Abstract: Compositions and methods for treating obesity in a subject are described. Some embodiments provide methods for administering pharmaceutical formulations including biocompatible emulsifiers in an amount effective to treat obesity. In some embodiments, pharmaceutical formulations include a combination of two or more biocompatible emulsifiers effective to treat obesity.

Abstract: The disclosure is directed to a nanoparticle comprising a porous framework core including a porous framework material and a compound, and a lipid layer disposed on the surface of the porous framework core.

Abstract: Methods, compositions, and kits for predicting whether a subject with chronic obstructive pulmonary disease (COPD) or at risk of developing COPD is likely to have progressive COPD are provided. Methods, compositions, and kits for predicting whether lung function is likely to decline in a subject with COPD or at risk for developing COPD are also provided.

Abstract: Injection systems comprising a powered injector and one or more hazardous agents are disclosed.

Abstract: The present invention provides an implantable device having a coating including a slow dissolving polymer or material and the methods of making and using the same.

Abstract: The present invention relates to the treatment of vascular disease in a diabetic patient using a drug-eluting implantable medical device that releases everolimus from three distinctly loaded drug reservoir layers wherein at least one of the layers comprises at least 200 ?g/cm2 of everolimus and further wherein the everolimus is the only therapeutic agent in the layers or the layers or any combination thereof further comprise an anti-inflammatory agent or an RGD peptide or both.

Abstract: The present invention relates to the diuretic effects of nitrate esters of corticoid compounds. A patient in heart failure may be treated by administering a therapeutically effective dosage of a pharmaceutical composition comprising a nitrate ester of corticoid compound as a diuretic having the general formula B—X1—NO2. A method of improving kidney function by administering a therapeutically effective dosage of a pharmaceutical composition having a nitrate ester of corticoid compound of the same formula is also described.

Abstract: Storage stable, topical lotion compositions for treating corticosteroid-responsive dermatoses are provided by the present invention which include a halobetasol material comprising halobetasol or its pharmaceutically acceptable salts, esters, and solvates; and a pharmaceutically acceptable carrier which includes: (a) one or more fatty alcohols and/or one or more alkoxylated fatty alcohols, (b) one or more polyol humectants, and (c) diisopropyl adipate. Storage stable, topical lotion compositions for treating corticosteroid-responsive dermatoses are provided by the present invention which include 0.05% halobetasol propionate; and a pharmaceutically acceptable carrier which includes: (a) one or more fatty alcohols and/or one or more alkoxylated fatty alcohols, (b) one or more polyol humectants, and (c) diisopropyl adipate.

Abstract: Storage stable, topical lotion compositions for treating corticosteroid-responsive dermatoses are provided by the present invention which include a halobetasol material comprising halobetasol or its pharmaceutically acceptable salts, esters, and solvates; and a pharmaceutically acceptable carrier which includes: (a) one or more fatty alcohols and/or one or more alkoxylated fatty alcohols, (b) one or more polyol humectants, and (c) diisopropyl adipate. Storage stable, topical lotion compositions for treating corticosteroid-responsive dermatoses are provided by the present invention which include 0.05% halobetasol propionate; and a pharmaceutically acceptable carrier which includes: (a) one or more fatty alcohols and/or one or more alkoxylated fatty alcohols, (b) one or more polyol humectants, and (c) diisopropyl adipate.

Abstract: An exosomal composition is provided that comprises a therapeutic agent encapsulated by an exosome. The therapeutic agent can be a phytochemical agent, a chemotherapeutic agent, or a Stat3 inhibitor. Pharmaceutical compositions comprising the exosomal compositions are also provided. Methods for treating an inflammatory disease or a cancer are further provided and include administering an effective amount of an exosomal composition to a subject in need thereof to thereby treat the inflammatory disorder or the cancer.

Abstract: The present invention provides an absorbable coating for an implantable device and the methods of making and using the same.

