Abstract: The present invention relates to compositions of methods of making and compositions small compositions of particles of an active agent. In accordance with the method of production, the active agent is dissolved in an aqueous or aqueous-miscible solvent containing a dissolved phase-separation enhancing agent (PSEA) to form a solution in a single liquid phase. The solution is subjected to a liquid-solid phase separation to cause the active agent to form small spherical that are substantially amorphous or non-crystalline and are injectable through fine gauge needles at high concentrations. The invention has special application for higher molecular weight proteins.

Abstract: The present invention is related to a method for preparing small spherical particles of an active agent by providing a solution in a single liquid phase. The single liquid phase comprises an active agent, a phase separation enhancing agent, and a first solvent. A phase change is induced at a controlled rate in the solution to cause a liquid-solid phase separation of the active agent and to form a solid phase and a liquid phase. The solid phase comprises solid small spherical particles of the active agent. The liquid phase comprises the phase separation enhancing agent and the solvent. The small spherical particles are substantially spherical and having a size from about 0.01 ?m to about 200 ?m.

Abstract: An encapsulated particle, comprising a plurality of preformed microparticles encapsulated in an amorphous matrix, wherein at least one of the preformed microparticles comprises a core microparticle and a monolayer associated with the outer surface of the core microparticle. The core microparticle comprises at least one active agent that is capable of being released from the encapsulated particle.

Abstract: Compositions of spherical insulin particles having improved pulmonary application potentials and methods of forming and using these compositions are disclosed in the present application. In one clinical trial with 30 healthy male human subjects, no coughing was observed upon a single pulmonary administration of the spherical insulin particles at an insulin dose of 6.5 mg, nor during the 10-hour post dosing period.

Abstract: Inhalable spherical particles that contain an active agent having unexpectedly good bioavailability when compared to the expected bioavailability are disclosed. Inhalable spherical particles, particles of the agent that contain an amount of a cation such as zinc provide for further improvement in bioavailability.

Abstract: Surface-modified microparticles and methods of making and using such particles are disclosed. The surface modified microparticles include a preformed or core microparticle that contains at least one active agent. The outer surface of the preformed or core microparticle carries a net surface charge. A monolayer is associated with the outer surface of the preformed or core microparticle.

Abstract: The present invention relates to compositions of methods of making and compositions small compositions of particles of an active agent. In accordance with the method of production, the active agent is dissolved in an aqueous or aqueous-miscible solvent containing a dissolved phase-separation enhancing agent (PSEA) to form a solution in a single liquid phase. The solution is subjected to a liquid-solid phase separation to cause the active agent to form small spherical that are substantially amorphous or non-crystalline and are injectable through fine gauge needles at high concentrations. The invention has special application for higher molecular weight proteins.

Abstract: The present invention is related to a method for preparing small spherical particles of an active agent by providing a solution in a single liquid phase. The single liquid phase comprises an active agent, a phase separation enhancing agent, and a first solvent. A phase change is induced at a controlled rate in the solution to cause a liquid-solid phase separation of the active agent and to form a solid phase and a liquid phase. The solid phase comprises solid small spherical particles of the active agent. The liquid phase comprises the phase separation enhancing agent and the solvent. The small spherical particles are substantially spherical and having a size from about 0.01 ?m to about 200 ?m.

Abstract: The present invention relates to methods of making and compositions of microencapsulated small particles of an active agent. In accordance with the method of production, the active agent is dissolved in an aqueous or aqueous-miscible solvent containing a dissolved phase-separation enhancing agent (PSEA) to form a solution in a single liquid phase. The solution is then subjected to a liquid-solid phase separation to cause the active agent to form solid spherical small particles in the solid phase while the PSEA and solvent comprising the liquid phase. The spherical small particles formed are then microencapsulated within a polymeric matrix using an emulsion/evaporation process.

Abstract: The present invention is related to a method for preparing small spherical particles of an active agent by providing a solution in a single liquid phase. The single liquid phase comprises an active agent, a phase separation enhancing agent, and a first solvent. A phase change is induced at a controlled rate in the solution to cause a liquid-solid phase separation of the active agent and to form a solid phase and a liquid phase. The solid phase comprises solid small spherical particles of the active agent. The liquid phase comprises the phase separation enhancing agent and the solvent. The small spherical particles are substantially spherical and having a size from about 0.01 ?m to about 200 ?m.

Abstract: The present invention relates to methods of making and compositions of microencapsulated small particles of an active agent. In accordance with the method of production, the active agent is dissolved in an aqueous or aqueous-miscible solvent containing a dissolved phase-separation enhancing agent (PSEA) to form a solution in a single liquid phase. The solution is then subjected to a liquid-solid phase separation to cause the active agent to form solid spherical small particles in the solid phase while the PSEA and solvent comprising the liquid phase. The spherical small particles formed are then microencapsulated within a polymeric matrix using an emulsion/evaporation process.

Abstract: The present invention is related to a method for preparing small spherical particles of an active agent by providing a solution in a single liquid phase. The single liquid phase comprises an active agent, a phase separation enhancing agent, and a first solvent. A phase change is induced at a controlled rate in the solution to cause a liquid-solid phase separation of the active agent and to form a solid phase and a liquid phase. The solid phase comprises solid small spherical particles of the active agent. The liquid phase comprises the phase separation enhancing agent and the solvent. The small spherical particles are substantially spherical and having a size from about 0.01 ?m to about 200 ?m.

Abstract: The present invention is related to a method for preparing small spherical particles of an active agent by providing a solution in a single liquid phase. The single liquid phase comprises an active agent, a phase separation enhancing agent, and a first solvent. A phase change is induced at a controlled rate in the solution to cause a liquid-solid phase separation of the active agent and to form a solid phase and a liquid phase. The solid phase comprises solid small spherical particles of the active agent. The liquid phase comprises the phase separation enhancing agent and the solvent. The small spherical particles are substantially spherical and having a size from about 0.01 ?m to about 200 ?m.

Abstract: Pulmonary formulations containing microparticles and a propellant are provided. The microparticles, preferably microspheres, contain protein and exhibit a fine particle fraction in the range of 25 to 100%.

Abstract: Methods for forming sustained release microspheres and the products produced thereby are provided. The microspheres have a smooth surface that includes a plurality of channel openings that are less than 1000 angstroms in diameter.

Abstract: Methods for forming sustained release microspheres and the products produced thereby are provided. The microspheres have a smooth surface that includes a plurality of channel openings that are less than 1000 angstroms in diameter.