CN116940351A - 前药组合物和治疗方法 - Google Patents
前药组合物和治疗方法 Download PDFInfo
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- CN116940351A CN116940351A CN202280019510.6A CN202280019510A CN116940351A CN 116940351 A CN116940351 A CN 116940351A CN 202280019510 A CN202280019510 A CN 202280019510A CN 116940351 A CN116940351 A CN 116940351A
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- hydrochloride
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- epinephrine
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Abstract
通过吸入递送药物产品(可包括前药组合物)的系统和方法。
Description
优先权的要求
本申请要求2021年1月15日提交的美国临时专利申请号63/137,881的优先权,其通过引用整体并入。
技术领域
本发明涉及药物组合物和通过吸入进行治疗的方法。
背景技术
使用一种或多种前药以有意的方式可以将活性成分(如药物或药品)递送给患者。作为药物递送系统的一部分,活性成分也可以与组合物中的至少一种其他活性或药物组合递送给患者。在某些情况下,前药本身可能具有生物活性以及转换或转化为一种或多种额外的活性药物或活性成分的能力。
发明内容
前药设计是药物发现的重要组成部分,并且与母体药物相比可以提供许多优势,如增加的溶解度、增强的稳定性、改善的生物利用度、减少的副作用、定制药代动力学特征、改善的感官和更好的选择性。前药的选择和设计可能被药物递送部位、组织类型、渗透、酶转化、空间位阻和其他分子因素影响。
药品或药物经皮、穿过肺组织或经粘膜的递送可能需要前药、药物、活性或药物单独或与渗透促进剂组合和/或以其他方式以有效和高效的方式部分或完全穿过至少一个生物膜。
总的来说,在受试者(例如哺乳动物或人类受试者)中治疗医学病症的方法可以包括通过吸入施用包含前药的组合物,该前药穿过肺组织以在人类受试者中达到前药的药物活性形式的有效血浆浓度。
在另一种方面,吸入装置可以包括壳体和壳体内的组合物,该组合物包含前药。
在某些实施方案中,该方法可以包括在吸入器中提供该组合物。该组合物可以是液体或颗粒尺寸小于1微米的粉末。该组合物可以是液体或颗粒尺寸小于3微米的粉末。该组合物可以是液体或颗粒尺寸小于5微米的粉末。该组合物可以是液体或颗粒尺寸小于7微米的粉末。该组合物可以是液体或颗粒尺寸小于10微米的粉末。该组合物可以是液体或颗粒尺寸小于12微米的粉末。该组合物可以是液体或颗粒尺寸小于15微米的粉末。在某些实施方案中,吸入器可以包含推进剂。
在某些实施方案中,该方法可以包括在喷雾器中提供该组合物。
在某些实施方案中,该方法可以包括在气溶胶中提供该组合物。在某些实施方案中,在气溶胶中提供该组合物可以包括快速加热组合物以汽化或升华组合物。
在某些实施方案中,该组合物可以基本上由前药组成。
在某些实施方案中,该组合物可以基本上由前药和肾上腺素组成。
在某些实施方案中,该组合物可以基本上由肾上腺素和肾上腺素的前药组成。
在某些实施方案中,该组合物可以基本上由前药和第二前药组成。
在某些实施方案中,该前药是药物活性化合物的酯。
在某些实施方案中,该前药包括药物活性化合物的烷基酯。
在某些实施方案中,该前药包括药物活性化合物的丁基酯。
在某些实施方案中,该前药包括药物活性化合物的异丙基酯。
在某些实施方案中,该前药包括药物活性化合物的乙基酯。
在某些实施方案中,该前药包括肾上腺素的酯。
在某些实施方案中,该前药被转换为活性化合物。
在某些实施方案中,该医学病症在过敏症谱中。在某些实施方案中,该医疗病症是紧急的或急性的医疗病症。在某些实施方案中,该医疗病症是慢性的医疗病症。医学病症可以包括过敏反应。在某些实施方案中,该医学病症是心脏异常。在某些情况下,医学病症可以包括荨麻疹和肥大细胞障碍、压力性尿失禁。在某些实施方案中,该医学病症是肺部异常。
在某些实施方案中,包含前药的该组合物可以包括一种以上的前药,其中每种前药是药物活性成分的衍生物。包含前药的该组合物可以是不同前药的组合,其中每个前药是不同药物活性成分的衍生物。在这些实施方案中的一些中,前药中的一种可以是地匹福林。
在某些实施方案中,第一前药是肾上腺素的第一酯,第二前药是肾上腺素的第二酯,肾上腺素的第一酯和肾上腺素的第二酯在化学成分或组成中不同。
在某些实施方案中,壳体可以是基于泡罩(blister-based)的壳体。该组合物可以包含预装载剂量的在可吸入范围中的微粉化API。
在某些实施方案中,壳体可以包括胶囊,所述胶囊包含单位剂量的该组合物的粉末。
在某些实施方案中,该组合物可以包含前药和肾上腺素。
在某些实施方案中,该组合物可以包含肾上腺素和肾上腺素的前药。
在某些实施方案中,该组合物可以包含前药和第二前药。
通常,在哺乳动物中治疗医学病症的方法可以包括施用治疗有效量的包含前药和肾上腺素的组合物。
在某些实施方案中,在哺乳动物中治疗医学病症的方法可以包括施用治疗有效量的包含肾上腺素和肾上腺素前药的组合物。
在某些实施方案中,可以局部和全身递送该组合物。
通常,在哺乳动物中治疗医学病症的方法可以包括施用治疗有效量的包含前药和第二前药的组合物,并局部和全身递送该组合物。
在某些实施方案中,该前药是式(I)的化合物,其中
R1a,R1b,R2和R3中的每一个独立地可以是H、C1-C16酰基、烷基氨基羰基、烷基氧羰基、苯甲酰甲基、硫酸酯基或磷酸酯基,或R1a和R1b一起、R1a和R2一起、R1a和R3一起、R1b和R2一起、R1b和R3一起,或R2和R3一起形成包含二羰基、二硫酸酯基或二磷酸酯基部分的环结构,条件是R1a,R1b,R2和R3中的一个不是H,或其药学上可接受的盐。
在某些实施方案中,R2和R3是H,并且每个R1a和R1b独立地可以是乙酰基、正丙酰基、异丙酰基、正丁酰基、异丁酰基、仲丁酰基、叔丁酰基、正戊酰基、异戊酰基、仲戊酰基、叔戊酰基或新戊酰基。在一些实施方案中,R1a和R1b都可以是乙酰基、正丙酰基、异丙酰基、正丁酰基、异丁酰基、仲丁酰基、叔丁酰基、正戊酰基、异戊酰基、仲戊酰基、叔戊酰基或新戊酰基。在一些实施方案中,R1a和R1b之一可以是乙酰基、正丙酰基、异丙酰基、正丁酰基、异丁酰基、仲丁酰基、叔丁酰基、正戊酰基、异戊酰基、仲戊酰基、叔戊酰基或新戊酰基。
前药可以被结构化以确保其可变或可定制的代谢稳定性或保护,例如,从酶促切割直到达到所需的靶点,以减轻某些副作用和/或提高疗效。例如,酶促切割可以由内源性酶产生。例如,在某些情况下,可以将酶有意的添加到身体中以增强代谢。
在某些实施方案中,包含前药的该组合物以大于0.05mg、大于0.1mg、大于0.2mg、大于0.3mg、大于0.4mg、大于0.5mg、大于1.0mg、大于2.0mg、大于3.0mg、大于4.0mg、大于4.5mg、小于5.0mg、小于4.5mg、小于4.0mg、小于3.5mg、小于3.0mg、小于2.0mg和小于1.0mg的剂量施用。
在某些实施方案中,该组合物具有大于5mg/kg、大于10mg/kg、大于20mg/kg、大于25mg/kg、大于50mg/kg、大于100mg/kg、大于200mg/kg、大于250mg/kg、小于300mg/kg、小于250mg/kg、小于200mg/kg、小于150mg/kg、小于100mg/kg、小于50mg/kg、小于25mg/kg或小于20mg/kg的Cmax。
在某些实施方案中,前药的药物活性形式的有效血浆浓度具有大于0.5秒、大于1秒、大于5秒、大于10秒、大于20秒、大于30秒、小于40秒、小于30秒、小于20秒、小于10秒、小于5秒、和小于1秒的Tmax。
根据以下描述、附图和权利要求,其他的方面、实施方案和特征将是显而易见的。
附图简述
图1描述了吸入器。
图2A-2B描述了在BAL流体中的稳定性测试。
图3A-3U描述了体外渗透性测试和临床前药代动力学数据。
图4A-4B描述了AQEP-09前药和地匹福林与乳糖一水合物的色谱图。
图5和6描述了通过空气动力学颗粒尺寸仪测量的地匹福林的微粉化粉末的颗粒尺寸分布。
图7和8描述了通过空气动力学颗粒尺寸仪测量的二异丁酰基L-肾上腺素(AQEP-09)的微粉化粉末的颗粒尺寸分布。
发明详述
前药可以提供活性药物成分例如肾上腺素的增强递送。由于该组织具有高度血管化和可渗透性的事实,组织表面(例如肺组织)可以是药物递送到身体的途径,其提供了增加的生物利用度和快速开始作用,因为它不通过消化系统并因此避免了首过代谢。前药描述于国际专利申请公开号2021/087359A1中,其通过引用整体并入。
药物组合物可以被设计为以故意的和定制的方式通过吸入递送药物活性成分的前药。某些活性化合物(例如肾上腺素)的递送以某些独特的挑战为特征。该化合物是亲水性的、内源性的、高度可变的、需要快速递送、并促进血管收缩。因此,其递送的浓度和时间往往对处理至关重要并且不容易实现。递送肾上腺素的有效方法可以是用允许化合物穿透肺组织,特别是纤毛顶端表面、粘膜纤毛上皮和微孔膜的系统。
药物活性化合物可以最容易地通过吸入应用于肺组织。有许多用于药物吸入递送的装置,包括干粉吸入器、喷雾器、气雾器、雾化器和加压定量剂量吸入器。由该装置产生的气溶胶或药物汽化器可以含有赋形剂。在某些实施方案中,可以在不存在赋形剂时产生气溶胶的方法。适用于药物吸入的装置的实例可在美国专利号7766013、美国专利号9107832、美国专利号10004858、美国专利号9192675和美国专利公开号2008/0078382中找到,其每一个通过引用整体并入。
提供了将药物活性化合物递送到肺组织的方法和装置。该方法和装置可以将粉末、薄雾或气溶胶递送到人类受试者的肺部。粉末、薄雾或气溶胶可以具有期望的质量平均空气动力学直径(MMAD),即从分子到约10微米,其可以用于将生理活性化合物有效地递送到器官和组织,例如肺、眼睛、粘膜和皮肤。MMAD可以小于10微米、小于5微米、小于4微米、小于3微米、小于2微米、小于1微米、小于500纳米、小于250纳米、小于100纳米或小于50纳米。颗粒尺寸可以在5nm和100nm之间。例如,气溶胶可以通过化合物的汽化,同时将所得蒸汽与气体以当气体中的颗粒达到稳定浓度时形成所需的颗粒尺寸的比例混合而形成。通常,该方法和装置可以使药物活性化合物挥发,并将挥发的化合物以气溶胶的形式向患者施用。汽化的化合物的质量与混合气体的体积之比可以被调节以改变颗粒尺寸分布。
不限于特定方法,该方法可以包括通过快速加热组合物使化合物挥发或升华。例如,该组合物可以被涂覆或以其他方式沉积在基底上,作为厚度小于10微米的层。优选地,该层可以小于5微米、4微米、3微米、2微米、1微米、500纳米、250纳米、100纳米或50纳米。该层可以是不连续的并且厚度可变。在其他实施方案中,该层的厚度可以基本上是一致的。该基底可以在高速率加热以产生蒸汽。该组合物可以通过向箔基底施加交变磁场或电流以快速加热(通过焦耳加热或电阻加热)而汽化,该化合物在不超过约1秒的时间段内依次汽化。这种加热速率可以大于2,000℃/s、5,000℃/s、7,500℃/s或10,000℃/s。加热可以在小于0.1秒、小于0.2秒、小于0.5秒或小于0.8秒内发生。该基底可以是金属箔,例如铝、铂、钯或不锈钢。
该组合物可以通过任何可接受的方法沉积在基底上,包括但不限于将包含前药的材料喷涂、浸涂、旋涂或熔融涂到基底上。可以使用溶剂将组合物沉积在基底上。可以去除溶剂以在基底上提供干燥材料。
这种蒸汽可以通过载气扫入肺部。载气可以通过外部源(例如推进剂)提供,或者通过吸入或其组合提供。
各种实施方案的气溶胶通常通过在导热和不可渗透的基底上制备含有药物组分的组合物,并加热所述基质以汽化该组合物并冷却该蒸汽,从而产生包含所述药物组分的气溶胶颗粒来形成。层通常是可以作为药物释放平台被有效地使用的薄涂层。层所需的特征包括具有足够的药物负载能力、可接受的制剂稳定性,以及无毒、低或可容忍的毒性、生物相容性和可生物降解性。快速加热与气流相结合有助于减少分解量。因此,热源可以将基底加热到大于50℃、优选地至少100℃、优选地至少150℃、优选地至少200℃、优选地至少250℃、更优选地至少300℃或更优选地最少350℃的温度,以在2秒的时期内,优选地在1秒内,并且更优选在0.5秒内从基底产生基本上完全挥发的药物组分。汽化化合物上的气体流速在约4和50L/分钟之间可以将前药扫入肺部。
在某些情况下,0.25mg、0.5mg、0.75mg或1mg的组合物可以从加热开始在小于100毫秒内汽化。更优选地,相同量的上述组合物从加热开始在小于75毫秒、50毫秒、25毫秒或10毫秒内汽化。这种汽化可以在基底上产生1微米、2微米、3微米、4微米或5微米的颗粒。
吸入剂可以是气体中的一种物质(或多种物质)的溶液、液体悬浮液或固体颗粒。吸入剂可以大于药物重量的10%。优选地,吸入剂可以大于药物重量的20%。更优选地,吸入剂可以大于药物重量的30%、40%、50%、60%、70%、80%、90%、95%、97%、98%或99%。在某些情况下,吸入剂可以是药物重量的100%。
该吸入剂可以包含小于10重量%的药物分解产物。优选地,吸入剂可以包含小于5重量%的药物分解产物。更优选地,吸入剂可以包含小于3重量%、2重量%、1重量%、0.5重量%、0.25重量%或0.1重量%的药物分解产物。
汽化或升华的化合物颗粒尺寸可受前药化合物的密度和其他物理化学性质(例如,溶解度、表面活性、络合、离解常数、分配系数、异构)、化合物的极性和温度的影响。在某些情况下,该化合物可以是盐。化合物的亲水或疏水的性质可以影响最终的颗粒尺寸。前药可以在可升华的载体,例如醇或芳香族,如薄荷醇、百里酚、樟脑、叔丁醇、三氯叔丁醇、咪唑、香豆素、醋酸(冰)、二甲基砜、尿素、香草醛、莰烯、水杨酰胺或2-氨基吡啶中结合。
另一种合适的吸入器可以是干粉吸入器或DPI。该化合物可以在含有活性药物成分(API)的有或没有其他佐剂的干粉中配制,其可以碾磨到所需的颗粒范围。所需的颗粒范围会影响API的吸收和/或药效作用。可吸入范围是指空气动力学直径范围为0.5–5μm的颗粒。0.5–3μm范围内的颗粒适用于在包括肺泡的远端区域内的全身吸收,3–5μm用于终末细支气管的局部作用。优选地,干粉颗粒应当是单分散的并且在形状上是球形或接近球形的。赋形剂如乳糖(或其他附加的赋形剂)可用于增加细颗粒剂量和流动性。DPI可以设计成具有解聚集引擎,以将API从较粗的颗粒形式中解聚集。DPI可以主动/被动方式运行,利用设备或患者提供的能量使粉末解聚集。DPI依赖于设备中的湍流和患者的吸气流速。DPI可以根据其设计提供不同的气流阻力。低阻力要求患者更大的努力(在高流速下深吸气),而高颗粒速度可能会导致更高的喉咙沉积。高阻力只要极少的努力,但由于流量低,也会感觉更受约束。中等阻力是所期望的。
微粉化API可以是可吸入范围内的微粉化药物,空气动力学直径约为0.5–5μm。微粉化是减小固体材料颗粒直径以使API溶解的过程。微粉化的传统技术是基于摩擦来减小颗粒尺寸,通常通过研磨或磨碎颗粒来实现。微粉化药物及其载体(例如乳糖)通过用该装置的患者吸入而解聚集。颗粒也可以通过微粉化以外的过程制成。例如,通过非润湿平板颗粒复制(PRINT)技术可以产生完全相同尺寸和形状的均匀颗粒。
API可以包括本文该前药。在某些实例中,可以提供在10%API/乳糖混合物中的剂量。混合物可以包括乳糖或麦芽糖。研磨后,可以将该化合物与载体或赋形剂混合以赋予流动性。提供粉末的其他方法包括高压均化、喷雾干燥、在水-有机溶剂混合物中溶液的冷冻干燥以及无机溶剂溶液的冷冻干燥。佐剂的额外实例包括无机盐、富马酰二酮哌嗪、糖类、D-甘露醇、山梨醇、赤藓糖醇、D-棉子糖、葡萄糖、海藻糖、环糊精或硬脂酸镁。糖类可以是无水的或水合物。制剂(例如用于干粉吸入器(DPI))可以包括单个载体或载体的混合物。在一些制剂中,硬脂酸镁可以与载体如乳糖或麦芽糖一起用作颗粒稳定剂。可用于制剂中的其他赋形剂包括白蛋白和二棕榈酰磷脂酰胆碱(DPPC),其可用于增强雾化过程。
在某些情况下,剂量可以在0.1–5mg之间,例如0.3mg剂量、0.7mg剂量、0.25mg剂量和0.6mg剂量。剂量可以是4.8mg的目标剂量。剂量可以在基于泡罩中或在基于胶囊的装置中施用。该组合物可以包含在泡罩或胶囊中,其可以装载到吸入器的壳体中。在某些实例中,递送的剂量可以包括预先装载在基于泡罩或基于胶囊的装置中的原始剂量的70%。在某些实例中,可以提供10%API/乳糖混合物,使得在胶囊或基于泡罩的装置中预先填充4.8mg。
另一种合适的吸入器可以是雾化器,其从液体中产生气溶胶。例如,雾化器可以使液体射流或者通过具有或不具有喷嘴的液体的超声波振动破裂。射流雾化器可以通过毛细管作用抽吸液体,使得液体到达喷射流,被吸入喷射流,并被粉碎成小颗粒。超声波喷雾器可以利用电流产生声波,将液体分解成气溶胶。超声波雾化器可以包括将电能转换为压力能的陶瓷换能器(包括压电电子技术)。换能器在高达约1.5mHz的非常高的频率振动。振动能量通过液体传递,并集中在振动的柔性隔膜上。隔膜与待雾化的液体接触,并将溶液震动成颗粒,在高频产生细雾。超声波雾化器可以产生比射流雾化器更一致的颗粒尺寸,并且可以产生非常大体积的可吸入颗粒,其会更多地沉积到肺部。液体制剂可以在防腐或无菌条件下制备和储存,因为它们可能含有微生物。这可能需要使用防腐剂或单位剂量包装。此外,溶剂、洗涤剂和其他试剂可用于稳定药物制剂。
另一种合适的吸入器可以是加压定量剂量吸入器。这种吸入器可以在压力下用溶剂和推进剂混合物将化合物包装在罐中,通常是氯氟碳化合物(由于环境问题正在逐步淘汰的CFC's)或氢氟烷烃(HFA's)。在被分配后,混合物的射流通过阀门和喷嘴喷出,然后推进剂“气干”,留下化合物的气溶胶。这种类型的吸入器的一个挑战是一部分剂量的可变性,其可能是在致动器的壁上损失的,并且由于气雾剂从喷嘴的高速喷出,一些剂量可能会在舌头、嘴巴和喉咙上影响弹道,并且可能不会到达肺组织。
在某些情况下,该组合物的药物可以是肾上腺素或肾上腺素衍生物,例如肾上腺素的前药。
参照图1,吸入器10可以具有壳体20。壳体20包含组合物60。壳体20包括气体源40,其可以是允许空气流动的开口或包含载气的压缩气体。壳体20包括给药孔口50,汽化的、雾化的或粉末化的前药通过吸入从该给药孔口50递送。受试者可以从给药孔口50吸入材料。组合物60可以包含在载体30中。载体30可以是包含该组合物的泡罩或胶囊。
如上描述,载体30可以是包括沉积在基底上的前药的汽化单元,该基底被加热以快速汽化前药。在另一种实施方式中,载体30可以是雾化前药的液体储存器。在另一种实施方式中,载体30可以是包含前药的粉末源。
如上描述,组件30可以是包含沉积在基底上的前药的汽化单元,该基底被加热以快速汽化前药。在另一种实施方式中,组件30可以是雾化前药的液体储存器。在另一种实施方式中,组合物30可以是包含前药的粉末源。
该装置可以提供气流以将汽化的前药运送到受试者的肺中。从气源40流出的气体可以是空气或氧气。受试者可以通过吸入来诱导该流量。或者,可以从外部源提供流量。在另一种实施方案中,气体从气源40流出并且是加压载气,例如氦气或氟化烃。
给药孔口50可以直接插入受试者的口中用于吸入。在某些实施方案中,给药孔口50可以连接到覆盖受试者口腔的面罩。
本文所述的该前药可以加热到优选地在50℃至400℃范围内的温度,而不会发生显著的热降解。在某些实施方案中,前药可以经受快速加热。在某些实例中,前药可以加热到在约100℃至500℃范围内的温度,而不会发生显著的热降解。例如,前药可加热至约50℃、约75℃、约100℃、约125℃、约150℃、约200℃、约250℃、约300℃、约350℃、约400℃、约450℃或约500℃。前药的高热稳定性可以促进无载体药物制剂的雾化,而不会降低气溶胶的纯度,并且在不使用载体的情况下,可以形成基本上纯的气溶胶。这种方法可以产生固体气溶胶和液体气溶胶。
在给定剂量下,例如在1-10mg之间,含有API的粉末可以在使用或不使用赋形剂的情况下递送。在其他实例中,剂量可能在0.1-20mg之间。该API可以是肾上腺素、前药,例如肾上腺素前药、肾上腺素与肾上腺素前药的组合或不同肾上腺素前药组合。
该剂量可以通过API填充的胶囊递送。胶囊可以用包含API的粉末填充。粉末可以是仅包含API的微粉化粉末。例如,在其他实例中,粉末可以是微粉化的API和乳糖混合物。在其他制剂中,粉末可以是API的制剂(例如API的工程或喷雾干燥制剂)和赋形剂。
前药设计可以为肾上腺素并且实际上可以为其他活性药物成分的递送提供替代。前药可以表现出改善的疏水性、更好的渗透性、减少剂量和提高吸收速度。它还可以提供具有独特稳定性特征的替代组合物。例如,虽然肾上腺素通过焦亚硫酸氢钠稳定,但发现前药地匹福林在焦亚硫酸氢钠中不稳定。其他前药可能具有类似的稳定性和/或基于某些添加剂表现出的所需稳定性特征来设计。未在胃中被吸收的前药也可以避免、最小化或消除上腹部痛的副作用。此外,前药可导致肾上腺素能受体结合减少,导致血管收缩的可变性减少并且更稳定。肾上腺素前药可能需要在血液中转化,这可能导致在作为其转化率的函数的肾上腺素暴露的延迟,并且由于分子量通常高于活性药物成分的分子量,它还可能需要更高质量的药物负载(例如,如果前药是活性药物成分分子量的两倍,其可能需要两倍的药物负载)。
前药可以被代谢,例如通过水解。代谢可以通过酶转化(例如通过外源或内源性水解酶)而发生,其将前药转化为活性化合物。前药可以在不同的时间以不同的方式在体内转化。前药可以基于靶向方法,以任何合适的方式基于所需的转化的位置和时间设计。在某些例子中,前药转化可以局部发生,例如在肺部内。在某些例子中,前药转化可以全身发生(例如在循环中)。在某些情况中,前药转化发生在细胞(例如,抗病毒核苷类似物、降脂他汀类药物)。在某些情况中,前药转化可以在细胞外发生,例如在消化液或其他细胞外体液中)。在某些例子中,伴随施用能够将前药转化为活性母体的成分。前药可能含有水解抑制剂(在供应药物之前),以及在供应药物时含有加速剂。每种前药或部分水解产物都可能有自己的药理活性
在某些实施方案中,至少一半的施用的前药在小于240分钟内转化。在某些实施方案中,至少一半的施用的前药在小于120分钟内转化。在其他实施方案中,至少一半的施用的前药在小于60分钟内转化。在其他实施方案中,至少一半的施用的前药在小于30分钟内转化。在其他实施方案中,至少一半的施用的前药在小于15分钟内转化。在其他实施方案中,至少一半的施用的前药在小于10分钟内转化。在其他实施方案中,至少一半的施用的前药在小于5分钟内转化。在其他实施方案中,至少一半的施用的前药在小于1分钟内转化。在其他实施方案中,至少一半的施用的前药在小于30秒内转化。在其他实施方案中,至少一半的施用的前药在小于15秒内转化。在其他实施方案中,至少一半的施用的前药在小于10秒内转化。在其他实施方案中,至少一半的施用的前药在小于5秒内转化。
