CN116075306A - 用于治疗冠状病毒感染的化合物 - Google Patents
用于治疗冠状病毒感染的化合物 Download PDFInfo
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- CN116075306A CN116075306A CN202180056484.XA CN202180056484A CN116075306A CN 116075306 A CN116075306 A CN 116075306A CN 202180056484 A CN202180056484 A CN 202180056484A CN 116075306 A CN116075306 A CN 116075306A
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- amino
- dihydro
- infection
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- phthalazinedione
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Abstract
本申请涉及一种酞嗪二酮在冠状病毒感染的预防或治疗中的用途。公开了药物组合物、组合和有利的制剂技术。
Description
技术领域
本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一在冠状病毒感染的预防或治疗中的用途。特别地,本发明涉及5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐用于所述目的的用途。公开了药物组合物、组合和有利的制剂技术。
背景技术
由于生态、气候和人口变化,所谓的'新兴'病毒越来越多地从它们的天然动物宿主向人类传播。由于全球化加速,它们承担着引发流行病的风险。新兴病毒可能会引起急性并且经常危及生命的疾病。冠状病毒科(Coronaviridae)由于此类传播已变得臭名昭著。实例为严重急性呼吸综合征冠状病毒(Severe acute respiratory syndrome coronavirus,SARS-CoV)和中东呼吸综合征相关冠状病毒(Middle East respiratory syndrome-related coronavirus,MERS-CoV),以及最近爆发的严重急性呼吸综合征冠状病毒2(SARS-CoV-2;COVID-19)。截至2021年5月31日,约翰霍普金斯大学冠状病毒资源中心已报告了全球总计超过1.7亿例SARS-CoV-2病例,其中约350万人死亡。SARS-CoV-2的潜伏期在2天和2周之间,在一些情况下长达一个月。由SARS-CoV-2感染导致的疾病称为COVID-19。
COVID-19的典型症状为发热、咳嗽和呼吸急促。然而,感染也可能会引起严重的肺损伤,导致肺部进行性功能障碍的迅速发作,尤其是在摄氧能力方面。这通常与其它器官的功能障碍相关。这种急性肺部损伤(acute lung injury,ALI)病况与广泛的肺部炎症和液体在肺泡中的积聚相关。其特征在于弥漫性肺微血管损伤,导致通透性增加,并且从而导致非心源性肺水肿。结果,这导致肺中的病理性低氧水平。与ICU监护中的COVID-19患者相关的其它常见症状为肺栓塞、血栓形成、静脉血栓栓塞和脑缺血。
冠状病毒主要通过密切接触、特别是通过由咳嗽和打喷嚏产生的呼吸道飞沫来传播。与SARS-CoV和MERS-CoV不同,SARS-CoV-2在潜伏期期间可以在人与人之间传播,而被感染的患者尚未显示出任何疾病症状。此外,SARS-CoV-2已经可以在咽喉中复制。相比之下,SARS-CoV和MERS-CoV的受体位于肺部深处。因此,与SARS-CoV和MERS-CoV相比,SARS-CoV-2可以更容易地在人与人之间传播,这使感染率大大提高。
通常,冠状病毒(冠状病毒科,冠状病毒组)形成一组相对多样化的大型、有包膜、正链RNA病毒,其可以在人和动物中引起不同类型的腹泻和呼吸道疾病。它们具有非常窄的宿主范围并且在细胞培养中复制非常差。然而,可以成功地建立SARS-CoV-2的细胞培养体系。
SARS-CoV-2的测序显示由14个开放阅读框构成的约29.8kbp的基因组。此外,病毒在系统发育方面与SARS-CoV密切相关(89.1%的核苷酸相似性)(参见Wu等人(2020)Nature,Epub ahead of print)。与其它冠状病毒一样,SARS-CoV-2通过内吞作用和膜融合进入细胞。病毒通过分泌途径从细胞中释放。病毒的天然储存宿主(reservoir)是未知的。
迄今为止,未建立用于治疗SARS-CoV-2感染或COVID-19的特定治疗方案。可以用抗病毒药物瑞德西韦、阿维法韦(avifavir)和法匹拉韦取得一些成功。包含抗SARS-CoV-2刺突蛋白的纳米抗体的鼻喷雾剂(AeroNabs)是有前景的发展。在重症COVID-19患者中,给予糖皮质激素地塞米松显示有效。
因此,对于用于感染SARS-CoV-2或类似的冠状病毒的患者和用于限制目前该病毒的流行性传播的有效药物治疗存在较强的医学需要。理想地,此类药物治疗还应当至少为未来的冠状病毒爆发提供治疗方案。
发明内容
令人惊讶的是,通过给予5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、或者其溶剂化物、水合物、结晶多晶型物、互变异构体或同位素富集形式解决了该任务。
因此,本申请公开了5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一,其用于冠状病毒感染的预防或治疗。
具体实施方式
5-氨基-2,3-二氢-1,4-酞嗪二酮(鲁米诺)属于酞嗪二酮的药物类别。该类化合物以它们有益的抗炎作用而闻名。已知5-氨基-2,3-二氢-1,4-酞嗪二酮也称为鲁米诺。鲁米诺具有优异的化学发光特性。鲁米诺广泛地应用于诊断分析中作为检测手段并且应用于法医学,例如用于追踪血斑。在医学中,已开发钠盐形式的5-氨基-2,3-二氢-1,4-酞嗪二酮。在一些国家,它被批准用于广泛范围的急性和慢性炎性病症,包括a.o.细菌来源和病毒来源的急性感染特别是肠道的急性感染、乙型肝炎和丙型肝炎、肠胃炎、炎症例如前列腺炎、子宫内膜异位症、咽喉炎症、支气管哮喘、肺炎、牙周炎、肾盂肾炎、以及自身免疫性疾病例如克罗恩病、溃疡性结肠炎、红斑狼疮和硬皮病。5-氨基-2,3-二氢-1,4-酞嗪二酮可以有效地预防由过度免疫反应引起的细胞因子风暴。此外,在科学文献和专利文献中仍有一长串适应症,在所述适应症的治疗中,据称测试了5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐或者启示了有益的用途(参见WO 2004/041169;WO 2007/018546;WO 2012/127441;WO 2016/096143;WO 2017/202496;WO 2018/082814:a.o.)。
虽然大多数常规的免疫调节药物显示严重的不良反应或者至少在长期治疗中存在问题,但是5-氨基-2,3-二氢-1,4-酞嗪二酮及其药学上可接受的盐被很好地耐受并且关于给药剂量具有高的安全界限。
为了确保更好的溶解度和生物利用度,使用5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐。记载了钠盐、钾盐和锂盐用于治疗应用(参见WO 2010/082858)。在Guzei等人(2013)Journal of Coordination Chemistry 66,3722-3739中记载了锂盐、钠盐、钾盐、铷盐和铯盐的晶体结构。因此,本专利申请还涉及5-氨基-2,3-二氢-1,4-酞嗪二酮的所有药学上可接受的盐的用途。
因此,本申请公开了5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于冠状病毒感染的预防或治疗。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于减少或抑制冠状病毒在人类中的复制。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中降低冠状病毒的病毒载量。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗COVID-19。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中所述人类是无症状的。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中所述人类显示轻微的与冠状病毒感染相关的症状并且不需要住院治疗。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中所述人类显示严重的与冠状病毒感染相关的症状并且需要住院治疗。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中所述人类显示严重的与冠状病毒感染相关的症状并且正在经历急性肺损伤。
特别地,本申请公开了5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于预防或治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于减少或抑制冠状病毒在人类中的复制,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中降低冠状病毒的病毒载量,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗COVID-19,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类是无症状的。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类显示轻微的与冠状病毒感染相关的症状并且不需要住院治疗。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类显示严重的与冠状病毒感染相关的症状并且需要住院治疗。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类显示严重的与冠状病毒感染相关的症状并且正在经历急性肺损伤。
5-氨基-2,3-二氢-1,4-酞嗪二酮通常作为水合物、例如作为二水合钠盐使用。因此,本专利申请还涉及5-氨基-2,3-二氢-1,4-酞嗪二酮及其药学上可接受的盐的所有水合物和其它溶剂化物的用途。5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一可以与合适的配体构建复合物。因此,本专利申请还涉及此类复合物。在本公开的范围内,术语“5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一”应当包括所有水合物和溶剂化物。
为了确保可重现和标准化的API生产并且提供活性剂的改进的稳定性特征,无水制剂经常是优选的。5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐的无水物形式在WO 2011/107295(I型、II型)和WO 2016/096143(III型)中记载为结晶多晶型物。这些结晶多晶型物几乎不含相杂质并且借助X射线粉末衍射来表征。该方法得到一组表示晶面间距的特征性d值和发生布拉格反射的相应的2-theta(2θ)角[°]。这得到了各多晶型物的独特且明确的指纹。
对于I型,确定了以下值:
d值:13.5;6.9;5.2;4.6;3.9;3.5;3.4;3.3;3.1;3.0和/或
2-θ值:6.5;12.7;16.9;19.3;22.8;25.8;26.6;27.2;28.7;30.3。
II型的特征在于以下值:
d值:12.9;7.9;7.1;6.5;5.3;4.0;3.7;3.6;3.3;3.2和/或
2-θ值:6.8;11.2;12.5;13.7;16.7;22.4;24.3;24.9;27.2;27.8。
III型得到以下值:
d值:13.131;7.987;7.186;6.566;6.512;5.372;3.994;3.662;3.406;3.288;3.283;3.222;3.215;3.127;2.889和/或
2-θ值:6.73;11.07;12.31;13.48;13.59;16.49;22.24;24.29;26.14;27.10;27.14;27.67;27.72;28.52;30.93。
优选使用无水的I型5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐。
在鼠COPD模型中,离体肺暴露于香烟烟雾。应用I型5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐引起3-硝基酪氨酸几乎完全被还原。因此,推测5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐可以保护肺免受作为COPD和其它炎性肺病的病理生理学的主要参与者的氧化应激和亚硝化应激(https://copdnewstoday.com/2020/04/16/mp1032-may-protect-lungs-from-oxidative-stress-inhibit-biomarker-3-nitrotyrosine-preclinical-study/,截至2021-03-03)。
5-氨基-2,3-二氢-1,4-酞嗪二酮自身也显示多态性。I型(Paradies(1992)Ber.Bunsen-Ges.Phys.Chem 96:1027-1031)和II型(WO 2017/140430)已被公开。
WO 2017/140430还公开了5-氨基-2,3-二氢-1,4-酞嗪二酮在炎性疾病和自身免疫性疾病的免疫调节治疗中具有很大潜力。II型晶型在例如上呼吸道感染和下呼吸道感染等炎性和自身免疫性呼吸系统疾病的治疗中是特别有用的。
因此,本专利申请还涉及5-氨基-2,3-二氢-1,4-酞嗪二酮及其药学上可接受的盐的所有结晶形式及其多晶型物的根据本发明的用途。优选使用II型5-氨基-2,3-二氢-1,4-酞嗪二酮。
对于各种各样的酞嗪二酮、分别为5-氨基-2,3-二氢-1,4-酞嗪二酮的衍生物及其药学上可接受的盐,已知类似的治疗效果。一个实例为6-氨基-2,3-二氢酞嗪-1,4-二酮(异鲁米诺)。在WO 2007/018546中给出了合适的酞嗪二酮的概述。合理地推定这些化合物在用于根据本发明的治疗应用时显示相当的效果。
