CN109562137A - 用于治疗与异常炎性反应有关的病况的方法和组合物 - Google Patents
用于治疗与异常炎性反应有关的病况的方法和组合物 Download PDFInfo
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- CN109562137A CN109562137A CN201680063216.XA CN201680063216A CN109562137A CN 109562137 A CN109562137 A CN 109562137A CN 201680063216 A CN201680063216 A CN 201680063216A CN 109562137 A CN109562137 A CN 109562137A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
本公开内容的特征在于可用于例如，在受试者(例如，人)中治疗特征为异常炎性反应的病理(例如，炎性肠病)的一种或多种症状的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)。本公开内容的特征还在于组合物以及使用和制备所述组合物的其它方法。
Description
相关申请的交叉引用
本申请要求2015年9月1日提交的美国临时申请号62/213,016和2015年10月14日提交的美国临时申请号62/241,508的权益；这些在先申请各自通过引用以其整体结合到本文中。
技术领域
本公开内容的特征在于可用于例如，在受试者(例如，人)中治疗特征为异常炎性反应的病理(例如，炎性肠病)的一种或多种症状的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶和/或药物组合；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶和/或药物组合；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或药物组合和/或共结晶)。本公开内容的特征还在于组合物以及使用和制备所述组合物的其它方法。
背景
溃疡性结肠炎(UC)和克罗恩病(CD)是在人中主要的慢性炎性肠病(IBD)。这些病症在性质上是自身免疫的，和在没有感染时发生。IBD影响达到2,000,000个美国人(每年增加约15%)和其与不可接受的高发病率和死亡率有关。IBD还是美国健康护理系统的重大负担，因为最有效的治疗是相当昂贵的生物学药物。
IBD因为在遗传易感个体中通过在环境刺激、微生物因素和肠免疫系统之间的复杂相互作用介导的不适合的免疫反应而发生。IBD的标志通过过度免疫反应表示，其直接或通过释放可溶性的促炎介质来介导胃肠组织损伤。
T细胞是一类浸润肠粘膜并且是IBD中胃肠组织损伤的重要驱动物的免疫细胞。因为试图检查或消除活化T细胞的正常生理机制在IBD的情况下不起作用，这些细胞持续和积聚在肠粘膜中。尽管未完全阐明在IBD中T细胞积聚的准确基础，但认为通过微生物刺激的慢性活化以及在胃肠组织内的炎症部位的细胞因子环境是重要的。不管这些细胞如何持续存在，增强肠粘膜中的T细胞死亡，与IBD的消退和通过杀死肠中存留的病原性T细胞来最有效管理IBD功能(部分地)的药物有关。
尽管不同形式的IBD显示病理生理学和临床差异，控制IBD的治疗方法共有许多共同要素。IBD的医学管理在很大程度上是根据经验的，利用抗炎性或免疫抑制性药物。柳氮磺吡啶和5-氨基水杨酸用于治疗轻度IBD和作为维持疗法(如果可实现疾病减轻)。皮质类固醇用于中等至严重疾病的患者。然而，仅可在约60%的患者中实现临床减轻，和这些的仅约一半在停止治疗后保持减轻。最后一点是重要的，因为长期使用皮质类固醇带有严重副作用的显著风险。
免疫抑制性药物也可用于治疗中等至严重的IBD病例，通常作为类固醇疗法的代替疗法。然而，免疫抑制性药物(例如，硫唑嘌呤)通常不能确保症状的控制，和治疗伴有许多禁忌和严重副作用。
在治疗IBD中通常显示最佳功效的药物是经系统给予(通过注射或输注)的单克隆抗体，其阻断TNF-α，一种在所有形式的IBD (例如，UC、CD、移植物抗宿主病、乳糜泻、医源性结肠炎例如通过检查点抑制剂诱导的结肠炎等)期间过度产生的促炎细胞因子。在IBD的情况下减少TNF-α的水平具有两个结果。首先，作为炎性细胞因子，TNF-α介导组织损伤。第二，高水平的TNF-α有助于引起疾病的T细胞存活，而阻断TNF-α活性最终导致T细胞死亡。事实上，通过抗-TNF-α药物例如英夫利昔单抗诱导细胞死亡，可预测患者的临床改善。
尽管有效，但使用抗-TNF-α药物涉及到严重的系统性副作用，包括潜伏病原体的再活化、超敏反应现象、癌症和形成自身抗体。一些患者对抗-TNF-α药物固有抵抗，和随时间进行，显示反应的所有患者的几乎一半发生抵抗。
根据前述内容，明显的是，对治疗IBD的新药物存在需要，与护理标准相比，所述新药物更有效、毒性更低、更便宜和更方便给药。
氯硝柳胺(5-氯-N-(2-氯-4-硝基苯基)-2-氢苯甲酰胺)是一种氢化的水杨苯胺，其属于一组称为驱肠虫药的药物。驱肠虫药是用于治疗蠕虫感染的药物。氯硝柳胺，其具有低的系统生物利用度和优秀的安全概况，用于治疗广谱或鱼绦虫、短小绦虫和牛肉绦虫感染。认为氯硝柳胺在绦虫(例如，tapeworm)的线粒体中抑制氧化磷酸化和刺激腺苷三磷酸酶活性，在体外和体内杀死绦虫的头节和近端区段(参见Li, Y.,等, Cancer Lett.2014349, 8-14.)。
最近的研究已鉴定了氯硝柳胺的其它可能用途；例如，作为可能的抗癌剂(Id.)；和作为用于治疗、预防和/或减轻II型糖尿病和糖尿病相关病症或并发症的症状的试剂(参见例如，WO 2012/068274)。美国专利8,148,328公开了氯硝柳胺提高某些肽的口服生物利用度。
概述
本公开内容的特征在于可用于例如，治疗受试者(例如，人)的特征为异常炎性反应的病理(例如，炎性肠病)的一种或多种症状的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶和/或药物组合；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶和/或药物组合；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或药物组合和/或共结晶)。本公开内容的特征还在于组合物以及使用和制备所述组合物的其它方法。
本公开内容部分地基于以下发现：氯硝柳胺杀死从IBD患者分离的病原性T细胞和在IBD的鼠模型中是有效的。尽管不希望受理论的约束，认为本文所述的化学实体(例如，氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶)在一种或多种T细胞中从氧化磷酸化解偶联线粒体呼吸，从而破坏一种或多种T细胞的线粒体能量循环和诱导一种或多种T细胞(例如，活化T细胞)的细胞死亡。令人惊讶地发现，本文所述的化学实体选择性地靶向和杀死与特征为异常炎性反应的病理有关的T细胞(例如，肠粘膜中的病原性T细胞)。
本文所述的化学实体、方法和组合物不仅提供高度有效和显著地杀死T细胞的治疗选项，而且提供解决与一些标准治疗方法有关的毒性、成本和方便问题的治疗选项。
在某些实施方案中，本文所述的方法可使用氯硝柳胺进行，其为一种具有确立和良好的安全性特征并且是FDA批准的驱肠虫药的小分子。
另外，本文所述的化学实体可容易和有效地局部给予，使得给予的化学实体产生的系统生物利用度相对低，和给予的化学实体产生的局部生物利用度相对高。在需要的治疗区域(例如，胃肠道)局部(非-系统)给予化学实体显著减少患者将经历与一些当前护理标准有关的系统毒性的可能性。前述内容可例如，通过选择具有相对低的口服生物利用度(F)的化学实体和/或通过利用在化学上和/或结构上易于使化学实体的系统暴露最小化的制剂实现(例如，所述制剂可设计为在GI道的目标区域中存在的pH下释放化学实体)。
根据上文描述的前述优点和特征，还预期本文所述的化学实体、方法和组合物是在不同的患者群体中有功能的和/或对细胞死亡机制的阻断具有较低敏感性。此外，利用传统小分子例如氯硝柳胺的能力可帮助降低成本和促进患者给予。
在一些实施方案中，本文所述的方法和组合物适合用于与各种其它治疗方案(例如，化学疗法和/或放射)的组合疗法。在某些实施方案中，本文所述的化学实体和方法可用于治疗由这样的治疗方案产生的副作用，例如，由化学治疗性免疫调节剂例如检查点抑制剂诱导的炎性肠病，在一些情况下其可能是相当严重的。另外，还预期本文所述的化学实体、方法和组合物可用于某些治疗抵抗患者群体，例如，对抗-TNFα疗法(例如，Humira,Enbrel, Remicade)的治疗无反应或抵抗的群体。
在一个方面，提供了用于诱导受试者的一种或多种T细胞(例如，在消化道和/或胃肠道(GI)、皮肤、眼睛或关节中)的细胞死亡的方法。所述方法包括使一种或多种T细胞与有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)接触。
在另一个方面，提供了用于治疗具有与受试者的一种或多种T细胞(例如，在消化道和/或胃肠道(GI)、皮肤、眼睛或关节)的不受调节的(异常的、提高的)募集和/或贮留有关的病况的受试者的方法。所述方法包括使一种或多种T细胞与有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)接触。
在进一步的方面，提供了用于治疗具有与受试者的一种或多种T细胞(例如，在消化道和/或胃肠道(GI)、皮肤、眼睛或关节中)的不受调节的(异常的、提高的)活化有关的病况的受试者的方法。所述方法包括使一种或多种活化T细胞与有效量的共结晶接触，所述共结晶包含(i) 线粒体解偶联剂或其药学上可接受的盐和/或水合物；和(ii) 本文任何地方定义的一种或多种药学上可接受的共形成物(coformer)。
在一个方面，提供了用于在有需要的受试者中治疗特征为异常炎性反应的病况(或其一种或多种症状)的方法(例如，自身免疫病症，例如，炎性肠病)。所述方法包括给予受试者有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)。
在另一个方面，提供了用于在有需要的受试者中治疗特征为异常炎性反应的病况(或其一种或多种症状)的方法(例如，自身免疫病症，例如，炎性肠病)。所述方法包括局部(topically)和局部(locally)给予受试者有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)。
在进一步的方面，提供了用于治疗受试者的自身免疫性结肠炎(或其一种或多种症状)的方法。所述方法包括局部(topically)和局部(locally)给予受试者有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)。
在一个方面，提供了用于治疗受试者的病况(或其一种或多种症状)的方法，所述病况选自乳糜泻、肠易激综合征、粘膜炎、葡萄膜炎、胶原性结肠炎、淋巴细胞性结肠炎、显微结肠炎、放射性小肠炎、类风湿性关节炎、狼疮、硬皮病、银屑病、皮肤T-细胞淋巴瘤、急性移植物抗宿主病和慢性移植物抗宿主病。所述方法包括局部(topically)和局部(locally)给予受试者有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)。
在一个方面，提供了共结晶，其包括：(i) 线粒体解偶联剂或其药学上可接受的盐和/或水合物；和(ii) 一种或多种药学上可接受的共形成物。
定义
为了便于理解本文提供的公开内容，下文定义了许多术语。通常，本文使用的命名法和本文所述的有机化学、药物化学和药理学中的实验程序是本领域众所周知和通常使用的那些。除非另外定义，本文使用的所有技术和科学术语通常具有本公开内容所属领域的普通技术人员通常理解的相同含义。本说明书和附件全文中提及的每个专利、申请、公开申请和其它出版物通过引用以其整体结合到本文中。
术语“消化道”理解为包括口、咽、食管、胃、小肠(十二指肠、空肠、回肠)、大肠(盲肠、结肠、直肠)和肛门。
术语"口腔"理解为包括口、咽和食管。
术语"胃肠道"或"GI道"理解为包括胃、小肠(十二指肠、空肠、回肠)、大肠(盲肠、结肠、直肠)和肛门。
如本文使用的关于制剂、组合物或成分的术语“可接受的”意指对治疗的受试者的一般健康没有持续的有害作用。
“API”是指活性药物成分。
如本文使用的术语“有效量”或“治疗有效量”是指给予的足够量的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)，其将在一定程度上减轻治疗的疾病或病况的一种或多种症状。结果包括减少和/或减轻疾病的迹象、症状或原因，或生物学系统的任何其它需要的改变。例如，对于治疗用途的“有效量”是提供疾病症状的临床显著减少所需的包含本文公开的化合物的组合物的量。在任何个体病例中适合的“有效”量使用任何适合的技术，例如剂量递增研究测定。
术语“赋形剂”或“药学上可接受的赋形剂”意指药学上可接受的材料、组分或媒介，例如液体或固体填充剂、稀释剂、载体、溶剂或包封材料。在一个实施方案中，在与药物制剂的其它成分相容，和适合用于与人和动物的组织或器官接触而无过度毒性、刺激、过敏反应、免疫原性或其它问题或并发症，与合理的收益/风险比相称的意义上，各组分是“药学上可接受的”。参见例如，Remington: The Science and Practice of Pharmacy, 21st ed.；Lippincott Williams & Wilkins: Philadelphia, PA, 2005；Handbook of Pharmaceutical Excipients, 6th ed.；Rowe等编辑；The Pharmaceutical Press andthe American Pharmaceutical Association: 2009；Handbook of Pharmaceutical Additives, 3rd ed.；Ash和Ash编辑；Gower Publishing Company: 2007；Pharmaceutical Preformulation and Formulation, 2nd ed.；Gibson编辑；CRC Press LLC: Boca Raton,FL, 2009。
术语“药学上可接受的盐”是指不引起对被给予它的生物的显著刺激和不废除化合物的生物活性和性质的化合物的制剂。在某些情况下，药学上可接受的盐通过使本文所述的化合物与酸例如盐酸、氢溴酸、硫酸、硝酸、磷酸、甲磺酸、乙磺酸、对甲苯磺酸、水杨酸等反应获得。在一些情况下，药学上可接受的盐通过使具有本文所述的酸性基团的化合物与碱反应形成盐例如铵盐、碱金属盐例如钠或钾盐、碱土金属盐例如钙或镁盐、有机碱例如二环己胺、N-甲基-D-葡萄糖胺、三(羟基甲基)甲胺的盐和与氨基酸例如精氨酸、赖氨酸的盐等，或通过之前确定的其它方法获得。药学上可接受的盐不特别受限，只要其可用于药物。本文所述的化合物与碱形成的盐的实例包括以下：其与无机碱例如钠、钾、镁、钙和铝的盐；其与有机碱例如甲胺、乙胺和乙醇胺的盐；其与碱性氨基酸例如赖氨酸和鸟氨酸的盐；和铵盐。盐可以是酸加成盐，其特别举例为与以下的酸加成盐：无机酸例如盐酸、氢溴酸、氢碘酸、硫酸、硝酸和磷酸；有机酸例如甲酸、乙酸、丙酸、草酸、丙二酸、琥珀酸、富马酸、马来酸、乳酸、苹果酸、酒石酸、柠檬酸、甲磺酸和乙磺酸；酸性氨基酸例如天冬氨酸和谷氨酸。
术语“药物组合物”是指本文所述的化合物与其它化学组分(本文统称为“赋形剂”)，例如载体、稳定剂、稀释剂、分散剂、助悬剂和/或增稠剂的混合物。药物组合物促进给予化合物至生物。本领域存在许多给予化合物的技术，包括但不限于：直肠、口服、静脉内、气雾剂、胃肠外、眼、肺和局部给予。
术语“受试者”是指动物，包括但不限于，灵长类动物(例如，人)、猴、牛、猪、绵羊、山羊、马、狗、猫、兔、大鼠或小鼠。提及例如，哺乳动物受试者，例如人时，术语“受试者”和“患者”在本文可互换使用。
在治疗疾病或病症的情况下术语“治疗(treat或treating或treatment)”意指包括减轻或消除病症、疾病或病况，或与病症、疾病或病况有关的一种或多种症状；或减慢疾病、病症或病况或其一种或多种症状的进展、传播或恶化。通常，受试者从治疗剂获得的有益效果不导致疾病、病症或病况的完全治愈。
如本文使用的，术语“烷基”和前缀“烷”包括直链和支链基团以及环状基团，即，环烷基。“C2-10烯基”是指含有一个或多个双键和具有2-10个碳原子的支链或非支链烃基团。“C2-10炔基”是指含有一个或多个三键和具有2-10个碳原子的支链或非支链烃基团。“C2-6杂环基”是指稳定的5-7元单环或7-14元双环杂环，其是饱和的、部分不饱和的或不饱和的(芳族)，和由2-6个碳原子和1、2、3或4个独立地选自N、O和S的杂原子组成，和包括任何双环基团，其中任何上文定义的杂环与苯环稠合。“C6-12芳基”是指具有包含碳原子与共轭电子的环系统的芳族基团(例如，苯基)。“C7-14烷芳基”是指具有7-14个碳原子的被芳基取代的烷基(例如，苯甲基、苯乙基或3,4-二氯苯乙基)。“C3-10烷杂环基”是指烷基取代的杂环基。“C1-10杂烷基”是指除了一个或多个杂原子外还具有1-10个碳原子的支链或非支链烷基、烯基或炔基，其中一个或多个亚甲基(CH2)或次甲基(CH)被氮、氧、硫、羰基、硫代羰基、磷酰基或磺酰基替换。术语“酰基”是指具有式R—C(O)—的化学部分，其中R选自C1-10烷基、C1-10烯基、C1-10炔基、C2-6杂环基、C6-12芳基、C7-14烷芳基、C3-10烷杂环基、C1-10杂烷基等。在某些实施方案中，酰基是具有式R—C(O)—的化学部分，其中R选自C1-10烷基、C1-10烯基、C1-10炔基、C2-6杂环基、C6-12芳基、C7-14烷芳基、C3-10烷杂环基和C1-10杂烷基。每个前述基团可独立地是取代的或非取代的。示例性的取代基包括烷氧基、芳基氧基、巯基、烷基硫基、芳基硫基、卤素、羟基、氟代烷基、全氟烷基、氨基、氨基烷基、二取代的氨基、季氨基、羟基烷基、羧基烷基和羧基。
本发明的一个或多个实施方案的细节在附图和下文的描述中阐明。根据描述和附图以及权利要求，本发明的其它特征和优点将是显而易见的。
附图简述
图1包含显示氯硝柳胺诱导来自活性IBD的固有层T细胞的细胞死亡的图。来自IBD受试者的LPMC (固有层单核细胞)从肉眼可见的发炎肠区域分离和用DMSO或氯硝柳胺(10 μM)处理16小时。固有层T细胞(CD3+)的细胞死亡通过流式细胞术测量7-AAD染色测定。
图2包括表明当直肠(局部)，而非通过腹膜内注射(系统)给予时，在溃疡性结肠炎的鼠TNBS模型中氯硝柳胺显示稳健功效的图和图像。
图3A-3C显示代表性的灌肠剂递送装置的元件。图3A显示瓶，图3B显示易碎胶囊，和图3C显示直肠插管(上箭头)和单流包(下箭头)。
图4A是显示在第1和2天以剂量30 mg/kg直肠给予的氯硝柳胺混悬液导致由于TNBS-诱导的结肠炎导致的初始损失的体重恢复的图。在未治疗或媒介对照治疗的小鼠中没有重量恢复。
图4B是显示基于结肠活检的H&E分析，与媒介对照治疗的小鼠或接受TNBS但没有其它治疗的小鼠相比，在第1和2天以剂量30 mg/kg直肠给予的氯硝柳胺混悬液导致显著更低的结肠炎评分的图。
图4C包括证实在肠活检组织中通过实时PCR检测的炎性细胞因子的表达的图。与不接受TNBS的EtOH对照动物相比，在媒介存在时TNBS暴露增加TNFa、IFNy和IL-17A的表达。相对于对于β-肌动蛋白(用作用于标准化的持家基因)的RNA的表达，以0.03、3.0和30 mg/kg体重直肠给予的氯硝柳胺剂量依赖性地降低每个细胞因子的RNA的水平。
图5是显示相对于仅媒介阴性对照，5 μM的氯硝柳胺导致产生促炎细胞因子(包括TNF、IFN和IL-17A)的人LPMC T细胞减少的图。
