Abstract: Agents, kits, and methods that utilize oxygenation to treat Inflammatory Bowel Disease (IBD) and/or provide prophylaxis against exacerbation of IBD are provided. In several embodiments, the agents, kits, and methods according to several embodiments generate in, or carry to, oxygen in the intestinal lumen to treat IBD and provide prophylaxis against exacerbation of IBD, including those caused by the presence of anaerobic bacteria in the intestine. The agents, kits, and methods provided herein generate an aerobic environment within the intestine to alleviate intestinal inflammation.

Abstract: Agents, kits, and methods that utilize oxygenation to treat Inflammatory Bowel Disease (IBD) and/or provide prophylaxis against exacerbation of IBD are provided. In several embodiments, the agents, kits, and methods according to several embodiments generate in, or carry to, oxygen in the intestinal lumen to treat IBD and provide prophylaxis against exacerbation of IBD, including those caused by the presence of anaerobic bacteria in the intestine. The agents, kits, and methods provided herein generate an aerobic environment within the intestine to alleviate intestinal inflammation.

Abstract: Disclosed herein are drug delivery devices and methods for the treatment of ocular disorders requiring targeted and controlled administration of a drug to an interior portion of the eye for reduction or prevention of symptoms of the disorder. The devices are capable of controlled release of one or more drugs and may also include structures which allow for treatment of increased intraocular pressure by permitting aqueous humor to flow out of the anterior chamber of the eye through the device.

Abstract: Agents, kits, and methods that utilize oxygenation to treat Inflammatory Bowel Disease (IBD) and/or provide prophylaxis against exacerbation of IBD are provided. In several embodiments, the agents, kits, and methods according to several embodiments generate in, or carry to, oxygen in the intestinal lumen to treat IBD and provide prophylaxis against exacerbation of IBD, including those caused by the presence of anaerobic bacteria in the intestine. The agents, kits, and methods provided herein generate an aerobic environment within the intestine to alleviate intestinal inflammation.

Abstract: The present disclosure is directed to methods of treating neurological disorders in a patient such as Parkinson's disease, drug-induced extrapyramidal reactions, and/or levodopa-induced dyskinesia comprising administering to the patient once daily in the morning a pharmaceutical composition comprising about 50 mg to about 400 mg of extended-release amantadine or a pharmaceutically acceptable salt thereof.

Abstract: The present invention generally relates to improved methods for the manufacture of inhalation powders. More particularly, aspects of the disclosure relate to methods for in-line monitoring of powder blending by Raman spectroscopy.

Abstract: A method for reducing odor, by providing a colloidal dispersion of particles of silica having a particle size of from 3 nm to 100 nm, said particles having ions of one or more metals selected from copper, silver, zinc and iron adsorbed at the particle surface, and bringing at least one of said particles into contact with an odorous compound; and/or providing an aqueous silicate solution containing metal ions selected from ions of copper, silver, zinc and iron, and bringing at least one metal ion-carrying silicate particle formed in the solution into contact with an odorous compound. A composition for use in such a method and a product treated by such a composition.

Abstract: A method of forming an ocular delivery device includes exposing a solid, shaped cellulose polymer to a solution including an active pharmaceutical ingredient (API) and a solvent capable of solubilizing the API, wherein the polymer absorbs at least a portion of the solution, including the API and solvent. The method may further include removing at least a portion of the absorbed solvent from the polymer by allowing the absorbed solvent to evaporate from the polymer or by drying the polymer. A variety of cellulose polymers may be used, including hydroxypropyl cellulose. A variety of APIs may be used, including Cyclosporine, Tobramycin and Vancomycin. Ocular delivery devices prepared by the methods may be used to treat a variety of eye disorders.

Abstract: Gastric residence systems comprising therapeutic agent formulations for sustained gastric release of therapeutic agents are disclosed, as well as methods for using such systems. The systems are characterized by use of a dispersant in the formulations, which improves the burst release characteristics and long-term release rate characteristics of the systems. Milling of therapeutic agent can also be performed to prepare agent particles of desired size.

