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: The invention provides molecules, e.g., antibodies or antibody fragments, that specifically bind thymic stromal lymphopoietin (TSLP), compositions comprising these molecules, and methods of using and producing these molecules.

Abstract: The invention provides molecules, e.g., antibodies or antibody fragments, that specifically bind thymic stromal lymphopoietin (TSLP), compositions comprising these molecules, and methods of using and producing these molecules.

Abstract: Embodiments of the invention relate to particulate agents and compositions comprising particulate agents for inhalation, and methods for preparing such particulate agents and compositions for inhalation, as well as therapeutic methods. Embodiments of the method comprise preparing an emulsion by combining an oil phase dispersion of hydrophobic seed particles and an aqueous dispersion comprising an emulsifier and an emulsion stabilizer and preparing a feedstock comprising encapsulated particles by homogenizing the emulsion, and forming a plurality of coated particles by spray drying the feedstock, wherein resulting particles comprises a porous shell disposed on or over a core and the core comprises at least one hydrophobic seed particle.

Abstract: Embodiments of the invention relate to a process for enhancing the bioavailability of poorly soluble active ingredients, and to formulations of powders made by such process. Embodiments of the invention comprise a spinodal decomposition method by which low, sparingly or poorly-soluble materials are converted to amorphous materials with, improved or enhanced solubility suitable for therapeutic use. The powder formulations are useful for the treatment of diseases and conditions, especially respiratory diseases and conditions.

Abstract: The invention provides molecules, e.g., antibodies or antibody fragments, that specifically bind thymic stromal lymphopoietin (TSLP), compositions comprising these molecules, and methods of using and producing these molecules.

Abstract: The invention provides molecules, e.g., antibodies or antibody fragments, that specifically bind thymic stromal lymphopoietin (TSLP), compositions comprising these molecules, and methods of using and producing these molecules.

Abstract: The invention provides molecules, e.g., antibodies or antibody fragments, that specifically bind thymic stromal lymphopoietin (TSLP), compositions comprising these molecules, and methods of using and producing these molecules.

Abstract: Embodiments of the invention relate to particulate agents and compositions comprising particulate agents for inhalation, and methods for preparing such particulate agents and compositions for inhalation, as well as therapeutic methods. Embodiments of the method comprise preparing an emulsion by combining an oil phase dispersion of hydrophobic seed particles and an aqueous dispersion comprising an emulsifier and an emulsion stabilizer and preparing a feedstock comprising encapsulated particles by homogenizing the emulsion, and forming a plurality of coated particles by spray drying the feedstock, wherein resulting particles comprises a porous shell disposed on or over a core and the core comprises at least one hydrophobic seed particle.

Abstract: Dry powder formulations for inhalation and their use in the treatment diseases and conditions. The formulation contains a uniform blend of a first spray-dried powder and a second spray-dried powder. The first spray-dried powder contains spray-dried particles of a therapeutically active ingredient dispersed in a pharmaceutically acceptable hydrophobic excipient. The second spray-dried powder contains spray-dried particles formed from a pharmaceutically acceptable hydrophobic excipient but are substantially free of any therapeutically active ingredient. The active ingredient in the first spray-dried powder is loaded sufficiently high to compensate for the second spray-dried powder being substantially free of any active ingredient. A process for preparing such formulations is also described.

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: 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: The present invention comprises compositions and formulations comprising amphotericin B, compositions and formulations comprising amphotericin B with one or more excipients, methods of making amphotericin B compositions and formulations, as well as systems for using amphotericin B compositions and formulations. Also provided are pharmaceutical compositions comprising the formulation, methods of administering the pharmaceutical compositions and methods of treating patients with the pharmaceutical compositions.

Abstract: A composition includes particles including at least about 95 wt % of amphotericin B, wherein the particles have a mass median diameter ranging from about 1.1 ?m to about 1.9 ?m. Another composition also includes particles including at least about 95 wt % of amphotericin B, wherein at least about 80 wt % of the particles have a geometric diameter ranging from about 1.1 ?m to about 1.9 ?m. Yet another composition includes particles including amphotericin B, wherein the particles have a mass median diameter less than about 1.9 ?m, and wherein the amphotericin B has a crystallinity level of at least about 20%. Unit dosage forms, delivery systems, and methods may involve similar compositions.

