Abstract: Methods of treating headache with antipsychotics are provided. A kit for treating headache is also provided, comprising an antipsychotic and a device for rapid delivery of the antipsychotic.

Abstract: A device for delivering a drug by inhalation is disclosed. The device includes a body defining an interior flow-through chamber having upstream and downstream chamber openings, and a drug supply unit contained within the chamber for producing, upon actuation, a heated drug vapor in a condensation region of the chamber. Gas drawn through the chamber region at a selected gas-flow rate is effective to form drug condensation particles from the drug vapor having a selected MMAD between 0.02 and 0.1 MMAD or between 1 and 3.5 &mgr;m. A gas-flow control valve disposed upstream of the unit functions to limit gas-flow rate through the condensation region to the selected gas-flow rate. An actuation switch in the device activates the drug-supply unit, such that the drug-supply unit can be controlled to produce vapor when the gas-flow rate through the chamber is at the selected flow rate.

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 &mgr;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: The present invention relates to the inhalation delivery of aerosols containing small particles. Specifically, it relates to the delivery of drug containing aerosols having particles with a mass median aerodynamic diameter less than 1&mgr; for inhalation therapy. In an aspect of the present invention the drug containing aerosol comprises particles having a mass median aerodynamic diameter between 10 nm and 1&mgr;. Preferably, the particles have a mass median aerodynamic diameter between 10 nm and 900 nm. More preferably, the particles have a mass median aerodynamic diameter between 10 nm and 800 nm, 10 nm and 700 nm, 10 nm and 600 nm, 10 nm and 500 nm, 10 nm and 400 nm, 10 nm and 300 nm, 10 nm and 200 nm, or 10 nm and 100 nm.

Abstract: The present invention relates to the inhalation delivery of aerosols containing small particles. Specifically, it relates to the delivery of drug containing aerosols having particles with a mass median aerodynamic diameter less than 1&mgr; for inhalation therapy. In a composition aspect of the present invention the drug containing aerosol comprises particles having a mass median aerodynamic diameter between 10 nm and 1&mgr;. Preferably, the particles have a mass median aerodynamic diameter between 10 nm and 900 nm. More preferably, the particles have a mass median aerodynamic diameter between 10 nm and 800 nm, 10 nm and 700 nm, 10 nm and 600 nm, 10 nm and 500 nm, 10 nm and 400 nm, 10 nm and 300 nm, 10 nm and 200 nm, or 10 nm and 100 nm.

Abstract: A method and device are provided to generate an aerosol having a desired particle sizes, i.e., from molecular to about 10 microns, which can be used to effectively deliver a physiologically active compound to organs and tissues such as the lung, eye, mucosa and skin. The aerosol is formed through vaporization of the compound while mixing the resulting vapor with a gas, in a ratio, to form the desired particle size when a stable concentration of particles in the gas is reached.

Abstract: A method and device are provided to generate an aerosol having a desired particle sizes, i.e., from molecular to about 10 microns, which can be used to effectively deliver a physiologically active compound to organs and tissues such as the lung, eye, mucosa and skin. The aerosol is formed through vaporization of the compound while simultaneously mixing the resulting vapor with air or other gas. The purity of the compound is maintained meet FDA requirements by closely controlling its degradant levels during vaporization.

Abstract: The present invention relates to the inhalation delivery of aerosols containing small particles. Specifically, it relates to the delivery of drug containing aerosols having particles with a mass median aerodynamic diameter less than 1&mgr; for inhalation therapy. In a composition aspect of the present invention the drug containing aerosol comprises particles having a mass median aerodynamic diameter between 10 nm and 1&mgr;. Preferably, the particles have a mass median aerodynamic diameter between 10 nm and 900 nm. More preferably, the particles have a mass median aerodynamic diameter between 10 nm and 800 nm, 10 nm and 700 nm, 10 nm and 600 nm, 10 nm and 500 nm, 10 nm and 400 nm, 10 nm and 300 nm, 10 nm and 200 nm, or 10 nm and 100 nm.

