Abstract: The invention provides immunostimulatory compositions comprising a small molecule immuno-potentiator (SMIP) compound and methods of administration thereof. Also provided are methods of administering a SMIP compound in an effective amount to enhance the immune response of a subject to an antigen. Further provided are novel compositions and methods of administering SMIP compounds alone or in combination with another agent for the treatment of cancer, infectious diseases and/or allergies/asthma. In a further aspect, the invention relates generally to methods of screening for small molecule immuno-modulatory compositions.

Abstract: The present invention provides ophthalmic formulations of fluticasone that provide a comfortable formulation when instilled in the eye and is effective in the treatment of allergic conjunctivitis and/or allergic conjunctivitis. The invention further provides methods of treating allergic conjunctivitis and/or allergic conjunctivitis in a subject in need of such treatment by topical application of the fluticasone formulations of the invention directly to the eye.

Abstract: The present disclosure relates to methods for visualizing the opening of a drug reservoir of an implantable medical device. In particular, the present disclosure provides methods for observing the release or exposure of contents from a drug reservoir of a medical device placed within the vitreous of an eye of a subject. The methods include implanting a drug delivery device within an anatomy of a subject. The drug device includes a plurality of reservoirs, each loaded with a therapeutic agent and a marker. Furthermore, the drug delivery device comprises a plurality of barrier layers for separating the contents of one of the plurality of reservoirs from the anatomy. The method further includes irradiating at least one of the plurality of barrier layers such that at least one of the plurality of reservoirs is breached, thereby triggering release of the therapeutic agent and the marker from the device.

Abstract: The present invention relates to materials having therapeutic compositions releasably contained within the materials. The materials are configured to release therapeutic compositions at a desired rate. The present invention also relates to devices incorporating the materials.

Abstract: The invention is directed to methods of inducing cell recruitment and tissue regeneration at a target site in a subject. It is also based, in part, on the discovery that a subject's own biologic resources and environmental conditions can be used for in situ tissue regeneration and thereby reduce or eliminate the need for donor cell procurement and ex vivo manipulation of such donor cells. Methods are disclosed for recruitment of a subject's own stem cells to a target region by inducing a sustained positive pressure at a target site, such as the kidney, thereby increasing the number of pluripotent cells capable of differentiating to regenerate the target tissue.

Abstract: A poly(thioester ester amide) copolymer and method of making and using the same are disclosed.

Abstract: A polyethylene glycol (PEG) aerogel particles having an average particle diameter not substantially above about 2?, a volumetric porosity of greater than about 50%, and pore sizes capable of retaining drug molecules. A method for preparing such polyethylene glycol (PEG) aerogel particles includes initiating a catalyzed reaction using a catalyst of PEG forming ingredients to form PEG particles; partially drying the formed PEG particles under conditions to control pore size; and subjecting the partially dried formed PEG particles to CO2 supercritical extraction for form the PEG aerogel particles. Drug molecules include chemotherapeutic agents. The surface of the PEG aerogel particles are reactable with a variety of agents, for example, to selectively target tumors, protects irreversible damage to labile proteins, and protects degradation of sensitive drugs with subsequent loss of biological efficacy.

Abstract: The present invention is directed to orally administered corticosteroid compositions. The present invention also provides a method for treating a condition associated with inflammation of the gastrointestinal tract in an individual. The method comprises administering to an individual in need thereof a pharmaceutical composition of the present invention.

Abstract: Pharmaceutical composition for intraocular use comprising a glucocorticoid derivative, such as beclomethasone 17,21-diproprionate admixed with a biodegradable polymer such as a poly(lactide-co-glycolide) polymer or a high molecular weight polymeric hyaluronic acid are disclosed.

Abstract: The invention features pharmaceutical compositions that include dipyridamole and a corticosteroid.

Abstract: A nebulizer formulation comprises particles of size 0.5-3 microns obtained by crystallization of beclomethasone diproprionate monohydrate in the presence of ultrasound.

