Abstract: A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.

Abstract: A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.

Abstract: A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.

Abstract: A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.

Abstract: A pharmaceutically acceptable insulin premix formulation contains about 0.1-10.0 Unit/mL of insulin for intravenous administration and preferably further contains a tonicity adjuster. The methods for making and using such formulation are also provided. The pharmaceutically acceptable insulin premix formulation may be aseptically filled into a flexible container assembly to form a pharmaceutical insulin premix product. The insulin premix product can be a sterile and ready-to-use aqueous solution for glycemic control in an individual with metabolic disorders through intravenous infusion. The insulin premix product is unexpectedly stable when freshly prepared and also during its shelf-life of storage at refrigeration temperatures of 2° C. to 5° C. for 24 months followed by additional 30 days at room temperatures of 23° C. to 27° C., even without any added preservative, any added zinc, any added surfactant or any other added stabilizing excipient.

Abstract: Stable pharmaceutical formulations and methods of making same are provided. In a general embodiment, the present disclosure provides a method of making a stable pharmaceutical formulation comprising adding one or more vitrifying additives to an aqueous pharmaceutical solution to raise the glass transition temperature of the aqueous pharmaceutical solution. The aqueous pharmaceutical solution can be cooled to a temperature of about ?50° C. to about ?10° C. The vitrifying additive enhances the formation of a glass or amorphous solid of the aqueous pharmaceutical solution at cryogenic temperatures (?50 to ?10° C.), and the pharmaceutical formulation can be thawed to liquid form and administered to a mammalian subject.

Abstract: Stable pharmaceutical formulations and methods of making same are provided. In a general embodiment, the present disclosure provides a method of making a stable pharmaceutical formulation comprising adding one or more vitrifying additives to an aqueous pharmaceutical solution to raise the glass transition temperature of the aqueous pharmaceutical solution. The aqueous pharmaceutical solution can be cooled to a temperature of about ?50° C. to about ?10° C. The vitrifying additive enhances the formation of a glass or amorphous solid of the aqueous pharmaceutical solution at cryogenic temperatures (?50 to ?10° C.), and the pharmaceutical formulation can be thawed to liquid form and administered to a mammalian subject.

Abstract: The present invention relates to compositions of submicron- to micron-size particles of antimicrobial agents. More particularly the invention relates to a composition of an antimicrobial agent that renders the agent potent against organisms normally considered to be resistant to the agent. The composition comprises an aqueous suspension of submicron- to micron-size particles containing the agent coated with at least one surfactant selected from the group consisting of: ionic surfactants, non-ionic surfactants, biologically derived surfactants, and amino acids and their derivatives. The particles have a volume-weighted mean particle size of less than 5 ?m as measured by laser diffractometry.

Abstract: Stable pharmaceutical formulations and methods of making same are provided. In a general embodiment, the present disclosure provides a method of making a stable pharmaceutical formulation comprising adding one or more vitrifying additives to an aqueous pharmaceutical solution to raise the glass transition temperature of the aqueous pharmaceutical solution. The aqueous pharmaceutical solution can be cooled to a temperature of about ?50° C. to about ?10° C. The vitrifying additive enhances the formation of a glass or amorphous solid of the aqueous pharmaceutical solution at cryogenic temperatures (?50 to ?10° C.), and the pharmaceutical formulation can be thawed to liquid form and administered to a mammalian subject.

Abstract: The disclosure describes apparatuses and methods of use that may be used to remove material with magnetic properties from compositions, particularly pharmaceutical compositions. The apparatuses provide a conduit or column in which a magnetic field exists and through which a composition flows. Magnetic material in the composition is substantially reduced after flowing through the conduit or column.

Abstract: Methods and apparatuses for comminuting and stabilizing small particles are provided. In one embodiment, an apparatus moves an organic compound dissolved in a solvent to form a suspension of particles in a first fluid stream and moves the suspension in a second fluid stream, wherein the second fluid stream is oriented and positioned with respect to the first stream to cause shearing between the streams and mixing of at least some of the particles in the first and second streams.

Abstract: The present invention provides a polymorphic form of itraconazole.

Abstract: The present invention provides a method for determining a particle size.

Abstract: The present invention provides a method for preparing submicron sized particles of an organic compound, the solubility of which is greater in a water-miscible first solvent than in a second solvent which is aqueous, the process including the steps of: (i) dissolving the organic compound in the water-miscible first solvent to form a solution, (ii) mixing the solution with the second solvent to define a pre-suspension; and (iii) adding energy to the pre-suspension to form particles having an average effective particle size of 400 nm to 2 microns.

Abstract: The present invention provides for measuring a particle size distribution of a population of particles using a light scattering particle sizing instrument having a plurality of selectable imaginary component values of the refractive index. The particles each having a particle size and the process includes the steps of: (i) providing a population of the particles, wherein the particles have a refractive index; (ii) determining a real component of the refractive index of the particles using the Becke Line Method; (iii) determining an imaginary component of the refractive index of the particles; and (iv) determining the particle size distribution of the particles by the light scattering particle sizing instrument wherein the particle size distribution is determined using the real component of the refractive index measured in step (ii) and the imaginary component of the refractive index determined in step (iii).

Abstract: The present invention provides a method for preparing submicron sized particles of an organic compound, the solubility of which is greater in a water-miscible first solvent than in a second solvent which is aqueous, the process including the steps of: (i) dissolving the organic compound in the water-miscible first solvent to form a solution, (ii) mixing the solution with the second solvent to define a pre-suspension; and (iii) adding energy to the pre-suspension to form particles having an average effective particle size of less than about 2 ?m.

Abstract: The present invention provides a method for preparing a suspension of a pharmaceutically-active compound, the solubility of which is greater in a water-miscible first organic solvent than in a second solvent which is aqueous. The process includes the steps of: (i) dissolving a first quantity of the pharmaceutically-active compound in the water-miscible first organic solvent to form a first solution; (ii) mixing the first solution with the second solvent to precipitate the pharmaceutically-active compound; and (iii) seeding the first solution or the second solvent or the pre-suspension.

Abstract: The present invention provides a method for preparing submicron sized particles of an organic compound, the solubility of which is greater in a water-miscible first solvent than in a second solvent which is aqueous, the process including the steps of: (i) dissolving the organic compound in the water-miscible first solvent to form a solution, (ii) mixing the solution with the second solvent to define a pre-suspension; and (iii) adding energy to the pre-suspension to form particles having an average effective particle size of 400 nm to 2 microns.

Abstract: Methods and apparatuses for comminuting and stabilizing small particles are provided. In one embodiment, an apparatus moves an organic compound dissolved in a solvent to form a suspension of particles in a first fluid stream and moves the suspension in a second fluid stream, wherein the second fluid stream is oriented and positioned with respect to the first stream to cause shearing between the streams and mixing of at least some of the particles in the first and second streams.

Abstract: The present invention provides for measuring a particle size distribution of a population of particles using a light scattering particle sizing instrument having a plurality of selectable imaginary component values of the refractive index. The particles each having a particle size and the process includes the steps of: (i) providing a population of the particles, wherein the particles have a refractive index; (ii) determining a real component of the refractive index of the particles using the Becke Line Method; (iii) determining an imaginary component of the refractive index of the particles; and (iv) determining the particle size distribution of the particles by the light scattering particle sizing instrument wherein the particle size distribution is determined using the real component of the refractive index measured in step (ii) and the imaginary component of the refractive index determined in step (iii).