Abstract: A composition and method for treating nosebleed, that is, epistaxis. The composition comprises bismuth subgallate and a vasoconstriction agent, preferably oxymetazoline. The composition is preferably a paste administered intranasally.

Abstract: Disclosed are compositions for inhibiting transmission of a sexually transmitted infection that contain one or more polyanionic microbicides, such as carrageenans, including lambda carrageenan, as well as water-soluble metal salts and specified antiretroviral agents comprising NNRTIs and NRTIs. Also disclosed are methods for making and using the compositions.

Abstract: A method of treating Eustachian tube dysfunction in a person includes placing the person's body in a position substantially lying on one of the person's left or right sides. The side on which the person is lying is the side affected by Eustachian tube dysfunction. A composition of simethicone in a concentration of about 0.05% to 0.65% wt/vol diluted in an aqueous carrier is introduced through the nasal cavity of the same side on which the person is lying. The simethicone composition is then allowed to coat the person's pharynx on the side of which the person is lying.

Abstract: A liquid aqueous formulation for the intranasal administration of apomorphine includes: (a) at least about 15 mg/ml of apomorphine; and (b) a solubilising agent selected from (i) at least one polyoxyethylene-polyoxypropylene copolymer (poloxamer); (ii) at least one cyclodextrin; and (iii) at least one cyclodextrin together with chitosan. The formulations of the invention can be used in the treatment or management of Parkinson's disease and erectile dysfunction.

Abstract: Disclosed are in vitro methods for evaluating the in vivo redispersibility of dosage forms of poorly water-soluble active agents. The methods utilize media representative of in vivo human physiological conditions.

Abstract: Opiate containing dosage forms and methods using same are described. These dosage forms include substantially less opiates by weight than known oral formulations. These dosage forms are intended for oral administration across the oral mucosa.

Abstract: The invention relates to a method and a device for producing small, thin sheets from an active-ingredient film (2), in which the latter is produced by casting the film material onto a substrate material or by coating a substrate material, storing it with or without substrate material on a reel, pulling it off the reel and cutting it. It achieves the object of designing a method of this type in such a way that with this method small sheets can be produced as exactly as possible in predetermined sizes. To do this, the active-ingredient film (2) is pulled off automatically, is separated from a substrate material which, if present, and in tensioned form, is fed to a cutting station and is cut, in the feed direction, into long, narrow strips (7) of predeterminable width, and the long strips (7) are brought together in the feed direction and together are fed by a further feed device (10) to a transverse cutter (11), which cuts through the combined long strips (7) at predetermined intervals.

Abstract: Certain embodiments include a method of improvising radiological outcomes by introducing a filler to between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location, and administering a dose of radioactivity to at least the first tissue location or the second tissue location. Collagen and hyaluronic acid are examples of fillers. Certain embodiments include a medical device having a biocompatible, biodegradable filler material, wherein the device comprises at least a portion that has a shape that substantially conforms to Denovillier's space between the rectum and prostate. Certain embodiments include a kit, the kit comprising a filler and instructions for placing the filler between a first tissue location and a second tissue location to increase a distance between the first tissue location and the second tissue location.

Abstract: A nasal cleaning apparatus is described that includes a grip portion and a cleaning portion. The grip portion may include a handle and one or more gripping members attached to the handle. Such gripping members may facilitate rotation of the grip portion or other handling of the apparatus. The cleaning portion includes a head that is attached to a nasal cleaning cloth. The nasal cleaning cloth is disposed around and attached to the head, and is formed of a flexible, anti-microbial material. An extension member connects the cleaning portion to the grip portion. The nasal cleaning apparatus may be disposable and/or modular to facilitate multiple uses of all or only portions of the apparatus.

Abstract: Buccal aerosol sprays or capsules using polar and non-polar solvents have now been developed which provide zolpidem for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprise formulation I: aqueous polar solvent, zolpidem, and optional flavoring agent; formulation II: aqueous polar solvent, zolpidem, optionally flavoring agent, and propellant; formulation III: non-polar solvent, zolpidem, and optional flavoring agent; formulation IV: non-polar solvent, zolpidem, optional flavoring agent, and propellant; formulation V: a mixture of a polar solvent and a non-polar solvent, zolpidem, and optional flavoring agent; formulation VI: a mixture of a polar solvent and a non-polar solvent, zolpidem, optional flavoring agent, and propellant.

