Ceftolozane-tazobactam pharmaceutical compositions

Patent metadata

Field	Value
Publication number	US-9925196-B2
Application number	US-201615071530-A
Country	US
Kind code	B2
Filing date	Mar 16, 2016
Priority date	Mar 15, 2013
Publication date	Mar 27, 2018
Grant date	Mar 27, 2018

Abstract

Pharmaceutical compositions are provided in unit dosage forms comprising ceftolozane and tazobactam in separate unit dosage form containers, ceftolozane prepared in the absence of tazobactam, tazobactam prepared in the absence of ceftolozane, and/or compositions where ceftolozane and tazobactam are first combined within a unit dosage form container.

First claim

What is claimed is:

1. A unit dosage form package comprising
a. a first sealed container enclosing a ceftolozane composition obtained by a process comprising the steps of lyophilizing a solution comprising ceftolozane sulfate and about 125 mg to about 500 mg sodium chloride per 1,000 mg of ceftolozane active in an aqueous solution with L-arginine to obtain a lyophilized ceftolozane composition prepared in the absence of tazobactam;
b. a second sealed container enclosing a tazobactam composition obtained by a process comprising the steps of lyophilizing a solution comprising tazobactam acid and sodium bicarbonate to obtain a lyophilized tazobactam composition prepared in the absence of ceftolozane;
c. instructions to combine the ceftolozane composition and the tazobactam composition in a fixed dose ratio to provide an injectable antibiotic formulation for the treatment of an infection selected from the group consisting of: complicated intra-abdominal infections, complicated urinary tract infections and pneumonia infections.

2. The unit dosage form package of claim 1 , wherein the first container comprises a total amount of 1,000 mg of ceftolozane active, the second container comprises a total amount of 500 mg of tazobactam active.

3. The unit dosage form package of claim 1 , wherein the instructions recite a fixed dose combination of the ceftolozane composition and the tazobactam composition in a 2:1 ratio of the ceftolozane active to the tazobactam active and formulate the fixed dose combination for intravenous administration for the treatment of a complicated urinary tract infection.

4. The unit dosage form package of claim 1 , wherein the instructions recite a fixed dose combination of the ceftolozane composition and the tazobactam composition in a 2:1 ratio of the ceftolozane active to the tazobactam active and formulate the fixed dose combination for intravenous administration for the treatment of a complicated intra-abdominal infection.

Assignees

• Merck Sharp & Dohme
• Merck Sharp & Dohme

Inventors

• Terracciano Joseph
• Damour Nicole Miller
• Jiang Chun
• Fogliato Giovanni
• Donadelli Giuseppe Alessandro
• Resemini Dario

Classifications

• A61K31/545

  Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula: [IMAGE cpc-sch-A61K-0953.gif] , e.g. cephalosporins, {cefaclor, or cephalexine} · CPC title

• A61K31/198

  Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) · CPC title

• A61K31/546 Primary

  containing further heterocyclic rings, e.g. cephalothin · CPC title

• A61K31/43

  Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula [IMAGE cpc-sch-A61K-0952.gif], e.g. penicillins, penems · CPC title

• A61K31/431

  containing further heterocyclic rings, e.g. ticarcillin, azlocillin, oxacillin · CPC title