Abstract: A pharmaceutical composition comprises, as a therapeutically active ingredient, a corticosteroid and/or vitamin D derivative incorporated as a solid solution or dispersion in lipid nanoparticles, said lipid nanoparticles being solid at ambient temperature and comprising a first lipid with a melting point above body temperature, the first lipid being a wax selected from the group consisting of esters of C12-24 alcohols and C12-24 fatty acids, glyceryl mono-, di- or triesters of C12-24 fatty acids, C12-24 fatty alcohols, and cholesterol, optionally a second lipid which is an oil at ambient temperature and miscible with the first lipid, and a pharmaceutically acceptable surfactant.

Abstract: The present disclosure is directed to a class of fluorinated copolymers, such as a PTFE copolymers, that can be dissolved in low toxicity solvents, such as Class III Solvents, and that enable the creation of stable water-in-solvent emulsions comprising the fluorinated copolymers dissolved in a low toxicity solvents and a hydrophilic agent (e.g., a therapeutic agent) dissolved in an aqueous solvent, such as water or saline.

Abstract: The present disclosure is directed to a class of fluorinated copolymers, such as PTFE copolymers, that can be dissolved in low toxicity solvents, such as Class III Solvents, and that enable the creation of stable water-in-solvent emulsions comprising the fluorinated copolymers dissolved in a low toxicity solvents and a hydrophilic agent (e.g., a therapeutic agent) dissolved in an aqueous solvent, such as water or saline.

Abstract: The invention involves methods and formulations for treating or preventing rhinosinusitis, including fungus-induced rhinosinusitis in mammals. In one embodiment, the formulation of the present invention comprises a steroidal anti-inflammatory agent having a specific particle size distribution profile. The formulation may also comprise an antifungal agent, antibiotic or antiviral agent.

Abstract: A pharmaceutical composition for treating cachexia, and in particular for treating cancer cachexia. The composition contains a lanostane compound as a potent component. A suitable source of the lanostane compound is a Poria extract from metabolite, sclerotium, or fermentation product of Poria cocos (Schw) Wolf. The Poria extract contains 1-60% of the lanostane compounds by weight of the extract, and is devoid of secolanostane.

Abstract: The present invention relates to a microvesicle that is derived from nucleated mammalian cells, which are smaller than the nucleated cells. The microvesicles of the present invention can be used in the delivery of a therapeutic or diagnostic substance to specific tissues or cells, and more particularly, relates to microvesicles derived from monocytes, macrophages, dendritic cells, stem cells or the like, which can be used to deliver specific therapeutic or diagnostic substances for treating and/or diagnosing tissue associated with cancer, diseased blood vessels, inflammation, or the like.

Abstract: The purpose of present invention is to provide a medicine which has low contamination with a fine-pulverizing medium, is safe and has improved bioavailability. A method for producing a composite organic compound powder for medical use is used which comprises: mixing a poorly water-soluble and crystalline organic compound powder, a physiologically acceptable salt, a physiologically acceptable polyol, and a carboxyvinyl polymer and fine-pulverizing the organic compound powder; and removing at least the salt and the polyol during or after fine-pulverizing.

Abstract: The current invention provides a new and original method for treatment of ocular inflammatory diseases. More particularly, the present invention relates a mineralocorticoid receptor agonist for use in the treatment of an ocular inflammatory disease.

Abstract: The present invention relates to methods and compositions for preventing and/or treating various conditions in a patient, including for example, T-cell lymphoblastic leukemia and lymphoma as well as neurodegenerative diseases, such as for example, Alzheimer's disease. In one preferred embodiment of the invention, such methods include providing a patient with an effective amount of a combination of a NOTCH-1 inhibitor and glucocorticoid. The present invention further encompasses methods for increasing the efficacy of, and mitigating resistance to, glucocorticoids in the treatment of T-cell lymphoblastic leukemia and lymphoma, which generally include providing a patient with an effective amount of one or more NOTCH-1 inhibitors.

Abstract: A method for determining the optimum location for placement of an intraocular implant containing used to treat an ocular condition, particularly implants comprised of a biodegradable polymer and a therapeutic agent for the treatment of retinal tissue.