Abstract: Methods of reducing injury to crop foliage and achieving weed control using encapsulated acetamide herbicides in pre-plant or preemergence crop plant applications are described. A composition comprising a first population of a particulate microencapsulated acetamide herbicide and a second population of a particulate microencapsulated acetamide herbicide is described wherein the application mixture exhibits a bimodal acetamide release profile. The compositions provide reduced crop injury through controlled herbicide release.

Abstract: Self-regulating, osmotic, floating gastroretentive compositions that provide extended release, delayed release, and/or delayed extended release of active pharmaceutical agents, as well as, optionally, immediate release of the same or a different active pharmaceutical agent, are provided here. The gastroretentive compositions of the disclosure comprise a swellable, extended release, multilayer core comprising a push layer and a pull layer; a water-insoluble permeable elastic membrane surrounding the multilayer core; and an orifice (e.g., a laser-drilled orifice, a manually drilled orifice) on the pull-layer side of the dosage form. The gastric retention of the composition is controlled by rapid floating of the composition and expansion of the membrane.

Abstract: The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. The programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, gastric motility, and volume and viscosity of gastric fluid. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm, e.g., that matches the human circadian rhythm of a condition's symptoms and/or of the individual being treated in the application of the therapy to optimize therapeutic outcome and minimize side effects.

Abstract: An oral pharmaceutical composition in unit dosage form comprising: (1) a first portion comprising: an active ingredient and a pH-dependent component, and (2) a second portion comprising a pH-raising agent is provided. Methods of administering the composition are also provided.

Abstract: An ingestible device, includes a storage reservoir configured to store a dispensable substance and a pressurized chamber configured so that, when a restraining force is removed from the pressurized chamber, the dispensable substance exits the ingestible device via openings in the ingestible device.

Abstract: The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. In certain embodiments, the programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, and volume of gastric fluid. The programmable osmotic-controlled oral compositions of the disclosure comprise a multilayer core comprising a drug for controlled release, wherein the core is coated with a semipermeable membrane comprising an orifice and, optionally, an immediate release coating, comprising a drug for immediate release, over the semipermeable membrane. The multilayered core comprises a pull layer containing the drug and a push layer.

Abstract: A method for the preparation of respirable zafirlukast monohydrate particles comprises the steps of preparation of an aqueous suspension of amorphous zafirlukast; size-reduction with conversion of the suspended zafirlukast into crystalline monohydrate nanoparticles; and isolation of the crystalline zafirlukast in the form of a dry powder. Also provided are zafirlukast respirable particles characterized by comprising crystalline monohydrate zafirlukast. Pharmaceutical compositions comprising the particles are also disclosed, as is the use of the particles or compositions for the treatment of respiratory diseases.

Abstract: A vibratory treatment device has a motor driving an output shaft on which is mounted an eccentric weight to create vibration of the motor as the shaft rotates. A frame is connected to the motor to which frame said vibrations are transmitted through the connection of the frame to the motor. A pad surrounds the frame and into which said vibrations of the frame are transmitted. The pad is applied to the affected limb or limbs of the patient and activated to cause vibrations of the motor to be transmitted through the frame and pad into the tissue of the patent's limb or limbs. The treatment is continued for a therapeutically effective period of time and repeated periodically.

Abstract: The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. The programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, gastric motility, and volume and viscosity of gastric fluid. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm, e.g., that matches the human circadian rhythm of a condition's symptoms and/or of the individual being treated in the application of the therapy to optimize therapeutic outcome and minimize side effects.

Abstract: A device for sustained delivery of a poorly water soluble drug is described. A drug reservoir within the device, when in operation, contains an aqueous suspension of the drug mixed with a suspension of an excipient that, in one embodiment, generates acidic groups for a sustained period of time to maintain a desired pH in the aqueous suspension that in turn provides a constant concentration of a soluble form of the drug.

