GRANULES COMPRISING A ß-LACTAM ANTIBIOTIC

摘要

The present invention relates to granules comprising a beta-lactam antibiotic, wherein C_H2S(72h)<50 muL OF H₂S gas per kg of beta-lactam antibiotic, wherein C_H2S(72h) is the volume of H₂S gas above said granules per kg of said beta-lactam antibiotic, when a sample of between 3.5 and 4.5 g of said granules is kept in a closed container having a volume of 20 ml at a temperature of 22° C. during 72 hours at atmospheric pressure (1 bar). The invention also relates to a process for the preparation of granules comprising a beta-lactam antibiotic, said process comprising feeding said beta-lactam antibiotic to a roller compactor to form compacts, size reducing, e.g. milling the compacts to produce granules, wherein the temperature of the beta-lactam antibiotic that is fed to the roller compactor is sufficiently low that C_H2S(72h)<50 muL OF H₂S gas per kg of beta-lactam antibiotic, wherein C_H2S(72h) is the volume of H₂S gas above said granules per kg of said beta-lactam antibiotic, when a sample of between 3.5 and 4.5 g of said granules is kept in a closed container having a volume of 20 ml at a temperature of 22° C. during 72 hours at atmospheric pressure (1 bar).