Abstract: The present invention relates to the inhalation delivery of aerosols containing small particles. Specifically, it relates to a device that forms drug containing aerosols for use in inhalation therapy. In a device aspect of the present invention, a device for delivering drug containing aerosols for inhalation therapy is provided. The device includes a housing and an airway that has a gas/vapor mixing airway. The airway further includes a subassembly, which has a metallic substrate coated on its surface with a composition comprising a drug.

Abstract: The present invention relates to the inhalation delivery of aerosols containing small particles. Specifically, it relates to a method of forming an aerosol for use in inhalation therapy. In a method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug at a rate greater than 1000° C./s, thereby forming an vapor; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. In another method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug to form a vapor, wherein the coated composition is in the form of a film less than 10&mgr; thick; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy.

Abstract: A disposable package, tape, and cassette are provided which makes it possible to hold and disperse therefrom liquid, flowable formulations including aqueous formulations (solutions or dispersions with particles less than 0.25 microns in diameter) of a pharmaceutically active drug. In one embodiment formulation is packaged in individual dosage unit containers which containers are preferably interconnected. The package is designed to be integrated into a cassette which can be loaded into a dispersing device capable of individually opening dosage unit containers and aerosolizing the contents through a porous membrane, into a mouth piece on the cassette, for delivery to a patient. In addition to and alongside of each porous membrane, the package may include one or more openings through which air is forced in order to aid in avoiding the accumulation of aerosolized particles.

Abstract: Devices, packaging and methodology for efficiently and repeatably creating aerosolized bursts of an insulin containing formulation are disclosed. Devices are hand-held, self-contained units which are automatically actuated at the same release point in a patient's inspiratory flow cycle. The release point is automatically determined either mechanically or, more preferably calculated by a microprocessor which receives data from a sensor making it possible to determine inspiratory flow rate and inspiratory volume. The device is loaded with a cassette comprised of an outer housing which holds a package of individual disposable collapsible containers of an insulin containing formulation for systemic delivery. Actuation of the device forces insulin formulation through a porous membrane of the container which membrane has pores having a diameter in the range of about 0.25 to 3.0 microns, preferably 0.25 to 1.5 microns.

Abstract: Devices, packaging and methodology for efficiently and repeatably creating aerosolized bursts of an analgesic (e.g., narcotic) containing formulation are disclosed. Devices are hand-held, self-contained units which are automatically actuated at the same release point in a patient's inspiratory flow cycle. The release point is automatically determined either mechanically or, more preferably calculated by a microprocessor which receives data from a sensor making it possible to determine inspiratory flow rate and inspiratory volume. The device is loaded with a cassette comprised of an outer housing which holds a package of individual disposable collapsible containers of an analgesic containing formulation for systemic delivery. Actuation of the device forces analgesic formulation through a porous membrane of the container which membrane has pores having a diameter in the range of about 0.25 to 3.0 microns, preferably 0.25 to 1.5 microns.

Abstract: A disposable package, tape, and cassette are provided which makes it possible to hold and disperse therefrom liquid, flowable formulations including aqueous formulations (solutions or dispersions with particles less than 0.25 microns in diameter) of a pharmaceutically active drug. In one embodiment formulation is packaged in individual dosage unit containers which containers are preferably interconnected. The package is designed to be integrated into a cassette which can be loaded into a dispersing device capable of individually opening dosage unit containers and aerosolizing the contents through a porous membrane, into a mouth piece on the cassette, for delivery to a patient. In addition to and alongside of each porous membrane, the package may include one or more openings through which air is forced in order to aid in avoiding the accumulation of aerosolized particles.

