Stable pharmaceutical form of an anticancer drug and method for production of stable pharmaceutical form of an anticancer drug.

摘要

The stable pharmaceutical form of the anti-cancer drug containing paclitaxel of the Fig. 1, according to the invention, is characterised in that it is a stable form of the active substance of a large surface, amorphous, possibly with some fine-crystalline additive. According to the invention, the method for production of the stable pharmaceutical form of the anticancer drug consists in dissolution of crystalline paclitaxel in a neutral organic solvent selected from the group comprising acetonitrile, dioxane, ethanol, or a mixture of those solvents, with possible addition of water, providing that the control of individual solvents in the mixture is in the range of 5 % to 95 %, while the content of water is in the range of 0 to 60 %; the resulting solution is possibly filtered, frozen, and solvents are removed by sublimation under reduced pressure, at a low temperature, and thereafter the preparation is possibly distributed into doses in conditions assuring its sterility.