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: Systemic delivery of parathyroid hormone to a mammalian host is accomplished by inhalation through the mouth of a dispersion of an N-terminal fragment of PTH. It has been found that such respiratory delivery of the PTH fragment provides a pulsatile concentration profile of the PTH in the host's serum. PTH fragment compositions include dry powder formulations having the PTH present in a dry bulking powder, liquid solutions or suspensions suitable for nebulization, and aerosol propellants suitable for use in a metered dose inhaler.

Abstract: The invention provides various apparatus and methods for aerosolizing a powdered medicament. In one exemplary embodiment, an apparatus includes a pressurization cylinder, and a piston which is slidable within the cylinder to pressurize a gas. A handle is coupled to the piston and is movable between an extended position and a home position to pressurize the gas. An aerosolizing mechanism is included and is configured to aerosolize a powdered medicament that is held within a receptacle with pressurized gas from the cylinder. A carriage assembly is included to receive the receptacle and to couple the receptacle to the aerosolizing mechanism. A first and a second interlock are operably engageable with the carriage assembly to prevent coupling of the receptacle with the aerosolization mechanism. The first interlock is released to allow movement of the carriage upon movement of the handle to the extended position.

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 provides sustained release compositions that can be manufactured easily while providing long duration of the pharmaceutically useful protein being delivered. The compositions comprise insoluble complexes of the pharmaceutically useful protein and a precipitating agent at an appropriate ratio to achieve a desired sustained release profile. The precipitating agent can be selected from a group of various agents including divalent metal cations, Hofmeister series salts and pH adjusters. Particularly provided are compositions comprising insulin that are suitable for pulmonary delivery.

Abstract: Provided are stabilized follicle stimulating protein (FSP) dry powder compositions for aerosolized delivery to the deep lung, methods of preparing and administering such compositions, and methods for treating infertility involving administering the dry powders by pulmonary delivery to the deep lung.