发明名称 PARENTERAL CEFTOLOZANE ANTIBIOTIC COMPOSITIONS
摘要 Parenteral pharmaceutical compositions including ceftolozane and tazobactam can be formulated to provide desired levels of osmolality, pH and ceftolozane stability.
申请公布号 US2014274995(A1) 申请公布日期 2014.09.18
申请号 US201414214324 申请日期 2014.03.14
申请人 Cubist Pharmaceuticals, Inc. 发明人 Zhou Jianxun;Damour Nicole Miller;Mohr John Fred;Terracciano Joseph;Walsh Jacqueline Marie
分类号 A61K31/546;A61K31/431 主分类号 A61K31/546
代理机构 代理人
主权项 1. 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 componentsNominal CompositionComponentmg per 1 g ceftolozane activeCeftolozane Sulfateabout 1147 (providing 1,000 mg ceftolozane active)Citric Acid21Sodium Chloride450-500L-Arginine500-700Tazobactamabout 537 (providing 500 mg tazobactam free acidSodiumper 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.
地址 Lexington MA US