Abstract: Self-regulating, osmotic, floating gastroretentive compositions that provide extended release, delayed release, and/or delayed extended release of active pharmaceutical agents, as well as, optionally, immediate release of the same or a different active pharmaceutical agent, are provided here. The gastroretentive compositions of the disclosure comprise a swellable, extended release, multilayer core comprising a push layer and a pull layer; a water-insoluble permeable elastic membrane surrounding the multilayer core; and an orifice (e.g., a laser-drilled orifice, a manually drilled orifice) on the pull-layer side of the dosage form. The gastric retention of the composition is controlled by rapid floating of the composition and expansion of the membrane.

Abstract: Methods of reducing undesirable side effects during therapeutic treatment using monomethyl fumarate and prodrugs of monomethyl fumarate are disclosed.

Abstract: The present disclosure provides programmable osmotic-controlled oral compositions providing delayed release of a therapeutically acceptable amount of a drug. The programmable osmotic-controlled compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, gastric motility, and volume and viscosity of gastric fluid. The compositions of the disclosure can be programmed to provide a desired and precise lag time, and release drug, after the lag time, at a rhythm, e.g., that matches the human circadian rhythm of a condition's symptoms and/or of the individual being treated in the application of the therapy to optimize therapeutic outcome and minimize side effects.

Abstract: The present invention provides methods for producing a lyophilized degarelix product which, upon reconstitution with water for injection in an amount of 20 mg/ml, shows a viscosity of up to 15 mPas. The present invention also provides a lyophilized degarelix drug substance which shows, upon dissolution in water in an amount of 20 mg/ml, a viscosity of up to 3.2 mPas, and processes for providing this lyophilized degarelix drug substance.

Abstract: This invention relates to the use of a parenteral formulation comprising the NNRTI TMC278 for the long term prevention of HIV infection in a subject at risk of being infected by HIV, which comprises the intermittent administration of the said formulation at long time intervals.

Abstract: Disclosed in the present invention are a composition containing lutein/lutein ester and applications thereof. Components of the composition containing lutein/lutein ester comprise lutein/lutein ester, ?-carotene and a pharmaceutically acceptable carrier. The weight ratio of lutein/lutein ester to ?-carotene is 1:0.1-100. In the present invention, by cooperatively using lutein/lutein ester and ?-carotene and using auxiliary natural healthy ingredients, the dosage form of an orally disintegrating tablet is prepared. The orally disintegrating tablet is absorbed through the oral cavity, has fast effectiveness and small first-pass effect, reduces damage of gastric acid to lutein/lutein ester, has high bioavailability, and has the characteristics of nutritional and health-care effects, good mouthfeel and fast absorption.

Abstract: A composition which comprises substance represented by Formula (I), [Meanings of the symbols that are included in the formula are given in the specification as definitions] a pharmaceutically acceptable carrier, and a dissolution aid.is useful for improving solubility, oral absorbability and/or absorbability in blood of a poorly water-soluble or water insoluble tetracyclic compounds having an ALK inhibitory activity that are useful as a prophylactic and/or therapeutic agent for cancer, depression, and cognitive function disorder.

Abstract: The invention provides a topical liquid antifungal composition containing an antifungal agent, a film-forming agent and a solvent. The composition is applied on the infected skin area to form a film that delivers the active agent. The invention also provides a method for treating a fungal infection on the skin by applying the topical antifungal composition that forms a film on the skin.

Abstract: The present invention provides drug therapy formulations for reducing the side effects associated with a therapeutic. In some embodiments, the present invention provides a reduction in sleep- and diet-related side effects associated with a therapeutic.

Abstract: A disinfectant appliance has a plurality of chlorite absorbent particles, a plurality of redox resin particles, and at least one absorbent material combined such that the absorbent material allows and can promote: infusion of water into the disinfectant appliance; release of the chlorite from the chlorite absorbent particles into the water to form a chlorite comprising solution; contacting of the chlorite comprising solution with the redox resin particles; and the expulsion of ClO2 comprising solution from the disinfectant appliance onto a surface to be disinfected. The disinfectant appliance can include a storage section and can include a handle. The disinfectant appliance can be in the form of a wipe or sponge that can be contacted with a surface suspected of being infected.

Abstract: The composition containing a pamoate salt of donepezil, the method of preparation and the use thereof are disclosed.

