Abstract: The present invention is directed to CNS pharmaceutical compositions and methods of use. The pharmaceutical compositions comprise a CNS active agent and preferably at least two vagal neuromodulators, one of which is a mechanoreceptor stimulator. The vagal neuromodulators are preferably in an amount sufficient to reduce a somnolence side-effect of the CNS active agent without changing its therapeutic efficacy/activity. The invention further encompasses a method of reducing CNS active agent side-effects. The method typically comprises oral administration of at least one CNS active agent to a patient at the conventionally accepted dose; and administration of at least two vagal neuromodulators to the patient so that at least one neuromodulator is administered or released from dosage form after the CNS active agent is administered and/or released.

Abstract: A composition and method adapted for delivery of hydrophilic, biologically-active agents are disclosed. The composition can include a reverse microemulsion formed from at least one hydrophilic, biologically-active agent solubilized by a hydrophobic reverse emulsion surfactant in a non-stinging, volatile, hydrophobic solvent. The non-stinging, volatile, hydrophobic solvent is selected from the group consisting of volatile linear and cyclic siloxanes, volatile linear, branched, and cyclic alkanes, volatile fluorocarbons and chlorofluorocarbons, liquid carbon dioxide under pressure, and combinations thereof. The reverse microemulsion can be an optically clear solution.

Abstract: A dental composition comprising: a) about 1 to about 80% by weight of particulate material including: (i) calcium silicate, calcium aluminate, tetracalcium aluminoferrite, calcium phosphate, calcium sulfate, silica, alumina, calcium oxide, calcium hydroxide, or mixtures thereof; and b) about 1 to about 50% by weight liquid carrier including: (i) water-soluble polymer, (ii) surfactant, the surfactant is selected from the group consisting of alkyl sulfates, alkyl ether sulfates, and sarcosinates, and mixtures thereof; and (iii) water; wherein the particulate and liquid carrier being mixed together to form a hydrate gel material that can harden.

Abstract: This invention relates to a synergistic pharmaceutical combination of glucose lowering drugs and autophagy inhibitors, kits containing such combinations, and methods of using such combinations to treat subjects suffering from cancers carrying a specific KRAS mutation. This invention also relates to a theranostic method for cancer treatment.

Abstract: Composition and method for irrigating a prepared dental root canal. The composition is an aqueous composition of ethylenediaminetetraacetic acid, chlorhexidine or orally acceptable addition salt, and N-cetyl-N,N,N-trimethylammonium bromide, and is effective for simultaneous smear layer removal and disinfection.

Abstract: A wound dressing includes one or more layers containing an antimicrobial agent and optionally at least one of: a chelating agent, a second antimicrobial agent, a zinc-containing agent, a cell-signaling agent, and an additional active ingredient or agent.

Abstract: Pharmaceutical formulations for treating neurological diseases are described, wherein the formulations comprise a pharmaceutically active agent-transport moiety complex. The formulations are suitable for administration via an intranasal route. Neurological diseases and conditions are associated with reduced brain insulin signaling (i.e., CNS insulin insensitivity), reduced dopaminergic signaling, reduced serotonergic signaling, reduced cholinergic signaling, or reduced GABAergic signaling, and include Alzheimer's disease, Parkinson's disease, epilepsy, neuropathic pain, fibromyalgia, post-herpetic neuralgia, insomnia, or anxiety. Neurological diseases also include cancers of the central nervous system (CNS).

Abstract: The present invention relates inter alia to the use of selectively moisture-adjusted tabletting material in the preparation of mechanically stable oral tablets which contain at least one hydrate-forming active substance and/or adjuvant relevant to the mechanical stability of the tablets, particularly arginine-containing oral tablets.

Abstract: Disclosed herein are ophthalmic cleaning systems and methods for their use, which comprise an ophthalmic solution and lens case, wherein the solution includes dual disinfectants and the lens case includes silver. When the lens case is combined with the solution according to the system of the present invention, it surprisingly exhibits synergistic activity which results in a faster antimicrobial activity.

Abstract: The invention provides methods for treating a patient having type 2 diabetes who has failed on previous regimens of one or more oral and/or injectable anti-diabetic agents, which include the step of administering a therapeutically effective amount of an SGLT2 inhibitor alone or in combination with another anti-diabetic agent and/or other therapeutic agent to such patient. A pharmaceutical composition containing dapagliflozin or dapagliflozin-S-propylene glycol solvate and one or more diabetic agents and/or other therapeutic agents for use in the methods of the invention is also provided.

