Abstract: The present invention provides a composition suitable for forming an intramuscular implant. It comprises a biodegradable thermoplastic polymer of polylactic acid (PLA), DMSO and an aromatase inhibitor compound. The invention also provides a kit suitable for the in situ formation of the composition and its use as a medicine for treating cancer, especially breast cancer.

Abstract: The present invention is directed toward respirable dry particles for delivery of divalent metal cation salts and/or monovalent cation salts to the respiratory tract and methods for treating a subject having a respiratory disease and/or infection.

Abstract: The present invention provides for a novel oil-in-water (O/W) emulsion, with increased stability in the presence of bacterial or viral suspensions, especially those concentrated and non-purified (crude extracts) or minimally purified. The emulsion of the present invention can act as vehicle for the delivery of a pharmaceutical composition comprising at least one immunogen and, in particular, an immunogen selected from the group consisting of an inactivated pathogen, an attenuated pathogen, a subunit, a recombinant expression vector, and a plasmid or combinations thereof.

Abstract: A topical foam pharmaceutical composition for rectal administration comprising rifaximin is described. Also described is a method of making the composition and the use of the composition as a medicament.

Abstract: Compositions, methods, and systems for controlling crystallization of an agent are generally described. In some embodiments, an agent is crystallized in the presence of polymer matrices, such as polymer particles. The polymer matrix may influence at least a portion of the crystallization process and/or the resulting composition. In some such embodiments, the polymer matrix allows one or more aspect of the process and/or composition to be controlled and/or altered. For instance, the polymer matrix may act as a crystallization promoter and/or acceptable carriers of the crystallized agent. In certain embodiments, the polymer matrix described herein, can be used with any agent regardless of its chemical and/or physical properties.

Abstract: The present invention describes novel nanoparticle compositions, and systems and methods utilizing them for treating disorders and/or conditions associated with the epidermal and/or dermal level of the skin. Such disorders include acne, hyperhidrosis, bromhidrosis, chromhidrosis, rosacea, hair loss, dermal infection, actinic keratosis, facial wrinkles, muscle contracture, and headache. Methods generally involve administering nanoparticle compositions to the skin.

Abstract: A method for providing immediate and sustained release of ibuprofen to a subject, including administering, in a single dose, a modified release formulation of ibuprofen including a hydrophilic polymer, ibuprofen in solid dosage form uniformly dispersed in the polymer, and a dissolution additive and an inert formulation additive dispersed in the polymer. The hydrophilic polymer comprises a first hydroxypropyl methylcellulose (HPMC) having a viscosity of about 100 cps and a second HPMC having a viscosity between about 200 cps to about 50,000 cps. The solid dosage form is a monolithic tablet that demonstrates a mean ibuprofen plasma concentration in a subject greater than or equal to 6.4 ?g/ml within two hours of administration, and also demonstrates a mean ibuprofen plasma concentration in a subject greater than or equal to 6.4 ?g/ml for at least 8 hours after administration.

Abstract: There is provided pharmaceutical compositions for the treatment of e.g. opioid dependency comprising microparticles of a pharmacologically-effective amount of buprenorphine, or a pharmaceutically-acceptable salt thereof, in associative admixture with particles comprising a weak acid, or particles comprising weakly-acidic buffer forming materials. The composition may further comprise a disintegrant and/or particles of a pharmacologically-effective amount of naloxone, or a pharmaceutically-acceptable salt thereof. The compositions are useful in the treatment of opioid dependency/addiction and/or pain.

Abstract: In one aspect the present invention features process for making a tablet comprising at least one pharmaceutically active agent, said method comprising the step of applying radiofrequency energy to a powder blend to sinter said powder blend into said tablet, wherein said powder blend comprises lossy coated particles and said at least one pharmaceutically active agent, wherein said lossy coated particles comprises a substrate that is at least partially coated with a lossy coating comprising at least one activator, wherein said substrate has a Q value of greater than 100 and said activator has a Q value of less than 75.

Abstract: The invention provides an oral dosage form for the anti-cancer drug picoplatin comprising a core and a coating, the dosage form being free of redox-active, metal salts. The core of the tablet is a substantially dry powder comprising about 10 to 60 wt % picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt % of a lubricant. The dosage form can further include a dispersant.

Abstract: A solid dosage form designed to facilitate rapid and reliable oral, esophageal and GI transit has a surface area of the contact patch, i.e., the area of contact between the dosage form and the bodily surface reduced. The dosage form can be an asymmetric oral dosage unit containing a bioactive, the dosage unit being asymmetric with respect to a rotational axis perpendicular to a longitudinal axis of the dosage form, the rotational axis being located substantially at a mid point along the longitudinal axis. The dosage unit may have an outer surface ridged or dimpled or have at least one annular ring so as to reduce the contact patch of the dosage unit with a flat surface compared to non-ridged dosage unit of the same size and shape. The oral dosage unit can also have a spherical shape with or without ridges and/or dimples. Dies for forming these oral dosage units have, in a closed state, a cavity having a shape corresponding to the oral dosage unit.

