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    • 5. 发明申请
    • ULTRASOUND CONTRAST AGENT DOSAGE FORMULATION
    • 超声对比剂剂量配方
    • WO2005120587A1
    • 2005-12-22
    • PCT/US2004/017813
    • 2004-06-04
    • ACUSPHERE, INC.WALOVITCH, RichardBERNSTEIN, HowardCHICKERING, Donald, E, IIISTRAUB, Julie
    • WALOVITCH, RichardBERNSTEIN, HowardCHICKERING, Donald, E, IIISTRAUB, Julie
    • A61K49/22
    • A61K49/223
    • Clinical studies have been conducted and specific dosage formulations developed using polymeric microparticles having incorporated therein perfluorocarbon gases that provide significantly enhanced images of long duration. The dosage formulation includes microparticles formed of a biocompatible polymer, preferably including a lipid incorporated therein, and containing a perfluorocarbon that is a gas at body temperature. The microparticles are provided to a patient in an amount effective to enhance ultrasound imaging in the ventricular chambers for more than 5 minutes or in the mycocardium for more than a minute, in a dose ranging from 0.025 to 8.0 mg microparticles/kg body weight. Preferably the dose ranges from 0.05 to 4.0 mg microparticles/kg body weight. The dosage formulation typically is provided in a vial. A typical formulation is in the form of a dry powder that is reconstituted with sterile water prior to use by adding the water to the vial or syringe of the dry powder and shaking to yield an isosmotic or isotonic suspension of microparticles.
    • 已经进行了临床研究,并且使用其中掺入了全氟化碳气体的聚合物微粒开发出特定的剂量制剂,其提供长时间显着增强的图像。 剂量制剂包括由生物相容性聚合物形成的微粒,其优选包括掺入其中的脂质,并且含有在体温下作为气体的全氟化碳。 将微粒以有效量的方式提供给患者,剂量范围为0.025至8.0mg微粒/ kg体重的剂量,以在室室内超过5分钟或在心肌中增强超声成像超过一分钟。 剂量范围优选为0.05至4.0mg微粒/ kg体重。 剂型通常提供在小瓶中。 典型的制剂是干粉的形式,其在使用前通过将水添加到干粉末的小瓶或注射器中并且摇动以产生微粒的等渗或等渗悬浮液而在使用前用无菌水重构。