CEFTOLOZANE PHARMACEUTICAL COMPOSITIONS
Pharmaceutical compositions can include an amount of sodium chloride effective to stabilize ceftolozane in a lyophilized formulation.
1 . 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.
2 . The pharmaceutical composition of claim 1 , wherein the stabilized ceftolozane is obtained by lyophilizing the sodium chloride and ceftolozane sulfate with L-arginine.
3 . The pharmaceutical composition of claim 2 , wherein the stabilized ceftolozane is obtained by lyophilizing an aqueous solution having a pH of about 6.0 to 7.0.
4 . The pharmaceutical composition of claim 1 , wherein the stabilized ceftolozane is obtained by lyophilizing the sodium chloride and ceftolozane sulfate with L-arginine and citric acid.
5 . The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is formulated for parenteral administration.
6 . The pharmaceutical composition of claim 5 , wherein the composition is a unit dosage form in a vial comprising 125 mg to 500 mg sodium chloride, 1,000 mg of ceftolozane in the form of ceftolozane sulfate, and L-arginine.
7 . The pharmaceutical composition of claim 1 , formulated for parenteral administration.
8 . The pharmaceutical composition of claim 1 , wherein the pH of the aqueous solution is 6.0 to 7.0.
9 . 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.
10 . The unit dosage form container of claim 9 , wherein the stabilized ceftolozane is obtained by lyophilizing the sodium chloride and ceftolozane sulfate with L-arginine.
11 . The unit dosage form container of claim 9 , wherein the stabilized ceftolozane is obtained by lyophilizing the sodium chloride and ceftolozane sulfate with L-arginine and citric acid.
12 . The unit dosage form container of claim 10 , wherein the stabilized ceftolozane is obtained by lyophilizing an aqueous solution having a pH of about 6.0 to 7.0.
13 . The unit dosage form container of claim 9 , wherein pharmaceutical composition is formulated for parenteral administration.
14 . The unit dosage form container of claim 13 , wherein the composition is a unit dosage form in a vial comprising 125 mg to 500 mg sodium chloride, 1,000 mg of ceftolozane in the form of ceftolozane sulfate, and L-arginine.
15 . The pharmaceutical composition of claim 1 , further comprising tazobactam or a pharmaceutically acceptable salt thereof.
16 . The unit dosage form container of claim 9 , further comprising tazobactam sodium.
17 . The unit dosage form container of claim 14 , further comprising lyophilized tazobactam sodium.
18 . 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.