Bone cement paste containing an antibiotic

A bone cement powder based on compounds comprising reactive amorphous calcium phosphate together with a cationic antibiotic salt for the production of an injectable, curable, bone cement paste with the ability to release the antibiotic in vivo in biologically active concentrations, after curing.

A process for the production of an injectable curable bone cement paste, based on bioresorbable reactive amorphous calcium phosphate, comprising a cationic antibiotic salt selected from gentamycin sulfate, tobramycin sulfate, amikacin sulfate and netilmycin sulfate, said process comprising:

• mixing bone cement powder comprising reactive amorphous calcium phosphate with an aqueous solution of the antibiotic, optionally with the addition of stabilizers, preservatives, binders, complexing agents or combinations thereof.

A kit for the production of an injectable bone cement paste, said kit comprising the following separately packed components:

• (i) a defined amount of bone cement powder based on compounds comprising reactive amorphous calcium phosphate and
• (ii) an amount of liquid comprising a cationic antibiotic salt, in an active concentration, selected from gentamycin sulfate, tobramycin sulfate, amikacin sulfate and netilmycin sulfate, and optionally further comprising one or more stabilizers, preservatives, binders, complexing agents or combinations thereof,
• wherein the amount of liquid is such that after combining the two components (i) and (ii) an easily injectable curable paste results.

A kit for the production of an injectable bone cement paste, said kit comprising the following separately packed components:

• (i) a defined amount of bone cement powder based on compounds comprising reactive amorphous calcium phosphate, blended with a cationic antibiotic salt in a biologically active concentration of between 5 and 80 mg/g of bone cement powder, said cationic antibiotic salt selected from gentamycin sulfate, tobramycin sulfate, amikacin sulfate and netilmycin sulfate, and optionally further comprising one or more stabilizers, preservatives, binders, complexing agents or combinations thereof and
• (ii) an amount of liquid such that after combination of the two components (i) and (ii) an easily injectable curable paste results.

In a method for the treatment and/or prophylaxis of osteomyelitis and osteitis comprising administering to a patient an active compound depot providing release of an antibiotic at biologically active concentrations, the improvement wherein said active compound depot comprises reactive amorphous calcium phosphate and a medicament, said medicament comprising a cationic antibiotic salt selected from gentamycin sulfate, tobramycin sulfate, amikacin sulfate and netilmycin sulfate.

In a method for the treatment and/or prophylaxis of osteomyelitis and osteitis the improvement comprising administering to a patient an active compound depot providing release of an antibiotic at a concentration of from 100 to 500 μg/ml, wherein said active compound depot comprises reactive amorphous calcium phosphate and a medicament, said medicament comprising a cationic antibiotic salt selected from gentamycin sulfate, tobramycin sulfate, amikacin sulfate and netilmycin sulfate.

A bone cement paste comprising bone cement powder, a medicament, and liquid wherein said bone cement powder comprises reactive amorphous calcium phosphate, said medicament is a cationic antibiotic salt selected from gentamycin sulfate, tobramycin sulfate, amikacin sulfate and netilmycin sulfate, and said liquid is an aqueous medium or a physiologically acceptable polar organic solvent.