Abstract: Disclosed herein is a fibrous tissue sealant in the form of an anhydrous fibrous sheet comprising a first component which is a fibrous polymer containing electrophilic or nucleophilic groups and a second component capable of crosslinking the first component when the sheet is exposed to an aqueous medium, thereby forming a crosslinked hydrogel that is adhesive to biological tissue. The fibrous tissue sealant may be useful as a general tissue adhesive for medical and veterinary applications such as wound closure, supplementing or replacing sutures or staples in internal surgical procedures, tissue repair, and to prevent post-surgical adhesions. The fibrous tissue sealant may be particularly suitable for use as a hemostatic sealant to stanch bleeding from surgical or traumatic wounds.

Abstract: A biocompatible polymeric controlled release matrix barrier structure for delivery of one or more bioactive agents from an implantable medical device is described. In an embodiment, a biocompatible polymeric controlled release matrix barrier structure is included. The biocompatible polymeric controlled release matrix can include a body structure formed of a compliant material comprising one or more compliant biocompatible polymers and one or more bioactive agents. The body structure can define a central aperture through which a subcutaneous element of an implantable medical device passes. Other embodiments are included herein.

Abstract: Hydroxytyrosol extracted from olives and/or from the solid residues of olives after the extraction of olive oil, by acid hydrolysis and purification on resin columns eluted with water contains hydroxytyrosol and tyrosol, is free from sugars, has a residual content of Benzo[a]pyrene that is less than 2 microg/Kg (weight BaP/weight of extract as dry matter), containing a weight ratio of hydroxytyrosol to hydroxymethylfurfural of between 45:1 and 10000:1, and the content of hydroxytyrosol in the extract is at least 0.5% (w/w) with purity of at least 40% (by HPLC 280 nm).

Abstract: Methods of inhibiting or preventing the proliferation of a fungus and/or a bacteria in a living organism, in water, in air, and/or on surfaces, include administering or providing a therapeutic amount or an effective amount of an antimicrobial composition including Octodrine.

Abstract: Pharmaceutical compositions and methods for the treatment of subjects, including humans, who have or are at risk for various disease, disorders and conditions, including, mitochondria-associated diseases, disorders, and conditions, including respiratory chain disorders, and diseases, disorders and conditions associated with or characterized at least in part by mitochondria swelling, mitochondria dysfunction, mitochondria leaking, oxidative stress, increased mitochondria number, increased mitochondria and mitochondria-related protein mass, and increased mitochondria and related-related proteins expression.

Abstract: Disclosed are compositions and methods for the treatment of a subject having an autism spectrum disorder. The disclosed compositions may contain racemic ketamine or S-ketamine. The disclosed methods of administering the compositions include intranasal administration to a subject having an autism spectrum disorder.

Abstract: Provided herein are pharmaceutical compositions comprising transnorsertraline, salts and polymorphic forms of transnorsertraline, methods of making the compositions, and methods for their use for the treatment of CNS diseases, including depression.

Abstract: The present invention relates to co-crystals of tramadol and co-crystal formers selected from NSAIDs/coxibs, processes for preparation of the same and their uses as medicaments or in pharmaceutical formulations, more particularly for the treatment of pain.

Abstract: The present invention relates to co-crystals of tramadol and co-crystal formers selected from NSAIDs/coxibs, processes for preparation of the same and their uses as medicaments or in pharmaceutical formulations, more particularly for the treatment of pain.

Abstract: A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once-daily oral administration to maintain an adequate plasma concentration-time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.

Abstract: The present invention relates to chewing gum formulations of dapoxetine or a pharmaceutically acceptable salt thereof and tadalafil or a pharmaceutically acceptable salt thereof. The present invention further relates to a process for preparing such a formulation and to the use thereof in the treatment of erectile dysfunction.

Abstract: The present invention is a method for increasing serotonin activity in mammary glands such that involution of milk secretion of the same mammary glands occurs. The present invention further is a composition that can be implanted, or infused into the mammary glands to cause involution of milk secretion.

Abstract: The invention provides compositions and methods for treatment of neurodegenerative diseases or disorders, particularly neurodegenerative diseases and disorders associated with protein aggregation. The present invention is based on the discovery of binding regions on the surface of PrPc, referred to as PrPc Binding Domains (PBD). In particular, the inventors have identified six different binding regions on PrPc, referred to herein as PrP-binding domain-1 (PBD-1), PrP-binding domain-2 (PBD-2), PrP-binding domain-3 (PBD-3), PrP-binding domain-4 (PBD-4), PrP-binding domain-5 (PBD-5), and PrP-binding domain-6 (PBD-6), herein. The PBD-1 to PBD-6 are each defined by a cluster of amino acids located in the globular domain of the protein, e.g., in the C-terminal half of the protein (i.e., in residues 120-230). One embodiment uses residues 127-226.

