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Generated: December 12, 2017

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Title:Optimised formulation of tobramycin for aerosolization
Abstract: The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacterium Pseudomonas aeruginosa associated to lung diseases such as cystic fibrosis.
Inventor(s): Malvolti; Chiara (Parma, IT), Garzia; Raffaella (Parma, IT)
Assignee: Chiesi Farmaceutici S.p.A. (Parma, IT)
Filing Date:May 06, 2011
Application Number:13/102,378
Claims:1. A method for treating bronchiectasis, said method comprising administering an effective amount of an aerosol formulation to a subject in need thereof, said aerosol formulation comprising: 75 mg/ml of tobramycin dissolved in an aqueous solution containing 0.45% w/v of sodium chloride; wherein said formulation has a pH of 4.5 to 5.5 and an osmolarity of 250 to 450 mOsm/l, and said formulation is free of preservatives and anti-oxidants.

2. A method according to claim 1, wherein said subject is suffering from bronchiectasis and infected with Pseudomonas aeruginosa.

3. A method according to claim 1, wherein the pH of said aerosol formulation is 5.2 and the osmolarity thereof is between 280 and 350 mOsm/l.

4. A method according to claim 1, wherein said osmolarity of said aerosol formulation is from 280 to 350 mOsm/l.

5. A method according to claim 1, wherein said osmolarity of said aerosol formulation is 292 to 350 mOsm/l.

6. A method according to claim 1, wherein said osmolarity of said aerosol formulation is 293 to 350 mOsm/l.

7. A method according to claim 1, wherein said osmolarity of said aerosol formulation is 295 to 350 mOsm/l.

8. A method according to claim 1, wherein said osmolarity is 304 to 350 mOsm/l.

9. A method according to claim 1, wherein said osmolarity of said aerosol formulation is 311 to 350 mOsm/l.

10. A method according to claim 1, wherein said osmolarity of said aerosol formulation is 314 to 350 mOsm/l.
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