Abstract: A method for making active pharmaceutical ingredient (“API”)-encapsulated polymer microspheres is provided, comprising: (A) preparing a dispersed phase (“DP”), comprising the steps of: (1) dissolving an API in a first solvent in a first vessel to form an API solution; (2) dissolving a biodegradable polymer in a second solvent in a second vessel to form a polymer solution; (3) combining the API solution and the polymer solution; and (4) mixing the combined solution to form the DP; (B) introducing the DP into a homogenization unit, wherein the time between the combining and the introducing consists of a predetermined contact time that is sufficiently short that the polymer does not undergo significant degradation attributable to the API, and the API does not undergo significant degradation or morphologic changes attributable to the polymer; (C) contacting the DP with a continuous phase (“CP”) in the homogenization unit; and (D) homogenizing the combined DP and CP.

Abstract: Microsphere formulations comprising naltrexone are provided. Methods of making and using the microsphere formulations are also provided.

Abstract: Extended-release microsphere formulations comprising a BTK inhibitor are provided. In one aspect, the microsphere formulations are characterized in that the BTK inhibitor is ibrutinib, and the ibrutinib is released in vivo in humans over a period of from about 7 to about 28 days. Methods for making and using the formulations are also provided.

Abstract: Extended-release injectable microsphere formulations comprising ketamine are provided. Methods for making and using the microsphere formulations are also provided.

Abstract: Various examples of systems and methods for making microspheres, microparticles, and emulsions are provided. In one example, a system and method for forming microspheres comprises: pumping a dispersed phase liquid and a continuous phase liquid into a levitating magnetic impeller pump to subject the dispersed phase liquid and continuous phase liquid to a high shear environment within the impeller pump's pump chamber. In another example, a system and method for forming an emulsion comprises: pumping a dispersed phase liquid and an inner aqueous phase liquid into a levitating magnetic impeller pump to subject the dispersed phase and the inner aqueous phase to a high shear environment within the impeller pump's pump chamber.

Abstract: Extended-release microsphere formulations comprising lurasidone are provided. In one aspect, the microsphere formulations are characterized in that the lurasidone is released in vivo in humans over a period of about 30 days. Methods for making and using the formulations are also provided.

Abstract: Extended-release, injectable microsphere formulations comprising ketamine are provided. Methods for making and using the microsphere formulations are also provided.

Abstract: Various examples of systems and methods for making microspheres, microparticles, and emulsions are provided. In one example, a system and method for forming microspheres comprises: pumping a dispersed phase liquid and a continuous phase liquid into a levitating magnetic impeller pump to subject the dispersed phase liquid and continuous phase liquid to a high shear environment within the impeller pump's pump chamber. In another example, a system and method for forming an emulsion comprises: pumping a dispersed phase liquid and an inner aqueous phase liquid into a levitating magnetic impeller pump to subject the dispersed phase and the inner aqueous phase to a high shear environment within the impeller pump's pump chamber.

Abstract: Various examples of systems and methods for making microspheres, microparticles, and emulsions are provided. In one example, a system and method for forming microspheres comprises: pumping a dispersed phase liquid and a continuous phase liquid into a levitating magnetic impeller pump to subject the dispersed phase liquid and continuous phase liquid to a high shear environment within the impeller pump's pump chamber. In another example, a system and method for forming an emulsion comprises: pumping a dispersed phase liquid and an inner aqueous phase liquid into a levitating magnetic impeller pump to subject the dispersed phase and the inner aqueous phase to a high shear environment within the impeller pump's pump chamber.

Abstract: Various examples of systems and methods for making microspheres, microparticles, and emulsions are provided. In one example, a system and method for forming microspheres comprises: pumping a dispersed phase liquid and a continuous phase liquid into a levitating magnetic impeller pump to subject the dispersed phase liquid and continuous phase liquid to a high shear environment within the impeller pump's pump chamber. In another example, a system and method for forming an emulsion comprises: pumping a dispersed phase liquid and an inner aqueous phase liquid into a levitating magnetic impeller pump to subject the dispersed phase and the inner aqueous phase to a high shear environment within the impeller pump's pump chamber.

Abstract: A method of making a sustained release microsphere formulation, wherein the release rate of a bioactive ingredient is manipulated by controlling the crystallinity of said bioactive ingredient, includes the steps of combining the active ingredient and an encapsulating polymer in at least one solvent, or mixtures thereof, to form a dispersed phase and processing the dispersed phase without filtering, filtering the combined dispersed phase with a hydrophobic or a hydrophilic filter, or filtering the active ingredient and encapsulating polymer individually with a hydrophobic or hydrophilic filter before combining them to form the dispersed phase. The dispersed phase is then combined with a continuous phase to form the microsphere formulation.

Abstract: A sustained release microsphere formulation with a high drug load may be formed by a continuous oil-in-water emulsion process by combining an organic dispersed phase with an aqueous continuous phase. The dispersed phase may include an encapsulating polymer, a primary solvent, such as dichloromethane, a pharmaceutically effective amount of an active agent having a solubility relative to the dispersed phase, and a co-solvent, such as benzyl alcohol, which is capable of increasing the solubility of the active agent relative to the dispersed phase. The continuous phase may include an aqueous solution of polyvinyl alcohol and water.

Abstract: A sustained release microsphere formulation with a high drug load may be formed by a continuous oil-in-water emulsion process by combining an organic dispersed phase with an aqueous continuous phase. The dispersed phase may include an encapsulating polymer, a primary solvent, such as dichloromethane, a pharmaceutically effective amount of an active agent having a solubility relative to the dispersed phase, and a co-solvent, such as benzyl alcohol, which is capable of increasing the solubility of the active agent relative to the dispersed phase. The continuous phase may include an aqueous solution of polyvinyl alcohol and water.

Abstract: A sustained release microsphere formulation with a high drug load may be formed by a continuous oil-in-water emulsion process by combining an organic dispersed phase with an aqueous continuous phase. The dispersed phase may include an encapsulating polymer, a primary solvent, such as dichloromethane, a pharmaceutically effective amount of an active agent having a solubility relative to the dispersed phase, and a co-solvent, such as benzyl alcohol, which is capable of increasing the solubility of the active agent relative to the dispersed phase. The continuous phase may include an aqueous solution of polyvinyl alcohol and water.

Abstract: A method of making a sustained release microsphere formulation, wherein the release rate of a bioactive ingredient is manipulated by controlling the crystallinity of said bioactive ingredient, includes the steps of combining the active ingredient and an encapsulating polymer in at least one solvent, or mixtures thereof, to form a dispersed phase and processing the dispersed phase without filtering, filtering the combined dispersed phase with a hydrophobic or a hydrophilic filter, or filtering the active ingredient and encapsulating polymer individually with a hydrophobic or hydrophilic filter before combining them to form the dispersed phase. The dispersed phase is then combined with a continuous phase to form the microsphere formulation.

Abstract: A sustained release microsphere formulation with a high drug load may be formed by a continuous oil-in-water emulsion process by combining an organic dispersed phase with an aqueous continuous phase. The dispersed phase may include an encapsulating polymer, a primary solvent, such as dichloromethane, a pharmaceutically effective amount of an active agent having a solubility relative to the dispersed phase, and a co-solvent, such as benzyl alcohol, which is capable of increasing the solubility of the active agent relative to the dispersed phase. The continuous phase may include an aqueous solution of polyvinyl alcohol and water.