Abstract: Provided herein are carrier-based dry powder formulations to be administered as dry powders for inhalation and that enable improved targeting within the respiratory tract (e.g., to the lower respiratory tract) of patients. The carrier-based dry powder formulations described herein have a desired size and impaction parameter that promotes targeted delivery of formulations to regions of the lungs and reduce the loss of drugs in the formulation to deposition in other regions of the respiratory tract (e.g., URT). Also provided herein are methods of producing the formulations, methods of making the formulations, and methods of aerosolizing and using the formulations to treat disease.

Abstract: The present invention comprises methods and formulations to increase drug payload, especially in regard to a receptacle-based, inhalation dosed, dry powder therapeutic, wherein the methods and formulations are characterized by a high product density, as well as a high TLD per receptacle, while maintaining highly efficient aerosol performance from the device. Embodiments of the present invention comprise a spray-dried pharmaceutical powder comprising particles deliverable from a dry powder inhaler, the composition comprising active agent, and a shell-forming excipient, wherein the powder is characterized by a product density greater than 50 mg/ml.

Abstract: Disclosed are inhalation formulations of dry powders comprising particles and processes which yield particles to effectively bypass unwanted deposition in the mouth and throat. Embodiments of the invention are characterized by an inertial parameter which provide an in vitro total lung dose of greater than 80% of a nominal dose. Embodiments of formulations include neat formulations containing active agent only; formulations of active agent and buffer; and formulations comprising active agent, a glass-forming, and/or a shell-forming excipient. Also provided are methods for making the dry powder formulations. The powder formulations are useful for the treatment of diseases and conditions especially respiratory diseases and conditions.

Abstract: A powder aerosolization apparatus comprises a housing comprising an outlet adapted to be inserted into a user's mouth and one or more bypass air openings. A receptacle support within the housing supports a receptacle containing a powder pharmaceutical formulation. A puncturing mechanism within the housing creates in the receptacle one or more inlet openings and one or more powder outflow openings, wherein the powder outflow openings have a total area of from 0.2 mm2 to 4.0 mm2. Upon a user's inhalation through the outlet, air flows through the one or more bypass air openings and through the receptacle to aerosolize the powder pharmaceutical formulation in the receptacle. In one version, the relative flow parameters between the flow through the one or more bypass openings and the one or more powder outflow openings are selected so that flow of aerosolized pharmaceutical formulation does not occur until a predetermined inhalation flow rate is achieved.

Abstract: Embodiments of the present invention provide a dry powder composition comprising porous carrier particles associated with one, two, three or more micronized drugs or APIs wherein an ordered mixture between the micronized drug or drugs and the carrier particle results, such that the micronized drug or drugs adhere strongly to the carrier particles forming a stable ordered mixture of respirable agglomerates. Embodiments of the present invention further comprise a spray-drying process to create the respirable agglomerates. Embodiments of the present invention further relate to the use of the dry powder formulation comprising respirable agglomerates for the treatment of a patient having a disease or condition which is treatable thereby.

Abstract: Embodiments of the present invention provide a dry powder composition comprising porous carrier particles associated with one, two, three or more micronized drugs or APIs wherein an ordered mixture between the micronized drug or drugs and the carrier particle results, such that the micronized drug or drugs adhere strongly to the carrier particles forming a stable ordered mixture of respirable agglomerates. Embodiments of the present invention further comprise a spray-drying process to create the respirable agglomerates. Embodiments of the present invention further relate to the use of the dry powder formulation comprising respirable agglomerates for the treatment of a patient having a disease or condition which is treatable thereby.

Abstract: Embodiments of the present invention provide a dry powder composition comprising porous carrier particles associated with one, two, three or more micronized drugs or APIs wherein an ordered mixture between the micronized drug or drugs and the carrier particle results, such that the micronized drug or drugs adhere strongly to the carrier particles forming a stable ordered mixture of respirable agglomerates. Embodiments of the present invention further comprise a spray-drying process to create the respirable agglomerates. Embodiments of the present invention further relate to the use of the dry powder formulation comprising respirable agglomerates for the treatment of a patient having a disease or condition which is treatable thereby.

Abstract: Phospholipid based powders for drug delivery applications are disclosed. The powders comprise a polyvalent cation in an amount effective to increase the gel-to-liquid crystal transition temperature of the particle compared to particles without the polyvalent cation. The powders are hollow and porous and are preferably administered via inhalation.

