Abstract: A device for simulating a chemosenzation of smoking includes an outer layer, a porous medium and a chemesthetic agent. The porous medium is disposed within the outer layer. The chemesthetic agent is disposed within the porous medium and activates a TRP channel.

Abstract: The present invention provides a composition comprising zinc and trimethoprim, particularly in a weight ration of about 1:3 to about 1:7, as well as a sustained- or prolonged-release preparation which comprises trimethoprim and zinc and a biodegradable polymer providing a clinically useful composition which has prolonged release over a long period of time.

Abstract: The present invention relates to protein biocoacervates and biomaterials vessel graft systems used in cardiovascular applications and other medical applications, the components utilized in the vessel graft systems and the methods of making and using such systems. More specifically the present invention relates to protein biocoacervates and biomaterials vessel graft systems used in various medical applications and/or the devices used in such vessel graft systems including, but not limited to, vessel grafts as drug delivery devices for the controlled release of pharmacologically active agents, tubular grafts, vascular grafts, protein biomaterial sutures and biomeshes, protein biomaterial adhesives and glues, and other biocompatible biocoacervate or biomaterial devices used in the vessel graft systems of the present invention.

Abstract: An exhausted-tobacco lozenge provided herein includes a body that is partially or wholly receivable in an oral cavity. The body includes a soluble-fiber matrix, exhausted-tobacco fiber, and one or more additives (e.g. nicotine or a derivative thereof) dispersed in the soluble-fiber matrix. In some cases, an exhausted-tobacco lozenge provided herein includes at least 40 weight percent of soluble fiber. In some cases, soluble fiber in exhausted-tobacco lozenge provided herein can include maltodextrin. The exhausted-tobacco lozenge is adapted to release the nicotine or a derivative thereof from the body when the body is received within the oral cavity of an adult tobacco consumer and exposed to saliva. A method of making exhausted-tobacco lozenges provided herein includes forming a molten mixture of at least 40 weight percent soluble fiber, exhausted-tobacco fiber, one or more additives (e.g., nicotine), and less than 15 weight percent water while maintaining a mixture temperature of less than 150° C.

Abstract: The chronic use of p-adrenergic inverse agonists such as nadolol, carvedilol, and ICI-118,551 provides an improved method for the treatment of mucus hypersecretion in subjects with such mucus hypersecretion. One aspect of a method according to the present invention is a method of preventing or controlling mucus hypersecretion in the respiratory tract comprising administering a therapeutically effective quantity of a p-adrenergic inverse agonist to a subject with mucus hypersecretion or at risk of mucus hypersecretion. The invention further encompasses pharmaceutical compositions comprising the p-adrenergic inverse agonist and the additional compound.

Abstract: The invention relates to a method for the manufacture of a pressurized Metered Dose Inhaler (pMDI) and components for use in said method, in particular, a pMDI compatible tablet (i.e. one that is able to be dispersed or disintegrates within a liquid phase, such as a propellant, used in a pMDI formulation) which contains at least one active pharmaceutical ingredient (API) and, optionally, one or more excipients.

Abstract: The present invention concerns particles containing at least one covalently cross-linked polysaccharide and at least one growth factor, a method of preparation, and uses thereof.

Abstract: A portioned moist tobacco product with a super-hydrated membrane coating and method of manufacturing is disclosed. The super-hydrated membrane coating is formed by ionic cross-linking using two polymers. The soluble component of the super-hydrated membrane coating dissolves upon placement in the mouth, while the insoluble component maintains the tobacco within the coating for the duration of the use of the product. The moist tobacco product is soft and flexible so as to fit comfortably in an oral cavity when placed therein.

Abstract: The described invention provides a topical bioadhesive film-forming pharmaceutical composition formulated for application directly to skin or to a substrate. The composition includes a therapeutic amount of an active agent; and one or more excipients selected from the group consisting of a non-cellulosic polymer or copolymer, a film forming agent, a plasticizer, a permeation enhancer, an antioxidant, a preservative, a solubilizer, a phase transfer catalyst, a viscosity modifier, a vitamin, a mineral nutrient, a solvent, a colorant and a fragrance. It further provides a delivery system comprising the composition and a means for administering the composition. It also describes uses of the delivery system in the manufacture of a medicament for treating a skin condition, disease or disorder, and a method for treating a skin condition, disease or disorder with the composition. The composition is characterized by: controlled release.