在EP 0531370 A1中,公开了使用例如鲁米诺等PARP(聚(ADP-核糖)聚合酶)抑制剂用于治疗病毒DNA在复制周期期间整合至宿主染色体中的病毒感染。病毒优选为逆转录病毒例如HIV。然而,冠状病毒为正链RNA病毒,因此无法整合至人类DNA中。因此,EP0531370 A1未启示5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于治疗冠状病毒感染的用途。
互变异构涉及有机化合物的快速内部转化,其中氢原子或质子在形式上在化合物内部迁移。这伴有单键和相邻双键的转换。将单一形式称为互变异构体。例如,在5-氨基-2,3-二氢-1,4-酞嗪二酮中发生酮-烯醇互变异构(Proescher和Moody(1939)J Lab ClinMed,1183–1189)。因此,本专利申请还涉及5-氨基-2,3-二氢-1,4-酞嗪二酮及其药学上可接受的盐的所有互变异构体的用途。
异构体是具有相同的化学式但是具有不同的化学结构的分子的通用术语。它们可以区分为构造(结构)异构体(其中发生原子的交换或官能团的交换)和立体异构体。立体异构体可以细分为对映异构体(同一分子的不可重叠的镜像)和非对映异构体(同一分子在一个或多个立体中心处具有不同的构型)。非对映异构体可以细分为顺式/反式异构体(是指分子内官能团的相对方向),并且另一方面可以细分为构象异构体(围绕形式上的单键转动)和旋转异构体(围绕单键不同的旋转定位)。5-氨基-2,3-二氢-1,4-酞嗪二酮的构造异构体的实例为6-氨基-2,3-二氢酞嗪-1,4-二酮(异鲁米诺)。立体异构体可能会出现在酞嗪二酮衍生物中。因此,本专利申请还涉及5-氨基-2,3-二氢-1,4-酞嗪二酮、其衍生物和药学上可接受的盐的所有异构体的用途。
对于一些应用,可能会期望使用同位素富集形式的本发明的化合物,例如用于诊断目的。因此,本专利申请还涉及此类同位素富集形式的本发明的化合物。
从药代动力学的观点或生产原理来看,使用前药作为剂型可能会是优选的。前药以在药理学上无活性的形式给药并且在体内代谢转化为活性形式。该转化可以全身地或者局部地发生。因此,本专利申请还涉及本发明的化合物的前药。
如贯穿本申请所使用的,术语“5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一”应当涵盖5-氨基-2,3-二氢-1,4-酞嗪二酮的所有前述分子变体,即5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一或其溶剂化物、水合物、结晶多晶型物、互变异构体或同位素富集形式。
除非另有说明,否则本发明中使用的任何技术或科学术语均具有相关技术领域的技术人员将赋予它们的含义。
根据本申请,如果没有另外说明或者以一般含义使用,术语“原料药”、“活性物质”、“活性剂”、“药物活性剂”、“活性成分”或“活性药物成分”(API)是指5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐。
可以用5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一治疗的冠状病毒感染首先是高致病性SARS-CoV、MERS-CoV和SARS-CoV-2的感染。但是也可以因此治疗以下所列出的致病性较低的冠状病毒科的感染。术语“冠状病毒(coronavirus)”或“冠状病毒(coronaviral)”主要是指正冠状病毒亚科。它们细分为α冠状病毒属、β冠状病毒属、γ冠状病毒属和δ冠状病毒属。冠状病毒包括colacovirus亚属(种:蝙蝠冠状病毒CDPHE15)、decavirus亚属(蝙蝠冠状病毒HKU10、马铁菊头蝠α冠状病毒HuB-2013)、duvinacovirus亚属(人冠状病毒229E)、luchacovirus亚属(鹿城褐家鼠冠状病毒)、minacovirus亚属(雪貂冠状病毒、水鼬冠状病毒1)、minunacovirus亚属(长翼蝠冠状病毒1、长翼蝠冠状病毒HKU8)、myotacovirus亚属(大足鼠耳蝠α冠状病毒Sax-2011)、nylactovirus亚属(绒山蝠α冠状病毒SC-2013)、pedacovirus亚属(猪流行性腹泻病毒、高头蝠冠状病毒512)、rhinacovirus亚属(菊头蝠冠状病毒HKU2)、setracovirus亚属(人冠状病毒NL63、与NL63相关的蝙蝠冠状病毒株BtKYNM63-9b)和tegacovirus亚属(α冠状病毒1模式种)。β冠状病毒包括embecovirus亚属(β冠状病毒1(亚种:人冠状病毒OC43)、中国鼠冠状病毒HKU24、人冠状病毒HKU1、鼠冠状病毒模式种)、hibecovirus亚属(蹄蝠β冠状病毒浙江2013)、merbecovirus亚属(刺猬冠状病毒1、MERS-CoV、伏翼蝠冠状病毒HKU5、扁颅蝠冠状病毒HKU4)、nobecovirus亚属(果蝠冠状病毒GCCDC1、果蝠冠状病毒HKU9)和sarbecovirus亚属(与严重急性呼吸综合征相关的冠状病毒(亚种:SARS-CoV、SARS-CoV-2))。γ冠状病毒包括cegacovirus亚属(鲸豚冠状病毒SW1)和igacovirus亚属(禽冠状病毒模式种)。δ冠状病毒包括andecovirus亚属(赤颈鸭冠状病毒HKU20)、buldecovirus亚属(鹎冠状冠状病毒HKU11模式种、猪冠状病毒HKU15、文鸟冠状病毒HKU13、绣眼鸟冠状病毒HKU16)、herdecovirus亚属(夜鹭冠状病毒HKU19)和Moordecovirus亚属(黑水鸡冠状病毒HKU21)。
迄今为止,在人类中致病的冠状病毒为SARS-CoV、SARS-CoV-2、MERS-CoV、HCoV-HKU1、HCoV-NL-63、HCoV-OC43和HCoV-229E。后四种仅引起相对轻微的症状(参见Andersen等人:The Proximal Origin of SARS-CoV-2,在virologica.org上,截至2020年2月17日)。
因此,本申请特别涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于预防或治疗冠状病毒感染,其中所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于减少或抑制冠状病毒在人类中的复制,其中所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中降低冠状病毒的病毒载量,其中所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中所述人类是无症状的并且所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中所述人类显示轻微的与冠状病毒感染相关的症状、不需要住院治疗并且所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中所述人类显示严重的与冠状病毒感染相关的症状、需要住院治疗并且所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中所述人类显示严重的与冠状病毒感染相关的症状、正在经历急性肺损伤并且所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于减少或抑制冠状病毒在人类中的复制,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中降低冠状病毒的病毒载量,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类是无症状的并且所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类显示轻微的与冠状病毒感染相关的症状、不需要住院治疗并且所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类显示严重的与冠状病毒感染相关的症状、需要住院治疗并且所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类显示严重的与冠状病毒感染相关的症状、正在经历急性肺损伤并且所述冠状病毒感染选自由SARS-CoV感染、SARS-CoV-2感染、MERS-CoV感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
因此,本申请特别涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于预防或治疗冠状病毒感染,其中所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于减少或抑制冠状病毒在人类中的复制,其中所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中降低冠状病毒的病毒载量,其中所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中所述人类是无症状的并且所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中所述人类显示轻微的与冠状病毒感染相关的症状、不需要住院治疗并且所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中所述人类显示严重的与冠状病毒感染相关的症状、需要住院治疗并且所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中所述人类显示严重的与冠状病毒感染相关的症状、正在经历急性肺损伤并且所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于减少或抑制冠状病毒在人类中的复制,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中降低冠状病毒的病毒载量,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类是无症状的并且所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中预防或治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类显示轻微的与冠状病毒感染相关的症状、不需要住院治疗并且所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类显示严重的与冠状病毒感染相关的症状、需要住院治疗并且所述冠状病毒感染为SARS-CoV-2感染。
在另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在人类中治疗冠状病毒感染,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐并且所述人类显示严重的与冠状病毒感染相关的症状、正在经历急性肺损伤并且所述冠状病毒感染为SARS-CoV-2感染。
更优选5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于预防或治疗冠状病毒感染,其中所述冠状病毒感染为SARS-CoV-2。
最优选5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐用于预防或治疗冠状病毒感染,其中所述冠状病毒感染为SARS-CoV-2。
其它上述动物冠状病毒尚未转移至人类(动物传染病(zoonosis)),但是这可能会在未来发生,具有无法预测的病理学。因此,本申请的范围还涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一用于在动物和人类中预防或治疗这些动物冠状病毒感染。
在所有物种中治疗冠状病毒感染的概念基于冠状病毒的结构相似性。因此,可以假定可以将治疗和/或预防方案从一种冠状病毒转用至另一种。冠状病毒颗粒包含四种主要的结构蛋白:刺突(S)、膜(M)、包膜(E)和核衣壳(N),所有这些蛋白均编码在病毒基因组3’端内。
冠状病毒包含~30kb的非分段正义RNA基因组。基因组包含5′帽结构以及3′多聚(A)尾部,使其起到用于复制酶多聚蛋白的翻译的mRNA的作用。与仅占病毒基因组的约10kb的结构蛋白和辅助蛋白不同,编码非结构蛋白(nsp)的复制酶基因占据基因组的三分之二,约20kb。冠状病毒基因组的组成为5′-前导序列-UTR-复制酶-S(刺突)-E(包膜)-M(膜)-N(核衣壳)-3′UTR-多聚(A)尾部,其中辅助基因散布在位于基因组的3′端的结构基因内。辅助蛋白几乎完全不是组织培养中的复制所必需的;然而,一些辅助蛋白已被证明在病毒发病机制中具有重要作用(参见Zhao等人(2012)Cell Host Microbe 11:607-616)。
冠状病毒生命周期始于病毒粒子通过S蛋白与其受体之间的相互作用向宿主细胞的初始附着。冠状病毒S蛋白的S1区域内的受体结合域(RBD)的位点取决于病毒而变化。S-蛋白-受体相互作用是冠状病毒感染宿主物种的主要决定因素并且还控制病毒的组织嗜性(tissue tropism)。很多冠状病毒利用肽酶作为它们的细胞受体。尚不清楚为什么使用肽酶,这是因为,即使在不存在这些蛋白的酶结构域(enzymatic domain)的情况下也发生进入(entry)。很多α冠状病毒利用氨肽酶N(APN)作为它们的受体,很多β冠状病毒例如SARS-CoV、SARS-CoV-2和HCoV-NL63使用血管紧张素转化酶II(ACE2)受体,MHV通过CEACAM1进入,并且MERS-CoV结合至二肽基肽酶4(DPP4)以得以进入人细胞中。在受体结合之后,病毒接下来必须进入宿主细胞的细胞溶质。这通常通过借助组织蛋白酶、TMPRRS2或另一蛋白酶使S蛋白进行酸依赖性蛋白水解性裂解(acid-dependent proteolytic cleavage)、然后使病毒膜和细胞膜融合并且最终将病毒基因组释放至细胞质中来完成。
冠状病毒编码两种或三种使复制酶多聚蛋白裂解的蛋白酶。它们是在nsp3内编码的木瓜蛋白酶样蛋白酶(PLpro)以及丝氨酸型蛋白酶(由nsp5编码的主要蛋白酶或Mpro)。除了仅表达一个PLpro的γ冠状病毒、SARS-CoV和MERS-CoV以外,大多数冠状病毒在nsp3内编码两个PLpro(Mielech等人(2014)Virus Res doi:10.1016)。