Abstract: The present invention provides pharmaceutical compositions comprising: (a) a modulator of hepatic parasympathetic tone, (b) at least one diabetes drug, and (c) a pharmaceutically acceptable carrier. The present invention includes methods for the treatment and/or prevention of insulin resistance, type 2 diabetes, impaired glucose intolerance, and other associated disorders with pharmaceutical compositions described herein. The invention also provides for a kit comprising a pharmaceutical composition and instructions for its use.

Abstract: The specification describes the use of selected DPP IV inhibitors for the treatment of physiological functional disorders and for reducing the risk of the occurrence of such functional disorders in at-risk patient groups. In addition, the use of the above-mentioned DPP IV inhibitors in conjunction with other active substances is described, by means of which improved treatment outcomes can be achieved. These applications may be used to prepare corresponding medicaments.

Abstract: Described herein are methods and compositions related to biologic matrices comprising at least one anti-infective. In certain embodiments, the invention relates to a biologic matrix comprising a slowed release anti-infective agent. In a particular embodiment, the invention relates to an acellular dermal matrix comprising a slowed release anti-infective agent, wherein the anti-infective agent is triclosan. In further embodiments, the invention relates to a biologic matrix comprising at least one anti-infective agent, wherein the biologic matrix is suitable for use in surgical procedures, such as, for example, for the replacement of damaged or inadequate integumental tissue or for the repair, reinforcement or supplemental support of soft tissue defects.

Abstract: Described are pharmaceutical compositions comprising phentermine, metformin, and at least one pharmaceutically acceptable carrier or excipient. Another aspect of the present invention relates to a method of treating a patient suffering from obesity or needing to lose weight, comprising the step of co-administering to said patient a therapeutically effective amount of phentermine and metformin. In certain embodiments, an aforementioned method is practiced in conjunction or tandem with a medical procedure or the use of a medical device or both.

Abstract: A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.

Abstract: The present invention concerns a process for producing a granulate based on lactose and cellulose (derivative), a granulate obtainable by the process and its use as a tabletting excipient.

Abstract: Compositions are provided that comprise a disinfectant, a pH indicator dye, and an alkaline substance. The pH indicator dye expresses a color when initially sprayed, but loses or changes color once sprayed. The compositions may be used to disinfect surfaces, and the pH indicator dye indicates what surface has been disinfected and ensures that a sufficient period of time has passed to disinfect the surface. Dispensing systems that are not fully air tight are provided for containing and dispensing the composition.

Abstract: The invention relates to a method of treating or preventing a condition in a subject, comprising administering to the subject an acceptable composition comprising meglumine or a salt thereof. The invention further relates to a method of improving a physiological function in a subject, comprising administering to the subject an acceptable composition comprising meglumine or a salt thereof.

Abstract: Provided herein are methods for treating conditions associated with a chemosensory receptor, including diabetes, obesity, and other metabolic diseases, disorders or conditions by administrating a composition comprising a chemosensory receptor ligand, such as a bitter receptor ligand. Also provided herein are chemosensory receptor ligand compositions, including bitter receptor ligand 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 provides thermo-sensitive, mucoadhesive biopolymer formulations that enhance the penetration of therapeutics across the skin or mucosal surfaces. In a preferred embodiment, the biopolymer formulation comprises co-polymer of poloxamer 188 and propylene glycol, laurocapram and, optionally, one or more therapeutic agents. Also provided are uses of the biopolymer formulations for topical therapy of cancer including cervical cancer.

Abstract: Single layer and multi-layer anti-microbial wound care fabrics, gloves, sleeves, anklets, socks, finger cots, masks, and similar wound care articles are disclosed.