在某些实施方案中,前药可以被设计为在小于120分钟的时间内转化以产生浓度在5pg/ml至约40ng/ml之间的活性化合物。前药可以被设计为在小于60分钟的时间内转化以产生浓度在20pg/ml至约40ng/ml之间的活性化合物。前药可以被设计为在小于30分钟的时间内转化以产生浓度在20pg/ml至约40ng/ml之间的活性化合物。前药可以被设计为在小于15分钟的时间内转化以产生浓度在20pg/ml至约40ng/ml之间的活性化合物。前药可以被设计为在小于10分钟的时间内转化以产生浓度在20pg/ml至约40ng/ml之间的活性化合物。前药可以被设计为在小于5分钟的时间内转化以产生浓度在20pg/ml至约40ng/ml之间的活性化合物。前药可以被设计为在小于1分钟的时间内转化以产生浓度在20pg/ml至约40ng/ml之间的活性化合物。
本文已经探索并描述了用于递送活性药物化合物的其它前药。例如,前药可以是式(I)的化合物
或其药学上可接受的盐。
在式I中,R1a、R1b、R2和R3中的每一个独立地可以是H、C1-C16酰基、烷基氨基羰基、烷基氧羰基、苯甲酰甲基、硫酸酯基或磷酸酯基、或者R1a和R1b一起、R1a和R2一起、R1a和R3一起、R1b和R2一起、R1b和R3一起、或者R2和R3一起形成包含二羰基、二硫酸酯基或二磷酸酯基部分的环状结构,条件是R1a、R1b、R2和R3其中之一不是H或其药学上可接受的盐。在优选的情况下,R2和R3是H,并且每个R1a和R1b独立地可以是C1-C16酰基,例如,乙酰基、正丙酰基、异丙酰基、正丁酰基、异丁酰基、仲丁酰基、叔丁酰基、正戊酰基、异戊酰基、仲戊酰基、叔戊酰基或新戊酰基。在某些情况下,R1a和R1b的每一个是相同的并且不是H,但是R2和R3是H。在某些情况下,R1a和R1b都不是新戊酰基。
该化合物可以是游离碱形式。或者,式I的化合物可以是药学上可接受的盐。药学上可接受的盐可以是酸加成盐或碱加成盐。酸加成盐可以通过使其游离碱形式的纯化化合物与合适的有机或无机酸反应并分离由此形成的盐来制备。药学上可接受的酸加成盐的实例包括不限于与无机酸如盐酸、氢溴酸、磷酸、硫酸和高氯酸或与有机酸如醋酸、草酸、马来酸、酒石酸、柠檬酸、琥珀酸或丙二酸形成的氨基基团的盐。碱加成盐可以通过使其酸形式的纯化化合物与合适的有机或无机碱反应并分离由此形成的盐来制备。这些盐包括不限于碱金属(例如钠、锂和钾)、碱土金属(例如镁和钙)、铵、烷基铵、取代的烷基铵和N+(C1-4烷基)4盐。烷基可以是羟烷基。该化合物的其它药学上可接受的盐可以包括己二酸盐、藻酸盐、抗坏血酸盐、天冬氨酸盐、苯磺酸盐、苯甲酸盐、硫酸氢盐、硼酸盐、丁酸盐、樟脑酸盐、樟脑磺酸盐、柠檬酸盐、环戊丙酸盐、双葡萄糖酸盐、十二烷基硫酸盐、乙磺酸盐、甲酸盐、延胡索酸盐、葡庚糖酸盐、甘油磷酸盐、乙醇酸盐、葡萄糖酸盐、乙醇酸盐、半硫酸盐、庚酸盐、己酸盐、盐酸盐、氢溴酸盐、氢碘化物、2-羟基乙烷磺酸盐、乳糖醛酸盐、乳酸盐、月桂酸盐、十二烷基硫酸盐、苹果酸盐、马来酸盐、丙二酸盐、甲基磺酸盐、2-萘磺酸盐、烟酸盐、硝酸盐、油酸盐、草酸盐、十六烷酸盐、棕榈酸盐(palmoate)、果胶酸盐、过硫酸盐、3-苯基丙酸盐、磷酸盐、苦味酸盐、新戊酸盐、丙酸盐、水杨酸盐、硬脂酸盐、琥珀酸盐,硫酸盐、酒石酸盐、硫氰酸盐、对甲苯磺酸盐、十一酸盐和戊酸盐。
为了递送肾上腺素,一类可以对肾上腺素的R1a、R1b、R2和R3基团做出如下所示的修饰的前药化合物。R1a和R1b基团可以包括酯、酰胺、碳酸酯和氨基甲酸酯、原酸酯或缩醛。这些基团可以包括例如烷基酯、氯烷基酯、酰胺、烷基酰胺、氯烷基酰胺。R2基团可以包括苄基醇修饰。R3基团可以包括胺修饰或噁唑烷。理想的前药将会有一个或多个的以下特性,在生物学上可接受,穿透一层或多层膜,在体内、组织或血液中稳定并转化。在某些情况下,前药可能根本不需要任何渗透促进剂,而是通过自身充分渗透。基于R1a、R1b、R2和R3基团的链长,前药向活性物质的转化是不可预测的。特别地,在R1a、R1b、R2或R3基团的第二个原子上的叔基团。基于R1a、R1b、R2和R3基团,前药的渗透也是不可预测的。
活性药物成分的前药选择过程是通过首先合成具有各种取代基的前药,进行离体渗透研究,并随后使用生物流体(如人全血)进行体外水解试验来进行的。
合成
一般合成步骤用于合成肾上腺素前药,如下所示。
2的制备:
向(-)-肾上腺素(5g)在水(50ml)和THF(25ml)中的混合物中添加NaHCO3(4.6g,2当量),并在0-5℃搅拌5分钟,然后缓慢添加N-(苄氧基羰基氧基)琥珀酰亚胺(6.82g,1当量)在THF(25ml)中的溶液,并在RT搅拌12小时。在旋转蒸发仪中去除溶剂,沉淀的残余物用乙酸乙酯(100ml)萃取,用2N HCl(50ml)洗涤,随后用盐水(100mL),在无水硫酸钠上干燥并除去溶剂,得到化合物2(8.5g),其如稠棕色浆液。
制备酯3a-3f的一般步骤。
在0-5℃向化合物2(1当量)、三乙胺(3当量)在二氯甲烷(化合物2的30体积)中的溶液中逐滴添加相应的酰氯(1.8当量)。然后,将混合物逐渐温热至室温并搅拌12小时。将反应混合物用饱和NaHCO3溶液(化合物2的30体积)淬灭。分离有机相,用无水硫酸钠干燥,并浓缩至残留物,将其通过柱色谱法纯化,以分离出干净的3a-3f(~60%产率),其为油状物。使用更低当量的酰氯合成单取代肾上腺素前药(在上述方案中未显示)。
制备4a-4f的一般步骤。
将3a-3f在甲醇(~20体积)、草酸(1当量)、10%Pd/C(50%湿,占原料的20%重量)中的混合物在氢气气氛下(使用气球)搅拌12小时;使用TLC来确保反应的完成。催化剂通过硅藻土床过滤并且将滤液浓缩至干。将固体悬浮在甲基叔丁基醚(5体积)中,搅拌30分钟;过滤固体并干燥。将4a-4f分离为白色固体,并通过NMR和质谱确认。
双碳酸酯6的合成:
化合物5:
遵循与3a-3f相同的步骤。
化合物6:
遵循与4a-4f相同的步骤。
AQEP-09的替代合成路线
使用替代合成方法制备AQEP-09。在该方法中,肾上腺素与Boc酸酐在四氢呋喃和水的混合物中在室温反应,直到反应完成。将中间体N-Boc-肾上腺素用四氢呋喃和碳酸钾的水溶液稀释,并与异丁酸酐反应,直到两个酚羟基的乙酰化完成。然后将产物用MTBE萃取分离,随后蒸发。在用正庚烷稀释中间体后,使用在乙酸乙酯中的1M盐酸实现Boc脱保护。在乙酸乙酯中添加HCl后,反应混合物开始变得澄清。反应完成后,产物沉淀析出,将其收集并纯化。
下表提供了通过类似步骤合成的示例性前药。
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单酯AQEP-14和AQEP-15是两种区域异构体的混合物。
前药可以被设计为能够使其有效递送的任何颗粒尺寸。在一些实施方案中,前药具有不超过200微米的颗粒尺寸。在一些实施方案中,前药具有不超过300微米的颗粒尺寸,前药具有不超过400微米的颗粒尺寸。
前药可以以允许有效代谢或水解成活性化合物的方式设计。例如,在某些实施方案中,前药是前药的药物活性形式的酯。在某些实施方案中,前药包括前药的药物活性形式的烷基酯。在某些实施方案中,前药包括前药的药物活性形式的丁基酯。在某些实施方案中,前药包括前药的药物活性形式的异丙基酯。在某些实施方案中,前药包括前药的药物活性形式的乙酯。在某些实施方案中,前药包括前药的药物活性形式的酰胺。在某些实施方案中,前药包括前药的药物活性形式的碳酸酯。
药物组合物可以包括一种或多种药物活性成分。药物活性成分可以是单一的药物成分或药物成分的组合。药物活性成分可以是抗炎镇痛剂、甾体抗炎剂、抗组胺剂、局部麻醉剂、杀菌剂、消毒剂、血管收缩剂、止血剂、化学疗法药物、抗生素、角质软化剂、烧灼剂、抗病毒药物、抗风湿药、抗高血压药、支气管扩张剂、抗胆碱能剂、抗焦虑药物、止吐化合物、激素、肽、蛋白质或疫苗。药物活性成分可以是药物、前药、衍生物、药物复合物或药物的类似物的药学上可接受的盐。
术语“前药”是指可以在体内代谢以产生生物活性药物的生物无活性化合物,或者“前药“可以是除了其固有的生物活性外还可以代谢为另一种甚至优选的生物活性药物的生物活性化合物。在某些实施方案中,前药可以具有它自己的生物活性,其可以与活性药物相似或不同。例如,前药可以是肾上腺素的酯,例如被水解成肾上腺素的地匹福林。参见,例如J.Anderson,et al.,Site of ocular hydrolysis of a prodrug,dipivefrin,and acomparison of its ocular metabolism with that of the parent compounds,epinephrine,Invest.,Ophthalmol.Vis.Sci.July 1980,其通过引用整体并入。
在一些实施方案中,在组合物中可以包含一种以上的药物活性成分。药物活性成分可以是ace-抑制剂、抗心绞痛药物、抗心律失常药、抗哮喘药、抗胆固醇血症药、镇痛药、麻醉剂、抗惊厥药、抗抑郁药、抗糖尿病药剂、抗腹泻制剂、解毒剂、抗组胺药、抗高血压药物、抗炎药剂、抗脂质药剂、抗躁狂药、抗恶心药、抗中风药剂、抗甲状腺制剂、安非他命、抗肿瘤药物、抗病毒药剂、痤疮药物、生物碱、氨基酸制剂、止咳药、抗尿酸血症药物、抗病毒药物、合成代谢制剂、全身和非全身抗感染药剂、抗肿瘤药、抗帕金森病药剂、抗风湿药剂、食欲刺激剂、血液调节剂、骨代谢调节剂,心血管药剂、中枢神经系统刺激,胆碱酯酶抑制剂、避孕药、减充血剂、膳食补充剂、多巴胺受体激动剂、子宫内膜异位症治疗药剂、酶、勃起功能障碍疗法、生育药剂、胃肠道药剂、顺势疗法药品、激素、高钙血症和低钙血症治疗药剂、免疫调节剂、免疫抑制剂、偏头痛制剂、晕动病治疗,肌肉松弛剂、肥胖症治疗药剂、骨质疏松症制剂、催产剂、副交感神经阻滞药、拟副交感神经药、前列腺素、心理治疗药剂、呼吸系统药剂、镇静剂、戒烟辅助剂、交感神经阻滞药、震颤制剂、泌尿道药剂、血管舒张剂、泻药、抗酸剂、离子交换树脂、解热药、食欲抑制剂、祛痰剂,抗焦虑药剂、抗溃疡药剂、抗炎物质、冠状动脉扩张器、脑扩张器,外周血管扩张药、精神药品、兴奋剂、抗高血压药物、血管收缩剂、偏头痛治疗、抗生素、镇静剂、抗精神病药、抗肿瘤药物、抗凝血剂、抗血栓药物、催眠药、止吐药、抗恶心药、抗惊厥药、神经肌肉药物、高血糖和低血糖药剂、甲状腺和抗甲状腺制剂、利尿剂、抗痉挛药、子宫松弛剂、抗肥胖药物、红细胞生成药物、抗哮喘药、止咳药、化痰药、DNA和基因修饰药物、诊断药剂、显像药剂、染料或示踪剂及其组合。用于本文组合物的合适的活性物包括但不限于以下治疗类别:ace-抑制剂;肾上腺素能药剂;肾上腺皮质类固醇;肾上腺皮质抑制剂;醛固酮拮抗剂;生物碱;氨基酸;合成代谢;兴奋药(analeptic);止痛药;麻醉剂;食欲抑制剂;抗痘药剂;抗肾上腺素能;抗过敏;抗阿米巴;抗贫血;抗心绞痛;抗焦虑;抗关节炎药;抗心律失常;抗哮喘;抗动脉粥样硬化剂;抗胆固醇血症;抗菌;抗生素;抗胆碱能;抗凝剂;抗惊厥剂;抗抑郁药;抗糖尿病药;抗腹泻药;抗利尿剂;解毒药;止吐药;抗癫痫药;抗纤维蛋白溶解;抗真菌剂;抗出血药;抗组胺药;抗高血脂药;抗高血压药;抗低血压药;抗感染药(全身和非全身);抗炎;抗脂质;抗躁狂药;抗菌剂;抗偏头痛药;抗有丝分裂;抗真菌,止恶心药;抗肿瘤药;抗中性白细胞减少药;抗肥胖;抗寄生虫药;抗帕金森病;抗增殖;精神抑制药;解热;抗风湿药;抗皮脂溢药;抑制分泌;镇痉剂;抗中风;抗血栓药;抗甲状腺;抗肿瘤;止咳药;抗溃疡;抗尿酸血症药物;抗病毒;食欲抑制剂;食欲兴奋剂;生物反应调节剂;血糖调节器;血液调节剂;血液代谢调节剂;骨吸收抑制剂;支气管扩张剂;心血管药剂;中枢神经系统兴奋剂;脑扩张器;避孕药;冠状动脉扩张器;胆碱能;抑制咳嗽;解充血药;镇定剂;诊断用辅助药;膳食补充剂;利尿剂;多巴胺能药剂;酶;雌激素受体激动剂;子宫内膜异位症治疗药剂;祛痰药;勃起功能障碍疗法;红细胞生成;纤维蛋白溶解;生育药剂;荧光药剂;自由氧自由基清除剂;胃酸抑制剂;胃肠动力效应器;遗传修饰因子;糖皮质激素;毛发生长刺激剂;止血药;组胺H2受体拮抗剂;顺势疗法药品;激素;高钙血症治疗药剂;低钙血症治疗药剂;降胆固醇血症;降血糖;降血脂;降血压;离子交换树脂;显象药剂;免疫药剂;免疫调制剂;免疫调节剂;免疫刺激剂;免疫抑制剂;角质软化剂;泻药;LHRH激动剂;情绪调节器;晕动病制剂;化痰药;肌肉松弛剂;散瞳药;鼻腔减充血剂;神经肌肉阻滞药剂;神经保护;NMDA拮抗剂;非激素甾醇衍生物;骨质疏松症疗法;催产剂;副交感神经阻滞药;拟副交感神经药;纤溶酶原激活剂;血小板活化因子拮抗剂;血小板聚集抑制剂;前列腺素;心理治疗;精神药物;放射性药剂;呼吸药剂;灭疥癣药;硬化药剂;镇静剂;镇静催眠;选择性腺苷A1拮抗剂;血清素拮抗剂;血清素抑制剂;血清素受体拮抗剂;戒烟疗法;类固醇;兴奋剂;交感神经阻滞药;terine松弛剂;甲状腺激素;甲状腺抑制剂;拟甲状腺素药;镇静剂;震颤疗法;肌萎缩侧索硬化药剂;脑缺血药剂;佩吉特病药剂;不稳定型心绞痛药剂;血管收缩剂;血管舒张剂;体重治疗;创伤愈合药剂;黄嘌呤氧化酶抑制剂;以及它们的组合。
适合本文使用的活性物的实例包括抗酸药、H2拮抗剂和镇痛药。例如,抗酸药的剂量可以单独使用碳酸钙成分或与氢氧化镁和/或氢氧化铝组合来制备。此外,抗酸剂可以与H2拮抗剂组合使用。
镇痛药包括阿片类和阿片类衍生物,如氧可酮(可商购为);布洛芬(可商购为/>Motrin/>Motrin/>Advil/>Motrin/>Motrin/> Midol Cramp Motrin Migraine/> 和/>)、阿司匹林(可商购为/>Genuine/>和/>),对乙酰氨基酚(可商购为Silapap/>Silapap/> Tylenol/>TylenolExtra/>Tylenol Infants'/>Tylenol/>Tylenol/> 和/>)、及其组合(可任选地包括咖啡因)。在本发明中可使用其他减轻疼痛的药剂,包括盐酸哌替啶(可商购为/>)、辣椒素(可商购为/>)、硫酸吗啡和盐酸纳曲酮(可商购为/>)、盐酸氢吗啡酮(可商购为/>)、萘磺酸丙氧酚和对乙酰氨基酚(可商购为/>)、芬太尼(可商购为/>和/>)、透明质酸钠(可商购为/>)、阿达木单抗(可商购为/>)、琥珀酸舒马曲坦(可商购为)、芬太尼离子电渗剂(可商购为/>)、柠檬酸邻甲苯海拉明(可商购为)、水杨酸镁四水合物(可商购为/>),盐酸氧吗啡酮(可商购为Opana)、美索巴莫(可商购为/>)、卡立普多(可商购为/>)、盐酸曲马多(可商购为/>和/>)、硫酸吗啡(可商购为MS/>)、美他沙酮(可商购为)、盐酸氧可酮(可商购为/>)、对乙酰氨基酚/盐酸氧可酮(可商购为/>)、氧可酮/阿司匹林(可商购为/>)、酒石酸氢可酮/对乙酰氨基酚(可商购为/>)、酒石酸氢可酮/布洛芬(可商购为/>)、奈帕芬胺(可商购为/>)和普瑞巴林(可商购为/>)。
本文公开的组合物可以进一步包括例如NSAIDs的药剂,包括依托度酸(可商购为)、酮咯酸氨丁三醇(可商购为/>或/>)、萘普生钠(可商购为)、氟比洛芬(可商购为/>)、双氯芬酸钠/米索前列醇(可商购为/>)、塞来昔布(可商购为/>)、舒林酸(可商购为/>)、奥沙普秦(可商购为/>)、吡罗昔康(可商购为/>)、吲哚美辛(可商购为)、美洛昔康(可商购为/>)、甲芬那酸(可商购为/>)、托美丁钠(可商购为/>)、三水杨酸胆碱镁(可商购为/>)、双氯芬酸钠(可商购为)、双氯芬酸钾(可商购为/>或/>)和米索前列醇(可商购为)。阿片激动剂和拮抗剂(例如丁丙诺啡和纳洛酮)是用于本发明的药物的进一步实例。
用于本文的其它活性物的其它药物包括抗腹泻药物,例如洛哌丁胺(可商购为Imodium Health Care America/>Leader/>和/>)、硝唑尼特(可商购为/>)和盐酸地芬诺酯/硫酸阿托品(可商购为/>)、抗组胺药、止咳药、减充血剂、维生素和呼吸清新剂。单独或组合用于感冒、疼痛、发烧、咳嗽、充血、流鼻涕和过敏的常见药物(如对乙酰氨基酚、布洛芬、马来酸氯苯那敏、右美沙芬、右美沙芬HBr、盐酸苯肾上腺素、盐酸伪麻黄碱、苯海拉明及其组合,如右美沙芬HBr和盐酸苯肾上腺素(可作为获得))可包括在本发明的组合物中。
本文中有用的其他活性物包括但不限于,酒精依赖性治疗,如阿坎酸钙(可商购为);过敏治疗药物,如盐酸异丙嗪(可商购为/>)、苯磺酸贝他斯汀(可商购为/>)、氢可酮磺化二乙烯苯-乙烯苯共聚物(hydrocodone polistirex)/氯苯吡胺磺化二乙烯苯-乙烯苯共聚物(可商购为/>)、盐酸西替利嗪(可商购为)、盐酸西替利嗪/盐酸伪麻黄碱(可商购为/>)、盐酸异丙嗪/磷酸可待因(可商购为/>含可待因)、吡嘧司特(可商购为/>)、盐酸非索非那丁(可商购为/>)、盐酸美克洛嗪(可商购为/>)、盐酸氮卓斯汀(可商购为)、尼扎替丁(可商购为/>)、地洛他定(可商购为/>)、色甘酸钠(可商购为/>)、盐酸依匹斯汀(可商购为/>)、盐酸氮卓斯汀(可商购为)、泼尼松龙磷酸钠(可商购为Orapred/>)、盐酸奥洛他定(可商购为)、富马酸酮替芬(可商购为/>)和孟鲁司特钠(可商购为Singulair);以及抗组胺剂,如苯海拉明HCl(可商购为/>)、氯雷他定(可商购为/>)、阿司咪唑(可商购为/>)、萘丁美酮(可商购为/>)、苯海拉明HCL(可商购为)和氯马斯汀(可商购为/>)。/>
本公开的组合物可进一步包括阿尔茨海默病治疗药物,如盐酸他克林(可商购为)、加兰他敏(可商购为/>)、盐酸多奈哌齐(可商购为/>)、酒石酸卡巴拉汀(可商购为/>)、辛炔(可商购为/>)和美金刚(可商购为);贫血症药物,如氰钴维生素(可商购为/>)和菲立莫妥(ferumoxytol)(可商购为/>);麻醉药,如具有苯佐卡因的安替比林(可商购为和/>);心绞痛药物,如苯磺酸氨氯地平(可商购为/>)、硝酸甘油(可商购为/>)、单硝酸异山梨醇(可商购为/>)和二硝酸异山梨醇(可商购为/>);止咳药,如愈创木酚甘油醚(guaifensin);抗阿尔茨海默病剂,例如尼麦角林;以及CaH-拮抗剂,如硝苯地平(可商购为/>和/>)。
在本公开中有用的活性物还可包括抗哮喘药,如硫酸沙丁胺醇(可商购为)、异丙托溴铵(可商购为/>)、昔萘酸沙美特罗(salmeterolxinafoate)(可商购为/>)、扎鲁司特(可商购为/>)、氟尼缩松(可商购为/>)、硫酸奥西那林(可商购为/>)、沙丁胺醇吸入剂(可商购为)、硫酸特布他林(可商购为Brethine)、福莫特罗(可商购为/>)、色甘酸钠(可商购为/>)、盐酸左旋沙丁胺醇(可商购为/>)、齐留通(可商购为)、丙酸氟替卡松/沙美特罗(可商购为/>)、硫酸沙丁胺醇/曲安奈德(可商购为/>)、二甲黄嘌呤(可商购为/>)和倍氯米松(可商购为 );血管性水肿药物,如C1酯酶抑制剂(人)(可商购为/>)和艾卡拉肽(可商购为/>);以及抗菌药物,如甲氧苄啶/磺胺甲唑(可商购为/>)、莫匹罗星(可商购为/>)、甲硝唑(可商购为/>)、乙酰磺胺异恶唑(可商购为/>)、次水杨酸铋和甲硝唑/盐酸四环素(可商购为Helidac/>)、呋喃妥因(可商购为/>)、诺氟沙星(可商购为/>)、琥乙红霉素/乙酰磺胺异恶唑(可商购为/>)和左氧氟沙星(可商购为/>)。
本公开的组合物可进一步包含一种或多种抗生素,包括阿莫西林(可商购为)、氨苄西林(可商购为/>和/>)、阿莫西林/克拉维酸钾(可商购为/>)、盐酸莫西沙星(可商购为Avelox)、贝西沙星(可商购为/>)、克拉霉素(可商购为/>)、头孢布坦(可商购为/>)、头孢呋辛酯(可商购为/>)、头孢丙烯(可商购为/>)、盐酸环丙沙星(可商购为和/>)、克林霉素磷酸酯(可商购为Cleocin/>)、盐酸多西环素(可商购为)、地红霉素(可商购为/>)、红霉素(可商购为E.E.S./>/> 和/>)、局部用红霉素(可商购为 )、吉米沙星(可商购为/>)、氧氟沙星(市场上已知为/> )、泰利霉素(可商购为/>)、盐酸洛美沙星(可商购为)、盐酸米诺环素(可商购为/>)、磷霉素氨丁三醇(fosfomycintromethamine)(可商购为/>)、具钾青霉素(penicillin with potassium)(可商购为Penicillin/> )、甲氧苄啶(可商购为/>)、盐酸环丙沙星(可商购为Proquin/>)、利福平、异烟肼和吡嗪酰胺(可商购为/>)、头孢托仑(可商购为/>)、头孢克肟(可商购为/>)、四环素(可商购为Achromycin/>和)、妥布霉素(可商购为/>)、利福昔明(可商购为/>)、阿奇霉素(可商购为/>)、阿奇霉素混悬剂(可商购为/>)、利奈唑胺(可商购为)、过氧苯甲酰和克林霉素(可商购为/>)、红霉素和过氧苯甲酰(可商购为/>)、地塞米松(可商购为/>)、环丙沙星和地塞米松(可商购为)、硫酸多粘菌素B/硫酸新霉素/氢化可的松(可商购为/>)、硫酸粘杆菌素/硫酸新霉素/醋酸氢化可的松/通佐溴胺(可商购为Cortisporin-TC/>)、头孢氨苄盐酸盐(可商购为/>)、头孢地尼(可商购为/>)和加替沙星(可商购为)。
本文所包含的组合物也可用于治疗荨麻疹。荨麻疹是一种常见的皮肤病,其特征是瘙痒性风团和突发型皮肤反应——伴有或不伴有血管性水肿——通常持续小于24小时。慢性荨麻疹(CU)的定义是在6周或更长时间内每周至少发生两次的复发性发作。慢性荨麻疹可以被分类为两类:(1)慢性诱导性(CIndU),也称为物理性荨麻疹,其由特定的环境刺激或触发引起;或(2)慢性自发性荨麻疹(CSU),也称为慢性特发性荨麻疹,其诱因未知。目前,美国的CU患病率估计为总人口的0.5%至1%。尽管所有年龄组都可能受到影响,但荨麻疹的发病率高峰发生在20至40岁的年龄之间。该疾病的持续时间通常为1-5年,但在更严重的情况下可能会持续更长时间。在儿童(年龄<18岁)中,患病率从小于1%到几乎5%不等。
其他有用的活性物包括癌症治疗药物,包括环磷酰胺(可商购为)、甲氨蝶呤(可商购为/>和/>)、柠檬酸他莫昔芬(可商购为/>)、贝伐单抗(可商购为/>)、依维莫司(可商购为/>)、帕唑帕尼(可商购为)和阿那曲唑(可商购为/>);白血病治疗物,例如奥法木单抗(可商购为/>);抗血栓药,例如抗凝血酶重组冻干粉(可商购为/>)、普拉格雷(可商购为/>);抗凝剂,例如具持续释放双嘧达莫的阿司匹林(可商购为/>)、华法林钠(可商购为/>)、双嘧达莫(可商购为/>)、达肝素(可商购为)、达那肝素(可商购为/>)、依诺肝素(可商购为/>)、肝素(可商购为Hep-Lock、Hep-Pak、Hep-Pak CVC、Heparin Lock Flush)、亭扎肝素(可商购为/>)和硫酸氢氯吡格雷(可商购为/>);止吐药,例如盐酸格拉司琼(可商购为/>)和大麻隆(可商购为/>)、盐酸曲美苄胺(可商购为/>)和盐酸昂丹司琼(可商购为/>);抗真菌治疗物,例如酮康唑(可商购为/>)、泊沙康唑(可商购为/>)、环吡酮(可商购为/>)、灰黄霉素(可商购为/>)、硝酸奥昔康唑(可商购为/>)、氟康唑(可商购为/>)、硝酸舍他康唑(可商购为/>)、盐酸特比萘芬(可商购为/>)、环吡酮(可商购为/>)、制霉菌素/曲安奈德(可商购为/>)、硝酸益康唑(可商购为/>)、伊曲康唑(可商购为/>)和特康唑(可商购为/>)。