该木瓜蛋白酶样蛋白酶(PLpro)在SARS-CoV中被发现与人类细胞泛素蛋白酶体系统(UPS)内的去泛素化酶的作用方式相同(参见Raaben等人(2010)J Virol 84:7869-7879)。SARS-CoV-2中的PLpro与SARS-CoV具有非常高的同源性(96.1%,Nguyen等人(2020)https://doi:org/10:1101/2020.02.05.936013)。
术语“组合物”或“药物组合物”以任何药理学上可接受的限定的剂量和剂型包含至少一种活性成分、以及至少一种药学上可接受的赋形剂、以及作为组合、累积物、复合物或晶体或者作为其它反应或相互作用的结果直接地或间接地从如下列出的成分生成的所有药剂、以及任选地至少一种如下列出的其它药物。
术语“赋形剂”在本申请中用于描述药物组合物的药物活性成分以外的任何组分。合适的赋形剂的选择取决于各种各样的因素,例如剂型、剂量、组合物的所需的溶解度和稳定性。
关于本发明的物质或说明书中提及的任何其它活性物质的术语“效果”、“治疗效果”、“作用”、“治疗作用”、“功效”和“有效性”是指在之前已给予所述物质的有机体中有原因地发生的有益结果。
根据本发明,术语“有效量”和“治疗有效量”是指足够大以在需要此类治疗的受试者中引起期望的有益效果的本发明的物质的量。
术语“治疗”和“疗法”包括将至少本发明的物质单独地或者与至少一种其它药物组合给药,与给药的时间顺序无关。此类给药旨在通过将疾病完全治愈或者通过在疾病过程期间使缺陷的增加停止或减缓来显著改善冠状病毒感染的病程。
术语“预防”或“预防性治疗”包括将至少本发明的物质单独地或者与至少一种其它药物组合给药,与给药的时间顺序无关,从而预防或抑制归因于冠状病毒感染的症状的表现。特别地,其是指此类症状的表现预期在较远或不久的将来以合理的概率发生的患者的身体状况。
术语“受试者”和“患者”包括患有与冠状病毒感染相关的疾病症状或缺陷的个体,其中所述诊断被认可或是疑似的。个体是哺乳动物,特别是人类。
在本申请的范围内,术语“医学”应当包括人类医学和兽医学。
5-氨基-2,3-二氢-1,4-酞嗪二酮或其可接受的盐之一可以用作单一疗法或者可以进一步与至少一种其它活性成分组合,所述活性成分选自包括在用于冠状病毒感染的疾病改进疗法、冠状病毒感染的对症疗法和合并症的治疗中使用的活性成分的组。
为了有效治疗冠状病毒感染,通过将5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一与至少一种抗病毒药剂组合向有需要的患者提供联合疗法可能会是有利的。
例如,从HIV或抗逆转录病毒疗法,已知以下类别:
适合于此类联合疗法的逆转录酶抑制剂为核苷逆转录酶抑制剂(NRTI)和非核苷逆转录酶抑制剂(NNRTI)。NRTI的实例包括但不限于阿巴卡韦(abacavir)、去羟肌苷(didanosine)、恩曲他滨、拉米夫定、司他夫定、替诺福韦、齐多夫定、扎西他滨、恩替卡韦、阿德福韦、艾夫他滨(elvucitabine)、磷夫定(磷夫定酯)(fosalvudine(-tidoxil))、fozivudintidoxil、拉昔洛韦(lagiciclovir)、阿拉福韦(alamifovir)、克拉夫定、帕拉德福韦(pradefovir)、替比夫定(telbivudine)。NNRTI的实例包括但不限于依法韦伦、依曲韦林(etravirine)、奈韦拉平、利匹韦林(rilpivirine)、地拉韦定(delavirdine)、乙米韦林(emivirine)、勒西韦林(lersivirine)。
适合于根据本发明的联合疗法的是整合酶抑制剂例如拉替拉韦(raltegravir)、埃替拉韦(elvitegravir)、多替拉韦(dolutegravir)、MK-2048。
适合于根据本发明的联合疗法的HIV蛋白酶抑制剂的实例为沙奎那韦、茚地那韦、利托那韦、奈非那韦、安普那韦、洛匹那韦、阿扎那韦、福沙那韦(fosamprenavir)、替拉那韦(tipranavir)、达芦那韦(darunavir)、布雷卡那韦(brecanavir)、莫泽那韦(mozenavir)、替拉那韦(tipranavir)。
适合于根据本发明的联合疗法的进入抑制剂的实例为恩夫韦肽(enfuvirtide)和马拉韦罗(maraviroc)。
此外,适合于根据本发明的联合疗法的一般病毒抑制剂可以选自包括以下的组:安立韦克(ancriviroc)、阿拉韦罗(aplaviroc)、西克里维罗(cenicriviroc)、恩夫韦肽、马拉韦罗、维立韦罗(vicriviroc)、金刚烷胺、金刚乙胺、普利康那利(pleconaril)、碘苷(idoxuridine)、阿昔洛韦、溴夫定(brivudine)、泛昔洛韦(famciclovir)、喷昔洛韦(penciclovir)、索立夫定(sorivudine)、伐昔洛韦(valaciclovir)、西多福韦(cidofovir)、更昔洛韦(ganciclovir)、缬更昔洛韦(valganciclovir)、索非布韦(sofosbuvir)、膦甲酸、利巴韦林、他巴韦林(taribavirine)、非利布韦(filibuvir)、奈司布韦(nesbuvir)、替戈布韦(tegobuvir)、福地韦林(fosdevirine)、法匹拉韦、阿维法韦、美泊地布(merimepodib)、阿舒瑞韦(asunaprevir)、巴拉匹韦(balapiravir)、波普瑞韦(boceprivir)、西鲁瑞韦(ciluprevir)、达诺瑞韦(danoprevir)、达拉他韦(daclatasvir)、那拉匹韦(narlaprevir)、特拉匹韦(telaprevir)、司美匹韦(simeprevir)、伐尼瑞韦(vanipevir)、鲁匹那韦(rupintrivir)、瑞德西韦、福米韦生(fomivirsen)、阿莫奈韦(amenamevir)、阿拉泊韦(alisporivir)、贝韦立马(bevirimat)、莱莫维韦(letermovir)、拉尼米韦(laninamavir)、奥司他韦(oseltamivir)、帕拉米韦(peramivir)、扎那米韦(zanamivir)。
适合于根据本发明的联合疗法的一般免疫刺激剂可以选自包括以下的组:干扰素(α-干扰素、β-干扰素、γ-干扰素、τ-干扰素)、白细胞介素、CSF、PDGF、EGF、IGF、THF、左旋咪唑、二甲氨丙醇、肌苷。
此外,根据本发明的可能组合包括例如可比司他(cobicistat)等佐剂。
合并症可以由冠状病毒感染导致的损伤引起或者与其无关。因此,5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一可以与选自包括以下的组中的至少一种其它活性成分组合用于冠状病毒感染的预防或治疗:甾体和非甾体抗炎药,免疫调节剂,免疫抑制剂,抗感染药剂如抗生素、抗逆转录病毒药剂、抗病毒药剂、抗真菌药剂和抗原虫药剂,镇痛剂,抗凝血剂,抗血小板药物,支气管扩张剂,肺血管扩张剂,化痰剂,肺表面活性物质,抗氧化剂,ENaC活化剂,HMG-CoA还原酶抑制剂或AT1受体拮抗剂。
此类甾体抗炎药的合适的实例包括皮质类固醇、糖皮质激素、可的松、醋酸可的松、氢化可的松、醋酸氢化可的松、地塞米松、倍他米松、强的松、泼尼松龙、甲基泼尼松龙、泼尼松(deltasone)、去炎松、新戊酸替可的松、莫米松、安西奈德、布地奈德、地奈德、氟苯奈德(fluociconide)、氟轻松、哈西奈德、氟考龙、氢化可的松-17-戊酸酯、卤米松、二丙酸阿氯米松、戊酸倍他米松、二丙酸倍他米松、泼尼卡酯(prednicarbate)、氯倍他松-17-丁酸酯、氯倍他索-17-丙酸酯、己酸氟考龙、新戊酸氟考龙、醋酸氟泼尼定(fluprednideneacetate)、氢化可的松-17-丁酸酯、氢化可的松-17-醋丙酸酯、氢化可的松-17-丙丁酸酯、环索奈德、氟尼缩松、糠酸氟替卡松、丙酸氟替卡松、曲安奈德、二丙酸倍氯米松。
此类非甾体抗炎药(NSAID)的合适的实例包括乙酰水杨酸、水杨酸和水杨酸盐、对乙酰氨基酚(扑热息痛)、水杨酰水杨酸(salsalate)、二氟尼柳、布洛芬、右旋布洛芬、萘普生、非诺洛芬、酮洛芬、右酮洛芬、氟比洛芬、奥沙普秦、洛索洛芬、吲哚美辛、托美汀、舒林酸、依托度酸、酮咯酸、双氯芬酸、醋氯芬酸、萘丁美酮、吡罗昔康、美洛昔康、替诺昔康、屈昔康、氯诺昔康、伊索昔康、保泰松、甲芬那酸、甲氯芬那酸、氟芬那酸、托芬那酸、塞来昔布、罗非昔布、伐地昔布、帕瑞昔布、罗美昔布、依托考昔、非罗考昔、尼美舒利、氯尼辛(clonixin)、利克飞龙(licofelone)、H-哈巴苷、氟尼辛、噻洛芬酸。
此类免疫调节剂的合适的实例包括沙利度胺、来那度胺、泊马度胺和阿普斯特等。
此类免疫抑制药物的合适的实例包括例如以上列出的糖皮质激素组,细胞抑制药物例如烷化剂(例如环磷酰胺),抗代谢药例如甲氨蝶呤、硫唑嘌呤、巯嘌呤、氟尿嘧啶、来氟米特,蛋白质合成抑制剂和某些抗生素例如更生霉素、蒽环类药物、丝裂霉素C、博来霉素和光神霉素,嵌入剂(intercalating agent)例如米托蒽醌,抗体例如莫罗单抗-CD3、利妥昔单抗、优特克单抗、阿仑单抗、那他珠单抗、巴利昔单抗、托珠单抗和达利珠单抗,作用于免疫亲和素的药物例如环孢素、他克莫司和西罗莫司,未分类的免疫抑制剂例如β-干扰素和γ-干扰素、阿片类药物,TNF结合蛋白例如英夫利昔单抗、依那西普、阿达木单抗,或者姜黄素、儿茶素、霉酚酸、芬戈莫德、多球壳菌素和富马酸二甲酯。
抗感染药剂为在细菌感染、病毒感染、真菌感染和寄生虫感染(例如原虫或蠕虫)的治疗中有用的化合物的通用术语并且包括抗生素、抗霉药剂(antimycotics agent)、抗原虫药剂和前述抗病毒药剂。
此类抗生素的合适的实例包括亚胺培南、美罗培南、厄他培南、头孢菌素、氨曲南、青霉素例如青霉素G和青霉素V、哌拉西林、美洛西林、氨苄西林、阿莫西林、氟氯西林、甲氧西林、苯唑西林、克拉维酸、舒巴坦、他唑巴坦、舒他西林、磷霉素、替考拉宁、万古霉素、杆菌肽、粘菌素、短杆菌肽、多粘菌素B、短杆菌素、泰斯巴汀(teixobactin)、膦胺霉素(fosmidomycin)、阿米卡星、庆大霉素、卡那霉素、新霉素、奈替米星、链霉素、妥布霉素、氯霉素、夫西地酸、赛红霉素、那波霉素(narbomycin)、泰利霉素、克林霉素、林可霉素、达托霉素、达福普汀、奎奴普汀、阿奇霉素、克拉霉素、红霉素、罗红霉素、利奈唑胺、强力霉素(doxycycline)、米诺环素、四环素、土霉素、替加环素、诺氟沙星、依诺沙星、环丙沙星、氧氟沙星、左氧氟沙星、莫西沙星、甲硝唑、替硝唑、氨基香豆素、磺胺嘧啶、磺胺多辛(sulfadoxin)、磺胺甲噁唑、柳氮磺胺吡啶、乙胺嘧啶、甲氧苄啶、利福平。
此类抗真菌(抗霉菌)药物的合适的实例包括阿巴芬净、两性霉素B、杀念珠菌素、菲律宾菌素(filipin)、哈霉素、游霉素、制霉菌素、龟裂霉素(rimocidin)、联苯苄唑、布康唑、克霉唑、益康唑、芬替康唑、异康唑、酮康唑、卢立康唑、咪康唑、奥莫康唑、奥昔康唑、舍他康唑、硫康唑、噻康唑、阿巴康唑、艾氟康唑(efinaconazole)、氟环唑、氟康唑、艾沙康唑(isavuconazole)、伊曲康唑、泊沙康唑、丙环唑、雷夫康唑(ravuconazole)、特康唑、伏立康唑、阿莫罗芬(amorolfin)、布替萘芬(butenafine)、萘替芬、特比萘芬、阿尼芬净、卡泊芬净、米卡芬净、苯甲酸、环吡酮、氟胞嘧啶、灰氟霉素、氯丙炔碘(haloprogin)、托萘酯、十一碳烯酸、结晶紫、秘鲁香脂。
此类抗原虫药物的合适的实例包括甲硝唑、替硝唑、奥硝唑、阿托伐醌、氯碘羟喹、氯喹那多(chlorquinaldol)、依米丁(emetin)、依西酸喷他脒(pentamidineisethionate)、依氟鸟氨酸、呋喃西林、卤夫酮、米替福新、氯喹、羟氯喹、米帕林(mepacrine)、伯氨喹、阿莫地喹、扑疟喹(pamaquine)、哌喹、氯胍、cyclohunailembonate、奎宁、甲氟喹、乙胺嘧啶、蒿甲醚、青蒿素、青蒿琥酯、双氢青蒿素、卤泛群、苯芴醇、磺胺多辛。
其它抗寄生虫药物的合适的实例包括葡甲胺锑酸盐、苄硝唑、葡萄糖酸锑钠、烟曲霉素、卤泛群、美拉胂醇(melarsoprol)、硝呋莫司(nifurtimox)、硝唑尼特、苄氯菊酯、林丹、马拉硫磷(malathion)、西维因、除虫菊、苯醚菊酯、生物丙烯菊酯、吡虫啉、莫昔克丁、烯啶虫胺、氟虫腈、吡丙醚(pyriprol)、塞拉菌素(selamectin)、敌匹硫磷(dimpylate)、多杀菌素、茚虫威、甲氧普林、蚊蝇醚(pyriproxyfen)、虱螨脲(lufenuron)、印度楝树油(neemoil)、香茅油、丁香油、薄荷油、桉树油。
镇痛剂的合适的实例包括以上列出的NSAID;阿片类镇痛剂例如吗啡、芬太尼、美沙酮、羟考酮、卡芬太尼、二氢埃托啡、羟甲芬太尼、埃托芬、舒芬太尼、瑞芬太尼、阿芬太尼、丁丙诺啡、氢化吗啡酮、左美沙酮、氢可酮、品特酰胺(pintramide)、纳布啡、他喷他多、喷他佐辛、二氢可待因、可待因、哌替啶、曲马多、替利定、美普他酚、纳洛酮、纳曲酮、二丙诺啡、洛哌丁胺、阿扑吗啡;地棘蛙素(epibatidine);东莨菪碱;齐考诺肽(ziconitide);大麻类例如四氢大麻酚、大麻二酚、屈大麻酚(marinol);氟吡汀;氯胺酮和以上列出的局部麻醉剂。
此类抗凝血剂的合适的实例包括肝素、香豆素例如苯丙香豆素(phenprocoumon)(苯丙香豆素(marcumar))和华法林、阿哌沙班、利伐沙班、依度沙班、达比加群、希美加群、水蛭素、来匹卢定(lepirudine)、比伐卢定(bivalirudine)、柠檬酸盐、EDTA、磺达肝癸钠、阿加曲班、奥米沙班。
此类抗血小板药剂的合适的实例包括阿昔单抗、乙酰水杨酸、双嘧达莫、氯吡格雷、依替巴肽、伊洛美定(ilomedin)、前列环素、普拉格雷、替格瑞洛、噻氯匹定和替罗非班。
合适的支气管扩张剂例如β2肾上腺素能受体激动剂包括短效β2激动剂(SABA)例如沙丁胺醇、舒喘宁、比托特罗、非诺特罗、异丙肾上腺素、左旋沙丁胺醇、左旋舒喘宁、奥西那林、吡布特罗、丙卡特罗、利托君和特布他林;长效β2激动剂(LABA)例如阿福莫特罗、班布特罗、克伦特罗、福莫特罗和沙美特罗;超长效β2激动剂例如阿贝地洛(abediterol)、卡莫特罗、茚达特罗、奥达特罗和维兰特罗,单独地或与乌美溴铵和/或糠酸氟替卡松组合;作用时间未知的β2激动剂例如异克舒令(isoxsuprine)、马布特罗或齐帕特罗。
