Freeze-dried injectable pharmaceutical combination of semisynthetic vinca alkaloids and carbohydrate stable at room temperature
This invention relates to pharmaceutical compositions consisting of a semisynthetic derivative of vinca alkaloid, stable at room temperature, in which said derivative is present in the form of a freeze dried product obtained in the presence of at least one carbohydrate.
1. Pharmaceutical compositions consisting of a hydrosoluble salt of vinflunine or vinorelbine, stable at room temperature, wherein said hydrosoluble salt of vinflunine or vinorelbine is in a freeze-dried form obtained in the presence of at least one carbohydrate, at least one buffer system and a hydrophilic anti-oxidation agent.
2. Compositions according to claim 1 wherein the hydrosoluble salt of vinflunine or vinorelbine is vinflunine ditartrate or vinorelbine ditartrate.
3. Compositions according to claim 1 wherein the carbohydrate (s) is chosen from among the monosaccharides, reduced or not, oligosaccharides or polysaccharides.
4. Compositions according to claim 3 wherein the carbohydrate (s) is chosen from among saccharose, trehalose and lactose.
5. Compositions according to claim 1 wherein the buffer system chosen to control the pH has a value between 3 and 4 and a molarity between 0.005 M and 0.5 M.
6. Compositions according to claim 1 wherein said compositions are manufactured and packaged under an inert gas atmosphere and/or with incorporation of a hydrophilic anti-oxidation agent into the formula.
7. Compositions according to claim 1 wherein said compositions are in a form suited to administration by infusion by intravenous route.
8. Compositions according to claim 3 wherein the carbohydrate (s) is disaccharides.
9. Compositions according to claim 3 wherein the carbohydrate (s) is inuline.
10. Compositions according to claim 5 wherein the buffer system chosen to control the pH has a value in the region of 3.5 and a molarity between 0.05 M and 0.2 M.
11. Pharmaceutical compositions consisting of a hydrosoluble salt of vinflunine or vinorelbine, stable at room temperature, wherein said hydrosoluble salt of vinflunine or vinorelbine is in a freeze-dried form obtained in the presence of at least one carbohydrate.