活性物还可能包括抗炎药,如硫酸羟氯喹(可商购为)、丙酸氟替卡松(可商购为/>)、康纳单抗(可商购为/>)安西奈德(可商购为/>)、甲基强的松龙(可商购为/>)、布地奈德(可商购为Entocort/>)、阿那白滞素(可商购为/>)、二醋酸双氟拉松(可商购为/>)和依那西普(可商购为);镇痉药物,如苯巴比妥/硫酸莨菪碱/硫酸阿托品/氢溴酸东莨菪碱(可商购为);抗病毒治疗物,如磷酸奥司他韦(可商购为/>);抗寄生虫药物,包括替硝唑(可商购为/>);食欲治疗药物,如醋酸甲地孕酮(可商购为Megace/>)、盐酸芬特明(可商购为/>)和盐酸二乙胺苯丙酮(可商购为/>);关节炎药物,包括来氟米特(可商购为/>)、赛妥珠单抗(可商购为/>)、双氯芬酸钠(可商购为/>)、戈利木单抗(可商购为/>)和托珠单抗(可商购为/>);膀胱控制药物,如曲司氯铵(可商购为/>)、醋酸去氨加压素(可商购为/>)、酒石酸托特罗定(可商购为/>)、氯化奥昔布宁(可商购为/>或/>)、达非那新(可商购为/>)和琥珀酸索非那新(可商购为/>);血管收缩药物,如马来酸甲麦角新碱(可商购为/>);血浆尿酸调节剂,如拉布立酶(可商购为/>);缺铁性贫血药物,如菲立莫妥(可商购为/>);淋巴瘤药物,如普拉曲沙(可商购为/>)、罗米地辛(可商购为/>);疟疾药物,如蒿甲醚/苯芴醇(可商购为/>);低钠血症药物,如托伐普坦(可商购为/>);用于治疗冯威利布兰德疾病(von Willebrand disease)的药物(可商购为/>);抗高血压药物,如曲前列环素(可商购为/>)、他达那非(可商购为/>);降胆固醇药物,包括帕立骨化醇(可商购为/>)、匹伐他汀(可商购为/>)、洛伐他汀、烟酸(可商购为)、盐酸考来替泊(可商购为/>)、瑞舒伐他汀钙(可商购为/>)、氟伐他汀钠(可商购为/>)、阿托伐他汀钙(可商购为/>)、洛伐他汀(可商购为/>)、烟酸(可商购为/>)、普伐他汀钠(可商购为/>)、具缓冲型阿司匹林的普伐他汀钠(可商购为Pravigard/>)、消胆胺(可商购为/>)、辛伐他汀和烟酸(可商购为/>)、阿替洛尔、氯噻酮(可商购为/>)、阿替洛尔(可商购为/>)、非诺贝特(可商购为/>)、非诺贝特(可商购为)、依泽替米贝/辛伐他汀(可商购为/>)、考来维仑(可商购为)、富马酸比索洛尔(可商购为/>)、依泽替米贝(可商购为/>)、富马酸比索洛尔/氢氯噻嗪(可商购为/>)和辛伐他汀(可商购为/>)。
本文所包括的活性物还可包括慢性肾脏疾病药物,如帕立骨化醇(可商购为);避孕药,包括依托孕烯(可商购为/>)、醋酸炔诺酮、乙炔雌二醇(可商购为Loestrin/>)、乙炔雌二醇、诺孕曲明(可商购为Ortho/>)、左炔诺孕酮(可商购为Plan/>)、左炔诺孕酮和乙炔雌二醇(可商购为/>)、左炔诺孕酮、乙炔雌二醇(可商购为/>)和醋酸甲羟孕酮(可商购为/>);COPD药物,如酒石酸阿福特罗(可商购为/>)和异丙托溴铵、硫酸沙丁胺醇(可商购为);咳嗽抑制剂,包括苯佐那酯(可商购为/>)、愈创甘油醚、磷酸可待因(可商购为Tussi-Organidin/>)以及对乙酰氨基酚、磷酸可待因(可商购为Tylenolwith/>);用于治疗糖尿病的药物,包括盐酸吡格列酮、盐酸二甲双胍(可商购为ACTOplus/>)、甲磺酸溴隐亭(可商购为/>)、利拉鲁肽(可商购为/>)、沙格列汀(可商购为/>)、盐酸吡格列酮(可商购为/>)、格列美脲(可商购为)、马来酸罗格列酮、盐酸二甲双胍(可商购为/>),马来酸罗格列酮(可商购为/>),马来酸罗格列酮(可商购为/>)、艾塞那肽(可商购为)、艾塞那肽(可作为/>商购)、氯磺丙脲(可商购为/>)、盐酸比格列酮、格列美脲(可商购为/>)、盐酸二甲双胍(可商购为/>)、格列吡嗪(可商购为/>)、格列本脲、二甲双胍(可商购为/>和)、盐酸二甲双弧(可商购为/>)、西他列汀(可商购为/>)、地特胰岛素(detemir)(可商购为/>)、格列吡嗪、盐酸二甲双胍(可商购为)、格列本脲(可商购为/>)、瑞格列奈(可商购为/>)、阿卡波糖(可商购为/>)、那格列奈(可商购为/>)、醋酸普兰林肽(可商购为),卡格列净(可作为/>商购),利拉利汀(可作为/>商购),达格列净(可作为/>商购),甘精胰岛素(可作为/>或/>商购),门冬胰岛素(可作为/>商购),赖脯胰岛素,恩格列净(可作为/>商购),和妥拉磺脲(可作为/>商购)。
其他有用的活性物可包括消化剂,如柳氮磺胺吡啶(可商购为)、雷贝拉唑钠(可商购为/>)、鲁比前列酮(可商购为/>)、盐酸双环胺(可商购为/>)、硫糖铝(可商购为/>)、乳果糖(可商购为/>)、多库酯(可商购为/>)、巴柳氮二钠(可商购为/>)、氯沙坦钾(可商购为/>)、奥沙拉嗪钠(可商购为/>)、盐酸氯氮克利溴铵(可商购为/>)、艾美拉唑镁(可商购为/>)、法莫替丁(可商购为/>)、兰索拉唑(可商购为/>)、兰索拉唑和萘普生(可商购为Prevacid/>)、阿莫西林/克拉霉素/兰索拉唑(可商购为/>)、奥美拉唑(可商购为/>)、泮托拉唑钠(可商购为/>)、盐酸甲氧氯普胺(可商购为/>或/>)、西咪替丁(可商购为/>)、盐酸雷尼替丁(可商购为/>)和奥美拉唑、碳酸氢钠(可商购为/>);利尿剂,包括螺内酯、氢氯噻嗪(可商购为/>)、螺内酯(可商购为/>)、布美他尼(可商购为/>)、托拉塞米(torsemide)(可商购为/>)、氯噻嗪(可商购为/>)、呋塞米(可商购为/>)、美托拉宗(可商购为/>)和氢氯噻嗪、氨苯蝶啶(可商购为/>)。
本文中有用的活性物还可包括治疗气肿,如噻托溴铵(可商购为);纤维肌痛药物,如盐酸米那普仑(可商购为/>);用于治疗痛风的药物,如秋水仙碱(可商购为/>)和非布索坦(可商购为/>);灌肠治疗物,包括氨基水杨酸(可商购为和/>);癫痫药物,包括丙戊酸(可商购为/>)、非尔氨酯(可商购为/>)、拉莫三嗪(可商购为/>)、普里米酮(可商购为)、奥卡西平(可商购为/>)、唑尼沙胺(可商购为/>)、左乙拉西坦(可商购为/>)和苯妥英钠(可商购为/>)。
本文中有用的活性物可进一步包括眼药物和治疗,如盐酸地匹福林(可商购为)、缬更昔洛韦(可商购为/>)、更昔洛韦眼用凝胶(可商购为/>);苯磺酸贝他斯汀(可商购为/>)、贝西沙星(可商购为/>)、溴芬酸(可商购为/>)、氟米龙(可商购为/>)、盐酸毛果芸香碱(可商购为/>)、环孢素(可商购为/>)、酒石酸溴莫尼定(可商购为Alphagan/>)、盐酸多佐胺/马来酸噻吗洛尔(可商购为/>)、比马前列素(可商购为/>)、马来酸噻吗洛尔(可商购为/>)、曲伏前列素(可商购为/>)、拉坦前列素(可商购为)、碘化二乙氧膦酰硫胆碱(可商购为Phospholine/>)和兰尼单抗(ranibizumab)(可商购为/>);流体控制剂,例如乙酰唑胺(可商购为/>);胆结石药物,包括熊去氧胆酸(ursodiol)(可商购为/>);用于治疗齿龈炎的药物,包括葡萄糖酸氯己定(可商购为/>);头痛药物,包括布他比妥/磷酸可待因/阿司匹林/咖啡因(可商购为Fiornal含可待因/>)、盐酸那拉曲坦(可商购为/>)、阿莫曲普坦(可商购为/>)、酒石酸麦角胺/咖啡因(可商购为/>)、布他比妥/对乙酰氨基酚/咖啡因(可商购为/>)、布他比妥/阿司匹林/咖啡因(可商购为/>)、琥珀酸夫罗曲坦(可商购为/>)、苯甲酸利扎曲坦(可商购为/>)、粘液酸异美汀/氯醛比林/对乙酰氨基酚(可商购为/>)、甲磺酸双氢麦角胺(可商购为)、氢溴酸依拉曲坦(可商购为/>)和佐米曲坦(可商购为/>);流感药物,如嗜血杆菌b缀合疫苗;破伤风类毒素缀合物(可商购为/>);和心脏治疗物,包括硫酸奎尼丁、二硝酸异山梨醇/盐酸肼苯哒嗪(可商购为/>)、地高辛(可商购为/>)、醋酸氟卡尼(可商购为/>)、盐酸美西律(可商购为/>)、磷酸丙吡胺(可商购为/>)、盐酸普鲁卡因胺(可商购为/>)和普罗帕酮(可商购为/>)。
其他有用的活性物包括肝炎治疗,包括恩替卡韦(可商购为)、乙肝免疫球蛋白(可商购为HepaGam/>)和利巴韦林(copegus/rebetol/ribasphere/vilona/virazole)(可商购为/>);疱疹治疗物,包括盐酸伐昔洛韦(可商购为/>)、喷昔洛韦(可商购为/>)、阿昔洛韦(可商购为/>)和泛昔洛韦(可商购为);用于高血压的治疗物,包括依那普利拉(可商购为/>)、卡托普利(可商购为/>)和赖诺普利(可商购为/>)、盐酸维拉帕米(可商购为/>)、雷米普利(可商购为/>)、奥美沙坦酯(可商购为/>)、氨氯地平/阿托伐他汀(可商购为/>)、盐酸尼卡地平(可商购为/>)、盐酸地尔硫(可商购为)、盐酸喹那普利(可商购为/>)、盐酸喹那普利/氢氯噻嗪(可商购为)、培哚普利(可商购为/>)、坎地沙坦酯(可商购为/>)、坎地沙坦酯/氢氯噻嗪(可商购为Atacand/>)、厄贝沙坦/氢氯噻嗪(可商购为/>)、厄贝沙坦(可商购为/>)、苯磺酸氨氯地平/奥美沙坦酯(可商购为/>)、盐酸左布诺洛尔(可商购为/>)盐酸倍他洛尔(可商购为/>)、奈必洛尔(可商购为)、卡托普利/氢氯噻嗪(可商购为/>)、甲磺酸多沙唑嗪(可商购为)、盐酸可乐定(可商购为/>)、卡维地洛(可商购为/>)、纳多洛尔(可商购为/>)、纳多洛尔/苄氟噻嗪(可商购为/>)、缬沙坦(可商购为)、伊拉地平(可商购为/>)、醋酸胍那苄(可商购为/>)、盐酸胍法辛(可商购为Tenex或/>)、氯沙坦钾/氢氯噻嗪(可商购为/>)、盐酸普萘洛尔(可商购为/>)、盐酸普萘洛尔/氢氯噻嗪(可商购为/>)、依普利酮(可商购为/>)、安倍生坦(可商购为/>)、马来酸依那普利/非洛地平(可商购为/>)、酒石酸美托洛尔(可商购为/>)、盐酸贝那普利(可商购为)、盐酸贝那普利/氢氯噻嗪(可商购为/>)、氨氯地平/盐酸贝那普利(可商购为/>)、吲达帕胺(可商购为/>)、群多普利(可商购为/>)、替米沙坦(可商购为/>)、替米沙坦/氢氯噻嗪(可商购为/>)、盐酸哌唑嗪(可商购为/>)、阿米洛利、氢氯噻嗪(可商购为/>)、福辛普利钠(可商购为/>)、福辛普利钠/氢氯噻嗪(可商购为/>)、吲哚洛尔(可商购为/>)、非洛地平(可商购为/>)、柠檬酸西地那非(可商购为/>)、尼索地平(可商购为/>)、群多普利/盐酸维拉帕米(可商购为/>)、阿利克仑(可商购为/>)、甲磺酸依普沙坦(可商购为/>)、甲磺酸依普沙坦/氢氯噻嗪(可商购为/>)、莫西普利盐酸盐/氢氯噻嗪(可商购为)、莫西普利盐酸盐(可商购为/>)、马来酸依那普利/氢氯噻嗪(可商购为/>)和赖诺普利/氢氯噻嗪(可商购为/>)。
本公开的组合物可包括在用于治疗HIV/AIDS的药物中有用的活性物,如安普那韦(可商购为)、替普那韦(可商购为/>)、依法韦仑/恩曲他滨/泰诺福韦(可商购为/>)、拉米夫定/齐多夫定(可商购为/>)、硫酸茚地那韦(可商购为/>)、拉米夫定(可商购为/>)、沙奎那韦(可商购为/>)、扎西他滨(可商购为/>)、洛匹那韦/利托那韦(可商购为/>)、福沙那韦钙(可商购为/>)、利托那韦(可商购为/>)、齐多夫定(可商购为/>)、硫酸阿扎那韦(可商购为/>)、依法韦仑(可商购为/>)、阿巴卡韦/拉米夫定/齐多夫定(可商购为/>)、地达诺新(可商购为/>)、甲磺酸奈非那韦(可商购为)、奈韦拉平(可商购为/>)、富马酸替诺福韦酯(可商购为/>)、司他夫定(可商购为/>)和硫酸阿巴卡韦(可商购为/>);同型半胱氨酸去除剂,包括无水甜菜碱(可商购为/>);药物,如胰岛素(可商购为 和/>);和HPV治疗物,例如人乳头瘤病毒疫苗(可商购为/>)或人乳头瘤病毒二价(可商购为/>);免疫抑制剂,包括环孢素(可商购为/>和/> )。
在本公开中有用的活性物可进一步包括催乳素抑制剂,如甲磺酸溴隐亭(可商购为);有助于压力测试的药物,例如瑞加德松(可商购为/>);秃顶药物,包括非那雄胺(可商购为/>和/>);胰腺炎治疗物,如吉非贝齐(可商购为);激素药物,如醋酸炔诺酮/乙炔雌二醇(可商购为/>)、醋酸戈舍瑞林(可商购为/>)、黄体酮凝胶(可商购为/>)、黄体酮(可商购为)、鲑鱼降钙素(可商购为/>)、骨化三醇(可商购为/>)、左甲状腺素钠(synthroid)(可商购为/>)、睾酮(可商购为/>和/>);绝经期药物,如雌二醇/醋酸炔诺酮(可商购为/>)、屈螺酮/雌二醇(可商购为/>)、雌二醇/左炔诺孕酮(可商购为/>)、雌二醇/醋酸炔诺酮(可商购为/>)、雌二醇(可商购为/>和/>)、酯化雌激素和甲睾酮(可商购为)、雌激素(可商购为/> )、雌酮硫酸酯哌嗪(可商购为)、缀合雌激素(可商购为/>)和醋酸甲羟孕酮(可商购为/>);月经药物,包括醋酸亮丙瑞林(可商购为/>)、凝血酸(可商购为/>)和醋酸炔诺酮(可商购为/>);以及肌肉松弛药,包括盐酸环苯扎林(可商购为)、替扎尼定(可商购为/>)和硫酸茛菪碱(可商购为/>)。
本文中有用的活性物还可包括骨质疏松症药物,包括伊班膦酸钠(可商购为)、利塞膦酸(可商购为/>)、盐酸雷洛昔芬(可商购为)和阿仑膦酸钠(可商购为/>);排卵增强剂,包括柠檬酸克罗米酚(可商购为/>);佩吉特病治疗物,如依替膦酸二钠(可商购为/>);胰酶缺乏症药物,如胰脂肪酶(可商购为/>或);用于治疗帕金森病的药物,如二盐酸普拉克索(可商购为/>)、盐酸罗匹尼罗(可商购为/>)、卡比多巴/左旋多巴(可商购为/>)、卡比多巴/左旋多巴/恩他卡朋(可商购为/>)、盐酸司来吉兰(可商购为/>)、雷沙吉兰(可商购为/>)、恩他卡朋(可商购为/>)和盐酸司来吉兰(可商购为);多发性硬化药物,如达伐吡啶(可商购为/>)和干扰素β-Ib(可商购为/>);前列腺药物,包括氟他胺(可商购为/>)、尼鲁米特(可商购为)、度他雄胺(可商购为/>)、盐酸坦索罗辛(可商购为/>)、盐酸特拉唑嗪(可商购为/>)和盐酸阿夫唑嗪(可商购为/>)。
本公开的组合物可进一步包括精神药物,包括阿普唑仑(可商购为)、氯氮平(可商购为/>)、氟哌啶醇(可商购为/>)、盐酸氟西汀(可商购为/>)、盐酸舍曲林(可商购为/>)、阿塞那平(可商购为)、伊潘立酮(可商购为/>)、盐酸帕罗西汀(可商购为/>)、阿立哌唑(可商购为/>)、胍法辛(可商购为/>)、苯丙胺和甲基苯丙胺(可商购为和/>)、盐酸氯米帕明(可商购为/>)、盐酸丁螺环酮(可商购为/>)、氢溴酸西酞普兰(可商购为/>)、盐酸度洛西汀(可商购为)、哌甲酯(可商购为/>)、双丙戊酸钠(丙戊酸)(可商购为/>)、硫酸右苯丙胺(可商购为/>)、盐酸文拉法辛(可商购为)、司来吉兰(可商购为/>)、卡马西平(可商购为/>)、碳酸锂(可商购为/>)、马来酸氟伏沙明/盐酸右哌甲酯(可商购为/>)、盐酸齐拉西酮(可商购为/>)、甲磺酸双氢麦角碱(可商购为/>)、草酸依他普仑(可商购为/>)、氯氮(可商购为/>)、盐酸吗茚酮(可商购为/>)、硫酸苯乙肼(可商购为/>)、替沃噻吨(可商购为/>)、盐酸地昔帕明(可商购为)、苯二氮类(例如可商购为/>的那些)、盐酸去甲替林(可商购为)、硫酸反苯环丙胺(可商购为/>)、丙氯拉嗪、米氮平(可商购为)、利培酮(可商购为/>)、富马酸喹硫平(可商购为/>)、盐酸多塞平(可商购为/>)盐酸托莫西汀(可商购为/>)、马来酸三甲丙咪嗪(可商购为/>)、奥氮平/盐酸氟西汀(可商购为/>)、盐酸丙咪嗪(可商购为/>)、盐酸普罗替林(可商购为/>)、盐酸丁氨苯丙酮(可商购为Wellbutrin/>和/>)和奥氮平(可商购为/>)。
本文中有用的活性物还可包括尿酸降低的治疗,包括别嘌醇(可商购为);癫痫(seizure)药物,包括加巴喷丁(可商购为/>)、乙苯妥英(可商购为/>)、氨己烯酸(可商购为/>)和托吡酯(可商购为/>);用于带状疱疹的治疗物,如带状疱疹活疫苗(可商购为/>);皮肤护理药物,包括卡西波曲(可商购为/>)、优特克单抗(可商购为/>)、特拉万星(可商购为)、异维A酸(可商购为/>)、氢化可的松/双碘喹啉(可商购为/>)、磺胺醋酰钠/硫(可商购为/>)、壬二酸(可商购为/>)、过氧苯甲酸(可商购为/>)、阿达帕林(可商购为/>)、氟尿嘧啶(可商购为)、吡美莫司(可商购为/>)、局部用红霉素(可商购为/> )、氢化可的松(可商购为/>)、甲硝唑(可商购为/>)、多西环素(可商购为/>)、维甲酸(可商购为和/>)、对甲氧酚/维甲酸(可商购为/>)、维生素A酸(可商购为)、卡泊三醇水合物/二丙酸倍他米松(可商购为/>)、他扎罗汀(可商购为/>)、醋酸氟轻松(可商购为/>)、地索奈德(可商购为/>)、硝酸咪康唑/氧化锌(可商购为/>)、酮康唑(可商购为/>)和依法珠单抗(可商购为/>)。
本文中有用的其他活性物可包括睡眠障碍药物,包括扎莱普隆(可商购为)、艾司佐匹克隆(可商购为/>)、酒石酸唑吡坦(可商购为/>Ambien/> )、劳拉西泮(可商购为/>)、盐酸氟西泮(可商购为)、三唑仑(可商购为/>)、氯硝西泮(可商购为/>)、巴比妥类,例如Phenobarbital)、莫达非尼(可商购为/>)、替马西泮(可商购为/>)、雷美替胺(可商购为/>)、氯酸钾(可商购为/>)、地西泮(可商购为)、夸西泮(可商购为/>)和艾司唑仑(可商购为/>);戒烟药物,例如瓦伦尼克林(可商购为/>)、烟碱如/>和盐酸丁氨苯丙酮(可商购为);和类固醇类,包括二丙酸阿氯米松(可商购为/>)、二丙酸倍他米松(可商购为/>)、糠酸莫美他松(可商购为/>)、氟替卡松(可商购为Flovent/>Flovent/>)、醋酸氟轻松(可商购为)、糠酸莫美他松一水合物(可商购为/>)、去羟米松(可商购为)、克霉唑/二丙酸倍他米松(可商购为/>)、醋酸泼尼松龙(可商购为Pred/> Budesonide/>Rhinocort/>)、泼尼松龙磷酸钠(可商购为/>)、地索奈德(可商购为/>)和丙酸卤倍他索(可商购为)。
本发明的组合物可进一步包括用于甲状腺疾病治疗的有用的活性物,如激素TC和TD(可商购为Armour);钾缺乏治疗,包括氯化钾(可商购为/>);甘油三酯调节剂,包括ω-3-酸乙酯(可商购为/>);泌尿系统药物,如盐酸非那吡啶(可商购为/>)和乌洛托品、亚甲基蓝/水杨酸苯酯/苯甲酸/硫酸阿托品/莨菪碱(可商购为/>);产前维生素(可商购为Advanced/> Prenate/>);体重控制药物,包括奥利司他(可商购为/>)和盐酸西布曲明(可商购为/>)。
本文中预期使用的常用H2拮抗剂包括西咪替丁、盐酸雷尼替丁、法莫替丁、尼扎替丁、乙溴替丁、咪芬替丁(mifentidine)、罗沙替丁、皮沙替丁(pisatidine)和哌芳替丁(aceroxatidine)。
本发明中使用的活性剂可以包括过敏原或抗原,例如但不限于来自草、树木或豚草的植物花粉;动物皮屑,其为猫或其他有毛动物皮肤和毛发脱落的微小的鳞屑(tinyscale);昆虫,例如屋尘螨、蜜蜂和黄蜂(wasp);以及药品,如青霉素。
具体的活性物的实例包括但不限于16-α氟雌二醇(16-alpha fluorocstradiol)、16-α-吉妥辛(16-alpha-gitoxin)、16-表雌三醇(16-epiestriol)、17α-二氢马萘雌酮(17alpha dihydroequilenin)、17α-雌二醇(17alpha estradiol)、17β-雌二醇(17betaestradiol)、17羟基孕酮(17hydroxy progesterone)、1α-羟基维生素D2(lalpha-hydroxyyitamin D2)、1-十二吡咯烷酮(1-dodecpyrrolidinone)、20-差向异构体-1,25二羟基维生素D3(20-epi-1,25dihydroxyvitamin D3)、22-骨化三醇(22-oxacalcitriol)、2CVV、2’-失碳-cGMP、3-异丁基GABA、5-乙炔基尿嘧啶、6-FUDCA、7-甲氧基他克林(7-methoxytacrine)、阿巴美丁(Abamectin)、阿巴诺喹(abanoquil)、阿贝卡尔(abecarnil)、阿比特龙(abiraterone)、阿鲁司特(Ablukast)、阿鲁司特钠(Ablukast Sodium)、阿卡地辛(Acadesine)、阿坎酸(acamprosate)、阿卡波糖(Acarbose)、醋丁洛尔(Acebutolol)、盐酸胺酰醋苯(Acecainide Hydrochloride)、醋克利定(Aceclidine)、醋氯芬酸(aceclofenae)、醋氨苯砜(Acedapsone)、醋谷胺铝(Aceglutamide Aluminum)、醋孟南(Acemannan)、醋氨酚、乙酰唑胺、乙酰苯磺酰环己脲(Acetohexamide)、醋羟胺酸(Acetohydroxamic Acid)、acetomepregenol、马来酸醋奋乃静(AcetophenazineMaleate)、磺胺苯砜钠(Acetosulfone Sodium)、氯化乙酰胆碱(AcetylcholineChloride)、乙酰半胱氨酸(Acetylcysteine)、乙酰基-L-肉碱、乙酰美沙醇、阿西呋喃(Acifran)、阿昔莫司(acipimox)、阿昔替酯(acitemate)、阿维A、阿西维辛(Acivicin)、阿柔比星(Aclarubicin)、乙乳胆铵(aclatonium)、盐酸阿考达唑(AcodazoleHydrochloride)、阿考烟肼(aconiazide)、吖啶琐辛(Acrisorcin)、阿伐斯汀(Acrivastine)、阿克罗宁(Acronine)、阿克索胺(Actisomide)、阿托地近(Actodigin)、阿昔洛韦(Acyclovir)、酰基富烯(acylfulvene)、金刚芬酯(Adafenoxate)、阿达帕林(Adapalene)、阿达帕林(Adapalene)、阿达色林(Adatanserin)、盐酸阿达色林(Adatanserin Hydrochloride)、腺环戊醇(adecypenol)、腺环戊醇(adecypenol)、阿德福韦(Adefovir)、阿地米屈(Adelmidrol)、腺苷蛋氨酸(Ademetionine)、腺苷(Adenosine)、阿地唑仑(Adinazolam)、盐酸阿地芬宁(Adipheinine Hydrochloride)、肥胖菌素(adiposin)、阿多来新(Adozelesin)、阿屈非尼(Adrafinil)、肾上腺酮(Adrenalone)、阿布他明(airbutamine)、阿拉普利(Alacepril)、阿来霉素(Alamecin)、丙氨酸、阿拉丙酯(Alaproclate)、阿莱肽(alaptide)、阿苯达唑(Albendazole)、白唇竹叶青素(albolabrin)、沙丁胺醇(Albuterol)、阿布妥因(Albutoin)、烯氯苯乙酸(Alclofenae)、阿氯米松二丙酸酯(Alclometasone Dipropionate)、铝克洛沙(Alcloxa)、aldecalmycin、阿地白介素(Aldesleukin)、尿囊素铝(Aldioxa)、阿仑膦酸钠(Alendronate Sodium)、阿仑磷酸(Alendronic