合适的毒蕈碱抗胆碱能药物(支气管扩张M3受体拮抗剂)包括异丙托溴铵、噻托溴铵、氧托溴铵、格隆溴铵、阿地溴铵、乌美溴铵、阿托品、莨菪碱、阿地溴铵、4-DAMP、达非那新、DAU-5884、HL-031、HL-120、J-104、J-129、普环啶、奥昔布宁、托特罗定和扎非那新。
其它支气管扩张剂包括肾上腺素、麻黄碱、茶碱和TSG12。
有效的肺血管扩张剂为一氧化氮。其它合适的肺血管扩张剂为前列环素(前列腺素PGI2)类似物例如伊洛前列素、依前列醇和曲前列尼尔(treprostinil)。
合适的化痰剂包括N-乙酰半胱氨酸(NAC)、氨溴索、溴己新、羧甲司坦、厄多司坦、半胱甲酯和链道酶α。
合适的肺表面活性物质包括合成组合物例如棕榈胆磷(Colfoscerilpalmitate)、嘌吗可坦(Pumactant)、KL-4、Venticute和芦西纳坦(Lucinactant)以及源自动物的表面活性物质例如贝拉克坦(Beractant)、卡尔法坦(Calfactant)和猪肺磷脂(Poractant alfa)。
有效的抗氧化剂为吸入的一氧化碳(CO)。
合适的ENaC(上皮钠通道)活化肽包括AP301和S3969。
合适的HMG-CoA还原酶抑制剂(他汀类药物)包括阿托伐他汀,单独地或与氨氯地平和/或培哚普利组合;西立伐他汀、氟伐他汀、洛伐他汀,单独地或与烟酸组合;美伐他汀、匹伐他汀、普伐他汀、罗素伐他汀,单独地或与依折麦布组合;辛伐他汀,单独地或与依折麦布或烟酸组合。
合适的AT1拮抗剂(血管紧张素II受体阻滞剂;沙坦类药物)包括氯沙坦、缬沙坦、坎地沙坦、替米沙坦、厄贝沙坦、奥美沙坦、依普沙坦、非马沙坦、阿齐沙坦、米法沙坦、泊米沙坦、普拉沙坦、利匹沙坦(ripisartan)、他索沙坦、沙普罗沙坦(saprosartan)和EXP3174。
5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一和其它活性成分可以同时、分开或依次使用以治疗或预防疾病症状。两种活性剂可以以单一剂型或作为分开的制剂提供,各制剂包含两种活性剂中的至少一种。可以将两种活性剂中的一种或两种配制为大丸剂(bolus)。
特别地,本申请公开了5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合用于治疗冠状病毒感染,其中使用至少一种其它药物活性剂的先前治疗是难治性的。
术语"医学(medicine)"或"医学的(medical)"包括人类医学和兽医学。
术语"有机体"是指具有自我调节的免疫系统的生物,尤其是人或动物。
就本申请而言,术语"宿主有机体"为在感染病毒、特别是本文中的逆转录病毒之后被所述病毒利用以进行复制的那些生物体。
如果没有另外说明,本申请中的术语"活性剂"是指5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一。此外,该术语可以包括现有技术已知的其它药剂。
术语"组合物"和"药物组合物"包含任何药理学上适当限定的剂量和剂型的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、以及至少一种合适的赋形剂或载体物质、以及作为前述成分的组合、累积物、复合物形成或晶体直接地或间接地产生或者由于其它反应或相互作用而形成的所有物质、以及任选地至少一种本领域已知的其它药剂。
术语"赋形剂"在本申请中用于描述除了活性剂以外的药物组合物的各组分。合适的赋形剂的选择取决于例如剂型和剂量等因素以及赋形剂自身对组合物的溶解度和稳定性的影响。
术语"作用"描述了本申请范围内的各药剂的固有特定作用模式。
关于至少一种根据本发明的活性剂的术语"效果"、"治疗效果"、"作用"、"治疗作用"是指已被给予至少一种活性剂的有机体有原因地发生的有益结果。
就本申请而言,"治疗有效剂量"意指将足够剂量的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一给予生物或者给予需要此类治疗的患者。
至少一种根据本发明的药剂和/或至少一种来自现有技术的药剂的术语"联合给药(joint administration)"、"组合给药(combined administration)"或"同时给药(simultaneous administration)"包括同时或在事实上彼此接近的时间点给予提及的药剂以及在连贯实验中在不同时间给予所述药剂。给予所述药剂的时间顺序不受这些术语限制。本领域技术人员由其知识和经验将不难推导出所述给药的时间顺序或局部顺序。
术语"生物"是指每一种动物,尤其是脊椎动物,包括人。就本申请而言,"患者"是患有可确定且可诊断的疾病并且可以对其给予合适的活性剂的生物。
术语"预防"、"治疗"和"疗法"包括将5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一单独地或者与至少一种本领域已知的其它药剂组合给予至生物,从而预防某种疾病的发展、抑制和减轻症状、或者引发相应疾病的治愈过程。
可以将5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的药物组合在冠状病毒感染的预防或治疗中通过任何医学上可接受的给药途径施用于有需要的患者。此类医学上可接受的给药途径可以为例如通过吸入、通过插管、口服、肠胃外、腹膜内、静脉内、动脉内、肌内、局部、经皮、皮下、皮内、舌下、经结膜、阴道内、经直肠或经鼻。
用于冠状病毒感染的预防或治疗的优选口服制剂为以50mg、100mg、150mg、200mg、300mg、400mg、500mg或600mg、优选100mg、150mg、200mg、300mg或400mg、最优选300mg的量含有5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一的胶囊剂或片剂。
在本发明的另一方面,公开了用于冠状病毒感染的预防或治疗的组合物,其中所述组合物包含5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、载体和至少一种药学上可接受的赋形剂。
术语“药学上可接受的赋形剂”是指与药物活性剂一起添加至药物制剂中的天然或合成的化合物。它们可以有助于使制剂增量,从而提高所需的制剂的药代动力学特性或稳定性以及有益于制造过程。根据本发明的有利类别的赋形剂包括载体、粘合剂、着色剂、缓冲剂、防腐剂、抗氧化剂、包衣剂、甜味剂、增稠剂、pH调节剂、酸度调节剂、酸化剂、溶剂、等渗剂、崩解剂、助流剂、润滑剂、乳化剂、增溶剂、稳定剂、稀释剂、抗结块剂(抗粘附剂)、吸附剂、发泡剂、消泡剂、遮光剂、加脂剂、稠度增强剂(consistency enhancer)、助水溶物(hydrotrope)、芳香物质和调味物质。
通常,将一种或多种药学上可接受的载体添加至药物活性剂中。符合条件的是本领域已知的所有载体及其组合。在固体剂型中,它们可以为例如植物和动物脂肪、蜡、石蜡、淀粉、西黄蓍胶、纤维素衍生物、聚乙二醇、硅酮、膨润土、二氧化硅、滑石、氧化锌。对于液体剂型和乳剂,合适的载体为例如溶剂、增溶剂、乳化剂,例如水、乙醇、异丙醇、碳酸乙酯、乙酸乙酯、苯甲醇、苯甲酸苄酯、丙二醇、1,3-丁二醇、棉籽油、花生油、橄榄油、蓖麻油、芝麻油、脂肪酸甘油酯、聚乙二醇、脱水山梨糖醇的脂肪酸酯。根据本发明的混悬剂可以使用本领域已知的载体,例如稀释剂(例如水、乙醇或丙二醇)、乙氧基化异硬脂醇、聚氧乙烯和聚氧乙烯脱水山梨糖醇酯、微晶纤维素、膨润土、琼脂、西黄蓍胶。
术语粘合剂是指将粉末粘合或将它们胶粘在一起、通过颗粒形成使它们凝聚的物质。它们用作制剂的“胶水”。粘合剂使所提供的稀释剂或填料的凝聚强度增加。
合适的粘合剂为例如来自小麦、玉米、大米或马铃薯的淀粉、明胶、例如葡萄糖、蔗糖或β-乳糖等天然存在的糖、来自玉米的甜味剂、天然和合成树胶例如阿拉伯树胶、西黄蓍胶、或海藻酸钙铵、海藻酸钠、羧甲基纤维素、羧甲基纤维素钠、羟丙基羧甲基纤维素、聚乙二醇、聚乙烯吡咯烷酮、硅酸铝镁、蜡和其它物质。组合物中的粘合剂的百分比的范围可以为1重量%-30重量%,优选2重量%-20重量%,更优选3重量%-10重量%并且最优选3重量%-6重量%。
着色剂是对药物制剂赋予着色的赋形剂。这些赋形剂可以为食品着色剂。它们可以吸附在合适的吸附手段例如粘土或氧化铝上。着色剂的其它优点为其可以使雾化器和/或吸嘴上溢出的水性溶液可视化以便于清洁。着色剂的量可以在药物组合物的0.01重量%和10重量%之间、优选在0.05重量%和6重量%之间、更优选在0.1重量%和4重量%之间、最优选在0.1重量%和1重量%之间变化。
合适的药物着色剂为例如姜黄素、核黄素、核黄素-5’-磷酸盐、酒石黄、紫草红(alkannin)、喹啉黄WS、坚牢黄AB、核黄素-5’-磷酸钠、黄2G、日落黄FCF、橙GGN、胭脂虫红、胭脂红酸、柑橘红2、偶氮胭脂红(carmoisine)、苋菜红(amaranth)、丽春红4R、丽春红SX、丽春红6R、赤藓红、红2G、诱惑红AC、阴丹士林蓝RS、专利蓝V、靛蓝胭脂红、亮蓝FCF、叶绿素和叶绿酸、叶绿素和叶绿酸的铜络合物、绿S、坚牢绿FCF、普通焦糖(Plain caramel)、苛性亚硫酸盐焦糖(Caustic sulphite caramel)、氨焦糖(ammonia caramel)、亚硫酸铵焦糖(sulphite ammonia caramel)、黑PN、炭黑、植物碳、棕FK、棕HT、α-胡萝卜素、β-胡萝卜素、γ-胡萝卜素、胭脂树红(annatto)、红木素(bixin)、降红木素(norbixin)、辣椒红色素(paprika oleoresin)、辣椒黄素(capsanthin)、辣椒红素(capsorubin)、番茄红素、β-阿朴-8’-胡萝卜醛、β-阿朴-8’-胡萝卜酸乙酯、毛莨黄素(flavoxanthin)、叶黄素、隐黄质、玉红黄质(rubixanthin)、紫黄素(violaxanthin)、紫杉紫素(rhodoxanthin)、角黄素(canthaxanthin)、玉米黄质(zeaxanthin)、柠檬黄素(citranaxanthin)、虾青素(astaxanthin)、甜菜红(betanin)、花色素苷(anthocyanins)、藏红花、碳酸钙、二氧化钛、氧化铁、氢氧化铁、铝、银、金、颜料宝红(pigment rubine)、鞣酸、地衣红(orcein)、葡萄糖酸亚铁、乳酸亚铁。
此外,缓冲溶液对于液体制剂、特别是对于药物液体制剂是优选的。术语缓冲剂、缓冲系统和缓冲溶液特别是水性溶液是指通过添加酸或碱或者通过用溶剂稀释而使系统抵抗pH变化的能力。优选的缓冲系统可以选自包括以下的组:甲酸盐、乳酸盐、苯甲酸、草酸盐、富马酸盐、苯胺、乙酸盐缓冲剂、柠檬酸盐缓冲剂、谷氨酸盐缓冲剂、磷酸盐缓冲剂、琥珀酸盐、吡啶、邻苯二甲酸盐、组氨酸、MES(2-(N-吗啉代)乙磺酸)、马来酸、卡可基酸盐(cacodylate)(二甲基砷酸盐)、碳酸、ADA(N-(2-乙酰氨基)亚氨基二乙酸、PIPES(4-哌嗪-双-乙磺酸)、BIS-TRIS丙烷(1,3-双[三(羟基甲基)甲基氨基]丙烷)、乙二胺、ACES(2-[(氨基-2-氧代乙基)氨基]乙磺酸)、咪唑、MOPS(3-(N-吗啡啉)丙磺酸)、二乙基丙二酸、TES(2-[三(羟基甲基)甲基]氨基乙磺酸)、和HEPES(N-2-羟基乙基哌嗪-N’-2-乙磺酸)、以及pKa在3.8和7.7之间的其它缓冲剂。
优选的是例如乙酸盐缓冲剂等碳酸缓冲剂、和例如富马酸盐、酒石酸盐和邻苯二甲酸盐等二羧酸缓冲剂、以及例如柠檬酸盐等三羧酸缓冲剂。
另一组优选的缓冲剂为无机缓冲剂,例如硫酸盐氢氧化物、硼酸盐氢氧化物、碳酸盐氢氧化物、草酸盐氢氧化物、氢氧化钙和磷酸盐缓冲剂。另一组优选的缓冲剂为含氮缓冲剂,例如咪唑、二乙二胺和哌嗪。此外,优选磺酸缓冲剂,例如TES、HEPES、ACES、PIPES、[(2-羟基-1,1-双-(羟基甲基)乙基)氨基]-1-丙磺酸(TAPS)、4-(2-羟基乙基)哌嗪-1-丙磺酸(EEPS)、MOPS和N,N-双-(2-羟基乙基)-2-氨基乙磺酸(BES)。另一组优选的缓冲剂为甘氨酸、甘氨酰-甘氨酸、甘氨酰-甘氨酰-甘氨酸、N,N-双-(2-羟基乙基)甘氨酸和N-[2-羟基-1,1-双(羟基甲基)乙基]甘氨酸(tricine)。还优选氨基酸缓冲剂,例如甘氨酸、丙氨酸、缬氨酸、亮氨酸、异亮氨酸、丝氨酸、苏氨酸、苯丙氨酸、酪氨酸、色氨酸、赖氨酸、精氨酸、组氨酸、天冬氨酸盐、谷氨酸盐、天冬酰胺、谷氨酰胺、半胱氨酸、甲硫氨酸、脯氨酸、4-羟基脯氨酸、N,N,N-三甲基赖氨酸、3-甲基组氨酸、5-羟基-赖氨酸、邻磷酸丝氨酸、γ-羧基谷氨酸盐、ε-N-乙酰基赖氨酸、ω-N-甲基精氨酸、瓜氨酸、鸟氨酸、以及它们的衍生物。特别优选的是KH2PO4缓冲剂。
用于液体剂型和/或固体剂型的防腐剂可以根据需要来使用。它们可以选自包括但不限于如下的组:山梨酸、山梨酸钾、山梨酸钠、山梨酸钙、尼泊金甲酯、尼泊金乙酯、甲基乙基尼泊金酯、尼泊金丙酯、苯甲酸、苯甲酸钠、苯甲酸钾、苯甲酸钙、对羟基苯甲酸庚酯、对羟基苯甲酸甲酯钠、对羟基苯甲酸乙酯钠、对羟基苯甲酸丙酯钠、苯甲醇、苯扎氯铵、苯乙醇、甲酚、氯化十六烷基吡啶、氯丁醇、硫柳汞(2-(乙基汞硫)苯甲酸钠)、二氧化硫、亚硫酸钠、亚硫酸氢钠、焦亚硫酸钠、焦亚硫酸钾、亚硫酸钾、亚硫酸钙、亚硫酸氢钙、亚硫酸氢钾、联苯、邻苯基苯酚、邻苯基苯酚钠、噻苯达唑、乳酸链球菌素(nisin)、游霉素、甲酸、甲酸钠、甲酸钙、六胺(hexamine)、甲醛、二碳酸二甲酯、亚硝酸钾、亚硝酸钠、硝酸钠、硝酸钾、乙酸、乙酸钾、乙酸钠、二乙酸钠、乙酸钙、乙酸铵、脱氢乙酸、脱氢乙酸钠、乳酸、丙酸、丙酸钠、丙酸钙、丙酸钾、硼酸、四硼酸钠、二氧化碳、苹果酸、富马酸、溶菌酶、硫酸铜(II)、氯、二氧化氯、以及本领域技术人员已知的其它合适的物质或组合物。
对于液体剂型和局部用剂型,添加足量的抗氧化剂是特别优选的。抗氧化剂的合适的实例包括焦亚硫酸钠、α-生育酚、抗坏血酸、马来酸、抗坏血酸钠、抗坏血酸棕榈酸酯、丁基化羟基茴香醚、丁基化羟基甲苯、富马酸或没食子酸丙酯。优选使用焦亚硫酸钠、α-生育酚和抗坏血酸棕榈酸酯。
片剂或丸剂通常是包衣的,即,包衣构成外层。这可以是薄膜包衣、具有糖类的糖衣和压制包衣。可以使用药学上可接受的清漆或蜡、HPMC(羟丙基甲基纤维素)、MC(甲基纤维素)或HPC(羟丙基纤维素)。此类包衣可以有助于掩饰味道、便于吞咽或识别。通常,包衣中包括增塑剂和颜料。胶囊通常具有包封活性物质的凝胶状包膜。该凝胶状层的具体组成和厚度决定了摄入胶囊后发生吸收的速度。特别感兴趣的是本领域已知的缓释制剂。
合适的甜味剂可以选自包括以下的组:甘露糖醇、甘油、乙酰磺胺酸钾、阿斯巴甜、甜蜜素(cyclamate)、异麦芽酮糖醇、异麦芽糖醇、糖精及其钠盐、钾盐和钙盐、三氯蔗糖、阿力甜、奇异果甜蛋白、甘草甜素、新橙皮苷二氢查耳酮、甜菊糖苷、纽甜、阿斯巴甜-乙酰舒泛盐、麦芽糖醇、麦芽糖醇糖浆、乳糖醇、木糖醇、赤藓糖醇。