图6是显示相对于阴性对照，5 μM的氯硝柳胺导致人LPMC T细胞的ΔΨm减少的图。
详细描述
本公开内容的特征在于可用于例如，治疗受试者(例如，人)的特征为异常炎性反应的病理(例如，炎性肠病)的一种或多种症状的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶和/或药物组合；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶和/或药物组合；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或药物组合和/或共结晶)。本公开内容的特征还在于组合物以及使用和制备所述组合物的其它方法。
化学实体
评价化学实体作为线粒体解偶联剂的活性
尽管不希望受理论的约束，认为本文所述的化学实体能够在一种或多种T细胞中从氧化磷酸化解偶联线粒体呼吸，从而破坏一种或多种T细胞的线粒体能量循环，和诱导一种或多种T细胞(例如，活化T细胞)的细胞死亡。化学实体在一种或多种T细胞中从氧化磷酸化解偶联线粒体呼吸的能力可使用本领域已知的常规测定法评价。
通过实例的方式，Jurkat T细胞模型可用于体外研究化合物对T细胞的潜在影响。该细胞系允许研究调节T细胞线粒体功能和存活的刺激和机制。作为T细胞，Jurkat具有淋巴细胞外观和在悬浮培养中复制。Jurkat还包含呼吸线粒体，因此可评价对线粒体解偶联剂例如氯硝柳胺的响应。解偶联通过检测跨越线粒体内膜的电化学梯度的下降(ΔΨm)(其与氧化磷酸化的相应增加不相关)来鉴定和量化。检测ΔΨm的变化的实验通过包括其中加入一定浓度的寡霉素以不可逆地抑制F1F0-ATP酶和阻断氧化磷酸化来证实ΔΨm的下降代表了解偶联(因为其独立于线粒体氧化磷酸化的增加而发生)的条件进行。参见实施例1。
作为另一个实例，人肠中的固有层单核细胞(LPMC)部分地被介导生理和病理过程包括炎性肠病的T细胞损害。LPMC可从人组织活检分离。分离后，在适合的培养条件下LPMCT细胞保持离体存活一段时间，其允许离体实验。这些细胞可用于研究调节它们的线粒体功能和存活的机制。它们包含呼吸线粒体，因此可评价它们对线粒体解偶联剂例如氯硝柳胺的响应。该细胞模型可结合阻断氧化磷酸化和TMRM的寡霉素使用，以监测如实施例1所述的ΔΨm。参见实施例2。
显示线粒体解偶联剂活性的化学实体还可包括显示轻度解偶联的那些，轻度解偶联是指通过增加线粒体氧消耗来补偿以防止跨膜电位显著下降的质子泄漏的水平。
化学实体的物理化学性质
在一些实施方案中，当给予的化学实体得到的系统生物利用度相对低，和给予的化学实体得到的局部生物利用度相对高时是有利的。可例如通过选择具有相对低的口服生物利用度(F)的化学实体实现前述内容，其中：
F = Fa x Fg x Fh
其中Fa = 吸收的分数；Fg = 逃脱肠代谢的分数；和Fh = 逃脱肝代谢的分数(参见Filipski, K.J.,等, Current Topics in Medicinal Chemistry, 2013, 13, 776-802)。如技术人员将理解的，口服生物利用度的程度可被各种物理化学属性影响，例如分子量(“MW”)、logP、氢键供体(“HBD”)的数量、氢键受体(“HBA”)的数量、可旋转键(“RB”)的数量和极性表面面积(“PSA”)。已认识到，通常在具有以下属性的化合物中观察到良好的口服生物利用度：MW ≤ 500, LogP ≤ 5, HBD ≤ 5, HBA ≤ 10, 可旋转键(RB) ≤ 10, PSA≤ 140 (Id.)。因此，用于设计和选择具有相对低的口服生物利用度(F)的化学实体的非限制性策略可包括选择赋予优选的口服药物空间之外的性质的物理化学属性(Id.)。
在一些实施方案中，本文所述的化学实体(包括它们的药学上可接受的盐和/或水合物和/或其共结晶)具有少于约50%、或少于约40%、或少于约30%、或少于约20%、或少于约10%、或少于约5%、或少于约2%、或少于约1%的口服生物利用度(F)。在某些实施方案中，本文所述的化学实体具有少于约20%，例如，少于约19%、少于约18%、少于约17%、少于约16%、少于约15%、少于约14%、少于约13%、少于约12%、少于约11%、少于约10%、少于约9%、少于约8%、少于约7%、少于约6%、少于约5%、少于约4%、少于约3%、少于约2%、少于约1%或少于约0.5%的口服生物利用度(F)。
在一些实施方案中，本文所述的化学实体(包括它们的药学上可接受的盐和/或水合物和/或其共结晶)具有相对低的水溶解度。低的水溶解度是指当在20°C测量时，在水中具有小于或等于10 mg/mL的溶解度的化合物。在某些实施方案中，当在20°C测量时，本文所述的化学实体具有小于或等于900、800、700、600、500、400、300、200、150、100、90、80、70、60、50、40、30、20微克/mL或进一步10、5或1微克/mL或进一步900、800、700、600、500、400、300、200、150、100、90、80、70、60、50、40、30、20或10 ng/mL或少于10 ng/mL的水溶解度。
在一些实施方案中，本文所述的化学实体(包括它们的药学上可接受的盐和/或水合物和/或其共结晶)具有相对低的药物渗透性。渗透性测量间接基于在人中药物吸收的程度进行，和直接基于跨越人肠膜的质量转移速率的测量进行。或者，可使用能够预测人的药物吸收的非人系统(例如体外培养方法)。当基于质量平衡测定或与静脉内剂量比较，在人中的吸收程度测定为给予剂量的约90%或更大时，药物被视为高度可渗透的。否则，药物被视为渗透性差(参见例如，https://books.google.com/booksid=4cfzT2ZY8hUC&pg=PA102&lpg=PA102&dq=low+permeability+drug+definition&source=bl&ots=WXEDT3C0sL&sig=g1laf7e47KJ-SSV4loN8RSs_sM&hl=en&sa=X&ved=0CFAQ6AEwBmoVChMIrv_6oL7FxwIVxBmSCh02ugoi#v=onepage&q=low%20permeability%20drug%20definition&f=false)。
在一些实施方案中，本文所述的化学实体可以是BCS II类药物或其药学上可接受的盐和/或水合物和/或共结晶。在其它实施方案中，本文所述的化学实体可以是BCS IV类药物或其药学上可接受的盐和/或水合物和/或共结晶。
化学实体
氯硝柳胺和氯硝柳胺类似物
在一些实施方案中，化学实体可以是氯硝柳胺或其药学上可接受的盐和/或水合物；例如，化合物，例如氯硝柳胺类似物或药学上可接受的盐和/或水合物。氯硝柳胺类似物是指化合物，其中氯硝柳胺中的一个或多个原子、官能团或子结构被一个或多个不同的原子、基团或子结构替换。
在某些实施方案中，化学实体可以是具有式I的化合物：
(I)
其中X是N或CR10；Y是N或CR11；Z是N或CR12；和R1、R2、R5、R6、R7、R8、R9、R10、R11和R12各自独立地选自H、卤素(F、Cl、Br或I)、NO2、OH、OR13、SR14、NR15R16、CN、CF3、C1-10烷基、C2-10 烯基、C2-10 炔基、C2-6 杂环基、C6-12 芳基、C7-14 烷芳基、C3-10 烷杂环基、C1-10杂烷基，或通过下式之一描述：
。
在式I的化合物中，R3和R4独立地选自C═O、C═S、C═NR42、NH、NR43、CHOR44、CH2等。使用通过以下基团之一所述的连接，基团R2和R4；X和R4；R5和R3；R9和R3可组合形成六元环：
；
对于式I的化合物，每个E1独立地是O、S或NR42；每个E2独立地是CR49R50、O或S；每个E3独立地是CR51R52、O、S或NR53；每个Q独立地是O、S或NR54。R13和R14各自独立地是酰基、C1-10烷基、C2-10 烯基、C2-10 炔基、C2-6 杂环基、C6-12 芳基、C7-14 烷芳基、C3-10 烷杂环基、C1-10杂烷基；R18、R23、R28、R29、R30、R42、R54 各自独立地是C1-10烷基、C2-10 烯基、C2-10 炔基、C2-6 杂环基、C6-12 芳基、C7-14 烷芳基、C3-10 烷杂环基、C1-10杂烷基；R15、R16、R17、R19、R20、R21、R22、R24、R25、R26、R27、R43、R44、R45、R46、R47、R48、R51、R52和R53 各自独立地是H、C1-10烷基、C2-10 烯基、C2-10 炔基、C2-6 杂环基、C6-12 芳基、C7-14 烷芳基、C3-10 烷杂环基、C1-10杂烷基；R31、R32、R33、R34、R35、R36、R37、R38、R39、R40、R41、R49和R50 各自独立地是H、卤素、NO2、CN、CF3、C1-10烷基、C2-10 烯基、C2-10 炔基、C2-6 杂环基、C6-12 芳基、C7-14 烷芳基、C3-10 烷杂环基或C1-10杂烷基。
在某些实施方案中，化学实体可以是具有式XVIII-XXI的任何一个的化合物：
其中X、Y、Z、E1、R1、R5、R6、R7、R8、R9、R47和R48 如上文所定义。
在某些实施方案中，化学实体可以是具有式XXII的化合物：
其中R1、R2、R5、R6、R7、R8、R9、R10、R11和R12独立地选自H、卤素、NO2、CF3、OH、酰基、CN、C1-C10烷基(优选地C1-C3烷基)、C1-C10杂烷基(优选地C1-C3杂烷基)；和其中R3和R4 如上文所定义。在某些实施方案中，R3 是C═O而R4是NH或R3是NH而R4是C═O。在这些和某些其它实施方案中，R1、R2、R10、R11和R12中的仅两个存在，和一个是H或OH而另一个是卤素(例如，Cl、Br或F)。在其它实施方案中，R1、R2、R10、R11和R12中的一个是H或OH，R1、R2、R10、R11和R12中的一个是卤素(例如，Cl、Br或F)，和其它的是氢。
在这些和某些其它实施方案中，R5、R6、R7、R8和R9中的仅两个存在和这些是NO2和卤素(例如，Cl、Br或F)。在其它实施方案中，R5、R6、R7、R8和R9中的一个是NO2，R5、R6、R7、R8和R9中的一个是卤素(例如，Cl、Br或F)，和剩余的是氢。在某些实施方案中氯硝柳胺类似物包括但不限于其中一个卤素基团在相同环内重新放置或两个卤素基团在相同环内重新放置的氯硝柳胺类似物、其中硝基在相同环内重新放置的氯硝柳胺、其中羟基在相同环内重新放置的氯硝柳胺类似物、其中卤素和羟基和/或硝基二者重新放置同时保持取代基在芳环内的氯硝柳胺类似物、(3-氯-4-硝基苯基)替换(2-氯-4-硝基苯基)的化合物、硝基和羟基重新放置的氯硝柳胺类似物、包含单个卤素交换的氯硝柳胺类似物、包含双卤素交换的氯硝柳胺类似物、包含Cl—至Br—的交换的氯硝柳胺类似物、包含Cl—至F—的交换的氯硝柳胺类似物等。
在某些实施方案中，氯硝柳胺类似物包括但不限于根据式XXIII的化合物：
其中R1、R2、R3、R4和R5独立地存在或不存在，和当存在时，独立地选自Cl、Br、烷基、甲基、羟基烷基等。这些类似物意图是说明性而非限制性的。
在某些实施方案中，化学实体可以是具有式XXIV的化合物或其药学上可接受的盐和/或水合物：
(XXIV)
其中R1、R2、R5、R6、R7、R8、R9、R10、R11和R12独立地选自H、卤素、NO2、CF3、OH、酰基、CN、C1-C10烷基(优选地C1-C3烷基)和C1-C10杂烷基(优选地C1-C3杂烷基)；和其中R3是C=O和R4是NH；或R3是NH和R4是C=O，其中R1、R2、R5、R6、R7、R8、R9、R10、R11和R12的至少一个不是H。
在某些这些实施方案中，R1、R2、R10、R11和R12中的两个独立地选自卤素、NO2、CF3、OH、酰基、CN、C1-C10烷基(优选地C1-C3烷基)和C1-C10杂烷基(优选地C1-C3杂烷基)，和其它的是H；和R5、R6、R7、R8和R9中的两个独立地选自卤素、NO2、CF3、OH、酰基、CN、C1-C10烷基(优选地C1-C3烷基)和C1-C10杂烷基(优选地C1-C3杂烷基)，和其它的是H。
在某些实施方案中，化学实体可以是具有式XXV的化合物或其药学上可接受的盐和/或水合物：
(XXV)
其中R1、R2、R3、R4和R5的一个或多个是卤素、NO2、CF3、OH、酰基、CN、C1-C10烷基(优选地C1-C3烷基)或C1-C10杂烷基(优选地C1-C3杂烷基)；和其它的是氢。
氯硝柳胺类似物的实例包括但不限于表1-3中列出的那些。
表1
表2
表3
在某些实施方案中，化学实体可以是具有式(XXVI)的化合物：
(XXVI)
R1表示C1-6烷基、C2-6烯基、C2-6炔基、C3-8环烷基、C4-8环烯基或芳基，其全部可任选地被C1-8烷基、C3-8环烷基、C4-8环烯基或苯基进一步取代；或R1 表示双环-C4-10烷基或三环-C4-10-烷基；和其中当R1是C3-8环烷基、双环-C4-10烷基、三环-C4-10-烷基或芳基时，R1可任选地被一个或多个选自卤素、羟基、氰基、硝基、C1-6烷基、C2-6烯基、C2-6炔基、C3-8环烷基、C4-8环烯基、C1-6烷氧基、C1-6卤代烷氧基和C1-6卤代烷基的取代基取代；R2和R4 独立地表示氢、卤素、C1-6烷基、C2-6烯基、C2-6炔基、C3-8环烷基、C4-8环烯基或C1-6烷氧基；
R5、R6和R7的至少一个表示C1-6卤代烷氧基，和R5、R6和R7的剩余部分独立地表示氢、硝基、氰基、卤素、C1-6烷基、C2-6烯基、C2-6炔基、C3-8环烷基、C4-8环烯基、C1-6卤代烷基、—OR10、—NR10R11、—C(O)OR10、—COR10、—C(O)NR10R11、—SH、—S(O)2OR10、—S(O)2NR10R11、—S(O)nR11、芳基或杂芳基，其中所述芳基或杂芳基可任选地被一个或多个C1-6烷基、卤素、羟基或苯基取代；R3表示氢、卤素、氰基、—OR10、—NR10R11、—C(O)OR10、—COR10、—C(O)NR10R11、—S(O)nR10、—S(O)2NR10R11、—NHCOR10或—NHSO2R10；
N是0、1或2；和
每个R10和R11独立地选自氢、C1-6烷基、C2-6烯基、C2-6炔基、C3-8环烷基、C4-8环烯基、C1-6 卤代烷基和C1-6 卤代烷氧基；和其药学上可接受的盐、溶剂合物和前药。
氯硝柳胺类似物的其它实例包括但不限于表4所列的那些。
表4
在某些实施方案中，化学实体可以是具有式XXVII的化合物：
(XXVII)
其中X是N或CR10；Y是N或CR11；Z是N或CR12；和R1、R2、R5、R6、R7、R8、R9、R10、R11和R12各自独立地选自H、卤素(F、Cl、Br或I)、NO2、OH、OR13、SR14、NR15R16、CN、CF3、酰基、C1-10烷基、C2-10 烯基、C2-10 炔基、C2-6 杂环基、C6-12 芳基、C7-14 烷芳基、C3-10 烷杂环基、C1-10杂烷基，或通过下式之一描述：
在式XXVII的化合物中，R3和R4独立地选自C═O、C═S、C═NR42、NH、NR43、CHOR44、C1-6亚烷基(例如，CH2)、S=O、S(O)2、NHC1-6亚烷基(例如，NHCH2)、C1-6亚烷基NH (例如，CH2NH)、C1-6亚烷基NR43、NHC(O)、C(O)NH。使用通过以下基团之一所述的连接，基团R2和R4；X和R4；R5和R3；R9和R3可组合形成六元环：
、(例如，-OC(O)-) .;
对于式I的化合物，每个E1独立地是O、S或NR42；每个E2独立地是CR49R50、O或S；每个E3独立地是CR51R52、O、S或NR53；每个Q独立地是O、S或NR54。R13和R14各自独立地是酰基、C(O)OC1-6烷基、C1-10烷基、C2-10 烯基、C2-10 炔基、C2-6 杂环基、C6-12 芳基、C7-14 烷芳基、C3-10 烷杂环基、C1-10杂烷基；R18、R23、R28、R29、R30、R42、R54 各自独立地是H、C1-10烷基、C2-10 烯基、C2-10 炔基、C2-6 杂环基、C6-12 芳基、C7-14 烷芳基、C3-10 烷杂环基、C1-10杂烷基；R15、R16、R17、R19、R20、R21、R22、R24、R25、R26、R27、R43、R44、R45、R46、R47、R48、R51、R52和R53 各自独立地是H、C1-10烷基、C2-10 烯基、C2-10 炔基、C2-6 杂环基、C6-12 芳基、C7-14 烷芳基、C3-10 烷杂环基、C1-10杂烷基；R31、R32、R33、R34、R35、R36、R37、R38、R39、R40、R41、R49和R50各自独立地是H、卤素、NO2、CN、CF3、C1-10烷基、C2-10 烯基、C2-10 炔基、C2-6 杂环基、C6-12 芳基、C7-14 烷芳基、C3-10 烷杂环基或C1-10杂烷基。
氯硝柳胺类似物的其它实例包括但不限于表5所列的那些。
表5
在某些前述实施方案中，酰基是具有式R—C(O)—的化学部分，其中R选自C1-10烷基、C2-6 杂环基(例如，杂芳族)和C6-12 芳基。
氯硝柳胺类似物的其它实例包括但不限于表6所列的那些。
表6
在某些实施方案中，化学实体是氯硝柳胺或其药学上可接受的盐或水合物。“氯硝柳胺”是指具有以下化学结构的化合物：
。
氯硝柳胺的IUPAC名称为：2′5-二氯-4′-硝基水杨苯胺和CAS名称为：CAS: 5-氯-N-(2-氯-4-硝基苯基)-2-羟基苯甲酰胺。氯硝柳胺在20° C具有约5-8 mg/L的相对低的水溶解度，微溶于乙醚、乙醇和氯仿，和可溶于丙酮。乙醇胺盐在20° C以180-280 mg/L溶解在蒸馏水中。
氯硝柳胺可以各种盐或溶剂合物的形式获得。这些包括但不限于，IUPAC名称5-氯-水杨酰基-(2-氯-4-硝基)苯胺2-氨基乙醇盐或CAS名称5-氯-N-(2-氯-4-硝基苯基)-2-羟基苯甲酰胺与2-氨基乙醇(1:1)的乙醇胺盐 – 参见例如，US 2013/0231312；IUPAC名称5-氯-水杨酰基-(2-氯-4-硝基)苯胺哌嗪盐或CAS名称5-氯-N-(2-氯-4-硝基苯基)-2-羟基苯甲酰胺与哌嗪(2:1)的哌嗪盐；和IUPAC名称5-氯-水杨酰基-(2-氯-4-硝基)苯胺一水合物或CAS名称5-氯-N-(2-氯-4-硝基苯基)-2-羟基苯甲酰胺与一水合物(1:1)的氯硝柳胺一水合物。
氯硝柳胺是以各种制剂市售可得的，包括但不限于BAYER 73®、BAYER 2353®、BAYER 25 648®、BAYLUSCID®、BAYLUSCIDE®、CESTOCID®、CLONITRALID、DICHLOSALE®、FENASAL®、HL 2447®、IOMESAN®、IOMEZAN®、LINTEX®、MANOSIL®、NASEMO®、NICLOSAMID®、PHENASAL®、TREDEMINE®、SULQUI®、VERMITID®、VERMITIN®、YOMESAN®等。
本文公开的化合物是市售可得的，或根据有机合成领域已建立的方法，从市售可得的起始材料可容易制备。合成化合物的通用方法可见于例如Stuart Warren和PaulWyatt，Workbook for Organic Synthesis: The Disconnection Approach，第二版，Wiley，2010。亦参见例如，美国专利8,148,328，其通过引用以其整体结合到本文中，和Mook等，Bioorg. Med. Chem2015，23，5829，其通过引用以其整体结合到本文中。
在其它实施方案中，化学实体可选自一般性、亚一般性和具体公开于WO 2004/006906；WO 2006/120178；US 2009/0062396；WO 2012/143377；WO 2012/068274；美国专利7,132,546；美国专利7,989,498；和美国专利8,263,857的任何一个或多个中的化合物；其各自通过引用以其整体结合到本文中。
其它化学实体