Abstract: The present invention provides novel condensation aerosols for the treatment of disease and/or intermittent or acute conditions. These condensation aerosols have little or no pyrolysis degradation products and are characterized by having an MMAD of between 1-3 microns. These aerosols are made by rapidly heating a substrate coated with a thin film of drug having a thickness of between 0.05 and 20 ?m, while passing a gas over the film, to form particles of a desirable particle size for inhalation. Kits comprising a drug and a device for producing a condensation aerosol are also provided. The device contained in the kit typically, has an element for heating the drug which is coated as a film on the substrate and contains a therapeutically effective dose of a drug when the drug is administered in aerosol form, and an element allowing the vapor to cool to form an aerosol. Also disclosed, are methods for using these aerosols and kits.

Abstract: Drug delivery compositions which are suitable for vaginal administration for the treatment of diseases and disorders in the urogenital tract are described. The compositions may be in the form of a tablet, liquid suspension or dispersion, dried powder, topical ointment, cream, foam, suppository, or aerosol. The drug delivery compositions are administered directly to the vagina and do not require the use of a solid device. This method of administration reduces the systematic levels of the drugs.

Abstract: Described herein are implantable medical devices comprising a biocompatible polymer comprising a triggerable bioadhesive property that allows the device to adhere to body tissue. The triggerable bioadhesive property of the polymer can be triggered or activated by exposure to a stimulus. Also, the present invention pertains to methods of making an implantable medical device comprising a biocompatible polymer comprising a triggerable bioadhesive property that allows the device to adhere to body tissue.

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: 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: 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: The present invention relates to the delivery of antipsychotics through an inhalation route. Specifically, it relates to aerosols containing antipsychotics that are used in inhalation therapy. In a method aspect of the present invention, an antipsychotic is delivered to a patient through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises an antipsychotic, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% antipsychotic drug degradation products. In a kit aspect of the present invention, a kit for delivering an antipsychotic through an inhalation route is provided which comprises: a) a thin coating of an antipsychotic composition and b) a device for dispensing said thin coating as a condensation aerosol.

Abstract: A stabilized bioadhesive composition containing an alkaline labile drug and a method for its preparation are provided. In one aspect, the composition is a hot-melt extruded (HME) composition comprising a preformed excipient mixture comprising an acidic component and an alkaline thermoplastic matrix-forming material, e.g. polymer. The excipient mixture is formed before blending with an alkaline labile drug. The blend is then hot-melt extruded to form the HME composition. By so doing, the acidic component is able to neutralize or render moderately acidic the excipient mixture. This particular process has been shown to substantially reduce the degradation of an alkaline labile drug during hot-melt extrusion. The excipient mixture softens or melts during hot-melt extrusion. It can dissolve or not dissolve drug-containing particles during extrusion.

Abstract: The present invention provides methods for enhancing transmucosal uptake of a medicament, e.g., fentanyl or buprenorphine, to a subject and related devices. The method includes administering to a subject a transmucosal drug delivery device comprising the medicament. Also provided are devices suitable for transmucosal administration of a medicament to a subject and methods of their administration and use. The devices include a medicament disposed in a mucoadhesive polymeric diffusion environment and a barrier environment.

Abstract: This invention relates to a polymeric pharmaceutical dosage form for the delivery, in use, of at least one pharmaceutical composition in a rate-modulated and site-specific manner. The dosage form comprises a biodegradable, polymeric, scaffold incorporating loaded with at least one active pharmaceutical ingredient (API). The polymer or polymers making up the scaffold degrade in a human or animal body in response to or in the absence of specific biological stimuli and, on degradation, release the API or APIs in an area where said stimuli are encountered. Preferably the polymeric scaffold is formed from poly (D1L-lactide) (PLA) and polymethacrylate (Eudragit S100/ES100) polymers.

Abstract: A quick and easy system and method for delivering a composition to a nasal membrane is presented. The applicator assembly includes a sleeve member which encases a swab having a portion that contacts a gelled composition. The sleeve member is manually severed to expose the applicator and the composition. The gelled composition contained on the applicator is applied to the nasal membrane.