Abstract: The invention relates to a transdermal therapeutic system (TTS), which is suited for the administration of a peptide to a patient through skin treated with ablation. The transdermal therapeutic system includes a back layer and an active substance-containing layer that contains at least one peptide and a carrier substance, preferably as a textile web material.

Abstract: The present invention provides a new forms of (R)-N-methylnaltrexone, and compositions thereof, useful as a peripheral mu opioid receptor antagonist.

Abstract: An intranasal spray device contains a composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (Cmax) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.

Abstract: The invention provides amphiphilic biocompatible copolymers which have a hydrophilic backbone and pendant hydrophobic groups. The polymers form nanoscale molecular aggregates in aqueous environments, which have hydrophobic interiors within which anticancer drugs may be solubilized. The polymers optionally feature attached antibodies, receptor ligands, and other targeting moieties which mediate adherence of the drug-carrying aggregates to targeted cancer cells.

Abstract: The present invention relates to compounds of formula (I) or pharmaceutical acceptable salts, wherein R1, R2, R3, R4, and B are defined in the description. The present invention relates also to compositions containing said compounds which are useful for inhibiting kinases such as wee-1 and methods of treating diseases such as cancer.

Abstract: Improved pharmaceutical solid oral film dosage forms for the buccal and/or sublingual delivery of pharmaceutical, nutraceutical or cosmetic ingredients are endowed with instant hydration potential and complete dissolution potentially enabling the active ingredient to become immediately available for enhanced buccal and/or sublingual absorption and/or reduced absorption through the gastrointestinal route. The improved delivery systems for solubilizing and stabilizing pharmaceutically active ingredients exhibit enhanced stability by the use of a combination of crystallization inhibitors, which together can maintain the active ingredient in a desired plurality of particles in an effective size range within a polymeric film matrix.

Abstract: A troche comprising at least 5 mg hyaluronan, wherein the troche is adherent, and wherein hyaluronan is released from the troche, is used to treat mucositis, including stomatitis, vestibulitis, aphthous ulcerations, lichen planus and Behcet's syndrome. A method for treating or preventing mucositis in a patient is provided, comprising applying to a mucosal surface or a tooth or orthodontic brace of a patient in need thereof an adhering troche comprising at least 5 mg hyaluronan.

Abstract: A surgical implant includes at least two porous film layers each having a plurality of pores. The porous film layers are in a stacked configuration and are interconnected to one another at a plurality of attachment points to define at least one void between the porous film layers.

Abstract: The present invention concerns a composition comprising micro particles of polyinosinic-polycytidylic acid (Poly (I:C)) and a carrier polymer selected from starch, alginate, blanose or DPPC (dipalmitoylphosphatidylcholine) for use in preventing and/or treating viral infections of the upper respiratory tract or the common cold and a device, preferably a nasal delivery system, comprising said composition for use by a patient in need to prevent and/or treat infections or the common cold.

Abstract: Provided is a method for preventing or treating sinusitis by administering a therapeutically effective amount of an oxidative reduction potential (ORP) water solution that is stable for at least about twenty-four hours. The ORP water solution administered in accordance with the invention can be combined with one or more suitable carriers. The ORP water solution can be administered alone or, e.g., in combination with one or more additional therapeutic agents.

Abstract: A method for treating at least one of neuro-olfactory triggered illnesses, and related conditions within a subject is provided. The method includes the steps of: a) providing a composition that includes one or more agents adapted to induce a level of anosmia/hyposmia in the subject, which level of anosmia/hyposmia is sufficient to substantially decrease olfactory sensory stimulation within the subject and a neurologic response to the stimulation that is one or both of triggering and aggravating the illness or condition; and b) applying the composition to a nasopharynx region of the subject.

