Claims for Patent: 8,664,187

Summary for Patent: 8,664,187

Title:	Methods of treatment of endobronchial infections
Abstract:	The present invention provides methods for the treatment of an endobronchial infection in a patient by administering to the endobronchial system of the patient a dry powder aerosol composition comprising from 90 to 130 mg of an aminoglycoside antibiotic one to three times a day for a first treatment period of 20 to 36 days.
Inventor(s):	Challoner; Peter (Emeryville, CA), Rodriguez; Carlos (Emeryville, CA), Samara; Emil (Emeryville, CA), Tarara; Thomas E (Burlingame, CA), Lord; John D (San Carlos, CA)
Assignee:	Novartis AG (Basel, CH)
Application Number:	13/404,359
Patent Claims:	1. A method of reducing the amount of time to administer a therapeutic amount of tobramycin to treat a Pseudomonas aeruginosa endobronchial infection in a cystic fibrosis patient, the method comprising formulating for administration via inhalation, in four equal unit doses, phospholipid-based dry powder particles prepared by an emulsification and spray-drying process and comprising 30% to 70% tobramycin wherein the formulation comprising is administered to the endobronchial system of the patient twice a day, whereby the administration delivers a dosage of 110 to approximately 120 mg free base tobramycin. 2. The method of claim 1 wherein the particles comprise tobramycin sulfate. 3. The method of claim 2, wherein the particles are phospholipid-based spherical particles with porous structures. 4. The method of claim 3 wherein the phospholipid comprises disteroyl phosphatidlycholine. 5. The method of claim 3 wherein the particles further comprise calcium chloride. 6. The method of claim 1 wherein the dosage is 110 to approximately 115 mg. 7. The method of claim 1 wherein the dry powder particles are administered for a first treatment period of 20 to 36 days. 8. The method of claim 7 wherein the first treatment period is 28 days. 9. The method of claim 7 wherein the first treatment period is followed by a second period of 26 to 30 days during which no aminoglycoside antibiotic is administered to the endobronchial system of the patient. 10. The method of claim 9 wherein the first treatment period and the second non-treatment period are repeated at least one time. 11. The method of claim 1 wherein the dry powder particles are administered using a dry powder inhaler. 12. The method of claim 11 wherein the inhaler is a T-326 inhaler. 13. A method of treating a Pseudomonas aeruginosa endobronchial infection in a cystic fibrosis patient, comprising administering via inhalation in four equal 28 mg unit doses of dry powder particles prepared by an emulsification and spray-drying process and comprising approximately 30% to 70% tobramycin wherein the particles are administered to the endobronchial system of the patient twice a day, in which the dry powder particles comprise phospholipid-based spherical particles with porous structures, the particles comprising disteroyl phosphatidlycholine and calcium chloride, whereby the administration delivers a dosage of 110 to approximately 120 mg free base tobramycin. 14. The method of claim 6 wherein the dosage is 112 mg. 15. The method of claim 13 wherein the dosage is 112 mg. 16. The method of claim 13 wherein a serum concentration of tobramycin is substantially similar to a serum concentration of nebulized liquid tobramycin. 17. The method of claim 13 wherein a mean serum concentration-time profile of tobramycin is substantially similar to a mean concentration-time profile of nebulized liquid tobramycin.