Acid)、阿仑替莫(Alentemol)、阿仑替莫氢溴酸盐(AlentemolHydrobromide)、盐酸烯丙他明、烯丙苯乙胺氯化物(Aleuronium Chloride)、阿来西定、阿法骨化醇、盐酸阿芬太尼、阿夫唑嗪、丙缩阿尔孕酮、阿糖脑苷酶、阿列氟烷、阿利那斯汀(alinastine)、阿利帕胺、尿囊素、阿洛巴比妥(Allobarbital)、别嘌醇、ALL-TK拮抗剂、阿格列汀(Alogliptin)、阿洛米酮、阿洛司琼、盐酸阿洛司琼、阿洛夫定、阿尔哌汀、α淀粉酶、αidosone、阿吡坦、阿普唑仑、盐酸阿普洛尔、盐酸阿普诺辛(AlprenoximeHydrochloride)、前列地尔(Alprostadil)、阿司他丁钠、酒石酸阿坦色林、阿替普酶、阿尔噻嗪(Althiazide)、六甲蜜胺、阿托霉素B(altromycin B)、柠檬酸阿尔维林(AlverincCitrate)、阿韦舒托(Alvircept Sudotox)、醋酸阿马地酮、盐酸金刚烷胺、氨莫司汀、安波霉素(Ambomycin)、安布替星、安布茶碱(Ambuphylline)、安布赛特、安西法尔、安西奈德、氮脒青霉素(Amdinocillin)、氮苄脒青霉素双酯(Amdinocillin Pivoxil)、盐酸氨甲达林、阿洛米松、氨托利、安麦角、醋酸阿美蒽醌、甲硫阿美铵(ameziniummetilsulfate)、安非他酮(amfebutamone)、氨芬酸钠、氨氟替唑、阿米环素、甲磺酸阿米福林、磺胺异唑(amidox)、氨氟沙星、氨磷汀、阿米卡星、盐酸阿米洛利、盐酸氨吖啶、氨基苯甲酸钾、氨基苯甲酸钠、氨基己酸、氨鲁米特、氨基马尿酸钠(Aminohippurate Sodium)、氨基乙酰丙酸、氨茶碱、阿米雷司(Aminorex)、氨基水杨酸钠(Aminosalicylate sodium)、氨基水杨酸、胺碘酮、盐酸氨普立糖、盐酸氨喹新、氨磺必利、阿米曲士、盐酸阿米替林、氨来呫诺、氨氯地平、异戊巴比妥钠、阿莫地喹、盐酸阿莫地喹、阿莫罗芬、阿莫沙平、阿莫西林(Amoxicillin)、安非氯醛(Amphecloral)、硫酸安非他命、安福霉素、两性霉素B(Amphotericin B)、氨苄青霉素、安吡昔康、二甲胺嗪硫酸酯、氨喹酯、氨力农、氨力农、氨柔比星、安吖啶、胰淀素、淀硫霉素(amythiamicin)、醋酸阿那孕酮、阿那格雷、阿那白滞素、ananain、阿那立肽、阿那立肽醋酸酯、阿那曲唑、阿那佐林钠(Anazolene Sodium)、安克洛酶、穿心莲内酯、雄烯二酮、血管生成抑制剂、血管紧张素酰胺(Angiotensin Amide)、阿尼多昔、阿尼利定、盐酸阿尼洛泮、茴拉西坦、阿尼罗酸、辛托品甲基溴化物(AnisotropineMethylbromide)、阿尼普酶、阿尼扎芬、双炔失碳酯(anordrin)、拮抗剂D、拮抗剂G、安雷利克斯(antarelix)、磷酸安他唑啉、抗蠕霉素(Anthelmycin)、地蒽酚、安曲霉素、抗雄激素(antiandrogen)、二乙酰氨苯砜(Acedapsone)、非尔氨酯、抗雌激素(antiestrogen)、抗瘤酮(antineoplaston)、安替比林、反义寡核苷酸、阿帕多林(apadoline)、阿帕泛、阿帕西林钠、阿帕茶碱、阿扎丙宗(apazone)、阿非迪霉素甘氨酸(aphidicolin glycinate)、Apixifylline、盐酸阿扑吗啡、阿可乐定(apraclonidine)、盐酸阿可乐定(ApraclonidineHydrochloride)、安普霉素、阿普林定、盐酸阿普林定、阿普硫钠(aprosulate sodium)、抑肽酶(aprotinin)、马来酸阿普氮平、阿替加奈、无嘌呤酸(apurinic acid)、无嘌呤酸(apurinic acid)、阿雷地平、阿拉诺丁、阿巴前列素、阿贝卡星(arbekicin)、阿比朵尔(Arbidol)、盐酸阿布他明、阿氯非林(Arclofenin)、阿地肝素钠(Ardeparin Sodium)、阿加曲班、精氨酸、单宁酸精氨加压素、阿立酮、阿立哌唑(aripiprazol)、阿罗洛尔(arotinolol)、阿普西特(Arpinocid)、阿替夫林、富马酸阿替利特、阿西马朵林、aspalatone、门冬酰胺酶、天门冬氨酸(Asparic Acid)、门冬托星、asperfuran、阿司匹林、阿扑西林、曲林菌素(Asprelin)、阿司咪唑、硫酸阿司米星、asulacrine、阿他美坦、阿替洛尔、阿替韦啶、阿替美唑、阿替丙嗪马来酸盐、阿托利特、阿托伐他汀钙、阿托西班、阿托伐醌、抗癣青霉素B(atpenin B)、苯磺酸阿曲库铵(AtracuriumBesylate)、阿莫司汀、阿曲肌醇、阿托品、金诺芬、短梗霉素A(aureobasidin A)、金硫葡糖、阿维霉素、阿伏帕星、阿夫立定、尼扎替丁(Axid)、axinastatin1、axinastatin 2、axinastatin 3、阿扎苯胺、阿扎胞苷(Azacitidinie)、盐酸氮氯嗪、阿扎康唑、印楝素(azadirachtine)、阿扎兰司他二盐酸盐、富马酸阿扎克生、马来酸阿扎那托、阿扎硝唑、阿扎哌隆、阿扎立平、重氮丝氨酸、阿扎司琼、马来酸阿扎他定、硫唑嘌呤、硫唑嘌呤钠、阿扎毒素(azatoxin)、重氮酪氨酸(azatyrosine)、壬二酸、氮革斯汀(azelastine)、阿折地平、氮革吲哚(Azepindole)、阿扎替派、阿齐利特、阿奇霉素、阿洛西林、阿佐利明、阿佐寒米、阿佐霉素(Ambomycin)、氨曲南、阿珠莫林钠、盐酸巴氨西林(Bacampicillin Hydrochloride)、浆果赤霉素III(baccatinIII)、杆菌肽、巴氯芬、假马齿苋皂素A(bacoside A)、假马齿苋皂素B(bacoside B)、bactobolamine、balanol、巴拉齐朋、balhimycin、巴洛沙星、巴柳氮、班贝霉素(Bambermycins)、班布特罗、硫酸巴美生、盐酸巴米茶碱、班硝唑(Bamidazole)、宝藿苷1(baohuoside 1)、巴马斯汀、巴尼地平、巴西芬净、盐酸巴他必利、巴布司特、马来酸巴氮平、巴马司他、白僵菌素(beauvericin)、盐酸贝恩酮、贝卡普勒明、贝康唑、二丙酸倍氯米松(Beclomethasone Dipropionate)、贝氟沙通、苄丝肼(Beinserazide)、贝磷地尔、颠茄(Belladonna)、贝洛酰胺、贝美司琼、贝米曲啶、贝莫拉旦、盐酸贝那利秦、盐酸贝那普利、贝那普利(Benazeprilat)、甲磺酸苯达洛尔、苄达酸、苄氟噻嗪(Bendroflumethiazide)、苯芴醇、贝尼地平、贝诺睾酮、苯洛芬、苯洛芬、盐酸奥布卡因(BenoxinateHydrochloride)、苯哌利多、苯他西泮、苯替酪胺、贝奴司他、苯溴马隆、苄索氯铵(Benzethonium Chloride)、盐酸苄替米特、苯咯溴铵溴化物(Benzilonium Bromide)、盐酸苄吲吡林、苯异唑、苯佐卡因(Benzocaine)、苯并二氢卟酚(benzochlorins)、盐酸苯佐他明、苯佐替派、benzoidazoxan、苯佐那酯、过氧化苯甲酰、苯沙酸钙(Benzoylpas Calcium)、苯甲酰星形孢菌素(benzoylstaurosporine)、苯喹胺、苄噻嗪、苯扎托品、甲磺酸苯扎托品、盐酸苄达明、青霉噻唑酰多聚赖氨酸(Benzylpenicilloyl Polylysine)、苄普地尔、盐酸苄普地尔、贝拉克坦(Beractant)、贝前列素、贝瑞福林、柏拉非农、柏托沙米、B红霉素、贝西吡啶、β-alethine、亚阿克拉霉素(betaclamycin B)、倍他米松、倍他米隆、倍他洛尔、盐酸倍他洛尔、氯贝胆碱(Bethanechol Chloride)、硫酸苄二甲胍(Bethanidine Sulfate)、桦木酸、贝凡洛尔、盐酸贝凡洛尔、苯扎贝特、bFGF抑制剂、盐酸比拉米可、比阿培南、比卡鲁胺、盐酸比西发定、盐酸二氯地尔、比地索胺、二苯美伦、联苯苄唑、比卡林、bimithil、宾达利、比尼霉素、比螺酮、bioxalomycinα2、盐酸比培那醇、比哌立登、盐酸珍尼柳酯、比立哌隆、比生群、比沙雷米、bisaziridinylspermine、双-苯并咪唑A、双-苯并咪唑B、双奈法德、乳酸比索布啉、比索洛尔、硫酸镁双巯氧吡啶(Bispyrithione Magsulfex)、bistramide D、bistramide K、bistratene A、硫氯酚钠、比托特罗甲磺酸盐、比伐卢定、比折来新、硫酸博来霉素、勃雄二醇二丙酸盐、勃拉军酮、勃地酮十一碳烯酸、波尔定碱(boldine)、勃来诺、勃金刚酯、波吲洛尔、波生坦、波克昔定、布雷菲尔德菌素(brefeldin)、breflate、布喹那钠、溴他西尼、溴苄胺对甲苯磺酸(Bretylium Tosylate)、盐酸布芬太尼、溴莫尼定、纤维蛋白酶、溴克立新、溴克利那、溴伏克辛(Brofoxine)、马来酸溴朵林、溴西泮、溴氯唑酮、菠萝蛋白酶、溴芬酸、Brominidione、溴隐亭、盐酸溴苯海拉明、溴沙尼特(Bromoxamide)、溴哌利多、溴哌利多癸酸盐、马来酸溴苯那敏(Brompheniramine Maleate)、溴哌莫、溴匹立明、溴替唑仑、马来酸布卡尼盐、布新洛尔、盐酸布克力嗪、布色酮、布地奈德、布地品、布度钛、丁福明、布美他尼(Bumetamide)、布那司特、布那唑嗪、盐酸布诺洛尔、丁吡考胺、盐酸布比卡因、盐酸丁丙诺啡、盐酸安非他酮(Bupropion Hydrochloride)、布拉氨酯、醋酸布舍瑞林、盐酸丁螺环酮、白消安、仲丁巴比妥(Butabarbital)、布他西丁、盐酸布他拉莫、布他比妥、氨苯丁酯、柠檬酸布他米酯(Butamirate Citrate)、布他哌嗪、布他前列素、布替膦酸四钠(ButedronateTetrasodium)、布替萘芬、布替利嗪、丁硫氨酸亚砜亚胺(buthioninesulfoximine)、布替卡星、丁苯宁、硫酸布替罗星、布替西雷、丙酸布替可特、硝酸布康唑、布托酯、布托巴胺、盐酸布托丙茚、布托啡诺、盐酸布他沙明、盐酸布替林、放线菌素C(Cactinomycin)、卡地姆碘、咖啡因、胡桐素A、骨化二醇、卡泊三醇(Calcipotriene)、卡泊三醇、降钙素、骨化三醇、十一碳烯酸钙(Calcium Undecylenate)、钙感光蛋白(calphostinC)、卡普睾酮、坎苯达唑(Cambendazole)、卡莫格雷、喜树碱衍生物、坎格列净(canagliflozin)、金丝雀痘IL-2、坎地沙坦、杀念菌素、坎沙曲、坎沙曲拉(candoxatrilat)、卡格列波糖(Caniglibose)、坎利酸钾(Canrenoate Potassium)、坎利酮、卡培他滨、克冠酸钠(CapobenateSodium)、卡泊酸(Capobenic Acid)、硫酸卷曲霉素、卡罗单抗、辣椒素、卡托普利、卡普脲、卡醋胺、卡巴胆碱、卡巴多司、卡马西平、过氧化脲(Carbamide Peroxide)、十二烷基硫酸卡班太尔(Carbantel Lauryl Sulfate)、卡巴匹林钙(Carbaspirin Calcium)、卡巴折伦、咔唑霉素C(carbazomycin C)、羧苄青霉素钾、甘珀酸钠(Carbenoxolone Sodium)、卡贝替姆、卡贝缩宫素、卡比多巴、卡比多巴-左旋多巴、马来酸卡比沙明、盐酸卡比芬、卡波氯醛、羧甲半胱氨酸(Carbocysteine)、石炭酸品红、卡铂、卡前列素、卡巴韦(carbovir)、甲酰胺-氨基-叠氮基-le、羧酰胺基三唑、羧酰胺基三唑β-1,3-葡聚糖、盐酸卡布特罗、CaRest M3、柠檬酸卡芬太尼、卡立普多、卡金刚酸、卡莫司汀、CARN 700、卡硝唑(Camidazole)、卡罗沙酮、卡培立肽、马来酸卡奋乃静(CarphenazineMaleate)、卡洛芬、琥珀酸卡沙群、卡他唑酯(Cartazolate)、卡替洛尔、盐酸卡替洛尔、软骨衍生抑制剂(cartilage derivedinhibitor)、盐酸卡柔比星、卡芦莫南钠、卡维地洛、卡伏曲林、盐酸卡伏曲林、卡折来新、酪蛋白激酶抑制剂(casein kinase inhibitors)(ICOS)、栗树精胺(castanospermine)、卡芦莫南(caurumonam)、西巴西坦、天蚕素B、西地芬戈、头孢克洛、头孢羟氨苄、头孢孟多(Cefamandole)、头孢帕罗、头孢曲秦、头孢氮氟钠、头孢唑啉(Cefazolin)、头孢拉宗、头孢卡品酯(cefcapene pivoxil)、头孢达肟喷替特甲苯磺酸盐(cefdaloxime pentexiltosilate)、头孢地尼、头孢妥仑匹酯(cefditoren pivoxil)、头孢吡肟、头孢他美、头孢替考、头孢克肟、头孢瑞南、盐酸头孢甲肟(CefinenoximeHydrochloride)、头孢美唑(Cefinetazole)、头孢雷特(cefminlox)、头孢地嗪、头孢尼西钠、头孢哌酮钠、头孢雷特(Ceforamide)、头孢噻利、头孢噻肟钠、头孢替坦、头孢替安、头孢西丁、头孢唑兰、头孢咪唑、头孢匹胺、头孢匹罗、头孢泊肟酯、头孢丙烯、头孢沙定、头孢磺啶、头孢他啶、头孢特仑、头孢布烯、头孢唑肟钠、头孢曲松、头孢呋辛、雷公藤红素(celastrol)、celikalim、塞利洛尔、cepacidiine A、头孢乙腈钠、头孢氨苄(cephalexin)、头孢来星、头孢噻啶(Cephaloridine)、头孢噻吩钠、头孢匹林钠、头孢拉定(Cephradine)、西文氯胺、西立伐他汀、西罗普利、舍托肝素钠、蓝肽、西他苯钠、西他氯铵、盐酸塞他洛尔、西替地尔、西替利嗪、乙酰氯霉素、盐酸西曲酸酯、西曲瑞克、氯化十六烷基吡啶、鹅去氧胆酸、盐酸氯苯达诺、氯醛甜菜碱、苯丁酸氮芥、氯霉素、氯登妥因(Chlordantoin)、氯氮革(Chlordiazepoxide)、氯己定葡糖酸盐、二氢卟酚(chlorins)、醋酸氯地孕酮、氯东方菌素A(chloroorienticin A)、盐酸氯普鲁卡因、氯磺丙脲(Chloropropamide)、氯喹、氯喹磺酰胺(chloroquinoxalinesulfonamide)、氯噻嗪、氯烯雌醚、氯喔星(Chloroxine)、氯二甲酚、氯苯甘油氨酯、马来酸氯苯那敏(Chlorpheniramine Maleate)、氯丙嗪、氯磺丙脲、氯普噻吨、金霉素硫酸氢盐、氯噻酮(Chlorthalidone)、氯唑沙宗、消胆胺树脂、盐酸卡波罗孟、西苯唑啉、西卡前列素、盐酸环拉福林、氢苯嘧吲哚(Ciclazindol)、环索奈德、西氯他宁、环吡酮、环洛芬、环丙洛尔、西多福韦、盐酸西多塞平、西苯唑啉(Cifenline)、环格列酮、盐酸西拉多巴、西兰司琼、西司他丁钠、西拉普利、西尼地平、甲磺酸西洛巴明、西洛雷定、西洛芬净、西洛他唑、西马特罗、西眯替丁、西托溴铵(cimetropium bromide)、西那司特、盐酸辛那色林、马来酸桂哌酯、环桂氟胺、烯孕醇、西尼必利、桂美君、桂利嗪、西诺西泮、西诺沙星、桂哌林、桂溴胺、辛喷他宗、辛曲胺、塞奥罗奈、西潘茶碱、琥珀酸环丙法朵、环丙奈德、环丙贝特、环丙沙星、西前列烯、西拉马朵、西罗霉素、西沙必利、苯磺顺阿曲库胺(cisatracuriumbesilate)、顺康唑、顺铂、顺-卟啉、西替克新、西酞普兰、西替酰胺、胞磷胆碱、柠檬小单孢菌抗生素类α(citreamicinα)、克拉屈滨、盐酸氯胺羟喹(Clamoxyquin Hydrochloride)、克拉霉素、黄皮酰胺(clausenamide)、克拉维酸钾(Clavulanate Potassium)、克拉唑仑、氯佐利明(Clazolimine)、氯波必利、氯马斯汀、马来酸克仑硫卓(Clentiazem Maleate)、克利溴铵(Clidinium Bromide)、克林沙星、克林霉素、氯碘羟喹、氯碘沙尼(Clioxamide)、克利洛芬、氯巴占、丙酸氯倍他索、丁酸氯倍他松、醋酸氯可托龙、氯达洛能(Clodanolene)、盐酸氯达酮、氯膦酸(clodronic acid)、氯法齐明、氯贝丁酯、磷酸氯非铵(ClofiliumPhosphate)、醋酸氯孕酮、磷酸氯马克仑(Clomacran Phosphate)、醋酸氯美孕酮、氯甲孕酮、氯美噻唑、氯米芬(clomifene)类似物、氯氨雷司、克罗米酚、盐酸氯米帕明、氯硝西泮、可乐定、氯硝甘油、氯尼塞利、氯尼辛、氯帕胺、氯哌噻吨、盐酸氯哌喹酮(CloperidoneHydrochloride)、氯吡格雷、氯哌莫齐、甲磺酸氯哌帕生、氯吡酸、氯泼尼醇、氯前列醇钠、二钾氯氮革(Clorazepate Dipotassium)、氯乙双酯、氯索隆、盐酸氯哌隆、盐酸氯丙那林、氯舒隆、盐酸邻氯苯丁胺、氯氰碘柳胺、乙酰甘氨酸氯西拉敏(Closiramine Aceturate)、氯噻平、马来酸氯噻吨胺(Clothixamide Maleate)、丙酸氯硫卡松、克霉唑、苄星氯唑西林(CloxacillinBenzathine)、氯羟喹啉、氯氮平、可卡因、球孢菌素、可待因、可多克辛、秋水仙碱、考来替兰(colestimide)、盐酸考来替泊、考来酮、考福新、棕榈酸考福西利(ColfoscerilPalmitate)、黏菌素甲烷磺酸钠(Colistimethate Sodium)、硫酸黏杆菌素(ColistinSulfate)、collismycin A、collismycin B、甲磺酸可尔特罗、康普瑞汀A4(combretastatinA4)、康普瑞汀(combretastatin)类似物、补体结合抑制素(complestatin)、conagenin、盐酸考诺封(Conorphone Hydrochloride)、考替特罗(contignasterol)、蛇毒解聚素(contortrostatin)、醋酸三氟米松(CormethasoneAcetate)、可的瑞林绵羊Triflutate、促肾上腺皮质激素(Corticotropin)、醋酸可的松、可的伐唑、可托多松、cosalane、costatolide、替可克肽(Cosyntropin)、可替宁、香豆素(Coumadin)、库马霉素、crambescidin 816、克伐他汀、克立那托(crisnatol)、克罗米腈钠、色甘酸钠、克罗米通、念珠藻素8(cryptophycin 8)、cucumariosid、铜迈星、curacin A、硫酸可德兰(curdlansulfate)、curiosin、环青霉素(Cyclacillin)、环佐辛、cyclazosin、环HPMPC、胺氢咔唑(Cyclindole)、马来酸赛利拉敏、赛克力嗪、环苯达唑(Cyclobendazole)、环苯扎林、环丁基甲酸A、环丁基甲酸G、氨甲环酸(cyclocapron)、环氯胍双羟萘酸盐(CycloguanilPamoate)、环己酰亚胺、环戊蒽醌(cyclopentanthraquinones)、环戊噻嗪、盐酸环喷托酯、盐酸环丙奋乃静、环磷酰胺、环铂(cycloplatam)、环丙烷、环丝氨酸、地诺前列素(cyclosin)、环孢菌素(Cyclosporine)、环噻唑烷(cyclothialidine)、环噻嗪、环噻唑霉素(cyclothiazomycin)、环庚米特、赛普霉素(cypemycin)、盐酸苯环戊胺、环丙西泮、盐酸赛庚啶、盐酸环丙利多、环丙孕酮、环丙米特、半胱胺、盐酸半胱氨酸、胱氨酸、阿糖胞苷、盐酸阿糖胞苷、阿糖胞苷十八烷基磷酸盐(cytarabine ocfosfate)、细胞松弛素B(cytochalasin B)、溶细胞因子(cytolytic factor)、磷酸己烷雌酚(cytostatin)、达卡巴嗪、达昔单抗、达地米星(dactimicin)、放线菌素(Dactinomycin)、黄豆苷元、甲苯磺酸达来达林、达福普汀、达肝素钠、达曲班、达伐他汀、达那肝素(danaparoid)、达那唑、丹曲林、达格列净(dapagliflozin)、daphlnodorin A、达哌唑、达匹坦、盐酸达泊西汀、氨苯砜、达托霉素、达格列酮钠、达非那新、darlucin A、达罗地平、达西多明、盐酸柔红霉素、马来酸达才促醇(Dazadrol Maleate)、盐酸氮革尼尔(Dazepinil Hydrochloride)、达美格雷、富马酸达佐必利、盐酸达唑氧苯、硫酸异喹胍(Debrisoquin Sulfate)、地西他滨、去铁酮、地夫可特、去氢胆酸(Dehydrocholic Acid)、dehydrodidemnin B、脱氢表雄酮(Dehydroepiandrosterone)、地拉普利、盐酸地拉普利、甲磺酸地拉韦啶、地来夸明、地发哌嗪、醋酸地马孕酮、地莫匹醇、花翠素(delphinidin)、地美溴铵(Demecarium Bromide)、地美环素、去甲环素、地莫西泮、地奴真菌素(Denofungin)、脱氧吡啶诺林(deoxypyridinoline)、丙戊酸钠(Depakote)、地泼罗酮、地前列素、酯肽霉素(depsidomycin)、德伦环烷、硫酸皮肤素(dermatan sulfate)、地昔洛韦、地西龙缩丙酮、地氟烷、盐酸地昔帕明、地西卢定、去乙酰毛花苷、德舍瑞林、去氨加压素、去氧孕烯、地奈德、去羟米松、desoxoamiodarone、醋酸去氧皮质酮(Desoxycorticosterone Acetate)、地他铵重酒石酸盐(detajmium bitartrate)、盐酸地特诺、醋酸地肽瑞里、地伐西匹、地塞米松、右旋米唑、马来酸右溴苯那敏(Dexbrompheniramine Maleate)、马来酸右氯苯那敏、盐酸代克拉莫(Dexclamol Hydrochloride)、右苄替米特、盐酸右芬氟拉明(DexfenfluramineHydrochloride)、右异环磷酰胺、苯双咪唑(Deximafen)、地昔卡因、右酮洛芬、右氯谷胺、右美托咪定、右奥马铂、右奥沙屈盐酸盐、右泛醇、右培美酸、盐酸右普萘洛尔、右雷佐生、右索他洛尔、糊精2-硫酸盐、右旋安非他命(Dextroamphetamine)、右美沙芬、盐酸右啡烷、右甲状腺素钠、右维拉帕米、地扎胍宁、地秦胺、地佐辛、盐酸二醋洛尔、环己氨磺酸二胺卡因、硫米齐特(Diapamide)、泛影葡胺(Diatrizoate Meglumine)、泛影酸(Diatrizoic Acid)、二氨藜芦啶、地西泮、地吖醌、二氮嗪、盐酸二苯西平、二苯并噻吩、地布卡因、敌敌畏(Dichliorvos)、氯醛比林、双氯非那胺、地西利酮、双氯芬酸钠、双氯西林、dicranin、双香豆素(Dicumarol)、盐酸双环维林、去羟肌苷、膜海鞘素B(didemnin B)、迪多克斯(didox)、双烯雌酚(Dienestrol)、地诺孕素、柠檬酸乙胺嗪、diethylhomospermine、二乙基去甲精胺(diethylnorspermine)、盐酸安非拉酮、己烯雌酚(Diethylstilbestrol)、盐酸地芬腈酰胺(Difenoximide Hydrochloride)、地芬诺辛、醋酸双氟拉松(DiflorasoneDiacetate)、盐酸二氟沙星、盐酸二氟嗪(Difluanine