Abstract: A polymeric material comprised of (i) at least one random copolymer comprised of ethylene oxide and one or more other alkylene oxide(s) and (ii) at least one non-random polymer comprised of one or more poly(alkylene oxide)s has been discovered. Preferably, it is a polymer alloy. Alkylene oxide homopolymers or block copolymers may be the non-random polymer. In a related discovery, an adhesive material can be made by suspending (a) particles in (b) a matrix of at least one poly(ethylene oxide) copolymer of ethylene oxide and propylene oxide, or a combination thereof. The handling characteristics may be adjusted for different utilities (e.g., from runny oil to hard wax). Applications include use as adhesive, cohesive, filler, lubricant, surfactant, or any combination thereof. In particular, the hard materials may be used for cleaning or waxing.

Abstract: Fentanyl-containing dosage forms and methods using same are described. These dosage forms include substantially less fentanyl by weight than known oral formulation and have advantages in terms of reduced cost and reduced side effects. These dosage forms are intended for oral administration of fentanyl across the oral mucosa.

Abstract: Compositions for appetite suppression and methods of making and using thereof are disclosed herein. The compositions are typically in the form of a tablet, such as a single or multi-layer sticker tablet. The compositions adhere to a buccal surface or mucosal surface in the oral cavity for at least 15 minutes, preferably for at least 30 minutes. In a preferred embodiment, the compositions contain herbal agents that are anti-appetite agents. The composition is generally effective for suppressing appetite for a time period ranging from at least 30 minutes up to eight hours following administration to the buccal or oral mucosa.

Abstract: Fentanyl containing dosage forms and methods using same are described. These dosage forms include substantially less fentanyl by weight than know oral formulation and have advantages in terms of cost and side effects. These dosage forms are intended for oral administration of fentanyl across the oral mucosa.

Abstract: According to the present invention, a vaccine or pharmaceutical-containing composition is applied to the muzzle area of the animal, which will then naturally use its tongue to clean itself. This behavior will cause the animal to deposit applied composition to the mucosa of the nasal and oral cavities, thus meeting the need for a simple, effective, and efficient vaccination or treatment method.

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 the particles or formulations. In one embodiment, an inhaler contains an aerosol formulation containing a particulate active substance of non-micronized, solid particles having a mass median aerodynamic diameter of less than 10 ?m. The particles may be suspended in a nonsolvent hydrofluorocarbon fluid vehicle (e.g., HFA 134a or 227ea) at a concentration within a range from about 0.2% w/v to about 5% w/v. The formulation exhibits a flocculation volume of about 85% or greater about 1 minute after mixing the particulate active substance and the vehicle. The particulate active substance may contain salmeterol xinafoate, budesonide, salbutamol sulfate, dihydroergotamine mesylate, risperidone-(9-hydroxy)-palmitate, bromocriptine mesylate, or derivatives thereof. In some examples, the active substance is dihydroergotamine mesylate.

Abstract: An oil-based composition for application to mucosal surfaces of the human body provides potent activators of cytoprotective antioxidants. The composition includes the following ingredients: soy oil; coconut oil; orange oil; peppermint oil; aloe vera oil; vitamin E; and may further include jojoba and a preservative. Application of the composition increases expression of antioxidant genes and inhibits proinflammatory action caused by exposure to oxidant pollutants, allergens and other cytotoxins.

Abstract: The present invention provides compositions for the intranasal administration of zolpidem or a pharmaceutically acceptable salt thereof. Preferred compositions of the invention are in the form of aqueous solutions. Optionally the compositions of the invention comprise a cyclodextrin and/or chitosan, a salt or derivative thereof or a salt of a derivative of chitosan. The compositions can be used for the treatment or prevention insomnia or the treatment of neurological disorders such as those arising from brain trauma, stroke and spinocerebellar ataxia or in the treatment of Parkinson's disease.

Abstract: A pharmaceutical composition for pulmonary delivery comprises glycopyrrolate in a controlled release formulation, wherein, on administration, the glycopyrrolate exerts its pharmacological effect over a period greater than 12 hours.

Abstract: The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.

Abstract: A method for improvement of tolerance for therapeutically effective agents delivered by inhalation comprising a pretreatment of a patient with a nebulized lidocaine or a lidocaine-like compound administered immediately or up to about thirty minutes before administration of the primary therapeutically effective agent. The pretreatment of the patient with the nebulized lidocaine or a lidocaine-like compound improves airway tolerance and deposition of the agent in the lungs and makes such deposition more safe, efficacious, controllable and predictable. The method of the invention is especially useful for enhancement of deposition of immunosuppressive agents in the lung(s) of transplant patients, improved tolerance of the drugs by reducing cough, and improving pulmonary drug deposition.