Abstract: A method for determining the levels of biomarkers, specifically, advanced glycation end products (AGEs) and oxidation products (Ops) in a biological sample such as a plasma ultrafiltrate, is used to determine a patient's risk and/or rate of developing diabetes related nephropathy. The preferred biomarkers to measure include N?-(1-carboxyethyl-lysine (CEL), methylglyoxyl-derived hydroimidazolone (MGHI) and N?-carboxymethyllysine (CML). Also provided herein is a method of diabetic care which includes determining a diabetic patient's risk of developing diabetes related kidney disease and adjusting the patient's treatment regimen to include in addition to glucose lowering agents, additional treatments such as medications that modify the renin-angiotensin system, or specialized diets with low levels of AGEs or oxidative products.

Abstract: This invention provides medical articles having antimicrobial efficacy and good barrier properties. In particular, the medical articles comprise a nonwoven material and a coating comprising chlorhexidine acetate and triclosan.

Abstract: Provided are methods and compositions for treatment of cancer. In particular, these methods and compositions may include an inhibitor of a deubiquitinating enzyme. In certain aspects, these methods and compositions may include a modulator of glucose metabolism. Also provided are methods of assaying the glucose content of cells and tissues using detection of uH2B.

Abstract: A pH responsive and mucoadhesive pharmaceutical dosage form for the release of a pharmaceutically active agent is described. The dosage form includes a mucoadhesive layer for site-specific mucoadhesion, a water-insoluble outer layer, and an intermediate layer including one or more pharmaceutically active agents for site-specific delivery. The different membranous layers perform different functions in order to create a drug delivery system which is able to deliver a drug to a specific site, for a particular period of time and with a specific drug release pattern. The dosage form can have two or more intermediate layers, each layer comprising an active agent. The mucoadhesive layer can also include an active agents. The dosage form is preferably an oral or buccal delivery form for release of the active agent into the gastro intestinal tract. The intermediate layer can be an electrospun fibrous membrane layer containing the active agent.

Abstract: Antimicrobial lubricant compositions are disclosed. The antimicrobial lubricant compositions are particularly useful in providing antimicrobial capability to a wide-range of medical devices. The compositions include an oil lubricant. Representative lubricants may include polydimethyl siloxane, trifluoropropyl copolymer polysiloxane, and a copolymer of dimethylsiloxane and trifluoropropylmethylsiloxane. The compositions include rheology modifiers as necessary. The compositions also include antimicrobial agents, which may be selected from a wide array of agents. Representative antimicrobial agents include of aldehydes, anilides, biguanides, bis-phenols, quaternary ammonium compounds, cetyl pyridium chloride, cetrimide, alexidine, chlorhexidine diacetate, benzalkonium chloride, and o-phthalaldehyde.

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: A method of moisturizing while decolonizing mammalian tissue, comprising applying a multi-valent cationic antiseptic composition to the tissue, and applying a moisturizer composition to at least a portion of the same tissue is provided. An oral care kit comprising a composition comprising the multi-valent cationic antiseptic and the moisturizer composition, and a method of moisturizing oral tissue of a patient requiring intubation using the moisturizer composition and an endotracheal tube coated or impregnated with a cationic antiseptic are also provided.

Abstract: The present invention deals with a method for the preparation of an antimicrobial aqueous solution containing chlorhexidine digluconate and tartaric acid for use with dental/orthodontic glass ionomer cement, and an antimicrobial aqueous solution substantially improved by the inclusion of chlorhexidine digluconate up to 18% and tartaric acid up to 11%.

Abstract: Disclosed herein are methods for treating obesity, metabolic syndrome, diabetes, or a combination of these conditions. The methods include selecting a subject with obesity, metabolic syndrome, or diabetes and administering to the subject a therapeutically effective amount of a composition comprising a compound that specifically inhibits hepatic protein kinase C (PKC)-?, thereby treating the obesity, metabolic syndrome, or diabetes in the subject. In some embodiments the compound that specifically inhibits hepatic PKC-? includes a thio-gold compound (such as aurothiomalate, aurothioglucose, and auranofin) or a derivative thereof, or a pharmaceutically acceptable salt thereof. In other embodiments, the compound that specifically inhibits hepatic PKC-? includes 1H-imidazole-4-carboxamide, 5-amino-1-[2,3-dihydroxy-4-[(phosphonooxy)methyl]cyclopentyl]-[1R-(1?,2?,3?,4?)] (ICAPP) or a derivative thereof, or a pharmaceutically acceptable salt thereof.

Abstract: Methods of using phenformin to treat certain types of cancers are described.

