GB2565941A — A process for preparing a formulation

USPTO Abstract

A process for preparing a tobramycin formulation is provided, wherein the process comprises the following steps in order: (i) providing a bulk solution consisting of tobramycin; water; sodium chloride, sodium citrate and a pH adjusting agent, preferably sulfuric acid or a combination of sulfuric acid and sodium hydroxide, wherein the bulk solution has a pH of 5.0 and an osmolality of 248 mOsmol/kg; (ii) sparging the bulk solution with nitrogen; (iii) filling, under sterile air, the bulk solution into ampoules, wherein each ampoule contains 4ml of the bulk solution and 300mg tobramycin. Preferably the sodium citrate is trisodium citrate dihydrate. A 4ml formulation for inhalation, the formulation consisting of: 300mg tobramycin; water; 13.5mg sodium chloride; 12.0mg sodium citrate; and an amount of sulfuric acid to a achieve a pH of 5.0, wherein the osmolality of the formulation is 248 mOsmol/kg is also provided. Preferably the formulation is for use in the treatment of a Pseudomonas aeruginosa infection in patients with cystic fibrosis.