Ceftolozane-tazobactam pharmaceutical compositions
OwnerJoseph Terracciano, Nicole Miller Damourinventors
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Abstract
Pharmaceutical compositions can include ceftolozane lyophilized in the absence of tazobactam.
Claims30
An antibacterial pharmaceutical composition comprising ceftolozane 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 prior to lyophilization to obtain a first lyophilized ceftolozane composition,
- b. blending the first lyophilized ceftolozane composition with tazobactam to obtain an antibacterial composition comprising less than 0.13% by HPLC of a compound of formula (III) detectable at a retention time relative to ceftolozane of 1.22 by high performance liquid chromatography using a Develosil column ODS-UG-5;
- 5 micrometers;
- 250×4.6 mm, a mobile phase of sodium perchlorate buffer solution (pH 2.5)/CH3CN 90:10 (v/v) at a 1.0 mL/min flow rate and oven temperature of 45° C.
A unit dosage form of a pharmaceutical composition formulated for parenteral administration for the treatment of a complicated intra-abdominal infection or a complicated urinary tract infection, the pharmaceutical composition comprising ceftolozane 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, 125 mg to 500 mg of sodium chloride per 1,000 mg of ceftolozane active, at a pH of 6-7 prior to lyophilization 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.
A composition comprising lyophilized ceftolozane and tazobactam in a ratio of 1,000 mg ceftolozane active per 500 mg of tazobactam active, and less than 0.13% by HPLC of a compound of formula (III) detectable at a retention time relative to ceftolozane of 1.22 by high performance liquid chromatography using a Develosil column ODS-UG-5;
- 5 micrometers;
- 250×4.6 mm, a mobile phase of sodium perchlorate buffer solution (pH 2.5)/CH3CN 90:10 (v/v) at a 1.0 mL/min flow rate and oven temperature of 45° C.
Dependencies are inferred from the claim text.