Claims for Patent: 9,421,166

Summary for Patent: 9,421,166

Title:	Pulmonary delivery of aminoglycoside
Abstract:	The present invention is directed to the administration of aminoglycosides. In particular, the present invention is directed to compositions and methods for the pulmonary administration of aminoglycosides. According to a preferred embodiment, compositions and methods are provided for the localized treatment of respiratory infections.
Inventor(s):	Tarara; Thomas E (Burlinggame, CA), Weers; Jeffry G (Belmont, CA), Venthoye; Maria Geraldine (Foster City, CA)
Assignee:	Novartis AG (Basel, CH)
Application Number:	14/247,546
Patent Claims:	1. A respirable unit dose of a dispersible powder composition, the composition comprising particles comprising an aminoglycoside and a phospholipid for delivery to the lungs by inhalation, wherein the particles have a geometric diameter of less than 5 microns, wherein the respirable unit dose comprises a fill mass of between 25 and 50 mg and said fill mass comprises between about 14-35 mg of aminoglycoside or salt thereof. 2. A respirable unit dose according to claim 1 wherein the composition is effective to provide a therapeutically effective therapy via administration of less than 6 respirable unit doses. 3. A respirable unit dose according to claim 1 wherein the composition comprises from about 50% to about 99% by weight aminoglycoside. 4. A respirable unit dose according to claim 1 wherein the particles further comprise calcium chloride. 5. A respirable unit dose according to claim 1 wherein the respirable unit dose is provided in a capsule, the capsule comprising hydroxypropylmethylcellulose. 6. A respirable unit dose according to claim 1 wherein the particles have a bulk density of between 0.08 and 0.20 g/cm.sup.3. 7. A respirable unit dose according to claim 1 wherein the particles have a mass median aerodynamic diameter less than 5 microns. 8. A respirable unit dose according to claim 1 wherein the composition has a pH of between 7 and 10. 9. A respirable unit dose according to claim 1 wherein the respirable unit dose comprises a volume equivalent to a size #00 capsule or smaller capsule size. 10. A respirable unit dose according to claim 1 wherein the respirable unit dose comprises a volume equivalent to a size #2 capsule or smaller capsule size. 11. A respirable unit dose according to claim 1 wherein the aminoglycoside comprises one or more of gentamicin, netilmicin, paramecin, tobramycin, amikacin, kanamycin, neomycin, and streptomycin. 12. A respirable unit dose according to claim 1 wherein the aminoglycoside comprises tobramycin or salt thereof. 13. A respirable unit dose according to claim 1 wherein the particles are spray dried particles. 14. A respirable unit dose according to claim 1 wherein the particles have a moisture content of less than 15% by weight. 15. A respirable unit dose according to claim 1 wherein the particles are hollow and/or porous. 16. A respirable unit dose according to claim 1 wherein each respirable unit dose comprises an emitted dose greater than 70%. 17. A method for administering a composition, the method comprising administering by inhalation less than 6 respirable unit doses according to claim 1 to provide at least 27.6 mg of aminoglycoside to the lungs. 18. A method for treating cystic fibrosis, the method comprising administering a pharmacologically effective amount of aminoglycoside comprising tobramycin to the lungs from a respirable unit dose according to claim 1. 19. A method for administering aminoglycoside to reduce the potential for development of bacteria in the lungs, the method comprising administering a pharmacologically effective amount of aminoglycoside to the lungs from a respirable unit dose according to claim 1.