Abstract: A pharmaceutical composition comprising a dipeptidyl peptidase IV inhibitor and a slow release biguanide is provided. A method for treating diabetes in a patient in need thereof including administering an anti-diabetic combination comprising a DPP inhibitor and a slow release biguanide is also provided.

Abstract: Ophthalmic compositions comprising 0.5 ppm to 5 ppm of alexidine, and 0.005 wt. % to 0.3 wt. % of glycereth-18-ethylhexanoate. The invention is also directed to the use of the ophthalmic compositions to clean and disinfect contact lenses, and in particular, soft, silicone, hydrogel contact lenses.

Abstract: An antimicrobial composition, generally comprising a biocidal agent, such as chlorhexidine gluconate, a lubricant, such as a modified siloxane, and a solvent, such as an alcohol and/or water. The biocidal agent acts as a highly effective biocide while the lubricant reduces friction between various components of a medical device during assembly. The antimicrobial composition may be applied to an internal component of the medical device prior to assembly. The process of assembling the medical device results in antimicrobial composition being distributed to various internal structures and geometries of the medical device as the coated, internal component is assembled into the interior of the medical device. Air is then used to further distribute excess antimicrobial agent to the remaining surfaces downstream from the installed, internal component. In some embodiments, additional air is passed through the assembled medical device to assist in removing the carrier solvent from the medical device via evaporation.

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: The present invention relates to pharmaceutical compositions that include a combination of a biguanide present in an extended-release form and a low dose antidiabetic agent present in an immediate-release form. The present invention further relates to processes for preparing such compositions.

Abstract: Suggested is a compound of the formula (X) or any salt of a compound of the formula (X) or any mixture containing or consisting of two or more different compounds of the formula (X), two or more different salts of compounds of the formula (X) or one or more different compounds of the formula (X) and one or more different salts of compounds of the formula (X), wherein for R1, R2 and R3 independently of one another in every compound of the formula (X) the following applies: R1 means hydrogen or methyl, R2 means an organic residue with 5 carbon atoms and one oxygen atom or none and R3 means an organic residue with 10 carbon atoms and one or more oxygen atoms, or R1 and R2 together with the carbon atoms in positions 4 and 5 and the oxygen atom bound to the carbon atom in position 4 form a ring and comprise 5 carbon atoms and one oxygen atom or none, and R3 means an organic residue with 10 carbon atoms and one or more oxygen atoms, for use in a method for the prophylaxis and/or treatment of inflammation.

Abstract: The present invention relates to N,N-dimethyl imidodicarbonimidic diamide acetate, a method of preparing the same and a pharmaceutical composition comprising the same, and more particularly, to N,N-dimethyl imidodicarbonimidic diamide acetate which is a crystalline acid addition salt prepared by reacting N,N-dimethyl imidodicarbonimidic diamide with acetic acid, and which is very effective as a therapeutic agent for treating metabolic syndromes that glycosuria and diabetes mellitus, obesity, hyperlipidemia, fatty liver, coronary heart disease, osteoporosis, polycystic ovarian syndrome, a cancer depleted of gene P53, etc. are complexly occurred; treating diabetes mellitus and preventing its complication; and treating a cancer and preventing myalgia, muscle cell cytotoxicity and rhabdomyolysis, etc. since the acid addition salt is excellent in physicochemical properties such as solubility, stability, non-hygroscopicity, anti-adhering property, etc.

Abstract: Antimicrobial skin prep solutions of the invention comprise: a major amount of at least one organic solvent, wherein at least about 80% by weight based on total weight of the solvent comprises at least one fugitive organic solvent; an antimicrobially effective amount of at least one antimicrobial agent; and an amount of at least one adhesive effective to increase adhesion of surgical drapes and medical dressings to skin prepped with the antimicrobial skin prep solution, wherein the at least one adhesive is distinct from the at least one antimicrobial agent and is a liquid at room temperature. Coated substrates, applicators, and related methods are also disclosed.

Abstract: The present invention relates to bilayer tablet formulations comprising metformin extended release (XR) or reduced mass metformin XR formulation as the first layer, an SGLT2 inhibitor formulation as the second layer, and optionally a film coating. The present invention provides methods of preparing the bilayer tablet formulations and methods of treating diseases or disorders associated with SGLT2 activity employing the bilayer tablet formulations.