在一些实施方案中，化学实体可以是选自硝唑尼特、氯生太尔、扑蛲灵和沙利霉素的驱蠕虫剂。参见例如，Senkowski, W.等, Mol. Cancer Ther. 2015, 14, 1504。
化学实体的共结晶
综述
在一些实施方案中，化学实体可呈共结晶的形式，其包括(i) 化学实体(例如，线粒体解偶联剂(例如，氯硝柳胺或氯硝柳胺类似物)或其药学上可接受的盐和/或水合物；和(ii)一种或多种药学上可接受的共形成物。如本文使用的术语"共结晶"是指在室温下以化学计量或非化学计量比率包含两种或更多种独特的固体的结晶材料，所述固体通过一种或多种非共价相互作用(例如，氢键、π堆积、客主复合和范德华相互作用)一起保持在晶格内。
在一些实施方案中，一种或多种非共价相互作用的至少一种是氢键。在某些这些实施方案中，化学实体是氢键供体，和一种或多种共形成物之一是氢键受体。在其它实施方案中，化学实体是氢键受体，和一种或多种共形成物之一是氢键供体。
本文所述的共结晶可在晶格内包括一个或多个溶剂合物(例如，水或含有一个或多个羟基的有机溶剂，例如，C1-C6醇或二醇，例如，C1-C6醇或二醇，例如，乙醇或丙二醇)分子。然而，不进一步包含共形成物(例如，固体共形成物)的化学实体的溶剂合物不包括在本公开内容所述的共结晶定义内。
在一些实施方案中，共结晶包括超过一种共形成物。例如，两种、三种、四种、五种或更多种共形成物可与化学实体掺入共结晶。化学实体与一种或多种药学上可接受的共形成物的每一种的比率可以是化学计量的或非化学计量的。作为非限制性实例，预期1:1、1:1.5和1:2比率的化学实体:共形成物。
化学实体和一种或多种药学上可接受的共形成物的每一种可各自独立地规定为游离形式，或更特别地，游离酸、游离碱或两性离子；盐，或更特别地例如，无机碱加成盐例如钠、钾、锂、钙、镁、铵、铝盐或有机碱加成盐，或无机酸加成盐，例如HBr、HCl、硫酸、硝酸或磷酸加成盐或有机酸加成盐，例如乙酸、丙酸、丙酮酸、丙二酸、琥珀酸、苹果酸、马来酸、富马酸、酒石酸、柠檬酸、苯甲酸、甲磺酸、乙磺酸、硬脂酸或乳酸加成盐；无水合物或游离形式或盐的水合物，或更特别地，例如，半水合物、一水合物、二水合物、三水合物、四水合物、五水合物；或游离形式或盐的溶剂合物。
化学实体
在一些实施方案中，在共结晶中化学实体(例如，线粒体解偶联剂(即，上述组分(i))可与一种或多种药学上可接受的共形成物形成一个或多个氢键。在一些实施方案中，在共结晶中化学实体可接受来自一种或多种药学上可接受的共形成物的一个或多个氢键。在一些实施方案中，化学实体可与一种或多种药学上可接受的共形成物形成一个或多个氢键，和在共结晶中化学实体可接受一种或多种药学上可接受的共形成物的一个或多个氢键。
在一些实施方案中，化学实体(例如，线粒体解偶联剂(即，上述组分(i))包括一个或多个官能团，其选自：醚、硫醚、羟基、巯基、醛、酮、硫酮、硝酸酯、磷酸酯、硫代磷酸酯、酯、硫酯、硫酸酯、羧酸、膦酸、次膦酸、磺酸、酰氨基、伯胺、仲胺、氨、叔氨基、sp2氨基、硫氰酸酯、氨腈、肟、腈、重氮基、卤代烷基、硝基、杂环、杂芳环、环氧化物、过氧化物和氧肟酸。
在一些实施方案中，化学实体(例如，线粒体解偶联剂(即，上述组分(i))是氯硝柳胺或其药学上可接受的盐或水合物；或氯硝柳胺类似物或其药学上可接受的盐或水合物。在一些这些实施方案中，化学实体可以是具有式(I)和(XVIII)-(XXV)的任何一个，例如式XXIV、XXV或XXVII的化合物；或下文所列的共形成物的列表的任何一个。在某些这些实施方案中，化学实体可以是具有式(I)和(XVIII)-(XXV)的任何一个，例如，式XXIV或XXV；或XXVI的氯硝柳胺类似物；或下文所列的共形成物的列表的任何一个。在某些这些实施方案中，化学实体可以是氯硝柳胺或其药学上可接受的盐或水合物(例如，氯硝柳胺)。
共形成物
在一些实施方案中，一种或多种药学上可接受的共形成物的至少一种可与化学实体在共结晶中形成一个或多个氢键。在一些实施方案中，一种或多种药学上可接受的共形成物的至少一种可接受在共结晶中来自化学实体的一个或多个氢键。在一些实施方案中，一种或多种药学上可接受的共形成物的至少一种可在共结晶中与化学实体形成一个或多个氢键，和一种或多种药学上可接受的共形成物的至少一种可接受在共结晶中来自化学实体的一个或多个氢键。
在一些实施方案中，一种或多种药学上可接受的共形成物的至少一种包含一个或多个官能团，其选自：醚、硫醚、羟基、巯基、醛、酮、硫酮、硝酸酯、磷酸酯、硫代磷酸酯、酯、硫酯、硫酸酯、羧酸、膦酸、次膦酸、磺酸、酰氨基、伯胺、仲胺、氨、叔氨基、sp2氨基、硫氰酸酯、氨腈、肟、腈、重氮基、卤代烷基、硝基、杂环、杂芳环、环氧化物、过氧化物和氧肟酸。
在某些实施方案中，一种或多种药学上可接受的共形成物之一各自独立地选自乙酰胺、苯甲酰胺、(+/-)-柠檬烯、1-(苯基偶氮基)-2-萘胺、1,2,6-己三醇、1,2-二肉豆蔻酰基-sn-甘油-3-(磷酸-s-(1-甘油))、1,2-二肉豆蔻酰基-sn-甘油-3-磷酸胆碱、1,2-二油酰基-sn-甘油-3-磷酸胆碱、1,2-二棕榈酰基-sn-甘油-3-(磷酸-rac-(1-甘油))、1,2-二硬脂酰基-sn-甘油-3-(磷酸-rac-(1-甘油))、1,2-二硬脂酰基-sn-甘油-3-磷酸胆碱、1,5-萘-二磺酸、1-羟基-2-萘酸、1-o-甲苯基双胍、2-乙基-1,6-己二醇、4-氨基苯甲酸、4-氨基吡啶、4-氨基水杨酸、4-氯苯磺酸、4-乙氧基苯基尿素、7-氧代-dhea、阿拉伯胶、阿拉伯胶浆、阿拉伯胶糖浆、乙酰舒泛、乙酰舒泛钾、醋羟胺酸、丙酮亚硫酸氢钠、乙酰基化羊毛脂醇、乙酰基化甘油一酯、乙酰基半胱氨酸、乙酰基三丁基柠檬酸酯、丙烯酸酯共聚物、丙烯酸-异辛基丙烯酸酯共聚物、腺嘌呤、已二酸、丙氨酸、聚集白蛋白、白蛋白胶体、人白蛋白、白蛋白、海藻酸、烷基磺酸铵甜菜碱、烷基芳基磺酸钠、尿囊素、别嘌呤醇、烯丙基α-紫罗兰酮、α-萜品醇、α-生育酚、α-生育酚乙酸酯、氨基苯甲酸钠、戊基乙酸酯、茴香脑、无水柠檬酸、无水葡萄糖、无水乳糖、无水磷酸三钠、无水柠檬酸三钠、精氨酸、arlacel、阿魏胶、抗坏血酸、抗坏血酸棕榈酸酯、天冬酰胺、阿司帕坦、天冬氨酸、抑菌性氯化钠注射液、硫酸钡、苯扎氯铵、苯磺酸、苄索氯铵、苯度氯铵、苯甲酸、苯甲基乙酸酯、苯甲醇、苯甲酸苄酯、苯甲基氯、β-胡萝卜素、β-萘酚、betose、双巴西肽、碱式碳酸铋、碱式没食子酸铋、硼酸、溴克利那、硬脂酸丁酯、丁基化羟基茴香醚、丁基化羟基甲苯、对羟基苯甲酸丁酯、丁酸、C-11-1-氨基环己烷甲酸、C12-15烷基乳酸酯、咖啡因、考布曲钙、卡地胺钠、卡洛酸三钠、钙立醇钙、樟脑酸、癸酸、克菌丹、captisol、羧聚乙烯、胭脂红、巴西棕榈蜡、巴西棕榈黄蜡、角叉菜胶、角叉菜胶钙、角叉菜胶盐、角叉菜胶钠、地蜡、鲸蜡硬脂醇聚醚-12、鲸蜡硬脂醇聚醚-15、鲸蜡硬脂醇聚醚-30、鲸蜡硬脂醇/鲸蜡硬脂醇聚醚-20、鲸蜡硬脂基乙基己酸酯、鲸蜡醇聚醚-10、鲸蜡醇聚醚-2、鲸蜡醇聚醚-20、鲸蜡醇聚醚-23、鲸蜡硬脂醇、西曲氯铵、鲸蜡醇、鲸蜡酯蜡、棕榈酸鲸蜡酯、西吡氯铵、氯甲酚、氯二甲酚、胆固醇、白杨黄素、肉桂醛、肉桂酸、柠檬酸盐、柠檬酸、柠檬酸一水合物、克立咪唑、椰油酰胺醚硫酸酯、氧化古柯碱、椰油甜菜碱、椰油二乙醇酰胺、椰油单乙醇酰胺、椰油-辛酸酯、椰油-甘油酯、肌酸、肌酸酐、甲酚、硫酸铜、环拉酸、环甲硅油、环甲硅油5、半胱氨酸、dalfampridine、癸基甲基亚砜、脱氢醋酸、苯甲地那铵、脱氧胆酸、葡聚糖、葡聚糖40、葡萄糖结合剂、糊精、葡萄糖、葡萄糖一水合物、二乙酰基化甘油一酯、泛影酸、二碱式无水磷酸钠、二碱式磷酸钠、二碱式磷酸钠二水合物、二碱式磷酸钠十二水合物、二碱式磷酸钠七水合物、邻苯二甲酸二丁酯、癸二酸二丁酯、邻苯二甲酸二乙酯、焦碳酸二乙酯、癸二酸二乙酯、二乙基氨基乙基硬脂酰胺磷酸酯、二乙二醇单乙基醚、二乙二醇单甲基醚、二乙基己基邻苯二甲酸酯、二异丙基己二酸酯、二异丙基二亚油酸酯、二异丙基苯并噻唑基-2-磺酰胺、医用二甲硅油流体360、二甲基异山梨醇、二甲基邻苯二甲酸酯、二甲基亚砜、二甲基双十八烷基铵膨润土、二甲基甘氨酸、二甲基硅氧烷/甲基乙烯基硅氧烷共聚物、地乐酚-铵、二丙二醇、椰油酰两性二乙酸二钠、柠檬酸氢二钠、月桂醇聚醚磺基琥珀酸二钠、月桂基磺基琥珀酸二钠、油酰氨基单乙醇胺磺基琥珀酸二钠、磺基水杨酸二钠、地索苯宁、dl-a350乳酸、dl-乙酰基色氨酸、dl-α-生育酚、dl-α-生育酚乙酸酯、dl-二棕榈酰基磷脂酰甘油、dl-二硬脂酰基磷脂酰胆碱、dl-谷氨酸、dl-酒石酸、d-甘露糖、dmdm乙内酰脲、二十二烷醇、多库酯钠、d-核糖、依地酸钙二钠、依地酸二钠、依地酸钠、依地酸、卵磷脂酰甘油、卵磷脂、辛苯氧磺酸、辛苯氧磺钠、表乳糖、盐酸表四环素、异抗坏血酸、赤藓糖醇、盐酸乙醇胺、乙基麦芽醇、油酸乙酯、香子兰酸乙酯、乙基香草醛、乙二胺二盐酸盐、乙基己基羟基硬脂酸酯、对羟苯甲酸乙酯、桉叶脑、丁香酚、依沙美肟、脂肪酸酯、脂肪酸甘油酯、脂肪酸五赤醇酯、脂肪酸、脂肪醇柠檬酸盐、脂肪醇、三氯化铁、氧化铁、磁性氧化铁、富马酸亚铁、氧化亚铁、荧光素、果糖、富马酸、富马酰二酮哌嗪、氧化钆、粘酸、半乳糖、γ环糊精、染料木黄酮、龙胆酸、龙胆酸乙醇酰胺、龙胆酸乙醇胺、红霉素钠、葡糖酸、葡萄糖酸内酯、葡糖胺、葡萄糖、葡糖醛酸、谷氨酸、谷氨酸盐酸盐、谷氨酰胺、戊二酸、谷胱甘肽、甘油基辛酸酯、甘油基二山萮酸酯、甘油基二硬脂酸酯、甘油基异硬脂酸酯、甘油基月桂酸酯、甘油基单硬脂酸酯、甘油基油酸酯、甘油基棕榈酸酯、甘油基棕榈硬脂酸酯、甘油基蓖麻油酸酯、甘油基硬脂酸酯、甘油基硬脂酸酯-月桂醇聚醚-23、甘油基硬脂酸酯/peg硬脂酸酯、甘油基硬脂酸酯/peg-100硬脂酸酯、甘油基硬脂酸酯/peg-40硬脂酸酯、甘油基硬脂酸酯-硬脂酰氨基乙基二乙基胺、甘油基三油酸酯、甘氨酸、甘氨酸盐酸盐、乙二醇二硬脂酸酯、乙二醇硬脂酸酯、乙醇酸、甘草皂苷、盐酸胍、己基间苯二酚、马尿酸、组氨酸、透明质酸钠、氢化可的松、氢醌、含水柠檬酸、羟基乙基哌嗪乙烷磺酸、羟基二十八烷基羟基硬脂酸酯、羟基黄体酮己酸酯、羟基丙基β-环糊精、hystrene、illicium anisatum、咪唑、咪脲、靛蓝二磺酸钠、碘沙酸、盐酸碘非他胺、依普黄酮、异亮氨酸、异丙基异硬脂酸酯、异丙基肉豆蔻酸酯、异丙基肉豆蔻酸酯-肉豆蔻醇、异丙基棕榈酸酯、异丙基硬脂酸酯、异硬脂酸、异硬脂醇、乳酸盐、拉克替醇一水合物、乳糖醛酸、乳糖、landalgine、羊毛脂、劳拉氯铵、月桂氧化胺、月桂醇聚醚硫酸酯、月桂酸、月桂酸二乙醇酰胺、月桂酸肉豆蔻酸二乙醇酰胺、月桂酰基肌氨酸、月桂基乳酸酯、月桂基硫酸酯、卵磷脂、亮氨酸、左薄荷脑、乙酰丙酸、利多苯宁、l-乳酸钠、赖氨酸、马来酸、苹果酸、丙二酸、麦芽糖醇、麦芽糊精、麦芽醇、无水麦芽糖、扁桃酸、甘露醇、脂肪族醇硫酸酯钠、甲溴菲宁、中链甘油三酯、亚甲基二磷酸二钠、亚甲基二磷酸、薄荷醇、间甲酚、蛋氨酸、甲基水杨酸酯、甲基硬脂酸酯、甲基氯异噻唑啉酮、甲基异噻唑啉酮、对羟基苯甲酸甲酯、对羟基苯甲酸甲酯钠、米吡氯铵、甘油单酯和甘油二酯、一碱式磷酸钠、一碱式无水磷酸钠、一碱式磷酸钠二水合物、一碱式磷酸钠一水合物、柠檬酸甘油一酯、甘油一酯、柠檬酸一钠、谷氨酸一钠、单硬脂酰基柠檬酸盐、单硫代甘油、肉豆蔻酸、肉豆蔻醇、肉豆蔻基乳酸酯、烟酰胺、烟酰胺、烟酸、N-甲基葡萄糖胺、辛酸、oleth-20、油醇、油酸油酯、乳清酸、草酸、羟亚甲基二膦酸二钠、羟喹啉、棕榈氧化胺、棕榈酸、巴莫酸、十五内酯、五赤藓糖醇椰油酸酯、三胺五乙酸五钠、三胺五乙酸钙三钠、三胺五乙酸、苯酚、phenonip、苯氧基乙醇、苯基丙氨酸、苯基乙醇、磷脂、哌嗪、哌嗪六水合物、普鲁卡因、产物wat、脯氨酸、丙烯基乙基愈创木酚、丙基没食子酸酯、碳酸丙烯、丙二醇、丙二醇-卵磷脂、丙二醇藻酸酯、丙二醇二乙酸酯、丙二醇二辛酸酯、丙二醇单月桂酸酯、丙二醇单棕榈硬脂酸酯、丙二醇棕榈硬脂酸酯、丙二醇蓖麻油酸酯、丙二醇/二唑烷基脲/对羟基苯甲酸甲酯/对羟基苯甲酸丙酯、对羟基苯甲酸丙酯、对羟基苯甲酸丙酯钠、对甲苯磺酸、吡多胺、吡哆素(4-吡哆酸)、槲皮素、白藜芦醇、核黄素、糖精、糖精钙、糖精钠、无水糖精钠、水杨酸、饱和脂肪酸酯、癸二酸、丝氨酸、1,2-乙烷二磺酸钠、2-萘磺酸钠、乙酸钠、无水乙酸钠、藻酸钠、烷基硫酸钠、硅酸铝钠、抗坏血酸钠、苯甲酸钠、碳酸氢钠、硫酸氢钠、硫酸氢钠丙酮、亚硫酸氢钠、酒石酸氢钠、硼酸钠、硼酸钠十水合物、碳酸钠、碳酸钠十水合物、碳酸钠一水合物、羧甲基β-葡聚糖钠(ds 065-085)、酪蛋白酸钠、纤维素钠、鲸蜡硬脂基硫酸钠、氯酸钠、氯化钠、氯化钠注射液、胆甾醇基硫酸钠、柠檬酸钠、含水柠檬酸钠、椰油酰基肌氨酸钠、环拉酸钠、脱氧胆酸钠、连二亚硫酸钠、十二烷基苯磺酸钠、对羟苯甲酸乙酯钠、次硫酸甲醛钠、葡糖酸钠、氢氧化钠、次氯酸钠、碘化钠、乳酸钠、月桂醇聚醚-2硫酸钠、月桂醇聚醚-3硫酸钠、月桂醇聚醚-5硫酸钠、月桂基肌氨酸钠、月桂基硫酸钠、月桂基磺基乙酸钠、偏亚硫酸氢钠、硝酸钠、油酸钠、磷酸钠、磷酸钠二水合物、亚磷酸钠、聚丙烯酸钠、聚丙烯酸钠(2500000 MW)、聚偏磷酸钠、丙酸钠、焦磷酸钠、吡咯烷酮甲酸钠、乙醇酸淀粉钠、玉米型乙醇酸淀粉钠、马铃薯型乙醇酸淀粉钠、B型马铃薯乙醇酸淀粉钠、硬脂酸钠、硬脂基延胡索酸钠、琥珀酸钠六水合物、硫酸钠、无水硫酸钠、硫酸钠十水合物、亚硫酸钠、磺基琥珀酸十一烯酸单烷醇酰胺钠、酒石酸钠、硫代乙醇酸钠、硫代苹果酸钠、硫代硫酸钠、无水硫代硫酸钠、三偏磷酸钠、三聚磷酸钠、二甲苯磺酸钠、山梨酸、去水山梨糖醇、去水山梨糖醇异硬脂酸酯、去水山梨糖醇单月桂酸酯、去水山梨糖醇单油酸酯、去水山梨糖醇单棕榈酸酯、去水山梨糖醇单硬脂酸酯、去水山梨糖醇倍半油酸酯、去水山梨糖醇三油酸酯、去水山梨糖醇三硬脂酸酯、山梨醇、角鲨烷、2-乙基己酸亚锡、stearalkonium chloride、stearalkonium hectorite/碳酸丙烯、硬脂酰氨基乙基二乙基胺、硬脂酸酯、硬脂酸、硬脂酸二乙醇酰胺、硬脂氧基三甲基甲硅烷、硬脂醇、琥珀酸、sucralose、蔗糖、蔗糖二硬脂酸酯、蔗糖月桂酸酯、蔗糖棕榈酸酯、蔗糖聚酯、蔗糖硬脂酸酯、蔗糖糖浆、磺基乙酰胺钠、磺基丁基醚β-环糊精、塔格糖、酒石酸、tegacid、叔丁基氢醌、替曲膦、茶碱、硫柳汞、苏氨酸、麝香草酚、生育酚、托可索仑、西黄蓍胶、三醋汀、三碱式磷酸钠、三碱式磷酸钠一水合物、tribehenin、三辛酸甘油酯、三鲸蜡硬脂醇聚醚-4磷酸酯、三乙醇胺月桂基硫酸酯、柠檬酸三乙酯、三羟基硬脂、trilaneth-4磷酸酯、三月桂醇聚醚-4磷酸酯、三肉豆蔻酸甘油酯、tris、柠檬酸三钠二水合物、三钠hedta、三硬脂酸甘油酯、三乙醇胺、曲金刚胺、氨丁三醇、色氨酸、泰洛沙泊、酪氨酸、十一烯酸、尿素、尿烷、熊去氧胆酸、缬氨酸、香草醛、维塞胺、viscarin、维生素E、维生素E乙酸酯、维生素K5、木糖醇和硫酸锌。亦参见美国专利7,927,613，其通过引用以其整体结合到本文中。其它药学上可接受的共形成物包括描述于“Generally Regarded as Safe” (“GRAS”)和/或US FDA “EverythingAdded to Food in the United States” (“EAFUS”)列表中的那些。
在某些实施方案中，一种或多种药学上可接受的共形成物的至少一种选自咖啡因、尿素、对氨基苯甲酸、茶碱、苯甲酸苄酯和烟酰胺。在其它实施方案中，一种或多种药学上可接受的共形成物并非选自咖啡因、尿素、对氨基苯甲酸、茶碱、苯甲酸苄酯和烟酰胺的那些。在其它实施方案中，一种或多种药学上可接受的共形成物并非选自乙酰胺、苯甲酰胺、2-氨基噻唑和异烟肼的那些。在仍其它实施方案中，一种或多种药学上可接受的共形成物是氨基酸(例如，脯氨酸，例如，D-脯氨酸或L-脯氨酸或外消旋脯氨酸)。在另一个实施方案中，一种或多种药学上可接受的共形成物是5-10 (例如，5-9、5-6或5)元杂芳基，例如，含氮杂芳基，例如，咪唑。
在某些实施方案中，一种或多种药学上可接受的共形成物的至少一种是第二API。在某些这些实施方案中，第二API独立地选自(−)-氨氯地平、(−)-卤芬酯、(R)-沙丁胺醇、(R)-沙丁胺醇、(R,R)-福莫特罗、(S)-多沙唑嗪、(S)-氟西汀、(S)-奥昔布宁、1,2-萘醌、17-甲睾酮、17α-羟基黄体酮、195mPt-顺铂、1-萘基水杨酸酯、1-萘胺-4-、1-theobromineacetic、1α-羟基胆钙化醇、2,4,6-三溴-m-甲酚、2,6-二氨基-2′-丁基氧基-3,5′-偶氮吡啶、2-[[[(1r)-2-(1h-咪唑-4-基)-1-甲基乙基]亚氨基]苯基甲基]-苯酚、21-乙酰氧基孕烯诺龙、2-氨基-4-甲基吡啶、2-氨基噻唑、2-乙氧基苯甲酸、2-萘酚、2-萘基苯甲酸脂、2-萘基乳酸酯、2-萘基水杨酸酯、2-p-对氨苯磺酰苯胺基乙醇、2-硫代尿嘧啶、3′,3″,5′,5″-四溴苯酚酞、3-氨基-4-羟基丁酸、3-溴-D-樟脑、3-羟基樟脑、3-O-月硅酰基吡哆醇二乙酸酯、3-十五烷基儿茶酚、3-奎宁醇、4,4′-氧基二-2-丁醇、4,4′-亚磺酰基二苯胺、4-氨基-3-羟基丁酸、4-氨基-3-苯基丁酸、4-氨基水杨酸、4-氯-m-甲酚、4-己基间苯二酚、4-水杨酰基吗啉、5′-硝基-2′-丙氧基乙酰苯胺、5-氨基乙酰丙酸、5-阿扎胞苷、5-溴水杨酰基-氧肟酸、5F-DF-203、5-FU、5-HT3拮抗剂、6-氮尿苷、6-巯嘌呤、8-羟基喹啉、9-氨基喜树碱、A-151892、A-5021、阿巴卡韦、阿巴哌酮、阿巴瑞克、阿昔单抗、阿贝卡尔、阿贝莫司、阿比特龙、ABLC、ABT-751、AC-5216、阿卡地新、阿坎酸、阿坎酸、阿卡波糖、醋酸溴茶碱、醋丁洛尔、乙酰卡尼、乙酰阿达林、醋氯芬酸、醋氨苯砜、氨苯砜乙酸、acefylline、醋谷胺、醋谷胺、阿西美辛、醋硝香豆素、aceponate、乙缩醛、乙酰氨基丁香酚、对乙酰氨基酚、醋氨沙洛、乙酰苯胺、乙酰胂胺、乙酰唑胺、乙酰硫胺、醋酸己脲、醋羟胺酸、醋奋乃静、acetophenide、苯乙酮、乙酰砜、acetoxolone、acetrizoat、乙酰基、乙酰肉毒碱、乙酰基胆碱、乙酰基胆碱、乙酰基半胱氨酸、乙酰基亮氨酸、乙酰基苯丁酰脲、乙酰基水杨酸酯、乙酰基水杨酸、阿昔洛韦、阿昔呋喃、阿昔莫司、阿扎司特、阿昔曲丁、阿柔比星、aclatonium、乌头碱、acranil ®、吖啶黄、吖啶琐辛、阿伐斯汀、阿伐斯汀、actagardine衍生物、阿克他利、ACTH、阿昔洛韦、阿达帕林、ADCON-L、阿德福韦、阿德福韦二匹伏酯、腺苷注射剂、腺苷三磷酸、ADEPT、阿地唑仑、阿地芬宁、ADL-10-0101、阿屈非尼、肾上腺酮、肾上腺色素、阿屈高莱、AEOL-10150、aesthinol、AET、AF-2259、氟喹酮、AG-041R、AG-2037、AGN-194310、阿戈美拉汀、二甲氨乙酰吩噻嗪、AHL-157、AIT-034、AIT-202、AJ-9677、AJG-049、阿义马林、akzo desogestrel、阿拉普利、alapivoxil、albaconazole、阿苯达唑、沙丁胺醇、阿布妥因、阿氯芬酸、阿氯米松、双烯丙毒马钱碱、尿囊素铝、丁间醇醛、醛固酮、阿伦膦酸盐、阿伦膦酸、阿来西定、阿法骨化醇、阿法多龙、阿法沙龙、阿芬太尼、alfimeprase、阿夫唑嗪、阿夫唑嗪、阿尔孕酮、阿尔孕酮、藻胶、阿糖脑苷酶、阿利苯多、阿利吉仑、alitertinoin、阿立必利、紫朱草素、氨磺苯丙酮、尿囊素、阿洛巴比妥、别嘌醇、烯丙基异硫氰酸酯、烯丙雌醇、铝镁加、阿明洛芬、阿米三嗪、阿莫曲坦、芦荟大黄素、芦荟素、阿洛司琼、阿洛夫定、阿洛普令、α-,α-1蛋白酶、阿法罗定、阿吡坦、阿吡必利、阿普唑仑、阿普洛尔、阿沙克肽、ALT-711、Althiazid、阿替克林、六甲蜜胺、氯化铝六水合物、铝试剂、乙酸铝溶液、氯酸铝、羟基氯化铝、硫酸铝钾、硫酸铝钠、铝硫复、阿尔维林、alvimopan、alvocidib、ALX-0646、AM-24、AM-36、AM-477、金刚烷胺、amantanium、ambazon、安贝氯铵、ambrisentan、氨溴索、氨布卡因、安布茶碱、ambusid、安布溴铵、安西奈德、AMD-3100、氮卓西林、氮卓脒青霉素匹酯、amdoxovir、amelubant、苯佐卡因、氨甲氧苯嗪、氨芬酸、amidephrine、脒霉素、氨磷汀、阿米谷胺、阿米卡星、阿米洛利、氨基吖啶、阿米庚酸、醋胺硝唑、氨基酸制剂、氨基己酸、氨鲁米特、氨基胍、氨基马尿酸盐、氨美啶、地美戊胺、氨茶碱、氨丙嗪、氨基比林、氨喹脲、阿米雷司、胺碘酮、amiodipine、阿米苯唑、氨普立糖、氨磺必利、阿米替林、阿米替林 + 氯胺酮、氧阿米替林、氨来呫诺、氨草胶、氯化氨汞、苯甲酸铵、扁桃酸铵、水杨酸铵、戊酸铵、异戊巴比妥、阿莫卡嗪、氨酚喹啉、阿莫罗芬、amoscanat、氨磺洛尔、胺氧三苯、阿莫沙平、阿莫西林、阿莫西林 + potassiumclavulan、AMPAlex、苯丙胺、苯丙胺苄氰、两性霉素B、氨苄西林、安吡昔康、聚肌胞、安泼那韦、amrinose、氨柔比星、安吖啶、呱氨托美丁、阿米卡因、AN-152、合成代谢类固醇、阿那孕酮、阿那格雷、阿那曲唑、anazolene、安西他滨、安克洛酶、安多司特、雄异噁唑、雄烯二醇、阿奈可他、茴香脑、茴香脑三硫酮、angiogenix、血管紧张素、无水长春碱、阿尼芬净、anilerdine、茴拉西坦、茴茚二酮、茴香霉素、辛托品、阿尼普酶、安他唑啉、安锑锂明、地蒽酚、安曲霉素、二羟基蒽酚、炭疽抑制剂、antiangiogenic、anticort、抗抑郁药、抗-玻糖酸酶、酒石酸钾锑、硫代乙醇酸钠锑、硫代乙醇酸酰胺锑、抗孕素、安替比林、安替比林水杨酸酯、抗凝血酶III、抗焦虑剂、AP-521、AP-5280、阿帕西林、apaziquone、阿扎丙宗、阿朴可待因、apomine、阿扑吗啡、阿可乐定、aprepitant、阿普林定、阿普比妥、丙戊酰脲、抑肽酶、阿替加奈、AQ4N、aquavan、AR-116081、AR-A2、花生四烯酸、阿雷地平、阿贝卡星、arbidol、阿布他明、阿西莫单抗、ardeparin、槟榔碱、阿加曲班、精氨酸、Ariflo ®、阿立哌唑、阿罗茶碱、阿罗洛尔、对乙酰氨基苯胂酸、三氧化二砷、胂凡纳明、蒿甲醚、阿替夫林、蒿甲醚、青蒿素、蒿乙醚、青蒿琥酯、阿佐昔芬、AS-3201、ASA、驱蛔素、抗坏血酸、asenapine、阿西马朵林、asocarboxazid、asoprisnil、asoxime、天冬氨酸、鳞毛蕨素、绵马酚、阿司匹林、阿司匹林双嘧达莫、阿扑西林、AST-120、阿司咪唑、asulacrine、AT-1015、阿他美坦、atazanavir、阿替洛尔、阿替洛尔 + 氯噻酮、阿替洛尔 + 硝苯地平、阿替韦啶、阿替美唑、阿替莫德马来酸氢酯、ATL-146e、阿托西汀、阿托伐他汀、阿托西班、阿托伐醌、阿托伐醌 + 氯胍、阿曲库铵、阿曲生坦、atrial natriuretic、苯乳胺、阿托品、安美汀、金诺芬、金硫葡糖、阿伐麦布、阿伏苯宗、AWD-12-281、阿扎胞苷、阿扎环醇、阿扎硝唑、阿扎丙宗、偶氮丝氨酸、azasertron、阿扎他定、azathipprine、AZD-4282、AZD-6140、壬二酸、氮卓斯汀、阿折地平、叠氮氯霉素、阿度西林、阿齐利特、阿嗪米特、阿奇霉素、阿洛西林、阿佐塞米、氨曲南、甘葡环烃、巴氨西林、杆菌肽、巴氯芬、黄芩黄素、巴洛沙星、巴柳氮、班布特罗、巴美生、巴米茶碱、巴米品、巴比妥、巴尼地平、BAS-118、碱性氧化铝、baslilximab、巴马司他、巴曲酶、Bay-41-2272、Bay-41-8543、BAY-43-9006、BAY-57-1293、bazedoxifen、BBR-3464、BBR-3576、BBR-3610、BCH-1868、比比林、贝克拉胺、倍氯米松、贝氟沙通、苯呋洛尔、贝美格、贝那替秦、贝那普利、苄环烷、苄达酸、苄氟噻嗪、benetonide、贝奈克酯、苯氟雷司、苯磷硫胺、琥珀呋酮、贝尼地平、贝诺酯、苯噁洛芬、benoxinate、苯哌利多、苯丙哌林、苄丝肼、苯他西泮、苯替酪胺、bentoquatam、苯扎贝特、洁尔灭、苯扎隆、苄星青霉素、苯溴马隆、苯乙铵、苄替米特、苯咯溴、苯碘达隆、苄硝唑、苯佐卡因、苯佐他明、苯佐那酯、苯佐氯铵、苯甲酰基过氧化物、苯酰胺水杨酸、苄非他明、苄哌吡酮、苯喹胺、苄噻嗪、苯扎托品、苄达明、苯甲酸苄酯、苯甲基氢氯噻嗪、苯甲基吗啡、苄酚宁、贝他斯汀、苄普地尔、贝前列素、小檗碱、佛手柑脑、柏莫洛芬、贝西吡啶、倍他司汀、甜菜碱、倍他米松、倍他米隆、二碘酪氨酸、倍他洛尔、倍他唑、氨甲酰甲胆碱、倍他尼定、贝托卡因、贝凡洛尔、bevonium、贝沙罗汀、贝齐米特、BG-9928、BIA-2-024、BIA-2-093、BIA-3-202、比拉米可、比阿培南、bibenzonium、铋溴酚、比卡鲁胺、比西发定、比西酯、二环、比地索胺、比坦维林、氨醇醋茶碱、比他舍平、bifermelane、戊双氟酚、联苯苄唑、比马前列素、氯吡哌醇、bimosiamose、比尼贝特、binodenoson、biomed-101、生物素、比哌立登、比立哌隆、birlcodar、比沙可啶、比生群、双苯酰硫胺、bisdequalinium、铋、铋、铋、铝酸铋、乙基铋、铋钠、氨三乙酸铋钠、碱式碳酸铋、碱式没食子酸铋、次硝酸铋、次水杨酸铋、比索洛尔、比索洛尔 + HCTZ、比索洛尔 + 三氯噻嗪、双酚沙丁、硫氯酚、比托特罗、bitoscanat、BL-3875、博来霉素、布南色林、BMS-184476、BMS-387032、BN-82451、BNP-7787、BO-653、勃雄二醇、勃拉睾酮、勃地酮、波吲洛尔、冰片基氯、水杨酸冰片酯、bortezomib、波生坦、bradycor、脑促尿钠排泄药、溴烯比妥、布索芬新、布喹那、溴苄胺、亮绿、溴莫尼定、布林唑胺、brivudin、溴莫普林、溴西泮、溴芬酸、bromhexine bromide、溴茚二酮、溴米那、溴隐亭、溴-苯海拉明、溴仿、溴必利、溴-水杨酰基氯苯胺、溴哌利多、溴苯那敏、溴底乙苯、溴匹立明、brostallicin、溴替唑仑、溴长春胺、溴羟喹啉、brozuridine、马钱子碱、布西丁、布西拉明、布新洛尔、布拉地新、布克力嗪、丁氯柳胺、布可隆、丁吖卡因、布库洛尔、布地奈德、布地奈德 + 福莫特罗、布地品、布屈嗪、丁苯碘胺、布非洛尔、丁苯羟酸、丁咯地尔、丁福明、丁呋洛尔、丁丙二苯肼、布美他尼、丁萘夫汀、丁碘桂酸钠、布那唑嗪、布尼洛尔、布比卡因、布拉洛尔、丁丙诺啡、丁氨苯丙酮、布拉氨酯、布舍瑞林、丁螺环酮、白消安、白消安、仲丁巴比妥、布他卡因、布他西丁、布他拉胺、布他比妥、丁溴比妥、氨苯丁酯、布他米酯、布坦卡因、布他哌嗪、布他维林、布他唑胺、布替膦酸、布替萘芬、正丁巴比妥、苯丁胺乙酯、丁胺卡因、buthalital、异丁噻嗪、布替布芬、布替君、布托苯定、布康唑、布酰胺、丁非洛尔、布托啡诺、丁托西卡因、布替林、butropium、硫代月桂酸丁酯、butyrate propio、buzepide、BVT-5182、BXT-51072、C-1311、卡麦角林、卡麦角林、二甲胂酸、放线菌素C、卡地姆碘、水杨酸镉、卡屈嗪、咖啡氨醇、咖啡因、骨化二醇、卡泊三烯、卡泊三醇、卡泊三醇 + 倍氯米松、骨化三醇、3-aurothio-2-丙醇-1-磺酸钙、乙酰基水杨酸钙、溴乳糖醛酸钙、碳酸钙、葡糖酸钙、甘油磷酸钙、高泛酸钙、碘山萮酸钙、碘硬脂酸钙、乳酸钙、乙酰丙酸钙、二羟丙二酸钙、N-氨基甲酰基天冬氨酸钙、聚卡波非钙、丙酸钙、琥珀酸钙、caldaret、卡普睾酮、卡马西泮、卡莫司他、樟脑、樟脑酸盐、樟吡他胺、喜树碱、坎地沙坦、坎地沙坦环庚塞、坎沙曲、canertinib、坎利酮、斑蝥素、cantuzumab mertansine、卡培他滨、卡泊酸、卡普韦林、卡罗单抗、辣椒辣素霜剂、卡普托胺、卡托普利、卡托普利 + HCTZ、卡普脲、卡拉博沙、卡拉美芬、卡拉洛尔、卡巴胆碱、卡马西平、尿素过氧化物、卡巴胂、酉维因、卡巴克络、苯咪氨甲酯、羧苄西林、甘珀酸、枸环戊酯、carbicarb、卡比多巴、卡比多巴 + 左旋多巴-1、卡比马唑、卡比沙明、卡波氯醛、羧甲司坦、四氯化碳、碳酸酯凝胶、卡铂、卡前列素、卡前列素、卡波醌、卡溴脲、卡布比妥、氨磺丁脲、卡布特罗、卡非氨酯、carglumic acid、卡古缩宫素、卡茚西林、卡立泊来德、卡立泊来德、卡立普多、卡莫氟、卡莫昔罗、卡莫司汀、卡尼汀、卡罗维林、卡罗沙酮、丙酰奋乃静、卡匹帕明、卡洛芬、卡沙兰、卡替洛尔、卡铁卡因、卡柔比星、卡芦莫南、香芹酚、卡维地洛、香芹酮、西印度苦香碱、卡泊芬净、西阿尼醇、组织蛋白酶K抑制剂、组织蛋白酶S抑制剂、CC-401、CCI-779、CCR5拮抗剂、CDC-394、CDC-801、CEE-03-310、cefactor、头孢羟氨苄、头孢氨苄、cefalexin pivoxil、头孢孟多、头孢曲秦、头孢西酮、头孢唑林、头孢拉宗、头孢卡品、头孢克定、头孢地尼、cefditoren pivoxil、头孢吡肟、头孢他美、头孢他美、头孢克肟、头孢甲肟、头孢美唑、头孢米诺、头孢地秦、头孢尼西、头孢哌酮、头孢哌酮 + 舒巴坦、头孢雷特、头孢噻利、cefotazime、头孢替坦、头孢替安、头孢替安己酯、头孢西丁、头孢唑兰、头孢咪唑、头孢匹胺、头孢匹罗、头孢泊肟、头孢丙烯、头孢沙定、头孢磺啶、头孢他啶、头孢特仑、头孢替唑、头孢布烯、头孢唑肟、头孢唑肟、头孢曲松、头孢呋辛、头孢呋肟酯、头孢唑南、塞来考昔、西戈斯韦、塞利洛尔、乙基纤维素、CEP-1347、CEP-701、头孢乙腈、吐根酚碱、头孢氨苄、头孢甘酸、头孢噻啶、头孢菌素C、头孢噻吩、头孢匹林、头孢霉定、西立伐他汀、西罗普利、certoparin、蛙皮素、cerviprost、cetalkonium、塞他洛尔、cethexonium、cethromycin、西替地尔、西替利嗪、西替利嗪、西替利嗪 + 伪麻黄碱、西托硫胺、西托肟、西曲酸酯、cetrimonium、西曲瑞克、鲸蜡基二甲基乙基铵、鲸蜡吡啶、西维美林、CG-1521、晁模酸、鹅脱氧胆酸、CHF-3381、氯苯达诺、氯酚嗪、水合氯醛、苯丁酸氮芥、氯胺-B、氯胺-T、氯氨基-氯霉素、氯拉扎尼、氯苄沙明、氯倍他胺、氯环力嗪、氯登妥因、氯胍、氯醛己醇、氯己定、chloriazepoxide、四氯吲哚胺、氯地孕酮、氯汞君、氯美扎酮、氯米达唑、萘氮芥、氯阿唑丁、叶绿素、氯泼尼松、氯普鲁卡因、氯吡拉敏、氯喹、氯噻吡二胺、氯噻嗪、氯烯雌醚、二氯羟喹、氯二甲酚、氯脲菌素、氯苯那敏、氯苯甘醚、氯苯那敏、克痢酰胺、克痢酰胺、对氯苯丁胺、氯丙沙嗪、氯丙胍、氯丙胍 + 氨苯砜、氯丙嗪、氯磺丙脲、氯普噻吨、氯喹那多、金霉素、氯噻酮、氯西诺嗪、氯唑沙宗、胆酸、胆碱、茶碱酸胆碱、胆碱-L-alfoscerate、色烯卡、卡波罗孟、柯衣定、CHS-828、CI-1031、CI-1040、西苯唑啉、环索奈德、西氯他宁、环烟酯、环吡酮、环西多明、环孢素A、西多福韦、西苯唑啉、西兰司琼、西司他丁、西拉普利、西仑吉肽、西尼地平、西洛司特、西洛他唑、西咪替丁、cimetropium、cinacalcet、金鸡尼丁、辛可宁、辛可芬、桂哌酯、桂哌齐特、桂哌齐特、西尼必利、桂美辛、桂美君、桂利嗪、西诺西泮、西诺沙星、西诺沙酯、桂溴胺、塞奥罗奈、西潘茶碱、cipralisant、环丙贝特、环丙沙星、环丙沙星 + 西拉马朵、西沙必利、顺-阿屈库铵、顺铂、西酞普兰、胞磷胆碱、西替沃酮、柠檬酸盐、柠檬酸、瓜氨酸、西唑来汀、CJ-13610、CKD-602、克拉屈滨、利胆丁酸、克拉霉素、clavulan、克拉维酸二钠、克拉维酸、氯波必利、氯马斯汀、clemizol、克仑特罗、克仑硫卓、氯维地平、克来夫定、环氯茚酸、可利啶、克林沙星、克林霉素、克林霉素、克林霉素 + 维A酸、克利贝特、克林前列素、氯巴占、氯苄呋醇、氮苄苷、氯苯西泮、氯苄雷司、氯苯托品、氯倍他索、氯倍他松、氯丁替诺、氯卡帕明、氯西尼嗪、氯康唑、氯可托龙、氯膦酸盐、氯膦酸、clofarabine、氯法齐明、氯非那胺、clofibrat、氯贝酸、氯氟苯脲、氯苯辛酚、氯福雷司、克麦兰、氯雌酮甲醚、氯美辛、氯美噻唑、氯甲西林、氯米芬、氯米帕明、氯莫环素、氯硝西泮、可乐定、氯尼他秦、氯硝甘油、氯尼辛、clopamid、氯哌噻吨、氯哌斯汀、氯吡格雷、氯吡酸、氯泼尼醇、氯拉洛尔、氯氮草、氯索隆、氯克罗、氯茚二酮、氯丙那林、氯特胺、氯螺旋嗪、氯司替勃、氯噻平、氯噻西泮、克霉唑、克霉唑 + 倍他米松、氯唑西林、氯噁唑仑、氯索睾酮、cloxyquin、氯氮平、CMI-392、CMT-3、CNI-1493、CNS-5161、腺苷钴胺、己基苯酰爱康因、可卡因、可待因、辅因子、秋水仙碱、考来维仑、考来替兰、考来替泊、达普酸考福新、colfosceril、collagraft、药西瓜苦苷、双醋羟雌酮、coluracetam、考布他汀A-4前药、化合物B、conivaptin缀合物、connettivina、铃兰毒苷、科帕腊芬内特、羊可的瑞林、皮质固醇、可的松、可的伐唑、合成促皮质素、可他宁、可替宁、复方增效磺胺甲基异噁唑、库美香豆素、CP-248、CP-461、CPC-211、CPI-1189、CRA-0450、creatinol-O-磷酸酯、CRL-5861、克罗奈汀、氯康唑、色甘酸、色甘酸钠、克罗丙胺、克罗米通、克罗乙胺、克立他杀、CS-502、CS-758、CS-834、CT-052923、CT-32228、柠檬酸铜、铜克索林、CVT-2584、CX-659S、氰乙酰肼、氰美马嗪、花青素、CYC400、氨环已青霉素、环扁桃酯、环佐辛、环沙酮、环己异丙甲胺、cyclidrol、细胞周期蛋白D1抑制剂、赛克力嗪、环己巴比妥、环苯达唑、环苯扎林、环丁酸醇、环香豆素、环戊君、环芬尼、环氯胍、环美卡因、cycloniumelodide、环喷他明、环戊噻嗪、环戊巴比妥、环喷托酯、环磷酰胺、cyclopiroxalamine、环丝氨酸、环噻嗪、环香草酮、磁麻甙、cymserine、西那林、cyp26抑制剂、赛庚啶、环丙孕酮、巯乙胺、囊性纤维化疗法、阿糖胞苷、D-24851、D-4418、DA-5018、DA-6034、DA-7867、DA-7911、DA-8159、达卡巴嗪、达克珠单抗、放线菌素D、dalbavancin、达福普汀、达福普汀 + 奎奴普丁、dalteparin、达曲班、达那肝素、达那唑、丹蒽醌、丹曲林、达哌唑、dapivirine、达泊西汀、氨苯砜、达托霉素、darbepoetin alfa、达非那新、柔红霉素、DAX< SciClone、DB-67、D-camphocarboxylic、DCF-987、DDT、去氨催产素、地阿诺、胍喹啶、十烷双胺、癸氧酰胺、地西他滨、地氯普胺、去铁酮、去铁胺、地夫可特、地磷酰胺、degarelix、脱氢抗坏血酸、去氢依米丁、脱氢胆酸、地拉普利 + 马尼地平、地拉普利、地拉韦啶、地马孕酮、地莫匹醇、地洛西泮、delucemine、demanyl、癸二胺苯酯、地美环素、秋水仙胺、地美孕酮、demexiptilline、地那维林、dendrimers、地尼白介素-毒素连接物、地诺帕明、二甲叶酸、脱氧胆酸、脱氧皮质固醇、脱氧二氢-链霉素、脱氧肾上腺素、地普奥肽、缩酚酸肽、地普托品、dequalinium、dersalazine、地舍平、去铁敏、地氟烷、地昔帕明、去乙酰毛花苷、地氯雷他定、地洛瑞林、去氨加压素、去氧孕烯、去氧孕烯 + 雌二醇、去氧孕烯 +ethinylestrad (1)、地素吗啡、地奈德、去羟米松、detaxtran、devacade、地塞米松、地塞比诺、右卡多曲、右依法克生、右苄替米特、右布洛芬、右酮洛芬、右氯谷胺、右美托咪定、dexmethylphenidate、右泛醇、右雷佐生、葡聚糖-1、聚糖酐、右旋苯丙胺、右美沙芬、右吗拉胺、右丙氧芬、地佐辛、DF-1012、DFA-IV、D-茴香酮、D-葡醛内酯、Diab II、双醋瑞因、地恩丙胺、地马唑、地百里砜、泛影葡胺、地西泮、地吖醌、二氮嗪、地贝卡星、二苯西平、双溴丙脒、狄布卡因、氯醛比林、二氯胺T、二氯松、二氯苯甲醇、二氯丙醇、双氯酚、二氯苯胂、二氯磺胺、双氯芬酸、双氯芬酸 + HA、双氯西林、双香豆素、双香豆素、双环胺、去羟肌苷、二脱氧腺苷、didox、己二烯雌酚、地诺孕素、地诺孕素 + 雌二醇、地沙双酮、二乙嗪、二乙基酰胺、二乙基溴-乙酰胺、二乙基乙胺嗪、安非拉酮、二乙基己烯雌酚、双苯美林、二苯米唑、地芬诺辛、联苯吡胺、diflomotecan、二氟拉松、二氟沙星、二氟可龙、二氟尼柳、二氟泼尼酯、洋地黄苷、洋地黄毒苷、地高辛、双己维林、双肼屈嗪、双氢可待因、双氢可待因酮烯醇、双氢麦角隐亭、双氢麦角隐亭、氢化麦角胺、二氢吗啡、二氢链霉素、二氢速固醇、二羟基铝、地索普明、二异丙基对氧磷、二异丙基胺、地拉卓、地来洛尔、二氯尼特、地尔硫卓、地美罗酸、二甲弗林、马根维显溶液、二甲啡烷、茶苯海明、地美沙朵、地美庚醇、二巯丙醇、二甲他林、二甲双酮、二甲沙生、二甲茚定、异喹卡因、地美炔酮、二甲卡因、地美索酯、二甲基亚砜、二甲基噻吩丁烯胺、二甲福林、地莫拉明、地诺前列酮、diosmectite、地奥司明、地奥沙屈、dioxaphetyl、双羟乙麻黄碱、二羟苯宗、二苯马尼、二苯茚酮、二苯莎莫酮、苯海拉明、地芬尼多、地芬诺酯、二苯拉林、双苯他胂、白喉和破伤风类毒素和吸附的无细胞百日咳疫苗、地匹哌酮、地匹福林、双嘧达莫、双嘧达莫、地匹乙酯、安乃近、diquafosol、地红霉素、氨羟二磷酸二钠、地索苯宁、丙吡胺、distigmine、二磺法胺、双硫仑、地他唑、噻唑青胺、地蒽酚、ditiocarb、二黄原酸、地西拉嗪、DJ-927、DK-507k、DL-乳酸、DMDC、DMXAA、DNA Stealth、氢醌磺酸盐、多巴酚丁胺、多卡巴胺、多西他赛、二十二碳六烯酸、二十二烷醇、多库酯、多非利特、甲磺酸多拉司琼、多米奥醇、度米芬、多米曲班、多潘立酮、多奈哌齐、多尼普曲坦、多巴胺、多培沙明、doramapimod、doranidazole、多利培南、多佐胺、多佐胺 + 噻吗洛尔、多司马酯、dosulepine、多他利嗪、二苯噻庚英、多沙氯铵、多沙普仑、多沙唑嗪、度氟西泮、去氧苯妥英、多塞平、度骨化醇、去氧氟尿苷、多索茶碱、多柔比星、多西环素、多西拉敏、DPC-817、DPI-3290、DQ-113、六氢芬宁、屈洛昔芬、甲酚曲唑、屈他雄酮、屈大麻酚、决奈达隆、氟哌利多、氢普拉明、羟丙哌嗪、屈螺酮、屈他维林、羟蒂巴酚、屈噁昔康、屈昔多巴、屈昔多巴、DU-125530、屈昔多巴、耐久霉素、羟磷灰石、度他雄胺、DW-1141、DW-286a、DW-471、DX-9065a、DY-9760e、达克罗宁、地屈孕酮、地孟汀、dyphyllin、E-1010、E-2101、E2F拮抗剂、E-3620、E-5564、E-5842、E-6259、EAA-90、依巴斯汀、依柏康唑、乙溴替丁、依布硒、长春西汀、依卡派特、依卡倍特、依卡曲尔、去水芽子碱、芽子碱、二乙氧膦酰硫胆碱、益康唑、依考匹泮、依克前列素、依克替脲、ED-71、依达拉奉、依达曲沙、依地酸钙二钠、依地酸二钠、依地酸钠、依地酸三钠、edonentan、edotreotide、依度尿苷、依决洛单抗、滕喜隆、依法锂、efaproxiral、依法韦仑、乙氟利嗪、依氟鸟氨酸、乙氧黄酮、eflucimibe、依福地平、EGIS-7229、eglumegad、乙呱仑、依拉非班、依降钙素、elcosapentaenoic