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US 11,951,216 B2Granted
Polymer protein microparticles
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsHunter Chen, Scott Walsh
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Abstract
Microparticles containing a core of therapeutic protein and a cortex of a biocompatible and biodegradable polymer, and methods of making and using the microparticles are provided. The extended release of a therapeutic protein from the microparticles in a physiological solution is demonstrated over an extended period of time.
Claims20
A method of manufacturing an extended release pharmaceutical composition comprising therapeutic protein microparticles coated with a biodegradable polymer, the method comprising:
- a. spray drying an aqueous therapeutic protein solution to form therapeutic protein microparticles wherein the inlet temperature of the spray dryer is set at a temperature greater than the boiling point of water and the outlet temperature that is above ambient and below the boiling point of water to form a powder comprising a population of therapeutic protein microparticles wherein the aqueous solution is pumped into the spray dryer at a rate of 2 mL/min to 15 mL/min,
- b. suspending the powder comprising the population of therapeutic protein microparticles in a solution comprising polyorthoester (POE) and an organic solvent to form a suspension;
- and
- c. spray drying the suspension to form the extended release pharmaceutical composition comprising a population of POE-coated therapeutic protein microparticles, wherein the extended release pharmaceutical composition comprises about 1 to about 500 mg/mL of therapeutic protein microparticles and releases the therapeutic protein for at least 60 days at a steady rate of release, wherein extended release pharmaceutical composition can treat conditions selected from the group consisting of cancers, cardiovascular diseases, vascular conditions, orthopedic disorders, dental disorders, wounds, autoimmune diseases, gastrointestinal disorders and ocular diseases.
1 more element
A method of providing an extended release coating for therapeutic protein comprising:
- a. atomizing an aqueous solution comprising a therapeutic protein;
- b. spray drying the atomized aqueous solution at a temperature greater than the boiling point of water to remove water in the solution and form a population of therapeutic protein microparticles;
- c. coating each therapeutic protein microparticle of the population therapeutic protein microparticles with a biodegradable polymer to form a population of polymer-coated therapeutic protein microparticles, wherein the biodegradable polymer is polyorthoester,
- wherein the extended release pharmaceutical composition releases the therapeutic protein for at least 60 days at a steady rate of release, wherein extended release pharmaceutical composition can treat conditions selected from the group consisting of cancers, cardiovascular diseases, vascular conditions, orthopedic disorders, dental disorders, wounds, autoimmune diseases, gastrointestinal disorders and ocular diseases.
1 more element
Dependencies are inferred from the claim text.