Abstract: We describe lipid based pharmaceutical compositions adapted for oral delivery and optionally delivery in accordance with a circadian rhythm.

Abstract: The embodiments set forth herein provide biocompatible self-setting compositions suitable for use in tissue augmentation applications. The biocompatible self-setting compositions described herein exhibit advantageous theological properties and may be applied to a site in the body of a patient by injecting the composition through a 20-30 gauge needle. Once applied to a site in the body, the composition sets to a slow resorbing or substantially non-resorbing matrix. Advantageously, exposure of the composition material to body heat at its site of use enhances setting of the composition.

Abstract: Pharmaceutical solutions containing hydrophobic or lipophilic therapeutic agents and methods for producing the same are provided. Pharmaceutical solutions of the invention are produced by dissolving the therapeutic agent in one or more tocopherols or tocotrienols and one or more alcohols or glycols. These solutions are used to produce pharmaceutical compositions.

Abstract: Steroid compounds processing a hydrogen donor in 3beta position, either in the form of a hydroxy- or a sulfate group, function as efficient blockers of the 3alpha-hydroxy-pregnan-steroid action and thus have utility as therapeutic substances for the prevention and/or treatment of steroid related CNS disorders. Treatment methods based on the administration of these substances are disclosed, and these substances either alone or in combination are also suggested for the manufacture of pharmaceuticals for the treatment of many specific steroid induced CNS disorders.

Abstract: This invention generally pertains to the field of psychiatry. In particular, this invention pertains to the discovery that agents which inhibit the binding of cortisol to its receptors can be used in methods for treating delirium. Mifepristone, a potent specific glucocorticoid receptor antagonist, can be used in these methods. The invention also provides a kit for treating delirium in a human including a glucocorticoid receptor antagonist and instructional material teaching the indications, dosage and schedule of administration of the glucocorticoid receptor antagonist.

Abstract: The present invention features methods of delivering corticosteroids or metabolites thereof for treating inflammatory conditions otherwise difficult to cure with topical administration.

Abstract: Disclosed herein are compositions and methods for the treatment of otic disorders with steroid, NSAID, and/or adenosine triphosphatase (“ATPase”) modulator agents. In these methods, the steroidal, NSAID, and/or ATPase compositions and formulations are administered locally to an individual afflicted with an otic disorder, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).

Abstract: Provided is a rapamycin analog composition including a crystalline form of a rapamycin analog. The crystal can be a hydrate. dehydrate, solvate, or desolvate.

Abstract: An appliance for the delivery of at least one bioactive agent to the eye has at least one diffusion attenuator within a hydrophilic or silicone-hydrogel contact lens. The bioactive agent can be a drug or a nutraceutical. The diffusion attenuator can be a plurality of solid particles or phase separated liquid aggregates within at least one continuous phase of the lens where the diffusion attenuators promote a tortuous path for the diffusion of the bioactive agent to mediate the rate by which the bioactive agent diffuses from the contact lens. The diffusion attenuator can be homogeneously dispersed throughout at least one continuous phase of the lens to modify the diffusivity of the bioactive agent through that phase. The diffusion attenuator can have little or no affinity for the bioactive agent or can be miscible with the bioactive agent. The diffusion attenuator can be incorporated while forming the contact lens by polymerization of a monomer mixture containing the diffusion attenuator.

Abstract: A biobeneficial coating composition for coating an implantable device, such as a drug eluting stent, a method of coating the device with the composition, and an implantable device coated with the composition are provided.

Abstract: The invention relates to particles which exhibit a stimulable shape change and allow control of their uptake in active cells. The particles can be used as carrier systems for bioactive molecules or as diagnostic agents, and the spherical shape thereof has a size permitting uptake in a cell. Each particle assumes a temporary, non-spherical and thus non-uptakeable or only slightly uptakeable shape which can be transformed into a spherical and thus uptakeable shape by a suitable stimulus.