acid、章鱼唾腺精、依来曲普坦、依高地平、柔花酸、elliptinium、依托拉嗪、elvucitabine、elzasonan、酸藤子酚、恩布拉敏、依美斯汀、emepronium、依米丁、乙嘧替氟、EMM-210525、布洛芬、依莫法宗、EMR-62203、恩曲他滨、依米氨酯、依那普利、依那普利拉、烯丙异丙甲巴比妥、恩卡尼、恩西拉嗪、恩屈嗪、苯乙氨茴酸、恩氟烷、恩康唑、恩尿嘧啶、ENMD-0995、依诺他滨、enol-3-IPA、依诺沙星、依诺肝素、依诺昔酮、甘草次酸、恩前列素、恩拉生坦、恩他卡朋、恩替卡韦、恩维霉素、eoinephrine、依帕司他、epavir、EPC-K1、乙哌立松、依培夫定、麻黄碱、依匹西林、表美雌醇、依匹斯汀、依匹唑、表柔比星、环硫雄醇、依普利酮、依利色林、依前列醇、环氧司坦、依普拉酮、爱普列特、依普罗沙坦、依普罗醇、依他匹隆、依他铂、依斯的明、依他佐辛、依替巴肽、去氢马烯雌酮、马烯雌酮、ERA-923、厄多司坦、麦角柯宁碱、麦角异柯宁碱、甲磺酰麦角碱、麦角新碱、麦角固醇、麦角胺、香茹嘌呤、厄罗替尼、ertapenem、丁四硝酯、红百金花内酯、醋硬脂红霉素、红霉素红皮素、依托红霉素、红霉素葡庚糖酸酯、乳糖红霉素、红霉素丙酸酯、红霉素硬脂酸酯、司丙红霉素、艾沙拉唑、依他普仑、七叶灵、依舍立定、艾司洛尔、艾美拉唑、艾司唑仑、酯、雌二醇、雌二醇、雌莫司汀、雌三醇、雌激素、雌酮、eszopiclone、乙非君、依他苯酮、二乙氨乙茶碱、依那西普、依他硝唑、依他喹酮、依特比妥、依沙吖啶、依他尼酸、ethadion、乙胺丁醇、香草二乙胺、酚磺乙胺、乙醇胺、依沙维林、乙氯维诺、乙水杨胺、乙噻嗪、炔己蚁胺、乙炔雌二醇、乙炔雌二醇、乙炔雌二醇、乙硫异烟胺、炔孕酮、依索庚嗪、普罗吩胺、乙琥胺、乙苯妥英、依索唑胺、乙苄托品、乙醇、双香豆乙酯、乙基氯、地布酸乙酯、乙醚、二十碳五烯酸乙酯、氯氟卓乙酯、氯氟卓乙酯、乙基胺、乙烯、乙雌烯醇、亚乙基、乙基甲基-噻吩丁烯胺、乙基吗啡、乙基去甲肾上腺素、炔诺醇、ethynylcytidine、依替卡因、依替膦酸酯、依替膦酸、双苯次甲丁胺、依替福辛、etilefrin、乙左旋多巴、etiprednol、依塞罗酯、依替唑仑、依托度酸、依托羟嗪、依托芬那酯、依托贝特、乙羟茶碱、益多酯、羟乙茶碱烟酸酯、依托格鲁、依托咪酯、依托多林、依托尼秦、依托孕烯、依托哌酮、依托泊苷、磷酸依托泊苷、艾托考昔、乙苯噁啶、依托唑啉、依曲替酯、乙色胺、乙异丁嗪、尤卡托品、丁香酚、EUK-134、EUK-189、伊文思蓝、依维莫司、依沙酰胺、依沙美肟、依沙替康、依西美坦、依昔苯酮、依昔舒林、Exosurf ®、依泽替米贝、因子IX、因子VIII、因子XIII、fadolmidine、法倔唑、氟骨三醇、泛昔洛韦、法莫替丁、氨吡啶、泛度沙星、泛托法隆、法罗培南、faropenem daloxate、法西多曲、法舒地尔、法扎溴铵、非巴氨酯、非布丙醇、febuxostat、非多托秦、非尔氨酯、联苯乙酸、非洛地平、苯赖加压素、非莫西汀、芬贝西林、芬布芬、芬布酯、芬坎法明、芬咖明、芬克洛酸、芬地林、芬度柳、苯丙胺乙茶碱、芬氟拉明、非尼戊醇、非诺贝特、非诺多泮、非诺洛芬、非诺特罗、非诺维林、非诺唑啉、非诺地尔、非诺唑酮、芬戊二醇、芬哌丙烷、fenpiverinium、芬普雷司、芬喹唑、芬维A胺、芬司匹利、芬太尼、芬替酸、芬替克洛、芬替康唑、芬托溴铵、非普地醇、非普拉宗、依地酸铁钠、铁氧胺B、铁胆盐、葡萄糖酸亚铁、ferumoxytol、fesoterodine、非索非那定、fibrostat、非达司他、非度索嗪、非那雄胺、芬罗唑、非哌西特、FK-960、flavopiridol、黄酮哌酯、氟卡尼、氟罗沙星、氟辛克生、氟班色林、夫洛非宁、氟氧头孢、夫洛丙酮、夫洛梯隆、氟司喹南、氟氯西林、氟尿苷、三氟丙嗪、氟阿尼酮、fluarizine、fluasterone、氟扎可特、氟二氯松、氟氯西林、氟康唑、氟胞嘧啶、氟达拉滨、氟脱氧葡萄糖F18、氟地西泮、氟氢可的松、氟芬那酸、氟茚二酮、氟马西尼、氟美西诺、氟甲喹、二氟美松、氟甲噻嗪、氟尼缩松、氟硝西泮、氟诺洛芬、氟轻松、氟轻松SAL、醋酸氟轻松、氟考丁酯、氟可龙、荧光素、氟苯乙砜、氟米龙、氟沙仑、氟尿嘧啶、氟西汀、氟甲睾酮、氟哌噻吨、氟培龙、氟奋乃静、氟吡丁、醋酸氟甲叉龙、氟泼尼龙、氟丙喹宗、氟羟可舒松、氟西泮、氟比洛芬、氟红霉素、氟孕酮、三氟乙醚、fluroxen、氟司必林、氟他胺、氟他唑仑、氟替卡松、氟托西泮、氟曲马唑、氟托溴铵、氟伐他汀、氟伏沙明、叶酸、亚叶酸、甲吡唑、福米诺苯、福米韦生、福莫卡因、二甲替嗪、fondaparinux、甲酰勃龙、福美坦、福莫可他、福莫特罗、膦沙那韦、膦甲酸、磷雌酚、膦氟康唑、磷霉素、磷霉素、磷柳酸、福辛普利、磷苯妥英、福莫司汀、夫罗培南、夫罗曲普坦、果糖、果糖-1,6-二磷酸、FTC、FTY-720、弗多司坦、氟维司群、fumagiline、烟曲霉素、呋喃他酮、夫拉扎勃、呋喃唑酮、呋唑氯铵、furonazide、呋塞米、呋喃硫胺、糠三甲铵、夫西地酸、G1、YM BioSciences、G25、GABA-A Α5、加巴喷丁、加贝酯、加波沙朵、gadobenat、钆布醇、钆双胺、钆、钆喷酸、钆特醇、钆弗塞胺、钆塞酸、加兰他敏、雪花胺、加柔比星、戈拉碘铵、没食子酸、麦芽酸镓、硝酸镓、戈洛帕米、加奈索酮、更昔洛韦、加尼瑞克、更斯的明、更托非班、garenoxacin、garnocestim、加替沙星、吉法酯、gefitinib、gemcabene、吉西他滨、吉美前列素、吉非贝齐、吉米沙星、庆大霉素、甲紫、龙胆苦苷、龙胆酸、吉培福林、吉哌隆、孕二烯酮、孕二烯酮 + ethinylest、孕诺酮己酸酯、孕三烯酮、gimatecan、吉拉克肽、羟基洋地黄毒苷、GL-406349、格拉非宁、格拉默、格列波脲、格列齐特、格列美脲、格列吡嗪、格列喹酮、格列索脲、glisoxepid、球蛋白(人)、葡美辛、葡庚糖酸、葡糖酸、葡糖胺、葡胺苯砜、葡磷酰胺、谷氨酸、戊二醛、格鲁米特、格列本脲、格列噻唑、格列丁唑、甘油、甘油磷酸酯、胍基乙酸、水杨酸羟乙酯、异烟腙葡萄糖醛酸内酯、格隆溴铵、格列己脲、格列嘧啶、格列平脲、GMDP、金钠、戈舍瑞林、GPI-1485、GPI-5693、皮肤替代物、格拉司琼、格帕沙星、灰黄霉素、愈创木酚、愈创哌特、愈创蓝油烃、愈创甘油醚、胍美柳、gualacolsulfonate、胍甲环素、胍那苄、胍那决尔、胍乙啶、胍法辛、胍诺沙苄、胍生、油状树脂、胍立莫司、GW-280430A、GW-320659、GYKI-16084、曲古霉素、哈拉西泮、哈西奈德、halobetasol、卤泛群、卤米松、氟哌啶醇、卤泼尼松、卤普罗近、卤丙烷、氟烷、卤沙唑仑、harkoseride、HE-2000、healos、血卟啉、癸烟酯、环庚比妥、辛胺醇、海他西林、羟乙基淀粉、hexacetonide、六氯酚、抗肝素灵、己芴铵、六甲季铵、己脒定、己丙氨酯、己丙氨酯、己烷雌酚、己烷雌酚双(β-二乙基氨基乙基醚)、己巴比妥、海克替啶、海索比妥、海索苯定、己环铵甲基硫酸盐、海索那林、人造血浆溶液、海克卡因、HF-0299、HGP-2、HGP-6A、hidrosmin、组胺、希司咯定、组氨瑞林、HM-101、HMN-214、后马托品、后莫肯芬、高氯环秦、高泛酸、HP-228、石杉碱A、透明质烷、海恩酮、副大风子油酸、肼屈嗪、白毛茛碱、白毛莨分碱、氢氯噻嗪、氢可酮、氢可他酯、氢化可的松、氢化可的松、氢氟噻嗪、氢吗啡酮、二氢奎尼丁、二氢奎宁、氢醌、氢氧化物、羟钴胺、羟基苯丙胺、羟基氯喹、羟孕酮酯、羟基乙基醚、羟基萘甲酸盐、羟哌替啶、奥芬氨酯、羟基丙基纤维素、羟芪巴脒、羟基丁卡因、羟嗪、Hylan G-F 20、羟甲香豆素、莨菪碱、金丝桃素、IACFT、伊班膦酸、异波帕胺、异波帕胺、Ibritumomab、ibrolipim、异丁司特、异丁芬酸、布洛芬、布洛芬吡啶甲醇、异丁普生、伊布利特、ICA-17043、艾考糊精、伊达比星、咪唑克生、IdB-1016、艾地苯醌、IDN-5109、idoxifen、idraparinux、羟乙桂胺、艾芬地尔、异环磷酰胺、iguratimod、ilaprazole、伊洛马司他、伊潘立酮、伊洛前列素氨丁三醇、ILX23-7553、imatinib、咪达普利、咪唑水杨酸酯、亚胺培南、丙米嗪、丙米嗪N-氧化物、咪喹莫特、伊莫拉明、英普他派、英丙舒凡(灭活的)、依那立松、英卡膦酸盐、英卡膦酸、吲达品、茚唑啉、吲达帕胺、英地卡胺、茚洛秦、茚洛秦、茚诺洛尔、茚地那韦、indiplon、吲地司琼、indisulam、吲哚布芬、吲哚菁绿、吲哚美辛、吲哚洛芬、吲哚拉明、induclem、英夫利昔单抗、抑制剂、抑制剂、异丙肌苷、肌醇、烟酸肌醇酯、反激动剂Mer、碘苄胍、碘苯扎酸、碘比醇、碘卡酸、碘西他酸、碘达胺、碘化物、碘、胆影酸、碘克沙醇、碘阿芬酸、氯碘羟喹、碘仿、碘奥酮、iodopyrrole、双碘喹啉、iodosubgallate、碘非他胺123I、碘甘卡酸、碘海醇、碘美拉酸、碘美普尔、碘帕醇、碘番酸、碘喷托、碘苯酯、碘酚酸、碘普胺、碘普罗酸、碘吡多、碘吡酮、碘他拉酸、碘曲仑、碘佛醇、碘克沙酸、碘昔兰、IP-751、伊匹达克林、IPL-576092、ipodate、iponiazid、ipratpopium、异丙托铵、异丙托溴铵、异丙佐罗、依普黄酮、伊普吲哚、iproclozid、ipsapiron、厄贝沙坦、IRFI-042、IRFI-165、虹蚁素、茚达酮、伊立替康、伊罗夫文、山梨醇铁、伊索拉定、IS-741、isaglitazone、ISAtx-247、伊波格雷、异帕米星、异米尼尔、异丁基对氨基苯甲酸脂、异康唑、乙基异丙肾上腺素、isofloxythepin、异氟烷、异氟磷、isoladol、异美沙酮、异美汀、异烟肼、异尼辛、异丙美沙嗪、异丙碘铵、异丙醇、异丙基乌诺前列酮、异丙肾上腺素、异山梨醇、异山梨醇二硝酸酯、异山梨醇单硝酸酯、异西喷地、异维A酸、异戊酰、伊索克酸、伊索昔康、异克舒令、伊拉地平、伊拉帕泛、ISV-403、伊他司琼、ITF-282、伊托必利、伊曲康唑、itramin、伊曲谷胺、伊妥瑞克、伊伐布雷定、ixabepilone、J-104132、J-107088、J-113397、Janex-1、交沙霉素、JTV-519、K-777、卡英酸、kalimate、血管舒张素、KB-130015、KCB-328、凯布宗、氯胺酮、酮色林、凯他唑仑、乙氧丁酮醛、凯托米酮、酮康唑、酮洛芬、酮咯酸、酮咯酸、酮替芬、凯林、玻璃酸酶、KNI-272、KP-103、KP-157、KP-544、KRN-5500、KT-136、KUL-7211、KW-2170、KW-6002、KW-7158、L-365260、L-5-羟基-色氨酸、L-745337、L-758298、L-826141、拉贝洛尔、拉西地平、乳酸、拉克替醇、乳果糖、拉呋替丁、拉米非班、拉米夫定、拉莫三嗪、兰地洛尔、拉尼西明、laniquidar、拉诺康唑、拉诺替普酶、兰瑞肽、兰索拉唑、碳酸镧、lapatinib、laquinimod、拉索昔芬、拉氧头孢、拉坦前列素、月桂胍、醋酸劳利铵、指甲花醌、LAX-111、拉扎贝胺、LB-30057、L-半胱氨酸、来苯胺、来氟米特、来氟米特、胺苯吡咯、利南西林、香菇多糖、来匹卢定、乐卡地平、来立司琼、来索吡琼、来普立宁、来托司坦、来曲唑、无色矢车菊素、醋酸亮丙瑞林、醋酸亮丙瑞林、亮丙瑞林、左洛啡烷、levaminsole、左克罗卡林、左乙拉西坦、左倍他洛尔、左布诺洛尔、左布比卡因、左卡巴斯汀、左西替利嗪、左旋多巴、左羟丙哌嗪、左氧氟沙星、左旋乙酰美沙酮、左莫普洛尔、左炔诺孕酮、左芬氟拉明、左丙氧芬、左啡诺、左西孟旦、levosulpride、左甲状腺素、levovirin、lexidronam、来昔帕泛、LF-15-0195、LF-16-0687、LGD-1550、LH、LH-RH、liarozote、licofelone、利可替奈、lidadronate、利达脒、利多卡因、利多苯宁、利多氟嗪、利马前列素、林可霉素、lindan、利奈唑胺、亚油酸、亚麻酸、碘塞罗宁、脂肪酶、脂质体-地塞米松、脂质体-氟比洛芬、Lipogel 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β-环糊精复合物、肉桂酸吡罗昔康、吡扎地尔、吡洛芬、匹伐他汀、匹伐加宾、特戊酰氧基甲基、特戊酰苯并肼、匹氨西林、匹氨西林/匹美西林、pivcefalexin、匹美西林、pixantrone、苯噻啶、苯噻啶、PKI-166、乳酰对乙氧苯胺、普拉贝脲、纤溶酶原激活药、甲氧胺喹、platonin、普劳诺托、PLD-118、PLD-147、普来可那立、普卡霉素、p-甲基苯海拉明、PMS-601、肺炎球菌、PNU-288034、鬼臼毒素、聚普瑞锌、泊尔定甲硫酸盐、聚甲酚磺醛、降胆葡胺、聚乙二醇单十二醚、脊髓灰质炎病毒疫苗、poly-ADPRT抑制剂、聚雌二醇、polyphenon E、泊利噻嗪、卟菲尔钠、泊沙康唑、泊替瑞林、钾、钾、钾、氯化钾、葡萄糖酸钾、p-氨基苯甲酸钾、聚维酮、碘聚维酮、PP-117、PR-2699、PR-608、普拉洛尔、丙缓脉灵、解磷定、pralnacasan、普拉克索、普拉西坦、pramiverin、普兰林肽、丙吗卡因、普拉地平、普仑司特、普拉洛芬、普拉睾酮、pratosartan、普伐他汀、普拉西泮、吡喹酮、哌唑嗪、泼尼卡酯、泼尼莫司汀、泼尼松龙、泼尼松龙21-二乙基氨基乙酸酯、泼尼松龙吉法酯、泼尼松龙钠、泼尼松、强的松龙戊酸酯、泼尼立定、普加巴林、孕烷-3α-醇-20-酮、倍美力 + 曲美孕酮、普瑞特罗、普诺地嗪、普尼拉明、prezatide、普立地诺、prifinium、丙胺卡因、伯氨喹、扑米酮、普啉司他、PRO-2000、丙磺舒、普罗布考、普鲁卡因胺、普鲁卡因、丙卡巴肼、丙卡特罗、丙氯拉嗪、procodazol、丙环定、丙环氨酯、普罗地平、原黄素、卤加比、黄体酮、丙谷美辛、丙谷胺、普罗庚嗪、促乳素、普罗林坦、prolonium、丙嗪、二甲哌替啶、普美孕酮、普罗雌烯、异丙嗪、丙萘洛尔、丙帕他莫、普罗帕酮、丙帕锗、丙溴比妥、普罗帕脒、丙烷-1,2-二醇、丙泮尼地、丙胺太林、丙对卡因、propatyl、普罗硝唑、丙戊茶碱、丙匹西林、丙酰马嗪、丙酸、丙酰l-肉毒碱、丙哌卡因、丙吡兰、丙哌维林、丙吡西平、丙泊酚、丙氧卡因、右丙氧芬、普萘洛尔、丙己君、丙碘酮、丙基硫尿嘧啶、异丙安替比林、普罗喹宗、海葱次苷、依前列醇、前列腺素E1、前列腺素E2、前列腺素F2α、丙舒硫胺、蛋白C、丙可可碱、丙硫喷地、丙噻酯、丙硫异烟胺、丙替嗪酸、原白头翁素、protoklol、原卟啉IX、普罗替林、尿激酶前体、普罗沙唑、普塞、丙羟巴比、普洛脉宁、羟丙茶碱、普罗扎平、普卢卡必利、普卢利沙星、右旋可卡因、假麻黄碱、伪麻黄碱、伪麻黄碱+ 曲普利啶、西洛西宾、PSK-3841、p-对氨苯磺酰-苯甲基胺、PT-141、蝶罗呤、嘌罗霉素、PX-12、噻嘧啶、吡嗪酰胺、吡醇氨酯、吡斯的明、吡哆醛5-磷酸、吡哆素、美吡拉敏、乙胺嘧啶、吡诺林、吡琥胺酯、巯氧吡啶、吡乙二酮、吡硫醇、焦儿茶酚、连苯三酚、咯萘啶、焦磷酸盐、吡咯戊酮、火棉、吡咯他敏、吡咯卡因、pyrrolntrin、扑蛲灵、夸西泮、槲皮素、喹硫平、喹那西林、米帕林、喹高利特、喹那普利、喹普利拉、喹匹拉明、奎勃龙、雌三醇环戊醚、炔雌醚、喹乙宗、喹法米特、奎尼丁、奎宁、喹西特、奎纽帕明、奎奴普丁、R-107500、R-667、雷贝拉唑、消旋卡多曲、消旋甲啡烷、雷洛昔芬、雷替曲塞、雷马曲班、雷米那酮、雷米普利、雷莫司琼、Ramot项目号1097、雷莫司汀、雷尼替丁、雷尼替丁铋、雷诺嗪、豹蛙酶、rapacuronium、雷沙吉兰、萝巴新、雷夫康唑、雷索司特、雷佐生、RC-529、瑞巴派特、rebimastat、reboxetime、瑞马西胺、瑞芬太尼、reminetant、瑞莫必利、伦扎必利、瑞格列奈、repertaxin L-赖氨酸盐、repinotan、瑞吡司特、双环辛巴比妥、瑞普特罗、瑞西美托、瑞西那明、利舍匹林、利舍平、残余蟾蜍配基、瑞喹莫德、间苯二酚、瑞替普酶、瑞替加滨、维A酸、revimid、R-氟比洛芬、rho (D)免疫、rho-激酶抑制剂、利巴韦林、核黄素、核糖霉素、顺蓖麻酸、利多格雷、利福布汀、利福拉齐、利福美坦、利福米特、利福平 + 甲氧苄啶、利福平、利福霉素SV、利福喷汀、利福昔明、利福昔明霜剂、利马扎封、利美尼定、利鲁唑、金刚乙胺、rimazolium、利美索龙、利米特罗、利莫那班、磺代酚、利奥前列素、利塞膦酸盐、利塞膦酸、利培酮、利坦色林、利替培南、利托君、利托那韦、利妥昔单抗、利凡斯的明、利扎曲普坦、RJR-2403、RNA Stealth、Ro-0094889、Ro-61-1790、罗西维林、罗库溴铵、罗非考昔、罗氟司特、罗他霉素、咯利普兰、罗利环素、罗莫肽、氯烟贝特、罗匹尼罗、罗哌卡因、罗喹美克、罗沙前列醇、罗沙米星、玫瑰红、罗西格列酮、罗索沙星、罗培泊芬、罗苏伐他汀、罗替戈汀、罗曲酸、罗沙胂、罗沙替丁、罗昔非班、roxindol、罗红霉素、RPR-109881A、RPR-130401、R-roscovitine、RS-0406、RSR-13、红介藜芦胺、卢比替康、ruboxistaurin、卢非酰胺、芦氟沙星、卢帕他定、芦丁、RWJ-54428、S-0139、S-15535、S-18886、S-34730、S-3578、S-36496、S-36527、S-5751、S-8510、S-8921、沙可美林、沙贝鲁唑、S-腺苷基蛋氨酸、safinamide、醋水杨胺、柳氮磺嘧啶、沙丁胺醇、水杨苷、水杨酰基醇、水杨酰基酰胺、水杨酰基酰胺O-醋酸、苯甲酰胺、水杨酸、水杨酰基silfuric acid、水杨烟肼、沙美特罗、双水杨酯、沙维林、钐153Sm、山帕曲拉、山环素、沙康唑、沙丙蝶呤、沙奎那韦、沙拉新、沙瑞度坦、沙瑞度坦、沙立佐坦、沙立佐坦、沙格雷酯、沙格雷酯、沙替格雷、沙替格雷、沙铂、沙铂、沙妥莫单抗、沙妥莫单抗、SB-237376、SB-237376、SB-238039、SB-238039、SB-277011、SB-277011、猩红、SCH-00013、SCH-00013、Sch-23863、Sch-23863、Sch-57790、Sch-63390、海葱苷、东莨菪碱、东莨菪碱、东莨菪碱N-氧化物、SCS技术、司骨化醇、塞克硝唑、司可巴比妥、司来吉兰、硒代蛋氨酸、司美利特、司莫地尔、西奥骨化醇、司匹司他、塞曲司特、舍他康唑、舍他康唑、舍吲哚、舍吲哚、舍曲林、舍曲林、sestamibi、司他斯汀、司他斯汀、司维拉姆、司维拉姆、七氟烷、七氟烷、SG-210、西布曲明、西卡宁、昔多芬、silodosin、silprostone、乳酸银、苦味酸银、磺胺嘧啶银、西美曲特、双贝特、辛伐他汀、辛卡利特、辛托溴铵、西索米星、西他沙星、西他马喹、sitaxsentan、西维来司他、SJA-6017、SL-65-1498、SLV-306、SLV-308、Sm153 lexidronam、S-甲基蛋氨酸、SMP-300、SN-38、SNAP-7941、SOA-132、soblidotin、索布瑞醇、索布佐生、氨基苯砷酸钠、胂凡纳明钠、氯化钠、地布酸钠、叶酸钠、甲醛合次硫酸钠、透明质酸钠、甲碘吡酮酸钠、亚硝酸钠、硝普钠、羟丁酸钠、苯酚磺酸钠、苯基丁酸钠、磷酸钠、硫酸普拉酮钠、丙酸钠、水杨酸钠、四癸基硫酸钠、索法酮、苯丙砜、solifenacin、山梨烟酯、山梨醇、索立夫定、索他洛尔、索特瑞醇、二碘酚磺酸、司谷氨酸、司帕沙星、司巴丁、SPA-S-843、解痉醚、SPD-754、大观霉素、SPI-339、螺哌隆、螺普利、锗螺胺、螺内酯、SR-121463、SR-144190、SR-146131、SR-271425、SR-27897、SR-31747、SR-58611、SS732、SS-750、SSR-149415、SSR-180575、SSR-181507、SSR-591813、SST-101、SSY-726、ST-200、stachyfilin、司他霉素、stampidine、亚锡、锡泊芬、二氢睾丸酮、司坦唑醇、staph aureus ther、STAT4抑制剂、司他夫定、司腾勃龙、stepronim、二巯琥珀酸锑钠、睇波芬、二苯乙烯脒、司替戊醇、链道酶、链霉素、链霉素异烟肼、链黑霉素、链佐星、strontium ranelate、氯化锶-89、二巯丁二酸、琥珀酰亚胺、琥珀酰胆碱、琥珀酰胆碱、琥珀磺胺噻唑、琥珀氨苯砜、琥氯非尼、硫糖铝、舒芬太尼、舒巴坦、舒巴坦 + 氨苄西林、磺苄西林、舒苯汀、舒布硫胺、硫康唑、suleptanate、硫索单抗、磺胺苯酰、磺胺醋酰、磺胺氯达嗪、磺胺柯定、磺胺乙胞嘧啶、磺胺嘧啶、磺胺戊烯、磺胺地索辛、磺胺多辛、磺胺乙二唑、磺胺脒、磺胺胍诺、磺胺林、磺胺洛西酸、磺胺甲嘧啶、磺胺对甲氧嘧啶、磺胺甲嘧啶、磺胺甲二唑、磺胺甲氧甲嘧啶、磺胺甲噁唑、吡嗪磺、吡嗪磺、磺胺美曲、磺胺米柯定、磺胺噁唑、磺胺、磺胺酸、对氨苯磺酰脲、磺胺异甲基嘧啶、磺胺苯吡唑、磺胺普罗林、磺胺吡嗪、磺胺吡啶、磺胺苯胂、硫胂凡纳明、柳氮磺吡啶、磺胺异噻唑、磺胺均三嗪、磺胺噻唑、磺胺硫脲、硫氧洛尔、磺吡酮、舒非仑、磺胺索嘧啶、磺胺异噁唑、磺溴酞、双乙磺丁烷、磺烟腙、磺酸、双乙磺丙烷、磺达嗪、阿地砜、舒林酸、磺酚丁、舒利苯酮、硫马林、硫马唑、舒洛地尔、sulphan