Abstract: A portable drug dispenser includes a chamber for holding a plurality of separately contained drug products, a dispensing mechanism for dispensing one or more of the plurality of drug products, and may optionally include a processor to determine the time of each activation of the dispensing mechanism and to transmit the determined time of activation to a computer located remote to the dispenser. The dispenser may include more than one chamber for holding drugs.

Abstract: An oral melatonin pharmaceutical dosage form that contains a sustained release dose of melatonin includes melatonin and an acid dispersed in a hydrogel-forming polymer matrix that combine after ingestion to form an acidic hydrogel containing the melatonin. The dosage form is effective to release melatonin therefrom for at least six hours after oral ingestion.

Abstract: The present invention relates to medical devices containing time-release drug substance, and more particularly, to medical tubing, catheters, stents, cables (including fiber optic cables), pills, capsules, sheaths, threads, clamps, sutures, and endotracheal devices. The invention also generally relates to a method for extruding multiple laminated flow streams using microlayer coextrusion to create these various time-release drug delivery products.

Abstract: The present invention provides a sustained release oral dosage form containing dalfampridine that can be administered once daily. The dosage form includes dalfampridine as the active pharmaceutical ingredient and the excipients comprising osmotic agents in a tablet core. The sustained release oral dosage form of the present invention can be administrated once daily and can provide a proper fluctuation index to reduce undesired adverse effect, prevent alcohol-induced dose dumping and release drug at a rate sufficient to maintain certain drug plasma concentration.

Abstract: Disclosed in certain embodiments is a dosage form comprising a plurality of extruded particles comprising an adverse agent or antagonist and a layer disposed about the particles.

Abstract: A tablet for the controlled release of a drug. The tablet is in the form of an asymmetrically coated tablet so that immediate release or time-delayed release times can be precisely controlled and the extended release slab may provide zero-order or first-order extended release and pulsatile release depending on the excipients used in the tablet formulations. The core of the tablet is coated with an asymmetrical coating, that is, a coating with regions having different properties. The coatings may include drugs in varying concentrations. Further, different regions of the coating may have different rates of dissolution. The core of the tablet may be provided with a constant cross-sectional area along a longitudinal length of the tablet, a coating having a first region with a more rapid rate of dissolution than a second region. The dissolution of the first region exposes only the cross-sectional area to the dissolution medium.

Abstract: The present invention relates to compounds characterized by having a structure according to the following Formula I: or a pharmaceutically acceptable salt thereof. Compounds of the present invention are useful for the treatment or prevention of HIV.

Abstract: In some embodiments, the present invention provides compositions that comprise: (1) a biodegradable polymer matrix; and (2) at least one biodegradable reinforcing particle that is dispersed in the matrix. In some embodiments, the biodegradable reinforcing particle is selected from the group consisting of porous oxide particles and porous semiconductor particles. In additional embodiments, the compositions of the present invention further comprise a (3) porogen particle that is also dispersed in the matrix. In further embodiments, the compositions of the present invention are also associated with one or more active agents. In various embodiments, the active agents are associated with the biodegradable polymer matrix, the biodegradable reinforcing particle, and/or the porogen particle. In various embodiments, the compositions of the present invention may be utilized as scaffolds, such as scaffolds for treating bone defects.

Abstract: The present invention relates to a pharmaceutical dosage form comprising an active ingredient combination of nifedipine or nisoldipine and at least one angiotensin II antagonist and/or at least one diuretic, characterized in that nifedipine or nisoldipine is released in the body in a controlled (modified) manner and the angiotensin II antagonist and/or the diuretic is released rapidly (immediate release (IR)), and also to processes for their preparation, to their use as medicaments and to their use for the prophylaxis, secondary prophylaxis or treatment of disorders.

Abstract: There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

Abstract: The present disclosure relates to novel dosage forms of xanthine oxidoreductase inhibitors.

