US2014274995A1PendingUtilityA1
Parenteral ceftolozane antibiotic compositions
Est. expiryMar 15, 2033(~6.6 yrs left)· nominal 20-yr term from priority
A61P 31/04A61P 31/12A61P 31/00A61P 43/00A61K 47/183A61K 31/546A61K 47/12A61K 31/431A61K 47/02A61K 47/36A61K 9/0019A61K 47/26A61K 9/19A61K 31/433Y02A50/30
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Claims
Abstract
Parenteral pharmaceutical compositions including ceftolozane and tazobactam can be formulated to provide desired levels of osmolality, pH and ceftolozane stability.
Claims
exact text as granted — not AI-modified1 . 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.
2 . The method of claim 1 , further comprising intravenously administering the parenteral pharmaceutical formulation over a period of about 1 hour to the patient.
3 . The method of claim 1 , further comprising administering a second and a third parenteral pharmaceutical formulation comprising ceftolozane and tazobactam to a patient in need thereof by repeating steps (a)-(c) three times a day.
4 . The method of claim 1 , wherein the infection is a Complicated Urinary Tract Infections (cUTI) or Complicated Intra-Abdominal Infections (cIAI).
5 . The method of claim 4 , wherein the parenteral pharmaceutical formulation contains a total of 1,000 mg of ceftolozane active present as ceftolozane sulfate.
6 . The method of claim 5 , wherein the parenteral pharmaceutical formulation contains a total of 500 mg of tazobactam acid present as tazobactam sodium.
7 . The method of claim 1 , wherein the lyophilized unit dosage form composition comprises 1,000 mg of ceftolozane active present as ceftolozane sulfate.
8 . The method of claim 1 , wherein the lyophilized unit dosage form composition is obtained by a process comprising the steps of:
a. lyophilizing a first aqueous solution in the absence of tazobactam, the first aqueous solution comprising ceftolozane, 450 mg to 500 mg of sodium chloride per 1,000 mg of ceftolozane active, at a pH of 6-7 prior to lyophilization to obtain a first lyophilized ceftolozane composition, b. lyophilizing a second solution comprising tazobactam in the absence of ceftolozane to form a second lyophilized tazobactam composition; and c. blending the first lyophilized ceftolozane composition and the second lyophilized tazobactam composition to obtain the antibacterial composition; and d. packaging a portion of the antibacterial composition as the lyophilized unit dosage form composition.
9 . The method of claim 8 , wherein the first aqueous solution further comprises L-arginine in an amount providing a pH of about 6-7.
10 . The method of claim 8 , wherein the first aqueous solution comprises water and the following components:
Nominal Composition
Component
mg per Vial
Ceftolozane Sulfate
about 1147 (providing 1,000 mg ceftolozane active)
Citric Acid
21
Sodium Chloride
487
L-Arginine
600
Q.S. for pH adjustment
Nitrogen
Q.S.
11 . 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.
12 . The method of claim 11 , wherein the bacterial infection is a complicated urinary tract infection.
13 . The method of claim 11 , wherein the bacterial infection is a complicated intra-abdominal infection.
14 . The method of claim 11 , wherein the bacterial infection comprises a bacteria selected from the group consisting of: Staphylococcus aureus, Escherichia coli, Acinetobacter baumanii, Haemophilus influenzae, Klebsiella pneumonia , and Pseudomonas aeruginosa.
15 . The method of claim 11 , further comprising the steps of
a. reconstituting a unit dosage form of ceftolozane/tazobactam having the composition:
Nominal Composition
Component
mg per Vial
Ceftolozane Sulfate
about 1147 (providing 1,000 mg ceftolozane active)
Citric Acid
21
Sodium Chloride
487
L-Arginine
600
Q.S. for pH adjustment
Tazobactam
about 537 (providing 500 mg tazobactam free acid
Sodium
per 1,000 mg ceftolozane active)
Nitrogen
Q.S.
in a pharmaceutically acceptable liquid carrier to obtain a reconstituted antibiotic composition;
b. intravenously administering the reconstituted antibiotic composition within the parenteral pharmaceutical antibiotic composition.
16 . The method of claim 15 , further comprising repeatedly intravenously administering separate doses of the parenteral pharmaceutical antibiotic composition to a patient in need thereof three times per day.
17 . The method of claim 16 , wherein each separate parenteral pharmaceutical antibiotic compositions are administered to the patient over a 1 hour period.Join the waitlist — get patent alerts
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