Abstract: A smokeless tobacco product is provided that includes a tobacco material in the form of a tobacco extract, a particulate tobacco material, or a combination thereof. In some embodiments, the smokeless tobacco product is substantially translucent. Methods for making and using the smokeless tobacco product are also provided. The smokeless tobacco product can include isomalt, maltitol syrup, particulate tobacco, and a translucent tobacco extract prepared by ultrafiltration.

Abstract: Embodiments of the invention relate to particles of active substances, methods for preparing the particles, formulations containing the particles, and metered dose inhalers containing such particles or formulations. In one embodiment, a composition of an aerosol formulation is provided and contains a particulate active substance of non-micronized, solid particles having a mass median aerodynamic diameter of less than 10 ?m suspended in a hydrofluorocarbon fluid vehicle at a concentration within a range from about 0.2% w/v to about 5% w/v. The aerosol formulation exhibits a flocculation volume of about 85% or greater about 1 minute after mixing the particulate active substance and the hydrofluorocarbon fluid vehicle. The particulate active substance contains an alkaloid ergotamine, pharmaceutically acceptable salts thereof, analogs thereof, or derivatives thereof.

Abstract: The layered drug delivery devices of the present invention have an outer side and an inner side. The device includes, in order from the outer side to the inner side, a first layer and a second layer. The first layer wherein the first layer is water insoluble, water swellable, and water permeable. The second layer includes a therapeutic amount of a water soluble drug and a water soluble mucoadhesive film. The second layer is disposed such that water passing through said first layer solubilizes the drug. The said solubilized drug then can permeate through a mucosal membrane when the inner side is in contact with the mucosal membrane. The drug delivery device is in sheet form.

Abstract: This invention provides a safe and effective agent for ameliorating chronic obstructive pulmonary disease (COPD) that has both a bronchodilator effect and an anti-inflammatory effect. The agent for ameliorating chronic obstructive pulmonary disease contains mepenzolate bromide as an active ingredient. More preferably the mode of administration of the agent for ameliorating chronic obstructive pulmonary disease is airway administration or inhalation administration, and furthermore the mode of administration thereof is oral administration or rectal administration. This invention is a safe and effective agent for ameliorating chronic obstructive pulmonary disease (COPD) that has both a bronchodilator effect and an anti-inflammatory effect of mepenzolate bromide.

Abstract: The present invention relates to the field of viral disorders, and in particular to the use of natural compounds to inhibit viruses and viral infection. Compositions comprising NGNA are provided for treating or preventing viral infections, such as those causing the common cold.

Abstract: This invention relates to pharmaceutical dosage forms, particularly to pH dependent pharmaceutical dosage forms with enhanced and/or prolonged distribution of a pharmaceutical compound at a target site. More specifically, this invention relates to a controlled release intravaginal pharmaceutical dosage form and, more particularly, to a pharmaceutical dosage form which comprises microspheres encapsulated and/or embedded within a bioerodible polymeric matrix, together the microspheres and the matrix are formed into a caplet and/or tablet.

Abstract: The present invention provides a pharmaceutical composition for sublingual or buccal administration of actives with low to poor aqueous solubility, e.g. the indole hormone melatonin, which contains a solution of the active in a pharmaceutically acceptable solvent adsorbed or absorbed onto particles of a pharmaceutically acceptable carrier and methods of preparing and using the pharmaceutical composition.

Abstract: Provided are supplemental compositions for a nutraceutical formulation and methods for administering the same to a user for inducing or maintaining sleep as well as for alleviating pain to improve sleep using a formulation of ingredients comprising of extract of ashwagandha, extract of lavender, extract of valerian, extract of hops, melatonin, magnesium, vitamin B12, and zinc, and/or devil's claw, bromelain and boswellia.

Abstract: Disclosed are preparations and formulations of high thermodynamic activity lipophilic associations (LA), in which there is pairing between an ionizable pharmaceutical agent and a lipophilic species having ionic characteristics opposite to that of the pharmaceutical agent. Such lipophilic associations manifest high thermodynamic activity, as evidenced by their being predominantly in a liquid phase at room temperature or solvated in a lower-than-water dielectric solvent. Further the pharmaceutical agent being solubilized means that dissolution is not rate limiting to transmucosal absorption. This LA or LA-solvate is formulated into a low dielectric dosage form, from whence, upon the dosage form's hydration, the pharmaceutical agent is driven through the mucosal tissue and into systemic circulation. The invention therefore provides an enhanced transmucosal drug delivery system for ionizable pharmaceutical agents at or near physiological pH.