blue、舒必利、舒他西林、舒噻美、舒托必利、磺托酸、sumanirole、舒马普坦、SUN-N8075、suplatast、舒洛芬、苏拉明、表面活性剂TA、舒立克隆、琥布宗、SYM-1010、SYM-2081、SYM-2207、氯氧三嗪、Syn-1253、Syn-2190、Syn-2869、昔奈福林、昔洛舍平、T-1095、T-1249、T-3912、T-588、T-67、T-82、TA-2005、TA-2005、TA-993、他莫瑞林、他卡西醇、tacedinaline、他克林、他克莫司、tadalafil、他非诺喹、tafluposide、TAK-375、TAK-427、TAK-559、高淀粉酶、他仑帕奈、酞氨西林、他拉泊芬、他拉斯汀、他布比妥、他林洛尔、他利克索、他奈坦、他尼氟酯、他替瑞林、他莫昔芬、坦洛新、坦度螺酮、鞣仿、他前列烯、tariquidar、TAS-103、他索沙坦、牛磺胆酸、牛磺罗定、他扎司特、他扎罗汀、三唑巴坦、三唑巴坦+ 哌拉西林、TBC-3711、TCH-346、替比培南、teboroxime、tecadenoson、tecastemizole、锝99Tc、四氯噻嗪、替克洛占、替地沙米、替氟烷、替加氟、替加氟 + 尿嘧啶、替加色罗、替考拉宁、telbivudine、替仑西平、泰利霉素、替美司坦、替米沙坦、telomerase inhibs、替马西泮、替米维林、替莫普利、替莫西林、替莫泊芬、替莫唑胺、替那拉唑、替奈普酶、替尼达普、替尼泊苷、替诺福韦、tenofovir disoproxil、替诺尼唑、替诺昔康、细格孢氮杂酸、替普瑞酮、特拉唑嗪、特比萘芬、特布他林、特康唑、丁苯哌丁醇、特麦角脲、特利加压素、特罗地林、特罗芬那酯、松油二醇、tertalolol、叔戊醇、tesaglitazar、替米利芬、睾内酪、睾酮、tetrabamate、替曲比妥、丁苯那嗪、丁卡因、四氯乙烯、丁卡因、四环素、tetrahydrozoline、粉防己碱、替群妥英、四氢西泮、替曲膦、四氧普林、Tevenel ®、tezacitabine、替唑生坦、沙利度胺、噻苯哌胺、西尼二胺、可可碱、益多酯、茶碱、噻苯达唑、氨硫脲、thiacymserine、硫烯比妥、硫胺、硫咪嘌呤、甲砜霉素、硫戊巴比妥、胺苯硫卓酮、thiazinamium、thiazolinobutazone、噻唑砜、硫苯唑林、thiemalat、硫乙拉嗪、thimerfonate、硫柳汞、硫巴比妥、仲丁硫巴比妥钠、硫柳脲苯胂、硫代卡巴胂、硫代秋水仙碱、硫代甲酚、硫辛酸、硫代甘油、硫鸟嘌呤、thioimrag、硫喷妥钠、塞替派、醋酸奋乃静、硫丙拉嗪、硫利达嗪、硫代硫酸盐、替沃噻吨、thiovir、双苯乙硫酯、塞仑、松齐拉敏、托扎啉酮、凝血质、烟酸呋酯、thymectacin、麝香草酚、胸腺喷丁、百里基N-异戊基氨基甲酸酯、甲状丙酸、甲状腺素、硫地醇、噻加宾、噻美尼定、噻奈普汀、硫必利、噻洛芬酸、噻拉米特、tiazofurin、tibezonium、替勃龙、替卡西林、噻氯匹定、替尼酸、tiemonium、tigecycline、替吉莫南、惕各假托品、替利定、替利洛尔、tilmacoxib、替鲁膦酸、特美汀、timepidium、替米哌隆、噻吗洛尔、噻莫西酸、本紫红素锡乙酯、替那唑唑、替硝唑、替诺立定、硫卡利特、噻氯香豆素、噻康唑、硫普罗宁、tiotropium、噻克索酮、替培啶、tipifarnib、替拉那韦、tiquizium、替拉扎明、替拉曲考、替拉扎特、替罗非班、苯酰胺桂胺、硫酸氧钛、tiuxetan、替可的松、替扎尼定、TLK-199、TLK-286、TNF-β类似物、TNP-470、TO-186、妥布霉素、妥卡尼、托莰非、托拉地新、tocoretinate、托屈嗪、托芬那辛、tofimilast、托非索泮、tolazamid、tolazolin、甲苯磺丁脲、托卡朋、托西拉酯、甲磺环己脲、tolevamer、托芬那酸、托林达酯、托利洛尔、托美丁、托萘酯、托洛尼定、托洛铵、托洛沙酮、托哌酮、托普帕敏、托瑞司他、tolserine、托特罗定、托伐普坦、托利卡因、托吡酯、拓扑异构酶、托泊替康、托拉塞米、torcetapib、torcitabine、托瑞米芬、托塞米、托西莫单抗、托磺沙星、曲马多、曲马唑啉、群多普利、氨甲环酸、曲尼司特、反式-维A酸、反苯环丙胺、曲匹地尔、曲妥单抗、曲伏前列素、曲呫诺、traxoprodil、曲唑酮、曲马卡拉、群勃龙、群孕酮、曲奥舒凡、曲匹布通、treprostinol、维A酸、曲托喹酚、TRH、TRI-50b、三醋汀、曲安西龙、曲安西龙、曲安西龙、曲安奈德、氨苯蝶啶、triapine、三亚胺醌、三唑仑、三苄糖苷、tribromophenate、美曲磷酯、三氯噻嗪、三氮芥、三氯乙烯、三双环季铵、三氯卡班、三氯酚哌嗪、三氯福司、三氯生、3-甲色酮、曲地碘铵、曲恩汀、三乙醇胺、曲他胺、三氟拉嗪、三氟哌多、三氟丙嗪、曲氟尿苷、三氟柳、三氟醋酸盐、苯海索、曲马唑嗪、曲美布汀、三甲卡因、阿利马嗪、曲美他嗪、三甲双酮、曲美芬、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、triolstane、三甲沙林、曲帕胺、曲帕拉醇、曲吡那敏、曲普利啶、曲普瑞林、曲硫秦、曲托喹啉、TRK-530、TRK-820、troclosene、曲磷胺、曲格列酮、醋竹桃霉素、三乙硝胺、曲金刚胺、氨丁三醇、氨丁三醇、氨丁三醇、氨丁三醇、二苯乙酸莨菪酯、tropesin、托吡卡胺、莨菪醇、托烷司琼、丙大观霉素、trospium、曲伐沙星、曲沙他滨、曲克芦丁、曲昔派特、锥虫红、锥虫胂胺、色氨酸、TSH、TSN-09、TU-2100、异庚胺、杀结核菌素、氯筒箭毒碱、妥洛特罗、TV-3326、TY-11223、TY-12533、TYB-3215、泰巴氨酯、泰洛沙泊、泰马唑啉、酪胺、吡罗培克、乌苯美司、乌芬那酯、十一烯酸、乌诺前列酮、UR-8880、乌拉莫司汀、消石素-U、乌拉地尔、尿素、乌瑞替派、乌拉坦、尿苷5′-三磷酸、尿抑制素、熊去氧胆酸、熊去氧胆酸、ushercell、乌沙苷、疫苗、白喉菌苗、多价疫苗、伐昔洛韦、伐地考昔、戊地胺、戊乙脂、缬更昔洛韦、戊诺酰胺、valomaciclovir、丙戊酸盐、丙戊酸、丙戊酰胺、丙戊塞胺、戊柔比星、缬沙坦、伐司朴达、伐地那非、varespladib、水痘-带状疱疹病毒、伐尼地平、VEA、维库溴铵、维吖啶、文拉法辛、维拉必利、维拉帕米、维替泊芬、维司力农、维曲布汀、VF-233、VI-0134、阿糖腺苷、氨己烯酸、维拉佐酮、维洛沙秦、维米醇、戊烯比妥、长春碱、长春布宁、长春胺、长春考酯、长春新碱、长春地辛、长春氟宁、长春瑞滨、长春西丁、乙烯基醚、乙烯比妥、维喹地尔、绿毛菌素、维司那定、维生素A、维生素B12、维生素C、维生素D2、维生素D3、维生素K5、产前维生素、VLA-4拮抗剂、VNP-4010M、伏格列波糖、伏立康唑、伏氯唑、VUF-K-8788、华法林、WF-10、WMC-79、伤口愈合基质、WP-170、扎利罗登、扎莫特罗、呫诺美林、脑脉康、珍米洛非班、联苯丁酸、希苯洛尔、希波酚、ximelagatran、希莫洛芬、希帕胺、佐尔啡诺、XR-5118、XR-5944、赛洛唑啉、木糖、YH-1885、YM-511、YM-598、育亨宾、YT-146、Z-321、Z-335、扎鲁司特、扎西他滨、扎达来特、扎来普隆、扎托洛芬、扎那米韦、zanapezil、扎替雷定、ZD-0473、ZD-0947、ZD-6126、ZD-9331、zebularine、zelandopam、折那司他、齐考诺肽、齐多夫定、齐留通、齐美定、醋酸锌、N-乙酰氨基乙酸锌、zinc ibuprofenate、p-苯酚磺酸锌、水杨酸锌、净司他丁、净司他丁斯酯、齐培丙醇、齐拉西酮、佐芬普利、佐芬普利+ HCTZ、唑来膦酸、佐利米定、佐米曲坦、唑吡坦、佐美酸、zonampanel、zoniporide、唑尼沙胺、佐匹克隆、唑泊司他、佐柔比星、zosuquidar、佐替平、ZP-123、Z-他莫昔芬、珠氯噻醇、α1-抗胰蛋白酶、α-没药醇、α-氯醛糖、α-乙基苯甲醇、α-葡萄糖-1-磷酸、α-苯基丁酰胺、α-蛔蒿素、α-萜品醇、α-生育酚、β-alethine、β-苯亚甲基丁酰胺、β-胡萝卜素、β-优卡因、β-丙内酯、β-谷甾醇、γ-氨基丁酸、γ-羟基丁酸盐、γ-亚麻酸、δ-氨基乙酰丙酸、ε-乙酰氨基己酸和ε-氨基己酸。亦参见美国专利7,927,613，其通过引用以其整体结合到本文中。其它药学上可接受的共形成物包括描述于“GenerallyRegarded as Safe” (“GRAS”)和/或US FDA “Everything Added to Food in the UnitedStates” (“EAFUS”)列表中的那些。
在一些实施方案中，一种或多种药学上可接受的共形成物的至少一种是氯硝柳胺或其药学上可接受的盐或水合物；或氯硝柳胺类似物或其药学上可接受的盐或水合物。在一些这些实施方案中，一种或多种药学上可接受的共形成物的至少一种可以是具有式(I)、(XVIII)-(XXV)和XXVII，例如式XXIV或XXV的任何一个的化合物；或上述任何一种化合物。在某些这些实施方案中，一种或多种药学上可接受的共形成物的至少一种可以是具有式(I)、(XVIII)-(XXV)和XXVII，例如式XXIV或XXV；或XXVI的任何一个的氯硝柳胺类似物；或上文特别描述的任何一种化合物。在某些这些实施方案中，化学实体可以是氯硝柳胺或其药学上可接受的盐或水合物(例如，氯硝柳胺)。
非限制性组合
在一些实施方案中，共结晶包括(i) 氯硝柳胺或氯硝柳胺类似物；和(ii) 氯硝柳胺的药学上可接受的盐和/或水合物；或氯硝柳胺类似物的药学上可接受的盐和/或水合物。
在一些实施方案中，共结晶包括(i) 氯硝柳胺；和(ii) 氯硝柳胺的药学上可接受的盐和/或水合物；或氯硝柳胺类似物的氯硝柳胺的药学上可接受的盐和/或水合物。
在一些实施方案中，共结晶包括(i) 氯硝柳胺或氯硝柳胺类似物；和(ii) 第二API。
在一些实施方案中，共结晶包括(i) 氯硝柳胺的药学上可接受的盐和/或水合物；或氯硝柳胺类似物的氯硝柳胺的药学上可接受的盐和/或水合物；和(ii) 第二API。
在一些实施方案中，共结晶包括(i) 氯硝柳胺；和(ii) 第二API。
在一些实施方案中，共结晶包括(i) 氯硝柳胺的药学上可接受的盐和/或水合物；或氯硝柳胺类似物的氯硝柳胺的药学上可接受的盐和/或水合物；和(ii) 氨基酸(例如，脯氨酸，例如，D-脯氨酸或L-脯氨酸，或外消旋脯氨酸)。
在一些实施方案中，共结晶包括(i) 氯硝柳胺；和(ii) 氨基酸(例如，脯氨酸，例如，D-脯氨酸或L-脯氨酸，或外消旋脯氨酸)。
在一些实施方案中，共结晶包括(i) 氯硝柳胺的药学上可接受的盐和/或水合物；或氯硝柳胺类似物的氯硝柳胺的药学上可接受的盐和/或水合物；和(ii) 5-10 (例如，5-9、5-6或5)元杂芳基，例如，含氮杂芳基，例如，咪唑。
在一些实施方案中，共结晶包括(i) 氯硝柳胺；和(ii) 5-10 (例如，5-9、5-6或5)元杂芳基，例如，含氮杂芳基，例如，咪唑。
例如参见Sanphui、P. Cryst. Growth Des. 2012，12，4588；Imramovský，A.Crystals2012，2，349-361；和Grifasi，F. Cryst. Growth Des. 2015，15，4588。
性质
在一些实施方案中，与游离形式(包括游离酸、游离碱和两性离子、水合物、溶剂合物等)的化学实体或其酸或碱盐相比，特别是在例如，溶解度、溶出、生物利用度、稳定性、Cmax、Tmax、渗透性、加工性、治疗剂血浆浓度、吸湿性、局部浓度、无定形化合物的结晶、形式多样性(包括多态性和晶癖)的减少、形态或晶癖的变化方面，得到的共结晶赋予化学实体(和/或一种或多种共形成物，例如，当共形成物是第二API时)增强和/或新的和有益的性质。
在一些实施方案中，共结晶具有少于约50%、或少于约40%、或少于约30%、或少于约20%、或少于约10%、或少于约5%、或少于约2%、或少于约1%的口服生物利用度(F)。在某些实施方案中，本文所述的化学实体具有少于约20%，例如，少于约19%、少于约18%、少于约17%、少于约16%、少于约15%、少于约14%、少于约13%、少于约12%、少于约11%、少于约10%、少于约9%、少于约8%、少于约7%、少于约6%、少于约5%、少于约4%、少于约3%、少于约2%、少于约1%或少于约0.5%的口服生物利用度(F)。
在一些实施方案中，共结晶具有相对低的水溶解度。低的水溶解度是指当在20°C下测量时，在水中具有小于或等于10 mg/mL的溶解度的化合物。在某些实施方案中，当在20°C下测量时，本文所述的化学实体具有小于或等于900、800、700、600、500、400、300、200、150、100、90、80、70、60、50、40、30、20微克/mL，或进一步10、5或1微克/mL，或进一步900、800、700、600、500、400、300、200、150、100、90、80、70、60、50、40、30、20或10 ng/mL，或少于10 ng/mL的水溶解度。
在一些实施方案中，共结晶具有相对低的药物渗透性。
药物组合物和给药
概要
化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)通过使化合物变得生物可利用(例如，局部生物可利用)的任何途径给予有需要的受试者。
在一些实施方案中，化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)作为包括化学实体和一种或多种药学上可接受的赋形剂和任选地本文所述的一种或多种其它治疗剂的药物组合物给予。
在一些实施方案中，化学实体可与一种或多种常规药用赋形剂组合给予。药学上可接受的赋形剂包括但不限于，离子交换剂、氧化铝、硬脂酸铝、卵磷脂、自乳化药物递送系统(SEDDS)例如d-α-生育酚聚乙二醇1000琥珀酸酯、用于药物剂型的表面活性剂例如吐温、泊洛沙姆或其它类似的聚合物递送基质、血清蛋白、例如人血清白蛋白、缓冲物质例如磷酸盐、tris、甘氨酸、山梨酸、山梨酸钾、饱和植物脂肪酸的偏甘油酯混合物、水、盐或电解质例如硫酸鱼精蛋白、磷酸氢二钠、磷酸氢钾、氯化钠、锌盐、胶体二氧化硅、三硅酸镁、聚乙烯吡咯烷酮、基于纤维素的物质、聚乙二醇、羧甲基纤维素钠、聚丙烯酸酯、蜡类、聚乙烯-聚氧丙烯-嵌段聚合物和羊毛脂。环糊精例如α-、β和γ-环糊精或化学改性衍生物例如羟基烷基环糊精，包括2-和3-羟基丙基-β-环糊精或其它可溶性衍生物也可用于增强本文所述的化合物的递送。可制备含有范围为0.005%-100%的本文所述的化学实体(余下的是无毒性赋形剂)的剂型或组合物。预期的组合物可包含0.001%-100%的本文提供的化学实体，在一个实施方案中为0.1-95%，在另一个实施方案中为75-85%，在又一个实施方案中为20-80%。制备这样的剂型的实际方法是本领域技术人员已知的，或显而易见的；例如参见Remington: The Science and Practice of Pharmacy，22nd Edition (Pharmaceutical Press，London，UK. 2012)。
在一些实施方案中，本文所述的化学实体或其药物组合物可通过任何可接受的给予途径给予有需要的受试者。可接受的给予途径包括但不限于，含服、皮肤、子宫颈内、窦内(endosinusial)、气管内、肠内、硬膜外、间质、腹内、动脉内、支气管内、囊内、大脑内、脑池内、冠状动脉内、真皮内、导管内、十二指肠内、硬膜内、表皮内、食管内、胃内、齿龈内、回肠内、淋巴管内、髓内、脑膜内、肌内、卵巢内、腹膜内、前列腺内、肺内、窦内(intrasinal)、脊柱内、滑膜内、睾丸内、鞘内、小管内、肿瘤内、子宫内、血管内、静脉内、鼻、鼻胃、口服、胃肠外、经皮、硬膜外、直肠、呼吸(吸入)、皮下、舌下、粘膜下层、局部、经皮肤、经粘膜、经气管、输尿管、尿道和阴道。
局部给予
在一些实施方案中，本文所述的化学实体或其药物组合物适合局部给予，例如，通过在特定的治疗部位(例如，消化道、胃肠(“GI”)道、眼、关节或皮肤)局部给予化学实体或其组合物局部给予，以提供化学实体的局部给予至需要治疗的区域(例如，口腔；GI道，例如，结肠；眼；皮肤；或关节)。在某些实施方案中，在所述局部给予期间发生化学实体的最少系统暴露。这样的组合物的实例包括但不限于，用于直肠给予、口服给予、皮肤给予或植入的组合物。在某些实施方案中，组合物用于非口服给予。
在一些实施方案中，本文所述的化学实体或其药物组合物适合局部给予至GI道。在某些实施方案中，在给予后，在GI道中化学实体的局部浓度高于(例如，约2倍至约50倍、约5倍至约50倍；约5倍至约25倍；约5倍至约15倍；例如，约50倍、约25倍、约20倍、约15倍、约10倍、约5倍，例如，至少约10倍)在血浆室中化学实体的浓度。在某些这些实施方案中，在血浆室中的化学实体经历首过代谢。
在一些实施方案中，本文所述的化学实体或其药物组合物适合局部给予至在消化道或GI道内的一个或多个特定位置。例如，化学实体的至少一些存在于上部GI道(例如，胃)；或所述剂的至少一些存在于下部GI道中(例如，大肠，例如，结肠，例如，升结肠和/或横结肠和/或末端结肠；或小肠)。作为进一步的实例，化学实体的至少一些存在于升结肠和/或横结肠和/或末端结肠和/或小肠和/或胃。所述局部给予的方法可包括但不限于，直肠给予和/或口服给予。
在某些实施方案中，本文所述的化学实体或其药物组合物适合局部(local)、局部(topical)给予至消化道或GI道，例如，直肠给予。直肠组合物包括但不限于，灌肠剂、直肠凝胶、直肠泡沫剂、直肠气雾剂、栓剂、胶冻剂栓剂和灌肠剂(例如，贮留灌肠剂)。
作为凝胶、霜剂、灌肠剂或直肠栓剂可用于直肠组合物的药理学上可接受的赋形剂包括但不限于以下任何一种或多种：可可脂甘油酯、合成聚合物例如聚乙烯吡咯烷酮、PEG (例如PEG软膏剂)、甘油、甘油化明胶、氢化植物油、泊洛沙姆、各种分子量的聚乙二醇和聚乙二醇的脂肪酸酯的混合物、凡士林、无水羊毛脂、鲨鱼肝油、糖精酸钠、薄荷醇、甜扁桃仁油、山梨醇、苯甲酸钠、anoxid SBN、香草精油、气雾剂、对羟苯甲酸酯类/苯氧乙醇、对氧苯甲酸甲基钠、对氧苯甲酸丙基钠、二乙基胺、卡波姆、聚羧乙烯、甲基氧基苯甲酸酯、聚乙二醇鲸蜡硬脂醚、椰油酰基辛酰基癸酸酯、异丙醇、丙二醇、液体石蜡、黄原胶、羧基-偏亚硫酸氢盐、依地酸钠、苯甲酸钠、偏亚硫酸氢钾、葡萄籽提取物、甲基磺酰基甲烷(MSM)、乳酸、甘氨酸、维生素、例如维生素A和E和醋酸钾。
在某些实施方案中，栓剂可通过混合本文所述的化学实体与适合的无刺激性赋形剂或载体例如可可脂、聚乙二醇或栓剂蜡(其在环境温度下是固体但在体温下是液体，因此在直肠融化和释放活性化合物)制备。在其它实施方案中，用于直肠给予的组合物呈灌肠剂的形式。
灌肠剂制剂
在一些实施方案中，含有本文所述的化学实体的灌肠剂制剂以"即用"形式提供。
在一些实施方案中，含有本文所述的化学实体的灌肠剂制剂在一个或多个试剂盒或包装中提供。在某些实施方案中，试剂盒或包装包括两个或更多个单独包含/包装的组分，例如两个组分，其当混合在一起时，提供需要的制剂(例如，作为混悬液)。在某些这些实施方案中，两组分系统包括第一组分和第二组分，其中：(i) 第一组分(例如，包含在小袋内)包括化学实体(如本文任何地方描述的)和任选地一种或多种药学上可接受的赋形剂(例如，一起配制为固体制剂，例如，一起配制为湿粒状固体制剂)；和(ii) 第二组分(例如，包含在小瓶或瓶中)包括一种或多种液体和任选地一种或多种其它药学上可接受的赋形剂(一起形成液体载体)。使用前(例如，使用前即刻)，将(i)和(ii)的内容物合并，以形成需要的灌肠剂制剂，例如，作为混悬剂。在其它实施方案中，组分(i)和(ii)各自在其自身的单独试剂盒或包装中提供。