合适的增稠剂可以选自包括但不限于以下的组:聚乙烯吡咯烷酮、甲基纤维素、羟丙基甲基纤维素、羟丙基纤维素、糊精、聚葡萄糖、改性淀粉、碱性改性淀粉、漂白淀粉、氧化淀粉、酶处理淀粉、单淀粉磷酸酯、用三偏磷酸钠或磷酰氯酯化的二淀粉磷酸酯、磷酸化二淀粉磷酸酯、乙酰化二淀粉磷酸酯、用乙酸酐酯化的淀粉乙酸酯、用乙酸乙烯酯酯化的淀粉乙酸酯、乙酰化二淀粉己二酸酯、乙酰化二淀粉甘油酯、二淀粉甘油酯、羟丙基淀粉、羟丙基二淀粉甘油酯、羟丙基二淀粉磷酸酯、羟丙基二淀粉甘油酯、辛烯基琥珀酸淀粉钠、乙酰化氧化淀粉、羟乙基纤维素。
用于液体剂型的合适的pH调节剂为例如氢氧化钠、盐酸、例如磷酸二氢钠或磷酸氢二钠等缓冲物质。
合适的酸度调节剂可以选自包括以下的组:乙酸、乙酸钾、乙酸钠、二乙酸钠、乙酸钙、二氧化碳、苹果酸、富马酸、乳酸钠、乳酸钾、乳酸钙、乳酸铵、乳酸镁、柠檬酸、柠檬酸一钠、柠檬酸二钠、柠檬酸三钠、柠檬酸一钾、柠檬酸二钾、柠檬酸三钾、柠檬酸一钙、柠檬酸二钙、柠檬酸三钙、酒石酸、酒石酸一钠、酒石酸二钠、酒石酸一钾、酒石酸二钾、酒石酸钾钠、正磷酸、柠檬酸卵磷脂(lecithin citrate)、柠檬酸镁、苹果酸铵、苹果酸钠、苹果酸氢钠、苹果酸钙、苹果酸氢钙、己二酸、己二酸钠、己二酸钾、己二酸铵、琥珀酸、富马酸钠、富马酸钾、富马酸钙、富马酸铵、1,4-庚内酯(1,4-heptonolactone)、柠檬酸三铵、柠檬酸铁铵、甘油磷酸钙、柠檬酸异丙酯、碳酸钾、碳酸氢钾、碳酸铵、碳酸氢铵、碳酸镁、碳酸氢镁、碳酸亚铁、硫酸铵、硫酸铝钾、硫酸铝铵、氢氧化钠、氢氧化钾、氢氧化铵、氢氧化镁、葡萄糖酸。
使用的酸化剂为产生酸或成为酸的无机化学品。合适的实例为:氯化铵、氯化钙。
合适的溶剂可以选自包括但不限于以下的组:水、碳酸水、注射用水、具有等渗剂的水、盐水、等渗盐水、醇类特别是乙醇和正丁醇、及其混合物。
合适的等渗剂为例如药学上可接受的盐、特别是氯化钠和氯化钾,糖例如葡萄糖或乳糖,糖醇例如甘露糖醇和山梨糖醇,柠檬酸盐,磷酸盐,硼酸盐,及其混合物。
合适的崩解剂可以选自包括以下的组:淀粉,冷水溶性淀粉例如羧甲基淀粉,纤维素衍生物例如甲基纤维素和羧甲基纤维素钠,微晶纤维素和交联微晶纤维素例如交联羧甲基纤维素钠,天然和合成树胶例如瓜尔胶、琼脂、刺梧桐胶(karaya)(印度黄蓍胶)、槐豆胶(locust bean gum)、西黄蓍胶,粘土例如膨润土,黄原胶,海藻酸盐如海藻酸和海藻酸钠,发泡组合物a.o.。水分膨胀(moisture expansion)由例如淀粉、纤维素衍生物、海藻酸盐、多糖、葡聚糖、交联聚乙烯吡咯烷酮支持。组合物中的崩解剂的量可以在1重量%和40重量%之间、优选在3重量%和20重量%之间、最优选在5重量%和10重量%之间变化。
助流剂是防止各补充剂的结块并且改善颗粒的流动特性以使流动平滑且保持不变的材料。合适的助流剂包括二氧化硅、硬脂酸镁、硬脂酸钠、淀粉和滑石。组合物中的助流剂的量可以在0.01重量%和10重量%之间、优选在0.1重量%和7重量%之间、更优选在0.2重量%和5重量%之间、最优选在0.5重量%和2重量%之间变化。
术语“润滑剂”是指添加至剂型中以促进片剂、颗粒等从压模或出口喷嘴脱模的物质。它们减少摩擦或磨耗。润滑剂通常在压制前不久添加,这是因为它们应当存在于颗粒的表面上以及颗粒与压模部件之间。组合物中的润滑剂的量可以在0.05重量%和15重量%之间、优选在0.2重量%和5重量%之间、更优选在0.3重量%和3重量%之间、最优选在0.3重量%和1.5重量%之间变化。合适的润滑剂为a.o.油酸钠,金属硬脂酸盐例如硬脂酸钠、硬脂酸钙、硬脂酸钾和硬脂酸镁,硬脂酸,苯甲酸钠,乙酸钠,氯化钠,硼酸,具有高熔点的蜡,聚乙二醇。
乳化剂可以例如选自以下阴离子乳化剂和非离子乳化剂:阴离子乳化剂蜡、鲸蜡醇、鲸蜡基硬脂醇、硬脂酸、油酸、聚氧乙烯聚氧丙烯嵌段聚合物、2mol至60mol环氧乙烷与蓖麻油和/或硬化蓖麻油的加成产物、羊毛蜡油(羊毛脂)、脱水山梨糖醇酯、聚氧乙烯烷基酯、聚氧乙烯脱水山梨糖醇脂肪酸酯、聚氧乙烯脱水山梨糖醇单月桂酸酯、聚氧乙烯脱水山梨糖醇单油酸酯、聚氧乙烯脱水山梨糖醇单棕榈酸酯、聚氧乙烯脱水山梨糖醇单硬脂酸酯、聚氧乙烯脱水山梨糖醇三硬脂酸酯、聚氧乙烯硬脂酸酯、聚乙烯醇、偏酒石酸、酒石酸钙、海藻酸、海藻酸钠、海藻酸钾、海藻酸铵、海藻酸钙、丙烷-1,2-二醇海藻酸酯、角叉菜胶、经加工的麒麟菜海草(processed eucheuma seaweed)、槐豆胶、西黄蓍胶、阿拉伯树胶、刺梧桐树胶、结冷胶、印度树胶(gum ghatti)、葡甘露聚糖(glucomannane)、果胶、酰胺化果胶、磷脂酸铵(ammonium phosphatide)、溴化植物油、蔗糖乙酸异丁酸酯(sucrose acetateisobutyrate)、木松香的甘油酯、磷酸二钠、二磷酸三钠、二磷酸四钠、二磷酸二钙、二磷酸二氢钙、三磷酸钠、三磷酸五钾、多磷酸钠、多磷酸钙钠、多磷酸钙、多磷酸铵、β-环糊精、粉末状纤维素、甲基纤维素、乙基纤维素、羟丙基纤维素、羟丙基甲基纤维素、乙基甲基纤维素、羧甲基纤维素、羧甲基纤维素钠、乙基羟乙基纤维素、交联羧甲基纤维素、酶水解的羧甲基纤维素、脂肪酸的甘油单酯和甘油二酯、甘油单硬脂酸酯、甘油二硬脂酸酯、脂肪酸的甘油单酯和甘油二酯的乙酸酯、脂肪酸的甘油单酯和甘油二酯的乳酸酯、脂肪酸的甘油单酯和甘油二酯的柠檬酸酯、脂肪酸的甘油单酯和甘油二酯的酒石酸酯、脂肪酸的甘油单酯和甘油二酯的单乙酰基酒石酸酯和二乙酰基酒石酸酯、脂肪酸的甘油单酯和甘油二酯的混合乙酸酯和酒石酸酯、琥珀酰化甘油单酯、脂肪酸的蔗糖酯、蔗糖甘油酯(sucroglyceride)、脂肪酸的聚甘油酯、聚甘油聚蓖麻醇酸酯(polyglycerol polyricinoleate)、脂肪酸的丙烷-1,2-二醇酯、脂肪酸的丙二醇酯、甘油和丙烷-1的乳酸化脂肪酸酯、与脂肪酸的甘油单酯和甘油二酯相互作用的热氧化大豆油、二辛基磺基琥珀酸钠、硬脂酰-2-乳酸钠、硬脂酰-2-乳酸钙、酒石酸硬脂酯、柠檬酸硬脂酯、硬脂酰富马酸钠、硬脂酰富马酸钙、酒石酸硬脂酯、柠檬酸硬脂酯、硬脂酰富马酸钠、硬脂酰富马酸钙、月桂基硫酸钠、乙氧基化甘油单酯和甘油二酯、甲基葡萄糖苷-椰油酯、脱水山梨糖醇单硬脂酸酯、脱水山梨糖醇三硬脂酸酯、脱水山梨糖醇单月桂酸酯、脱水山梨糖醇单油酸酯、脱水山梨糖醇单棕榈酸酯、脱水山梨糖醇三油酸酯、多磷酸钠钙、多磷酸钙、多磷酸铵、胆酸、胆碱盐、二淀粉甘油酯、辛烯基琥珀酸淀粉钠、乙酰化氧化淀粉。优选的是单油酸甘油酯、硬脂酸、磷脂例如卵磷脂。
适合作为表面活性增溶剂(增溶剂(solubilizer))的是例如二甘醇单乙酯、聚乙二醇聚丙二醇共聚物、环糊精例如α-环糊精和β-环糊精、单硬脂酸甘油酯例如Solutol HS15(来自BASF的聚乙二醇-15-羟基硬脂酸酯、PEG 660-15羟基硬脂酸酯)、脱水山梨糖醇酯、聚氧乙烯二醇、聚氧乙烯脱水山梨糖酸酯、聚氧乙烯脱水山梨糖醇单油酸酯、聚氧乙烯氧基硬脂酸甘油三酯、聚乙烯醇、十二烷基硫酸钠、(阴离子)单油酸甘油酯。
稳定剂是可以添加以防止不需要的变化的物质。虽然稳定剂不是真正的乳化剂,但是它们也可以有助于乳剂的稳定性。稳定剂的合适实例为氧化硬脂精(oxystearin)、黄原胶、琼脂、燕麦胶、瓜尔豆胶、塔拉胶、聚氧乙烯硬脂酸酯、阿斯巴甜-乙酰舒泛盐、淀粉酶、蛋白酶、木瓜蛋白酶、菠萝蛋白酶、无花果蛋白酶、转化酶、聚右旋糖、聚乙烯吡咯烷酮、聚乙烯聚吡咯烷酮、柠檬酸三乙酯、麦芽糖醇、麦芽糖醇糖浆。
稀释剂或填充剂是添加至药物中用于应对最小量的活性剂的非活性物质。合适的稀释剂的实例为水、甘露糖醇、预胶化淀粉、淀粉、微晶纤维素、粉末状纤维素、硅化微晶纤维素、磷酸氢钙二水合物、磷酸钙、碳酸钙、羟丙基纤维素、羟乙基纤维素、羟丙基甲基纤维素、聚乙二醇、黄原胶、阿拉伯树胶或其任意组合。
可以将抗结块剂(抗粘附剂)添加至补充剂或补充剂的组合物中,用于防止团块的形成并且便于包装、运输、从分配盖(dispensing cap)的至少一个腔室释放和消耗。合适的实例包括磷酸三钙、粉末状纤维素、硬脂酸镁、碳酸氢钠、亚铁氰化钠、亚铁氰化钾、亚铁氰化钙、骨质磷酸盐(bone phosphate)、硅酸钠、二氧化硅、硅酸钙、三硅酸镁、滑石粉、铝硅酸钠、硅酸铝钾、铝硅酸钙、膨润土、硅酸铝、硬脂酸、聚二甲基硅氧烷。
吸附剂是从水中吸收油的物质。合适的实例包括天然吸附剂例如泥炭藓(peatmoss)、锯屑、羽毛和任何其它含有碳的天然物质以及合成吸附剂例如聚乙烯和尼龙。吸附剂通过在干燥状态下限制流体吸附(通过吸附或通过吸收来吸收液体或气体)用于片剂/胶囊防潮。
在一些盖仑制剂(galenic formulation)中,可能会期望液体口服剂型在溶解时产生一些泡沫。可以通过添加降低液体的表面张力从而促进气泡的形成或者通过抑制气泡的聚结来提高其胶体稳定性的发泡剂来支持此类效果。可选地,其可以使泡沫稳定。合适的实例包括矿物油、皂皮树提取物(quillaia extract)、柠檬酸三乙酯、月桂基醚硫酸钠、月桂基硫酸钠、月桂基硫酸铵。
可选地,一些液体口服剂型在制备时可能会出现轻微起泡。虽然这不会干扰所需的应用,但是可能会影响药物情况下的患者依从性或者膳食补充剂情况下的商业成功。因此,可能会期望添加药学上可接受的抗发泡剂(消泡剂)。实例为膳食补充剂中的聚二甲基硅氧烷或硅油、或者药品中的二甲基硅油。
遮光剂是根据需要使液体剂型不透明的物质。它们必须具有与溶剂(在大多数情况下为水)大幅不同的折射率。同时,它们对于组合物的其它组分应当是惰性的。合适的实例包括二氧化钛、滑石、碳酸钙、山嵛酸、鲸蜡醇或其混合物。
合适的加脂剂为例如油酸癸酯、水合蓖麻油、轻质矿物油、矿物油、聚乙二醇、月桂基硫酸钠。
稠度增强剂为例如鲸蜡醇、鲸蜡酯蜡、水合蓖麻油、微晶蜡、非离子乳化剂蜡、蜂蜡、石蜡或硬脂醇。
合适的助水溶物为例如乙醇、异丙醇等醇,或者例如甘油等多元醇。
合适的芳香物质和调味物质包括上述所有可用于该目的的精油。通常,该术语是指具有相应的特征性气味的来自植物或植物的一部分的挥发性提取物。可以通过蒸汽蒸馏将它们从植物或植物的一部分提取出来。
合适的实例为来自以下物质的精油或芳香物质:水芹(achillea)、鼠尾草、雪松、丁香、洋甘菊、茴香、洋茴香、八角茴香、百里香、茶树、薄荷、薄荷油、薄荷醇、桉树脑、冰片、姜油、桉树、芒果、无花果、薰衣草油、洋甘菊花、松针、柏树、柑桔、玫瑰、花梨木、李子、红醋栗、樱桃、桦树叶、肉桂、酸橙、葡萄柚、橘子、杜松、缬草、柠檬、香蜂草、柠檬草、玫瑰草(palmarosa)、蔓越莓、石榴、迷迭香、生姜、菠萝、番石榴、紫锥菊、常春藤叶提取物、蓝莓、柿子、甜瓜、α-或β-蒎烯、α-氧化蒎烯、α-龙脑醛、α-香茅醇、α-异戊基肉桂、α-肉桂松油烯、α-松油醇、α-松油烯、C16醛、α-水芹烯、戊基肉桂醛、水杨酸戊酯、大茴香醛、罗勒、茴香脑、月桂(bay)、乙酸苄酯、苯甲醇、佛手柑、苦橙皮、黑胡椒、菖蒲、樟脑、卡南加油、豆蔻、康乃馨、香芹酚、香苇醇(carveol)、肉桂、蓖麻、雪松、肉桂醛、肉桂醇、顺式蒎烷、柠檬醛、香茅、香茅醛、右旋香茅醇(citronellol dextro)、香茅醇、乙酸香茅酯、香茅腈、蜜柑、鼠尾草、丁香花蕾、芫荽、玉米、棉籽、d-二氢香芹酮、癸醛、邻苯二甲酸二乙酯、二氢茴香脑、二氢香芹醇、二氢芳樟醇、二氢月桂烯、二氢月桂烯醇、乙酸二氢月桂烯酯、二氢松油醇、水杨酸二甲酯、二甲基辛醛、二甲基辛醇、乙酸二甲基辛酯、二苯醚、二丙二醇、d-柠檬烯、d-胡薄荷酮、草蒿脑、乙基香兰素、桉叶油素、柠檬桉、蓝桉、丁香酚、月见草、小茴香醇、茴香、ferniol、鱼、海风醛(florazon)、佳乐麝香(galaxolide)、香叶醇、天竺葵、乙酸香叶酯、香叶腈、愈创木酚、愈创木、古云香脂(gurjun balsam)、胡椒醛、奇华丹(herbanate)、罗汉柏、羟基香茅醛、i-香芹酮、i-乙酸甲酯、紫罗兰酮、异丁基喹啉、乙酸异冰片酯、异冰片基甲醚、异丁香酚、异长叶烯、茉莉、薰衣草、柠檬烯、氧化芳樟醇、芳樟醇(linallol)、沉香醇(linalool)、乙酸芳樟酯、亚麻籽、山苍子(litsea cubeba)、I-乙酸甲酯、长叶烯、柑橘、薄荷、薄荷烷氢过氧化物、薄荷醇晶体、左旋薄荷醇(menthol laevo)、左旋薄荷酮(menthone laevo)、邻氨基苯甲酸甲酯、甲基雪松基酮、甲基胡椒酚(methyl chavicol)、甲基己基醚、甲基紫罗兰酮、水杨酸甲酯、矿物质、薄荷、葵子麝香(musk ambrette)、麝香酮、二甲苯麝香、月桂烯、橙花醇、乙酸橙花酯、壬醛、肉豆蔻、鸢尾根、对伞花烃、对羟基苯丁酮晶体、广藿香、对伞花烃、胡薄荷油(pennyroyal oil)、胡椒、紫苏醛、苦橙叶、苯乙醇、苯基乙基丙酸酯、苯基乙基2-甲基丁酸酯、甜椒浆果、甜椒叶、蒎烷氢过氧化物、蒎烷醇、松酯(pine ester)、松树、蒎烯、胡椒醛、乙酸胡椒酯、胡椒醇、普林醇(plinol)、乙酸普林酯、假紫罗兰酮、玫瑰醇、乙酸玫瑰酯、结晶玫瑰(rosalin)、ryu、檀香木、檀香、黄樟、芝麻、大豆、留兰香、香料、宽叶薰衣草(spikelavender)、绶草醇(spirantol)、星花(starflower)、茶籽、萜类化合物、松油醇、异松油烯、乙酸松油酯、乙酸叔丁基环己酯、四氢沉香醇、乙酸四氢芳樟酯、四氢月桂烯醇、圣罗勒(thulasi)、麝香草酚、番茄、反式-2-己烯醇、反式茴香脑、姜黄、松节油、香草醛、香根草、vitalizair、白杉木、白葡萄柚、冬青等、或其混合物、以及薄荷醇、薄荷和八角茴香油或者薄荷醇和樱桃香精的混合物。
可以以相对于整个组合物为0.0001重量%至10重量%(特别是在组合物中)、优选0.001重量%至6重量%、更优选0.001重量%至4重量%、最优选0.01重量%至1重量%的范围包含这些芳香物质或调味物质。与用途或个案相关地,使用不同的量会是有利的。
根据本发明,所有前述赋形剂和赋形剂的类别可以单独地或者以其任何可想到的组合来使用而没有限制,只要不阻碍本发明的用途、发生毒性作用或者违反各国法规即可。
在本发明的另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合以用于口服给药的制剂用于冠状病毒感染的预防或治疗。
适合于5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合的口服剂型的药物制剂可以作为例如如下的分开的单位给药:片剂、软明胶胶囊剂、硬明胶胶囊剂、糖衣片剂或丸剂;散剂或颗粒剂;汁液、糖浆剂、滴剂、茶、在水性液体或非水性液体中的溶液剂或混悬剂;可食用泡沫或慕斯;或者水包油乳剂或油包水乳剂。
在例如片剂或胶囊剂等口服剂型中,由此可以将活性剂与无毒且药学上可接受的惰性载体例如乙醇、甘油或水组合。通过将化合物研磨至合适的微小粒径并且以类似的方式将它们与药物载体例如可食用的碳水水合物例如淀粉或甘露醇混合来生产散剂。也可以存在调味剂、防腐剂、分散剂或着色剂。
