Parenteral ceftolozane antibiotic compositions
OwnerJianxun Zhou, Nicole Miller Damour +3inventors
InventorsJianxun Zhou, Nicole Miller Damour, John Fred Mohr, Joseph Terracciano, Jacqueline Marie Walsh
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Abstract
Parenteral pharmaceutical compositions including ceftolozane and tazobactam can be formulated to provide desired levels of osmolality, pH and ceftolozane stability.
Claims17
A method of treating an infection selected from the group consisting of Complicated Urinary Tract Infections (cUTI), Complicated Intra-Abdominal Infections (cIAI) and Hospital-Acquired Bacterial Pneumonia (HABP)/Ventilator-Associated Bacterial Pneumonia (VABP), the method comprising
- a. reconstituting a lyophilized unit dosage form composition comprising the following components
- Nominal Composition
- Component
- mg per 1 g ceftolozane active
- Ceftolozane Sulfate
- about 1147 (providing 1,000 mg ceftolozane active)
- Citric Acid
- 21
- Sodium Chloride
- 450-500
- L-Arginine
- 500-700
- Tazobactam
- about 537 (providing 500 mg tazobactam free acid
- Sodium
- per 1,000 mg ceftolozane active)
- in one or more pharmaceutically acceptable liquid carriers selected from the group consisting of 0.9% sodium chloride aqueous solution for injection, 0.45% sodium chloride aqueous solution for injection, and 5% dextrose for injection and water for injection, to form a dissolved unit dosage form;
- b. diluting the dissolved unit dosage form in one or more pharmaceutically acceptable liquid carriers selected from the group consisting of 0.9% sodium chloride aqueous solution for injection, 0.45% sodium chloride aqueous solution for injection, and 5% dextrose for injection and water for injection, to form a parenteral pharmaceutical formulation comprising a therapeutically effective amount of ceftolozane sulfate and tazobactam, and having an osmolality of about 400-600 mOsm/kg and a pH of about 5-7;
- and
- c. intravenously administering to a patient in need thereof the parenteral pharmaceutical formulation comprising the therapeutically effective dose of ceftolozane sulfate and tazobactam;
- tazobactam in an amount providing 500 mg of tazobactam acid per 1,000 mg of ceftolozane active in the parenteral pharmaceutical formulation;
- 450 to 500 mg of sodium chloride per 1,000 mg of ceftolozane active in the parenteral pharmaceutical formulation;
- and L-arginine.
A method of treating a bacterial infection in a subject comprising administering to a patient in need thereof a parenteral pharmaceutical antibiotic composition having an osmolality of 400-500 mOsm/kg at a pH of 5-7, the composition comprising
- a. an amount of ceftolozane sulfate providing 1,000 mg ceftolozane active,
- b. about 450 mg to 500 mg sodium chloride per 1,000 mg ceftolozane active, and
- c. an amount of tazobactam sodium providing 500 mg of tazobactam free acid;
- in a pharmaceutically acceptable liquid carrier selected from the group consisting of 0.9% sodium chloride aqueous solution for injection, 5% dextrose for injection and water for injection.
Dependencies are inferred from the claim text.