Abstract: New crystalline forms of lopinavir are disclosed.

Abstract: This invention provides compositions and methods for stabilizing a live attenuated virus in dried formulations. In particular, compositions and methods of preparing a dried vaccine are provided that stabilize the viability of live vaccines such as measles and adenovirus at room temperature.

Abstract: Compositions, methods and systems are provided for pulmonary or nasal delivery of two or more active agents via a metered dose inhaler. In one embodiment, the compositions include a suspension medium, active agent particles, and suspending particles, in which the active agent particles and suspending particles form a co-suspension within the suspension medium.

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: This invention provides methods and compositions for stabilizing proteins and vaccines in dried formulations. In particular, a cavitation method and compositions of preparing a dried vaccine are provided that stabilize the viability of live bacteria and live virus vaccines at room temperature.

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: This invention provides formulations and methods for stabilizing viruses in liquid and dried formulations. In particular, formulations are provided including Zn2+ cations that stabilize the viability of Rotaviruses. Methods of vaccination include neutralization of gastric contents and administration of the vaccine formulations of the invention.

Abstract: Methods of modifying the rate of systemic absorption of a drug administered to a subject by a pulmonary route, the method comprising covalently conjugating a hydrophilic polymer to a drug, wherein the drug has a half-life of elimination from the lung of less than about 180 minutes, to form a drug-polymer conjugate, wherein the drug-polymer conjugate has a net hydrophilic character and a weight average molecular weight of from about 50 to about 20,000 Daltons, and wherein the half-life of elimination from the lung of the drug-polymer conjugate is at least about 1.5-fold greater than the half-life of elimination from the lung of the drug, wherein the half-life of elimination from the lung is measured by bronchoalveolar lavage followed by assaying residual lung material.

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: 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: 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: New crystalline forms of lopinavir are disclosed.

Abstract: Methods of modifying the rate of systemic absorption of a drug administered to a subject by a pulmonary route, the method comprising covalently conjugating a hydrophilic polymer to a drug, wherein the drug has a half-life of elimination from the lung of less than about 180 minutes, to form a drug-polymer conjugate, wherein the drug-polymer conjugate has a net hydrophilic character and a weight average molecular weight of from about 50 to about 20,000 Daltons, and wherein the half-life of elimination from the lung of the drug-polymer conjugate is at least about 1.5-fold greater than the half-life of elimination from the lung of the drug, wherein the half-life of elimination from the lung is measured by bronchoalveolar lavage followed by assaying residual lung material.

Abstract: One or more embodiments of the invention provide various novel formulations, and tablet dosage forms, comprising losartan that are non-crystalline, stable, and/or otherwise improvements over known losartan formulations. One or more embodiments of the invention further provide methods for preparing the formulation, methods for preparing the tablet dosage form, and to methods of administering the tablet dosage and/or formulation comprising losartan. The losartan-containing formulations may be administered to a user to treat hypertension, and related conditions.

Abstract: A powder containing methotrexate particles in liquid crystal form suitable for inhalation.

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: An aerosolizable formulation comprises free-base nicotine, an organic acid, and a hydrofluoroalkane propellant. The organic acid is present in a mole ratio with said nicotine in a range of about 0.25:1 (organic acid:nicotine) to about 4:1 (organic acid:nicotine). The organic acid and said free-base nicotine form a nicotine salt. An equivalent mixture of free-base nicotine and organic acid in water has a pH between about pH 3.0 and about pH 9.0. The aerosolizable formulation is aerosolizable, for example, by a metered dose inhaler for administration to a user.

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: New crystalline forms of lopinavir are disclosed.

Abstract: New crystalline forms of lopinavir are disclosed.