EP4117625A1 — Daptomycin formulations containing a combination of sorbitol and mannitol

USPTO Abstract

In an aspect, a method of manufacture of a pharmaceutically acceptable solid composition containing daptomycin includes drying an aqueous solution containing (i) water, (ii) the daptomycin, (iii) sorbitol in an amount of about 1.2 wt.% to about 9.0 wt.% of total volume of the aqueous composition and (iv) mannitol in an amount of about 0.6 wt.% to about 9.5 wt.% of total volume of the aqueous composition to form the solid composition. The drying can include an sublimation drying of about -25 °C to about 50 °C for a time period of about 15 hours to about 120 hours, most preferably about 15 °C for about 20 hours, optionally preceded and/or followed by one or more additional drying steps. Other aspects are the solid composition containing the daptomycin and also methods of treating a bacterial infection including administering a pharmaceutically acceptable product made by reconstituting the solid composition.