Abstract: The present invention is directed to the administration of aminoglycosides. In particular, the present invention is directed to compositions and methods for the pulmonary administration of aminoglycosides. According to a preferred embodiment, compositions and methods are provided for the localized treatment of respiratory infections.

Abstract: Dry powder formulations for inhalation comprising spray-dried particles and their use in the treatment of an obstructive or inflammatory airways disease. Each particle has a core of a first active ingredient in substantially crystalline form that is coated with a layer of a second active ingredient in substantially amorphous form that is dispersed in a pharmaceutically acceptable hydrophobic excipient. A process for preparing such formulations is also described.

Abstract: A microparticle for drug delivery comprises an active agent and an excipient, the excipient comprising a metal ion-lipid complex. The metal ion is chosen from the group consisting of lanthanide metals, actinide metals, group IIa and IIIb metals, transition metals or mixtures thereof. The lipid comprises a phospholipid. The complex results in a glass transition temperature increase of the microparticle.

Abstract: A microparticle for drug delivery comprises an active agent and an excipient, the excipient comprising a metal ion-lipid complex. The metal ion is chosen from the group consisting of lanthanide metals, actinide metals, group IIa and IIIb metals, transition metals or mixtures thereof. The lipid comprises a phospholipid. The complex results in a glass transition temperature increase of the microparticle.

Abstract: A powder aerosolization apparatus comprises a housing comprising an outlet adapted to be inserted into a user's mouth and one or more bypass air openings. A receptacle support within the housing supports a receptacle containing a powder pharmaceutical formulation. A puncturing mechanism within the housing creates in the receptacle one or more inlet openings and one or more powder outflow openings, wherein the powder outflow openings have a total area of from 0.2 mm2 to 4.0 mm2. Upon a user's inhalation through the outlet, air flows through the one or more bypass air openings and through the receptacle to aerosolize the powder pharmaceutical formulation in the receptacle. In one version, the relative flow parameters between the flow through the one or more bypass openings and the one or more powder outflow openings are selected so that flow of aerosolized pharmaceutical formulation does not occur until a predetermined inhalation flow rate is achieved.

Abstract: Embodiments of the present invention provide a dry powder composition comprising porous carrier particles associated with one, two, three or more micronized drugs or APIs wherein an ordered mixture between the micronized drug or drugs and the carrier particle results, such that the micronized drug or drugs adhere strongly to the carrier particles forming a stable ordered mixture of respirable agglomerates. Embodiments of the present invention further comprise a spray-drying process to create the respirable agglomerates. Embodiments of the present invention further relate to the use of the dry powder formulation comprising respirable agglomerates for the treatment of a patient having a disease or condition which is treatable thereby.

Abstract: Phospholipid based powders for drug delivery applications are disclosed. The powders comprise a polyvalent cation in an amount effective to increase the gel-to-liquid crystal transition temperature of the particle compared to particles without the polyvalent cation. The powders are hollow and porous and are preferably administered via inhalation.

Abstract: The present invention is directed to the administration of aminoglycosides. In particular, the present invention is directed to compositions and methods for the pulmonary administration of aminoglycosides. According to a preferred embodiment, compositions and methods are provided for the localized treatment of respiratory infections.

Abstract: A dispersible powder composition comprises aminoglycoside for delivery to the lungs. The composition is effective to provide a therapeutically effective therapy via administration of less than 6 respirable unit doses by inhalation, wherein each unit dose comprises a volume of 0.30 to 0.95 mL.

Abstract: Phospholipid based powders for drug delivery applications are disclosed. The powders may include a polyvalent cation in an amount effective to increase the gel-to-liquid crystal transition temperature of the particle compared to particles without the polyvalent cation. The powders are hollow and porous and are preferably administered via inhalation.

Abstract: Dry powder formulations for inhalation comprising spray-dried particles and their use in the treatment of an obstructive or inflammatory airways disease. Each particle has a core of a first active ingredient in substantially crystalline form that is coated with a layer of a second active ingredient in substantially amorphous form that is dispersed in a pharmaceutically acceptable hydrophobic excipient. A process for preparing such formulations is also described.

Abstract: A microparticle for drug delivery comprises an active agent and an excipient, the excipient comprising a metal ion-lipid complex. The metal ion is chosen from the group consisting of lanthanide metals, actinide metals, group IIa and IIIb metals, transition metals or mixtures thereof. The lipid comprises a phospholipid. The complex results in a glass transition temperature increase of the microparticle.