Abstract: A method of treating human patients is provided by the intrapulmonary delivery of a pharmaceutically active peptide formulation. The formulation is automatically released in an aerosolized form from a hand-held, self-contained, portable device comprised of a means for automatically releasing a measured amount of drug into the inspiratory flow path of a patient in response to information obtained from a means for measuring the inspiratory flow rate and determining the inspiratory volume of a patient. Reproducible dosing is obtained by providing for automatic release at the same inspiratory flow rate and inspiratory volume each time drug is released. The device includes a timer to enable a patient to take a drug at the same time each day. Further, overadministration of hormone formulations is avoided by providing a pre-programmed microprocessor designed to avoid overdosing.

Abstract: Devices, packaging and methodology for creating aerosols are provided which allow for efficient and repeatable delivery of drugs to the lungs of a patient. Devices are hand-held, self-contained units which are automatically actuated at the same release point in a patient's inspiratory flow cycle. The release point is calculated by a microprocessor which receives data from a sensor making it possible to determine inspiratory flow rate and inspiratory volume. The device is loaded with a cassette comprised of an outer housing which holds a package of individual collapsible containers of pharmaceutically active drug. Actuation of the device forces drug through a porous membrane of the container which membrane has pores having a diameter in the range of about 0.25 to 6.0 microns. The porous membrane is positioned in alignment with a surface of a channel through which a patient inhales air.

Abstract: Devices, packaging and methodology for efficiently and repeatably creating aerosolized bursts of a formulation of respiratory drug are disclosed. Devices are hand-held, self-contained units which are automatically actuated at the same release point in a patient's inspiratory flow cycle. The release point is automatically determined either mechanically or, more preferably calculated by a microprocessor which receives data from a sensor making it possible to determine inspiratory flow rate and inspiratory volume. The device is loaded with a cassette comprised of an outer housing which holds a package of individual collapsible containers of formulation which comprises a respiratory drug useful in topically treating lung tissue. Actuation of the device forces respiratory drug through a porous membrane of the container which membrane has pores having a diameter in the range of about 0.25 to 6.0 microns. The porous membrane is positioned in alignment with a surface of a channel through which a patient inhales air.

Abstract: Devices, packaging and methodology for efficiently and repeatably creating aerosolized bursts of an insulin containing formulation are disclosed. Devices are hand-held, self-contained units which are automatically actuated at the same release point in a patient's inspiratory flow cycle. The release point is automatically determined either mechanically or, more preferably calculated by a microprocessor which receives data from a sensor making it possible to determine inspiratory flow rate and inspiratory volume. The device is loaded with a cassette comprised of an outer housing which holds a package of individual disposable collapsible containers of an insulin containing formulation for systemic delivery. Actuation of the device forces insulin formulation through a porous membrane of the container which membrane has pores having a diameter in the range of about 0.25 to 3.0 microns, preferably 0.25 to 1.5 microns.

Abstract: A disposable package, tape, and cassette are provided which makes it possible to hold and disperse therefrom liquid, flowable formulations including aqueous formulations (solutions or dispersions with particles less than 0.25 microns in diameter) of a pharmaceutically active drug. In one embodiment formulation is packaged in individual dosage unit containers which containers are preferably interconnected. The package is designed to be integrated into a cassette which can be loaded into a dispersing device capable of individually opening dosage unit containers and aerosolizing the contents through a porous membrane, into a mouth piece on the cassette, for delivery to a patient. In addition to and alongside of each porous membrane, the package may include one or more openings through which air is forced in order to aid in avoiding the accumulation of aerosolized particles.

Abstract: A device and method for the detection of small particles in a fluid. The device is a collapsible sample container having a opening which is covered, at least in part, by a porous membrane having a plurality (e.g., 100) of pores therein having a pore diameter equal to or smaller than the diameter of the particles to be detected (e.g., 01. to 100 microns). A means for collapsing the container to extrude the liquid sample through the membrane pores is provided along with a means for detecting pressure during the extrusion. The size and number of particles in the liquid is calculated by relating the extrusion pressure required to a pre-calibrated standard. When a constant pressure is applied the rate at which fluid is extruded decreases as the pores of the membrane become clogged with particles.