Abstract: The present invention relates to the use of a compound of formula (I), or a pharmaceutically acceptable salt, crystal form, complex, hydrate, or hydrolysable ester thereof, in the preparation of a medicament for treating a patient suffering from leukaemia, cancer or other proliferative disorder. A further embodiment relates to the use a compound of formula (I) in an assay for detecting the phosphorylation state of cellular substrates. The present invention also relates to novel compounds of formula (I), and the chemical synthesis thereof.

Abstract: Sustained release microparticles suitable for various types of drugs, or drug-containing sustained release microparticles capable of sustained release of drugs over a period of three days or more and capable of inhibiting initial burst release; a process for producing the same; and preparations containing the microparticles are disclosed. The drug-containing sustained release microparticles comprise a drug other than human growth hormone and a porous apatite derivative, and optionally include a water-soluble bivalent metal compound.

Abstract: This invention relates to novel glucocorticoid receptor agonists of formula (I): and to processes and intermediates for their preparation. The present invention also relates to pharmaceutical compositions containing these compounds, to their combination with one or more other therapeutic agents, as well as to their use for the treatment of a number of inflammatory and allergic diseases, disorders and conditions.

Abstract: The invention provides nanodevices or products of manufacture for use as drug delivery vehicles. In one aspect, the invention provides nanodevices or products of manufacture having on-off release mechanisms, e.g., that are “switchable”, or “actuatable” (for example magnetically or ultrasonically switchable), for compounds contained within, e.g., for use as drug delivery nano-vehicles having on-off drug release mechanisms, and their therapeutic applications.

Abstract: Microparticle comprising a cross-linked polymer comprising (a) a cross-linker comprising two or more radically polymerizable groups, preferably selected from the group consisting of alkenes, sulfhydryl (SH), thioic, unsaturated esters, unsaturated urethanes, unsaturated ethers, and unsaturated amides; (b) a monofunctional reactive diluent comprising maximum one unsaturated C—C bond represented by the formula R0—C(R1)?CHR2 Formula (I) wherein —R0 is chosen depending on the structure of a selected active agent (c) to be loaded into the microparticle and is chosen to have a structure that when combined with the other components of the microparticle provides a higher affinity of the selected active agent (c) for the microparticle; —each R1 is chosen from hydrogen and substituted and unsubstituted, aliphatic, cycloaliphatic and aromatic hydrocarbon groups which groups optionally contain one or more moieties selected from the group of ester moieties, ether moieties, thioester moieties, thioether moieties, carbamate

Abstract: The description discloses methods of enhancing or maintaining the viability or lifespan of platelets comprising administering an agent that down modulates apoptosis. The description also discloses a method of decreasing the survival, lifespan or viability of platelets comprising administering an effective amount of an agent that enhances apoptosis.

Abstract: Compositions comprising nanoparticles, such as silver or gold nanoparticles or carbon nanotubes (CNTs), and apoptotic agents are described. The nanoparticles can significantly enhance the cancer chemotherapeutic effects of the apoptotic agents. In particular, a highly increased anti-tumor activity has been demonstrated for the combination of etoposide and CNTs against HeLa cells compared to the administration of either etoposide alone or nanoparticles alone. Data provided by flow cytometry, Caspase 3 and other methods, suggest a strong interaction between the nanoparticles and the cellular structure, which can result in the improved effectiveness of chemotherapeutic agents. These findings provide potential new cancer therapies by carefully selecting the right combination of cytostatic drugs and nanostructural materials which synergistically provide significantly greater curative rates.

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: A solid, implantable dosage form comprising a therapeutically active agent in solid form, optionally with one or more pharmaceutically acceptable excipients, wherein the one or more excipients, when present, do not lead to a significant delay or prolongation of the release of active agent, as compared to an equivalent dosage form containing no excipients when tested in vitro.

