Pharmaceutical compositions with antibiotic activity
The use of certain salts and aminoacids as stabilizer of the antibiotic Fosfomycin Tromethamol and pharmaceutical compositions containing them, is described.
1. A process for stabilizing a Fosfomycin Tromethamol composition, the process comprising:
combining Fosfomycin Tromethamol with at least one of the following substances in an amount effective to stabilize the Fosfomycin Tromethamol:
a tribasic sodium citrate;
a tribasic potassium citrate;
a monoacidic sodium citrate;
a monoacidic potassium citrate;
a tribasic sodium phosphate;
a tribasic potassium phosphate;
a monoacidic sodium phosphate;
a monoacidic potassium phosphate;
a sodium carbonate;
a potassium carbonate;
a sodium bicarbonate;
a potassium bicarbonate;
a sodium tartrate;
a potassium tartrate;
an arginine; and
a lysine.
2. The process of claim 1 , wherein the stabilizing substance is one or more of: a tribasic sodium citrate, a sodium carbonate, a potassium carbonate, a sodium bicarbonate, a potassium bicarbonate, and an arginine.
3. The process of claim 1 , wherein a molar ratio of the substance with respect to Fosfomycin Tromethamol is in a range between 10% and 100%.
4. The process of claim 1 , wherein a molar ratio of the substance with respect to Fosfomycin Tromethamol is in a range between 30% and 70%.
5. The process of claim 1 , wherein a molar ratio of the substance with respect to Fosfomycin Tromethamol is at least 50%.
6. The process of claim 1 , wherein the Fosfomycin Tromethamol and the stabilizing agent are produced as a hydrosoluble granulate.
7. The process of claim 1 , wherein the Fosfomycin Tromethamol is present in the composition in an amount of approximately 5.6 g.
8. The process of claim 1 , further comprising adding an excipient agent.
9. A pharmaceutical composition comprising Fosfomycin Tromethamol and at least one substance, in an amount effective for stabilizing, selected from the group consisting of:
a tribasic sodium citrate;
a tribasic potassium citrate;
a monoacidic sodium citrate;
a monoacidic potassium citrate;
a tribasic sodium phosphate;
a tribasic potassium phosphate;
a monoacidic sodium phosphate;
a monoacidic potassium phosphate;
a sodium carbonate;
a potassium carbonate;
a sodium bicarbonate;
a potassium bicarbonate;
a sodium tartrate;
a potassium tartrate;
an arginine; and
a lysine.
10. The pharmaceutical composition of claim 9 , wherein the stabilizing substance is one or more of: a tribasic sodium citrate, a sodium carbonate, a potassium carbonate, a sodium bicarbonate, a potassium bicarbonate, and an arginine.
11. The pharmaceutical composition of claim 9 , wherein a molar ratio of the substance with respect to Fosfomycin Tromethamol is in a range between 10% and 100%.
12. The pharmaceutical composition of claim 1 , wherein a molar ratio of the substance with respect to Fosfomycin Tromethamol is in a range between 30% and 70%.
13. The pharmaceutical composition of claim 1 , wherein a molar ratio of the substance with respect to Fosfomycin Tromethamol is at least 50%.
14. The pharmaceutical composition of claim 1 , wherein the Fosfomycin Tromethamol is present in an amount of approximately 5.6 g.
15. The pharmaceutical composition of claim 1 , which is produced as a hydrosoluble granulate.