Oral and injectable formulations of tetracycline compounds

Abstract

Injectable and oral formulations of a tetracycline compound are described. In one embodiment, the invention pertains to an oral formulation of a 9-aminomethyl tetracycline compound, or a salt thereof, in tablet form or capsule. The formulations may be used, for example, to treat infections.

1 - 14 . (canceled) 
     
     
         15 . An injectable formulation comprising about 90-100 mg of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline a pharmaceutically acceptable carrier. 
     
     
         16 . The injectable formulation of  claim 15 , further comprising one or more components selected from the group consisting of a lyoprotectant, and a pH adjustment compound. 
     
     
         17 . The injectable formulation of  claim 16 , wherein the formulation consists essentially of about 100 mg of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline, 100 mg of sucrose, a pH adjustment compound and an aqueous carrier. 
     
     
         18 . A method for treating bacterial infection in a subject in need thereof, said method comprising administering to said subject an effective amount of the formulation of  claim 15 , such that said bacterial infection in said subject is treated. 
     
     
         19 - 20 . (canceled) 
     
     
         21 . The injectable formulation of  claim 16 , wherein the lycoprotectant is a sugar. 
     
     
         22 . The injectable formulation of  claim 21 , wherein the sugar is sucrose. 
     
     
         23 . The injectable formulation of  claim 16 , wherein the pH adjustment compound is hydrochloric acid or sodium hydroxide. 
     
     
         24 . The injectable formulation of  claim 16 , wherein pH is adjusted to between about 4.0 and about 4.5. 
     
     
         25 . The injectable formulation of  claim 24 , wherein pH is adjusted to about 4.2. 
     
     
         26 . An injectable formulation comprising tosylate salt of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline and a pharmaceutically acceptable carrier. 
     
     
         27 . The injectable formulation of  claim 26 , further comprising one or more components selected from the group consisting of a lyoprotectant and a pH adjustment compound. 
     
     
         28 . The injectable formulation of  claim 27 , wherein the lyoprotectant is s sugar. 
     
     
         29 . The injectable formulation of  claim 28 , wherein the sugar is sucrose. 
     
     
         30 . The injectable formulation of  claim 27 , wherein the pH adjustment compound is hydrochloric acid or sodium hydroxide. 
     
     
         31 . The injectable formulation of  claim 27 , wherein pH is adjusted to between about 4.0 and about 4.5. 
     
     
         32 . The injectable formulation of  claim 31 , wherein pH is adjusted to about 4.2. 
     
     
         33 . The injectable formulation of  claim 27 , wherein the formulation consists essentially of about 100 mg of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline, 100 mg of sucrose, a pH adjustment compound and an aqueous carrier. 
     
     
         34 . A method for treating bacterial infection in a subject in need thereof, said method comprising administering to said subject an effective amount of the formulation of  claim 26 , such that said bacterial infection in said subject is treated.