Abstract: Nanocells allow the sequential delivery of two different therapeutic agents with different modes of action or different pharmacokinetics. A nanocell is formed by encapsulating a nanocore with a first agent inside a lipid vesicle containing a second agent. The agent in the outer lipid compartment is released first and may exert its effect before the agent in the nanocore is released. The nanocell delivery system may be formulated in pharmaceutical composition for delivery to patients suffering from diseases such as cancer, inflammatory diseases such as asthma, autoimmune diseases such as rheumatoid arthritis, infectious diseases, and neurological diseases such as epilepsy. In treating cancer, a traditional antineoplastic agent is contained in the outer lipid vesicle of the nanocell, and an antiangiogenic agent is loaded into the nanocore. This arrangement allows the antineoplastic agent to be released first and delivered to the tumor before the tumor's blood supply is cut off by the antiangiogenic agent.

Abstract: The present invention is drawn to adhesive solidifying formulations, methods of drug delivery, and solidified layers for dermal delivery of a drug. The formulation can include a drug, a solvent vehicle, and a solidifying agent. The solvent vehicle can include a volatile solvent system comprising at least one volatile solvent, and a non-volatile solvent system comprising at least one non-volatile solvent, wherein at least one non-volatile solvent is a flux-enabling non-volatile solvent(s) capable of facilitating the delivery of the drug at therapeutically effective rates over a sustained period of time. The formulation can have a viscosity suitable for application to a skin surface prior to evaporation of the volatile solvents system. When applied to the skin, the formulation can form a solidified layer after at least a portion of the volatile solvent system is evaporated.

Abstract: Biodegradable polymeric microparticle compositions containing one or more active agents, especially those useful for treating or preventing or one or more diseases or disorders of the eye, and methods of making and using thereof, are described. The microsphere compositions release an effective amount of the one or more active agents for a period greater than 14 days in vivo, preferably greater than 60 days in vivo, more preferably up to 73 days in vivo, more preferably greater than 90 days in vivo, even more preferably over 100 days in vivo, and most preferably greater than 107 days in vivo. In a preferred embodiment, the microparticle compositions contain one or more active agents useful for managing elevated intraocular pressure (TOP) in the eye. In one embodiment, the microspheres are formed from polylactide-co-glycolide (“PLGA”); in another embodiment, the microspheres are formed from a blend PLGA and poly lactic acid (“PLA”).

Abstract: The instant invention provides methods and compositions for the treatment of cancer.

Abstract: A new topical formulation is provided, with a high chemical stability, of for example a low dose clobetasol propionate, suitable for the topical treatment of skin and mucous membrane conditions associated with disorders including psoriasis, eczema, and other forms of dermatitis and also topical use associated with the mouth, such as lichen planus. The formulation includes an aqueous vehicle of based on propylene glycol as a solvent and moisture-retaining agent, and macrogol-glycerol hydroxystearate as a non-ionic emulsifier, being capable of holding surprisingly low concentrations of clobetasol. The vehicle holds concentrations about 0.005% to about 0.05% by weight of 17-clobetasol propionate, more preferably about 0.02 to 0.025%, even more preferably 0.025% by weight of 17-clobetasol propionate. The formulation has a good chemical stability, resulting in a long durability.

Abstract: An inhalable dry powder medicament is provided. The medicament, which provides improved fine particle fraction, may be prepared by (i) fractionating a particulate active ingredient based on aerodynamic particle size, (ii) recovering at least one fraction of the particulate active ingredient and (iii) combining the recovered fraction with a carrier to provide the inhalable dry powder medicament.

Abstract: Compositions and methods for alleviating the symptoms associated with chronic fatigue syndrome and fibromyalgia syndrome are provided. The compositions are based on use of a transdermal gel formulation delivery system for androgens, either alone or in combination with other hormones.

