Abstract: According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 ?m mass median diameter (MMD), usually 1.0-4.0 ?m MMD, and preferably 1.0-3.0 ?m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 ?m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 ?m MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.

Abstract: A carry case is provided for use by a diabetic patient. The carry case comprises a first compartment sized and shaped to contain an aerosolization apparatus, a second compartment sized and shaped to contain one or more receptacles for use in the aerosolization apparatus, and a third compartment sized and shaped to contain a glucose meter. In one version, the receptacles contain an aerosolizable pharmaceutical formulation comprising insulin. The carry case allows the patient to conveniently monitor and regulate the patient's glucose level.

Abstract: A pharmaceutical package comprises a first compartment and a second compartment. The first compartment contains an aerosolization apparatus, the aerosolization apparatus comprising a housing defining a chamber having one or more air inlets and one or more air outlets, the chamber being sized to contain a capsule; a puncturing mechanism moveable within the housing to create one or more openings in a capsule in the chamber; and a mouth or nose piece in communication with the one or more air outlets, whereby when a user inhales, air enters into the chamber through the inlet to cause the capsule to move within the chamber so that the pharmaceutical formulation exits through one or more openings in the capsule and is aerosolized and transported through the outlet for delivery to the user through the mouth or nose piece. The second compartment contains a capsule.

Abstract: An aerosolization device comprises a housing, a container comprising a reservoir storing a pharmaceutical formulation which comprises a propellant, and a metering valve. The metering valve is in communication with the reservoir and is moveable into the container to an actuated position where a predetermined amount of the pharmaceutical formulation is released. A contact member is provided in the housing. In one version, the contact member is moveable between a first position and a second position to allow for selective actuation of the metering valve. In another version, the contact member's configuration may be changed to allow for selective actuation of the metering valve.

Abstract: An aerosolization apparatus comprises a container containing a pharmaceutical formulation, the pharmaceutical formulation comprising an active agent and a propellant. The aerosolization apparatus further comprises a metering chamber in communication with the container, the metering chamber adapted to hold a metered amount of the pharmaceutical formulation, a valve to allow the metered amount of the pharmaceutical formulation to be released from the metering chamber when the valve is actuated, and a pressurizer that applies pressure to the pharmaceutical formulation in the metering chamber while the pharmaceutical formulation is being released from the metering chamber. In one version, the metering chamber is sized so that at least 2 mg, and preferably at least 5 mg, of the active agent is be aerosolized for delivery to a user during inhalation.

Abstract: An apparatus is provided for sealing a first layer to a second layer, the second layer comprising one or more cavities adapted to contain a pharmaceutical formulation. The apparatus comprises a roller comprising a heating element, and a surface adapted to support the first and second layers, the surface being translatable relative to the roller. The first layer may be heat sealed to the second layer when contacted by the roller to contain the pharmaceutical formulation within the one or more cavities.

Abstract: An aerosolization apparatus comprises a body defining an inlet opening, an outlet opening, and an aerosolization chamber between the inlet opening and the outlet opening. The aerosolization chamber is adapted to receive an elongated receptacle, such as a capsule, containing a pharmaceutical formulation. The elongated receptacle rotates end-over-end about an axis substantially orthogonal to an axis passing through the outlet opening when air or gas flows through the body. In another version, the elongated receptacle rotates end-over-end about an axis substantially orthogonal to an inhalation direction.

Abstract: An aerosolization device comprises a housing having an inlet and an outlet and an airway extending from the inlet to the outlet. A valve in the airway comprises a piezoelectric element which controls the valve, and a reservoir in communication with the airway is adapted to contain a pharmaceutical formulation so that the pharmaceutical formulation may be introduced into the airway and passed through the outlet in an aerosolized form. The piezoelectric element may alternatively or additionally be used to sense a condition in the aerosolization device.

Abstract: An aerosolization apparatus comprises a body having an inlet, an endpiece having an outlet, the endpiece being connectable to the body to define a chamber, wherein the chamber is sized to receive a capsule containing a pharmaceutical formulation in a manner which allows the capsule to move within the chamber. The apparatus further includes a connection mechanism to provide selective connection of the endpiece to the body, wherein a rotational force between the endpiece and the body is needed to connect or disconnect the endpiece from the body, the rotational force being applied about an axis passing through the chamber. When a user inhales, air enters into the chamber through the inlet so that the pharmaceutical formulation is aerosolized within the chamber and the aerosolized pharmaceutical formulation is delivered to the user through the outlet. The connection mechanism prevents inadvertent disconnection of the endpiece from the body.

