Fosfomycin pharmaceutical composition
View Patent ↗The present invention relates to a solid fosfomycin pharmaceutical composition stable in front the coloration, suitable for diabetics and not entailing gastrointestinal problems. The pharmaceutical composition of this invention comprises fosfomycin trometamol, glycine, and optionally other excipients as sucralose, silice dioxide, polyvinylpyrrolidone and flavor; and is substantially free from sugars and sugar alcohols as sucrose, fructose, glucose, xylitol, mannitol, sorbitol or mixtures thereof.
1. A stable solid fosfomycin pharmaceutical composition for oral administration characterized by comprising
a) fosfomycin trometamol,
b) glycine and
c) optionally other pharmaceutical acceptable excipients,
and it is substantially free from sugars and sugar alcohols.
2. The pharmaceutical composition according to claim 1 , characterized by further comprising a pharmaceutically acceptable sweetener.
3. The pharmaceutical composition according to claim 2 , characterized in that the sweetener is selected from the group including sucralose, acesulfame, aspartame, saccharine, alitame, cyclamate, neohesperidine dihydrochalcone, thaumatina and mixture thereof.
4. The pharmaceutical composition according to claim 3 , characterised in that the sweetener is sucralose.
5. The pharmaceutical composition according to claim 1 , characterised by comprising other pharmaceutically acceptable excipients.
6. The pharmaceutical composition according to claim 1 , characterised by comprising, expressed as weight of the total composition:
a) between 30% and 99.9% fosfomycin trometamol,
b) between 0.1 and 70% glycine, and
c) optionally other pharmaceutically acceptable excipients in quantity enough to complete the 100% of the composition total weight.
7. The pharmaceutical composition according to claim 6 , characterised by comprising, expressed as weight of the total composition:
a) about 63% fosfomycin trometamol,
b) about 32% glycine, and
c) optionally other pharmaceutically acceptable excipients in quantity enough to complete the 100% of the composition total weight.
8. The pharmaceutical composition according to claim 6 , characterised by comprising, expressed as weight of the total composition:
a) between 30% and 99.9% fosfomycin trometamol,
b) between 0.1 and 70% glycine,
c) between 0.0 and 5.0% sweetener, and
d) optionally other pharmaceutically acceptable excipients in quantity enough to complete the 100% of the composition total weight.
9. The pharmaceutical composition according to claim 7 , characterised by comprising, expressed as weight of the total composition:
a) about 63% fosfomycin trometamol,
b) about 32% glycine,
c) about 1.3% sucralose,
d) about 0.1% silicon dioxide,
e) about 2.2% polyvinylpyrrolidone, and
f) about 1.4% lemon flavour.
10. The pharmaceutical composition according to claim 8 , characterised in being powder or granulate for solution.
11. The pharmaceutical composition according to claim 10 , characterised in that the powder or granulate for solution is soluble in water.
12. A method of treatment and/or prophylaxis of a mammal suffering from or being susceptible to uncomplicated acute infections of the lower urinary tract, said method comprising the administration to said mammal, of the fosfomycin stable solid pharmaceutical composition for oral administration as defined in claim 1 .