Abstract: The present invention comprises compositions and formulations comprising amphotericin B, compositions and formulations comprising amphotericin B with one or more excipients, methods of making amphotericin B compositions and formulations, as well as systems for using amphotericin B compositions and formulations. Also provided are pharmaceutical compositions comprising the formulation, methods of administering the pharmaceutical compositions and methods of treating patients with the pharmaceutical compositions.

Abstract: A composition includes particles including at least about 95 wt % of amphotericin B, wherein the particles have a mass median diameter ranging from about 1.1 ?m to about 1.9 ?m. Another composition also includes particles including at least about 95 wt % of amphotericin B, wherein at least about 80 wt % of the particles have a geometric diameter ranging from about 1.1 ?m to about 1.9 ?m. Yet another composition includes particles including amphotericin B, wherein the particles have a mass median diameter less than about 1.9 ?m, and wherein the amphotericin B has a crystallinity level of at least about 20%. Unit dosage forms, delivery systems, and methods may involve similar compositions.

Abstract: A protectant mixture for use in preserving biological materials comprising (1) at least one polyhydroxy compound, where the total amount of polyhydroxy compound in the mixture is from about 5% to about 60% by weight of the mixture where the mixture is an aqueous solution and is from about 10% to about 95% where the mixture is in solid form, and (2) phosphate ions, where the total amount of phosphate ions in the mixture is such that the molar ratio of phosphate ions to hydroxy groups in the polyhydroxy compound is from about 0.025 to about 0.625; a preservation medium comprising (1) a biological material, (2) at least one polyhydroxy compound, where the total amount of polyhydroxy compound in the medium is from about 5% to about 60% by weight of the medium, and (3) phosphate ions, where the total amount of phosphate ions in the mixture is such that the molar ratio of phosphate ions to hydroxy groups in the polyhydroxy compound is from about 0.025 to about 0.

Abstract: A method of preparing a pharmaceutical formulation comprises providing a solution comprising a first solvent, a second solvent, an active agent, and an excipient. The second solvent is less polar than the first solvent and the excipient is more soluble in water than the active agent. The first and second solvents are removed from the solution to produce particles comprising the active agent and the excipient. In one version, the excipient comprises an amino acid and/or a phospholipid. A pharmaceutical formulation made by a version of the invention comprises particles comprising an active agent and an excipient which at least partially encapsulates the active agent, wherein the excipient is more soluble in water than the active agent.

Abstract: A protectant mixture for use in preserving biological materials comprising (1) at least one polyhydroxy compound, where the total amount of polyhydroxy compound in the mixture is from about 5% to about 60% by weight of the mixture where the mixture is an aqueous solution and is from about 10% to about 95% where the mixture is in solid form, and (2) phosphate ions, where the total amount of phosphate ions in the mixture is such that the molar ratio of phosphate ions to hydroxy groups in the polyhydroxy compound is from about 0.025 to about 0.625; a preservation medium comprising (1) a biological material, (2) at least one polyhydroxy compound, where the total amount of polyhydroxy compound in the medium is from about 5% to about 60% by weight of the medium, and (3) phosphate ions, where the total amount of phosphate ions in the mixture is such that the molar ratio of phosphate ions to hydroxy groups in the polyhydroxy compound is from about 0.025 to about 0.

Abstract: Pulmonary delivery of dry powder formulations by aerosol inhalation has received much attention as an attractive alternative to intravenous, intramuscular, and subcutaneous injection, since this approach eliminates the necessity for injection syringes and needles. The present invention provides dry powder filled cellulose-based capsules having particular utility for use with dry powder inhalers. Such capsules not only readily coordinate with conventional DPIs but also coordinate with conventional powder filling technologies, thereby saving time, labor and cost. The invention further provides a novel procedure for determining, ab initio, appropriate and optimal conditions for preparing such powder filled capsules. Specifically, when packaging dry powder formulations for long-term storage, it is important to ensure that the water content of the powder does not exceed the critical moisture point, that point at which the powder loses physical and chemical stability.