在一些实施方案中，一种或多种液体的每一种是水，或生理学上可接受的溶剂，或水和一种或多种生理学上可接受的溶剂的混合物。典型的这样的溶剂包括但不限于，甘油、乙二醇、丙二醇、聚乙二醇和聚丙二醇。在某些实施方案中，一种或多种液体的每一种是水。在其它实施方案中，一种或多种液体的每一种是油，例如常用于药物制剂的天然和/或合成的油。
可用于本文所述的药品的其它药用赋形剂和载体在各种手册中列出(例如D. E.Bugay和W. P. Findlay (编辑) Pharmaceutical excipients (Marcel Dekker, NewYork, 1999), E-M Hoepfner, A. Reng和P. C. Schmidt (编辑) Fiedler Encyclopediaof Excipients for Pharmaceuticals, Cosmetics and Related Areas (EditionCantor, Munich, 2002)以及H. P. Fielder (编辑) Lexikon der Hilfsstoffe fürPharmazie, Kosmetik and angrenzende Gebiete (Edition Cantor Aulendorf,1989))。
在一些实施方案中，一种或多种药学上可接受的赋形剂各自可独立地选自增稠剂、粘度增强剂、膨胀剂、粘膜粘着剂、渗透促进剂、缓冲剂、防腐剂、稀释剂、粘合剂、润滑剂、助流剂、崩解剂、填充剂、增溶剂、pH调节剂、防腐剂、稳定剂、抗氧化剂、湿润剂或乳化剂、助悬剂、色素、着色剂、等张剂、螯合剂、乳化剂和诊断剂。
在某些实施方案中，一种或多种药学上可接受的赋形剂的每一种可独立地选自增稠剂、粘度增强剂、粘膜粘着剂、缓冲剂、防腐剂、稀释剂、粘合剂、润滑剂、助流剂、崩解剂和填充剂。
在某些实施方案中，一种或多种药学上可接受的赋形剂的每一种可独立地选自增稠剂、粘度增强剂、膨胀剂、粘膜粘着剂、缓冲剂、防腐剂和填充剂。
在某些实施方案中，一种或多种药学上可接受的赋形剂的每一种可独立地选自稀释剂、粘合剂、润滑剂、助流剂和崩解剂。
增稠剂、粘度增强剂和粘膜粘着剂的实例包括但不限于：树胶，例如黄原胶、瓜尔胶、豆角胶、西黄蓍胶、刺梧桐树胶、茄替胶、仙人掌胶、车前籽胶和阿拉伯胶；基于聚(含羧酸)的聚合物，例如具有强的氢-键合基团的聚(丙烯酸、马来酸、衣康酸、柠康酸、羟基乙基甲基丙烯酸或甲基丙烯酸)或其衍生物例如盐和酯；纤维素衍生物，例如甲基纤维素、乙基纤维素、甲基乙基纤维素、羟基甲基纤维素、羟基乙基纤维素、羟基丙基纤维素、羟基乙基乙基纤维素、羧甲基纤维素、羟基丙基甲基纤维素或其纤维素酯或醚或衍生物或盐；粘土，例如manomorillonite粘土、例如Veegun、硅镁土粘土；多糖，例如葡聚糖、果胶、支链淀粉、琼脂、甘露聚糖或聚半乳糖酸或淀粉例如羟基丙基淀粉或羧甲基淀粉；多肽，例如酪蛋白、谷蛋白、明胶、纤维蛋白胶；壳聚糖，例如乳酸盐或谷氨酸盐或羧甲基甲壳质；葡萄糖胺聚糖，例如透明质酸；海藻酸的金属或水可溶性盐，例如藻酸钠或藻酸镁；schleroglucan；含有氧化铋或氧化铝的粘合剂；atherocollagen；聚乙烯基聚合物，例如羧基乙烯基聚合物；聚乙烯吡咯烷酮(聚维酮)；聚乙烯基醇；聚乙烯基乙酸酯、聚乙烯基甲基醚、聚乙烯基氯、聚偏乙烯和/或等等；聚羧基化乙烯基聚合物，例如上述的聚丙烯酸；聚硅氧烷；聚醚；聚乙烯氧化物和二醇；聚烷氧基和聚丙烯基酰胺和其衍生物和盐。优选实例可包括纤维素衍生物，例如甲基纤维素、乙基纤维素、甲基乙基纤维素、羟基甲基纤维素、羟基乙基纤维素、羟基丙基纤维素、羟基乙基乙基纤维素、羧甲基纤维素、羟基丙基甲基纤维素或其纤维素酯或醚或衍生物或盐(例如，甲基纤维素)；和聚乙烯基聚合物，例如聚乙烯吡咯烷酮(聚维酮)。
防腐剂的实例包括但不限于：苯扎氯铵、苯佐氯铵、苄索氯铵、十六烷基三甲基溴化铵、氯化三苯唑、西吡氯铵、度米芬(Bradosol®)、硫柳汞、苯基硝酸汞、苯基醋酸汞、苯基硼酸汞、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、氯丁醇、苯甲醇、苯乙醇、氯己定、聚六亚甲基双胍、过硼酸钠、咪唑烷基脲、山梨酸、Purite®)、Polyquart®)和过硼酸钠四水合物等。
在某些实施方案中，防腐剂是对羟基苯甲酸酯或其药学上可接受的盐。在一些实施方案中，对羟基苯甲酸酯是烷基取代的4-羟基苯甲酸酯或其药学上可接受的盐或酯。在某些实施方案中，烷基是C1-C4烷基。在某些实施方案中，防腐剂是4-羟基苯甲酸甲酯(对羟基苯甲酸甲酯)或其药学上可接受的盐或酯、4-羟基苯甲酸丙酯(对羟基苯甲酸丙酯)或其药学上可接受的盐或酯，或其组合。
缓冲剂的实例包括但不限于：磷酸盐缓冲液系统(磷酸二氢钠去水合物、磷酸二钠十二水合物、二碱式磷酸钠、无水一碱式磷酸钠)、碳酸氢盐缓冲液系统和硫酸氢盐缓冲液系统。
崩解剂的实例包括但不限于：羧甲纤维素钙、低取代的羟基丙基纤维素(L-HPC)、羧甲纤维素、交联羧甲纤维素钠、部分预胶化淀粉、干淀粉、羧甲基淀粉钠、交聚维酮、聚山梨酯80 (聚氧乙烯去水山梨糖醇油酸酯)、淀粉、乙醇酸淀粉钠、羟基丙基纤维素预胶化淀粉、粘土、纤维素、藻蛋白碱、树胶或交联聚合物，例如交联PVP (来自GAF Chemical Corp的Polyplasdone XL)。在某些实施方案中，崩解剂是交聚维酮。
助流剂和润滑剂(聚集抑制剂)的实例包括但不限于：滑石粉、硬脂酸镁、硬脂酸钙、胶体二氧化硅、硬脂酸、水性二氧化硅、合成硅酸镁、细粒状氧化硅、淀粉、月桂基硫酸钠、硼酸、氧化镁、蜡类、氢化油、聚乙二醇、苯甲酸钠、硬脂酸甘油山萮酸酯、聚乙二醇和矿物油。在某些实施方案中，助流剂/润滑剂是硬脂酸镁、滑石粉和/或胶体二氧化硅；例如，硬脂酸镁和/或滑石粉。
稀释剂(亦称为“填充剂”或“膨胀剂”)的实例包括但不限于：磷酸二钙二水合物、硫酸钙、乳糖(例如，乳糖一水合物)、蔗糖、甘露醇、山梨醇、纤维素、微晶纤维素、高岭土、氯化钠、干淀粉、水解淀粉、预胶化淀粉、二氧化硅、氧化钛、硅酸镁铝和糖粉。在某些实施方案中，稀释剂是乳糖(例如，乳糖一水合物)。
粘合剂的实例包括但不限于：淀粉、预胶化淀粉、明胶、糖(包括蔗糖、葡萄糖、右旋糖、乳糖和山梨醇)、聚乙二醇、蜡类、天然和合成树胶，例如阿拉伯胶、西黄蓍胶、藻酸钠、纤维素包括羟基丙基甲基纤维素、羟基丙基纤维素、乙基纤维素和veegum，和合成聚合物例如丙烯酸和甲基丙烯酸共聚物、甲基丙烯酸共聚物、甲基丙烯酸甲酯共聚物、氨基烷基甲基丙烯酸酯共聚物、聚丙烯酸/聚甲基丙烯酸和聚乙烯吡咯烷酮(聚维酮)。在某些实施方案中，粘合剂是聚乙烯吡咯烷酮(聚维酮)。
在一些实施方案中，含有本文所述的化学实体的灌肠剂制剂包括水和一种或多种(例如，全部)以下赋形剂：
·一种或多种(例如，一种、两种或三种)增稠剂、粘度增强剂、粘合剂和/或粘膜粘着剂(例如，纤维素或其纤维素酯或醚或衍生物或盐(例如，甲基纤维素)；和聚乙烯基聚合物例如聚乙烯吡咯烷酮(聚维酮)；
·一种或多种(例如，一种或两种；例如，两种)防腐剂，例如对羟基苯甲酸酯，例如，4-羟基苯甲酸甲酯(对羟基苯甲酸甲酯)或其药学上可接受的盐或酯、4-羟基苯甲酸丙酯(对羟基苯甲酸丙酯)或其药学上可接受的盐或酯，或其组合；
·一种或多种(例如，一种或两种；例如，两种)缓冲剂，例如磷酸盐缓冲液系统(例如，磷酸二氢钠去水合物、磷酸二钠十二水合物)；
·一种或多种(例如，一种或两种，例如，两种)助流剂和/或润滑剂，例如硬脂酸镁和/或滑石粉；
·一种或多种(例如，一种或两种；例如，一种)崩解剂，例如交聚维酮；和
·一种或多种(例如，一种或两种；例如，一种)稀释剂，例如乳糖(例如，乳糖一水合物)。
在某些这些实施方案中，化学实体是氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，氯硝柳胺。
在某些实施方案中，含有本文所述的化学实体的灌肠剂制剂包括水、甲基纤维素、聚维酮、对羟基苯甲酸甲酯、对羟基苯甲酸丙酯、磷酸二氢钠去水合物、磷酸二钠十二水合物、交聚维酮、乳糖一水合物、硬脂酸镁和滑石粉。在某些这些实施方案中，化学实体是氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，氯硝柳胺。
在某些实施方案中，含有本文所述的化学实体的灌肠剂制剂在一个或多个试剂盒或包装中提供。在某些实施方案中，试剂盒或包装包括两个单独包含/包装的组分，其当混合在一起时提供需要的制剂(例如，作为混悬液)。在某些这些实施方案中，两组分系统包括第一组分和第二组分，其中：(i) 第一组分(例如，包含在小袋内)包括化学实体(如本文任何地方描述的)和一种或多种药学上可接受的赋形剂(例如，一起配制为固体制剂，例如，一起配制为湿粒状固体制剂)；和(ii) 第二组分(例如，包含在小瓶或瓶中)包括一种或多种液体和一种或多种其它药学上可接受的赋形剂(一起形成液体载体)。在其它实施方案中，组分(i)和(ii)各自在其自身的单独试剂盒或包装中提供。
在某些这些实施方案中，组分(i)包括化学实体(例如，氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，氯硝柳胺)和一种或多种(例如，全部)以下赋形剂：
(a) 一种或多种(例如，一种)粘合剂(例如，聚乙烯基聚合物，例如聚乙烯吡咯烷酮(聚维酮)；
(b) 一种或多种(例如，一种或两种，例如，两种)助流剂和/或润滑剂，例如硬脂酸镁和/或滑石粉；
(c) 一种或多种(例如，一种或两种；例如，一种)崩解剂，例如交聚维酮；和
(d) 一种或多种(例如，一种或两种；例如，一种)稀释剂，例如乳糖(例如，乳糖一水合物)。
在某些实施方案中，组分(i)包括约40重量%-约80重量% (例如，约50重量%-约70重量%、约55重量%-约70重量%；约60重量%-约65重量%；例如，约62.1重量%)的化学实体(例如，氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，氯硝柳胺)。
在某些实施方案中，组分(i)包括约0.5重量%-约5重量% (例如，约1.5重量%-约4.5重量%、约2重量%-约3.5重量%；例如，约2.76重量%)的粘合剂(例如，聚维酮)。
在某些实施方案中，组分(i)包括约0.5重量%-约5重量% (例如，约0.5重量%-约3重量%、约1重量%-约3重量%；约2重量%，例如，约1.9重量%)的崩解剂(例如，交聚维酮)。
在某些实施方案中，组分(i)包括约10重量%-约50重量% (例如，约20重量%-约40重量%、约25重量%-约35重量%；例如，约31.03重量%)的稀释剂(例如，乳糖，例如，乳糖一水合物)。
在某些实施方案中，组分(i)包括约0.05重量%-约5重量% (例如，约0.05重量%-约3重量%)的助流剂和/或润滑剂。
在某些实施方案中(例如，当组分(i)包括一种或多种润滑剂，例如硬脂酸镁时)，组分(i)包括约0.05重量%-约1重量% (例如，约0.05重量%-约1重量%；约0.1重量%-约1重量%；约0.1重量%-约0.5重量%；例如，约0.27重量%)的润滑剂(例如，硬脂酸镁)。
在某些实施方案中(当组分(i)包括一种或多种润滑剂，例如滑石粉时)，组分(i)包括约0.5重量%-约5重量% (例如，约0.5重量%-约3重量%、约1重量%-约3重量%；约1.5重量%-约2.5重量%；约1.8重量%-约2.2重量%；约1.93重量%)的润滑剂(例如，滑石粉)。
在某些这些实施方案中，上述(a)、(b)、(c)和(d)的每一个均存在。
在某些实施方案中，组分(i)包括表7所示的成分和量。
表7
在某些实施方案中，组分(i)包括表8所示的成分和量。
表8
| 成分 | 重量百分比 |
| 氯硝柳胺 | 约62.1重量% |
| 交聚维酮(Kollidon CL) | 约1.93重量% |
| 乳糖一水合物(Pharmatose 200M) | 约31.03重量% |
| 聚维酮(Kollidon K30) | 约2.76重量% |
| 滑石粉 | 约1.93重量% |
| 硬脂酸镁 | 约0.27重量% |
在某些实施方案中，组分(i)配制为湿粒状固体制剂。在某些这些实施方案中将成分(化学实体、崩解剂和稀释剂)的内相合并，和在高剪切颗粒机中混合。粘合剂(例如，聚维酮)溶于水以形成粒化溶液。将该溶液加入内相混合物，导致产生颗粒。尽管不希望受理论的约束，认为颗粒产生受聚合物粘合剂与内相的材料的相互作用促进。一旦颗粒形成和干燥，将外相(例如，一种或多种润滑剂 – 并非干燥颗粒的固有组分)加入干颗粒。认为颗粒的润滑对于颗粒的流动性，特别是对于包装是重要的。参见例如，实施例8。
在某些前述实施方案中，组分(ii)包括水和一种或多种(例如，全部)以下赋形剂：
(a’) 一种或多种(例如，一种、两种；例如，两种)增稠剂、粘度增强剂、粘合剂和/或粘膜粘着剂(例如，纤维素或其纤维素酯或醚或衍生物或盐(例如，甲基纤维素)；和聚乙烯基聚合物例如聚乙烯吡咯烷酮(聚维酮)；
(b’) 一种或多种(例如，一种或两种；例如，两种)防腐剂，例如对羟基苯甲酸酯，例如，4-羟基苯甲酸甲酯(对羟基苯甲酸甲酯)或其药学上可接受的盐或酯、4-羟基苯甲酸丙酯(对羟基苯甲酸丙酯)或其药学上可接受的盐或酯，或其组合；和
(c’) 一种或多种(例如，一种或两种；例如，两种)缓冲剂，例如磷酸盐缓冲液系统(例如，磷酸二氢钠二水合物、磷酸二钠十二水合物)。
在某些前述实施方案中，组分(ii)包括水和一种或多种(例如，全部)以下赋形剂：
(a’’) 第一增稠剂、粘度增强剂、粘合剂和/或粘膜粘着剂(例如，纤维素或其纤维素酯或醚或衍生物或盐(例如，甲基纤维素))；
(a’’’) 第二增稠剂、粘度增强剂、粘合剂和/或粘膜粘着剂(例如，聚乙烯基聚合物，例如聚乙烯吡咯烷酮(聚维酮))；
(b’’) 第一防腐剂，例如对羟基苯甲酸酯，例如，4-羟基苯甲酸丙酯(对羟基苯甲酸丙酯)或其药学上可接受的盐或酯；
(b’’) 第二防腐剂，例如对羟基苯甲酸酯，例如，4-羟基苯甲酸甲酯(对羟基苯甲酸甲酯)或其药学上可接受的盐或酯；
(c’’) 第一缓冲剂，例如磷酸盐缓冲液系统(例如，磷酸二钠十二水合物)；
(c’’’) 第二缓冲剂，例如磷酸盐缓冲液系统(例如，磷酸二氢钠去水合物)。
在某些实施方案中，组分(ii)包括约0.05重量%-约5重量% (例如，约0.05重量%-约3重量%、约0.1重量%-约3重量%；例如，约1.4重量%)的(a’’)。
在某些实施方案中，组分(ii)包括约0.05重量%-约5重量% (例如，约0.05重量%-约3重量%、约0.1重量%-约2重量%；例如，约1.0重量%)的(a’’’)。
在某些实施方案中，组分(ii)包括约0.005重量%-约0.1重量% (例如，约0.005重量%-约0.05重量%；例如，约0.02重量%)的(b’’)。
在某些实施方案中，组分(ii)包括约0.05重量%-约1重量% (例如，约0.05重量%-约0.5重量%；例如，约0.20重量%)的(b’’’)。
在某些实施方案中，组分(ii)包括约0.05重量%-约1重量% (例如，约0.05重量%-约0.5重量%；例如，约0.15重量%)的(c’’)。
在某些实施方案中，组分(ii)包括约0.005重量%-约0.5重量% (例如，约0.005重量%-约0.3重量%；例如，约0.15重量%)的(c’’’)。
在某些这些实施方案中，(a’’) - (c’’’)的每一个均存在。
在某些实施方案中，组分(ii)包括水(直至100%)和表9所示的成分和量。
表9
在某些实施方案中，组分(ii)包括水(直至100%)和表10所示的成分和量。
表10
| 成分 | 重量百分比 |
| 甲基纤维素(Methocel A15C premium) | 约1.4重量% |
| 聚维酮(Kollidon K30) | 约1.0重量% |
| 4-羟基苯甲酸丙酯 | 约0.02重量% |
| 4-羟基苯甲酸甲酯 | 约0.20重量% |
| 磷酸二钠十二水合物 | 约0.15重量% |
| 磷酸二氢钠二水合物 | 约0.15重量% |
“即用”灌肠剂通常在塑料或玻璃的"单次使用"密封一次性容器中提供。这些由聚合物材料形成，优选地具有足够的柔韧性，以易于由独立患者使用。典型的塑料容器可由聚乙烯制成。这些容器可包含用于直接引入直肠的尖端。这样的容器在容器和尖端之间还可包含管。尖端优选地提供有防护罩，其在使用前除去。任选地，尖端具有润滑剂以改进患者的顺应性。
在一些实施方案中，在单独容器中制备后将灌肠剂制剂(例如，混悬剂)倾入递送用的瓶中。在某些实施方案中，所述瓶是塑料瓶(例如，柔韧以允许通过挤压瓶递送)，其可以是聚乙烯瓶(例如，白色)。在一些实施方案中，所述瓶是单室瓶，其包含混悬液或溶液。在其它实施方案中，所述瓶是多室瓶，其中每个室包含单独的混合物或溶液。在仍其它实施方案中，所述瓶可进一步包括用于直接引入直肠的尖端或直肠插管。在一些实施方案中，灌肠剂制剂可在图3A-3C显示的装置中递送，其包括塑料瓶、易碎胶囊和直肠插管和单流包。
口服递送
在其它实施方案中，本文所述的化学实体或其药物组合物适合通过口服给予(例如，固体或液体剂型)局部递送至消化道或GI道。
用于口服给予的固体剂型包括胶囊剂、片剂、丸剂、粉剂和颗粒剂。在这样的固体剂型中，化学实体与以下混合：一种或多种药学上可接受的赋形剂，例如柠檬酸钠或磷酸二钙，和/或：a) 填充剂或膨胀剂，例如淀粉、乳糖、蔗糖、葡萄糖、甘露醇和硅酸，b) 粘合剂，例如，羧甲基纤维素、藻酸盐、明胶、聚乙烯吡咯烷酮、蔗糖和阿拉伯胶，c) 湿润剂，例如甘油，d) 崩解剂，例如琼脂-琼脂、碳酸钙、马铃薯或木薯淀粉、海藻酸、某些硅酸盐和碳酸钠，e) 溶液阻滞剂，例如石蜡，f) 吸收加速剂，例如季铵化合物，g) 浸湿剂，例如，鲸蜡醇和甘油单硬脂酸酯，h) 吸收剂，例如高岭土和膨润土粘土，和i) 润滑剂，例如滑石粉、硬脂酸钙、硬脂酸镁、固体聚乙二醇、月桂基硫酸钠和其混合物。在胶囊剂、片剂和丸剂的情况下，剂型还可包含缓冲剂。在使用赋形剂例如乳糖(lactose或milk sugar)以及高分子量聚乙二醇等的软和硬填充明胶胶囊中，类似类型的固体组合物也可用作填充剂。
在一个实施方案中，组合物呈单位剂型的形式，例如丸剂或片剂，因此组合物可与本文提供的化学实体一起包含稀释剂例如乳糖、蔗糖、磷酸二钙等；润滑剂，例如硬脂酸镁等；和粘合剂，例如淀粉、阿拉伯胶、聚乙烯吡咯烷酮、明胶、纤维素、纤维素衍生物等。在另一固体剂型中，将粉末、marume、溶液或混悬液(例如，在丙烯碳酸酯、植物油、PEG、泊洛沙姆124或甘油三酯中)包封在胶囊(基于明胶或纤维素的胶囊)中。其中本文提供的一种或多种化学实体或其它活性剂是物理分开的单位剂型也是预期的；例如，含各药物的颗粒的胶囊(或胶囊中的片剂)；双层片剂；双室凝胶帽等。肠溶包衣或延迟释放口服剂型也是预期的。
其它生理学上可接受的化合物包括浸湿剂、乳化剂、分散剂或特别用于防止微生物的生长或活动的防腐剂。各种防腐剂是众所周知的，和包括，例如，苯酚和抗坏血酸。
在某些实施方案中赋形剂是无菌的和通常不含不需要的物质。这些组合物可通过常规的众所周知的除菌技术除菌。对于各种口服剂型赋形剂例如片剂和胶囊，不需要无菌。USP/NF标准通常是足够的。
在某些实施方案中，固体口服剂型可进一步包括在化学和/或结构上使组合物易于递送化学实体至胃或下部GI；例如，升结肠和/或横结肠和/或末端结肠和/或小肠的一个或多个组分。示例性的制剂技术描述于例如，Filipski，K.J.等Current Topics in Medicinal Chemistry，2013，13，776-802，其通过引用以其整体结合到本文中。
实例包括上部-GI靶向技术，例如，Accordion丸剂(Intec Pharma)、漂浮胶囊和能够粘附至粘膜壁的材料。
其它实例包括下部-GI靶向技术。对于靶向肠道的各个区域，可利用数种肠溶/pH-响应性涂层和赋形剂。这些材料通常是聚合物，其经设计以在基于需要的药物释放的GI区选择的特定pH范围下溶解或侵蚀。这些材料还用于保护酸敏感性药物免于胃液或在活性成分可刺激上部GI的情况下限制暴露(例如，邻苯二甲酸羟基丙基甲基纤维素系列、Coateric(聚乙酸乙烯酯邻苯二甲酸酯)、乙酸邻苯二甲酸纤维素、乙酸琥珀酸羟基丙基甲基纤维素、Eudragit系列(甲基丙烯酸–甲基丙烯酸甲酯共聚物)和Marcoat)。其它技术包括对GI道中的局部菌群有反应的剂型、压力控制型结肠递送胶囊和Pulsincap。
