Tazobactam arginine antibiotic compositions
OwnerJan-Ji Lai, Jian-Qiao Gu +4inventors
InventorsJan-Ji Lai, Jian-Qiao Gu, Pradip M. Pathare, Valdas Jurkauskas, Joseph Terracciano, Nicole Miller Damour
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Abstract
This disclosure provides compositions comprising a beta-lactam compound and crystalline tazobactam arginine, and related methods and uses of these compositions.
Claims21
1-48. (canceled)
A composition comprising ceftolozane and a solid form of tazobactam arginine characterized by an X-ray powder diffraction pattern having peaks expressed in degrees 2-theta+/−0.2 deg at angles of 8.9, 18.0 and 21.2.
A composition obtained by a process comprising the steps of:
- a. combining tazobactam arginine polymorph Ia and ceftolozane sulfate in an aqueous solution at a pH of 5-7;
- and
- b. lyophilizing the aqueous solution to obtain the composition.
A pharmaceutical composition comprising ceftolozane active and tazobactam in a 2:1 weight ratio, the composition obtained by a process comprising the steps of:
- a. combining tazobactam arginine polymorph Ia, ceftolozane sulfate, and sodium chloride in an aqueous solution at a pH of 5-7;
- and
- b. lyophilizing the aqueous solution to obtain a lyophilized composition;
- and
- c. preparing the lyophilized composition as a pharmaceutical composition for intravenous administration.
A unit dosage form of a pharmaceutical composition for intravenous administration for the treatment of infections selected from the group consisting of:
- complicated intra-abdominal infections, complicated urinary tract infections and pneumonia, the unit dosage form comprising ceftolozane active and tazobactam in a 2:1 weight ratio, wherein the pharmaceutical composition is obtained by a process comprising the steps of:
- a. lyophilizing an aqueous solution comprising tazobactam arginine polymorph Ia to obtain a lyophilized composition;
- and
- b. combining the lyophilized composition with ceftolozane to obtain the pharmaceutical composition comprising tazobactam and ceftolozane in amounts providing ceftolozane active and tazobactam in a 2:1 weight ratio;
- and
- c. preparing the pharmaceutical composition as a unit dosage form containing the pharmaceutical composition for intravenous administration.
Dependencies are inferred from the claim text.