通过生产、制粒或干压粉末混合物、添加润滑剂和崩解剂并且将混合物压制成片剂来配制片剂。粉末混合物通过如下来生产:将适当研磨的化合物与如前所述的稀释剂或碱混合,并且,如果适用,与以下物质混合:粘合剂,例如羧甲基纤维素、藻酸盐、明胶或聚乙烯吡咯烷酮;溶解延缓剂,例如,如石蜡;吸收促进剂,例如,如季盐;和/或吸收剂,例如,如膨润土、高岭土或磷酸二钙。可以通过将粉末混合物用例如,如糖浆、淀粉糊、阿拉伯胶浆或者纤维素或聚合物材料的溶液等粘合剂润湿并且将其按压过筛来制粒。作为制粒的替代方案,可以使粉末混合物通过压片机,产生形状不均匀的团块,使所述团块破碎以形成颗粒。可以通过添加硬脂酸、硬脂酸盐、滑石或矿物油来润滑颗粒,以防止对片剂铸模的粘附。然后压制经润滑的混合物以得到片剂。也可以将根据本发明的化合物与自由流动的惰性赋形剂组合,然后直接压制以得到片剂,而不进行制粒工序或干压工序。
在本发明的另一方面,5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一以硬明胶胶囊剂提供。它们是通过生产如前所述的粉末混合物并且将其填充至成形的明胶盖中来制造的。可以将助流剂和润滑剂例如高度分散的二氧化硅、滑石、硬脂酸镁、硬脂酸钙或聚乙二醇作为固体添加至粉末混合物中。同样可以添加崩解剂或增溶剂例如琼脂、碳酸钙或碳酸钠,从而提高摄入胶囊后药物的可用性。此外,如果需要或必要,可以将合适的粘合剂和/或着色剂添加至混合物中。
在本发明的另一方面,5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一包含在软明胶胶囊剂(SGC)中。SGC在通过胃肠道时溶解。它们主要由富含可变量的增塑剂例如甘油或山梨聚糖的明胶构成。释放速率取决于SGC载体材料的具体配方。它们也适合于活性剂的缓释。SGC对于水溶性差的活性剂的给药是特别有用的。
在本发明的另一方面,5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一包含在咀嚼片或硬焦糖(hard caramel)中。本文中,将该物质引入片剂或焦糖的基质中。
在本发明的另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合以用于吸入给药的制剂用于冠状病毒感染的预防或治疗。
对于可能会引起肺炎、肺水肿和/或急性肺损伤的冠状病毒感染的有效预防性或治疗性治疗,有利的是5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合到达患者的肺泡。因此,粒径必须足够小以到达肺组织的气道的最低部分。用于药物活性剂的吸入应用的最佳吸入装置类别是所谓的筛网雾化器。在本申请的范围内,可以使用几乎所有本领域已知的筛网雾化器,从用于咳嗽和感冒或用于花哨目的(fancy purpose)的相当简单的一次性筛网雾化器到用于下气道的严重疾病或病况的临床治疗或家庭治疗的复杂高端的筛网雾化器。
合适的商购可得的筛网雾化器、喷射雾化器、超声雾化器、干粉吸入器和(加压的)计量吸入器包括但不限于PARIrapid、PARI LCPARI Velox和PARI VeloxJunior(PARI GmbH,Starnberg,德国),Philips Respironics I-neb和Philips InnoSpireGo(Koninklijke Philips N.V.,Eindhoven,荷兰),VENTA--ir、OPTI-M-dose+筛网雾化吸入器MN-300/8、M-Neb Flow+和M-筛网雾化器MN-300/X(NEBU-TEC,Eisenfeld,德国),Hcmed Deepro HCM-86C和HCM860(HCmed Innovations Co.,Ltd,台北,台湾,中国),OMRON MicroAir U22和U100(OMRON,Kyoto,日本),Solo、Ultra和PRO(Aerogen,Galway,爱尔兰),KTMED NePlus NE-SM1(KTMED Inc.,Seoul,韩国),Vectura Bayer BreelibTM(Bayer AG,Leverkusen,德国),Vectura Fox、MPV Truma和Smarty(MPV MEDICAL GmbH,Kirchheim,德国),MOBI MESH(APEX Medical,新北市,台湾,中国),B.Well WN-114、TH-134和TH-135(B.WellSwiss AG,Widnau,瑞士),Babybelle Asia BBU01(Babybelle Asia Ltd.,香港,中国),CA-MI Kiwi以及其它(CA-MI sri,Langhirano,意大利),Diagnosis PRO MESH(DiagnosisS.A.,波兰),DIGI O2(DigiO2International Co.,Ltd.,新北市,台湾,中国),来福士AIR PLUS、AEROCENTRE+、AIR 360+、AIR GARDEN、AIRICU、AIR MASK、AIRGEL BOY、AIRANGEL、AIRGEL GIRL和AIR PRO 4(Feellife Health Inc.,深圳,中国),Hannox MA-02(Hannox International Corp.,台北,台湾,中国),Health and Life HL100和HL100A(HEALTH&LIFE Co.,Ltd.,新北市,台湾,中国),Honsun NB-810B(Honsun Co.,Ltd.,南通,中国),K-KN-9100(K-jump Health Co.,Ltd.,新北市,台湾,中国),microlife NEB-800(Microlife AG,Widnau,瑞士),OK Biotech Docspray(OK Biotech Co.,Ltd.,HsinchuCity,台湾,中国),Prodigy Mini-(Prodigy Diabetes Care,LLC,Charlotte,USA),Quatek NM211、NE203、NE320和NE403(Big Eagle Holding Ltd.,台北,台湾,中国),SimzoNBM-1和NBM-2(Simzo Electronic Technology Ltd.,东莞,中国),BBU01和BBU02(Tai Yu International Manufactory Ltd.,东莞,中国),TaiDoc TD-7001(TaiDocTechnology Co.,新北市,台湾,中国),和HIFLO Miniheart Circulaire II(Westmed Medical Group,Purchase,USA),KEJIAN(Xuzhou Kejian Hi-Tech Co.,Ltd.,徐州,中国),YM-252、P&S-T45和P&S-360(TEKCELEO,Valbonne,法国),Maxwell YS-31(Maxwell India,Jaipur,印度),JLN-MB001(Kernmed,Durmersheim,德国)。
优选的是带有雾化过程的压电激活的筛网雾化器、或者振动筛网雾化器。
因此,在本发明的另一方面,本申请涉及用于吸入给药的制剂中的、用于冠状病毒感染的预防或治疗的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合,其中吸入给药借助振动筛网雾化器来进行。
可以将筛网雾化器根据患者互动分为两组:连续模式装置和触发激活装置。在连续模式筛网雾化器中,将雾化的气雾剂连续地释放至吸嘴中并且患者不得不吸入所提供的气雾剂。在触发激活装置中,仅在主动且深呼吸时释放一定量的气雾剂。这样,与使用连续模式装置相比,更大量的含有活性剂的气雾剂被吸入并且到达最低的气道。连续模式装置使大量的含有活性剂的气雾剂散失至周围环境中或者散失在上气道的通道上,这是因为气雾剂释放未连接至呼吸循环。
因此,触发激活的筛网雾化器是优选的,特别是振动筛网雾化器。
特别优选的是带有雾化过程的压电激活的触发激活的筛网雾化器。
优选的是筛网雾化器型号PARIrapid、Philips Respironics I-neb、Philips InnoSpire Go、M-dose+筛网雾化吸入器MN-300/8、Hcmed Deepro HCM-86C和HCM860、OMRON MicroAir U100、Solo、KTMED NePlus NE-SM1、Vectura Fox、Vectura Bayer BreelibTM。
最优选的振动筛网雾化器型号为高端型号,例如PARIrapid、PARI Velox、Philips Respironics I-neb、M-dose+筛网雾化吸入器MN-300/8、Solo、Vectura Fox、Vectura Bayer BreelibTM。
平均液滴尺寸通常以MMAD(中位质量空气动力学直径(median mass aerodynamicdiameter))来表征。单个液滴尺寸称为MAD(质量空气动力学直径)。该值表示雾化颗粒(液滴)的直径,在此处,分别有50%更小或更大。MMAD>10μM的颗粒通常不会到达下气道,它们经常卡在咽喉里。MMAD>5μM且<10μM的颗粒通常会到达支气管而不是肺泡。MMAD在100nm与1μM之间的颗粒不会沉积在肺泡中并且立即被呼出。因此,最佳范围为MMAD在1μM与5μM之间。最近的出版物甚至支持在3.0μM与4.0μM之间的更窄的范围(参见Amirav等人(2010)JAllergy Clin Immunol 25:1206-1211;Haidl等人(2012)Pneumologie 66:356-360)。
另一个普遍接受的质量参数为所生成的气雾剂中的直径在1μM至5μM范围内的颗粒的百分比(FPM;细颗粒质量)。FPM是颗粒分布的量度。通过从所生成的气雾剂中的直径在<5μM范围内的颗粒的总百分比减去所生成的气雾剂中的直径在<1μM范围内的颗粒的百分比来计算(FPF;细颗粒分数)。
在本发明的另一方面,本申请还涉及生产用于冠状病毒感染的预防或治疗的根据本发明的气雾剂的方法,其包括以下步骤:
a)将0.1ml至5ml含有5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合和任选地至少一种药学上可接受的赋形剂的水溶液填充至筛网雾化器的雾化室中,
b)以80kHz至200kHz的频率启动筛网雾化器的筛网的振动,并且
c)在筛网雾化器的筛网的与雾化室相对的一侧排出所生成的气雾剂。
振动筛网雾化器的振动频率通常在80kHz至200kHz、优选90kHz至180kHz、更优选100kHz至160kHz、最优选105kHz至130kHz的范围内(参见Chen,The Aerosol Society:DDL2019;Gardenshire等人(2017)A Guide to Aerosol Delivery Devices forRespiratory Therapists,第4版)。
因此,前述方法也公开了所述振动频率范围。
因此,根据本发明的方法的特征在于所述水溶液中包含的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合的至少80重量%、优选至少85重量%、最优选至少90重量%在所生成的气雾剂中雾化。
本发明的方法在使高百分比的药物活性剂在短时间内从所提供的水溶液雾化方面是特别有效的。这对于患者依从性是重要的特征。相当大的百分比的患者群体发现吸入过程不舒服、令人疲倦并且对体力要求较高。另一方面,患者的积极配合对于有效且有针对性的吸入应用至关重要。因此,期望在尽可能短的时间段内施加治疗上足够的量。令人惊讶的是,显示在三分钟的时间跨度内可以使水溶液中提供的物质的95%雾化。这对于高的患者依从性是理想的时间跨度。
因此,根据本发明的方法的特征在于在筛网雾化器中启动雾化后三分钟期间产生至少80%、优选至少85%并且最优选至少90%的所生成的气雾剂。
虽然药物活性剂通常在单剂量容器中提供以用于每个雾化程序,但是雾化器和/或吸嘴可以在特定时间段内使用并且必须以特定间隔更换。默认情况下,建议在每次雾化后清洁雾化器和吸嘴。但是在此不能合理地认为患者依从性是理所当然的。但是,即使在细致的清洁之后,在雾化室、出口和/或吸嘴中也总会存在一些气雾剂的沉积物。由于气雾剂是由水溶液产生的,因此这些沉积物具有产生可能会污染吸入的气雾剂的细菌生物负载的风险。沉积物还可能会堵塞筛网雾化器的筛网膜中的孔。通常,雾化器和/或吸嘴应当每一周或每两周更换一次。因此,将药物和雾化器作为组合产品来提供是方便的。
因此,在本发明的另一方面,本申请还涉及一种试剂盒,其包括筛网雾化器和药学上可接受的容器,所述药学上可接受的容器具有水溶液,所述水溶液包含有效量的用于冠状病毒感染的预防或治疗的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合和任选至少一种药学上可接受的赋形剂。
在可选的试剂盒中,5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合不是以水溶液的形式提供,而是在两个分开的容器中提供,一个用于活性剂的固体形式并且另一个用于水溶液。通过将活性剂溶解于最终溶液中来新鲜制备最终水溶液。随后将最终水溶液填充至筛网雾化器的雾化室中。这两个容器可以是完全分开的容器,例如两个小瓶,或例如双室小瓶。为了溶解活性剂,例如将两个腔室之间的膜打孔以允许两个腔室的内容物的混合。
因此,本申请还公开了一种试剂盒,其包括筛网雾化器、具有注射用水或生理盐水溶液的第一药学上可接受的容器、和具有有效剂量的用于冠状病毒感染的预防或治疗的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合的固体形式的第二药学上可接受的容器,其中任选至少一种药学上可接受的赋形剂包含在第一药学上可接受的容器和/或第二药学上可接受的容器中。
借助吸嘴将通过根据本发明的方法生成的气雾剂进行给药或自行给药。任选地,前述试剂盒中可以额外地包括此类吸嘴。
借助配备有注射针的注射器将所提供的水溶液或最终水溶液转移至筛网雾化器的雾化室中的常见方式。首先,将水溶液吸入至注射器中,然后注入雾化室。任选地,前述试剂盒中可以额外地包括此类注射器和/或注射针。在不受限制的情况下,可以使用由聚乙烯、聚丙烯或环状烯烃共聚物制成的典型注射器,并且不锈钢注射针的典型规格会在14至27的范围内。
