Abstract: The application relates to an aqueous pharmaceutical formulation for use in the treatment of Type I or Type II Diabetes Mellitus, wherein the treatment reduces the risk of nocturnal hypoglycemia, said formulation comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine, with the proviso that the concentration of said formulation is not 684 U/mL of insulin glargine.

Abstract: The present invention relates to a pharmaceutical composition comprising at least one liposome, at least one polyvalent counterion donor or a pharmaceutically acceptable salt thereof, at least one monovalent counterion donor or a pharmaceutically acceptable salt thereof, and an amphipathic therapeutic agent. The present invention also relates to methods of inhibiting cancer cell growth, comprising administering the pharmaceutical composition described herein.

Abstract: The present invention provides liposome compositions containing substituted ammonium and/or polyanion, and optionally with a desired therapeutic or imaging entity. The present invention also provide methods of making the liposome compositions provided by the present invention.

Abstract: The present invention provides liposome compositions containing substituted ammonium and/or polyanion, and optionally with a desired therapeutic or imaging entity. The present invention also provide methods of making the liposome compositions provided by the present invention.

Abstract: A treatment method, system, and compound comprise directly targets osteomyelitis-infected bone tissue with one or more surface-modified liposomes. The surface-modified liposome(s) includes an alendronate targeting moiety utilized to modify the surface of the liposome. Alendronate targets hydroxyapatite in bone tissue, wherein the surface-modified liposome further comprises encapsulated vancomycin that directly targets the hydroxyapatite in the infected bone tissue and prevents bone implant related infection.

Abstract: The present disclosure relates to a composition that includes an apolipoprotein and a lipid bilayer, and methods and systems for preparing the composition. The apolipoprotein may be incorporated within at least a portion of the lipid bilayer. The lipid bilayer may form a liposome or other suitable carrier for transporting the apolipoprotein. The apolipoprotein incorporated lipid bilayer may provide a suitable delivery vehicle for the apolipoprotein to the body. Compositions of the present disclosure may be formed by exposing a mixture of an apolipoprotein and a lipid formulation to focused acoustic energy which, in some embodiments, may result in a liposome that at least partially encapsulates the apolipoprotein. In some embodiments, apolipoprotein A-V may be incorporated within a liposome, where the apolipoprotein A-V is suitably bioactive, or therapeutic, when delivered to cells and/or into the body of a patient.

Abstract: The present invention is directed to a process for adsorbing an active pharmaceutical ingredient onto a substrate, comprising the steps of (a) adding and mixing an inert adsorbent to a non-solid form comprising the active pharmaceutical ingredient, thereby forming a mixture; and (b) drying the mixture to form a solid crumbly material.

Abstract: An engineered aerosol particle for use in aerosol applications is provided. The engineered aerosol particle comprises a fabricated nanoparticle body member being non-spherical. The fabricated nanoparticle body member is configured to provide at least one of auto-rotation, tumbling, or lift when entrained in an airstream to thereby increase settling time of the fabricated nanoparticle body member. An associated method is also provided.

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: The present invention is directed to vaccination composition comprising a particle comprising a polymer matrix incorporating an adjuvant and/or an antigen, to method of making them and use. Particularly, the present invention results in adjuvants and/or antigens, covalently entrapped in or coupled to polymer carriers or polymeric devices, such as micelles, nanoparticles, microspheres and other types of polymer devices for controlled release; the adjuvant and/or antigen are covalently bonded in or to the polymer carriers or polymeric devices.

Abstract: The present invention relates to core-shell nanoparticles, methods for their production, and their use, in particular as adjuvants. Generally, the nanoparticles of the invention comprise a solid core consisting of a biodegradable polymer and a shell of amphiphilic molecules disposed about said core.

Abstract: Processes for preparing antioxidant-rich compositions, for example from coffee cherries, are disclosed. These processes can involve promptly contacting de-beaned coffee cherries with a preservative coating, and optionally storing under refrigerated conditions, prior to the preparation of an extract or powder.

Abstract: A method of making a sustained release microsphere formulation, wherein the release rate of a bioactive ingredient is manipulated by controlling the crystallinity of said bioactive ingredient, includes the steps of combining the active ingredient and an encapsulating polymer in at least one solvent, or mixtures thereof, to form a dispersed phase and processing the dispersed phase without filtering, filtering the combined dispersed phase with a hydrophobic or a hydrophilic filter, or filtering the active ingredient and encapsulating polymer individually with a hydrophobic or hydrophilic filter before combining them to form the dispersed phase. The dispersed phase is then combined with a continuous phase to form the microsphere formulation.

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: The present invention relates to a solid pharmaceutical dosage form comprising dolutegravir, a method of its preparation and its use in the treatment of an HIV infection.