Abstract: Compositions and methods comprising at least one biguanide compound and at least one statin combined with at least one additional active agent in fixed dose combinations are provided for reducing cardiometabolic risk, and for the treatment of cardiovascular disease, wherein the biguanide compound is formulated for delayed release.

Abstract: A process for making nanoparticles of biocompatible materials is described, wherein an aqueous reaction mixture comprising a metal ion, a biguanide, an oxidant, and water; optionally further comprising an alpha-amino acid or a nucleobase; is provided along with temperature conditions to directly form within the reaction mixture, a stable dispersion of metal-containing nanoparticles. Biocompatible nanoparticles comprised of cerium and a biguanide, and optionally containing an alpha-amino acid or a nucleobase, are also described. The use of metal oxide nanoparticles comprising a biguanide as a nanoparticle core/corona in the preparation of nanoscale ionic (liquid) material compositions is disclosed.

Abstract: The present invention relates to a composition comprising metformin as an active ingredient for preventing or treating inflammatory bowel disease. The metformin compound or the metformin-etanercept (product name: Enbrel) composite according to the present invention may have excellent effects of maintaining the thickness of the small intestine and length of the large intestine normal, inhibiting or decreasing the activity of IL-17 and TNF-a, and promoting or increasing the activity of IFNr, and therefore can be effectively used as a pharmaceutical composition for preventing or treating autoimmune diseases including inflammatory bowel disease.

Abstract: Formulations and methods are provided for improving the function, i.e. clinical outcome, of solid organ transplants. Lung transplantation is of particular interest. In the methods of the invention, a nanoparticle formulation comprising an effective dose of an iron chelator active agent in nanoparticle form, including without limitation, deferoxamine (DFO), deferasirox (DFX), and deferiprone (DFP), etc. suspended in a carrier compatible with the tissue of interest, is topically applied to the surface of tissues at the site of anastomosis. The nanoparticles are comprised of the active agent and a pharmaceutically acceptable stabilizer.

Abstract: Methods of treating and/or preventing a cardiovascular event in a patient, the method comprising orally administering a colchicine to a patient who is receiving concurrent treatment with at least one antiplatelet agent, thereby treating and/or preventing the cardiovascular event in the patient are provided.

Abstract: Methods of treating and/or preventing a cardiovascular event in a patient, the method comprising orally administering a colchicine to a patient who is receiving concurrent treatment with at least one antithrombotic drug, thereby treating and/or preventing the cardiovascular event in the patient are provided.

Abstract: The present disclosure pertains to a construction consisting of in the order from the outside towards the inside: an occlusive or non-occlusive backing substrate; a drug-loaded layer including a therapeutic concentration of at least one or a combination of cosmetic and/or pharmaceutical active ingredients; a permeable or semi-permeable support substrate; a non-drug loaded cured silicone gel adhesive layer cured onto the permeable or semi-permeable support substrate; and a temporary release liner configured to protect the cured silicone gel adhesive layer.

Abstract: Pharmaceutical formulations are described for use in the treatment of pulmonary arterial hypertension (PAH). The formulations comprise polymeric nanoparticles encapsulated within crosslinked polymeric hydrogel microparticles, wherein the polymeric nanoparticles carry a therapeutic agent suitable for treatment of PAH loaded within them (for example, prostacyclin synthetic analogs, PPAR ? agonists and NO donors). Preferred formulations are inhalable, dry powder pharmaceutical formulations, which are able to swell on administration to the lungs of a patient.

Abstract: The present specification provides RXR agonist compounds, compositions comprising such RXR agonists, and methods using such compounds and compositions to treat an autoimmune disorder, inflammation associated with an autoimmune disorder and/or a transplant rejection as well as use of such RXR agonists to manufacture a medicament and use of such compounds and compositions to treat an autoimmune disorder, inflammation associated with an autoimmune disorder and/or a transplant rejection.

Abstract: The present invention relates to pharmaceutical compositions of mesalamine. The composition of the invention is a capsule dosage form filled with a tablet. The invention also relates to process for preparing such compositions. The invention specifically relates to a composition comprising an effective amount of mesalamine having higher bulk density.

Abstract: This invention relates to novel acetylcysteine compositions in solution, comprising acetylcysteine and which are substantially free of metal chelating agents, such as EDTA. Further, this invention relates to methods of making and using the acetylcysteine compositions. The present compositions and methods are designed to improve patient tolerance and compliance, while at the same time maintaining the stability of the pharmaceutical formulation. The compositions and methods of this invention are useful in the treatment of acetaminophen overdose, acute liver failure, various cancers, methacrylonitrile poisoning, reperfusion injury during cardio bypass surgery, and radiocontrast-induced nephropathy, and can also be used as a mucolytic agent.

