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BI-DOSE NASAL SPRAY

机译:BI-dose nasal spray

摘要

The present invention relates to a novel nasal spray containing an aqueous solution or a fluid with an anxiolytic or anticonvulsant substance, wherein the nasal spray is characterized in that with the nasal spray, two sprays with each an equivalent, defined volume of the aqueous solution or liquid of the active agent, can be intranasally administered to a patient and wherein the nasal spray allows for an administration, independent of the spatial orientation of the nasal spray in any position of the patient (standing upright, sitting, lying or in any intermediate position). The nasal spray can be used directly without prior activation. Preferably it is apparent from the nasal spray whether a spray or even a second spray has been made with the nasal spray. Preferably, a spray of the nasal spray can be administered one- handed by the patient or a third person. The active agent in the inventive nasal spray is a benzodiazepine or a GABA-receptor agonist, preferably midazolam or a derivative thereof or a salt of these active agents. The nasal spray according to the present invention may be used for sedation, premedication or treatment of patients with claustrophobia, anxiety disorders or panic attacks or for the treatment of convulsions in CNS diseases, particularly in epileptic seizures or other manifestations of seizures (e.g. febrile convulsions). The invention also relates to a method for hermetically sealing an active agent container for use in supplying an nasal spray in accordance with the invention. The invention also relates to a method of detection by localizing the locally precise administration of an active agent in nasal application, as well as a nasal spray, preferably a bi-dose nasal spray, for which, using the cited method of detection, it has been shown both visually (qualitatively) and quantitatively that an orientation-independent, uniform and locally precise administration of the dose of the active agent onto the nasal mucosa of a patient can be achieved. Also provided is a method for airless and air-tight sealing of an active agent container in accordance with the invention.
机译:本发明涉及含有含水溶液或具有抗焦力或抗惊厥药物的流体的新型鼻喷雾,其中鼻喷雾的特征在于,用鼻喷雾,两个喷雾用每种相当,定义体积的水溶液或活性剂的液体可以鼻内给予患者,其中鼻喷雾允许给药,与患者的任何位置的鼻喷雾的空间取向无关(竖立,坐着,躺着或在任何中间位置。 )。鼻喷雾可以直接使用,无需先前激活。优选地,从鼻喷雾是显而易见的,无论是用鼻喷雾制成的喷雾甚至第二喷雾。优选地,鼻喷雾的喷雾可以由患者或第三人单手施用。本发明鼻喷雾中的活性剂是苯二氮卓或GABA受体激动剂,优选咪达唑仑或其衍生物或这些活性剂的盐。根据本发明的鼻喷雾可用于镇静,预诊断或治疗患有幽闭恐惧症,焦虑症或恐慌发作或治疗CNS疾病中的抽搐,特别是在癫痫发作或癫痫发作的其他表现(例如发热抽搐)。本发明还涉及一种用于气密密封活性剂容器的方法,用于供应根据本发明的鼻喷雾。本发明还涉及通过定位鼻腔应用中的局部精确施用活性剂的检测方法,以及使用所引用的检测方法,鼻喷雾,优选双剂量鼻喷雾,其具有在视觉上(定性)和定量地显示,可以实现与患者的鼻粘膜上的定向无关,均匀和局部精确地施用在患者的鼻粘膜上。还提供了根据本发明的活性剂容器的无气空气密封的方法。

著录项

  • 公开/公告号EP3790614A2

    专利类型

  • 公开/公告日2021-03-17

    原文格式PDF

  • 申请/专利权人 AKROSWISS AG;

    申请/专利号EP20190721637

  • 申请日2019-05-08

  • 分类号A61M15/08;A61M11;A61M15;A61M5/315;G09B23/28;B65B3;B65B7/16;B65B7/28;B65B31/02;B65B31/04;G09B23/30;A61M5/31;

  • 国家 EP

  • 入库时间 2022-08-24 17:45:20

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