Hydrochloride)、二氟可龙、二氟米酮钠、二氟尼柳、二氟泼尼酯、地弗他酮、洋地黄(Digitalis)、洋地黄毒苷、地高辛、盐酸双己维林、二羟西汀(dihVdrexidine)、二氢-5-氮杂胞苷、酒石酸二氢可待因(DihVdrocodeine Bitartrate)、二氢麦角胺甲磺酸盐、二氢睾酮(Dihydroestosterone)、硫酸二氢链霉素、双氢速甾醇、二氢紫杉醇、9-、狄兰汀(Dilantin)、盐酸地来洛尔、盐酸地尔硫卓、二甲法登、盐酸二甲弗林、茶苯海明、二巯丙醇、二甲双酮、马来酸二甲茚定、地美炔酮、二甲基前列腺素A1、二甲基亚砜、二甲基高精胺(dimethylhomospermine)、地来西坦、盐酸地莫沙明(DimoxamineHydrochloride)、地诺前列素、地诺前列酮、盐酸地奥沙屈、二霉素(dioxamycin)、柠檬酸苯海拉明、地芬尼多、盐酸地芬诺酯、二苯基螺莫司汀、盐酸地匹福林(DipivefinHydrochloride)、地匹福林(Dipivefrin)、dipliencyprone、地丙苯酮、dipropylnorspermine、双嘧达莫、双吡硫翁、安乃近、地红霉素、圆皮海绵内酯(discodermolide)、地索布胺、地索苯宁、丙吡胺、二沙利、双硫仑、地特吉仑(Ditekiren)、双丙戊酸钠(Divalproex Sodium)、马来酸地佐环平、多巴酚丁胺、多卡巴胺、多西苯醌、多西他赛、多康唑、二十二烷醇(docosanol)、多非利特、多拉司琼、依巴斯汀、依比拉肽、乙溴替丁、依布硒、依卡派特、依卡倍特、依卡曲尔、ecdisteron、echicetin、蛇毒锯鳞蝰素(echistatin)、依可碘酯(Echothiophate Iodide)、依氯那明马来酸盐、乙唑司特、依考莫司汀、益康唑、海鞘素722(ecteinascidin 722)、依达拉奉、依达曲沙、依地福新、醋酸依地福龙、埃巴单抗、依度尿苷、依决洛单抗、氯化腾喜龙(Edrophonium Chloride)、醋酸edroxyprogesteone、依非加群、依氟鸟氨酸、依福地平、egualcen、依兰群、依降钙素(eleatonin)、榄香烯(elemene)、依来曲普坦、依高地平、依利罗地、依沙芦星、eltenae、依鲁卡因、emalkalim、依美斯汀、盐酸依米丁、乙格列酯、甲苯磺酸依米铵(EmiliumTosylate)、乙嘧替氟、依莫白介素、恩格列净(empagliflozin)、盐酸依那朵林、依那普利、依那普利拉、依那吉仑、依那扎群、恩环丙酯、恩屈嗪甲磺酸盐、恩甲羟松(Endrysone)、恩氟烷、恩格列酮、恩康唑、依尼前列素、恩莫单抗、恩洛铂、乙诺司特、依诺利康钠、依诺沙星、依诺沙星、依诺肝素钠、依诺肝素钠、依诺昔酮、磷酸恩哌罗林、恩丙茶碱、恩普氨酯、恩他卡朋、肠抑肽(enterostatin)、恩韦拉登、恩韦肟、麻黄碱、依匹西林、表美雌醇、肾上腺素、环硼肾上腺素(Epinephryl Borate)、依匹哌啶、依匹唑、表柔比星、盐酸差向四环素(Epitetracycline Hydrochloride)、依匹噻嗪、阿法依泊汀(Epoetin Alfa)、倍他依泊汀(Epoetin Beta)、依前列醇、依前列醇钠、依普利酮(epoxymexrenone)、依立雄胺、依普罗沙坦、依斯的明、马萘雌酮(equilenin)、马烯雌酮(Equilin)、厄布洛唑、厄多司坦、甲磺酸双氢麦角碱(Ergoloid Mesylates)、马来酸麦角新碱、酒石酸麦角胺、艾生利特、厄索夫明、赤藓糖醇(erythritol)、赤癣四硝酸酯(Erythrityl Tetranitrate)、红霉素、盐酸艾司洛尔、盐酸依索比星、盐酸乙硫酰丙喹(Esproquin Hydrochloride)、艾司唑仑、雌二醇、雌莫司汀、雌莫司汀类似物、雌秦醇氢溴酸盐、雌三醇、雌呋酯、雌激素激动剂(estrogenagonists)、雌激素拮抗剂(estrogen antagonists)、雌激素(Estrogens)、缀合雌激素(Conjugated Estrogens)、酯化雌酮、雌酮硫酸酯哌嗪(Estropipate)、乙磺普隆、盐酸乙基麻黄碱、依他硝唑、依坦特罗、依他洛汀(Etarotene)、依他唑酯盐酸盐、依特比妥、乙沙西嗪(ethacizin)、依他尼酸钠、依他尼酸、盐酸乙胺丁醇、香草二乙胺、油酸氨基乙醇(Ethanolamine Oleate)、乙氯戊烯炔醇(Ethehlorvynol)、乙醚、乙炔雌二醇、乙碘油(Ethiodized Oil)、乙硫异烟胺、依托南硝酸盐、普罗吩胺盐酸盐(EthopropazineHydrochloride)、乙琥胺、乙苯妥英、依托沙秦盐酸盐(EthoxazeneHydrochloride)、乙苯托品(Ethybenztropine)、乙基氯、地布酸乙酯(Ethyl Dibunate)、乙雌烯醇、Ethyndiol、氯炔诺酮(Ethynerone)、双醋炔诺酮(Ethynodiol Diacetate)、依苯达唑、依替卡因、依替膦酸二钠(Etidronate Disodium)、依替膦酸(Etidronic Acid)、依替菲宁、依汀替丁盐酸盐、依替唑仑、依托度酸、依托芬那酯、依托福明盐酸盐、依托咪酯、依托孕烯、盐酸依托哌酮、依托泊苷、艾托卜宁(Etoprine)、盐酸乙苯啶盐、依托唑啉、依曲巴明、依曲替酯(Etretinate)、醋酸乙色胺、盐酸优卡托品(Eucatropine Hydrochloride)、丁香油酚、盐酸尤普罗辛、扁枝衣霉素(eveminomicin)、依沙美肟、艾沙瑞林、盐酸已丙洛尔、依西美坦、法倔唑、faeriefungin、泛昔洛韦、法莫替丁、氨吡啶、泛托法隆、盐酸泛曲酮、法罗培南、法西多曲、法舒地尔、法扎拉滨、非多托秦、非尔氨酯、联苯乙酸、非洛地平、苯赖加压素、非那拉胺、非那莫、芬苯达唑、芬布芬、芬西布醇、芬氯酸、芬克洛宁、苯克洛酸、芬度柳、芬雌酸、盐酸芬乙茶碱、盐酸芬氟拉明、酚加宾、非尼米特、非尼雷司、盐酸芬美托唑(FenmetozoleHydrochloride)、苯甲吗啉酮、非诺班、硫酸苯辛替明、非诺贝特、非诺多泮、非诺洛芬、非诺特罗、奋匹帕隆(Fenpipalone)、盐酸苯呤司特、芬前列林、芬喹唑、芬尼替尼(fenretinide)、芬司匹利、柠檬酸芬太尼、芬替酸、芬替克洛、芬替康唑、盐酸非尼啶醇、非普地醇、吡磷铁钠、铁利司坦(ferristene)、ferrixan、干燥硫酸亚铁、菲立磁(Ferumoxides)、非莫西尔(ferumoxsil)、盐酸非托西酯、非索非那定、富马酸非唑拉明(Fezolamine Fumarate)、非西他滨、非阿尿苷、纤维蛋白原1125、非格司亭、菲律宾菌素、非那雄胺、黄酮地洛马来酸盐、夫拉平度(flavopiridol)、盐酸黄酮哌酯、夫拉扎酮、氟卡尼、氟丁特罗、氟罗沙星、氟辛克生、硫酸氟司洛尔、氟乙西泮、氟卓斯汀(flezelastine)、氟罗布芬(flobufen)、夫洛非宁、氟氧头孢、氟地平、氟苯尼考、氟非宁、氟沙地尔、氟司喹南、氟氯西林、氟尿苷、氟拉睾酮(fluasterone)、氟扎可特、盐酸氟巴尼酯、氟苯达唑(Flubendazole)、氟西吲哚、氟氯奈德、氟康唑、氟胞嘧啶、氟氘丙氨酸、磷酸氟达拉滨、氟氯达唑(Fludazonium Chloride)、氟代脱氧葡糖F18、氟多雷司、醋酸氟氢可的松、氟灭酸(Flufenamic Acid)、氟苯柳、氟马西尼、氟美西诺、氟甲喹、氟美立酮、氟米松(Flumethasone)、氟美吗酮、氟甲氮平、氟氨雷司、芬氟咪唑、氟莫奈德、氟桂利嗪、氟硝唑、氟尼缩松、氟硝西泮、氟尼辛、氟骨化三醇(fluocalcitriol)、醋酸氟轻松(FluocinoloneAcetonide)、醋酸氟轻松(Fluocinolone)、氟考丁酯(Fluocortin Butyl)、氟可龙、荧光素、盐酸氟柔红霉素(fluorodaunorunicin hydrochloride)、氟多巴F18、氟米龙、氟尿嘧啶、盐酸氟曲辛、氟西汀、氟甲睾酮、氟洛克生、氟哌醇胺、醋酸氟培龙、氟非那嗪癸酸酯(Fluphenazine Decanoate)、氟吡汀(flupirtine)、氟泼尼龙、氟丙喹宗、氟前列醇钠、氟喹宗、盐酸氟朵林、氟氢缩松(Flurandrenolide)、盐酸氟西泮、氟比洛芬、氟瑞托芬、氟红霉素、氟西他滨、氟法胺、醋酸氟孕酮、六氟二乙酯(Flurothyl)、氟乙烯醚、氟司哌隆、氟司必林、丙酸氟替卡松、氟曲马唑、氟曲林、氟伐他汀、氟伐他汀钠、氟伏沙明、氟齐胺、叶酸、卵泡调节蛋白(Follicle regulatory protein)、卵泡抑素(Folliculostatin)、甲吡唑、二甲替嗪甲磺酸盐、福拉沙坦、福酚美克、forfenirmex、福美坦、福莫可他、福莫特罗、磷利酯、膦西泮、膦甲酸钠、磷霉素、膦乙醇钠、福辛普利、福辛普利拉(Fosinoprilat)、磷苯妥英(fosphenyloin)、磷喹酮、福司地尔、福司曲星、福莫司汀、碱性品红、呋莫西林、培里霉素(Fungimycin)、呋喃洛芬、呋喃唑酮、呋唑氯铵(Furazolium Chloride)、呋格雷酸钠、呋罗布芬、呋罗达唑、呋塞米、夫西地酸钠、夫西地酸、加巴喷丁、钆贝葡胺(GadobenateDimeglumine)、钆贝酸(gadobenic acid)、钆布醇、钆双胺、钆特沙弗林、钆喷酸葡胺、钆特酸(gadoteric acid)、钆特醇、钆弗塞胺、加兰他敏、加丹司琼、盐酸加丹司琼、三碘季胺酚(Gallamine Triethiodide)、硝酸镓、戈洛帕米、加洛他滨、更非辛、gamolenicacid、更昔洛韦、加尼瑞克、白明胶酶抑制剂、四甲癸二醇(Gemcadiol)、吉西他滨、吉美前列素、吉非贝齐、硫酸庆大霉素、龙胆紫(Gentian Violet)、吉哌隆、孕氯酮、孕二烯酮、孕诺酮己酸酯、孕三烯酮、盐酸吉伏曲林、吉立索泮、格拉莫德(glaspimod)、蓝萼甲素(glaucocalyxin A)、格来色林、格列胺脲、格列波脲、格列他尼钠、格列氟胺、格列美脲、格列吡嗪、格洛莫南、胰高血糖素、glutapyrone、谷胱甘肽抑制剂、格鲁米特、格列本脲、glycopine、glycopril、格隆溴铵(Glycopyrrolate)、格列己脲、格列嘧啶钠、格列辛脲、格列帕脲、金Au 198、Gonadoctrinins、戈那瑞林、促性腺激素(Gonadotropins)、戈舍瑞林、短杆菌肽、格拉司琼、格帕沙星、灰黄霉素、哌苯四醚、愈甘醚茶碱(Guaithylline)、胍那苄、醋酸胍那苄、硫酸胍那决尔、胍西定、胍乙啶单硫酸盐、盐酸胍法辛、硫酸胍尼索喹、硫酸胍氯酚、盐酸胍诺克汀、胍诺沙苄、硫酸胍生、硫酸胍诺西芬、胍立莫司三盐酸化物、哈拉西泮、哈西奈德、软海绵素B(halichondrin B)、丙酸卤倍他索(Halobetasol Propionate)、卤泛群、盐酸卤泛群、卤芬酯、卤夫酮氢溴酸盐、海乐萌(halomon)、卤培米特、氟哌啶醇、卤泼尼松、卤孕酮、卤普罗近、氟烷、哈喹诺、哈霉素、Han memopausal促性腺激素、鸠麻霉素(hatomamicin)、hatomarubigin A、hatomarubigin B、hatomarubigin C、hatomarubiginD、肝素钠、hepsulfam、调蛋白(heregulin)、海他西林、海特溴铵(Heteronium Bromide)、六氯酚、过氧化氢、己芴溴铵(Hexafluorenium Bromide)、六亚甲基二乙酰胺、海克西定、海索苯定、硫酸海索那林、己雷琐辛、磷酸组胺、组氨酸、组织胞浆菌素、组氨瑞林、氢溴酸后马托品(Homatropine Hydrobromide)、盐酸胡喹嗪、人绒毛膜促性腺激素(Humanchorionicgonadotropin)、海恩酮、盐酸肼屈嗪、肼苯哒嗪乙烯苯共聚物(HydralazinePolistirex)、氢氯噻嗪、氢可酮酒石酸氢盐、氢化可的松、氢氟甲噻嗪、盐酸氢吗啡酮、氢溴酸羟苯丙胺、硫酸羟基氯喹、奥芬氨酯(Hydroxyphenamate)、己酸羟孕酮(HydroxyprogesteroneCaproate)、羟基脲(Hydroxyurca)、盐酸羟嗪、羟甲香豆素、莨菪碱、金丝桃素(hypericin)、依巴沙星、伊班膦酸(ibandronic acid)、伊博格碱、异波帕胺、异丁司特、异丁芬酸、布洛芬、富马酸伊布利特、醋酸艾替班特、鱼石脂、亚可替定(Icotidine)、伊达比星、艾多昔芬、碘苷、伊决孟酮、Iemefloxacin、Iesopitron、伊非曲班、异环磷酰胺、Ilepeimide、illimaquinone、伊莫福新、伊洛马司他、伊洛达普、伊潘立酮、伊洛前列素、盐酸伊马芬(Imafen Hydrochloride)、盐酸伊马唑旦、咪达普利、米达西尼(imidazenil)、咪唑并吖啶酮(imidazoacridones)、咪癸碘(Imidecyl Iodine)、盐酸咪多卡、盐酸咪多林、咪脲(Imidurea)、盐酸咪洛克生、亚胺培南、盐酸丙咪嗪、咪喹莫特、免疫促进剂多肽、盐酸英普咪定、茚达立酮、吲达帕胺、盐酸英地卡尼、盐酸茚洛秦、靛胭脂、茚地那韦、吲哚氰绿(Indocyanine Green)、盐酸吲哚普利、吲哚利旦、吲哚美辛、吲哚美辛钠、吲哚洛芬、吲哚拉明、吲哚瑞酯盐酸盐、吲哚克索、盐酸茚屈林、伊诺特隆、伊诺加群、伊诺莫单抗、烟酸肌醇酯(Inositol Niacinate)、胰岛素、干扰素、白介素、吲四唑、盐酸英曲替林、碘苄胍、碘苯扎酸(Iobenzamic Acid)、碘比醇、碘卡酸葡甲胺(Iocarmate Meglumine)、碘卡酸(IocarmicAcid)、碘西他酸(Iocetamic Acid)、碘达胺、碘、胆影酸葡甲胺、碘克沙醇、iodoamiloride、碘安替比林I131(Iodoantipyrine I 131)、碘胆甾醇I 131、碘多柔比星、碘马尿酸钠I131、碘奥酮I 125、双碘喹啉、碘沙酸葡甲胺、Iodoxamie Acid、碘格利酸(Ioglicic Acid)、碘非他胺盐酸盐I 123、碘拉醇、碘葡醇、碘葡胺、碘甘卡酸(IoglycamicAcid)、Iogulamide、碘海醇、碘美普尔、Iomethin I 125、碘帕醇、碘泛酸(Iopanoic Acid)、碘喷托、碘苯酯、碘普西酸(Ioprocemic Acid)、碘普胺、碘普罗酸(Iopronic Acid)、碘吡多、碘吡酮、iopyrol、碘西法酸(Iosefamic Acid)、碘丝酸(Ioseric Acid)、碘磺拉胺葡甲胺、碘琥酸(Iosumetic Acid)、碘酞硫、碘替酸(Iotetric Acid)、碘酞酸钠、碘他拉酸(Iothalamic Acid)、碘赛特、碘曲仑、碘曲西酸(Iotroxic Acid)、Iotyrosine I 131、碘佛醇、碘克酸钠(Ioxagiate Sodium)、碘克酸葡甲胺(Ioxaglate Meglumine)、碘克沙酸(Ioxaglic Acid)、碘昔兰、羟泛影酸(Ioxotrizoic Acid)、依帕利特、伊培沙宗、伊匹达克林、碘泊酸钙(Ipodate Calcium)、甘薯苦醇(ipomeanol)、4-、异丙托溴铵(IpratropiumBromide)、依普黄酮、伊普吲哚、异丙苯甘酸(Iprofenin)、异丙硝唑(Ipronidazole)、异丙铂、盐酸异丙沙明、伊沙匹隆、厄贝沙坦、伊立替康、伊洛沙星、伊罗普拉、伊索拉定、伊替马唑、伊沙司坦、依沙莫可苏(Isamoxole)、伊波格雷、异帕米星、isobengazole、异氨苯丁酯、异卡波肼、异康唑、异他林(Isoetharine)、isofloxythepin、醋酸异氟泼尼龙、异氟烷、异氟磷、isohomohalicondrin B、异亮氨酸、盐酸伊索马唑、盐酸异戊拉明、异烟肼、异丙碘铵、异丙醇、异丙基乌诺前列酮、异丙肾上腺素盐酸盐、异山梨醇、异山梨醇一硝酸盐、依索喹胺、异维甲酸(Isotretinoin)、伊索克酸、伊索昔康、盐酸异克舒令、伊拉地平、伊他美林、伊他司琼、伊他格雷、伊托必利、伊曲康唑、伊维菌素、茉莉素(jasplakinolide)、交沙霉素、kahalalide F、卡拉芬净、硫酸卡那霉素、盐酸氯胺酮、酮色林、酮佐辛、凯他唑仑、乙氧二羟丁酮(Kethoxal)、富马酸氧丙咪嗪(KetipramineFumarate)、酮康唑、酮洛芬、酮啡诺、酮咯酸、富马酸酮替芬、吉他霉素、盐酸拉贝洛尔、拉西地平、拉西地平、拉克替醇、拉替维辛(lactivicin)、莱乃康(laennec)、拉呋替丁、三醋酸片螺素-N(lamellarin-Ntriacetate)、拉米非班、拉米夫定、拉莫三嗪、拉诺康唑、拉诺辛(Lanoxin)、兰吡立松、兰瑞肽、兰索拉唑、拉坦前列素、砖红镰孢菌素(lateritin)、月桂氮酮(laurocapram)、月桂基异喹啉氮溴化物、琥珀酸拉伏替丁(Lavoltidine Succinate)、拉扎贝胺、来西贝特、雷拉霉素(leinamycin)、来米地平、来明拉唑、来那西普、来尼喹新、来格司亭、仑哌隆、硫酸香菇多糖(lentinan sulfate)、瘦素(leptin)、leptolstatin、乐卡地平、麦角腈、来立司琼、盐酸来替米特、来曲珠利、来曲唑、亮氨酸、leucomyzin、醋酸亮丙瑞林(Leuprolide Acetate)、亮丙瑞林+雌激素+黄体酮、亮丙瑞林、琥珀酸左旋苯丙胺(Levamfetamine Succinate)、左旋咪唑、乳糖酸左旋多巴酚丁胺(LevdobutamineLactobionate)、D-克罗卡林(Leveromakalim)、左乙拉西坦、左环丝氨酸(Leveycloserine)、左倍他洛尔、左布诺洛尔、左布比卡因、左卡巴斯汀、左卡尼汀、左旋多巴、左羟丙哌嗪、左氧氟沙星、左呋喃他酮、左亚叶酸钙(Levoleucovorin Calcium)、左醋美沙朵、盐酸左醋美沙朵(Levomethadyl AcetateHydrochloride)、左莫普洛尔、盐酸左南曲朵、左旋异肾上腺素、左炔诺孕酮、左丙氧芬萘磺酸(Levopropoxyphene Napsylate)、左普皮西林钾(Levopropylcillin Potassium)、左美洛昔芬、左啡诺酒石酸(LevorphanolTartrate)、左西孟旦、左舒必利、左甲状腺素钠、盐酸左沙屈尔、来昔帕泛、来红霉素、利阿唑、赖苯普利、盐酸利达脒、利多卡因、利多苯宁、利多氟嗪、利法利嗪、利贝特、利非贝罗、林那罗汀、林可霉素、线性多胺类似物、利诺格列、利诺吡啶、利诺曲班、林西多明、林替曲特、林托必利、碘塞罗宁I 125、碘塞罗宁钠、复方甲状腺素(Liotrix)、利沙必利、赖诺普利、lissoclinamide 7、硫酸利沙齐农、洛铂、氯苯扎利钠、洛布卡韦、氯德拉苯、洛度沙胺(Iodoxamide)、盐酸洛非咪唑、草酸洛芬太尼、盐酸洛非帕明、盐酸洛非西定、蚯蚓磷脂(lombricine)、洛美沙星、洛美利嗪、盐酸洛美曲林、洛美曲索、洛蒙真菌素(Lomofungin)、氯诺昔康(Lomoxicam)、洛莫司汀、氯萘帕林、氯那唑酸、氯尼达明、盐酸洛哌丁胺、氯碳头孢、盐酸劳拉义明、氯雷他定、劳拉西泮、劳氨酯、盐酸劳卡尼、氯瑞唑、Loreinadol、氯戊米特、氯甲西泮、氯诺昔康、氯诺昔康、氯他拉明、氯扎封、氯沙坦、氯西加酮、洛索蒽醌、盐酸洛硫嗪、氯替泼诺、洛伐他汀、洛韦胺、洛沙平、洛索立宾、芦贝鲁唑、盐酸硫蒽酮、鲁非罗尼、甲磺酸卢罗司、勒托替康、促黄体激素(luteinizing hormone)、鲁拉西酮(Lurasidone)、镥、醋酸黄体瑞林、褪黑素受体拮抗剂(luzindole)、阿朴酸钠(Lyapolate Sodium)、氨棕己胺(Lycetamine)、lydicamycin、利迪霉素(Lydimycin)、利奈孕酮、赖氨加压素、赖氨酸、利索茶碱(lysofylline)、溶葡萄球菌素、裂解肽、马度米星、磺胺米隆、抗菌肽2酰胺、水杨酸镁、硫酸镁、厚朴酚(magnolol)、美坦新、马来他姆(Malethamer)、野梧桐色烯(mallotochromene)、mallotojaponin、马洛替酯、马洛替酯、锰福地吡、马尼地平、maniwamycin A、甘露醇、制甘糖酶素A、手霉素E、手霉素F、马哌斯汀、马普替林、马立马司他、马提克8708(Martek 8708)、马提克92211(Martek 92211)、马索罗酚、乳腺丝氨酸蛋白酶抑制剂(maspin)、massetolide、基质溶解因子抑制剂(matrilysininhibitor)、美登素(Maytansine)、琥珀酸马扎哌汀、马吲哚、甲苯达唑、盐酸美贝维林、甲溴菲宁、美布氨酯、盐酸美卡拉明、盐酸氮芥、甲氯环素、甲氯灭酸钠、甲氯喹酮、二丁酸甲氯松、盐酸美达西泮、美多力农、美屈孕酮、美沙洛尔、甲羟孕酮、甲羟松、盐酸美克洛嗪(MeelizineHydrochloride)、甲芬那酸、甲苯地尔、盐酸美芬雷司、美非沙胺、盐酸甲氟喹、美夫西特、巨霉素磷酸二氢钾、醋酸甲地孕酮、葡甲胺、美格鲁托、醋酸美仑孕酮、盐酸美利曲辛、美法仑、盐酸美莫汀、盐酸美大麻坦、美诺克酮、美诺立尔、尿促性素、硫酸甲氧苯汀、美帕曲星、溴美喷酯、盐酸哌替啶、硫酸美芬丁胺、甲苯妥应(Mephenyloin)、甲苯巴比妥、盐酸甲哌卡因、甲丙氨酯、盐酸美普他酚、美喹多司、汞林钠、美巴龙(merbarone)、巯嘌呤、氯汞苯酚(Mercufenol Chloride)、氯化氨汞、汞Hg197丙醇、美罗培南、美沙拉嗪、美西拉宗、美索达嗪、美睾酮、美雌醇、盐酸美舒令、盐酸美他洛尔、聚苯烯奥西那林、重酒石酸间羟胺(Metaraminol Bitartrate)、美他沙酮、甲烯前列素、美替瑞林(meterelin)、二甲双胍、氯醋甲胆碱、美他环素、盐酸美沙酮、左醋美沙朵、美沙噻嗪、盐酸脱氧麻黄碱(Methamphetamine Hydrochloride)、甲喹酮、醋甲唑胺、甲地嗪、乌洛托品、醋酸美替诺龙、美替妥英、甲氧西林钠、甲巯咪唑、甲硫氨酸酶(methioninase)、甲硫氨酸、美替沙腙、盐酸美噻吨、美索巴莫、美索比妥钠、甲氧夫啉、甲氨蝶呤、左美丙嗪、甲苯酮(methoxatone)、甲氧氟烷、甲琥胺、甲氯噻嗪、帕莫酸甲酯(Methy1 Palmoxirate)、甲硝阿托品、甲苄索氯铵、甲基多巴、盐酸甲基多巴乙酯、亚甲基蓝、马来酸甲麦角新碱、甲基组胺、R-α、甲基肌苷单磷酸盐、盐酸哌甲酯、甲基泼尼松龙、甲睾酮、双醋甲异炔诺醇(MethynodiolDiacelate)、美西麦角、马来酸美西麦角、甲硫米特、甲硫平、美替普林、甲硫咪胺(metipamide)、美替洛尔、盐酸美替唑啉、醋酸美克法胺(Metkephamid Acetate)、甲氧氯普胺、碘二甲箭毒(MetocurineIodide)、16,16-二甲诺龙(Metogest)、美托拉宗、美托哌丙嗪、氯苯氨啶、美托洛尔、美托喹嗪、美曲磷酯、甲泛葡胺、甲泛影钠、甲硝唑、美妥替哌、美替拉酮、甲酪氨酸、盐酸美西律、美利酸钾、美洛西林、mfonelic