Abstract: Processes for preparing micronized particles comprising a poorly water soluble bioactive agent are provided. The processes utilize a superheated aqueous phase which can serve as the continuous phase of an emulsion. The superheated aqueous phase can be used to melt poorly water soluble bioactive agents and/or matrix materials which them form molten droplets dispersed within the superheated aqueous phase. The size and size distribution of the molten droplets can be controlled using a variety of suitable methods. The molten droplets can then be cooled to form micronized particles comprising the poorly water soluble bioactive agent. If desired, the cooling rate can be selected to control the crystalline morphology of the resulting micronized particles.

Abstract: A device for coating dry powder microparticles onto a surface may include a jet mill configured to mill dry powder particles into microparticles having a desired aerodynamic diameter and to deaggregate the microparticles, a feed hopper structured and arranged to feed dry powder particles to the jet mill, a surface configured to receive dry powder microparticles and an exit nozzle associated with the jet mill. The exit nozzle may be arranged to direct deaggregated micronized dry powder particles from the jet mill to the surface to be coated. The device may further include a holder structured and arranged to hold an item, wherein the item includes the surface. In some aspects of the device, the item may be a film.

Abstract: Disclosed are aerosol-mediated methods for synthesizing particles for biomedical and drug delivery applications. The method is based on the production of particles from sprayed polymeric micro or nano-droplets obtained by, for example, an air-jet nebulization process that is followed by gelation and/or hardening in a crosslinking fluid, non-solvent, precipitating solvent, or supercritical fluid.

Abstract: A device for coating dry powder microparticles onto a surface may include a jet mill configured to mill dry powder particles into microparticles having a desired aerodynamic diameter and to deaggregate the microparticles, a feed hopper structured and arranged to feed dry powder particles to the jet mill, a surface configured to receive dry powder microparticles and an exit nozzle associated with the jet mill The exit nozzle may be arranged to direct deaggregated micronized dry powder particles from the jet mill to the surface to be coated. The device may further include a holder structured and arranged to hold an item, wherein the item includes the surface. In some aspects of the device, the item may be a film.

Abstract: A dry powder inhaler including a housing defining a chamber for receiving a dose of powdered medicament, an inhalation port in fluid communication with the chamber, at least one airflow inlet providing fluid communication between the chamber and an exterior of the housing, and a flutter element in the chamber and associated with a dose of powdered medicament. The flutter element has a tensioned distal end proximate the at least one airflow inlet and a free proximal end opposite to the distal end and downstream of the inlet. The flutter element is configured to vibrate in response to airflow through the chamber and aerosolize the dose of powdered medicament.

Abstract: A method of method of coating powdered medical agent onto a carrier particle for use in a dry powder inhaler may include applying ultrasonic energy to agglomerated powdered medical agent to deaggregate and aerosolize particles of the medical agent into particles having a desired average particle size, and coating at least one carrier particle with a desired amount of the deaggregated and aerosolized particles of the medical agent.

Abstract: Dry powder aerosol generators and related methods are provided. The dry powder aerosol generator includes a dispersion chamber having an internal cavity therein capable of receiving a dry powdered drug. The dispersion chamber includes a dosing port defined therein that is in fluid communication with the internal cavity. A dosing chamber for receiving a test subject is attachable to the dosing port, such that, when an airflow is created within the internal cavity, any dry powdered drug contained therein may fluidize and travel into the dosing chamber to provide opportunity for inhalation of the dry powdered drug by a test subject contained within the dosing chamber.

Abstract: Disclosed are aerosol-mediated methods for synthesizing particles for biomedical and drug delivery applications. The method is based on the production of particles from sprayed polymeric micro or nano-droplets obtained by, for example, an air-jet nebulization process that is followed by gelation and/or hardening in a crosslinking fluid, non-solvent, precipitating solvent, or supercritical fluid.

Abstract: An apparatus for generating an aerosol of a therapeutic agent and methods of using the same are disclosed. The apparatus comprises a heating element having a surface and a composition coating at least a portion of the heating element surface. The composition comprises a carrier and a therapeutic agent, wherein when the heating element surface is heated to at least the vaporization point of the carrier, the carrier vaporizes and releases the therapeutic agent from the composition as an aerosol. The heating element can be a coiled filament. The therapeutic agent can be a small molecule, a polynucleotide, a polypeptide, or a recombinant virus. The apparatus can be incorporated into a delivery device, such as a metered dose inhaler or an exposure chamber.

Abstract: Methods of modulating a characteristic of a pharmaceutical compound spray by acoustic measurement and control of the pharmaceutical spray are disclosed. The methods include analyzing a selected characteristic of a pharmaceutical compound spray utilizing acoustic measurement to develop corresponding acoustic data. The methods further include controlling the selected characteristic by applying acoustic excitation to the pharmaceutical compound spray in accordance with the acoustic data developed.

Abstract: A dry powder inhaler may include a drug chamber configured to contain a formulation including carrier particles and working agent particles, a mouthpiece configured to direct flow of working agent particles to a user, and a retaining member proximal the mouthpiece. The retaining member be sized and arranged to prevent flow of substantially all carrier particles to the user while permitting flow of working agent particles to a user. The inhaler may include a formulation including carrier particles for delivering working agent to the pulmonary system of a patient. The carrier particles may have an average sieve diameter greater than about 500 ?m. The carrier particles may be one of polystyrene, PTFE, silicone glass, and silica gel or glass.

Abstract: Dry powder aerosol generators and related methods are provided. The dry powder aerosol generator includes a dispersion chamber having an internal cavity therein capable of receiving a dry powdered drug. The dispersion chamber includes a dosing port defined therein that is in fluid communication with the internal cavity. A dosing chamber for receiving a test subject is attachable to the dosing port, such that, when an airflow is created within the internal cavity, any dry powdered drug contained therein may fluidize and travel into the dosing chamber to provide opportunity for inhalation of the dry powdered drug by a test subject contained within the dosing chamber.

Abstract: An apparatus for generating an aerosol of a therapeutic agent and methods of using the same are disclosed. The apparatus comprises a heating element having a surface and a composition coating at least a portion of the heating element surface. The composition comprises a carrier and a therapeutic agent, wherein when the heating element surface is heated to at least the vaporization point of the carrier, the carrier vaporizes and releases the therapeutic agent from the composition as an aerosol. The heating element can be a coiled filament. The therapeutic agent can be a small molecule, a polynucleotide, a polypeptide, or a recombinant virus. The apparatus can be incorporated into a delivery device, such as a metered dose inhaler or an exposure chamber.

Abstract: Methods of modulating a characteristic of a pharmaceutical compound spray by acoustic measurement and control of the pharmaceutical spray are disclosed. The methods include analyzing a selected characteristic of a pharmaceutical compound spray utilizing acoustic measurement to develop corresponding acoustic data. The methods further include controlling the selected characteristic by applying acoustic excitation to the pharmaceutical compound spray in accordance with the acoustic data developed.