Docetaxel formulations with lipoic acid
AssigneeScidose LLC
InventorNageswara R. Palepu
Life of this patent
Estimating the term…
Abstract
Pharmaceutical formulations comprising docetaxel or a pharmaceutically acceptable salt thereof, one or more solubilizers, α-lipoic acid, TPGS, one or more hydrotropes, and optionally one or more agents having a pKa of about 3 to about 6. The pharmaceutical formulations are stable and substantially free of excipients that can cause severe side effects and maintains chemical stability during storage. The pharmaceutical formulations are ready to be combined with an infusion solution for administration to patients in need thereof. Methods of treating patients in need thereof comprise administering the pharmaceutical formulations combined with an infusion solution.
Claims20
A sterile pharmaceutical formulation for use in treatment of a patient in need thereof, comprising:
- (a) docetaxel, or a pharmaceutically acceptable salt thereof;
- (b) a solubilizer selected from the group consisting of ethanol, glycofurol, and mixtures thereof;
- (c) d-alpha-tocopheryl polyethylene glycol 1000 succinate (TPGS 1000);
- (d) one or more hydrotropes, wherein the one or more hydrotropes are selected from the group consisting of polyethylene glycol, propylene glycol, acetic acid, and a combination thereof;
- (e) one or more agents having a pKa of about 3 to about 6, wherein the one or more agents comprise weak acids or salts thereof, or buffers;
- and
- (f) α-lipoic acid, or a pharmaceutically acceptable salt thereof, in an amount of about 0.1 mg/mL to about 5 mg/mL;
- wherein the formulation is substantially free of polysorbates and polyethoxylated castor oil.
A sterile pharmaceutical formulation for use in treatment of a patient in need thereof, comprising:
- (a) docetaxel, or a pharmaceutically acceptable salt thereof;
- (b) glycofurol;
- (c) α-lipoic acid, in an amount of about 0.1 mg/mL to about 5 mg/mL;
- (d) d-alpha-tocopheryl polyethylene glycol 1000 succinate;
- (e) citric acid;
- (f) water for injection;
- and
- (g) PEG 400;
- wherein the formulation is substantially free of polysorbates and polyethoxylated castor oil.
A sterile pharmaceutical formulation for use in treatment of a patient in need thereof, comprising:
- (a) docetaxel, or a pharmaceutically acceptable salt thereof;
- (b) ethanol;
- (c) α-lipoic acid, in an amount of about 0.1 mg/mL to about 5 mg/mL;
- (d) d-alpha-tocopheryl polyethylene glycol 1000 succinate;
- (e) citric acid;
- (f) water for injection;
- and
- (g) PEG 400;
- wherein the formulation is substantially free of polysorbates and polyethoxylated castor oil.
Dependencies are inferred from the claim text.