Acid、盐酸米安色林、米贝拉地尔、二盐酸米贝拉地尔、米勃酮、米歇尔胺B(michellamine B)、咪康唑、microcolin A、氟咪胺、盐酸咪达唑仑、米多君、米非司酮、米福贝特、米格列醇、米拉醋胺、米拉美林、米屈肼、咪仑哌隆、米利哌汀、米那普仑、米力农、米替福新、盐酸米姆本、米那普林(minaprine)、米那索龙、米诺罗米、米诺环素、米诺地尔、盐酸米氟嗪、米奥卡霉素(miokamycin)、米普拉苷、米芬太尼、米立司亭、盐酸米林霉素、马来酸米立司琼、米氮平、错配的双链RNA、米索硝唑、米索前列醇、米丁度胺、米托卡星(Mitocarcin)、丝裂红素(Mitocromin)、米托洁林、米托胍腙、二溴卫矛醇、米托马星、丝裂霉素、米托萘胺、米托司培、米托坦、米托蒽醌、米库氯铵、米伐折醇、mixanpril、米克昔定、咪唑斯汀、咪唑立宾、吗氯贝胺、莫达非尼、硫酸莫达林、莫地卡尼、莫昔普利、莫法罗汀、盐酸莫非吉兰、莫苯唑酸、莫拉司亭、吗啉那宗、盐酸吗茚酮、吗多明、莫米松、马来酸莫那匹尔、莫能菌素、甘油辛酸酯和甘油癸酸酯混合物(Monoctanoin)、孟鲁司特钠、孟替瑞林、莫哌达醇、莫雷西嗪(Moracizine)、酒石酸莫仑太尔、莫雷西嗪(Moricizine)、吗尼氟酯、硫酸吗啡、鱼肝油酸钠、莫沙帕明、莫沙必利、动能内酯(motilide)、莫维A胺、拉氧头孢二钠、莫沙佐辛、莫昔普令、吗硝唑、莫索尼定、腮腺炎皮肤试验抗原、芥抗癌剂、莫唑胺、印度洋海绵(mycaperoxide)B、麦考酚酸、myriaporone、大麻折尼、大麻隆、盐酸大麻坦、盐酸大麻克酯、萘丁美酮、N-乙酰基地那林、辅酶I、那氟沙星、纳多洛尔、那屈肝素钙、那法道曲(nafadotride)、萘莫司他、那法瑞林、萘夫西林钠、萘酚平、盐酸萘咪酮、萘非可特、苹果酸萘甲羟胺、盐酸萘福昔定、草酸萘呋胺、盐酸萘替芬、萘哌地尔、那格列钒、nagrestip、盐酸纳布啡、Naldemedine、萘啶酮酸钠、萘啶酮酸、纳美芬、盐酸纳美酮、纳洛酮+喷他佐辛、纳曲酮、纳莫雷特、苯丙酸诺龙、盐酸南曲朵、盐酸萘帕他定、萘二磺酸盐、盐酸萘帕咪唑、napaviin、盐酸萘甲唑林、萘萜二醇(naphterpin)、萘普生、萘普索、奈沙加群、盐酸萘拉诺、甲基盐霉素(Narasin)、那拉曲坦、那托司亭、那沙普酶、纳他霉素、那替普酶、盐酸那高利特、奈必洛尔、尼拉霉素、奈达铂、奈多罗米、盐酸奈法唑酮、盐酸萘氟齐特、盐酸奈福泮、马来酸奈来扎林、盐酸奈马唑啉、奈莫柔比星、棕榈酸新霉素、溴新斯的明、奈立膦酸、硫酸奈替米星、中性内肽酶、中性霉素、奈韦拉平、盐酸奈西利定、烟酸、硝溴生、盐酸尼卡地平、尼麦角林、氯硝柳胺、尼可地尔、烟醇、硝苯地平、Nifirmerone、氟蚁灵(Nifluridide)、硝呋拉定、硝呋地腙、硝呋太尔、硝呋隆、硝呋达齐、硝呋米特、硝呋吡醇、硝呋奎唑、硝呋噻唑、尼鲁米特、尼伐地平、尼马宗、尼莫地平、尼培替丁、尼拉伏林、尼立达唑、nisamycin、甲磺酸尼司特罗、乳酸链球菌素、尼索氨酯、尼索地平、尼索西汀、醋酸尼司特林、硝苯胂酸、硝唑尼特(nitazoxamide)、硝替卡朋、盐酸硝呋坦、盐酸硝拉明、盐酸硝拉咪唑、硝西泮、尼群地平、硝环素、硝丹宁、呋喃妥因、呋喃西林、硝酸甘油、硝甲酚汞、硝米特、柠檬酸硝米芬、氧化亚氮、氮氧化物抗氧化剂、nitrullyn、尼伐可醇、尼维美酮钠、尼扎替丁、诺柏斯汀、诺考达唑、诺拉霉素、诺利溴铵、马来酸诺米芬辛、盐酸诺美沙朵、诺勃酮、重酒石酸去甲肾上腺素、炔诺酮、异炔诺酮、诺氟沙星、诺氟烷、诺孕酯、诺孕美特、炔诺孕酮、盐酸去甲替林、诺司卡品、新生霉素钠、N-取代benzaimides、奴芬克索、尼尔雌醇(Nylestriol)、制霉菌素、O6-苄基鸟嘌呤、双复磷、奥卡哌酮、盐酸奥芬太尼、奥西普隆、辛酸、奥他酰胺、盐酸奥替尼啶、奥托君、奥曲肽、磷酸奥克替林、氧氟沙星、奥福宁(Oformine)、okicenone、奥氮平、寡核苷酸、奥洛他定、奥普力农、奥沙拉秦、奥沙拉嗪钠、奥伐尼、奥美拉唑、奥那司酮、昂丹司琼、昂唑司特、卵母细胞成熟抑制剂、盐酸奥匹哌醇、oracin、硝酸奥康唑、奥古蛋白、奥利司他(Orlislat)、奥马铂、奥美普林、奥硝唑、奥帕诺辛、柠檬酸奥芬那君、奥沙特隆、奥腾折帕、苯唑西林钠(Oxacillin Sodium)、氧格雷酯、奥沙利铂、盐酸奥沙香豆素、奥沙米索、奥沙尼喹、氧雄龙、双羟萘酸甲嘧烯酚、盐酸羟丙替林、奥沙普秦、奥沙巴唑、奥沙米特、oxaunomycin、奥沙西泮、奥卡西平、奥生多龙、奥昔卡因、富马酸奥昔托隆、奥芬达唑、羟苯甘氨酸、奥苯达唑、奥昔康唑、羟多巴胺、奥昔磷酸、盐酸奥昔芬净、奥昔啡烷、肟莫南、肟莫南钠、奥哌咪酮、奥拉西坦、奥昔拉米、奥昔舒仑、盐酸奥美替丁、奥索地平、苯丙酸奥索孕酮、喹酸、盐酸氧烯洛尔、胆茶碱、氯化奥昔布宁(Oxybutynin Chloride)、奥昔氯生、羟考酮、盐酸羟甲唑啉、羟甲烯龙、盐酸羟吗啡酮、奥昔哌汀、羟基保泰松、羟嘌呤醇、氧四环素、催产素、奥扎格雷、奥唑林酮、紫杉醇、palauamine、帕地霉素、帕利那韦、棕榈酰根霉素(palmitoylrhizoxin)、帕莫酸钠、帕马苷、硫酸帕马洛尔、帕米格雷、帕米膦酸二钠、帕米膦酸、帕那普隆、帕那美新、人参炔三醇(panaxytriol)、泮考必利、泮库溴铵、帕尼培南、pannorin、帕诺米芬、泛硫乙胺、泮托拉唑、盐酸罂粟碱、副球菌素(parabactin)、对乙酰氨基酚、三聚乙醛、醋酸帕拉米松、盐酸瑞尼托林、溴帕拉喷酯、双羟萘酸副品红(Pararosaniline Pamoate)、帕苯咪唑(Parbendazole)、盐酸帕康唑、复方樟脑酊(Paregoric)、硫酸帕立太特、盐酸帕吉林、帕肝素钠、硫酸巴龙霉素、帕罗西汀、欧苷菊、帕曲星、保洛霉素、帕折普汀、帕秦克隆、帕佐昔特、帕珠沙星、培氟沙星、培门冬酶、培戈汀、盐酸培兰色林、培得星(peldesine)、培利霉素、培维A、盐酸培力农、培美酸、硝酸哌美立特、吡嘧司特、匹莫林、培那西林、硫酸喷布洛尔、喷昔洛韦、五氟利多、苄星青霉素G、青霉素G钾、普鲁卡因青霉素、青霉素G钠、青霉素V、苄星青霉素V、海巴青霉素V、青霉素V钾、喷他氨酯、季戊四醇四硝酸酯、喷他夫西(pentafuside)、喷他脒、戊吗酮、戊氮芥、甲硫戊哌铵(Pentapiperium Methylsulfate)、喷他佐辛、喷替酸、马来酸喷硫平、喷替吉肽、喷替米星、戊胺唑酮钠、戊巴比妥、喷托孟、喷托普利、戊聚糖、喷司他丁、己酮可可碱、戊硝醇、戊四氮(pentrozole)、硫酸培洛霉素、胃酶抑素、全氟溴烷、perfofamide、培磷酰胺、培高利特、马来酸哌克昔林、紫苏子醇、培哚普利、培哚普利拉、哌拉平、扑灭司林、哌罗匹隆、奋乃静、苯乙酰脲、苯乙利定(phenaridine)、苯连氮霉素(phenazinomycin)、盐酸非那吡啶、保泰松甘油酸钠、芬卡米特(Phencarbamide)、盐酸苯环利定、酒石酸苯甲曲秦、硫酸苯乙肼、盐酸苯甲吗啉、苯巴比妥、盐酸酚苄明、苯丙香豆素、苯羟基丙氨酸(phenserine)、phensuccinal、苯琥胺、芬特明、盐酸芬特明、甲磺酸酚妥拉明、Phentoxifylline、对氨基水杨酸苯酯、乙酸苯酯、苯丙氨酸、苯丙氨酰基酮康唑、保泰松、盐酸去氧肾上腺素、盐酸苯丙醇胺、苯丙醇胺磺化二乙烯苯-乙烯苯共聚物(Phenylpropanolamine Polistirex)、盐酸非尼拉朵、苯妥英(Phenyloin)、磷酸酶抑制剂、毒扁豆碱、哌西那朵、溶链菌(picibanil)、匹可曲林二乙醇胺、胡黄连活素、吡库特罗、匹多莫德、哌法宁(Pifamine)、毛果芸香碱、吡西卡尼、匹马吉定、盐酸匹美汀、匹米前列素、匹莫苯、匹莫齐特、吡那地尔、匹那朵林、吲哚洛尔、吡美诺(pinnenol)、匹诺塞林(pinocebrin)、盐酸哌氧平、吡格列酮、匹泮哌隆、匹哌氮酯、哌库溴铵、哌西他嗪、哌拉西林钠、马来酸哌拉酰胺、哌嗪、哌泊溴烷、哌泊舒凡、棕榈酸哌泊噻嗪、盐酸哌泊索仑、哌普唑啉、盐酸匹喹酮、盐酸哌喹齐尔、吡拉西坦、盐酸吡喃达明、吡柔比星、吡拉莫南钠、吡拉唑酸、吡苄青霉素钠、醋酸吡布特罗、匹仑哌隆、盐酸哌仑西平、吡咯他尼(piretamide)、吡非尼酮、吡地西林钠、吡膦酸钠、吡前列素、吡曲克辛、盐酸吡利霉素、吡吲哚、吡吗格雷、盐酸吡美诺、吡大麻(Pirnabine)、吡罗克酮、吡罗达韦、吡咯司特、酒石酸吡咯格列、匹罗酯、吡拉酰胺、盐酸吡罗蒽醌、吡罗昔康、匹罗昔酮、吡洛芬、吡喹诺唑、哌多明、普尼拉明、垂体后(Pituitary,Posterior)、盐酸匹氨苄青霉素、匹伏普利、苯噻啶、胎盘浸膏A(placetinA)、铂化合物、铂-三胺配合物、普卡霉素、普洛美坦、泊比司特乙二胺、普达非洛、毒葛提取物、甲基硫酸波定(Poldine Methylsulfate)、聚氨葡糖、木质素磺酸钠、硫酸多黏菌素B、泊利噻嗪、泊那司他、卟吩姆钠、泊非霉素、氯化钾、碘化钾、高锰酸钾、聚维酮碘、普拉洛尔、氯解磷定(Pralidoxime Chloride)、盐酸普拉西坦、盐酸普莫卡因、普拉氯铵、马来酸普拉朵林、普伐他汀(Pravastatin/Pravachol)、普拉西泮、哌唑嗪、盐酸哌唑嗪、泼那扎特、泼尼卡酯、泼尼莫司汀、泼尼松龙、泼尼松、泼尼松龙戊酸酯(Prednival)、琥珀酸孕烯诺龙、盐酸普瑞特罗、盐酸普立地芬、普立非酮、盐酸丙胺卡因(PrilocalneHydrochloride)、洛赛克(Prilosec)、磷酸伯氨喹、普米洛尔、扑米酮、赖诺普利(Prinivil)、普林米特氨丁三醇、普啉索旦、盐酸普齐地洛、盐酸普罗地芬、丙磺舒、安克罗米钙、普罗布考、盐酸普鲁卡因胺、盐酸普鲁卡因、盐酸丙卡巴肼、盐酸丙卡特罗、丙氯拉嗪、普西奈德、丙氯诺、盐酸丙环定、盐酸普地利定、普罗度酸、盐酸普罗法朵、普罗加比(Progabide)、黄体酮、丙谷胺、人胰岛素原、脯氨酸、盐酸普罗林坦、盐酸丙嗪、盐酸异丙嗪、盐酸普罗帕酮、丙帕锗、丙泮尼地、溴丙胺太林、盐酸丙美卡因、丙帕硝酯、丙戊茶碱、盐酸奥昔利平、普匹卡星、丙酰马嗪、丙酸、丙酰肉碱、丙酰左旋肉碱、丙吡胺、丙吡胺+扑热息痛、丙哌维林、丙泊酚、盐酸丙氧卡因、盐酸右丙氧芬、盐酸普萘洛尔、西沙必利(Propulsid)、丙基双-吖啶酮、丙己君、丙碘酮、丙硫氧嘧啶、普罗喹宗、丙利酸钾、盐酸普罗克生、海葱次苷、前列他林、酪氨酸激酶抑制剂(prostratin)、硫酸鱼精蛋白、内源性抗微生物多肽(protegrin)、普罗瑞林、妥舒沙星、盐酸普罗替林、普罗沙唑、柠檬酸普罗沙唑、普昔罗米、酒石酸普罗啡烷、普卢利沙星、盐酸伪麻黄碱、嘌罗霉素、红紫素(purpurins)、吡拉布隆、扑酸噻嘧啶、吡嗪酰胺、吡唑呋喃菌素(Pyrazofurin)、吡唑啉吖啶(pyrazoloacridine)、溴吡斯的明、马来酸美吡拉敏、乙胺嘧啶、吡诺林、吡啶硫酮钠、吡啶硫酮锌、盐酸吡咯戊酮、马来酸吡咯沙敏、吡咯卡因、盐酸吡咯利芬、吡咯尼群、恩波吡维铵、甲磺酸夸达佐辛、夸西泮、喹齐酮、夸唑定、喹唑司特、喹硫平、喹夫拉朋、喹高利特、喹那定蓝、喹那普利、喹那普利拉、盐酸喹唑嗪、奎勃龙、Quinctolate、醋酸喹地卡明、喹度溴铵、盐酸喹洛雷、炔雌醚、喹法米特、醋酸奎孕醇、奎孕酮、葡萄糖酸奎尼丁、盐酸喹洛雷、硫酸奎宁、盐酸喹吡罗、硫酸喹丙那林、奎纽溴铵、奎奴普丁、马来酸喹哌嗪、雷贝拉唑钠、消旋甲砜霉素(Racephenicol)、消旋肾上腺素、raf拮抗剂、雷复尼特(Rafoxamide)、雷利托林、雷洛昔芬、雷替曲塞、雷马曲班、雷米普利、雷莫拉宁、雷莫司琼、雷奈酸、雷尼霉素、雷尼替丁、雷诺嗪、萝芙木提取物(RauwolfiaSerpentina)、瑞卡南、盐酸瑞卡南、瑞氯西泮、瑞加韦单抗、瑞拉司亭、松弛素、雷洛霉素、盐酸瑞马酰胺、盐酸瑞芬太尼、瑞前列醇、瑞莫必利、瑞吡司特、瑞普米星、盐酸瑞普特罗、利舍平、辣椒辣素(resinferatoxin)、间苯二酚、脱甲基化瑞替普汀、网状蛋白(reticulon)、瑞肝素钠、瑞维齐农、铼Re 186依替膦酸盐、根瘤菌素(rhizoxin)、利巴米诺、利巴韦林、利波腺苷、核酶、利卡司琼、利多格雷、利福布汀、利福美坦、利福克昔、利福米特、利福平、利福喷汀、利福昔明、RII retinamide、利洛吡司、利鲁唑、金刚乙胺、盐酸林卡唑、利美索龙、利米特罗氢溴酸盐、利莫罗近、利奥地平、利奥前列素、利帕西泮、利匹沙坦、利塞膦酸钠、利塞膦酸、利索卡因、盐酸利索利特、利喷西平、维思通(Risperdal)、利培酮、利坦色林、利替培南、利托君、利托司特、利托那韦、苯甲酸利扎曲普坦、盐酸柔卡斯啶、罗库溴铵、罗多卡因、罗氟烷、罗谷亚胺(Rogletimide)、罗希吐碱、罗他霉素、Roletamicide、罗加米定、罗利普令(Rolicyprine)、咯利普兰、罗利环素、罗咯定、氯马扎利、罗莫肽、罗硝唑、罗匹尼罗、盐酸罗匹妥英、罗哌卡因、罗匹嗪、罗喹美克、罗沙米星、罗格列酮、罗索沙星、罗托沙敏、roxaitidine、洛克沙肿、罗克吲哚、罗红霉素、鲁必金醇B1、ruboxyl、芦氟沙星、卢帕他定(rupatidine)、芦他霉素、卢扎朵仑、沙贝鲁唑、沙芬戈、沙非罗尼、saintopin、沙丁胺醇、R-柳胆来司、马来酸沙乙酰胺、水杨醇、水杨酰胺、水杨酸葡甲胺、水杨酸、沙美特罗、沙那西定(Salnacediin)、双水杨酯、沙美利定、山帕曲拉、山环素、山费培南、血根氯铵、沙康唑、沙普立沙坦、沙丙蝶呤、沙奎那韦、盐酸沙氟沙星、醋酸沙拉新、SarCNU、肌肉叶绿醇(sarcophytol)A、沙格司亭、沙莫西林、沙匹西林、沙格雷酯、沙芦普酶、沙特力农、沙替格雷、沙妥莫单抗喷地肽、锡克试验对照品、司可芬净、氢溴酸东莨菪碱、盐酸Scrazaipine、Sdi 1模拟物、司骨化醇、司可巴比妥、Seelzone、醋酸司格列肽、司来吉兰、盐酸司来吉兰、硫化硒、硒代甲硫氨酸Se 75、塞福太、司美利特、生度米星、司莫地尔、司莫司汀、有义寡核苷酸、氯化三苯唑(Sepazonium Chloride)、盐酸氯氟哌醇、司普立糖、盐酸塞罗西汀、醋酸丝拉克肽、马来酸麦角克索、丝氨酸、丝美辛、醋酸舍莫瑞林、舍他康唑、舍吲哚、舍曲林、司普替林、司托哌隆、司韦单抗、七氟烷、司佐胺、西波吡啶、盐酸西布曲明、信号转导抑制剂、硅雄酮、西立匹特、西替普酶、硝酸银、西孟旦、辛曲秦、辛伐他汀、辛卡利特、西奈芬净、西硝地尔、sinnabidol、西帕曲近、西罗莫司、西索米星、西托糖苷、西佐喃、索布佐生、淀粉硫酸钠、碘化钠I 123、硝普钠、羟丁酸钠、苯乙酸钠、水杨酸钠、solverol、酒石酸索立哌汀、猪丙氨生长素、盐酸索金刚胺、生长介素B、生长介素C、人蛋氨生长素、生长激素、猪诺生长素、牛度生长素、索纳明、索比尼尔、索立夫定、索他洛尔、盐酸索特瑞醇、司帕沙星、磷乙酰天冬氨酸钠、磷乙酰天冬氨酸、司帕霉素、硫酸司巴丁、盐酸大观霉素、穗霉素(spicamycin)D、螺哌隆、甲磺酸螺朵林、螺旋霉素、盐酸螺普利、螺普利拉、盐酸锗螺胺、螺莫司汀、螺内酯、螺铂、螺沙宗、斯耐潘定(splenopentin)、海绵抑制素1(spongistatin 1)、镝双胺、角鲨胺、盐酸司他霉素、焦磷酸亚锡、亚锡硫胶体、司坦唑醇、维司托隆、星孢菌素(staurosporine)、司他夫定司替霉素、醋酸司腾勃龙、司替罗宁、司替碘铵、司洛碘铵、stipiamide、司替戊醇、斯哚巴丁、硫酸链霉素、链霉素异烟肼(Streptonicozid)、链黑菌素、链脲霉素、基质溶素抑制剂、氯化锶Sr 89、succibun、二巯丁二酸、氯化琥珀酰胆碱、硫糖铝、硫糖酯钾、舒多昔康、舒芬太尼、舒福替丁、硫西泮、舒巴坦匹酯、硝酸硫康唑、磺胺苯、磺胺苯酰、磺胺醋酰、磺胺西汀、磺胺嘧啶、磺胺多辛、磺胺林、磺胺甲嘧啶、磺胺对甲氧嘧啶、磺胺二甲嘧啶、磺胺甲二唑、磺胺甲唑、磺胺间甲氧嘧啶、磺胺二甲唑、氨苯磺酸锌、磺胺硝苯、柳氮磺吡啶、磺胺异噻唑、磺胺吡唑、盐酸硫氧洛尔、sulfinosine、磺吡酮、磺胺异唑、磺黏菌素、盐酸磺酰特罗、砜亚胺(sulfoxamine)、舒林酸(Sulinldac)、硫马林、舒硝唑、舒洛地尔、磺氯苯脲、硫培南、草酸舒洛昔芬、舒必利、硫前列酮、舒他西林、舒噻嗪(Sulthiame)、舒托必利、硫鲁司特、舒马罗汀、舒马普坦、磺氨苄青霉素钠、舒普罗酮、舒洛芬、suradista、舒拉明、舒福姆、马来酸舒立卡尼、舒立托唑、马来酸舒罗吖啶、硫酸琥甲哌酯、苦马豆素(swainsonine)、司马卡林(symakalim)、氯氧三嗪、盐酸昔美汀、合成糖胺聚糖、盐酸Taciamine、盐酸他克林、他克莫司、盐酸酞氨西林、玉米赤霉醇(Taleranol)、他利霉素、他莫司汀、他美辛、他尼氟酯、盐酸他洛普仑、他洛柳酯、盐酸他美曲林、他莫昔芬、富马酸坦帕明、盐酸坦洛新、盐酸坦达明、坦度螺酮、tapgen、他前列烯、他索沙坦、牛磺莫司汀、紫杉烷(Taxane)、紫杉烷(Taxoid)、琥珀酸他扎朵林、他扎司特、他扎罗汀、盐酸他齐茶碱、三唑巴坦、他唑非隆、盐酸他佐洛尔、特丁非隆、替布喹、比西酸锝Tc 99m、替克洛占、替可加兰钠、Teecleukin、替氟烷、替加氟(Tegafur)、得理多(Tegretol)、替考拉宁、替仑西平、tellurapyrylium、替美司坦、替米沙坦、端粒酶抑制剂、盐酸替洛蒽醌、盐酸替鲁地平、盐酸替马沙星、甲硫托铵(Tematropium Methyl sulfate)、替马西泮、替美斯汀、替莫普利、替莫西林、替莫泊芬、替莫唑胺、替尼达普、替尼泊苷、替诺柳、替诺昔康、替吡吲哚、替泊沙林、替普罗肽、特拉唑嗪、特比萘芬、硫酸特布他林、特康唑、特非那定、特拉伏沙、特麦角脲、醋酸特立帕肽、特拉吉仑、特利加压素、特罗地林、盐酸特罗扎林、替罗昔隆、特他洛尔、替昔康、替昔米德(Tesimide)、睾内酪、睾酮、丁卡因、tetrachlorodecaoxide、四环素、盐酸四氢唑啉、盐酸四咪唑、四唑司特葡甲胺、tetrazomine、替曲膦、四羟醌、四氧普林、四氢甲吲胺、松草碱(thaliblastine)、沙利度胺、羟乙茶碱安妥明(Theofibrate)、茶碱、噻苯达唑、硫咪嘌呤、甲砜霉素、硫戊巴比妥、盐酸硫西新、噻丙铵氯(Thiazinamium Chloride)、硫乙哌丙嗪(Thiethylperazine)、硫汞苯磺钠、硫柳汞、噻可拉林(thiocoraline)、thiofedrine、硫鸟嘌呤、thiomarinol、硫喷妥钠、噻普酰胺(thioperamide)、硫利达嗪、噻替哌、替沃噻吨、盐酸替芬那米、替芬西林鉀(Thiphencillin Potassium)、塞仑、托扎啉酮、苏氨酸、凝血酶、血小板生成素、血小板生成素模拟物、胸腺法新、胸腺生成素受体激动剂、胸腺曲南、盐酸甲状米登、甲状腺素I 125、甲状腺素I 131、硫克司特、硫克司特钠、噻加宾、噻美尼定(Tiamenidine)、噻奈普汀、tiapafant、盐酸噻帕米、盐酸噻拉米特、噻唑呋林、硫苯司特钠、替勃龙、替贝酸、丙酸替卡贝松、替卡波定、替卡西林甲苯酯钠、替克拉酮、噻氯匹定、替尼酸、替诺洛尔、替呋酸钠、二胆碱替吉莫南、替孕醇、盐酸替来他明、盐酸替利定、替利洛尔、替洛芬阿酯、盐酸替洛隆、替鲁膦酸二钠、替鲁膦酸、替美呋酮、醋酸替莫贝松、噻吗洛尔、tin ethyl etiopurpurin、替大麻酚、替硝唑(Timidazole)、亭扎肝素钠、噻康唑、硫达唑嗪、碘氯化物、盐酸硫哌立酮、硫平酸、盐酸替螺酮、硫替丁、噻托溴铵、噻昔达唑、盐酸噻戊托辛、替泼尼旦、盐酸替普洛尔、替普司特葡甲胺、盐酸替普地尔、替奎安、盐酸替喹胺、提莱菌素(tirandalydigin)、替拉扎明、替拉扎特(tirilazad)、替罗非班、替罗酰胺(tiropramide)、二氯二茂钛、替呫诺、新戊酸替可的松、盐酸替扎尼定、妥布霉素、妥卡尼、托莰非、盐酸托芬那辛、妥拉洛尔、妥拉磺脲、盐酸妥拉唑林、甲苯磺丁脲、托卡朋、托西拉酯、托法胺、托加比特、拉莫三嗪、托利咪酮、托林达酯、托美丁、托萘酯、托泊酮I 131、甲苯磺吡胺、托瑞司他、托鲁司特、盐酸托莫西汀、甲磺酸托那佐辛、托吡酯、托泊替康、盐酸托泊替康、topsentin、托普雄酮、托喹嗪、托拉塞米、托瑞米芬、托拉塞米、托西芬、托氟沙星、全能干细胞因子、曲卡唑酯、曲弗明、曲洛奈德、盐酸曲马多、盐酸曲马唑啉、群多普利、氨甲环酸、曲尼司特、群司卡尼、转录抑制剂、曲呫诺、盐酸曲唑酮、曲唑酮-HCl、盐酸曲苯佐明、盐酸曲芬太尼、曲洛酯、马来酸曲匹泮、醋酸曲托龙、维A酸、三醋酸甘油酯、三乙酰尿苷(triacetyluridine)、三嗪芬净、曲安西龙、硫酸曲安吡嗪、氨苯蝶啶、三唑仑、三苄糖苷、甘油三辛酸酯(tricaprilin)、三甲氧苯醋酰胺(Tricetamide)、三氯噻嗪、毛透明蛋白(trichohyalin)、曲西立滨、三柠檬酸盐(Tricitrates)、三氯酚哌嗪、三氯福司钠、三氯奈德、曲恩汀、三苯格雷、triflavin、三氟洛辛、三氟巴占、三氟米酯、盐酸三氟培拉嗪、三氟哌多、三氟丙嗪、盐酸三氟丙嗪、曲氟尿苷、盐酸苯海索、曲洛司坦、盐酸曲马唑嗪、曲美孕酮、酒石酸阿利马嗪、三甲双酮、樟磺咪芬(Trimethaphan Camsylate)、盐酸曲美苄胺、甲氧苄啶、曲美托嗪、三甲曲沙、曲米帕明、曲莫前列素、盐酸曲莫沙明、三油酸甘油酯I 125、三油酸甘油酯I 131、甲磺酸曲沃昔芬、曲帕胺、盐酸曲吡那敏、盐酸曲普利啶、曲普瑞林、三磺嘧啶、曲氯新钾、曲格列酮、三乙醇胺、醋竹桃霉素、trombodipine、氨丁三醇、盐酸托烷色林、托吡卡胺、托品酯、托烷司琼、丙大观霉素、曲伐沙星、曲韦定、色氨酸、结核菌素、氯筒箭毒碱、盐酸妥布氯唑、tucarcsol、妥洛特罗、妥罗雄脲、泰巴氨酯、tylogenin、酪泮酸钠、酪氨酸、短杆菌素、酪氨酸磷酸化抑制剂(tyrphostins)、乌苯美司、乌达西泮、十一烯酸、乌拉莫司汀、乌拉地尔、脲、乌瑞替派、三磷酸尿苷、尿促卵泡素、尿激酶、熊二醇(Ursodiol)、伐昔洛韦、缬氨酸、戊诺酰胺、丙戊酸钠、丙戊酸、缬沙坦、伐米胺、vanadeine、万古霉素、vaninolol、盐酸伐哌前列素、伐普肽、variolin B、升压素、维库溴铵、维拉雷琐、马来酸维吖啶、文拉法辛、盐酸维拉朵林、藜芦胺(veramine)、盐酸维拉帕米、verdins、盐酸维立洛泮、维鲁司特、维罗茶碱、veroxan、维替泊芬、维司力农、马鞭草烷醇(vexibinol)、阿糖腺苷、氨己烯酸、盐酸维洛沙秦、硫酸长春花碱、柠檬酸长春布宁、乙烯磷、长春考酯、硫酸长春新碱、长春地辛、硫酸长春地辛、硫酸长春匹定、硫酸长春甘酯、硫酸长春罗新、长春瑞滨、长春西汀、长春培醇、vinxaltine、长春利定、维前列醇、维吉霉素、绿黄菌素、韦罗肟、牡荆黄素(vitaxin)、伏拉佐辛、伏立康唑、伏氯唑、伏高利特、华法林钠、扎莫特罗、呫诺美林、异丙氧蒽酸钠、烟酸占替诺(Xanthinol Niacinate)、珍米洛非班、联苯利平、联苯丁酸、希洛班、希莫洛芬、希帕胺、甲磺酸佐尔啡诺、甲苯磺酸甲苯乙脒、盐酸赛拉嗪、盐酸赛洛唑啉、木糖、yangambin、扎普利、扎考必利、扎鲁司特、扎西他滨、扎来普隆、扎螺酮、盐酸唑替丁、扎托洛芬、扎那米韦、占吉仑、扎诺特隆、善胃得(Zantac)、扎鲁司特(Zarirlukast)、扎替雷定、扎托司琼、马来酸扎托司琼、折那司他、甲磺酸泽来索兴(Zenazocine Mesylate)、折尼铂、折仑诺、齐多美辛、齐多夫定、齐罗硅酮、齐仑太尔、亚苄维C、齐留通、盐酸齐美定、十一烯酸锌、嗪多群、盐酸齐诺康唑、净司他丁、盐酸净特罗、净韦肟、齐拉西酮、Zobolt、佐芬普利钙、佐芬普利拉、盐酸佐拉敏、盐酸唑拉西泮、唑来膦酸、盐酸佐勒汀、佐米曲普坦、唑吡坦、佐美酸钠、佐美他平、盐酸佐尼氯唑、唑尼沙胺、佐匹克隆、唑泊司他、佐尔博霉素(Zorbamyciin)、盐酸佐柔比星、佐替平、珠卡赛辛。
