Nebulised Antibiotics for Inhalation Therapy
First Claim
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1. A pharmaceutical aerosol for nasal, sinunasal or pulmonary administration comprising a dispersed liquid phase and a continuous gas phase, wherein the dispersed liquid phase(a) essentially consists of aqueous droplets comprising an active compound selected from the group of quinolone antibiotics;
- (b) has a mass median diameter from about 1.5 to about 6 μ
m; and
(c) has a droplet size distribution exhibiting a geometrical standard deviation from about 1.2 to about 3.0.
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Abstract
The present invention provides pharmaceutical aerosols which are useful for the prevention or treatment of infectious diseases of the airways, such as the lungs, the bronchi, or the sinunasal cavities. The aerosols comprise an active agent selected from the group of quinolone antibiotics. Also disclosed are liquid and solid compositions suitable for being converted into the aerosols, and kits comprising such compositions.
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Citations
25 Claims
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1. A pharmaceutical aerosol for nasal, sinunasal or pulmonary administration comprising a dispersed liquid phase and a continuous gas phase, wherein the dispersed liquid phase
(a) essentially consists of aqueous droplets comprising an active compound selected from the group of quinolone antibiotics; -
(b) has a mass median diameter from about 1.5 to about 6 μ
m; and(c) has a droplet size distribution exhibiting a geometrical standard deviation from about 1.2 to about 3.0. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 21, 22, 23)
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13. A kit for the preparation and delivery of a pharmaceutical aerosol for nasal, sinunasal or pulmonary administration comprising a dispersed liquid phase and a continuous gas phase, wherein the dispersed liquid phase
(a) essentially consists of aqueous droplets comprising an active compound selected from the group of quinolone antibiotics; -
(b) has a mass median diameter from about 1.5 to about 6 μ
m; and(c) has a droplet size distribution exhibiting a geometrical standard deviation from about 1.2 to about 3.0, wherein the kit comprises a nebuliser and an aqueous liquid composition, said composition comprising an effective dose of the active compound within a volume of not more than about 10 ml and more preferably less than 5 ml. - View Dependent Claims (14, 15, 16, 17, 18)
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19. A method of preparing and delivering an aerosol to a person in need of nasal, sinunasal or pulmonary antibiotic treatment or prophylaxis, said method comprising the steps of:
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(a) providing a liquid pharmaceutical composition comprising an effective dose of an active compound selected from the group of quinolone antibiotics in a volume of not more than about 10 ml and more preferably less than 5 ml; (b) providing a nebuliser capable of aerosolising said liquid pharmaceutical composition at a total output rate of at least 0.1 ml/min, the nebuliser further being adapted to emit an aerosol comprising a dispersed phase having a mass median diameter from about 1.5 to about 6 μ
m and a geometrical standard deviation from about 1.2 to about 3; and(c) operating the nebuliser to aerosolise the liquid composition. - View Dependent Claims (20)
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- 24. The use of a polymeric compound as excipient in a pharmaceutical composition for the preparation of an aerosol, wherein the composition comprises an active compound selected from the group of quinolone antibiotics.
Specification