Disodium cromoglycate compositions and methods for administering same
AssigneePARI Pharma GmbH
InventorManfred Keller
Life of this patent
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Abstract
Methods for the treatment of patients that are afflicted with pulmonary conditions, such as a pulmonary disease are described. The methods may involve the administration of aerosolized medicines. More specifically, compositions including disodium cromoglycate (DSCG) and therapeutic methods that include the pulmonary administration of such compositions are described.
Claims58
A method for treating a patient afflicted with a pulmonary disease or condition selected from the group consisting of chronic obstructive pulmonary disease, allergic asthma, non-allergic asthma, wheezing, and any other inflammatory or allergic lung diseases, said method comprising the steps of:
- providing a volume of a pharmaceutically acceptable aqueous composition including disodium cromoglycate in dissolved form at a concentration of greater than 2 wt.-%;
- nebulizing the volume by a nebulizer into an aerosol, wherein the aerosol exhibits a fine particle fraction of at least 30% of droplets having a size less than 3.3 μm, and wherein the difference between the mass median aerodynamic diameter when measured at room temperature and at a relative humidity of about 50% and the mass median aerodynamic diameter when measured at room temperature and at a relative humidity of about 95% is less than 0.5 μm;
- and
- delivering said aerosol to the patient;
- wherein the fine particle fraction is defined as the percentage of aerosol droplets having a diameter of less than 3.3 μm.
A pharmaceutically acceptable nebulized aerosol adapted for pulmonary administration by oral or nasal inhalation or administration, said aerosol comprising droplets of an aqueous solution of disodium cromoglycate, such that the aerosol has a fine particle fraction of at least 30% in droplets having a size less than 3.3 μm, wherein the fine particle fraction is defined as the percentage of aerosol droplets having a diameter of less than 3.3 μm, wherein the difference between the mass median aerodynamic diameter when measured at room temperature and at a relative humidity of about 50% and the mass median aerodynamic diameter when measured at room temperature and at a relative humidity of about 95% is less than 0.5 μm, and wherein the concentration of the disodium cromoglycate in the solution is in the range of about 2 wt.-% to about 5 wt.-%.
A method for reaching target cells located in deep airways of a patient afflicted with a pulmonary disease or condition selected from the group consisting of chronic obstructive pulmonary disease, allergic asthma, non-allergic asthma, wheezing, and any other inflammatory or allergic lung diseases, said method comprising the steps of:
- providing a pharmaceutically acceptable composition including an effective amount of disodium cromoglycate (DSCG) in dissolved form at a concentration of greater than 2 wt.-%;
- nebulizing the composition using a nebulizer to produce an aerosol exhibiting a fine particle fraction of at least 30% of droplets having a size less than 3.3 μm, wherein the difference between the mass median aerodynamic diameter when measured at room temperature and at a relative humidity of about 50% and the mass median aerodynamic diameter when measured at room temperature and at a relative humidity of about 95% is less than 0.5 μm.
A method of delivering a pharmaceutically acceptable aerosolized composition to a patient, said method comprising the steps of:
- providing a nebulizer such that the nebulizer exhibits a residual volume of less than 0.2 ml;
- nebulizing an aqueous composition including an effective amount of dissolved disodium cromoglycate having a concentration in the range of about 2 wt.-% to about 5 wt.-% into an aerosol exhibiting a fine particle fraction of at least 30% in droplets less than 3.3 μm such that the aerosolized composition is delivered to the patient;
- and
- wherein the fine particle dose in droplets less than 3.3 μm is at least 2 mg and wherein more than 20 wt.-% of the effective amount of disodium cromoglycate is contained in the droplets having a size in the range of about 2 μm to about 3.3 μm, and wherein the difference between the mass median aerodynamic diameter when measured at room temperature and at a relative humidity of about 50% and the mass median aerodynamic diameter when measured at room temperature and at a relative humidity of about 95% is less than 0.5 μm.
Dependencies are inferred from the claim text.