Abstract: A process for preparing ultrafine powders of biological macromolecules comprises atomizing liquid solutions of the macromolecules, drying the droplets formed in the atomization step, and collecting the particles which result from drying. By properly controlling each of the atomization, drying, and collection steps, ultrafine dry powder compositions having characteristics particularly suitable for pulmonary delivery for therapeutic and other purposes may be prepared.

Abstract: A method and apparatus are provided for atomizing a liquid under dispersal conditions suitable for spray drying at a commercial plant scale. In one embodiment, a liquid atomizer has a structural body adapted for connection with a spray dryer and a plurality of atomizing nozzles. Each of the atomizing nozzles includes a liquid nozzle adapted to disperse a supply of liquid and a gas nozzle adapted to disperse a supply of gas. In another embodiment, a process for producing a powder blend of at least two target substances in a single processing step is provided.

Abstract: According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (%w) water, usually below about 5%w and preferably less than about 3%w; a particle size of about 1.0-5.0 &mgr;m mass median diameter (MMD), usually 1.0-4.0 &mgr;m MMD, and preferably 1.0-3.0 &mgr;m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 &mgr;m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 &mgr;m MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.

Abstract: Methods for preparing dry powders having hydrophobic and hydrophilic components comprise combining solutions of the components and spray drying them simultaneously in a spray dryer. The hydrophilic and hydrophobic component are separately dissolved in separate solvents and directed simultaneously through a nozzle, usually a coaxial nozzle, into the spray dryer. The method provides dry powders having relatively uniform characteristics.

Abstract: An aerosolization apparatus comprises a body having an inlet, an endpiece having an outlet, the endpiece being connectable to the body to define a chamber, wherein the chamber is sized to receive a capsule containing a pharmaceutical formulation in a manner which allows the capsule to move within the chamber. A connection mechanism is provided to provide selective connection of the endpiece to the body, and a locking member prevents undesired disconnection of the endpiece from the body. When a user inhales, air enters into the chamber through the inlet so that the pharmaceutical formulation is aerosolized within the chamber and the aerosolized pharmaceutical formulation is delivered to the user through the outlet. In another version, the endpiece and the body are hinged together.

Abstract: Spray drying methods for forming powder compositions for pharmaceutical applications are disclosed. According to one aspect of the invention, the spray drying feed stock comprises a bioactive agent, surfactant, and a blowing agent. Another aspect of the invention is directed to spray drying a feed stock comprising a phospholipid and calcium chloride.

Abstract: The invention provides various apparatus and methods for aerosolizing a powdered medicament. In one exemplary embodiment, an apparatus includes a pressurization cylinder, and a piston which is slidable within the cylinder to pressurize a gas. A handle is coupled to the piston and is movable between an extended position and a home position to pressurize the gas. An aerosolizing mechanism is included and is configured to aerosolize a powdered medicament that is held within a receptacle with pressurized gas from the cylinder. A carriage assembly is included to receive the receptacle and to couple the receptacle to the aerosolizing mechanism. A first and a second interlock are operably engageable with the carriage assembly to prevent coupling of the receptacle with the aerosolization mechanism. The first interlock is released to allow movement of the carriage upon movement of the handle to the extended position.

Abstract: A method for aerosolizing a powdered medicament comprises coupling a powder inlet end of a feed tube with a penetration in a receptacle containing the powder. Powder is drawn upward through the tube and dispersed in a high pressure gas stream flowing past a portion of the feed tube. Apparatus comprise the feed tube mounted within a base enclosure proximate a holder for one or more receptacles, which may be in the form of a cartridge containing a plurality of receptacles formed in a continuous web. The cartridge may be reciprocated relative to the feed tube and a separate piercing mechanism in order to sequentially piercing the receptacle and thereafter couple the feed tube through the resulting penetration for extracting the powder. Alternatively, penetration(s) through the receptacle may be formed as the feed tube is coupled, or some penetrations formed prior to coupling with other penetrations formed at the time of coupling.

Abstract: The present invention provides a highly dispersible formulation comprising an active agent and a dipeptide or tripeptide comprising at least two leucyl residues. The composition of the invention possesses superior aerosol properties and is thus preferred for aerosolized administration to the lung. Also provided are a method for (i) increasing the dispersibility of an active-agent containing formulation for administration to the lung, and (ii) delivery of the composition to the lungs of a subject.

Abstract: This invention relates to dispersible antibody compositions and methods for preparing and using these compositions. In particular, the present invention relates to dry powder dispersible antibody compositions wherein antibody conformation is preserved. The compositions have good powder dispersibility and other desirable characteristics for pulmonary delivery of therapeutic antibodies.

Abstract: According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 &mgr;m mass median diameter (MMD), usually 1.0-4.0 &mgr;m MMD, and preferably 1.0-3.0 &mgr;m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 &mgr;m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 &mgr;m MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.