Abstract: Provided herein are systems for treating a subject with a pulmonary infection, for example, a nontuberculous mycobacterial pulmonary infection, a Burkholderia pulmonary infection, a pulmonary infection associated with bronchiectasis, or a Pseudomonas pulmonary infection. The system includes a pharmaceutical formulation comprising a liposomal aminoglycoside dispersion, and the lipid component of the liposomes consist essentially of electrically neutral lipids. The system also includes a nebulizer which generates an aerosol of the pharmaceutical formulation at a rate greater than about 0.53 gram per minute. The aerosol is delivered to the subject via inhalation for the treatment of the pulmonary infection.

Abstract: Provided herein are systems for treating a subject with a pulmonary infection, for example, a nontuberculous mycobacterial pulmonary infection, a Burkholderia pulmonary infection, a pulmonary infection associated with bronchiectasis, or a Pseudomonas pulmonary infection. The system includes a pharmaceutical formulation comprising a liposomal aminoglycoside dispersion, and the lipid component of the liposomes consist essentially of electrically neutral lipids. The system also includes a nebulizer which generates an aerosol of the pharmaceutical formulation at a rate greater than about 0.53 gram per minute. The aerosol is delivered to the subject via inhalation for the treatment of the pulmonary infection.

Abstract: Provided herein are systems for treating a subject with a pulmonary infection, for example, a nontuberculous mycobacterial pulmonary infection, a Burkholderia pulmonary infection, a pulmonary infection associated with bronchiectasis, or a Pseudomonas pulmonary infection. The system includes a pharmaceutical formulation comprising a liposomal aminoglycoside dispersion, and the lipid component of the liposomes consist essentially of electrically neutral lipids. The system also includes a nebulizer which generates an aerosol of the pharmaceutical formulation at a rate greater than about 0.53 gram per minute. The aerosol is delivered to the subject via inhalation for the treatment of the pulmonary infection.

Abstract: Provided herein are systems for treating a subject with a pulmonary infection, for example, a nontuberculous mycobacterial pulmonary infection, a Burkholderia pulmonary infection, a pulmonary infection associated with bronchiectasis, or a Pseudomonas pulmonary infection. The system includes a pharmaceutical formulation comprising a liposomal aminoglycoside dispersion, and the lipid component of the liposomes consist essentially of electrically neutral lipids. The system also includes a nebulizer which generates an aerosol of the pharmaceutical formulation at a rate greater than about 0.53 gram per minute. The aerosol is delivered to the subject via inhalation for the treatment of the pulmonary infection.

Abstract: Provided herein are systems for treating a subject with a pulmonary infection, for example, a nontuberculous mycobacterial pulmonary infection, a Burkholderia pulmonary infection, a pulmonary infection associated with bronchiectasis, or a Pseudomonas pulmonary infection. The system includes a pharmaceutical formulation comprising a liposomal aminoglycoside dispersion, and the lipid component of the liposomes consist essentially of electrically neutral lipids. The system also includes a nebulizer which generates an aerosol of the pharmaceutical formulation at a rate greater than about 0.53 gram per minute. The aerosol is delivered to the subject via inhalation for the treatment of the pulmonary infection.

Abstract: The invention relates to an aerosol delivery device (A) comprising an aerosol generator for generating an aerosol in the aerosol delivery device with a membrane (1) and a vibrator (7) which is configured to vibrate a fluid and to aerosolise the fluid by the membrane (1).

Abstract: Medical devices having a barrier layer comprising an inorganic material. The medical device has a reservoir containing a therapeutic agent and the barrier layer is disposed over the reservoir. In one aspect, the barrier layer has one permeability to the therapeutic agent at one portion of the medical device and a different permeability at another portion of the medical device. In another aspect, the dosage amount of the therapeutic agent in the reservoir at one portion of the medical device is different from the dosage amount of the therapeutic agent in the reservoir at another portion of the medical device. In another aspect, a bioresorbable layer is disposed over the barrier layer at one or more portions of the medical device, wherein the bioresorbable layer comprises a bioresorbable material. Also, methods of coating a medical device are disclosed, in which a barrier layer over a medical device is formed using a lithographic etching process where a plurality of particles serve as an etch mask.

Abstract: Provided herein are systems for treating a subject with a pulmonary infection, for example, a nontuberculous mycobacterial pulmonary infection, a Burkholderia pulmonary infection, a pulmonary infection associated with bronchiectasis, or a Pseudomonas pulmonary infection. The system includes a pharmaceutical formulation comprising a liposomal aminoglycoside dispersion, and the lipid component of the liposomes consist essentially of electrically neutral lipids. The system also includes a nebulizer which generates an aerosol of the pharmaceutical formulation at a rate greater than about 0.53 gram per minute. The aerosol is delivered to the subject via inhalation for the treatment of the pulmonary infection.

Abstract: An expandable medical device having a particle layer disposed over a reservoir containing a therapeutic agent. The particle layer has a first porosity when the medical device is in the unexpanded configuration and a second porosity when the medical device is in the expanded configuration. The particle layer comprises a plurality of micron-sized or nano-sized particles. In certain embodiments, the particles are not connected to each other, and as such, the different porosities are provided by changes in the spacing between the particles as the medical device is expanded/unexpanded. Also disclosed are medical devices having a particle layer, wherein the particle layer comprises a plurality of encapsulated particles, and methods of coating medical devices with particles.