可用于本文的另一种药物活性物为卢美哌隆(lumateperone),如美国专利号9,745,300、9,708,322、7,183,282、7,071,186、6,552,017、8,648,077、8,598,119、9,751,883、9,371,324、9,315,504、9,428,506、8,993,572、8,309,722、6,713,471、8,779,139、9,168,258、RE039680E1、9,616,061、9,586,960和美国专利公开号2017/0114037、2017/0183350、2015/0072964、2004/0034015、2017/0189398、2016/0310502、2015/0080404中所公开,其上述内容通过引用整体并入本文。
抗糖尿病活性物的更多的实例包括但不限于JTT-501(PNU-182716)(Reglitazar)、AR-H039242、MCC-555(Netoglitazone)、AR-H049020(Tesaglitazar)、CS-011(CI-1037)、GW-409544×、KRP-297、RG-12525、BM-15.2054、CLX-0940、CLX-0921、DRF-2189、GW-1929、GW-9820、LR-90、LY-510929、NIP-221、NIP-223、JTP-20993、LY 29311Na、FK614、BMS 298585、R 483、TAK 559、DRF 2725(Ragaglitazar)、L-686398、L-168049、L-805645、L-054852、去甲基asteriquinone B1(L-783281)、L-363586、KRP-297、P32/98、CRE-16336和EML-16257。
本文中有用的勃起功能障碍疗法包括但不限于用于促进血液流向阴茎并用于实现自主神经活动(例如增加副交感神经(胆碱能)和减少交感神经(肾上腺素能)活动)的药剂。用于治疗勃起功能障碍的有用上午活性物包括,例如,但不限于前列地尔、他达拉非、伐地那非、阿扑吗啡、盐酸育亨宾、柠檬酸西地那非、西地那非及其任意组合。在一个实施方案中,活性物为他达拉非。
用于治疗头痛和/或偏头痛的活性物或药物也可在本文中使用。具体活性物的实例包括但不限于曲坦类,例如依来曲坦、那拉曲坦、利扎曲坦(苯甲酸利扎曲坦)、舒马曲坦和佐米曲坦。在一个实施方案中,活性物为利扎曲坦,任选地与NSAID组合。
在某些实施方案中,药物活性成分可以是肾上腺素、肾上腺素的前药、类似物、衍生物或盐。
在一个实例中,包括前药(例如肾上腺素的前药)的组合物可具有与通过注射施用的肾上腺素相似的生物递送特征。
在某些实例中,组合物可包括肾上腺素和前药的组合。在其他实例中,该组合物可包括两种或更多前药的组合。在其他实例中,该组合物可包括肾上腺素和两种或更多前药的组合。
肾上腺素或其前药可存在的量为每剂量从约0.01mg至约100mg,例如0.1mg、5mg、10mg、20mg、30mg、40mg、50mg、60mg、70mg、80mg、90mg或100mg剂量,包括大于0.1mg、大于5mg、大于20mg、大于30mg、大于40mg、大于50mg、大于60mg、大于70mg、大于80mg、大于90mg,或小于100mg、小于90mg、小于80mg、小于70mg、小于60mg、小于50mg、小于40mg、小于30mg、小于20mg、小于10mg或小于5mg,或其任意组合。肾上腺素或前药可以单剂量提供。肾上腺素或前药也可以以两种或更多种剂量提供。
地匹福林可存在的量为每剂量从约0.5mg至约100mg,例如0.5mg、1mg、5mg、10mg、20mg、30mg、40mg、50mg、60mg、70mg、80mg、90mg或100mg剂量,包括大于1mg、大于5mg、大于20mg、大于30mg、大于40mg、大于50mg、大于60mg、大于70mg、大于80mg、大于90mg,或小于100mg、小于90mg、小于80mg、小于70mg、小于60mg、小于50mg、小于40mg、小于30mg、小于20mg、小于10mg或小于5mg,或其任意组合。地匹福林可以单剂量提供。地匹福林也可以以两种或更多种剂量提供。
前药组合物
作为前药如地匹福林或前药AQEP-03、AQEP-04、AQEP-05、AQEP-06、AQEP-07、AQEP-08、AQEP-09、AQEP-10、AQEP-11、AQEP-12、AQEP-13、AQEP-14或AQEP-15施用肾上腺素赋予某些优点。一方面,地匹福林和前药AQEP-03、AQEP-04、AQEP-05、AQEP-06、AQEP-07、AQEP-08、AQEP-09、AQEP-10、AQEP-11、AQEP-12、AQEP-13、AQEP-14和AQEP-15是亲脂性的,并因此具有更高的渗透性通过肺组织。地匹福林和前药AQEP-03、AQEP-04、AQEP-05、AQEP-06、AQEP-07、AQEP-08、AQEP-09、AQEP-10、AQEP-11、AQEP-12、AQEP-13、AQEP-14、AQEP-15、AQEP-16、AQEP-17、AQEP-18、AQEP-19、AQEP-20、AQEP-21、AQEP-22、AQEP-23、AQeps-24、AQEP-25、AQEP-26、AQEPS-27和AQEP-28由于更高的蛋白质结合,各自都具有较长的血浆半衰期。地匹福林能够维持血液水平,并减少与α-受体的相互作用,因此最大限度地减少或消除不需要或有害的血管收缩。前药(例如AQEP-09)可以对α-和β-受体表现出更高的结合亲和力,其结合和激活特性相比地匹福林更类似于肾上腺素。其他前药和前药的组合可以表现出有利于一种或多种受体的对α-和β-受体的结合亲和力,与肾上腺素相似或不同。
地匹福林或前药AQEP-03、AQEP-04、AQEP-05、AQEP-06、AQEP-07、AQEP-08、AQEP-09、AQEP-10、AQEP-11、AQEP-12、AQEP-13、AQEP-14、AQEP-15、AQEP-16、AQEP-17、AQEP-18、AQEP-19、AQEP-20、AQEP-21、AQEP-22、AQEP-23、AQeps-24、AQEP-25、AQEP-26、AQEPS-27和AQEP-28可单独或组合通过吸入递送,与用肾上腺素相似的方式。例如,参见Breuer etal.Eur J Clin Pharmacol(2013)69:1303–1310,或Kerwin et al.Journal Of AerosolMedicine And Pulmonary Drug Delivery Volume33,Number 5,2020,每一篇都通过引用整体并入。
空间位阻是由于空间体积导致的化学反应的减慢。它通常在分子间反应中表现,如酶促反应。通常利用空间位阻以控制选择性,例如减缓不需要的副反应。在药理学中,空间效应决定了药物将怎样和以何等速率与目标生物分子相互作用。前药的设计需要考虑由前药取代基产生的空间位阻及其与相应酶(包括例如水解酶、酯酶和酰胺酶)相互作用。添加剂,例如下面描述的那些,也可以影响活性和/或与酶的相互作用。在某些实施方案中,这些酶中的一种或更多种可以是内源性的。在其他实施方案中,这些酶中的一种或更多种可以是外源性的。在取代碳原子上的立体特异性亲核攻击是一种简单而通用的方法,以用立体化学的整体反转在杂原子旁边构建立体中心。当与非叔基团相比时,与酯相邻的叔基团出乎意料地更阻碍水解。
添加剂可包括在组合物中。各类添加剂的实例包括防腐剂、抗菌剂、赋形剂、润滑剂、缓冲剂、稳定剂、发泡剂、颜料、着色剂、填料、填充剂、甜味剂、调味剂、芳香剂、释放改性剂、佐剂、增塑剂、盐、流动加速剂、脱模剂、多元醇、制粒剂、稀释液、结合剂、缓冲液、吸收剂、助流剂、粘合剂、抗粘附剂、酸化剂、软化剂、树脂、缓和剂(demulcent)、溶剂、表面活性剂、乳化剂、弹性体、抗粘着(anti-tacking)剂、抗静电剂及其混合物。这些添加剂可与一种或多种药物活性组分一起添加。赋形剂是指优化制剂(例如,增加其流动性)的化合物或颗粒。如本文所用,术语“稳定剂”是指能够防止活性药物成分、另一赋形剂或其组合的聚集或其他物理降解以及化学降解的赋形剂。
稳定剂也可分类为抗氧化剂、螯合剂、pH修饰剂、乳化剂和/或表面活性剂或紫外线稳定剂。
抗氧化剂(即,减缓、抑制、中断和/或停止氧化过程的药学上兼容的一种或多种化合物或组合物)特别包括以下物质:生育酚及其酯、芝麻油的芝麻酚、安息香树脂的松柏醇苯甲酸酯、去甲二氢愈创木树脂(nordihydroguaietic resin)和去甲二氢愈创木酸(NDGA)、没食子酸、没食子酸酯(尤其是甲基、乙基、丙基、戊基、丁基、月桂基没食子酸酯),丁基羟基茴香醚(BHA/BHT,也是丁基对甲酚);抗坏血酸及其盐和酯(例如抗坏血酸棕榈酸酯)、赤藻糖酸(异抗坏血酸)及其盐和酯、硫代甘油、甲醛次硫酸氢钠、焦亚硫酸钠、亚硫酸氢钠、亚硫酸钠、偏重亚硫酸钾、乙二胺四乙酸(EDTA)、乙二醇-二(β-氨基乙醚)-N,N,N′,N′-四乙酸(EGTA)、丁基羟基甲苯(BHT)(包括叔丁基羟基甲苯)、半胱氨酸、阿魏酸、咖啡酸、单宁酸、尿酸和丙酸。典型的抗氧化剂例如生育酚(如α-生育酚和其酯)、丁基羟基甲苯和丁基羟基茴香醚。术语“生育酚”也包括生育酚的酯。已知的生育酚为α-生育酚。术语“α-生育酚”包括α-生育酚的酯(例如α-生育酚-醋酸酯)。
螯合剂(即,可以与另一种化合物(如活性成分或另一赋形剂)形成主-客体复合物的任何化合物;也称为螯合剂)包括氯化钙、乙二胺四乙酸钙二钠、葡萄糖酸δ-内酯、葡萄糖酸钠、葡萄糖酸钾、三聚磷酸钠、六偏磷酸钠及其组合。螯合剂还包括环状低聚糖,如环糊精、cyclomannins(通过α键在1,4位连接的5个或更多个α-D-吡喃甘露糖单元)、cyclogalactins(通过β键在1,4位连接的5个或更多个β-D-吡喃半乳糖单元),cycloaltrins(通过α键在1,4位连接的5个或更多个α-D-吡喃阿卓糖单元),及其组合。
pH调节剂或稳定剂包括酸(例如,盐酸、氢氟酸、酒石酸、柠檬酸、乳酸、富马酸、磷酸、抗坏血酸、乙酸、琥珀酸、丙酸、丁酸、异丁酸、新戊酸、苹果酸、酒石酸、己二酸和马来酸)、酸性氨基酸(例如,谷氨酸、天冬氨酸等),这种酸性物质的无机盐(碱金属盐、碱土金属盐、铵盐等)、这种酸性物质与有机碱(例如,碱性氨基酸如赖氨酸、精氨酸等、葡甲胺等)的盐及其溶剂化物(例如水合物)。pH调节剂的其它实例包括硅化微晶纤维素、偏硅酸铝镁、磷酸的钙盐(例如磷酸氢钙无水或水合物、钙、钠或钾的碳酸盐或碳酸氢盐和乳酸钙或其混合物)、羧甲基纤维素的钠和/或钙盐,交联的羧甲基纤维素(例如交联羧甲基纤维素钠和/或钙)、波拉克林钾、海藻酸钠和/或钙、多库酯钠、镁钙、铝或锌的硬脂酸盐、棕榈酸镁和油酸镁、硬脂基富马酸钠及其组合。
乳化剂和/或表面活性剂的实例包括泊洛沙姆或普朗尼克、聚乙二醇、聚乙二醇单硬脂酸酯、聚山梨酯、月桂基硫酸钠、聚乙氧基化和氢化的蓖麻油、alkyl polyoside、疏水主链上的接枝水溶性蛋白质、卵磷脂、单硬脂酸甘油酯、单油酸甘油酯、单硬脂酸甘油酯/聚氧乙烯硬脂酸酯、酮硬脂醇/月桂基硫酸钠、卡波姆、磷脂、(C10-C20)-烷基和亚烷基羧酸酯、烷基醚羧酸酯、脂肪醇硫酸酯、脂肪醇醚硫酸酯、烷基酰胺硫酸酯和磺酸酯、脂肪酸烷基酰胺聚乙二醇醚硫酸酯、链烷烃磺酸酯和羟基链烷烃磺酸酯、烯烃磺酸酯、羟乙基磺酸的酰基酯、α-磺基脂肪酸酯、烷基苯磺酸酯、烷基酚乙二醇醚磺酸酯、磺基琥珀酸酯、磺基琥珀酸单酯和二酯、脂肪醇醚磷酸酯、蛋白质/脂肪酸缩合产物、烷基单甘油硫酸酯和磺酸酯、烷基甘油酯醚磺酸酯、脂肪酸氨基乙磺酸甲基(methyltauride)、脂肪酸肌氨酸酯、磺基蓖麻醇酸酯、和酰基谷氨酸酯、季铵盐(例如,二-(C10-C24)-烷基-二甲基氯化或溴化铵)、(C10-C24)-烷基-二甲基乙基氯化或溴化铵、(C10-C24)-烷基-三甲基氯化或溴化铵(例如、鲸蜡基三甲基氯化或溴化铵)、(C10-C24)-烷基-二甲基苄基氯化或溴化铵(例如、(C12—C18)-烷基-二甲基苄基氯化铵)、N—(C10-C18)-烷基-吡啶鎓氯化物或溴化物(例如、N—(C12-C16)-烷基-吡啶鎓氯化物或溴化物)、N—(C10-C18)-烷基-异喹啉鎓氯化物、溴化物或单烷基硫酸盐、N—(C12-C18)-烷基-多羟基氨基甲酰基甲基吡啶鎓氯化物、N—(C12-C18)-烷基-N-甲基吗啉鎓氯化物、溴化物或单烷基硫酸盐、N—(C12-C18)-烷基-N-乙基吗啉鎓氯化物、溴化物或单烷基硫酸盐、(C16-C18)-烷基-五氧乙基氯化铵、二异丁基苯氧基乙氧基乙基二甲基苄基氯化铵、N,N-二乙基氨基乙基硬脂基酰胺和-油酰胺与盐酸、乙酸、乳酸、柠檬酸、磷酸的盐、N-酰基氨基乙基-N,N-二乙基-N-甲基铵的氯化物、溴化物或单烷基硫酸盐、和N-酰基氨基乙基-N,N-二乙基-N-苄基铵的氯化物、溴化物或单烷基硫酸盐(在上述之中,“酰基”表示,例如,硬脂基或油烯基(oleyl)),及其组合。
该组合物可以包括肺表面活性剂,例如,类似于肺中自然产生的脂蛋白物质的材料,其对正确的呼吸、肺泡稳定性和气体交换至关重要。肺表面活性剂可以是通过II型肺泡细胞自然形成的表面活性剂,其降低肺泡气液界面的表面张力。肺表面活性剂通常由约90%的脂质(其中约一半是磷脂二棕榈酰磷脂酰胆碱(DPPC))和约10%的蛋白质组成。已经鉴定出至少四种天然表面活性剂:SP-A、B、C和D。疏水性表面活性剂蛋白B(SP-B)和C(SP-C)与磷脂紧密结合,并促进其吸附到肺泡的气液界面中。这些蛋白质对于表面活性剂组合物的形成是关键的。术语“表面活性剂”还包括目前可用的表面活性剂制剂,包括但不限于(贝拉克坦)、/>(卡尔法坦(calfactant))、Exosurf />(棕榈胆磷)、/>(猪肺磷脂α)、/>(lucinatant)、/>(雾化/>)、(卢舒普肽)、/>(bovacant)等。
UV稳定剂的实例包括UV吸收剂(例如二苯甲酮)、UV淬灭剂(即,将UV能量作为热量消散,而不是使能量具有降解作用的任何化合物)、清除剂(即消除由暴露于UV辐射产生的自由基的任何化合物),及其组合。
在其他实施方案中,稳定剂包括抗坏血酸棕榈酸酯、抗坏血酸、α生育酚、丁基羟基甲苯、丁基羟基茴香醚、半胱氨酸HC1、柠檬酸、乙二胺四乙酸(EDTA)、甲硫氨酸、柠檬酸钠、抗坏血酸钠、硫代硫酸钠、焦亚硫酸钠、亚硫酸氢钠、没食子酸丙酯、谷胱甘肽、硫代甘油、单线态氧淬灭剂、羟自由基清除剂、过氧化氢清除剂、还原剂、金属螯合剂、洗涤剂、离液剂及其组合。“单线态氧淬灭剂”包括但不限于烷基咪唑(例如组氨酸、L-肌肽、组胺、咪唑4-乙酸)、吲哚(例如色氨酸及其衍生物,例如N-乙酰基-5-甲氧基色胺、N-乙酰血清素、6-甲氧基-1,2,3,4-四氢-β-咔啉)、含硫氨基酸(例如甲硫氨酸、乙硫氨酸、黎豆氨酸、羊毛硫氨酸、N-甲酰基甲硫氨酸、猫尿氨酸、S-烯丙基半胱氨酸、S-氨乙基-L-半胱氨酸)、酚化合物(例如酪氨酸及其衍生物)、芳香酸(例如抗坏血酸、水杨酸及其衍生物)、叠氮化物(例如叠氮化钠)、生育酚和相关的维生素E衍生物和胡萝卜素和相关的维生素A衍生物。“羟基自由基清除剂”包括但不限于叠氮化物、二甲基亚砜、组氨酸、甘露醇、蔗糖、葡萄糖、水杨酸盐和L-半胱氨酸。“过氧化氢去除剂”包括但不限于过氧化氢酶、丙酮酸盐、谷胱甘肽和谷胱甘肽过氧化物酶类。“还原剂”包括但不限于半胱氨酸和巯基乙烯。“金属螯合剂”包括但不限于EDTA、EGTA、邻菲咯啉和柠檬酸盐。“洗涤剂”包括但不限于SDS和十二烷基肌氨酸钠。“离液剂”包括但不限于盐酸胍、异硫氰酸盐、脲和甲酰胺。如本文所讨论,稳定剂可以0.0001%-50%重量存在,包括大于0.0001%、大于0.001%、大于0.01%、大于0.1%、大于1%、大于5%、大于10%、大于20%、大于30%、大于40%、大于50%、小于50%、小于40%、小于30%、小于20%、小于10%、小于1%、小于0.1%,小于0.01%、小于0.001%或小于0.0001%重量。
有用的添加剂可以包括,例如明胶、明胶水解产物、重组明胶;植物蛋白,如向日葵蛋白、大豆蛋白、棉籽蛋白、花生蛋白、葡萄籽蛋白、乳清蛋白、乳清蛋白分离物、血蛋白、卵蛋白、丙烯酸化蛋白;多糖或碳水化合物,例如阿拉伯胶、甲壳素、壳聚糖、黄原胶、琼脂、印度树胶、硫酸软骨素、葡聚糖、角叉菜胶、刺梧桐树胶、透明质酸、凝胶多糖、海藻酸、黄蓍胶、支链淀粉、昆布多糖、khaya、zanflo、合欢胶、瓜尔豆胶、面包酵母、刺槐豆胶、聚糖、淀粉、裂褶多糖、淀粉酶、香菇多糖、纤维素、krestin、果胶、硬葡聚糖、落叶松胶、马铃薯淀粉、豌豆淀粉、hetastarch、淀粉乙酸酯、淀粉磷酸酯、菊粉和果胶,水溶性多糖,如海藻酸盐、角叉菜胶、瓜尔胶、琼脂、黄原胶、结冷胶、阿拉伯胶和相关胶(印度树胶、刺梧桐树胶、黄耆胶)、果胶;纤维素的水溶性衍生物:烷基纤维素,羟烷基纤维素和羟烷基烷基纤维素,如甲基纤维素、羟甲基纤维素、羟乙基纤维素、羟丙基纤维素、羟乙基甲基纤维素、羟丙基甲基纤维素、羟丁基甲基纤维素;纤维素酯和羟烷基纤维素酯,如乙酸邻苯二甲酸纤维素(CAP)、羟丙基甲基纤维素(HPMC);羧烷基纤维素、羧烷基烷基纤维素、羧烷基纤维素酯,如羧甲基纤维素及它们的碱金属盐;水溶性合成聚合物,如聚丙烯酸和聚丙烯酸酯、聚甲基丙烯酸和聚甲基丙烯酸酯、聚乙酸乙烯酯、聚乙烯醇、聚乙酸邻苯二甲酸乙烯酯(polyvinylacetatephthalate)(PVAP)、聚乙烯吡咯烷酮(PVP)、PVA/乙酸乙烯酯共聚物和聚巴豆酸;合适的还有邻苯二甲酸化明胶、明胶琥珀酸酯、交联的明胶、虫胶、淀粉的水溶性化学衍生物、阳离子改性的丙烯酸酯和甲基丙烯酸酯(其具有例如叔氨基或季氨基,例如二乙基氨基乙基,需要时可以使其季铵化);或其它类似聚合物。
稳定剂可以包括纳米颗粒稳定剂,例如纳米颗粒表面周围的分散剂层。例如,参见Langmuir 2007,(23)3,1081-1090,2006年12月20日,doi.org/10.1021/la062042s,其通过引用整体并入。稳定剂可以包括稳定剂配体,例如,具有可以化学吸附在纳米颗粒上以形成可聚合单层的官能团的单体。例如,参见Jadhav等人doi.org/10.1002/ppsc.201400074,其通过引用整体并入。稳定剂可以包括表面稳定剂。参见例如美国专利号6428814和日本专利JP 4598399B2,其每一个通过引用整体并入。表面稳定剂可以包括泰洛沙泊(美国专利号5429824)、聚亚烷基嵌段共聚物(美国专利号5565188)、硫酸化非离子嵌段共聚物(美国专利号5,569,448)、高分子量线性聚(环氧乙烷)聚合物(美国专利号5580579)、环氧丁烯-环氧乙烷嵌段共聚物(美国专利号5,587,143),羟丙基纤维素(美国专利号5591456)和基于糖的表面稳定剂(美国专利号5622938),其每一个通过引用整体并入。稳定剂可以包括肽稳定剂。参见例如WO2006097748A2,其通过引用整体并入。稳定剂可以包括例如L-半胱氨酸盐酸盐、甘氨酸盐酸盐、苹果酸、偏亚硫酸氢钠、柠檬酸、酒石酸和L-胱氨酸二盐酸盐。参见例如U.S.Pat.6,153,223,其通过引用整体并入。稳定剂可以包括天然化合物。稳定剂可以包括合成化合物。稳定剂可以包括上述一种或更多种化合物或化合物类别的混合物。稳定剂可以起到保护前药代谢直至所需的时间或直至其到达特定的靶点、组织或环境的作用。
基于所有组合物组分的重量,附加组分的范围可以高达约80%,理想地约0.005%至50%,更理想地在1%至20%的范围内,包括大于1%、大于5%、大于10%、大于20%、大于30%、大于40%、大于50%、大于60%、大于70%、约80%、大于80%、小于80%,小于70%、小于60%、小于50%、小于40%、小于30%、小于20%、小于10%、小于5%、约3%或小于1%。
其他添加剂可以包括抗粘着剂、流动剂和遮光剂,例如镁铝、硅、钛等的氧化物,基于所有组合物组分的重量,理想地浓度范围为约0.005%至约5%重量,且理想地约0.02%至约2%,包括大于0.02%、大于0.2%、大于0.5%、大于1%,大于1.5%、大于2%、大于4%、约5%、大于5%、小于4%、小于2%、小于1%、小于0.5%、小于0.2%或小于0.02%。
该组合物的其它合适的添加剂可以包括水;萜烯,如薄荷醇;醇类,如乙醇、丙二醇、甘油和其他类似的醇类;二甲基甲酰胺;二甲基乙酰胺;蜡以及其混合物。
在某些实施方案中,该组合物可包含增塑剂,其可包括聚亚烷基氧化物,例如聚乙二醇、聚丙二醇、聚乙-丙二醇、具有低分子量的有机增塑剂例如甘油、甘油单乙酸酯、二乙酸酯或三乙酸酯、三乙酸甘油酯、聚山梨酯、鲸蜡醇、丙二醇、糖醇山梨醇、二乙基磺基琥珀酸钠、柠檬酸三乙酯、柠檬酸三丁酯、植物提取物、脂肪酸酯、脂肪酸、油等,基于组合的重量,添加的浓度范围为约0.1%至约40%,且理想地约0.5%至约20%,包括大于0.5%、大于1%、大于1.5%、大于2%、大于4%、大于5%,大于10%、大于15%、约20%、大于20%、小于20%、小于15%、小于10%、小于5%、小于4%、小于2%、小于1%或小于0.5%。在某些实施方案中,可进一步添加化合物以改善组合物材料的质地特性,例如动物或植物脂肪,理想地为它们的氢化形式。组合物还可包含改善产品质地特性的化合物。其他成分可以包括有助于组合物的易于形成和一般质量的粘合剂。粘合剂的非限制性实例包括淀粉、天然胶、预糊化淀粉、明胶、聚乙烯吡咯烷酮、甲基纤维素、羧甲基纤维素钠、乙基纤维素、聚丙烯酰胺、聚乙烯氧唑烷酮或聚乙烯醇。
其他潜在的添加剂包括溶解度增强剂,例如与活性成分形成包合化合物的物质。这样的试剂可用于改善非常不溶和/或不稳定的活性物质的性质。一般来说,这些物质是具有疏水的内部空腔和亲水的外部的环状分子。不溶的和/或不稳定的药物活性成分可配置在该疏水腔内,从而产生可溶于水的包合配合物。因此,包合配合物的形成允许非常不溶和/或不稳定的药物活性成分溶解在水中。这种试剂的一个特别理想地的例子是环糊精,其是衍生自淀粉的环状碳水化合物。然而,其他类似物质也被认为完全在本发明的范围内。
