. Such a composition may be used to combat microorganisms.

Abstract: Compositions and methods for combination therapy are provided. The compositions comprise a multiple unit dosage form having both a therapeutic agent and a nutritional supplement. The combination therapy is useful for restoring a nutrient depletion associated with a particular disease state. Additionally, the combination therapy can prevent or attenuate the depletion of a nutrient caused, in whole or in part, by the co-administrated therapeutic drug. Methods of manufacturing the formulations are likewise described.

Abstract: Methods of delaying the onset of an infection or preventing an infection caused by a microbial organism in an internal cavity of a subject are provided. Methods of killing or inactivating microorganisms in at least a portion of the urethra of a subject are provided.

Abstract: It is reported herein that certain muscle diseases and conditions, including forms of muscular dystrophy, are characterized by impaired insulin-dependent signaling in the muscle tissue, in essence, a form of insulin resistance. The present disclosure relates to therapeutic agents, compositions and methods for treating a muscle disease or condition characterized by impaired insulin-dependent signaling by targeting components of the defective insulin signaling pathway. The disease or condition may be treated by administering a therapeutic agent that activates the insulin signaling pathway, in particular, therapeutic agents that act post-insulin receptor to modulate intracellular effector molecules. An exemplary modulator is metformin. Metformin may be administered alone or may be coadministered with another therapeutic agent for treating the muscle disease or condition, such as a corticosteroid.

Abstract: The present disclosure invention relates to medical devices treated with a solution comprising one or more solvents and a combination of chlorhexidine free base and a water-soluble chlorhexidine salt in a weight/weight ratio of between about 1:1 to about 1:5, preferably about 1:1.

Abstract: The antimicrobial composition of the present invention comprises a cationic active ingredient, a quaternized sugar-derived surfactant, and an optional foam boosting surfactant. These formulations have a high cidal activity in a short amount of time and provide stable copious foam. The formulations of the present invention also exhibit enhanced tissue (e.g. skin) compatibility as defined by an in vitro whole toxicology assessment method.

Abstract: Provided herein are methods of utilizing bile acid transport inhibitors and/or enteroendocrine peptide enhancing agents for the treatment of obesity, diabetes, and inflammatory gastrointestinal conditions.

Abstract: Nutritive proteins are provided. In some embodiments the nutritive proteins comprise a protein digestibility corrected amino acid score (PDCAAS) that exceeds a benchmark protein. Also provided are nucleic acids encoding the proteins, recombinant microorganisms that make the proteins, methods of making the proteins using recombinant microorganisms, compositions that comprise the proteins, and methods of using the proteins, among other things.

Abstract: The present invention relates to a method of treating an incretin related disease such as diabetes, obesity and the like by delivery of metformin to the colon by bypassing the upper digestive tract.

Abstract: Methods for improving the gastrointestinal tolerability of biguanide compounds and for treating metabolic disorders and/or inducing weight loss in patients in need thereof, particularly in individuals having a contraindication for treatment with biguanide compounds, are provided comprising administering delayed release formulations of such biguanide compounds, including metformin, targeted to the small intestine.

Abstract: The present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein at least one bioactive agent is dissolved or dispersed in the low viscosity mixture and wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents. The invention additionally relates to a method of delivery of an active agent comprising administration of a preformulation of the invention, a method of treatment comprising administration of a preformulation of the invention and the use of a preformulation of the invention in a method for the manufacture of a medicament.

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: The present disclosure relates to methods for making extended-release formulations of water-soluble active pharmaceutical ingredients such as metformin HCl. In one aspect, the disclosure provides a method that includes adding an aqueous solution of an active pharmaceutical ingredient to an agitated mixture of one or more release-modifying polymers and optionally one or more binders in one or more organic solvents, the one or more organic solvents together being an antisolvent for the active pharmaceutical ingredient, water being sufficiently soluble in the one or more organic solvents such that the water added as part of the aqueous solution dissolves in the mixture, the addition thereby precipitating the active pharmaceutical ingredient; separating the active pharmaceutical ingredient and the one or more release-modifying polymers and, if present, the one or more binders from the one or more organic solvents to yield co-processed particles; and drying the co-processed particles.

Abstract: Disclosed is a dental composition, comprising unsaturated double bond-containing monomers and/or oligomers, a catalytic amount of polymerization initiator to initiate polymerization, and a filler, wherein the dental composition comprises an organic nanotube containing an antibacterial or anticariogenic material to inhibit or prevent tooth decay. The dental composition comprises an organic nanotube containing an antibacterial or anticariogenic material, thus uniformly and continuously exhibiting anticariogenic and antibacterial activities, while avoiding deterioration in physical properties required for the dental material.