Abstract: In one aspect, a medical device has a first configuration and a second configuration, a reservoir containing a therapeutic agent, and a barrier layer disposed over the reservoir, wherein the barrier layer comprises an inorganic material. In another aspect, a medical device has a reservoir containing a therapeutic agent, a barrier layer disposed over the reservoir, wherein the barrier layer comprises an inorganic material, and a swellable material disposed between the barrier layer and a surface of the medical device, wherein the swellable material is a material that swells upon exposure to an aqueous environment. In yet another aspect, a medical device has a multi-layered coating having alternating reservoir layers and barrier layers, and a plurality of excavated regions penetrating through at least a partial thickness of the multi-layered coating.

Abstract: An aerosol generator for generating an aerosol from a fluid, comprising: a vibratable membrane (22) having a first side (24) for being in contact with the fluid and an opposite second side (25), the membrane having a plurality of through holes (26) penetrating the membrane in an extension direction (E) from the first side to the second side, whereby the fluid passes the through holes from the first side to the second side when the membrane is vibrated for generating the aerosol at the second side, each through hole (26) having along its extension direction (E) a smallest diameter (Ds), a larger diameter (DL) that is larger than the smallest diameter and defined by that diameter that is closest to triple, preferably twice said smallest diameter, each through hole having a nozzle portion (32) defined by that continuous portion of the through hole in the extension direction comprising the smallest diameter of the through hole and bordered by the larger diameter of the through hole, characterized in that the rati

Abstract: Aerosol generator having a liquid reservoir (10) defining in a sealed state a volume VR configured to hold an initial volume of liquid VL; a membrane (5) having openings, the liquid reservoir (10) being connected to the membrane (5) to feed the liquid to one side of the membrane, the membrane being oscillatable to transport the liquid through the openings whereby the liquid is emitted in the form of an aerosol on the other side of the membrane, wherein the volume VR of the liquid reservoir (10) before the membrane (5) is oscillated is configured to contain more than 5 ml of gas at an initial volume of the liquid VL of at least 5 ml.

Abstract: Medical devices having a barrier layer comprising an inorganic material. The medical device has a reservoir containing a therapeutic agent and the barrier layer is disposed over the reservoir. In one aspect, the barrier layer has one permeability to the therapeutic agent at one portion of the medical device and a different permeability at another portion of the medical device. In another aspect, the dosage amount of the therapeutic agent in the reservoir at one portion of the medical device is different from the dosage amount of the therapeutic agent in the reservoir at another portion of the medical device. In another aspect, a bioresorbable layer is disposed over the barrier layer at one or more portions of the medical device, wherein the bioresorbable layer comprises a bioresorbable material. Also, methods of coating a medical device are disclosed, in which a barrier layer over a medical device is formed using a lithographic etching process where a plurality of particles serve as an etch mask.

Abstract: A drug-eluting endoprosthesis that includes a bioerodible metal portion and a therapeutic agent. In some aspects, the endoprosthesis includes a plurality of discrete deposits and a plurality of overlying layers each overlying one of the plurality of discrete deposits. Each discrete deposit includes one or more therapeutic agents and each overlying layer includes one or more bioerodible metals. In other aspects, the bioerodible metal portion includes at least two bioerodible metal regions having different electronegativities. The at least two bioerodible metal regions being in electrical contact with each other. The bioerodible metal erodes in a physiological environment to release the therapeutic agent.

Abstract: An expandable medical device having a particle layer disposed over a reservoir containing a therapeutic agent. The particle layer has a first porosity when the medical device is in the unexpanded configuration and a second porosity when the medical device is in the expanded configuration. The particle layer comprises a plurality of micron-sized or nano-sized particles. In certain embodiments, the particles are not connected to each other, and as such, the different porosities are provided by changes in the spacing between the particles as the medical device is expanded/unexpanded. Also disclosed are medical devices having a particle layer, wherein the particle layer comprises a plurality of encapsulated particles, and methods of coating medical devices with particles.

Abstract: In one aspect, a medical device has a first configuration and a second configuration, a reservoir containing a therapeutic agent, and a barrier layer disposed over the reservoir, wherein the barrier layer comprises an inorganic material. In another aspect, a medical device has a reservoir containing a therapeutic agent, a barrier layer disposed over the reservoir, wherein the barrier layer comprises an inorganic material, and a swellable material disposed between the barrier layer and a surface of the medical device, wherein the swellable material is a material that swells upon exposure to an aqueous environment. In yet another aspect, a medical device has a multi-layered coating having alternating reservoir layers and barrier layers, and a plurality of excavated regions penetrating through at least a partial thickness of the multi-layered coating.

Abstract: A system and method for providing a coating on a self-expandable medical device such as a stent are disclosed. The system comprises a coating applicator at the distal end of a sheath which delivers coating material onto the stent as the stent is deployed from the sheath. Thus, the stent may be loaded into the sheath without a coating on the stent, thereby avoiding shearing off or damaging the coating during loading. Also, the coating is applied only as the stent exits the sheath, thereby avoiding shearing off or damaging the coating during deployment.