Abstract: The present invention relates to a new therapeutic approach for the treatment of eye diseases or conditions that allows for the delivery of corticosteroids to the eye's surface but does not cause any of the usual side effects associated with topical administration of corticosteroids. More specifically, the present invention provides methods of treatment involving the administration of a corticosteroid prodrug, such as dexamethasone palmitate, to the surface of the eye. Also provided are pharmaceutical compositions and kits for carrying out such methods of treatment.

Abstract: Disclosed is a stable liquid formulation for parenteral injection comprising a biocompatible non-aqueous solvent and a small molecule drug, or a salt thereof, solubilized within the non-aqueous solvent, wherein the liquid formulation comprises less than 10% by weight residual water, and wherein the volume of the liquid formulation to be parenterally injected is from 0.1 ?l to 3 ml.

Abstract: A composition for delivery of a hydrophobic bioactive agent is provided that provides for a partially solubilized storage solution that upon exposure to the air results in a fully solubilized bioactive agent in a molecular form for optimal delivery to the skin of a subject. The composition is used for the therapeutic treatment or diagnosis of numerous skin conditions such as acne, wrinkles, inflammation, and epidermal or musculoskeletal pain.

Abstract: Nanocrystals, compositions, and methods that aid particle transport in mucus are provided. In some embodiments, the compositions and methods involve making mucus-penetrating particles (MPP) without any polymeric carriers, or with minimal use of polymeric carriers. The compositions and methods may include, in some embodiments, modifying the surface coatings of particles formed of pharmaceutical agents that have a low water solubility. Such methods and compositions can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for administration routes involving the particles passing through a mucosal barrier.

Abstract: This invention provides for biocompatible, biodegradable eye drop pharmaceutical formulations useful for the treatment of ocular indications. In particular, tocopherols and their esters of low water solubility, notably ?-tocopheryl acetate, are exceptional vehicles for biocompatible, nonirritating topical eye drop formulations that provide sustained release of active agents.

Abstract: This disclosure relates to replication competent viral vectors for treating cell proliferative disorders. The disclosure further relates to the use of such replication competent viral vectors for delivery and expression of a heterologous nucleic acid in normal and diseased tissues and methods and compositions that facilitate such delivery and expression to tissues in vivo and in vitro. The disclosure further relates to replication competent retroviral vectors for these uses and in conjunction with methods and compositions that facilitate in vivo therapeutics.

Abstract: A pharmaceutical composition is provided comprising microparticles encapsulating high weight percent active agent and providing sustained release over a prolonged period of time of active agent levels bioequivalent to direct administration of active agent. Polymeric microparticle compositions containing one or more active agents, and methods of making and using thereof, are described. The microparticles are optimized for the agent to be delivered, so that the hydrophobicity or hydrophilicity of the polymer and charge of the polymer maximizes loading of the agent, and the selection and molecular weight of the polymers maximize release of an effective amount of the active agent for the desired period of time.

Abstract: Particles, compositions, and methods that aid particle transport in mucus are provided. The particles, compositions, and methods may be used, in some instances, for ophthalmic and/or other applications. In some embodiments, the compositions and methods may involve modifying the surface coatings of particles, such as particles of pharmaceutical agents that have a low aqueous solubility. Such compositions and methods can be used to achieve efficient transport of particles of pharmaceutical agents though mucus barriers in the body for a wide spectrum of applications, including drug delivery, imaging, and diagnostic applications. In certain embodiments, a pharmaceutical composition including such particles is well-suited for ophthalmic applications, and may be used for delivering pharmaceutical agents to the front of the eye and/or the back of the eye.

Abstract: An active agent delivery composition is provided that allows topical delivery of active agents including vitamin A and its derivatives. A volatile vehicle serves as a coupler for an active agent and an organosiloxane carrier so as to allow full solubilization of active agents not normally miscible in silicones and providing a non-irritating, targeted evaporating composition.

