Manufacturing beta-lactam combination products
OwnerJoseph Terracciano, Nicole Miller Damourinventors
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Abstract
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.
Claims20
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.
A facility for manufacturing a pharmaceutical composition formulated for parenteral administration for the treatment of complicated intra-abdominal infections or complicated urinary tract infections, the pharmaceutical composition comprising ceftolozane sulfate and tazobactam in a ratio of 1,000 mg ceftolozane active per 500 mg of tazobactam active, the pharmaceutical composition obtained by a process comprising the steps of
- a. lyophilizing a first aqueous solution in the absence of tazobactam, the first aqueous solution comprising ceftolozane sulfate, 125 mg to 500 mg of sodium chloride per 1,000 mg of ceftolozane active, to obtain a first lyophilized ceftolozane composition,
- b. lyophilizing a second solution comprising tazobactam in the absence of ceftolozane to form a second lyophilized tazobactam composition;
- and
- c. blending the first lyophilized ceftolozane composition and the second lyophilized tazobactam composition to obtain the antibacterial composition;
- wherein the process is performed in the absence of any additional non-cephalosporin beta-lactam compounds.
Dependencies are inferred from the claim text.