Abstract: The present invention relates to a nanowire array (15, 16) for electrically-controlled elution of a therapeutic composition (5) comprising a plurality of nanoscopic-sized wires (12, 12), nanowires, attached to an electrically conducting solid support (7), said nanowires formed from electroactive conjugated polymer (4) containing or doped with said therapeutic composition (5) coated over a plurality of nanoscopic sized electrically conducting protrusions (8). It also relates to a method for preparing a nanowire array and an electrode.

Abstract: The invention concerns a foaming composition for washing and treating hair and/or scalp essentially characterised in that it contains in an aqueous medium: at least an active principle selected among corticoids and retinoids; at least an anionic surfactant; at least an amphoteric surfactant; and a pro-penetrating

Abstract: The present invention comprises a composition, method of enhancing potency and method of delivering corticosteroids in a vehicle comprising at least two penetration enhancers, and solvents and emulsifiers. The propylene glycol and penetration enhancers are present in ratio to the total of the propylene glycol, penetration enhancers, and solvents and emulsifiers of at least about 0.70.

Abstract: A peptide of the structural formula: or a pharmaceutically acceptable salt thereof, wherein R1, R2, R3, R4, R5, R6, m and n are as defined. Further provided are methods for treatment of sexual dysfunction, including erectile dysfunction and female sexual dysfunction, and combination drugs and method of use thereof, including a peptide of the invention and one or more second sexual dysfunction pharmaceutical agents.

Abstract: A respiratory dispersion is provided for the pulmonary delivery of at least two bioactive agents. The dispersion comprises a propellant suspension medium having dispersed therein a plurality of perforated microstructures, wherein the two bioactive agents are incorporated into individual perforated microstructures.

Abstract: The present invention refers to the treatment of asthma by administering a delayed-release dosage form of a glucocorticoid to a subject in need thereof.

Abstract: An aqueous pharmaceutical composition which is capable of being sprayed into the nasal cavity of an individual and which comprises: (A) a pharmaceutically effective amount of solid particles of medicament which is effective in treating a bodily condition by virtue of its being present on the mucosal surfaces of the nasal cavity; and (B) a suspending agent in an amount effective to maintain said particles dispersed uniformly in the composition and to impart to the composition the following thixotropic properties: (i) the viscosity of the position in unsheared form is relatively high, with the composition being in gel-like form; (ii) as the composition is subjected to shear (shaken) in preparation for spraying, the viscosity of the composition becomes relatively low and such that the composition in the form of a mist flows readily into the nasal passages for deposit on the mucosal surfaces of the nasal cavity; and (D) in deposited form on the mucosal surfaces, the viscosity of the composition is relatively high

Abstract: A process for improving the penetration of at least one pharmaceutical active agent into the skin, including formulating at least one volatile silicone, a non-volatile oily phase and a pharmaceutically acceptable alcoholic vehicle herewith, and spraying the formulation onto the skin of an individual in need of such treatment.

Abstract: Provided herein are methods for treating the symptoms of and inflammation associated with gastroesophageal reflux disease (GERD) and other conditions. Also provided herein are pharmaceutical compositions useful for the methods of the present invention.

Abstract: The invention provides a multi-compartmented container suitable for the delivery of pharmaceuticals, medicines, vitamins, and the like.

Abstract: The present invention comprises a composition, method of enhancing potency and method of delivering corticosteroids in a vehicle comprising at least two penetration enhancers, and solvents and emulsifiers. The propylene glycol and penetration enhancers are present in ratio to the total of the propylene glycol, penetration enhancers, and solvents and emulsifiers of at least about 0.70.

Abstract: The present invention discloses a method of treating an individual having irritable bowel syndrome or a related disorder, comprising the step of administering to said individual a pharmacologically effective dose of a luminally active anti-inflammatory or immunosuppressive compound with minimal or no systemic side effects. Further provided is a method of inhibiting the onset of symptoms of irritable bowel syndrome or a related disorder in an individual in need of such treatment, comprising the step of administering to the individual a prophylactically effective dose of a luminally active anti-inflammatory or immunosuppressive compound with minimal or no systemic side effects.