MANUFACTURING BETA-LACTAM COMBINATION PRODUCTS

摘要

This disclosure relates to the manufacture of pharmaceutical compositions comprising an antibiotic compound and a beta-lactamase inhibitor compound when both compounds have a chemical structure that includes a beta-lactam ring, as well as resulting pharmaceutical compositions.

主权项

1. A method of manufacturing an antibacterial pharmaceutical composition comprising ceftolozane and tazbactam in a facility that does not manufacture or house beta-lactam products selected from the group consisting of: penicillins, penems, carbacephems and monobactams, the pharmaceutical composition comprising a therapeutically effective amount of ceftolozane sulfate and tazobactam in a ratio of 1,000 mg ceftolozane active per 500 mg of tazobactam active, the method comprising the steps of:
a. lyophilizing a first aqueous solution comprising ceftolozane sulfate to obtain a lyophilized ceftolozane composition in the absence of tazobactam, penicillins, penems, carbacephems and monobactams; b. blending the lyophilized ceftolozane composition with a tazobactam composition in the absence of penicillins, penems, carbacephems and monobactams, the tazobactam composition comprising tazobactam prepared and provided in the absence of ceftolozane to obtain the antibacterial pharmaceutical composition.