Abstract: The invention relates to the compositions of formula I or its pharmaceutical acceptable polymorphs, solvates, enantiomers, stereoisomers and hydrates thereof. The pharmaceutical compositions comprises a salt of metformin and the methods for treating or preventing metabolic syndrome, prediabetes and diabetes may be formulated for oral, buccal, rectal, topical, transdermal, transmucosal, intravenous, parenteral administration, syrup, or injection. Such compositions may be used to treatment of diabetes mellitus, obesity, lipid disorders, hypertriglyceridemia, hyperglycemia, hyperinsulinemia and insulin resistance.

Abstract: The invention relates to a kit-in-part comprising of a composition for the use as a cleaning and treating of ears of a companion animal and suitable packaging material, wherein the kit-in part additionally consists of components selected from the group of a pharmaceutical composition for use in the treatment of otitis externa, application and dosage information, cannules, cotton swabs, gauzes and information about the cleaning and maintenance ears of a companion animal.

Abstract: The present invention relates to a nutritional product comprising a biguanide in a concentration of 20 to 1600 mg per 100 g, based on total weight of the nutritional product, the nutritional product further comprising at least one dietary component selected from the group of (i) digestible carbohydrates, (ii) amino acid sources, such as proteins, peptides, free amino acids including salts of free amino acids, (iii) lipids, and (iv) dietary fibre. The invention further relates to a nutritional product comprising a biguanide for use in a prophylactic or therapeutic treatment of an aging-associated disorder.

Abstract: A coating comprised of a polymeric material and a bioactive agent where the properties of the casting solvent dictate the dispersion of the embedding bioactive agent. In preferred embodiments, controlled release of the bioactive agent is achieved by homogeneous dispersion of the bioactive agent within the coating. A further aspect of the invention is directed to formulations where the heterogeneous dispersion of the bioactive agent provides an initial rapid release of the bioactive agent. Methodology for production of coating formulations of the desired properties and the application of the coating to an article are also described.

Abstract: The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55° C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.

Abstract: A method for treating a periodontal disease affecting a periodontal pocket of a patient. The method comprises inserting an oral delivery device into the periodontal pocket at a frequency of about once every 4 days to about once every 6 weeks. The oral delivery device is a controlled release solid unit dosage form suitable for insertion into a periodontal pocket of a patient, comprising a therapeutically effective amount of at least one anti-inflammatory agent, at least one antibacterial agent, or the combination of at least one anti-inflammatory agent and at least one antibacterial agent.

Abstract: The present disclosure relates to a pharmaceutical composition, a health functional food composition, and a method for preventing or treating a brain disease or diabetes. The pharmaceutical composition, health functional food composition, and method includes at least one active ingredient that is chlorhexidine, thioguanosine, mebendazole, fenbendazole, colchicine, farnesol, trimethobenzamide hydrochloride, disulfuram, azathioprine, mebeverine hydrochloride, zaprinast, tosufloxacin hydrochloride, efavirenz, thiostrepton, probenecid, entacapone, harmine hydrochloride, flunisolide, thimerosal, hexestrol, sulfaquinoxaline sodium salt, monensin sodium salt, raloxifene hydrochloride, 2-chloropyrazine, or topotecan.

Abstract: An ocular composition consisting essentially of purified water, PEG-80 sorbitan laurate, sodium trideceth sulfate, PEG-150 distearate, sodium lauroamphoacetate, cocamidopropyl hydroxysultaine, sodium laureth-13 carboxylate, sodium chloride, PEG-15 cocopolyamine, polyhexamethylene biguanide, potassium sorbate, 1,2 hexanediol, and caprylyl glycol. The composition can be applied to a fabric pad for use as an eyelid cleanser, where the fabric pad is pre-moistened with the composition and packaged for use. The composition may also be used in an eyelid treatment kit for convenient combination treatments to improve overall eyelid hygiene and adjunctive eyelid therapy.

Abstract: The antimicrobial composition of the present invention comprises a cationic active ingredient, a quaternized sugar-derived surfactant, and an optional foam boosting surfactant. These formulations have a high cidal activity in a short amount of time and provide stable copious foam. The formulations of the present invention also exhibit enhanced tissue (e.g. skin) compatibility as defined by an in vitro whole toxicology assessment method.

Abstract: A medicant composition is provided. The composition includes a film layer and a powder matrix layer. The powder matrix layer includes a medicant. The powder matrix layer is applied to the film layer by admixing particulate to form a powder matrix and by then applying the powder matrix to the film layer by any desired method. The composition of the powder matrix is varied to alter the dissolution rate of the medicant, the adhesion of the medicant composition, and other physical properties of the powder matrix. The powder matrix layer can be cured.

Abstract: The present invention relates to nanoparticles for encapsulating compounds, the preparation and uses thereof, said nanoparticles being based on a vegetable hydrophobic protein, particularly zein, and a water miscible non-volatile organic solvent, particularly propylene glycol. Said nanoparticles can encapsulate or incorporate a product of interest for use in the agricultural, cosmetic, food or pharmaceutical fields.