在某些实施方案中,可以添加着色剂。合适的着色剂包括食品、药物和化妆品颜料(FD&C)、药物和化妆品颜料(D&C)或外用药物和化妆品颜料(Ext.D&C)。这些颜料是染料、它们相应的色淀以及某些天然和衍生的着色剂。色淀是吸收在氢氧化铝上的染料。着色剂的其它实例包括已知的偶氮染料、有机或无机颜料、或天然来源的着色剂。无机颜料是优选的,例如氧化物或铁或钛,基于所有组分的重量,这些氧化物的添加浓度范围为约0.001-约10%,并且优选地约0.5至约3%,包括大于0.001%、大于0.01%、大于0.1%、大于0.5%、大于1%、大于2%、大于5%、约10%、大于10%、小于10%、小于5%、小于2%、小于1%、小于0.5%、小于0.1%、小于0.01%或小于0.001%。
香料可以选自天然和合成的调味液体。这类试剂的例证性的列表包括挥发性油、合成香料油、芳香调味料、油、液体、油树脂或源自植物、叶、花、果实、茎及其组合的提取物。实例的非限制性代表性列表包括薄荷油、可可和柑橘油(例如柠檬、橙子、酸橙和葡萄柚),以及水果香精,包括苹果、梨、桃、葡萄、草莓、树莓、樱桃、李子、菠萝、杏或其他水果香料。其他有用的调味剂包括醛和酯,例如苯甲醛(樱桃、杏仁)、柠檬醛,即α-柠檬醛(柠檬、酸橙)、橙花醛,即β-柠檬醛(柠檬、酸橙)、癸醛(桔子、柠檬)、C-8醛(柑橘类水果)、C-9醛(柑橘类果类)、C-12醛(柑橘类果实)、甲苯基醛(樱桃、杏仁)、2,6-二甲基辛醇(绿色水果)或2-十二烯醛(柑橘类、柑橘),其组合等。
甜味剂可选自以下非限制性列表:糖、葡萄糖(玉米糖浆)、右旋糖、转化糖、果糖及其组合、糖精及其各种盐如钠盐;基于二肽的甜味剂,如阿斯巴甜、纽甜、爱德万甜(advantame);二氢查尔酮化合物,甘草甜素;甜叶菊(甜菊苷);蔗糖的氯衍生物,例如三氯蔗糖;糖醇如山梨醇、甘露醇、木糖醇等。还涵盖了氢化淀粉水解物和合成甜味剂3,6-二氢-6-甲基-1-1-1,2,3-噁噻嗪-4-酮-2,2-二氧化物,特别是钾盐(乙酰舒泛-K)及其钠盐和钙盐,以及天然强化甜味剂,如罗汉果。也可使用其他甜味剂。
消泡和/或去泡组分也可与组合物一起使用。这些组分有助于从组合物中去除空气(例如截留的空气)。这种截留的空气可能导致不均匀的组合物。二甲基硅油是一种特别有用的消泡和/或去泡剂。然而,本发明不限于此,并且可使用其他合适的消泡和/或去泡剂。二甲硅油和相关试剂可用于致密化的目的。更具体地,这样的试剂可有助于去除空隙、空气、湿气和类似的不需要的成分,从而提供更致密且因此更均匀的组合物。执行此功能的试剂或组分可以称为致密化剂或稠密剂。如上描述,截留的空气或不需要的成分可导致不均匀的组合物。
上述提到的共同指定的美国专利号7425292和美国专利号8765167中描述的任何其他任选组分也可包含在本文描述的组合物中,其每一个都通过引用整体并入。
组合物还理想地含有缓冲液以控制组合物的pH。任何所需水平的缓冲液都可以掺入组合物中,以提供当遇到药物活性组分从组合物中释放时所需的pH水平。缓冲剂优选以足以控制药物活性成分从组合物中释放和/或吸收到体内的量提供。在一些实施方案中,缓冲剂可以包括柠檬酸钠、柠檬酸、酒石酸氢盐及其组合。
对肾上腺素前药进行了评价。采用体外吸入模型。特别是,使用酯酶水解测定(使用人支气管肺泡灌洗液)以检查前药的稳定性。还进行了使用人肺上皮细胞的体外3D培养模型(EpiAirways,MatTek)的渗透性测定。3D培养系统模拟肺的结构,其允许研究前药在肺中通过酯酶的水解和全身渗透性数据。EpiAirway 3D培养物包括纤毛顶端表面、粘膜纤毛上皮和微孔膜。
通过测量肾上腺素的浓度,在人BAL液中对地匹福林或AQEP-09的水解进行了体外研究。使用来自2名受试者的冷冻BAL液。化合物在稳定剂(偏亚硫酸氢钠,8.9mM)的存在下在1μM培养。在不同时间点使用NaF或SigmaFast停止酶反应后移除样品。样品通过LC-MS法进行提取和分析。地匹福林和AQEP-09显示了对肾上腺素的水解作用最小。参见图2A-2B。观察到的水解小于5%。
研究了3D培养物的体外渗透性。
Franz扩散池是用于离体组织渗透测定的设备,用于制剂开发以鉴定最有效的渗透促进剂。Franz扩散池设备由两个通过膜分隔的腔室组成。使用3D肺细胞培养物进行渗透研究。组织膜将含有前药的供体隔室和含有收集介质的受体隔室分隔开,所述收集媒介被选择以在整个实验中提供下沉条件。通过分析受体介质中的药物浓度,历经数小时观察渗透速率。
将化合物在不同浓度(5mM、10mM和50mM)下孵育。通过LDH细胞毒性检测试剂盒(Takara#MK401)和MTT组织活力测定试剂盒(MatTek,#MTT-100)评估细胞活力。在不同的时间点(0.5、1、2、3、4、6hrs)移除接受体介质以测试渗透性;样品通过LC-MS方法提取并分析。
肾上腺素没有发现毒性,但是,通过MTT测定,在所有剂量的地匹福林,细胞活力都降低了。在LDH测定中,在所有剂量的地匹福林,细胞活力在6h降低,但在24hr活力改善。
参照图3A和3B,在人肺模型中进行了渗透性研究。确定了浓度和时间进程。如图所示,肾上腺素随着浓度的增加没有表现出显著的渗透性,但观察到地匹福林的剂量依赖的渗透性。
参照图3C-3D,在EpiAirway模型中还使用人肺上皮细胞研究了地匹福林和AQEP-09的毒性和渗透性。将化合物在不同浓度(0.1mM、1mM、2mM)培养,并通过LDH释放测定和MTT测定评估细胞活力。例如,参见Aysun Adan,Kiraz and Yusuf Baran,“CellProliferation and Cytotoxicity Assays”,Current Pharmaceutical Biotechnology(2016)17:1213,其通过引用整体并入。在不同的时间点(1、2、3、4hrs)移除接受体介质以测试渗透性。样品通过LC-MS法提取和分析。
AQEP-09在MTT测定或LDH测定中没有显示任何毒性,但是观察到地匹福林的细胞活力较低。与地匹福林相比,AQEP-09在所有测试剂量都显示了较低的渗透性。参见图3C-3I。
总之,肾上腺素的酯前药(如地匹福林和AQEP-09)显示出在BAL流体中对肾上腺素的水解作用最小。肾上腺素即使在比酯前药高5-10倍的浓度也不能渗透。与地匹福林相比,AQEP-09在肺上皮细胞模型中显示出更低的渗透性。MTT和LDH释放数据都显示出,与地匹福林相比,AQEP-09在所有测试浓度均无毒性或毒性较小。由于AQEP-09毒性较小,增加剂量可潜在地有助于实现更高的药物渗透性(剂量增加50%显示出与地匹福林相当的渗透性)。
参照图3J-3U,显示了在肾上腺素产品的深肺递送后比格犬的肾上腺素血浆水平。
参照图4A-B,显示了前药和乳糖一水合物的色谱图,如下面实施例1和2中所讨论的。
参照图5和6,显示了地匹福林微粉化粉末的颗粒尺寸分布。
参照图7和8,显示了AQEP-09的微粉化粉末的颗粒尺寸分布。
实施例
实施例1肾上腺素前药的微粉化
地匹福林和二异丁酰基L-肾上腺素均采用氮气使用喷射研磨工艺进行微粉化。确定了压力和进料速率的影响。微粉化材料的颗粒尺寸在表1中显示,并制备了适用于药物粉末吸入(2-5μm)的微粉化/研磨材料。
表1.1用于吸入的微粉化肾上腺素前药的颗粒尺寸分布
实施例2颗粒尺寸分布
表中给出了通过空气动力学颗粒尺寸仪测量的暴露气溶胶的MMAD和GSD。地匹福林和AQEP-09的空气动力学颗粒尺寸分布在图5-8显示。AQEP-09的质量中位数空气动力学直径(MMAD)为1.57μm(几何标准偏差(GSD)1.74),地匹福林的MMAD为1.47μm(GSD 2.63)。如图7所示,约50%的颗粒小于1.47μm(GSD 2.63),约62%的小于2μm,以及约74%的小于3μm。
表2.1颗粒尺寸分布的总结
暴露组 | MMAD(μm) | GSD |
地匹福林 | 1.47 | 2.63 |
AQEP-09 | 1.57 | 1.74 |
实施例3赋形剂相容性研究
研究了肾上腺素前药二异丁酰基L-肾上腺素(AQEP-09)和地匹福林与用于干粉吸入应用中常用载体的相容性。乳糖一水合物、无水乳糖和甘露醇被用于稳定性评价。在稳定条件(25℃/60%RH和40℃/75%RH)测试了微粉化API和载体的混合物。该数据在表3.1和表3.2中显示。初步评估表明,它们在室温(保质期条件)至少稳定4周。在图4A中显示的色谱图证明了在乳糖一水合物存在时AQEP-09的色谱图谱(单个活性峰)。在图4B中显示的色谱图证明在乳糖一水合物存在时地匹福林的色谱图谱(单个活性峰)。
表3.1二异丁酰基L-肾上腺素与干粉吸入载体的相容性
表3.2地匹福林与干粉吸入载体的相容性
实施例4比格犬研究
完成了一项研究,以评估在比格犬中推注(bolus)吸入AQEP-09和地匹福林后肾上腺素的药代动力学(PK)。将推注吸入与肌肉内(IM)递送肾上腺素进行比较。在这项研究之前,没有足够的狗毒理学数据来支持通过吸入使用计划的前药的临床应用。在计划的临床试验中,在狗中的推注吸入涵盖了这些TA的给药途径。
本研究的实验设计如下所示。12只比格犬随机分为3组。第1组的动物接受了单次肌肉内(IM)剂量的肾上腺素(自动注射器,0.3mg)。第2组和第3组的动物分别通过推注吸入接受单剂量的AQEP-09或地匹福林前药。给药后采集血液用于PK分析。暴露后收集一次支气管肺泡灌洗液。
对第1组和第2组的动物遭受至少7天的清洗期。在研究的第二臂中,第1组的动物用地匹福林给药并且第2组的动物用AQEP-09给药,然后像研究的第一臂中那样进行血液和支气管肺泡灌洗液(BAL)采样。使用Lovelace推注递送系统,通过气管内导管将供试品(TA)作为干粉递送到麻醉犬体内。麻醉动物被诱导呼吸暂停,吹药器连接到膨胀室和气管导管上,并且气溶胶使用Ambubag和注射器以正压“吹”入肺部。一旦气溶胶被递送,动物就从麻醉中恢复过来。
使用0.3mg(Mylan,Canonsburg,PA)递送给药。
B就所提供的剂量而言(前药游离碱的mg);假设是10kg的狗。在第一臂中,第2组和第3组的动物分别通过推注吸入接受单剂量的AQEP-09或地匹福林。
C第1组和第2组的动物经历了至少7天的冲洗期。在本研究的第二臂中,第1组的动物服用了地匹福林。在研究的第二臂中中,第2组的动物服用AQEP-09。
D对于每个臂,仅从AQEP-09和地匹福林组的动物中收集BAL。
在递送之前和之后对吹药装置进行称重,以确定提供的递送材料量的净重。测试和暴露是在将每种相应的供试品装载到吹药器储存器中的标称吹药器装载重量为10±1.5mg的情况下进行的。为了达到目标剂量,使用的吹药器的数量各不相同。每只动物使用两个吹药器以进行低剂量暴露。高剂量的地匹福林暴露使用了8个吹药器,并减少到4个吹药器。表4.1和表4.2分别总结了低剂量和高剂量AQEP-09暴露的气溶胶数据;并且低剂量和高剂量地匹福林暴露的数据分别总结在表4.3和表4.4中。低剂量和高剂量AQEP-09暴露期间喷出的物质平均量分别为12.92和23.32mg。低剂量和高剂量地匹福林暴露期间喷出的物质平均量分别为16.56和54.44mg。
表4.1低剂量AQEP-09暴露总结(第一臂,第2组)
表4.2高剂量AQEP-09暴露总结(第二臂,第2组)
表4.3低剂量地匹福林暴露总结(第二臂,第1组)
表4.4高剂量地匹福林暴露总结(第二臂,第3组)
对于AQEP-09和地匹福林,剂量按提供和沉积剂量通过性别和性别的组合计算。上表中包括了在mg/kg的基础上的总提供和肺沉积剂量。对于AQEP-09,低剂量和高剂量组的平均提供剂量(presented dose)分别为3.91和7.55mg/kg,平均递送剂量分别为1.17和2.27mg/kg。对于地匹福林,低剂量和高剂量组的平均提供剂量分别为2.67和8.79mg/kg,平均递送剂量分别为0.80和2.64mg/kg。
对于肾上腺素组,通过将IM给药递送的量(mg)除以动物体重(千克)来确定剂量(表4.5)。肾上腺素的平均剂量为0.037mg/kg。
表4.5.肾上腺素给药总结(第一臂,第1组)/>
根据从吹药器喷出的物质量、递送效率和TA的药物组分百分比计算提供和沉积剂量。每种TA的总效率在暴露前确定,AQEP-09为0.41,地匹福林为0.19。
AQEQ-09的计算的平均提供剂量为低剂量0.50mg/kg(标准偏差0.09),高剂量0.91mg/kg(标准偏差0.11)。地匹福林的计算的平均提供剂量为低剂量为0.34mg/kg(标准偏差0.06),高剂量为1.07mg/kg(标准偏差0.19)。提供和沉积剂量概述如下。提供的量是从注射器中喷出的量。沉积的量是到达气管插管的量。
参见图3J,给出了吸入研究的结果,其反映了所指示的前药在深肺递送后比格犬的肾上腺素血浆水平。点划线和虚线反映了与自动注射器数据相比的前药数据。
参见图3K,前药的结果被放大了。参见图3K和3I,显示了反映体外和Beagle模型之间结果一致性的数据。渗透性大约有四倍的差异。
参见图3M,提供了狗的曲线图以供参考。显示血浆浓度大于1且小于4.0ng/ml并反映在下表中。例如,大于1.2、大于1.3、大于1.5和大于1.8。
给药剂量为0.3mg/动物,结果为0.03–0.05mg/kg.
参见图3N至3U,比格犬中通过吸入的肾上腺素的曲线图在下图表中所示和反映。
图3N显示了通过吸入来自AQEP-09(0.2mg/kg)的肾上腺素的曲线图。图3O是放大的图3N的插入图。
图3P显示了通过吸入来自AQEP-09(0.4mg/kg)的肾上腺素的曲线图。图3Q是放大的图3P的插入图。如下提到的,Cmax大于100mg/kg、大于120mg/kg、大于130mg/kg和大于140mg/kg、大于200mg/kg、大于300mg/kg、大于500mg/kg、大于1000mg/kg和小于1500mg/kg。
图3R显示了通过吸入来自地匹福林(0.2mg/kg)的肾上腺素的曲线图。图3S是放大的图3R的插入图。
图3T显示了通过吸入来自地匹福林(0.8mg/kg)的肾上腺素的曲线图。图3U是放大的图3T的插入图。如下提到的,Cmax大于200mg/kg、大于300mg/kg、大于400mg/kg和小于1000mg/kg。
获得了前药AQEP-09的以下pK数据。狗2002与其他3只狗相比有显著不同的剂量反应。总体剂量反应略低于剂量比例(目标2X)。
获得了前药地匹福林的以下pK数据。如下所示,4X的剂量增加产生了~2X的剂量反应。
在某些实施方案中,包含前药的该组合物以大于0.05mg且小于5mg的剂量施用。
在某些实施方案中,该组合物具有大于5且小于300mg/kg的Cmax。
在某些实施方案中,该前药的药物活性形式的有效血浆浓度具有大于0.5秒且小于40秒的Tmax。
其他实施方案在以下权利要求的范围内。
Claims (60)
1.在人类受试者中治疗医学病症的方法,包括:
通过吸入施用包含前药的组合物,所述前药穿过肺组织以在所述人类受试者中达到所述前药的药物活性形式的有效血浆浓度。
2.权利要求1所述的方法,其进一步包括在吸入器中提供所述组合物。
3.权利要求2所述的方法,其中所述组合物是具有小于5微米的平均中位数空气动力学直径的粉末。
4.权利要求2所述的方法,其中所述组合物是液体、凝胶或悬浮液。
5.权利要求2所述的方法,其中所述吸入器包含推进剂。
6.权利要求1所述的方法,其进一步包括在喷雾器中提供所述组合物。
7.权利要求1所述的方法,其进一步包括在气溶胶中提供所述组合物。
8.权利要求7所述的方法,其中在气溶胶中提供所述组合物包括快速加热所述组合物以汽化或升华所述组合物。
9.权利要求1所述的方法,其中所述组合物基本上由所述前药组成。
10.权利要求1所述的方法,其中所述组合物基本上由所述前药和肾上腺素组成。
11.权利要求1所述的方法,其中所述组合物基本上由所述前药和第二前药组成。
12.权利要求1所述的方法,其中所述前药包括所述前药的药物活性形式的烷基酯。
13.权利要求1所述的方法,其中所述前药包括所述前药的药物活性形式的丁基酯。
14.权利要求1所述的方法,其中所述前药包括所述前药的药物活性形式的异丙基酯。
15.权利要求1所述的方法,其中所述前药包括所述前药的药物活性形式的乙基酯。
16.权利要求1所述的方法,其中所述前药包括肾上腺素的酯。
17.权利要求1所述的方法,其中所述医学病症在过敏症谱中。
18.权利要求1所述的方法,其中所述医学病症是过敏反应。
19.权利要求1所述的方法,其中所述医学病症是心脏异常。
20.权利要求1所述的方法,其中所述医学病症是肺部异常。
21.权利要求1所述的方法,其中所述包含前药的组合物包含一种以上的前药,其中每种前药是药物活性成分的衍生物。
22.权利要求21所述的方法,其中所述第一前药是肾上腺素的第一酯且第二前药是肾上腺素的第二酯,所述肾上腺素的第一酯和所述肾上腺素的第二酯是不同的。
23.权利要求1所述的方法,其中所述前药是式(I)的化合物或其药学上可接受的盐,其中
R1a、R1b、R2和R3中的每一个独立地可以是H、C1-C16酰基、烷基氨基羰基、烷基氧羰基、苯甲酰甲基、硫酸酯基或磷酸酯基,或R1a和R1b一起、R1a和R2一起、R1a和R3一起、R1b和R2一起、R1b和R3一起,或R2和R3一起形成包含二羰基、二硫酸酯基或二磷酸酯基部分的环结构,条件是R1,R2和R3中的一个不是H。
24.权利要求23所述的方法,其中R2和R3为H并且每个R1a和R1b独立地是乙酰基、正丙酰基、异丙酰基、正丁酰基、异丁酰基、仲丁酰基、叔丁酰基、正戊酰基、异戊酰基、仲戊酰基、叔戊酰基或新戊酰基。
25.吸入装置,包括:
壳体和在所述壳体内的组合物,所述组合物包含前药。
26.权利要求25所述的装置,其中所述组合物基本上由所述前药组成。
27.权利要求25所述的装置,其中所述前药包括药物活性化合物的烷基酯。
28.权利要求25所述的装置,其中所述前药包括药物活性化合物的丁基酯。
29.权利要求23所述的装置,其中所述前药包括药物活性化合物的异丙基酯。
30.权利要求25所述的装置,其中所述前药包括药物活性化合物的乙基酯。
31.权利要求25所述的装置,其中所述前药包括肾上腺素的酯。
32.权利要求25所述的装置,其中所述包含前药的组合物包含一种以上前药,其中每种前药是药物活性成分的衍生物。
33.权利要求25所述的装置,其中第一前药是肾上腺素的第一酯且第二前药是肾上腺素的第二酯,所述肾上腺素的第一酯和所述肾上腺素的第二酯是不同的。
34.权利要求25所述的装置,其中所述前药是式(I)化合物或其药学上可接受的盐,其中
R1a,R1b,R2和R3中的每一个独立地可以是H、C1-C16酰基、烷基氨基羰基、烷基氧羰基、苯甲酰甲基、硫酸酯基或磷酸酯基,或R1a和R1b一起、R1a和R2一起、R1a和R3一起、R1b和R2一起、R1b和R3一起,或R2和R3一起形成包含二羰基、二硫酸酯基或二磷酸酯基部分的环状结构,条件是R1,R2和R3中的一个不是H。
35.权利要求25所述的装置,其中R2和R3是H并且每个R1a和R1b独立地为乙酰基、正丙酰基、异丙酰基、正丁酰基、异丁酰基、仲丁酰基、叔丁酰基、正戊酰基、异戊酰基、仲戊酰基、叔戊酰基或新戊酰基。
36.权利要求25所述的吸入装置,其中所述壳体是基于泡罩的壳体且所述组合物是预装载剂量的粉末。
37.权利要求25所述的吸入装置,其中所述壳体包括胶囊,所述胶囊包含单位剂量的所述组合物的粉末。
38.权利要求25所述的组合物,其中所述组合物包含所述前药和肾上腺素。
39.权利要求25所述的组合物,其中所述组合物包含所述前药和第二前药。
40.在哺乳动物中治疗医学病症的方法,其包括施用治疗有效量的包含前药和肾上腺素的组合物,以及局部和全身递送所述组合物。
41.在哺乳动物中治疗医学病症的方法,其包括施用治疗有效量的包含第一前药和第二前药的组合物,并局部和全身递送所述组合物。
42.权利要求41所述的方法,其中所述治疗有效量是提供剂量与沉积剂量的比率。
43.权利要求42所述的方法,其中所述比率大于0.28。
44.权利要求42所述的方法,其中所述比率为约0.3。
45.权利要求41所述的方法,其中所述第一前药的沉积量大于0.09mg/kg。
46.权利要求41所述的方法,其中所述第二前药的沉积大于0.13mg/kg。
47.权利要求41所述的方法,其中所述第一前药的沉积量大于0.3mg/kg。
48.权利要求41所述的方法,其中所述第二前药的沉积大于0.25mg/kg。
49.权利要求12所述的方法,其中所述药物活性形式为肾上腺素。
50.权利要求13所述的方法,其中所述药物活性形式为肾上腺素。
51.权利要求14所述的方法,其中所述药物活性形式为肾上腺素。
52.权利要求15所述的方法,其中所述药物活性形式为肾上腺素。
53.权利要求1所述的方法,其中所述组合物产生的肾上腺素的血浆水平大于0.5mg/g和小于450mg/kg。
54.权利要求1所述的方法,其中所述包含前药的组合物以大于0.05mg和小于5mg的剂量施用。
55.权利要求54所述的方法,其中所述剂量为约0.5mg。
56.权利要求54所述的方法,其中所述剂量为约1.0mg。
57.权利要求54所述的方法,其中所述剂量为约1.5mg。
58.权利要求54所述的方法,其中所述剂量为约2.0mg。
59.权利要求1所述的方法,其中所述组合物具有大于5和小于300mg/kg的Cmax。
60.权利要求1所述的方法,其中所述前药的药物活性形式的所述有效血浆浓度具有大于0.5秒和小于40秒的Tmax。
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2022
- 2022-01-15 WO PCT/US2022/012633 patent/WO2022155544A1/en active Application Filing
- 2022-01-15 KR KR1020237027653A patent/KR20230134136A/ko unknown
- 2022-01-15 EP EP22703176.2A patent/EP4277611A1/en active Pending
- 2022-01-15 US US17/576,923 patent/US20220233471A1/en active Pending
- 2022-01-15 CA CA3208345A patent/CA3208345A1/en active Pending
- 2022-01-15 JP JP2023542915A patent/JP2024505429A/ja active Pending
- 2022-01-15 CN CN202280019510.6A patent/CN116940351A/zh active Pending
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KR20230134136A (ko) | 2023-09-20 |
JP2024505429A (ja) | 2024-02-06 |
US20220233471A1 (en) | 2022-07-28 |
EP4277611A1 (en) | 2023-11-22 |
CA3208345A1 (en) | 2022-07-21 |
WO2022155544A1 (en) | 2022-07-21 |
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