Abstract: A process is described for loading hydrophilic polymer particles with a water-insoluble solvent-soluble drug. The particles are preferably embolic agents. The method provides particles having little or no drug at the surface and in a surface layer, whereby the burst effect is minimised. The drug is precipitated in the core of the particle, leading to extended release. The drug is, for instance, paclitaxel, rapamycin, dexamethasone or ibuprofen.

Abstract: The invention provides pharmaceutical compositions based on liquid vehicles whose density is substantially higher than that of aqueous physiological fluids. The compositions are useful as medicines in ophthalmology, in particular for the treatment of conditions affecting the posterior segment of an eye. They may be administered topically into the eye or in a minimally invasive manner by periocular injection. Preferred liquid carriers are selected from semifluorinated alkanes.

Abstract: Devices, systems, and methods for delivery of an active agent into the eye of a subject can include an intraocular active agent delivery device including an active agent dispersed within a biodegradable active agent matrix. The active agent includes dexamethasone and the delivery device is adapted to fit within a lens capsule or ciliary sulcus of an eye. The delivery device can be inserted into the lens capsule or ciliary sulcus of an eye during cataract surgery or for treatment of uveitis.

Abstract: The present invention further provides method of preparing nanocrystals of a hydrophobic therapeutic agent such as fluticasone, pharmaceutical compositions (e.g., topical or intranasal compositions) thereof and methods for treating and/or preventing the signs and/or symptoms of disorders such as blepharitis, meibomian gland dysfunction or skin inflammation or a respiratory disease (e.g., asthma).

Abstract: An oil in water microemulsion or sub-micron emulsion composition for dermal delivery of at least one pharmaceutically active ingredient, is provided. The composition includes an oil phase dispersed throughout a water phase, the oil phase including at least one member selected from the group consisting of an animal oil, a mineral oil, a vegetable oil, a silane member, a siloxane, an ester, a fatty acid, a fat, a halogen compound, and an alkoxylated alcohol; and at least one lipophilic surfactant, the water phase including at least one hydrophilic surfactant, water and optionally a non-surfactant amphiphilic compound, the weight ratio of the at least one hydrophilic surfactant to the at least one lipophilic surfactant being approximately 9.0:1.0 to 2.0:3.0.

Abstract: The invention provides biodegradable implants sized for implantation in an ocular region and methods for treating medical conditions of the eye. The implants are formed from a mixture of hydrophilic end and hydrophobic end PLGA, and deliver active agents into an ocular region without a high burst release.

Abstract: The invention provides a method for the controlled assembly of layered silk fibroin coatings using aqueous silk fibroin material. The methods described herein can be used to coat substrates of any material, shape, or size. Importantly, the described methods enable control of the biomaterial surface chemistry, thickness, morphology and structure using layered thin film coatings, or bulk coatings. Furthermore, the methods can be performed in all water and do not require intensive chemical processing enabling controlled entrapment of labile molecules such as, drugs, cytokines, and even cells or viruses to generate functional coatings that can be used in a variety of applications.

Abstract: The present invention relates to a glucocorticoid (GC) for use in the amelioration, treatment or prophylaxis of neurological/psychiatric adverse events caused by a CD3 binding domain. Kits comprising a GC, a CD3 binding domain and instructions for use which indicate that the GC is to be employed for the treatment amelioration and/or prophylaxis of neurological adverse events caused by said CD3 binding domain, are also disclosed.

Abstract: Composition for delivery of at least one active principle at the implantation site of an implant device, including: at least one active principle, and at least a first excipient combined with the at least one active principle, wherein the at least a first excipient is selected among fatty acids with a linear or branched, saturated chain, including a number of carbon atoms between 14 and 36.

Abstract: Methods, compositions, systems, devices and kits are provided for preparing and using a multi-layer polymeric microstructure composition for delivering a therapeutic agent to a subject. In various embodiments, the therapeutic agent includes at least one selected from the group of: a drug, a protein, a sugar, a carbohydrate, and a nucleotide sequence. In related embodiments, the composition is a fiber, a suture, a sphere, an implant, or a scaffold.