Abstract: A pharmaceutical composition in the form of a combination tablet is described. The tablet has a rapidly absorbed component that enters the circulation by traversing the buccal mucosa, oral mucosa and combinations thereof, and a more slowly absorbed component that is swallowed. The therapeutic agent in the swallowed portion is absorbed across the gastric mucosa. The combination tablet may be modified, by varying the specific combinations of excipients, fillers, and the like to effect distinct release rates. In addition, the rapid and slow components may have identical or different therapeutic agents depending on the application to a specific medical condition. One embodiment of the combination tablet includes a prostaglandin inhibitor in the rapidly absorbed component in order to mitigate the side effects of immediate release niacin that is in the slow absorbing component.

Abstract: An oral osmotic pharmaceutical delivery system comprises a highly water-soluble drug exhibiting an erratic or an incomplete release profile when formulated in an elementary osmotic pump delivery system and at least one release enhancing agent.

Abstract: The present invention relates to stable solid formulations of vitamin D3 and to processes for preparation of the same. The present invention provides stabilized compositions comprising vitamin D3 at least one lipophilic dispersant, one or more antioxidants, at least one adsorbent and one or more pharmaceutically acceptable excipients and further coated with a barrier coating.

Abstract: The present invention relates to a method of manufacturing an orally disintegrating dosage form which masks a bitter or unpleasant taste. A composition including a ratio of excipients and a coated active substance prevents a coating layer on the active substance from being destroyed during manufacture.

Abstract: A solid dosage form comprises coated particles of bisphosphonate or a pharmaceutically acceptable analogue or derivative thereof.

Abstract: Biomedical devices for implantation with decreased pericapsular fibrotic overgrowth are disclosed. The device includes biocompatible materials and has specific characteristics that allow the device to elicit less of a fibrotic reaction after implantation than the same device lacking one or more of these characteristic that are present on the device. Biocompatible hydrogel capsules encapsulating mammalian cells having a diameter of greater than 1 mm, and optionally a cell free core, are disclosed which have reduced fibrotic overgrowth after implantation in a subject. Methods of treating a disease in a subject are also disclosed that involve administering a therapeutically effective amount of the disclosed encapsulated cells to the subject.

Abstract: Covalently modified alginate polymers, possessing enhanced biocompatibility and tailored physiochemical properties, as well as methods of making and use thereof, are disclosed herein. The covalently modified alginates are useful as a matrix for coating of any material where reduced fibrosis is desired, such as encapsulated cells for transplantation and medical devices implanted or used in the body.

Abstract: The present invention is directed to a cargo-loaded cholesteryl ester nanoparticle with a hollow compartment (“cholestosome”) consisting essentially of at least one non-ionic cholesteryl ester and one or more encapsulated active molecules which cannot appreciably pass through an enterocyte membrane in the absence of said molecule being loaded into said cholestosome, the cholestosome having a neutral surface and having the ability to pass into enterocytes in the manner of orally absorbed nutrient lipids using cell pathways to reach the golgi apparatus. Pursuant to the present invention, the novel cargo loaded cholestosomes according to the present invention are capable of depositing active molecules within cells of a patient or subject and effecting therapy or diagnosis of the patient or subject.

Abstract: Described herein are silicone-containing acrylic polymers useful, for example, in transdermal drug delivery compositions, to methods of making and using them, to transdermal drug delivery compositions comprising them, and to methods of making and using such transdermal drug delivery compositions. The polymers are particular suitable for formulating amine drugs, such as amphetamine, methylphenidate, rivastigmine, paroxetine and clonidine.

Abstract: Methods and formulations for infusing bioavailable resveratrol tinctures into food, beverage, cosmetic or drug products with minimal effect on the alcohol by volume of the product is provided. A resveratrol tincture includes an amount of trans-resveratrol mixed with a solvent of pure, or majority by weight, ethanol. The tincture is added to various food and beverages to make a bioavailable amount of trans-resveratrol to be absorbed and metabolized by the body providing demonstrated health benefits.

Abstract: This invention provides pharmaceutical compositions comprising compounds including 5-phenylpenta-2,4-dienoic acid, 3-methyl-3-butenyl caffeic acid, 1,1-dimethylallyl caffeic acid, pinobanksin-3-acetate, tectochrysin, pinostrobin chalcone, benzyl ferulate and benzyl isoferulate. Methods of using such compositions, in particular in the treatment or prevention of gastrointestinal cancers, and the resensitisation of gastrointestinal cancers to therapy are also provided.

