Cabazitaxel composition
The present invention is directed to a composition comprising (a) cabazitaxel and (b) sulfobutyl ether beta cyclodextrin. Such composition exhibits unexpectedly desirable stability in aqueous media, permitting therapeutic dosages of the drug to be administered without the use of either ethanol or surfactants.
1. An aqueous composition comprising: (a) cabazitaxel and (b) sulfobutylether beta-cyclodextrin, wherein such composition (i) does not contain any ethanol and (ii) exhibits an equilibrium solubility of cabazitaxel of at least 0.27 mg/mL at 23° C.
2. The composition of claim 1 wherein said composition is in the form of an aqueous solution comprising between 1% and 40% sulfobutylether beta-cyclodextrin by weight.
3. The composition of claim 2 wherein said composition is in the form of an aqueous solution comprising between 2% and 20% sulfobutylether beta-cyclodextrin by weight.
4. A solid lyophilizate formed from the composition of claim 1 .
5. The composition of claim 1 wherein such composition does not contain any surfactant.
6. The composition of claim 1 wherein the composition exhibits an equilibrium solubility of cabazitaxel of between 0.27 and 4.17 mg/mL.
7. The composition of claim 6 wherein the composition exhibits an equilibrium solubility of cabazitaxel of between 0.46 and 4.17 mg/mL.
8. The composition of claim 7 wherein the composition exhibits an equilibrium solubility of cabazitaxel of between 0.99 and 4.17 mg/mL.