US2017348378A1PendingUtilityA1
Methods of treating lung infection with caspofungin
Est. expiryAug 21, 2035(~9.1 yrs left)· nominal 20-yr term from priority
A61K 38/08A61K 9/0078A61P 31/06A61P 11/00A61K 9/0075
46
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Claims
Abstract
Methods for the treatment and/or prevention of a fungal infection in the pulmonary system of a subject in need thereof with caspofungin or a derivative thereof are disclosed herein.
Claims
exact text as granted — not AI-modified1 - 29 . (canceled)
30 . A kit comprising:
a composition suitable for administration via inhalation, wherein the composition comprises caspofungin, or a polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof, and wherein the composition is an aqueous solution essentially free of mannitol; and an inhalation device; wherein the composition is administered as droplets or particles having a mass median aerodynamic diameter (MMAD) from about 0.5 μm to about 10 μm.
31 . The kit of claim 30 , wherein the composition is essentially free of sugar alcohol.
32 . The kit of claim 30 , wherein the composition is essentially free of sugar alcohol or sugar.
33 . The kit of claim 30 , wherein the pharmaceutically acceptable salt of caspofungin is an acetate salt.
34 . The kit of claim 30 , wherein the administration of the composition provides a lung tissue concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof that is from about 1-fold to about 100-fold greater than intravenous administration at the same delivery dose.
35 . The kit of claim 34 , wherein the lung tissue concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof is greater than intravenous administration at the same delivery dose for about 0.5 hour to about 168 hours.
36 . The kit of claim 30 , wherein the administration of the composition provides a lung tissue concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof that is from about 1-fold to about 50-fold greater than intravenous administration at the same delivery dose.
37 . The kit of claim 36 , wherein the lung tissue concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof is greater than intravenous administration at the same delivery dose for about 0.5 hour to about 168 hours.
38 . The kit of claim 30 , wherein the administration of the composition provides a concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof in the lung that is from about 1-fold greater to about 1000-fold greater than a concentration of capsofungin or the polymorph, the pharmaceutically acceptable salt, hydrate, or solvate thereof in the liver, kidney, spleen, pancreas or plasma.
39 . The kit of claim 38 , wherein the concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof in the lung is greater than a concentration of capsofungin or the polymorph, the pharmaceutically acceptable salt, hydrate, or solvate thereof in the liver, kidney, spleen, pancreas or plasma for about 0.5 hour to about 168 hours.
40 . The kit of claim 30 , wherein the administration of the composition provides a concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof in the lung that is from about 1-fold greater to about 150-fold greater than a concentration of capsofungin or the polymorph, the pharmaceutically acceptable salt, hydrate, or solvate thereof in the liver, kidney, spleen, pancreas or plasma.
41 . The kit of claim 40 , wherein the concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof in the lung is greater than the concentration of capsofungin or the polymorph, the pharmaceutically acceptable salt, hydrate, or solvate thereof in the liver, kidney, spleen, pancreas or plasma for about 0.5 hour to about 168 hours.
42 . The kit of claim 30 , wherein the administration of the composition provides a concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof in the lung that is above the minimum inhibitory concentration (MIC) or the minimum effective concentration (MEC) for about 3 hours after administration.
43 . The kit of claim 30 , wherein the administration of the composition provides a concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof in the lung that is above the minimum inhibitory concentration (MIC) or the minimum effective concentration (MEC) for about 12 hours after administration.
44 . The kit of claim 30 , wherein the administration of the composition provides a concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof in the lung that is above the minimum inhibitory concentration (MIC) or the minimum effective concentration (MEC) for about 24 hours after administration.
45 . The kit of claim 30 , wherein the administration of the composition provides a concentration of caspofungin or the polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof in the lung that is above the minimum inhibitory concentration (MIC) or the minimum effective concentration (MEC) for about 48 hours after administration.
46 . The kit of claim 42 , wherein the minimum inhibitory concentration (MIC) is from about 0.001 μg/mL to about 128 μg/mL.
47 . The kit of claim 42 , wherein the minimum inhibitory concentration (MIC) is from about 0.001 μg/mL to about 32 μg/mL.
48 . The kit of claim 42 , wherein the minimum effective concentration (MEC) is from about 0.001 μg/mL to about 128 μg/mL.
49 . The kit of claim 42 , wherein the minimum inhibitory concentration (MEC) is from about 0.001 μg/mL to about 32 μg/mL.
50 . The kit of claim 30 , wherein the inhalation device is selected from a jet nebulizer, ultrasonic wave nebulizer, high efficiency nebulizer, heat vaporizer, soft mist inhaler, thermal aerosol inhaler, and electrohydrodynamic-based solution misting inhaler.
51 . The kit of claim 30 , wherein the composition is administered as droplets or particles having a mass median aerodynamic diameter (MMAD) from about 1 μm to about 5 μm.
52 . The kit of claim 30 , wherein the half-life of the caspofungin, or a polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof in the lung is about 1 hour to about 50 hours.
53 . The kit of claim 30 , wherein the half-life of the caspofungin, or a polymorph, pharmaceutically acceptable salt, hydrate, or solvate thereof in the lung is about 20 hours to about 50 hours.
54 . The kit of claim 30 , wherein the composition is stable from at about −20° C. to about 25° C.
55 . The kit of claim 30 , wherein the composition is stable for at least about 6 months.
56 . The kit of claim 30 , wherein the composition has a pH from about 4.0 to about 7.5.
57 . The kit of claim 30 , wherein the kit is for treating a fungal infection caused by Candida sp., and/or by Aspergillus sp., and/or by Pneumocystis jirovecii.Cited by (0)
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