Abstract: The invention concerns the use of compounds of formula (I) R-N1-spermidine, or 1,4-butandiamine,N-(3-amino propyl)-N1—R, (I) H2N—(CH2)3—N1 (R)—(CH2)4—NH2, as such or in the form of pharmaceutically acceptable derivatives, as the active principle in a pharmaceutical or cosmetic composition to preserve and protect epithelial stem cells, and progenitor cells that derive from them, through topical application on the skin or through the use of compounds in cell cultures. Hence, the invention especially concerns the use of compounds of formula (I) to treat cicatricial alopecia, and to stimulate and accelerate tissue repair and healing of both wounds and epidermal scars.

Abstract: The present invention relates to compositions and methods for treatment of proliferative disease. In specific aspects, the present invention relates to compositions including (1R,4aS,10aR)-1,2,3,4,4a,9,10,10a-octahydro-1-,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (leelamine) and arachidonyl trifluoromethyl ketone (ATK) in combination; methods for treatment of cancer including administration of leelamine and ATK in a subject in need thereof; and particularly methods for treatment of skin cancer including administration of leelamine and ATK in a subject in need thereof.

Abstract: The invention relates to an AMPK activator (such as for instance metformin) for use in preventing metastasis in a patient suffering from a cancer, wherein said patient has a non-mutated p53 gene or lacks a mutant form of the p53 protein. The invention also relates to an AMPK activator for use in improving the survival time of a patient suffering from a cancer, wherein said patient has a non-mutated p53 gene or lacks a mutant form of the p53 protein.

Abstract: An apparatus and method for anesthetizing various portions of a patient's nasal sinuses. For example, a kit can be provided that includes a first agent configured to modulate a rate of absorption of a subsequently-applied topical agent by one or more nasal structures. The kit also includes a first applicator configured to apply the first agent to a first portion of the one or more nasal structures. The kit also includes a second agent configured to anesthetize the first portion of the one or more nasal structures subsequent to application of the first agent and a second applicator configured to apply the second agent to the second portion of the one or more nasal structures.

Abstract: Liposomes comprising an FKBP52 targeting agent (FTA) are disclosed. Pharmaceutical compositions comprising an FTA, a solvent, and a surfactant are disclosed. Pharmaceutical compositions comprising a cyclodextrin and/or a derivative thereof and an FTA are also disclosed. Method of detecting one or more compounds in a sample by liquid chromatography/tandem mass spectrometry (LC/MS/MS), methods of treating or preventing cancer, benign prostatic hyperplasia (BPH), prostatic intraepithelial neoplasia (PIN), prostatitis, enlarged prostate, or insulin-independent diabetes, and methods of inhibiting spermatogenesis or fertilized oocyte implantation in a mammal are also provided.

Abstract: The present disclosure is drawn to a method of treating a patient in need of treatment, comprising identifying a patient in need of treatment for stroke, traumatic brain injury, spinal cord injury, myocardial infarction, shock, organ ischemia, ventricular arrhythmias, ischemic injury, or hypoxia/ischemia; administering a bolus of glyburide to the patient; and administering a continuous infusion of glyburide to the patient at from about 15 ?g/hr and about 300 ?g/hr, wherein the continuous infusion glyburide is administered for a period of time more than about 20 hours.

Abstract: This invention pertains generally to prostacyclin formulations and methods for their use in promoting vasodilation, inhibiting platelet aggregation and thrombus formation, stimulating thrombolysis, inhibiting cell proliferation (including vascular remodeling), providing cytoprotection, preventing atherogenesis and inducing angiogenesis.

Abstract: This invention teaches the use of chelating agents to diagnose and treat metal toxins in a patient. Chelation agents are given to the mother for the benefit of the baby. Metal toxins such as lead, arsenic, mercury, tin, antimony, aluminum and others are known to cause miscarriages, birth defects, maldevelopment of the organs and tissues and maldevelopment of the brain. Chelation treatments of the mother can prevent these problems in the embryo, fetus and infant. Removal of lead and mercury and other toxins allows improved development of the offspring, both during the chelation and after the chelation is discontinued. Determining whether a mother who has just delivered a baby has elevated levels of heavy metals can also be used to identify the elevated metals of the mother as a possible cause of birth defects.

Abstract: Methods for treating a glucose-related metabolic disorder (e.g., diabetes) comprising administration of 2-aminoadipic acid (2-AAA) to subjects in need thereof. Also described are methods for predicting a subject's risk of developing a glucose-related metabolic disorder, and to methods for selecting and monitoring a treatment for a glucose-related metabolic disorder (e.g., diabetes).

Abstract: According to a first aspect the invention relates to the use of fumaric acid derivatives selected from the group consisting of dialkyl fumarates, monoalkyl hydrogen fumarates, fumaric acid monoalkyl ester salts, fumaric acid monoamides, monoamido fumaric acid salts, fumaric acid diamides, monoalkyl monoamido fumarates, carbocyclic and oxacarbocyclic oligomers of these compounds and mixtures thereof for preparing a drug for the treatment or prevention of cardiac insufficiency, in particular left ventricular insufficiency, myocardial infarction and angina pectoris.

