Pharmaceutical anti-infective composition for inhalation

Abstract

An anti-infective composition for inhalation, containing, at least an effective amount of an antimicrobial aminoglycoside compound or a salt thereof; and an effective amount of a biofilm modifier which is a macrolide compound or salt thereof.

1 - 23 . (canceled) 
     
     
         24 . A composition for inhalation, comprising at least:
 (a) an effective amount of an antimicrobial aminoglycoside compound or a salt thereof, and   (b) an effective amount of a biofilm modifier which is a macrolide derivative or salt thereof.   
     
     
         25 . The composition of  claim 24 , in a form of a dry powder. 
     
     
         26 . The composition according to  claim 24 , in a form of a suspension, solution, or a combination thereof. 
     
     
         27 . The composition of  claim 24 , wherein a ratio (weight/weight) of each of said aminoglycoside compound and said macrolide is greater or equal to 10% of said composition. 
     
     
         28 . The composition of  claim 27 , wherein the ratio is between 10-99% of the composition. 
     
     
         29 . The composition of  claim 28 , wherein the ratio is between 15-90% of the composition. 
     
     
         30 . The composition of  claim 24 , wherein a ratio (weight/weight) aminoglycoside/macrolide is between 0.2 to 5. 
     
     
         31 . The composition of  claim 30 , wherein the ratio is between 0.3 and 3. 
     
     
         32 . The composition of  claim 31 , wherein the ratio is between 0.8 and 2. 
     
     
         33 . The composition of  claim 24 , wherein a sum of active ingredients represents more than 20% (weight/weight) of the composition. 
     
     
         34 . The composition  claim 33 , wherein the sum of the active, ingredients is more than 30% of the composition. 
     
     
         35 . The composition of  claim 34 , wherein the sum of the active ingredients in more than 40% of the composition. 
     
     
         36 . The composition of  claim 24 , containing at least one or more pharmaceutically acceptable excipients. 
     
     
         37 . The composition of  claim 36 , wherein at least one of said pharmaceutically acceptable excipients is a carbohydrate or a mixture of two or more carbohydrates. 
     
     
         38 . The composition of  claim 37 , wherein at least one of said pharmaceutically acceptable carbohydrate comprises anhydrous lactose, lactose monohydrate, mannitol, xylitol, dextrose, saccharose, a cyclodextrin compound or a mixture thereof. 
     
     
         39 . The composition of  claim 36 , wherein at least one of said pharmaceutically acceptable excipient is a lipidic excipient. 
     
     
         40 . The composition of  claim 39 , wherein at least one of said lipidic excipients comprises cholesterol and derivatives, phospholipid, ethers of fatty alcohols, esters of fatty acids, hydrogenated oils, polyoxyethylenated derivatives, esters of glycerol. 
     
     
         41 . The composition of  claim 40 , wherein said composition contains a mixture of cholesterol or a cholesterol compound and a phospholipid or a phospholipid. 
     
     
         42 . The composition of  claim 24 , further containing one or more chelating agent(s). 
     
     
         43 . The composition of  claim 42 , wherein the chelating agent is edetic acid, citric acid, malic acid or a salt thereof. 
     
     
         44 . The composition of  claim 24 , further containing one or more antioxidant(s). 
     
     
         45 . The composition of  claim 44 , wherein at least one antioxidant comprises a cystein compound, of ascorbic acid compounds, tocopherol compounds, propylgallate, butylhydroxyanisole, or butylhydroxytoluene. 
     
     
         46 . The composition of  claim 24 , wherein the aminoglyscoside compound is Tobramycin, Kanamycin, Streptomycin, Gentamicin, Amikacin, Apramycin, Arbekacin, Bekanamycin, Astromycin, Dihydrostreptomycin, Framycetin, Neomycin, Netilmicin, Isepamicin, Micronomicin, Sisomicin or a pharmaceutically acceptable salt thereof. 
     
     
         47 . The composition of  claim 24 , wherein the macrolide compound is a biofilm modifier macrolide or an antibiotic macrolide, and comprises of Clarithromycin, Azithromycin, Roxithromycin, Erythromycin, Telithromycin, Dirithromycin, Flurithromycin, Josamycin, Kitasamycin, Midecamycin, Dalfopristin, Oleandomycin, Midecamycin, Pristinamycin, Rokitamycin, Spiramycin, Tilmicosin, Troleandomycin, Tylosin, Virginiamycin, and the pharmaceutically acceptable salts. 
     
     
         48 . The composition of  claim 24 , wherein the aminoglyscoside compound is Tobramycin or a salt thereof and the macrolide compound is clarithromycin or a salt thereof, said composition being free of another antimicrobial agent. 
     
     
         49 . The composition of  claim 24 , wherein said composition is free of excipients. 
     
     
         50 . The composition of  claim 25 , wherein said dry powder composition is filled in pharmaceutically acceptable capsules. 
     
     
         51 . The composition of  claim 48 , wherein said pharmaceutically acceptable capsule contains, as main polymer, gelatin, hydroxypropylcellulose or starch. 
     
     
         52 . The composition of  claim 25 , wherein the said dry powder composition is filled into a multidose dry powder inhaler device.