Pharmaceutical compositions comprising docetaxel and methods for preparation thereof
AssigneeBeijing Century Biocom Pharmaceutical Technology Co. Ltd.
InventorShouzhu Hao
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Abstract
A pharmaceutical composition of docetaxel comprising an effective amount of docetaxel, a polysorbate (TWEEN® compound) and a co-solvent, wherein the co-solvent is at least one member selected from the group consisting of glycerol and polyethylene glycol. The composition is an injectable solution or a freeze-dried powder for injection. The solubility of decetaxel is improved by adding a polysorbate and a co-solvent. Methods of preparation of the pharmaceutical composition are also disclosed.
Claims22
A pharmaceutical composition comprising:
- a) between 1 mg/mL and 80 mg/mL docetaxel;
- b) between 20 mg/mL and 500 mg/mL of a polysorbate surfactant selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, and mixtures thereof;
- and
- c) between 5 mg//mL and 500 mg/mL of a solubilizing agent selected from the group consisting of glycerol, polyethylene glycol, and mixtures thereof;
- wherein
- said pharmaceutical composition does not comprise ethanol;
- wherein the weight ratio of docetaxel to said polysorbate surfactant to said solubilizing agent is 1:10-80:5-50;
- and
- wherein said pharmaceutical composition forms a clear solution when mixed with water.
A pharmaceutical composition comprising an aqueous solution of:
- a) between 1 mg/mL and 80 mg/mL docetaxel;
- b) between 20 mg/mL and 500 mg/mL of a polysorbate surfactant selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, and mixtures thereof;
- and
- c) between 5 mg//mL and 500 mg/mL of a solubilizing agent selected from the group consisting of glycerol, polyethylene glycol, and mixtures thereof;
- wherein
- said pharmaceutical composition does not comprise ethanol;
- said pharmaceutical composition is clear and does not comprise any solid particles;
- and
- wherein the weight ratio of docetaxel to said polysorbate surfactant to said solubilizing agent is 1:10-80:5-50.
Dependencies are inferred from the claim text.