Abstract: Methods for treating inflammation-mediated conditions of the eye are described, comprising: implanting into the vitreous of the eye of an individual a bioerodible implant comprising a steroidal anti-inflammatory agent and a bioerodible polymer, wherein the implant delivers the agent to the vitreous in an amount sufficient to reach a concentration equivalent to at least about 0.05 ?g/ml dexamethasone within about 48 hours and maintains a concentration equivalent to at least about 0.03 ?g/ml dexamethasone for at least about three weeks.

Abstract: Self-assembled gel compositions including a gelator, e.g., an enzyme-cleavable gelator, e.g., having a molecular weight of 2500 or less, are described. The self-assembled gel compositions can encapsulate one or more agents. Methods of making the self-assembled gel compositions, and methods of drug delivery using the self-assembled gel compositions are also described.

Abstract: Provided herein are methods and compositions for the treatment of motor neuron diseases including, for example, amyotrophic lateral sclerosis. Suitable therapeutic agents include, for example, agents that up-regulate the expression IGF-II or guanine deaminase in a cell.

Abstract: Topically applicable compositions in the form of oil-in-water (O/W) emulsions contain a pro-penetrating system including at least one glycol and at least one additional pro-penetrating agent, a suitable emulsifying system and at least one active agent of the family of steroidal anti-inflammatory agents, and are useful e.g., for the treatment of psoriasis.

Abstract: Topically applicable compositions in the form of oil-in-water emulsions contain a pro-penetrating system including at least one glycol and at least one additional pro-penetrating agent, a suitable gelling agent and at least one active agent of the family of steroidal anti-inflammatory agents and are useful, e.g., for the treatment of psoriasis.

Abstract: Effective treatments of acute pain for extended periods of time are provided. Through the administration of an effective amount of dexamethasone at or near a target site, one can relieve pain cause by diverse sources, including but not limited to spinal disc herniation (i.e. sciatica), spondilothesis, stenosis, discongenic back pain and joint pain as well as pain that is incidental to surgery. When appropriate formulations are provided within biodegradable polymers, this relief can be continued for at least twenty-five days. In some embodiments, the relief can be for at least fifty days, at least one hundred days, at least one hundred and thirty-five days or at least one hundred and eighty days.

Abstract: Embodiments of the present invention include methods of treating, preventing, or ameliorating a vascular disease and/or disorder in a diabetic or pre-diabetic patient. The methods include implanting a stent in a vascular region in a diabetic patient, and during the implantation procedure, delivering a drug formulation from a source other than the stent to the vascular region. The stent may be a bare metal stent, or a drug eluting stent, such as a metal stent having a coating including a drug. The drug may be everolimus, sirolimus, or a combination thereof. The drug formulation may include dexamethasone, paclitaxel, or a combination thereof.

Abstract: The present invention relates to a particular class of biodegradable linkers, ensuring transiently stable conjugation of building blocks and/or bioactive compounds into drug delivery systems (DDS), such as DDS based on polymeric micelles or hydrogels. In addition, the present invention relates to compounds, comprising said linkers, such compounds preferably being prodrugs. Further, the invention is directed to the use of said linkers, and especially said biodegradable linkers, in a drug delivery system. Moreover, the invention relates to controlled release system comprising a polymer matrix, capable of releasing an active ingredient, wherein the active ingredient is covalently linked to the polymer molecules of the polymer matrix through said linkers, as well as to a method of synthesising these linkers and preparing such controlled release systems.

Abstract: Effective treatments of pain and/or inflammation are provided. Through the administration of an effective amount of at least analgesic and/or at least one anti-inflammatory agent at or near a target site, one can reduce, prevent or treat inflammation and pain.

Abstract: The invention provides biodegradable implants sized for implantation in an ocular region and methods for treating medical conditions of the eye. The implants are formed from a mixture of hydrophilic end and hydrophobic end PLGA, and deliver active agents into an ocular region without a high burst release.