Abstract: Provided is a die roll for manufacturing softgels, a softgel, and methods for producing a softgel. The die roll includes a die roll surface and a pocket defined therein. The pocket includes a floor, an interior sidewall surface, a chamfer, and an exterior sidewall surface. The floor is recessed relative to the die roll surface and the interior sidewall surface is connected to the floor and extends above the die roll surface to the chamfer. The pocket also includes a landing surface that is elevated from the die role surface and connects the chamfer to the exterior sidewall surface of the pocket. The landing surface includes a taper (such that the landing surface tapers inwardly towards the pocket floor) and a radius (such that the landing surface is not flat). Also provided is a softgel having a trailing edge thickness that is at least about 40% the thickness of the softgel wall thickness.

Abstract: The present invention relates to controlled-release pharmaceutical dosage forms comprising a solid dispersion of a poorly water-soluble or insoluble drug with improved solubility and thus improved dissolution in an aqueous medium. The invention further discloses a process of preparation of these controlled-release dosage forms.

Abstract: A pharmaceutical composition comprises nanoparticles comprising a poorly water-soluble drug and a poorly aqueous soluble polymer, and a resuspending material selected from the group consisting of hydroxypropyl methyl cellulose acetate succinate, carboxymethyl ethylcellulose, and pharmaceutically acceptable salt forms thereof.

Abstract: The group of inventions relates to the field of organic chemistry and can be used for cleaning water, industrial and domestic waste water or waste water sediment, and for the containment and recovery of petroleum and petroleum product spills in large bodies of water, rivers, lakes and seas. In the claimed group of inventions, aqueous solutions of polysaccharide microgels, having a molecular mass of 20000-200000 daltons and a particle size of 50-600 nm, are used as a substance for cleaning water of petroleum and petroleum products. Moreover, low concentrations of polysaccharide microgels in water, ranging from 0.1 to 20 g/l, are used. Said solutions are used as a surface modifier for a filter used in separating water-oil emulsions, as a sorbent for the containment and recovery of oil spills in an aqueous medium, and also as a coagulant for the cleaning of water polluted by petroleum and petroleum products.

Abstract: The present invention is concerned with novel pharmaceutical compositions of itraconazole which can be administered to a mammal suffering from a fungal infection, whereby a single such dosage form can be administered once daily, and in addition at any time of the day independently of the food taken in by said mammal. These novel compositions comprise particles obtainable by melt-extruding a mixture comprising itraconazole and an appropriate water-soluble polymer and subsequently milling said melt-extruded mixture.

Abstract: Layered pharmaceutical composition suitable for oral use in the treatment of diseases where absorption takes place over a large part of the gastrointestinal tract. The composition comprising A) a solid inner layer comprising i) an active substance, and ii) one or more disintegrants/exploding agents, one of more effervescent agents or a mixture thereof.

Abstract: Controlled release dosage forms comprising a pharmaceutically active agent capable of not more than 90% release in 12 hours in a simulated gastric juice in first order release rate USP type 1 dissolution test, comprising (a) a tablet made from polymer matrix of at least two biocompatible polymers, the pharmaceutically active agent and excipients; the tablet capable of rapid swelling without disintegration in simulated gastric juice to a size resulting in gastric retention in the stomach and controlled release of the active agent by controlled erosion and diffusion immediately after coming into contact with the gastric juice, or (b) microspheres of ungrafted chitosan or a chitosan derivative or CARBOPOL® incorporating the active agent which is not a polymeric molecule and after administration in stomach, the microspheres adhere to the gastric mucosa for a long and controlled time release of the active agent.

Abstract: The present invention provides drug therapy formulations. In some embodiments, the present invention provides combinations of pharmaceutical agents (e.g., stimulant and non-stimulant), pharmaceutical formulations (e.g., nanoparticualte, non-nanoparticualte, etc.), and release profiles (e g, immediate release, delayed release, sustained release, etc.) to provide therapeutic benefit with reduced side effects.

Abstract: In one aspect, pharmaceutical compositions comprising dispersions of an acid-sensitive drug and a neutral dispersion polymer are disclosed. The acid-sensitive drug has improved chemical stability relative to dispersions of the drug and acidic polymers. In another aspect, pharmaceutical compositions of low-solubility drugs and amphiphilic, hydroxy-functional vinyl copolymers are disclosed.