Aerosol pirfenidone and pyridone analog compounds and uses thereof
First Claim
1. A method for clinically efficacious treatment of idiopathic pulmonary fibrosis in an adult human comprising:
- delivering a therapeutically effective dose of pirfenidone compound to the lung of the adult human by inhalation of an aerosol formed by nebulization of an aqueous solution comprising water;
pirfenidone, at a concentration from about 5.0 to about 19.0 mg/mL;
a permeant ion concentration of between about 30 mM and about 300 mM, wherein the permeant ions are chloride ions, bromide ions, or a combination thereof;
a citrate or phosphate buffer; and
a taste masking agent at a concentration of between 0.1 and 2.0 mM, wherein a total daily dose of inhaled pirfenidone does not exceed 480 mg, and wherein the therapeutically effective dose treats idiopathic pulmonary fibrosis by reducing a decline in forced vital capacity (FVC) in the lung of the adult human.
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Accused Products
Abstract
Disclosed herein are formulations of pirfenidone or pyridone analog compounds for aerosolization and use of such formulations for aerosol administration of pirfenidone or pyridone analog compounds for the prevention or treatment of various fibrotic and inflammatory diseases, including disease associated with the lung, heart, kidney, liver, eye and central nervous system. In some embodiments, pirfenidone or pyridone analog compound formulations and delivery options described herein allow for efficacious local delivery of pirfenidone or pyridone analog compound. Compositions include all formulations, kits, and device combinations described herein. Methods include inhalation procedures, indications and manufacturing processes for production and use of the compositions described.
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Citations
11 Claims
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1. A method for clinically efficacious treatment of idiopathic pulmonary fibrosis in an adult human comprising:
delivering a therapeutically effective dose of pirfenidone compound to the lung of the adult human by inhalation of an aerosol formed by nebulization of an aqueous solution comprising water;
pirfenidone, at a concentration from about 5.0 to about 19.0 mg/mL;
a permeant ion concentration of between about 30 mM and about 300 mM, wherein the permeant ions are chloride ions, bromide ions, or a combination thereof;
a citrate or phosphate buffer; and
a taste masking agent at a concentration of between 0.1 and 2.0 mM, wherein a total daily dose of inhaled pirfenidone does not exceed 480 mg, and wherein the therapeutically effective dose treats idiopathic pulmonary fibrosis by reducing a decline in forced vital capacity (FVC) in the lung of the adult human.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
Specification