Abstract: Kits comprising an M2 inhibitor selected from amantadine and rimantadine; ribavirin, and a neuraminidase inhibitor (NAi) in an amount that is antivirally effective in the combination, an oral dosage form containing 75-250 mg of the M2 inhibitor, an oral dosage form comprising 100-400 mg of ribavirin and a neuraminidase inhibitor are provided for the treatment of influenza. Some embodiments of the kits comprise an oral dosage form containing 75-250 mg of the M2 inhibitor, an oral dosage form comprising 100-400 mg of ribavirin, and a neuraminidase inhibitor.

Abstract: Compositions, kits and methods are provided for the treatment or prophylaxis of influenza.

Abstract: A composition is provided for administration to a subject by way of a needleless syringe. The composition is formed from particles having a mean mass aerodynamic diameter of from 1 to 250 microns, and an envelope density of from 0.1 to 25 g/cm.sup.3, where the particles include a biologically active agent and a sustained-release material that controls release of the active agent to a subject following administration of the composition thereto. Methods for delivering a biologically active agent to a subject are also provided.

Abstract: Stockpiles and methods of stockpiling a combination antiviral therapy for responding to an epidemic viral outbreak are described. Methods and systems of inventory control for co-deployment of drugs used in combination during a pandemic are described.

Abstract: Compositions, kits and methods are provided for the treatment or prophylaxis of influenza.

Abstract: The present invention relates to a catheter with an expandable distal end for delivering one or more medicaments. The catheter is manufactured with materials of construction that allow the transfer of electrical energy from the proximal end of the catheter to the distal expandable end. The catheter also has a means for controlling or manipulating the expandable distal end to expand and contract into various configurations. The distal end of the catheter is processed by a specific method of manufacturing whereby the expandable distal end is coated with one or more layers of a hydrogel copolymer wherein at least one layer of which coating encapsulates one or more medicaments and zero or more charged carriers to facilitate the electrophoretic and electro-osmostic mobilities of the medicaments.

Abstract: A process for producing a powder comprises spray freeze-drying an aqueous solution or suspension comprising a pharmaceutical agent, said solution or suspension having a solids content of 20% by weight or more. The spray freeze-dried powder may be administered to a subject via a needleless syringe.

Abstract: The present invention relates to a catheter with an expandable distal end for delivering one or more medicaments. The catheter is manufactured with materials of construction that allow the transfer of electrical energy from the proximal end of the catheter to the distal expandable end. The catheter also has a means for controlling or manipulating the expandable distal end to expand and contract into various configurations. The distal end of the catheter is processed by a specific method of manufacturing whereby the expandable distal end is coated with one or more layers of a hydrogel copolymer wherein at least one layer of which coating encapsulates one or more medicaments and zero or more charged carriers to facilitate the electrophoretic and electro-osmostic mobilities of the medicaments.

Abstract: A process for producing a powder comprises spray freeze-drying an aqueous solution or suspension comprising a pharmaceutical agent, said solution or suspension having a solids content of 20% by weight or more. The spray freeze-dried powder may be administered to a subject via a needleless syringe.

Abstract: An apparatus for sensing an analyte is described, wherein the apparatus includes an interface contact element that is used to establish an interface with a quantity of body fluid. The interface contact element is adapted to facilitate diffusion of a target analyte across the interface essentially free of net mass fluid transport. The quantity of body fluid is exposed to the interface contact element through micro-pathways. The apparatus can also include a sensing material adapted to sense the target analyte with at least one analytical method. Methods for using the apparatus in a non- or minimally invasive monitoring technique are also described.

Abstract: Methods for detecting the presence or amount of an analyte present beneath a target skin or mucosal surface of an individual are provided. The methods entail disruption of the target skin or mucosal surface, for example using a particle delivery method to provide micro-passages in the tissue. The methods further provide a resealable occlusive dressing or patch for protecting the target site from outside agents as well as maintaining hydration of the sample area. Maintaining hydration over the sampling site allows for continuous diffusion of the analyte of interest from beneath the target site to the target site. Multiple samples over time may then be taken, allowing the user to monitor for the presence of analyte over time. In a preferred embodiment, the methods are used to monitor blood glucose levels.

Abstract: Hard, dense particles of a pharmaceutical agent, suitable for administration to a subject via a needleless syringe are described. The particles are prepared by a multi step process that entails forming particles of a first size where the particles are an admixture of a pharmaceutical agent and a macromolecular carrier and the admixture has a first glass transition temperature; admixing a plasticizer that lowers the first glass transition temperature of the admixture to a second glass transition temperature which is below the first glass transition temperature; maintaining the articles at a temperature above the second glass transition temperature for a time period adequate to cause the particles to shrink and/or collapse; removing the plasticizer from the particles to yield modified particles having an increased glass transition temperature; recovering the modified particles; and then storing the recovered particles.

Abstract: An apparatus for sensing an analyte is described, wherein the apparatus includes an interface contact element that is used to establish an interface with a quantity of body fluid. The interface contact element is adapted to facilitate diffusion of a target analyte across the interface essentially free of net mass fluid transport. The quantity of body fluid is exposed to the interface contact element through micro-pathways. The apparatus can also include a sensing material adapted to sense the target analyte with at least one analytical method. Methods for using the apparatus in a non- or minimally invasive monitoring technique are also described.

Abstract: A composition of matter for application to a body surface or membrane to administer oxybutynin by permeation through the body surface or membrane, the composition comprising, in combination, the oxybutynin to be administered, in a therapeutically effective amount; and a permeation-enhancing mixture comprising a monoglyceride or a mixture of monoglycerides, and a lactic ester or a mixture of lactate esters; present in specific concentrations.

Abstract: A dosage form is disclosed comprising means for lessening the tackiness and/or irritation of the components of the dosage form to mucosal tissue. The dosage form provides means for forming in the dosage form a floc comprising a drug, which floc, when delivered from the dosage form, lessens the tackiness and/or irritation of the mucosal tissue of a warm-blooded recipient.

Abstract: Compositions, devices, and methods for transdermal administration of an active agent are disclosed using a novel dual permeation enhancer mixture comprising lauryl acetate and a monoglyceride, preferably glycerol monolaurate. The dual permeation enhancer mixture comprising lauryl acetate is a potent permeation enhancer and provides stable systems which are more readily characterized.

Abstract: A dosage form is disclosed comprising means for lessening the tackiness and/or irritation of the components of the dosage form to mucosal tissue. The dosage form provides means for forming in the dosage form a floc comprising a drug, which floc, when delivered from the dosage form, lessens the tackiness and/or irritation of the mucosal tissue of a warm-blooded recipient.

Abstract: Compositions, devices, and methods for transdermal administration of an active agent are disclosed using a novel dual permeation enhancer mixture comprising lauryl acetate and a monoglyceride, preferably glycerol monolaurate. The dual permeation enhancer mixture comprising lauryl acetate is a potent permeation enhancer and provides stable systems which are more readily characterized.

Abstract: A composition of matter for application to a body surface or membrane to administer oxybutynin by permeation through the body surface or membrane, the composition comprising, in combination the oxybutynin to be administered, in a therapeutically effective amount; and a permeation enhancing mixture comprising a monoglyceride or a mixture of monoglycerides, and a lactic ester or a mixture of lactate esters, present in specific concentrations.

Abstract: A device for the transdermal administration of oxybutynin comprising a microporous tie layer located between the oxybutynin reservoir and the contact adhesive. The tie layer eliminates blooming and delamination and has no appreciable adverse effect on either the oxybutynin flux or release rate from the device.