Abstract: The invention concerns the role of Glo 1 in the prevention and reversal of proteomic and genomic damage by carbonyl substrates thereof and, in particular, therapeutics that promote Glo 1 production.

Abstract: The present invention relates to a new method for treating or processing a cross-linked hyaluronan hydrogel prior to its use in applications involving three-dimensional cell culture. The invention also relates to cross-linked hyaluronan hydrogels prepared by such a method and to their use in 3D cell culture, stem cell/tissue engineering, drug discovery, toxicology testing, and broad cell biology applications.

Abstract: The present invention relates to a veterinary zoo-technical drug delivery system (device) for the simultaneous release of two or more active substances, which system releases the active substances in a substantially constant ratio over a prolonged period of time. The drug delivery system can be in different forms, such as e.g. an implant, or a intravaginal device such as a helical coil, a spring or a ring.

Abstract: A composition is provided, wherein the composition comprises a water-swellable, water-insoluble polymer, a blend of a hydrophilic polymer with a complementary oligomer capable of hydrogen or electrostatic bonding to the hydrophilic polymer. The composition also includes a backing member. Active ingredients, such as a whitening agent, may be included. The composition finds utility as an oral dressing, for example, a tooth whitening composition that is applied to the teeth in need of whitening. The composition can be designed to be removed when the degree of whitening has been achieved or left in place and allowed to erode entirely. In certain embodiments, the composition is translucent. Methods for preparing and using the compositions are also disclosed.

Abstract: An intrasnal spray device contains a composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (Cmax) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.

Abstract: The present application relates to pharmaceutical compositions for reducing glucose excursions in a normal subject or a subject having an insulin-related disorder or dysglycemia. The pharmaceutical composition contains one or more active agent-containing layers, which each contain a dry blended mixture including a therapeutically effective amount of a polar ionizable insulin-sensitizing oral hypoglycemic agent or a pharmaceutically acceptable salt thereof, and an amphipathic compound in monomelic form consisting of an amphipathic ionic compound in monomelic form. Each dry blended mixture contains a sufficient amount of the amphipathic ionic compound such that upon contact with an aqueous fluid, the amphipathic ionic compound forms a reverse micelle comprising the polar ionizable insulin-sensitizing oral hypoglycemic agent.

Abstract: A hydrophilic biocompatible sustained-release material is disclosed. The material comprises amounts of Pluronic F-127, PEG-400, HPMC and water, effective to produce a composition of sufficiently low viscosity at room temperature to be injectable into an internal body cavity via a tube inserted within a urinary catheter. At body temperature, the material exhibits a much higher viscosity and will stably adhere to the internal surface of a body cavity. As the material dissolves, a therapeutic agent incorporated therein is slowly released to the body cavity, while the material itself is excreted from the body.

Abstract: The present invention relates to a plurality of dosage forms comprising a first dosage form and second dosage form each comprising a therapeutic agent, such as an opioid; wherein the dosage strength of the second dosage form is greater than that of the first dosage form; and wherein the steady state Cave and the steady state AUC of the first and second dosage forms are dose proportional and the single dose Cmax of the second dosage form is less than the minimum level for dose proportionality with respect to the first dosage form. The present invention also relates to methods of administering such dosage forms to a patient, as well as to kits comprising such dosage forms and instructions for administration of the dosage forms to a patient. The inventors believe that the dosage forms and methods of the present invention will lead to improved safety and patient acceptance.