Abstract: A method for treating glycogen storage disease by administering an effective amount of a composition that includes ketogenic odd carbon fatty acids that ameliorate the symptoms of these diseases.

Abstract: This invention relates to methods of using genotyping to select patients for treatment with compounds capable of elevating ketone body concentrations in amounts effective to treat reduced neuronal metabolism associated with reduced neuronal metabolism, for example Alzheimer's disease.

Abstract: The present invention provides a use of a lipid composition for the preparation of a nutritional, pharmaceutical or nutraceutical composition or a functional food, for the prevention and treatment of gastrointestinal diseases and disorders, and for promoting intestinal development, maturation, adaptation and differentiation.

Abstract: The disclosure provides for a method for treating a fatty liver disease or disorder in a subject in need thereof, comprising selecting a subject having or suspected of having a fatty liver disease or disorder, wherein the subject is non diabetic, pre-diabetic, mildly diabetic; has normal or substantially normal biliary tract function; or has non or early stage hepatocyte apoptosis; and administering a therapeutically effective amount of a pharmaceutical composition comprising EPAs.

Abstract: A method for treating phytophotodermatitis including the steps of applying an isothiocyanate functional surfactant to an area affected by phytophotodermatitis, wherein said isothiocyanate functional surfactant comprises at least one isothiocyanate functional group associated with an aliphatic and/or aromatic carbon atom of the isothiocyanate functional surfactant.

Abstract: A method for treating phytophotodermatitis including the steps of applying an isothiocyanate functional surfactant to an area affected by phytophotodermatitis, wherein said isothiocyanate functional surfactant comprises at least one isothiocyanate functional group associated with an aliphatic and/or aromatic carbon atom of the isothiocyanate functional surfactant.

Abstract: A method for treating phytophotodermatitis including the steps of applying an isothiocyanate functional surfactant to an area affected by phytophotodermatitis, wherein said isothiocyanate functional surfactant comprises at least one isothiocyanate functional group associated with an aliphatic and/or aromatic carbon atom of the isothiocyanate functional surfactant.

Abstract: The present invention provides a pharmaceutical composition for preventing and/or treating a epilepsy or epilepsy-related syndrome, for example an intractable epilepsy or its related syndrome such as drug-resistant epilepsy, comprising the phenyl carbamate compound as an active ingredient, and a use of the phenyl carbamate compound for preventing and/or treating epilepsy or epilepsy-related syndrome.

Abstract: Methods of treating sleep disorders, particularly certain aspects of insomnia, in elderly patients (65 years and older) by administering initial daily dosages of doxepin of 1-3 mg. These ultra-low initial dosages are more effective in elderly versus non-elderly patients in decreasing wake time during sleep, latency to persistent sleep and wake time after sleep, and are particularly efficacious in treating those conditions in the last hour of an 8-hour sleep cycle. Also, the dosages described herein are safe tor elderly individuals.

Abstract: The invention provides naphthofuran compounds, polymorphs of naphthofuran compounds, naphthofuran compounds in particle form, purified compositions that contain one or more naphthofuran compounds, purified compositions that contain one or more naphthofuran compounds in particle form, and methods of using these naphthofuran compounds, polymorphs, purified compositions and/or particle forms to treat subjects in need thereof.

Abstract: The present invention is directed to a pharmaceutical composition comprised of one or more SGLT-2 inhibitor compound(s) in combination with one or more therapeutic agents which is suitable for the treatment of metabolic disorders including type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance, hyperglycemia, postprandial hyperglycemia, overweight, obesity, including class I obesity, class II obesity, class III obesity, visceral obesity and abdominal obesity, and metabolic syndrome.

Abstract: The disclosure demonstrates the role of mast cell stabilizers in treating rosacea. The disclosure also shows the role of mast cells, cathelicidin, serine protease and/or vitamin D3 in rosacea pathology and the use of antagonists and inhibitors thereof to treat rosacea.

Abstract: The present invention provides stable, fast-acting liposomal and micelle formulations of cannabinoids that are suitable for pharmaceutical and nutraceutical applications.

Abstract: In a screening program, the Antarctic sponge Dendrilla membranosa was found to produce diterpenoid secondary metabolites with activity against the leishmaniasis-causing parasite Leishmania donovani. The present invention concerns compositions useful for control of Leishmania spp. parasites in vitro and in vivo and treatment of leishmaniasis; methods for treatment of leishmaniasis; and methods for controlling Leishmania spp. parasites in vitro and in vivo.