Pharmaceutical composition containing taxane derivative destined for the preparation of an infusion solution, method of preparation thereof and use thereof

2:

• The pharmaceutical composition according to claim 1, characterized in that it contains a premix consisting of the mixture of the concentrate and the co-solvent.

3:

• The pharmaceutical composition according to claim 2, characterized in that it contains the premix, which is adjusted to the form suitable for administration.

4:

• The pharmaceutical composition according to claim 3, characterized in that it contains the premix, which is adjusted to the form suitable for administration by the addition of an aqueous solution for infusions, selected from the group consisting of 0.9% aqueous solution of sodium chloride and 5% aqueous solution of glucose.

5:

• The pharmaceutical composition according to claim 1, characterized in that the suitable solvent is selected from the group, consisting of ethanol, 2-propanol and their mixture.

6:

• The pharmaceutical composition according to claim 5, characterized in that the suitable solvent is ethanol.

7:

• The pharmaceutical composition according to claim 1, characterized in that the suitable surfactant is polysorbate 80.

8:

• The pharmaceutical composition according to claim 1, characterized in that the suitable buffer is a pharmaceutically acceptable buffer or its combination with a mineral acid.

9:

• The pharmaceutical composition according to claim 8, characterized in that the suitable buffer is selected from the group, consisting of a citrate buffer, tartrate buffer, lactate buffer and a combination of one of said buffers with hydrochloric acid or its aqueous solution.

10:

• The pharmaceutical composition according to claim 9, characterized in that the particularly suitable buffer is citrate buffer or its combination with hydrochloric acid or with an aqueous solution of hydrochloric acid.

15:

• A pharmaceutical composition containing a taxane derivative, characterized in that it contains a concentrate consisting of a pharmaceutically effective amount of docetaxel in the mixture of a solvent, a surfactant and a buffer.

16:

• The pharmaceutical composition according to claim 15, characterized in that it contains the concentrate adjusted to the form suitable for administration.

17:

• The pharmaceutical composition according to claim 16, characterized in that the concentrate is adjusted to the form suitable for administration by the addition of an aqueous solution for infusions, selected from the group consisting of 0.9% aqueous solution of sodium chloride and 5% aqueous solution of glucose.

18:

• The pharmaceutical composition according to claim 15, characterized in that the suitable solvent is selected from the group, consisting of ethanol, 2-propanol and their mixture.

19:

• The pharmaceutical composition according to claim 18, characterized in that the suitable solvent is ethanol.

20:

• The pharmaceutical composition according to claim 15, characterized in that the surfactant is polysorbate 80.

21:

• The pharmaceutical composition according to claim 15, characterized in that the suitable buffer is a pharmaceutically acceptable buffer or its combination with a mineral acid.

22:

• The pharmaceutical composition according to claim 21, characterized in that the suitable buffer is selected from the group, consisting of a citrate buffer, tartrate buffer, lactate buffer and a combination of one of said buffers with hydrochloric acid or its aqueous solution.

23:

• The pharmaceutical composition according to claim 22, characterized in that the particularly suitable buffer is citrate buffer or its combination with hydrochloric acid or with an aqueous solution of hydrochloric acid.

28:

• Method of preparation of the pharmaceutical composition of claim 1, characterized in that the taxane derivative docetaxel in the solution consisting of a solvent, surfactant polysorbate 80 and a buffer is mixed with the solution consisting of an aqueous solution of a solvent, polysorbate 80, and optionally a buffer for the preparation of the premix, which is subsequently adjusted to the form suitable for administration.

29:

• The method of preparation of the pharmaceutical composition according to claim 28, characterized in that the suitable solvent is selected from the group, consisting of ethanol, 2-propanol and their mixture.

30:

• The method of preparation of the pharmaceutical composition according to claim 29, characterized in that the particularly suitable solvent is ethanol.

31:

• The method according to claim 28, characterized in that the premix is adjusted to the form suitable for administration by the dilution in the ratio of 1 to 2 parts of the premix to 25 parts of infusion with an aqueous solution for infusions, selected from the group consisting of 0.9% aqueous solution of sodium chloride and 5% aqueous solution of glucose.

32:

• Method of preparation of the pharmaceutical composition of claim 15, characterized in that the taxane derivative docetaxel is dissolved in the solution consisting of solvent, polysorbate 80, and a buffer in order to obtain the concentrate, which is subsequently adjusted to the form suitable for administration.

33:

• The method of preparation of the pharmaceutical composition according to claim 32, characterized in that the suitable solvent is selected from the group, consisting of ethanol, 2-propanol and their mixture.

34:

• The method of preparation of the pharmaceutical composition according to claim 33, characterized in that the particularly suitable solvent is ethanol.

35:

• The method of preparation of the pharmaceutical composition according to claim 32, characterized in that the concentrate is adjusted to the form suitable for administration by the dilution in the ratio of 1 part of the concentrate into 19-90 parts of the infusion with an aqueous solution for infusions, selected from the group consisting of 0.9% aqueous solution of sodium chloride and 5% aqueous solution of glucose.

36:

• The method of preparation of the pharmaceutical composition according to claim 28, characterized in that the composition is adjusted to the form suitable for intravenous administration.

37:

• The use of the pharmaceutical composition according to claim 1 for the preparation of a medicament in the form suitable for intravenous administration for the treatment of various types of cancerous diseases and other diseases manifested by an abnormal proliferation of cells.

38:

• A kit for inhibiting the tumor growth, characterized in that it comprises a concentrate, consisting of the taxane derivative docetaxel, a suitable solvent, a surfactant and a pharmaceutically effective amount of a buffer, and a co-solvent containing a pharmaceutically effective amount of a surfactant, a suitable solvent and optionally also a pharmaceutically effective amount of a buffer, wherein the concentrate and the co-solvent are destined for use in combination in order to prepare a premix, which is diluted with a sterile aqueous solution for infusions prior to administration to a patient.