Methods for the treatment of mast cell related disorders with mast cell stabilizers
AssigneeRespivant Sciences GmbH
InventorsWilliam Gerhart, Pravin Soni, Ahmet Tutuncu
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Abstract
Methods for the treatment of systemic mast cell related disorders treatable with mast cell stabilizers, including mast cell related disorders, are provided.
Claims46
A method of treating a subject having a mast cell related disorder, comprising administering to the subject a composition comprising cromolyn, or a salt thereof;
- wherein the composition is administered to the subject using a high-efficiency nebulizer and produces in the subject an AUC(0-∞) of cromolyn greater than about 5.3 ng*h/mL per milligram of cromolyn, or a salt thereof, administered to the subject;
- and
- wherein the mast cell related disorder is selected from primary biliary cirrhosis, secondary sclerosing cholangitis due to mast cell cholangiopathy, itching caused by or associated with primary biliary cirrhosis, bronchiolitis obliterans syndrome after lung transplantation, bronchopulmonary dysplasia in infants, cardiac fibrosis, atrial fibrosis, primary sclerosing cholangitis (PSC), chronic pelvic pain syndrome (prostatitis), viral pneumonia caused by respiratory syncytial virus, and interstitial lung disease.
A method of treating a subject having a mast cell related disorder, comprising administering to the subject a composition comprising cromolyn, or a salt thereof;
- wherein the composition is administered to the subject using a high-efficiency nebulizer and produces in the subject a Cmax of cromolyn greater than about 2.2 ng/mL per milligram of cromolyn, or a salt thereof, administered to the subject;
- and
- wherein the mast cell related disorder is selected from primary biliary cirrhosis, secondary sclerosing cholangitis due to mast cell cholangiopathy, itching caused by or associated with primary biliary cirrhosis, bronchiolitis obliterans syndrome after lung transplantation, bronchopulmonary dysplasia in infants, cardiac fibrosis, atrial fibrosis, primary sclerosing cholangitis (PSC), chronic pelvic pain syndrome (prostatitis), viral pneumonia caused by respiratory syncytial virus, and interstitial lung disease.
A method of treating a subject having a mast cell related disorder, comprising administering to the subject a composition comprising cromolyn sodium;
- wherein the composition is administered to the subject using a high-efficiency nebulizer and produces in the subject a Cmax of cromolyn greater than about 2.2 ng/mL per milligram of cromolyn sodium administered to the subject and an AUC(0-∞) of cromolyn greater than about 5.3 ng*h/mL per milligram of cromolyn sodium administered to the subject;
- wherein the high-efficiency nebulizer produces an aerosol of the composition having an RF (≤3.3 μm) of at least about 30% and an RF (≤5 μm) of at least about 65%;
- and
- wherein the mast cell related disorder is selected from primary biliary cirrhosis, secondary sclerosing cholangitis due to mast cell cholangiopathy, itching caused by or associated with primary biliary cirrhosis, bronchiolitis obliterans syndrome after lung transplantation, bronchopulmonary dysplasia in infants, cardiac fibrosis, atrial fibrosis, primary sclerosing cholangitis (PSC), chronic pelvic pain syndrome (prostatitis), viral pneumonia caused by respiratory syncytial virus, and interstitial lung disease.
Dependencies are inferred from the claim text.