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Parenteral esmolol formulation

机译:肠胃外艾司洛尔制剂

摘要

A parenteral formulation of esmolol hydrochloride for use in the treatment of a patient suffering from tachycardia comprising a lyophilized powder consisting of pure esmolol hydrochloride, wherein said powder is reconstituted to obtain a ready-to-use i.v. solution of esmolol hydrochloride at a concentration of 20-100 mg/mL, and said i.v. solution is directly administered to the patient, and further a method of producing a ready-to-use i.v. solution of esmolol hydrochloride by reconstituting a lyophilized powder consisting of pure esmolol hydrochloride with a solvent, characterized in that said solvent is an i.v. solvent devoid of alcohol or a buffer excipient, in an amount necessary to obtain a ready-to-use i.v. solution at a concentration of 20-100 mg/mL, and the ready-to-use i.v. solution containing a parenteral formulation of 20-100 mg/mL pure esmolol hydrochloride in an infusion device or consisting of a parenteral formulation of 20-100 mg/mL pure esmolol hydrochloride, WFI and/or saline solution, devoid of any alcohol or buffer excipients.
机译:用于治疗心动过速的患者的盐酸艾司洛尔的肠胃外制剂,其包含由纯艾司洛尔组成的冻干粉末,其中所述粉末被重建以获得即用型静脉内注射剂。盐酸艾司洛尔溶液的浓度为20-100 mg / mL,溶液直接施用于患者,还有一种制备即用型静脉内注射的方法。通过将由纯艾司洛尔盐酸盐组成的冻干粉末与溶剂复溶而成的艾司洛尔盐酸盐溶液,其特征在于所述溶剂为静脉内注射。不含酒精或缓冲赋形剂的溶剂,其用量应为可立即使用的i.v.浓度为20-100 mg / mL的溶液,即可使用的i.v.输液器中含有20-100 mg / mL的纯艾司洛尔盐酸盐的肠胃外制剂的溶液或由20-100 mg / mL的纯艾司洛尔盐酸盐,WFI和/或盐溶液的肠胃外制剂组成,不含任何酒精或缓冲剂。

著录项

  • 公开/公告号DK2846776T3

    专利类型

  • 公开/公告日2020-06-15

    原文格式PDF

  • 申请/专利权人 AOP ORPHAN PHARMACEUTICALS AG;

    申请/专利号DK20130721740T

  • 发明设计人 WIDMANN RUDOLF;

    申请日2013-05-08

  • 分类号A61K9/19;A61K9;A61K9/08;A61K31/24;A61P9/06;

  • 国家 DK

  • 入库时间 2022-08-21 11:17:49

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