在本发明的又一方面,公开了5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合用于预防或治疗冠状病毒感染,其中所述物质、组合物或组合作为心肺转流装置(辅助通气形式)的通气空气的添加物来提供。当重症监护室中的患者的病况恶化时,他们经常需要以此类设备无限期地进行通气,直至他们的自主呼吸允许提供足够的氧气供给。当使用在Y形接头处与吸入室结合的计量吸入器中的气雾剂时,取得了好的结果。这可以将支气管扩张剂的应用剂量提高1.5至4倍(Fuller等人(1994)Chest 105:214-218)。可以递送38%的药物活性剂(Marik等人(1999)Chest 115:1653-1657)。可选地,如在闪烁显像研究中所评估的,恒定输出的筛网雾化器产生10%-15%的速率(Dugernier等人(2016)Ann Intensive Care 6:73)。对于抗生素的给药,振动筛网雾化器比超声雾化器或喷射雾化器提供更好的结果。当恒定输出的振动筛网雾化器放置在距离Y形接头10cm处的吸气肢上并且设定具体的通气参数(潮气量为8ml/kg,呼吸频率为12c/min,占空比为50%,恒定的吸气流速和低吸气流速低于30l/min并且吸气末暂停为20%),63%的给药药物(头孢他啶、阿米卡星)到达气管内导管的入口,而肺外沉积率为37%(Lu等人(2011)Am J Respir Crit Care Med 184:106-115)。大多数情况下,给药的药物均匀地分布在双肺之间。在猪中,发现在吸入气体中使用氦气(He/O2)代替氮气(N2/O2)使胸膜下肺标本中的头孢他啶浓度增加(Tonnelier等人(2005)Anesthesiology102:995-1000)。
在这些情况下,可以将5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一以固体形式(干粉)或者以液体形式(以水溶液剂或作为雾化的气雾剂,如前所述)添加至插管的通气空气中。
因此,本申请还公开了5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合用于预防或治疗冠状病毒感染,其中将所述物质、组合物或组合添加至心肺转流装置的通气空气中。
在本发明的又一方面,5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合用于预防或治疗冠状病毒感染,其中所述物质、组合物或组合以脂质体、胶束、多层囊泡或环糊精复合物的形式应用。
在本发明的又一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合以用于舌下片的制剂用于预防或治疗冠状病毒感染。
在本发明的又一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合以液体剂型用于预防或治疗冠状病毒感染。
本申请还公开了在冠状病毒感染的预防或治疗中以静脉内注射、动脉内注射或腹膜内注射的形式肠胃外给予5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合。
这些液体剂型包括溶液剂、混悬剂和乳剂。实例是用于肠胃外注射的水溶液剂和水/丙二醇溶液剂、或对于口服溶液剂、混悬剂和乳剂添加甜味剂或遮光剂。
这些液体剂型可以储存在小瓶、IV袋、安瓿、药筒和预填充注射器中。合适的赋形剂包括增溶剂、稳定剂、缓冲剂、张力调节剂、增量剂、粘度增强剂/粘度降低剂、表面活性剂、螯合剂和佐剂。
在本发明的又一方面,5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合用于预防或治疗冠状病毒感染,其中将所述物质、组合物或组合配制为冻干物。冻干物可以用注射用水或生理盐水或水/乙醇溶液重构,然后通过注射给药。
用于静脉内注射的典型应用形式包括输注泵、皮下注射针、滴注器、外周插管(外周静脉导管)和压力袋。
通常,水溶液或生理盐水溶液是优选的。在根据本发明的难溶性药剂的情况下,也可以使用乙醇或乙醇/水混合物。
其它合适的液体剂型包括滴剂、滴眼剂和滴耳剂。
虽然SARS-CoV和MERS-CoV主要感染下气道,但是SARS-CoV-2首先感染咽/喉区域。这些患者中仅有一小部分随后发展为肺部感染和肺炎。虽然这些咽部感染通常仅引起与感冒一样的轻微的症状或者根本不引起症状,但是这些患者对他们的环境具有高度传染性。在大多数情况下,他们不知道自己已成为感染的传播者。因此,存在当冠状病毒感染仍处于咽部阶段时就对其进行治疗的医学需要,这不仅是为了治疗此类患者,而且也是出于流行病学原因,以防止流行病的传播。对于具有咽部感染的患者,在使用也可能会引起不良副作用的高效药物或药物组合的情况下,只有全身给药途径例如静脉内或口服是不理想的。因此,期望提供局部治疗受感染的咽部组织的给药途径。
因此,在本发明的又一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合以用于咽部给药的制剂用于预防或治疗冠状病毒感染。
对咽部给药可以通过局部给药来实现,例如用合适的液体剂型如滴剂、洗剂或酊剂、或者用粘性剂型例如凝胶或水凝胶来冲洗喉咙/咽部区域、用漱口水含漱、舌下片、锭剂、咽喉喷雾剂或咽后壁注射剂。
洗剂是旨在应用于皮肤或黏膜的低粘度局部制剂。用裸手、刷子、干净的布或脱脂棉将洗剂应用于皮肤或黏膜。
洗剂的优点在于其可以较薄地铺展并且可以覆盖大面积的皮肤或黏膜。典型的可以以洗剂的形式给药的药物包括抗生素、防腐剂、抗真菌剂、皮质类固醇、抗痤疮剂、舒缓剂(soothing agent)、平滑剂、保湿剂或保护剂、或抗过敏药(anti-allergen)。
大多数洗剂是使用例如鲸蜡硬脂醇等物质使乳液保持在一起的水包油乳液,但是也配制油包水洗剂。关键组分是水相和油相、防止这两相与药物分离的乳化剂。通常将很多种赋形剂例如香料、甘油、凡士林、染料、防腐剂、蛋白质和稳定剂添加至洗剂中。
可以在制造期间调整洗剂的浓稠度(thickness)、稠度(consistency)和粘度。制造洗剂可以分两个周期进行:a)将润肤剂和润滑剂与配混剂和增稠剂分散在油中。b)将香精、色素和防腐剂分散在水相中。药学上有活性的成分在两个周期中均被裂解,这取决于所涉及的原材料和期望的洗剂特性。
酊剂通常是酒精提取物或制剂。25%–60%(或甚至90%)的溶剂浓度是常见的。其它用于生产酊剂的溶剂包括醋、甘油、乙醚和丙二醇。乙醇具有对于酸性成分和碱性成分二者均为优异溶剂的优点。使用甘油的酊剂称为甘油剂(glycerite)。甘油通常是比乙醇差的溶剂。酸性的醋对于获得生物碱是较好的溶剂但是对于酸性组分是较差的溶剂。
凝胶是一种胶体,其中固体分散相与流体连续相结合形成网络得到粘性半刚性溶胶。凝胶特性的范围为从柔软且脆弱至坚硬且坚韧。将它们定义为大幅稀释的交联体系,其在稳态下不表现出流动。按重量计算,凝胶主要是液体,但是它们由于液体中的三维交联网络而表现为类似于固体。正是流体内的交联赋予凝胶稠度并且有助于粘合。凝胶是液体分子在固体介质内的分散体。
水凝胶是亲水性的聚合物链的网络,有时发现为其中水为分散介质的胶态凝胶。由于亲水性聚合物链通过交联结合在一起而得到三维固体。由于内在的交联,水凝胶网络的结构完整性不会在高浓度的水中解散。水凝胶是高吸收性(它们可以包含超过90%的水)的天然或合成聚合物网络。水凝胶由于其较大的水含量还具有与天然组织非常相似的柔韧度。在药物中,水凝胶可以包封化学体系,其在受到外部因素例如pH的变化的刺激时可能会导致特定的药物活性剂释放至环境中,在大多数情况下通过凝胶-溶胶转变为液态。
合适的凝胶形成剂可以选自包括但不限于以下的组:琼脂、藻胶、海藻酸、膨润土、卡波姆、角叉菜胶、锂蒙脱石、羟乙基纤维素、羟丙基纤维素、聚乙烯醇、聚乙烯吡咯烷酮、卡波姆钠。
漱口水是通过口周肌肉的收缩和/或头部的移动被动地含在口中或者围绕口腔冲洗的液体,并且可以含漱,在该情况下,头部向后倾斜并且液体在口腔的后部起泡。由此,可以配制5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合的水溶液或醇溶液并且将其给药至咽部。
当与口服药物递送相比时,舌下药物递送可以为替代方案,这是因为舌下给药的剂型绕过肝脏代谢。对于一些药物、尤其是用于治疗急性病症的那些,经常期望药理作用的快速起效。舌下片迅速地崩解,并且存在的少量唾液通常足以实现剂型的崩解以及更好的溶出和提高的生物利用度。
药物必须具有足够的亲脂性从而能够通过脂质双层进行分配,但是不能过于亲脂以至于一旦其进入脂质双层就不会再分配出来。根据吸收的扩散模型,通过脂质双层的通量与浓度梯度成正比。因此,较低的唾液溶解度导致较低的吸收率,反之亦然。通常,配制为用于舌下的药物应当理想地具有小于500的分子量以促进其扩散。口腔具有在5.0至7.0之间的窄pH范围。在配制可电离药物期间包含合适的缓冲剂使得可以控制水性唾液的pH。
为了避免药物的可能令人不快的味道或气味,需要掩味。甜味剂、调味剂和其它掩味剂是必不可少的组分。糖基赋形剂快速溶解在唾液中并且产生溶解吸热。它们在口中产生令人愉悦的感觉并且最适合与其它调味剂一起用于舌下片。
制造舌下片的典型技术包括直接压缩、压缩成型、冷冻干燥和热熔挤出(Khan等人(2017)J Pharmaceut Res 16:257-267)。
当避免吞咽时,借助舌下片给予药物活性剂也可以局部到达咽/喉。药物活性剂的吸收大部分经由咽部粘膜发生。
锭剂(lozenge)(锭剂(troche))是小的圆盘形体或菱形体,其由包含收敛剂、防腐剂或缓和剂(demulcent drug)的固化糊剂(solidifying paste)构成,用于口腔或咽喉的局部治疗,将锭剂含在口中直至溶解。锭剂的载体(vehicle)或基质通常是糖,通过与阿拉伯树胶或西黄蓍胶、由黑醋栗或红醋栗、玫瑰蜜饯或吐鲁香胶(balsam of tolu)制成的果泥(fruit paste)混合而使其具有粘性。
特别地,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合以用于咽部给药的制剂用于预防或治疗冠状病毒感染,其中咽部给药借助咽喉喷雾剂来进行。
咽喉喷雾剂是作为喷雾剂给药至咽喉的药液,通常用于治疗咽喉痛或咳嗽。
咽喉喷雾剂通常可以包含局部麻醉剂(例如利多卡因、苯佐卡因)、防腐剂(例如氯己定、氯化十六烷基吡啶)、草药提取物或其组合。无论何种配方都不应当含有过多的进一步刺激黏膜的糖或乙醇。最后,使用者不应当体验到任何令人不快的回味。
目前,咽喉喷雾剂的标准是连接至含有10ml至30ml的液体制剂的瓶的计量泵。将制剂填充至玻璃瓶或塑料瓶中,通过夹压在瓶颈上或简单地卡在瓶颈上的螺纹盖来固定泵。无论选择何种固定方式,体系应当是密闭的,在使用者携带或操作期间没有观察到泄漏。通常,容器由玻璃或塑料制成。
通常,咽喉喷雾泵每次启动将递送在50μl至200μl的范围内的剂量。对于靶向给药,泵将配备有具有延长喷嘴的致动器(actuator)。喷嘴长度可以在30mm至70mm的范围内。使用此类长固定喷嘴更容易靶向受影响的区域,但是这对于使用者而言可能会太笨重而无法携带,这是优选具有可折叠或旋转安装的喷嘴的致动器的原因。
可选地,装置使用连续阀。连续阀递送靶向治疗但不提供精确的剂量,这是因为在按下致动器时制剂将雾化。一种技术方案为具有加压顶部空间的锡罐或铝罐。当启动阀门时,只要阀杆被按下,升高的内部压力将使制剂从罐中挤出。
相关但更复杂的系统为阀上袋(bag-on-valve,BOV)系统。将产品置于袋内部,而将抛射剂(propellant)(在大多数情况下为压缩空气)填充在袋与外罐之间的空间中。当启动连续阀时,借助压缩空气将产品从袋中挤出。BOV系统将适用于任何360°方向。
应当小心,这是因为咽喉喷雾制剂可能会包含非常具有侵蚀性的(aggressive)并且可以降低表面张力的成分。对喷雾性能的简单测试将确保可以借助系统使制剂雾化并且提供的喷雾模式和粒径适合预期用途。
喷雾模式和液滴尺寸分布是咽喉喷雾剂最重要的参数。喷雾模式是用于描述完全展开的喷雾的喷雾角度和羽流形状(shape of the plume)的术语。一旦喷雾完全展开,就可以使用激光衍射法来表征液滴尺寸。细颗粒(平均动力学直径小于10μm的液滴)应当尽可能低,以避免下气道中的液滴沉积。
可选地,可以使用具有高输出速率和用于在上气道中沉积的经调整的液滴尺寸的便携式雾化器。通过面罩呼吸可以使液滴沉积在整个上气道的黏膜上(参见Marx和Nadler(2018)Drug Development&Delivery)。
特别地,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合以用于咽部给药的制剂用于预防或治疗冠状病毒感染,其中咽部给药借助咽后壁注射剂来进行。
该技术用于通过注射羟基磷灰石钙和整形手术中的其它方法来进行的咽部成形术。然而,也可以对咽部组织进行局部注射以给予药物活性剂。注射溶液可以与静脉内注射剂或肌内注射剂大致相同。优选水溶液、生理盐水溶液,或者在相当亲脂的药物活性剂的情况下,优选乙醇/水混合物。
在本发明的另一方面,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合以用于经鼻给药的制剂用于预防或治疗SARS-CoV-2感染。
特别地,经鼻给药借助鼻喷雾剂或滴鼻剂来进行。
用于鼻喷雾剂产品的常见制剂类型为溶液剂、混悬剂和乳剂。鼻喷雾制剂可以是水基的、水醇基的或非水基的。取决于体系的类型,制剂将包括一系列功能性赋形剂,包括溶剂和助溶剂;黏膜粘附剂;pH缓冲剂;抗氧化剂;防腐剂;渗透压剂和张度剂(osmolalityand tonicity agents);渗透促进剂;助悬剂;和表面活性剂。制剂类型的选择和所选择的赋形剂将由5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一的溶解度和稳定性以及在典型的100μl喷雾剂中递送有效剂量所需的浓度来决定(参见Kulkarni和Shaw(2016),在Essential Chemistry for Formulators of Semisolid and Liquid Dosages,Elsevier中)。前述技术也用于鼻喷雾剂。
滴鼻剂以相似的配方给药,但是为滴加而不是按压分配器。
特别地,本申请涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合以用于经鼻给药的制剂用于预防或治疗SARS-CoV-2感染,其中经鼻给药借助鼻喷雾剂或滴鼻剂来进行。
已知眼黏膜是SARS-CoV-2进入有机体的另一个切入点,例如一个人在揉眼睛时手上携带病毒。