Abstract: The present invention relates to the delivery of drug amines through an inhalation route. Specifically, it relates to aerosols containing drug amines that are used in inhalation therapy. In one aspect of the present invention, a method of delivering an amine drug in an aerosol form is provided. The method comprises: a) heating a coating, which includes an amine drug salt on a substrate contained in a device to a temperature sufficient to volatilize the amine drug from the coating, b) by said heating, forming an amine drug vapor, and c) during said heating, drawing air through said device, condensing said vapor to form aerosol particles containing less than 10% degradation products of the compound.

Abstract: An anti-tussive nebulized solution for targeted delivery of lidocaine into conducting and central airways. A method for treatment of cough and tussive attacks or episodes using said lidocaine solution. A nebulized lidocaine solution administered in daily dose from about 10 mg to 80 mg of lidocaine dissolved in a saline and nebulized into an aerosol having a mass median aerodynamic diameter 3 ?m to 10 ?m and a geometric standard deviation less than 1.7 using an electronic nebulizer.

Abstract: The present invention relates to the delivery of drug esters through an inhalation route. Specifically, it relates to aerosols containing drug esters that are used in inhalation therapy. In a method aspect of the present invention, a drug ester is delivered to a patient through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises a drug ester, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% drug ester degradation product. In a kit aspect of the present invention, a kit for delivering a drug ester through an inhalation route is provided which comprises: a) a thin coating of a drug ester composition and b) a device for dispensing said thin coating as a condensation aerosol.

Abstract: The invention relates to a gastric juice-resistant device for releasing active substance excipients having delayed intestinal passage from a gastric juice-resistant enclosure, and which serves to increase the active substance concentration in the intestines. The inventive device is characterized in that the active substance excipient containing at least one active substance is provided in the form of a multiparticulate preparation whose individual particles have mucoadhesive properties. The invention also relates to a method for producing said device.

Abstract: A method for managing at least one breathing condition may include storing an agent near a patient's airway and delivering the agent to the mucosal tissue in the pharyngeal area in a time-released manner during a sleep period. The delivered agent may cause increased contraction of muscle tissue in the pharyngeal area.

Abstract: Consumable or dissolvable tablets are manufactured by supplying a liquid containing a biodissolvable carrier to an outlet; establishing an electric field between the outlet and a support surface to cause liquid issuing from the outlet to form at least one fiber or fibrils of the biodissolvable carrier which fiber or fibrils deposit(s) onto the surface to form a fiber web or mat; separating the web or mat into a plurality of individual tablets; and incorporating at least one active ingredient on or in the tablets.

Abstract: The invention provides biodegradable implants for treating sinusitis. The biodegradable implants have a size, shape, density, viscosity, and/or mucoadhesiveness that prevents them from being substantially cleared by the mucociliary lining of the sinuses during the intended treatment period. The biodegradable implants include a sustained release therapeutic, e.g., an antibiotic, a steroidal anti-inflammatory agent, or both. The biodegradable implants may take various forms, such as rods, pellets, beads, strips, or microparticles, and may be delivered into a sinus in various pharmaceutically acceptable carriers.

Abstract: The invention provides biodegradable implants for treating sinusitis. The biodegradable implants have a size, shape, density, viscosity, and/or mucoadhesiveness that prevents them from being substantially cleared by the mucociliary lining of the sinuses during the intended treatment period. The biodegradable implants include a sustained release therapeutic, e.g., an antibiotic, a steroidal anti-inflammatory agent, or both. The biodegradable implants may take various forms, such as rods, pellets, beads, strips, or microparticles, and may be delivered into a sinus in various pharmaceutically acceptable carriers.

Abstract: The invention provides biodegradable implants for treating sinusitis. The biodegradable implants have a size, shape, density, viscosity, and/or mucoadhesiveness that prevents them from being substantially cleared by the mucociliary lining of the sinuses during the intended treatment period. The biodegradable implants include a sustained release therapeutic, e.g., an antibiotic, a steroidal anti-inflammatory agent, or both. The biodegradable implants may take various forms, such as rods, pellets, beads, strips, or microparticles, and may be delivered into a sinus in various pharmaceutically acceptable carriers.

Abstract: The invention provides biodegradable implants for treating sinusitis. The biodegradable implants have a size, shape, density, viscosity, and/or mucoadhesiveness that prevents them from being substantially cleared by the mucociliary lining of the sinuses during the intended treatment period. The biodegradable implants include a sustained release therapeutic, e.g., an antibiotic, a steroidal anti-inflammatory agent, or both. The biodegradable implants may take various forms, such as rods, pellets, beads, strips, or microparticles, and may be delivered into a sinus in various pharmaceutically acceptable carriers.