Abstract: The present invention provides for compositions, methods and kits for regulating energy metabolism. In one aspect, the invention provides for compositions that comprise a combination of (a) branched chain amino acids, such as leucine, and (b) vitamin B6, or any precursors or metabolites of (a) or (b). These combinations may be synergistic and/or effective for reducing weight or adipose volume. In another aspect, the invention provides for methods of regulating energy metabolism by the administration of one or more compositions comprising branched chain amino acids and vitamin B6. The invention also provides for kits comprising compositions of branched chain amino acids and vitamin B6 packaged in an oral dose form with usage instructions.

Abstract: The present invention provides antimicrobial solutions that in certain cases comprise a biguanide and a glycol ether and, in some cases, optionally also includes combinations of at least one an alcohol, at least one chelator, glycerol, deoxycholate, and/or at least one alkylpolyglucoside. In certain aspects the invention comprises a biguanide and deoxycholate or a combination of chelator, ethanol, and alkylpolyglucoside. Also provided are methods for rapidly killing and/or reducing bacteria, fungi, or virus from surfaces, for example, including surfaces of indwelling medical devices and organic surfaces such as skin and sutures, and inorganic surfaces such as medical equipment, pipelines etc.

Abstract: The invention relates to a wound dressing comprising a polymer substrate and a compound comprising a) at least one antimicrobial active agent and b) an agent that reduces the cytotoxicity, comprising an oil-in-water emulsion that additionally has one or more alkanediol(s) and/or one or more glyceryl ether(s).

Abstract: The present invention relates to solid, semisolid, or liquid formulations comprising water soluble antioxidants that prevent or reduce formic acid and/or formyl species generation in the dosage form during the manufacturing process and/or during shelf-life storage. The formulations of the present invention prevent or reduce formation of N-formyl impurities (and gelatin cross-linking) during the manufacturing process and/or during shelf-life storage.

Abstract: The present invention is directed to the treatment of muscular dysfunction or increasing muscle strength and/or decreasing muscle fatigue in a subject using a composition that includes a biguanide or a pharmaceutically acceptable salt thereof, e.g., at a low dosage.

Abstract: The invention provides compositions and methods for determining cardiodiabetes status in a subject. The invention also provides compositions and methods for treating a subject experiencing cardiodiabetes.

Abstract: Ophthalmic composition that includes 0.05% w/v to 2% w/v diglycine or a salt thereof; 0.01 ppm to 3 ppm poly(hexamethylene biguanide); 1 ppm to 10 ppm ?-[4-tris(2-hydroxyethyl)ammonium chloride-2-butenyl]poly[1-dimethylammonium chloride-2-butenyl]-?-tris(2-hydroxyethyl)ammonium chloride; and 0.1% w/v to 2% w/v of one or more boron buffering compounds.

Abstract: Ophthalmic compositions that comprise 0.1 ppm to 2 ppm of poly(hexamethylene biguanide); and 0.005 wt. % to 0.3 wt. % of a PEG-glycerol ester of general formula I wherein R1 is a C3-C8alkyl and R2 is H or a C1-C4alkyl; and x+y+z has an average value from 8 to 30. The invention is also directed to the use of the ophthalmic compositions to clean and disinfect contact lenses, and in particular, soft, silicone hydrogel contact lenses.

Abstract: An antimicrobial product is provided in which an antimicrobial substance is encapsulated in capsules suspended within a suspending substance. The antimicrobial substance is released upon abrasion of the surface of the antimicrobial product. The antimicrobial product is used to coat surfaces to provide released antimicrobial substance to the hands of someone touching the surfaces.

Abstract: Disclosed are methods of treatment for adipogenic virus-related conditions. The methods may comprise administering a composition comprising an effective dose of an antiviral agent to a subject having an adipogenic adenovirus-related condition. Administration of the antiviral agent may prevent or reduce viral proliferation in the subject. The method may also include administering a composition comprising an effective dose of a therapeutic agent known to treat the adipogenic adenovirus-related condition in conjunction with the composition comprising an effective dose of an antiviral agent. Administration of the antiviral agent and the therapeutic agent may reduce or eliminate one or more symptoms of the adipogenic adenovirus-related condition more efficiently than administration of either the antiviral agent and the therapeutic agent alone.