Stabilizing ceftolozane
OwnerNicole Miller Damourinventor
Life of this patent
Estimating the term…
Abstract
Pharmaceutical compositions can include an amount of a ceftolozane and a stabilizing agent in a formulation for parenteral administration.
Claims20
A pharmaceutical composition comprising stabilized ceftolozane obtained by a process comprising lyophilizing a composition including ceftolozane and a stabilizing agent selected from the group consisting of:
- sodium chloride, sucrose, and trehalose, to obtain a lyophilized stabilized ceftolozane pharmaceutical composition, wherein the stabilized ceftolozane is characterized by a reduction in purity of less than 5% at 60 degrees C. over 7 days in a sealed container, as determined by 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 pharmaceutical composition comprising stabilized ceftolozane and about 300 mg of a stabilizing agent, wherein the stabilizing agent is selected from the group consisting of sucrose and trehalose.
A unit dosage form container enclosing a pharmaceutical composition formulated for parenteral administration for the treatment of complicated intra-abdominal infections or complicated urinary tract infections, the pharmaceutical composition comprising 1,000 mg of ceftolozane active, L-arginine, citric acid and about 300-500 mg of a stabilizing agent selected from the group consisting of:
- sodium chloride, trehalose, and sucrose, wherein the pharmaceutical composition after 7 days at 60 degrees C. wherein the reduction in the purity of ceftolozane active in the pharmaceutical composition is not more than 5% less than the initial amount.
Dependencies are inferred from the claim text.