因此,本申请还涉及5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合,其中5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合的给药借助滴眼剂来进行。
滴眼剂大多为含有药物活性剂的水溶液。通常将pH调整为7.1至7.5。常见的滴眼剂用缓冲剂为硼酸和磷酸二氢钠。应当借助0.9%盐水(或者另一等渗剂例如硝酸钾、硼酸、乙酸钠、乙酸钠磷酸盐缓冲液或甘露糖醇)将张度(tonicity)调整至与角膜上皮等渗的渗透压(225-430mosm/kg)。合适的防腐剂包括硫柳汞、例如苯基汞等有机汞化合物、苯扎氯铵、氯己定和苯甲醇。为了延长接触时间,可以添加增粘物质(增稠剂)例如纤维素衍生物(羟丙甲纤维素、甲基纤维素、羟丙基甲基纤维素)、透明质酸、邻苯二甲酸乙酸纤维素、聚乙二醇、聚乙烯醇或泊洛沙姆。可以包括润湿剂或表面活性剂例如苯扎氯铵、聚山梨醇酯20、聚山梨醇酯80、二辛基磺基琥珀酸钠。如果需要,一些氨基酸单独或与透明质酸钠组合可以有助于促进组织重建。合适的氨基酸为甘氨酸、亮氨酸、赖氨酸和脯氨酸(参见EP 1940381B1)。
在本发明的另一方面,公开了治疗冠状病毒感染的方法,其中将有效剂量的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明的组合物或根据本发明的组合给予有需要的患者或有感染冠状病毒的风险的健康人。
实施例
在所有实验中,5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐的溶液使用前述无水的I型5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐(由MetrioPharm提供)来制备。
实施例1:5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐抑制感染的Vero B4细胞中SARS-CoV-2的复制
为了研究5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐是否对病毒感染的传播有效果,进行了免疫印迹(WB)分析。将Vero B4细胞(美国国立卫生研究院,Bethesda,USA;Meyer等人(2015)Emerg Infect Dis 21:181-182)保持在含有10%(v/v)灭活的胎牛血清(FCS)、2mML-谷氨酰胺、100U/mL青霉素和100μg/mL链霉素的Dulbecco改良的Eagle培养基(DMEM)中。将Vero B4细胞的会合单层在不含FCS的DMEM中用现场分离物SARS-CoV-2PR-1(在推定的感染日期后六天和出现轻微的COVID-19症状后两天从61岁的患者中分离)的100倍稀释物感染一小时。然后将细胞用PBS(磷酸盐缓冲盐水)洗涤,提供以无细胞毒性的浓度(0.5μM、1μM、2μM)包含5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐的新鲜培养基。在整个实验过程中进行使用5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐的处理。感染后3天(dpi),收获含有病毒的细胞培养物上清液。通过20%(w/v)蔗糖垫(20,000×g、4℃、90min)从细胞培养物上清液中纯化病毒粒子。将细胞用PBS洗涤并且将团块溶解于SDS(十二烷基硫酸钠)样品缓冲液中,通过SDS-PAGE凝胶电泳分离,转移至硝酸纤维素膜上并且用3%牛血清白蛋白封闭,并且与适当的一抗温育。使用恢复期的SARS-CoV-2患者血清使SARS-CoV-2蛋白可视化。与辣根过氧化物酶偶联的抗人二抗获自Dianova(Hamburg,Germany)。借助电化学发光反应来实现可视化。
在本文中,在Vero B4细胞中显示SARS-Cov-2复制的抑制。5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐显示SARS-CoV-2核衣壳蛋白的明显减少。各凝胶带在图1A中示出。
使用分析程序进行SARS-CoV-2核衣壳的光密度评价。光密度评价允许免疫印迹中的信号强度的量化并且从而得出关于样品中某种蛋白的量的结论。该评价清楚地显示,在添加5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐之后,SARS-CoV-2蛋白的生成剂量依赖性地受到抑制(图1B)。使用具有Welch’s校正的非配对T检验来进行统计学分析;**p<0.01,*p<0.05。
实施例2:在有效浓度下,5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐在Vero B4细胞培养物中没有细胞毒性
为了解决5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐在上述体系中是否显示细胞毒性作用的问题,将未感染的Vero B4细胞用递增浓度的5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐(0.25mM、0.5mM、1mM、2mM、4mM)与免疫印迹研究平行地进行处理。用WST(水溶性四唑盐1)分析来评估毒性。在本文中,具有完整的线粒体琥珀酸-四唑脱氢酶体系的活细胞影响微红色四唑盐WST-1(4-[3-(4-碘苯基)-2-(4-硝基苯基)-2H-5-四唑鎓]-1,3-苯二磺酸盐)向暗红色甲臜的酶转化。该颜色变化可以在分光光度计中用光度法测量。因此,WST分析是用于测量物质对细胞代谢的毒性的非常灵敏的方法。将未处理的细胞的该值设定为100%。
可以看出,在3天的观察期间,5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐在Vero B4细胞中、在抗病毒有效浓度下不显示任何显著的毒性作用。
在图2中,相对于未处理的细胞,描绘了活细胞的百分比。将未处理的细胞的该值设定为100%。使用1μM十字孢碱(来自链霉菌星形孢菌素(Streptomyces staurosporeus)的吲哚并咔唑化合物,一种细胞凋亡诱导剂)作为阳性对照。使用具有Welch’s校正的非配对T检验来进行统计学分析;**p<0.01,*p<0.05。
因此,可以说5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐的抗病毒作用不是由于非特异性的细胞毒性作用。
附图
图1:A:分别用0.5mM、1mM和2mM 5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐处理3天后SARS-CoV-2核衣壳的免疫印迹条带,相对于溶媒和未处理的细胞。
B:分别用0.5mM、1mM和2mM 5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐处理3天后在免疫印迹条带中检测到的SARS-CoV-2核衣壳的光密度评价,相对于溶媒和未处理的细胞。显示检测到的病毒蛋白的百分比。将溶媒设定为100%。(平均值±SEM;n=3/组;各自一式两份;**p<0.01,*p<0.05)
图2:用不同浓度的5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐处理3天后WST分析中的细胞活力。显示活细胞的百分比。将未处理的细胞取作100%。使用十字孢碱(1μM)作为阳性对照。(平均值±SEM;n=3/组;各自一式两份)。
Claims (15)
1.5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一,其用于冠状病毒感染的预防或治疗。
2.根据权利要求1使用的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一,其中5-氨基-2,3-二氢-1,4-酞嗪二酮的药学上可接受的盐为5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐。
3.根据权利要求2使用的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一,其中5-氨基-2,3-二氢-1,4-酞嗪二酮钠盐作为结晶无水多晶型物I型、II型或III型中的一种来提供,其特征在于借助x射线粉末图确定的晶体学值如下:
对于I型:
d值:13.5;6.9;5.2;4.6;3.9;3.5;3.4;3.3;3.1;3.0和/或
2-θ值:6.5;12.7;16.9;19.3;22.8;25.8;26.6;27.2;28.7;30.3,
对于II型:
d值:12.9;7.9;7.1;6.5;5.3;4.0;3.7;3.6;3.3;3.2和/或
2-θ值:6.8;11.2;12.5;13.7;16.7;22.4;24.3;24.9;27.2;27.8,和
对于III型:
d值:13.131;7.987;7.186;6.566;6.512;5.372;3.994;3.662;3.406;3.288;3.283;3.222;3.215;3.127;2.889和/或
2-θ值:6.73;11.07;12.31;13.48;13.59;16.49;22.24;24.29;26.14;27.10;27.14;27.67;27.72;28.52;30.93。
4.根据权利要求1至3中任一项使用的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一,其中所述冠状病毒感染选自由SARS-CoV感染、MERS-CoV感染、SARS-CoV-2感染、HCoV-HKU1感染、HCoV-NL-63感染、HCoV-OC43感染和HCoV-229E感染组成的组。
5.一种药物组合物,其用于冠状病毒感染的预防或治疗,其中所述组合物包含5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、载体和至少一种药学上可接受的赋形剂。
6.5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一与至少一种活性剂的组合,所述活性剂选自包括以下的组:甾体和非甾体抗炎药,免疫调节剂,免疫抑制剂,抗感染药剂如抗生素、抗逆转录病毒药剂、抗病毒药剂、抗真菌药剂和抗原虫药剂,镇痛剂,抗凝血剂,抗血小板药物,支气管扩张剂,肺血管扩张剂,化痰剂,肺表面活性物质,抗氧化剂,ENaC活化剂,HMG-CoA还原酶抑制剂或AT1受体拮抗剂,所述组合用于冠状病毒感染的预防或治疗。
7.如权利要求1至3中任一项所限定的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、如权利要求5所限定的组合物、或者如权利要求6所限定的组合,其用于冠状病毒感染的预防或治疗,其中所述物质、组合物或组合以如下形式口服施用:片剂、软明胶胶囊剂、硬明胶胶囊剂、糖衣片剂、丸剂、散剂、颗粒剂、汁液、糖浆剂、滴剂、茶、在水性液体或非水性液体中的溶液剂或混悬剂、可食用泡沫、慕斯、水包油乳剂或油包水乳剂。
8.如权利要求1至3中任一项所限定的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、如权利要求5所限定的组合物、或者如权利要求6所限定的组合,其以用于吸入给药的制剂用于冠状病毒感染的预防或治疗。
9.如权利要求1至3中任一项所限定的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、如权利要求5所限定的组合物、或者如权利要求6所限定的组合,其用于根据权利要求8所述的制剂,其中所述吸入给药借助振动筛网雾化器来进行。
10.如权利要求1至3中任一项所限定的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、如权利要求5所限定的组合物、或者如权利要求6所限定的组合,其用于冠状病毒感染的预防或治疗,其中将所述物质、组合物或组合添加至心肺转流装置的通气空气中。
11.如权利要求1至3中任一项所限定的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、如权利要求5所限定的组合物、或者如权利要求6所限定的组合,其以用于舌下片的制剂用于冠状病毒感染的预防或治疗。
12.如权利要求1至3中任一项所限定的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、如权利要求5所限定的组合物、或者如权利要求6所限定的组合,其用于冠状病毒感染的预防或治疗,其中5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、根据本发明所述的组合物或根据本发明的组合的给药借助鼻喷雾剂、滴鼻剂或滴眼剂来进行。
13.如权利要求1至3中任一项所限定的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、如权利要求5所限定的组合物、或者如权利要求6所限定的组合,其以用于咽部给药的制剂用于冠状病毒感染的预防或治疗。
14.如权利要求1至3中任一项所限定的5-氨基-2,3-二氢-1,4-酞嗪二酮或其药学上可接受的盐中之一、如权利要求5所限定的组合物、或者如权利要求6所限定的组合,其以根据权利要求13所述的制剂用于冠状病毒感染的预防或治疗,其中所述咽部给药借助咽喉喷雾剂来进行。
15.一种治疗冠状病毒感染的方法,其中将有效剂量的如权利要求5所限定的药物组合物给予有需要的患者或有感染冠状病毒的风险的健康人。
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EP4164651A1 (en) | 2023-04-19 |
WO2021249667A1 (en) | 2021-12-16 |
MX2022015601A (es) | 2023-01-30 |
US20230218614A1 (en) | 2023-07-13 |
AU2021288757A1 (en) | 2023-02-02 |
IL298899A (en) | 2023-02-01 |
JP2023529022A (ja) | 2023-07-06 |
BR112022025134A2 (pt) | 2022-12-27 |
CA3182022A1 (en) | 2021-12-16 |
KR20230027150A (ko) | 2023-02-27 |
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