Abstract: An aerosol preparation assembly includes an entrainment chamber defining an entrainment volume. The entrainment chamber includes a gas inlet port, an aerosol inlet port and an outlet port. The entrainment chamber is configured such that a velocity of a flow of a gas within the entrainment volume is less than a velocity of the flow of the gas within the gas inlet port. The entrainment chamber is configured such that at least a portion of inlet aerosol is entrained into the flow of the gas within the entrainment volume to produce an entrained aerosol flow at the outlet port. The particle selection chamber is configured to receive the entrained aerosol flow and produce an outlet aerosol flow. The particle selection chamber and nozzle are collectively configured such that a volumetric median diameter of the outlet aerosol flow is less than a volumetric median diameter of the inlet aerosol.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: The present invention is directed to compositions, devices, and methods for non-irritatively treating and preventing mucositis, such as chronic rhinosinusitis (CRS). Some aspects of the invention concern compositions comprising or consisting essentially of sodium phosphate buffer (e.g., sodium phosphate dibasic and sodium phosphate monobasic) and calcium carbonate; mucoadministration devices and kits containing such compositions; and methods for treating or preventing mucositis conditions such as CRS, comprising mucoadministering a composition of the invention to a subject in need thereof.

Abstract: The invention includes compositions for transmucosal administration to an animal comprising at least one active agent and a pharmaceutically acceptable carrier. A preferred active agent is selected from the group consisting of meloxicam, carprofen, enrofloxacin, clemastine, diphenhydramine, digoxin, levothyroxine, cyclosporine, ondansetron, lysine, zolpidem, propofol, nitenpyram, ivermectin, milbemycin, and pharmaceutically acceptable salts, solvates and esters thereof. In another embodiment, the invention includes methods of treating or preventing a condition in an animal comprising transmucosally administering a composition comprising a therapeutically or prophylactically effective amount of an active agent and a pharmaceutically acceptable carrier.

Abstract: The invention relates to pharmaceutical compositions suitable for oral administration in the form of edible films comprising diclofenac.

Abstract: The invention relates to a mucoadhesive medicinal preparation for administering active substances in veterinary or humane medicine, containing at least one active substance, which preparation is characterized in that it is a mucoadhesive matrix disintegratable in aqueous media, which matrix contains at least one matrix-forming polymer and wherein at least one active substance is dissolved or dispersed, and in that the said preparation disintegrates or erodes within maximally 15 minutes after introduction in an aqueous medium or in body fluids, or in that the preparation initially gels within maximally 15 min after its introduction in an aqueous medium or in body fluids, and disintegrates or erodes within maximally 30 min after said introduction.

Abstract: The present invention is directed to formulations of genistein and methods for making and using the same. In particular embodiments, the formulations described herein include suspension formulations of nanoparticulate genistein.

Abstract: A composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (Cmax) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.

Abstract: This invention relates to a pernasally administrable preparation for the controlled release of sexual hormones to the systemic circulation, in particular to a formulation which enables its active ingredient to be absorbed in a sustained manner providing a better bioavailability at very low doses and longer duration of action.

Abstract: A composition containing therapeutic agents and/or breath freshening agents for use in the oral cavity is disclosed. The carrier comprises water-soluble polymers in combination with certain ingredients and provides a therapeutic and/or cosmetic effect. The film is coated and dried utilizing existing coating technology and exhibits instant wettability followed by rapid dissolution/disintegration upon administration in the oral cavity.

Abstract: Substance delivering spacer devices may comprise expandable reservoirs that are implantable in paranasal sinuses and other cavities, openings and passageways of the body to maintain patency and to provide sustained local delivery of a therapeutic or diagnostic substance. Also provided are sinus penetrator devices and systems for performing ethmoidotomy procedures or for creating other openings in the walls of paranasal sinuses or other anatomical structures.

Abstract: A method is disclosed for self-administered delivery of a pre-determined amount of liquid medication where a portion of the liquid medication is administered sublingually and the remaining portion is swallowed for and gastro-intestinal absorption.

Abstract: This invention comprises a sterically stabilized liposome carrier encapsulating a selected drug for the aerosol delivery of the drug effectual in the treatment of the lungs of a mammal, a composition containing the sterically stabilized liposome carrier and the selected drug effective for the treatment of the lungs of a mammal for asthma and inflammation of the lungs of the mammal as an aerosol and a method of, treatment using the composition. The composition provides effective treatment for the longer of a period of time at least twice as long as the selected drug alone or up to at least one week.