Ceftolozane pharmaceutical compositions
OwnerNicole Miller Damour, Joseph Terraccianoinventors
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Abstract
Pharmaceutical compositions can include ceftolozane and an amount of sodium chloride effective to provide improved ceftolozane stability.
Claims17
A pharmaceutical composition comprising about 1,000 mg of ceftolozane active per 189 mg sodium from sodium chloride, and not more than 0.03% by high performance liquid chromatography (HPLC) of a RT63 Impurity at a retention time of about 63 minutes observed by HPLC 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.,
- the pharmaceutical composition obtained by a process comprising the step of lyophilizing an aqueous solution comprising sodium chloride and ceftolozane sulfate to obtain a lyophilized ceftolozane composition, and formulating the pharmaceutical composition from the lyophilized ceftolozane composition.
A pharmaceutical composition obtained by a process comprising the step of lyophilizing an aqueous solution comprising about 1,000 mg of ceftolozane per 189 mg sodium from sodium chloride, to obtain a lyophilized ceftolozane composition.
A unit dosage form container containing a unit dosage form of a pharmaceutical composition formulated for parenteral administration for the treatment of one or more infections selected from the group consisting of:
- complicated intra-abdominal infections, complicated urinary tract infections and pneumonia infections, the pharmaceutical composition comprising about 1,000 mg ceftolozane active in the form of ceftolozane sulfate per 189 mg sodium from sodium chloride.
A method of manufacturing a ceftolozane composition having not more than 0.03% of a RT63 impurity as measured by high performance liquid chromatography (HPLC) of a RT63 Impurity at a retention time of about 63 minutes observed by HPLC 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., the method comprising the step of lyophilizing an aqueous solution comprising about 1,000 mg of ceftolozane per 189 mg sodium from sodium chloride, to obtain the ceftolozane composition.
Dependencies are inferred from the claim text.