Ceftolozane pharmaceutical compositions
OwnerJoseph Terracciano, Nicole Miller Damourinventors
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Abstract
Pharmaceutical compositions can include an amount of sodium chloride effective to stabilize ceftolozane in a lyophilized formulation.
Claims18
A pharmaceutical composition comprising stabilized ceftolozane sulfate obtained by a process comprising lyophilizing an aqueous solution comprising 125 mg to 500 mg sodium chloride with an amount of ceftolozane sulfate providing 1,000 mg of ceftolozane active, to obtain the lyophilized stabilized ceftolozane sulfate composition.
A unit dosage form container comprising a pharmaceutical composition of stabilized ceftolozane sulfate, obtained by a process comprising the step of
- a. lyophilizing an aqueous solution comprising 125 mg to 500 mg sodium chloride with an amount of ceftolozane sulfate providing 1,000 mg of ceftolozane active, to obtain the lyophilized stabilized ceftolozane sulfate composition;
- b. filling the lyophilized stabilized ceftolozane composition into a unit dosage form container.
A unit dosage form of a pharmaceutical composition comprising 1,000 mg ceftolozane and 500 mg tazobactam, the 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, obtained by a process comprising the steps of:
- a. lyophlizing an aqueous solution to obtain a lyophilized ceftolozane composition, wherein the aqueous solution comprises water, ceftolozane sulfate, 125-500 mg sodium chloride per 1,000 mg ceftolozane active in the aqueous solution, an amount of L-arginine to provide a pH of 6-7 in the solution prior to lyophilization;
- b. blending the lyophilized ceftolozane composition with a lyophilized tazobactam composition in an amount providing about 500 mg tazobactam free active per 1,000 mg of ceftolozane active to obtain the unit dosage form.
Dependencies are inferred from the claim text.