Abstract: The present invention provides a drug that is effective in treating and/or completely curing dermatophytosis with ease. More specifically, the present invention provides a dermatophytosis pharmaceutical composition characterized in that it is topically applied and includes, as a main active ingredient, at least one organic acid salt selected from the group consisting of ethylenediaminetetraacetic acid salts.

Abstract: The disclosure provides compositions comprising 15-HEPE or derivatives thereof used singly or in combination with other active agents for the treatment and/or prevention of lung diseases and disorders such as asthma.

Abstract: (1S,3S)-3-amino-4-difluoromethylenyl-1-cyclopentanoic acid also known as CPP-115 can be used to treat addiction and neurological disorders without side effects such as visual field defects caused by vigabatrin (Sabril).

Abstract: Provided are antimicrobial solutions comprising a glyceryl nitrate (e.g., glyeryl trinitrate) in combination with a chelator (e.g., citrate), a peroxide, a fatty acid, and/or an alcohol (e.g., ethanol). In various aspects these components may synergistically act to kill or reduce the growth of microbes, such as bacteria or fungi, present in a biofilm.

Abstract: The novel therapeutic potential of Calebin A and compositions thereof to prevent pathological damage to mammalian articular cartilage is disclosed.

Abstract: The invention relates to the combination of a sulforaphane precursor, an enzyme capable of converting the sulforaphane precursor to sulforaphane, an enzyme potentiator, and a milk thistle extract or powder. The invention also relates to the combination of a sulforaphane or a derivative thereof and a milk thistle extract or powder. The invention also relates to the combination of a broccoli extract or powder and a milk thistle extract or powder. The invention provides compositions and methods relating to these combinations.

Abstract: The present invention provides ?-keto peracids and methods for producing and using the same. In particular, ?-keto peracids are useful as antimicrobial agents.

Abstract: One embodiment of the invention provides a method for administering tasimelteon to a human patient that comprises orally administering an effective dose of tasimelteon under fasted conditions. Fasted conditions may comprise administering the tasimelteon without food, no food at least ½ hour prior to administration, no food at least 1 hour prior to administration, no food at least 1½ hours prior to administration, no food at least 2 hours prior to administration, no food at least 2½ hours prior to administration, or no food at least 3 hours prior to administration. According to such embodiments, tasimelteon may be administered, for example, at a dose of 20 mg/d. Tasimelteon may be administered where, for example, the patient is being treated for a circadian rhythm disorder or for a sleep disorder, including, for example, Non-24 Disorder.

Abstract: The disclosure relates to a pharmaceutical composition for oral administration, containing, as active principle, a benzofuran derivative having antiarrhythmic activity, in particular dronedarone and the pharmaceutically acceptable salts thereof, and at least one lipid carrier, said pharmaceutical composition being intended to be used in unit dosage form of the capsule type, in particular with a hard shell. This pharmaceutical composition and the dosage form comprising such a composition aim to limit the meal time effect following oral administration in humans. The lipid carrier allows: the solubilization of the active principle of the invention; and the shielding thereof from the negative effects of pH in the intestinal tract, thereby allowing same to be spared from the meal effect to a significant extent.

Abstract: Disclosed is a use of flavones derivatives and flavanone derivatives in preparation of sedative and hypnotic drugs.

Abstract: In certain aspects, the invention relates to methods of treating proliferative cervical disorders (such as cervical cancer and cervical dysplasia) and treating virus infection by administering artemisinin-related compounds. In certain aspects, the invention relates to methods of treating a tumor induced by an oncogenic virus, methods of killing or inhibiting a squamous cell carcinoma, and methods of inhibiting the replication of a virus, by administering artemisinin-related compounds.

Abstract: Provided herein are methods of treating a sleep-related breathing disorder, such as obstructive sleep apnea, comprising the administration of O-desmethylvenlafaxine or duloxetine.

Abstract: Salts of glycopyrrolate, including solid forms and formulations such as topicals thereof, are disclosed. Methods of making glycopyrrolate salts, including formulations such as topicals thereof, and methods of treating hyperhidrosis with salts of glycopyrrolate, and formulations such as topicals thereof, are disclosed.

Abstract: Provided herein are methods for the concurrent treatment of pain and depression in a patient based, at least in part, on the discovery that the comorbid interaction between pain and depression can be treated by regulating two opposing pathways of tryptophan metabolism.

Abstract: The subject invention provides therapeutic compositions, and uses thereof for the treatment or amelioration of injury to small intestine mucosa. In preferred embodiments, the composition comprises one or more nutrients and/or electrolytes that acquire or retain considerable absorptive capacity.