Abstract: The invention provides biodegradable implants for treating sinusitis. The biodegradable implants have a size, shape, density, viscosity, and/or mucoadhesiveness that prevents them from being substantially cleared by the mucociliary lining of the sinuses during the intended treatment period. The biodegradable implants include a sustained release therapeutic, e.g., an antibiotic, a steroidal anti-inflammatory agent, or both. The biodegradable implants may take various forms, such as rods, pellets, beads, strips, or microparticles, and may be delivered into a sinus in various pharmaceutically acceptable carriers.

Abstract: The invention provides biodegradable implants for treating sinusitis. The biodegradable implants have a size, shape, density, viscosity, and/or mucoadhesiveness that prevents them from being substantially cleared by the mucociliary lining of the sinuses during the intended treatment period. The biodegradable implants include a sustained release therapeutic, e.g., an antibiotic, a steroidal anti-inflammatory agent, or both. The biodegradable implants may take various forms, such as rods, pellets, beads, strips, or microparticles, and may be delivered into a sinus in various pharmaceutically acceptable carriers.

Abstract: Compositions are provided for the intranasal administration of granisetron or a pharmaceutically acceptable salt thereof. Preferred compositions are in the form of an aqueous solution. Optionally, the compositions comprise chitosan, a salt or derivative thereof or a salt of a derivative of chitosan. The compositions can be used for the treatment or prevention of nausea and/or vomiting.

Abstract: Compositions and methods for vaginal, buccal or nasal transmucosal delivery of drugs and for cryoprotecting of cells and embryos. For cryoprotection, the composition consisting essentially consist of a non-ionizable glycol derivative. For transmucosal delivery, the compositions essentially consist of a non-ionizable glycol derivative in a combination with a pharmaceutically active agent. For transmucosal delivery, the non-ionizable glycol derivative may be further combined with a mucoadhesive agent and/or a penetration enhancer and/or lipophilic or hydrophilic carrier for adhesion to and transport through a mucosa. The compositions are particularly suitable for administration of drugs through a nasal, buccal and vaginal mucosa or for long-term preservation of cell or embryos.

Abstract: According to the present invention, a vaccine or pharmaceutical-containing composition is applied to the muzzle area of the animal, which will then naturally use its tongue to clean itself. This behavior will cause the animal to deposit applied composition to the mucosa of the nasal and oral cavities, thus meeting the need for a simple, effective, and efficient vaccination or treatment method.

Abstract: A delivery agent for delivering a biologically active agent to a warm-blooded animal includes a hydrophobic moiety covalently bonded to a hydrophilic moiety. The hydrophobic moiety can include bile acids, sterols, or hydrophobic small molecules. The hydrophilic moiety can include ?-amino acids, dipeptides or tripeptides, or hydrophilic small molecules. An illustrative delivery agent is N?-deoxycholyl-L-lysine-methylester. The delivery agent and the biologically active agent are mixed together to form a complex, which is then administered to the animal. These complexes are particularly useful for oral administration of biologically active agents, but other routes of administration may be used.

Abstract: A stable pharmaceutical mercury-free aqueous solution of cyanocobalamin comprised of cyanocobalamin and water wherein said solution of cyanocobalamin is suitable for intranasal administration, has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin with the proviso that the solution is essentially free of mercury and mercury-containing compounds. The present invention is also directed towards a method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally a sufficient amount of a mercury-free cyanocobalamin solution so as to increase the average ratio of vitamin B12 in the CSF to that in the blood serum (B12 CSF/B12 Serum×100) to at least about 1.

Abstract: Compositions and methods for improving cellular internalization of one or more compounds are disclosed. The compositions include a compound to be delivered and a biocompatible viscous material, such as a hydrogel, lipogel, or highly viscous sol. The composition also include, or are administered in conjunction with, an enhancer in an amount effective to maximize expression of or binding to receptors and enhance RME of the compound into the cells. This leads to high transport rates of compounds to be delivered across cell membranes, facilitating more efficient delivery of drugs and diagnostic agents. Compositions are applied topically orally, nasally, vaginally, rectally, and ocularly. The enhancer is administered with the composition or separately, either systemically or preferably locally. The compound to be delivered can also be the enhancer.