用于口服给予的液体剂型包括药学上可接受的乳剂、微乳剂、溶液剂、混悬剂、糖浆剂和酏剂。除了本文所述的化学实体，液体剂型还可包含本领域常用的惰性稀释剂，例如，水或其它溶剂、增溶剂和乳化剂，例如乙醇、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、二甲基甲酰胺、油(特别地，棉籽油、花生油、玉米油、胚芽油、橄榄油、蓖麻油和芝麻油)、甘油、四氢呋喃甲醇、聚乙二醇和去水山梨糖醇的脂肪酸酯和其混合物。除了惰性稀释剂，口服组合物还可包括助剂，例如浸湿剂、乳化剂和助悬剂、甜味剂、矫味剂和芳香剂。在某些实施方案中，液体剂型是漱口剂。在某些实施方案中，这样的液体口服剂型可用于局部(local)和局部(topical)给予至消化道或GI道，例如，消化道，例如，口腔。
其它递送形式
在一些实施方案中，本文所述的化学实体或其药物组合物适合局部(local)和局部(topical)给予至眼(例如，滴眼剂)。眼用组合物可包括但不限于，任何以下组分的一种或多种：增稠剂(viscogen) (例如，羧甲基纤维素、甘油、聚乙烯吡咯烷酮、聚乙二醇)；稳定剂(例如，普卢兰尼克(三嵌段共聚物)、环糊精)；防腐剂(例如，苯扎氯铵、ETDA、SofZia (硼酸、丙二醇、山梨醇和氯化锌；Alcon Laboratories，Inc.)、Purite (稳定的氧氯复合物；Allergan，Inc.))。
在一些实施方案中，本文所述的化学实体或其药物组合物适合局部(local)和局部(topical)给予至皮肤(例如，软膏剂和霜剂)。软膏剂是半固体制剂，其通常基于矿脂或其它石油衍生物。含有选择的活性剂的霜剂通常是粘性液体或半固体乳剂，通常是水包油或油包水型。霜剂基质通常是水-可洗涤的，和包含油相、乳化剂和水相。油相，有时亦称为“内”相，通常包含矿脂和脂肪醇，例如鲸蜡醇或硬脂醇；水相体积通常(尽管不必然)超过油相，通常包含湿润剂。霜剂制剂中的乳化剂通常是非离子、阴离子、阳离子或两性表面活性剂。关于其他载体或媒介，软膏剂基质应该是惰性的、稳定的、无刺激性和无致敏性的。
剂量
剂量可根据患者的需要、治疗的病况的严重性和使用的具体化合物改变。对于特定情况的合适剂量的测定可由医学领域的技术人员测定。每日总剂量可被分开，和在一天内按部分给予，或通过提供持续递送的手段给予。
在一些实施方案中，化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)以约0.01 mg/Kg-约200 mg/Kg (例如，约0.01 mg/Kg-约150 mg/Kg；约0.01 mg/Kg-约100 mg/Kg；约0.01 mg/Kg-约50 mg/Kg；约0.01 mg/Kg-约10mg/Kg；约0.01 mg/Kg-约5 mg/Kg；约0.1 mg/Kg-约200 mg/Kg；约0.1 mg/Kg-约150 mg/Kg；约0.1 mg/Kg-约100 mg/Kg；约0.1 mg/Kg-约50 mg/Kg；约0.1 mg/Kg-约10 mg/Kg；约0.1mg/Kg-约5 mg/Kg)的剂量给予。
在某些实施方案中，化学实体以约15 mg/Kg-约100 mg/Kg (例如，约15 mg/Kg-约90 mg/Kg、约20 mg/Kg-约100 mg/Kg；约20 mg/Kg-约90 mg/Kg；约20 mg/Kg-约80 mg/Kg；约30 mg/Kg-约90 mg/Kg；约30 mg/Kg-约80 mg/Kg；约35 mg/Kg-约75 mg/Kg；约10 mg/Kg-约50 mg/Kg；约15 mg/Kg-约45 mg/Kg；例如，约35 mg/Kg或约75 mg/Kg)的剂量给予。在其它实施方案中，化学实体以约0.1 mg/Kg-约10 mg/Kg (例如，约0.1 mg/Kg-约5 mg/Kg；约1mg/Kg-约10 mg/Kg；约1 mg/Kg-约5 mg/Kg)的剂量给予。
在一些实施方案中，灌肠剂制剂包括在约1 mL-约3000 mL (例如，约1 mL-约2000mL、约1 mL-约1000 mL、约1 mL-约500 mL、约1 mL-约250 mL、约1 mL-约100 mL、约10 mL-约1000 mL、约10 mL-约500 mL、约10 mL-约250 mL、约10 mL-约100 mL、约30 mL-约90 mL、约40 mL-约80 mL；约50 mL-约70 mL；例如，约1 mL、约5 mL、约10 mL、约15 mL、约20 mL、约25 mL、约30 mL、约35 mL、约40 mL、约45 mL、约50 mL、约55 mL、约60 mL、约65 mL、约70mL、约75 mL、约100 mL、约250 mL或约500 mL或约1000 mL或约2000mL或约3000 mL；例如，60 mL)的液体载体中约0.5 mg-约2500 mg (例如，约0.5 mg-约2000 mg、约0.5 mg-约1000mg、约0.5 mg-约750 mg、约0.5 mg-约600 mg、约0.5 mg-约500 mg、约0.5 mg-约400 mg、约0.5 mg-约300 mg、约0.5 mg-约200 mg；例如，约5 mg-约2500 mg、约5 mg-约2000 mg、约5mg-约1000 mg；约5 mg-约750 mg；约5 mg-约600 mg；约5 mg-约500 mg；约5 mg-约400 mg；约5 mg-约300 mg；约5 mg-约200 mg；例如，约50 mg-约2000 mg、约50 mg-约1000 mg、约50mg-约750 mg、约50 mg-约600 mg、约50 mg-约500 mg、约50 mg-约400 mg、约50 mg-约300mg、约50 mg-约200 mg；例如，约100 mg-约2500 mg、约100 mg-约2000 mg、约100 mg-约1000 mg、约100 mg-约750 mg、约100 mg-约700 mg、约100 mg-约600 mg、约100 mg-约500mg、约100 mg-约400 mg、约100 mg-约300 mg、约100 mg-约200 mg；例如，约150 mg-约2500mg、约150 mg-约2000 mg、约150 mg-约1000 mg、约150 mg-约750 mg、约150 mg-约700 mg、约150 mg-约600 mg、约150 mg-约500 mg、约150 mg-约400 mg、约150 mg-约300 mg、约150mg-约200 mg；例如，约150 mg-约500 mg；例如，约300 mg-约2500 mg、约300 mg-约2000mg、约300 mg-约1000 mg、约300 mg-约750 mg、约300 mg-约700 mg、约300 mg-约600 mg；例如，约400 mg-约2500 mg、约400 mg-约2000 mg、约400 mg-约1000 mg、约400 mg-约750mg、约400 mg-约700 mg、约400 mg-约600 约400 mg-约500 mg；例如，150 mg或450 mg)的化学实体。
在某些实施方案中，灌肠剂制剂包括在约10 mL-约100 mL (例如，约20 mL-约100mL、约30 mL-约90 mL、约40 mL-约80 mL；约50 mL-约70 mL)的液体载体中约50 mg-约250mg (例如，约100 mg-约200；例如，约150 mg)的化学实体。在某些实施方案中，灌肠剂制剂包括在约60 mL的液体载体中约150 mg的化学实体。在某些这些实施方案中，化学实体是氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶。例如，灌肠剂制剂可包括在约60mL的液体载体中约150 mg的氯硝柳胺。
在某些实施方案中，灌肠剂制剂包括在约10 mL-约100 mL (例如，约20 mL-约100mL、约30 mL-约90 mL、约40 mL-约80 mL；约50 mL-约70 mL)的液体载体中约350 mg-约550mg (例如，约400 mg-约500；例如，约450 mg)的化学实体。在某些实施方案中，灌肠剂制剂包括在约60 mL的液体载体中约450 mg的化学实体。在某些这些实施方案中，化学实体是氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶。例如，灌肠剂制剂可包括在约60mL的液体载体中约450 mg的氯硝柳胺。
在一些实施方案中，灌肠剂制剂包括在液体载体中约0.01 mg/mL-约50 mg/mL(例如，约0.01 mg/mL-约25 mg/mL；约0.01 mg/mL-约10 mg/mL；约0.01 mg/mL-约5 mg/mL；约0.1 mg/mL-约50 mg/mL；约0.01 mg/mL-约25 mg/mL；约0.1 mg/mL-约10 mg/mL；约0.1mg/mL-约5 mg/mL；约1 mg/mL-约10 mg/mL；约1 mg/mL-约5 mg/mL；约5 mg/mL-约10 mg/mL；例如，约2.5 mg/mL或约7.5 mg/mL)的化学实体。在某些这些实施方案中，化学实体是氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶。例如，灌肠剂制剂可包括在液体载体中约2.5 mg/mL或约7.5 mg/mL的氯硝柳胺。
前述剂量可以每日基础(例如，作为单剂量/天；或作为两个或更多个分开的剂量/天；或两个或更多个剂量；例如，两个剂量/天)或非每日基础(例如，每隔一天、每两天、每三天、每周一次、每周两次、每两周一次、每月一次)给予。在某些实施方案中，可给予剂量约1周、约2周、约3周、约4周、约5周、约6周、约7周、约8周、约3个月、约6个月、约1年或更久。例如，在液体载体中一定剂量(例如，约2.5 mg/mL或约7.5 mg/mL)的化学实体可以每日基础一天两次给予，持续约6周。在某些这些实施方案中，化学实体是氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶。例如，在液体载体中约2.5 mg/mL或约7.5 mg/mL的氯硝柳胺可以每日基础一天两次给予，持续约6周。代表性的液体载体包括，例如之前结合组分(ii)描述的那些。
治疗方法
在一些实施方案中，提供用于诱导受试者的一种或多种T细胞(例如，在消化道和/或胃肠道(GI)、皮肤、眼睛或关节中)的细胞死亡的方法。所述方法包括使一种或多种T细胞与有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)接触。在某些实施方案中，所述方法基本上由或由本段落中上述的接触步骤组成。
在一些实施方案中，提供用于治疗具有与受试者的一种或多种T细胞(例如，在消化道和/或胃肠道(GI)、皮肤、眼睛或关节处)的不受调节的(异常的、提高的)募集和/或贮留有关的病况的受试者的方法。所述方法包括使一种或多种T细胞与有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)接触。在某些实施方案中，所述方法基本上由或由本段落中上述的接触步骤组成。
在一些实施方案中，提供用于治疗具有与受试者的一种或多种T细胞(例如，在消化道和/或胃肠道(GI)、皮肤、眼睛或关节中)的不受调节的(异常的、提高的)活化有关的病况的受试者的方法。所述方法包括使一种或多种活化T细胞与有效量的共结晶接触，所述共结晶包含(i) 线粒体解偶联剂或其药学上可接受的盐和/或水合物；和(ii) 一种或多种药学上可接受的本文任何地方定义的共形成物。在某些实施方案中，所述方法基本上由或由本段落中上述的接触步骤组成。
在一些实施方案中，诱导一种或多种T细胞的细胞死亡包括一种或多种以下途径：程序化细胞死亡、坏死性凋亡(Necroptosis)、凋亡、坏死、细胞焦亡(Pyroptosis)、铁死亡(Ferroptosis)、失巢凋亡(Anoikis)、有丝分裂障碍、副凋亡(Paraptosis)、Pyronecrosis、Entosis、Netosis、Parthanatos、自噬性细胞死亡、RGD: 调节细胞死亡、非凋亡性程序化细胞死亡、诱导一种或多种T细胞的坏死或凋亡的半胱天冬酶非依赖性程序化细胞死亡，例如，一种或多种T细胞的坏死或凋亡。在某些实施方案中，有效量是足以诱导一种或多种T细胞的至少一种的细胞死亡的量(例如，通过上述任何一种或多种途径，例如，一种或多种T细胞的坏死或凋亡)。
在一些实施方案中，一种或多种T细胞包括一种或多种活化T细胞，例如，独立地选自以下的一种或多种活化T细胞：
CD45+CD3+TCRαβ+CD62L- ;
CD45+CD3+ TCRαβ+CD62L-CCR7-;
CD45+CD3+ TCRαβ+CD62L-CD69+;
CD45+CD3+ TCRαβ+CD62L-CD69+PD-1+;
CD45+CD3+TCRαβ+CD62L-CTLA4+;
CD45+CD3+ TCRαβ+CD62L-PD-1++CTLA4+;
CD45+CD3+TCRγδ+CD62L-;
CD45+CD3+TCRγδ+CD62L-CCR7-;
CD45+CD3+TCRγδ+CD62L-CD69+;
CD45+CD3+ TCRγδ+CD62L-CD69+PD-1+；
CD45+CD3+CD62L- TCRγδ+CTLA4+；和
CD45+CD3+ TCRγδ+CD62L-PD-1++CTLA4+。
在某些实施方案中，有效量是足以诱导一种或多种活化T细胞的至少一种的细胞死亡的量(例如，通过上述任何一种或多种途径，例如，一种或多种活化T细胞的坏死或凋亡)。
在一些实施方案中，一种或多种T细胞存在于肠上皮内和/或固有层内和/或派尔集合淋巴结(PP)内和/或GALT (肠相关淋巴样组织)内和/或肠粘膜内和/或肠粘膜下层内和/或肠肌层内和/或肠浆膜内。
在一些实施方案中，一种或多种T细胞包含一种或多种肠向性(gut tropic) T细胞。在某些实施方案中，一种或多种肠向性T细胞的每一种独立地表达一种或多种肠归巢受体，其选自：
(CD3+CCR9+;
CD3+α4+或CD3+β7+;
CD3+α4+ β7+;
CD3+β1+;
CD3+α4+ β1+;
CD3+LFA1;
CD3+CCR4+；和
CD3+CCR10+。
在一些实施方案中，提供用于在有需要的受试者中治疗特征为异常炎性反应的病况(或其一种或多种症状)的方法(例如，自身免疫病症，例如，炎性肠病)。所述方法包括给予受试者有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)。在某些实施方案中，所述方法基本上由或由本段落中上述的给予步骤组成。
在一些实施方案中，提供用于在有需要的受试者中治疗特征为异常炎性反应的病况(或其一种或多种症状)的方法(例如，自身免疫病症，例如，炎性肠病)。所述方法包括局部(topically)和局部(locally)给予受试者有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)。在某些实施方案中，所述方法基本上由或由本段落中上述的给予步骤组成。
在一些实施方案中，提供用于治疗受试者的自身免疫性结肠炎(或其一种或多种症状)的方法。所述方法包括局部(topically)和局部(locally)给予受试者有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)。在某些实施方案中，所述方法基本上由或由本段落中上述的给予步骤组成。
在一些实施方案中，提供用于治疗受试者的选自乳糜泻、肠易激综合征、粘膜炎、葡萄膜炎、胶原性结肠炎、淋巴细胞性结肠炎、显微结肠炎、放射性小肠炎、类风湿性关节炎、狼疮、硬皮病、银屑病、皮肤T-细胞淋巴瘤、急性移植物抗宿主病和慢性移植物抗宿主病的病况(或其一种或多种症状)的方法。所述方法包括局部(topically)和局部(locally)给予受试者有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)。在某些实施方案中，所述方法基本上由或由本段落中上述的给予步骤组成。
在某些这些实施方案中，所述病况是自身免疫性疾病。在某些实施方案中，所述病况是炎性肠病。在某些实施方案中，所述病况是克罗恩病、自身免疫性结肠炎、医源性自身免疫性结肠炎、溃疡性结肠炎、由一种或多种化学治疗剂诱导的结肠炎、由继承性细胞疗法的治疗诱导的结肠炎、伴随一种或多种同种异体免疫疾病的结肠炎(例如移植物抗宿主病，例如，急性移植物抗宿主病和慢性移植物抗宿主病)、放射性小肠炎、胶原性结肠炎、淋巴细胞性结肠炎、显微结肠炎和放射性小肠炎。
在某些这些实施方案中，所述病况是同种异体免疫性疾病(例如移植物抗宿主病，例如，急性移植物抗宿主病和慢性移植物抗宿主病)、乳糜泻、肠易激综合征、类风湿性关节炎、狼疮、硬皮病、银屑病、皮肤T-细胞淋巴瘤、葡萄膜炎和粘膜炎(例如，口腔粘膜炎、食管粘膜炎或肠粘膜炎)。
在某些实施方案中，所述病况是自身免疫性结肠炎。
在某些这些实施方案中，自身免疫性结肠炎由一种或多种化学治疗剂，例如，化学治疗性免疫调节剂，例如，免疫检查点抑制剂诱导。在某些这些实施方案中，免疫检查点抑制剂靶向免疫检查点受体，其选自CTLA-4、PD-1、PD-L1、PD-1 – PD-L1、PD-1 – PD-L2、白细胞介素-2 (IL-2)、吲哚胺2,3-加双氧酶(IDO)、IL-10、转化生长因子-β (TGFβ)、T细胞免疫球蛋白和粘蛋白3 (TIM3或HAVCR2)、半乳凝素9 – TIM3、磷脂酰丝氨酸– TIM3、淋巴细胞活化基因3蛋白(LAG3)、MHC II类– LAG3、4-1BB–4-1BB配体、OX40–OX40配体、GITR、GITR配体–GITR、CD27、CD70-CD27、TNFRSF25、TNFRSF25–TL1A、CD40L、CD40–CD40配体、HVEM–LIGHT–LTA、HVEM、HVEM – BTLA、HVEM – CD160、HVEM – LIGHT、HVEM–BTLA–CD160、CD80、CD80 –PDL-1、PDL2 – CD80、 CD244、CD48 – CD244、CD244、ICOS、ICOS–ICOS配体、B7-H3、B7-H4、VISTA、TMIGD2、HHLA2–TMIGD2、嗜乳脂蛋白，包括BTNL2、Siglec家族、TIGIT和PVR家族成员、KIRs、ILTs和LIRs、NKG2D和NKG2A、MICA和MICB、CD244、CD28、CD86 – CD28、CD86 – CTLA、CD80 – CD28、CD39、CD73 腺苷–CD39–CD73、CXCR4–CXCL12、磷脂酰丝氨酸、TIM3、磷脂酰丝氨酸– TIM3、SIRPA–CD47、VEGF、Neuropilin、CD160、CD30和CD155；例如，CTLA-4或PD1或PD-L1)。参见例如，Postow，M. J. Clin. Oncol. 2015，33，1。
在某些这些实施方案中，免疫检查点抑制剂选自：Urelumab、PF-05082566、MEDI6469、TRX518、Varlilumab、CP-870893、Pembrolizumab (PD1)、纳武单抗(PD1)、Atezolizumab (旧称MPDL3280A) (PDL1)、MEDI4736 (PD-L1)、Avelumab (PD-L1)、PDR001(PD1)、BMS-986016、MGA271、Lirilumab、IPH2201、Emactuzumab、INCB024360、Galunisertib、Ulocuplumab、BKT140、Bavituximab、CC-90002、贝伐单抗和MNRP1685A和MGA271。
在某些这些实施方案中，免疫检查点抑制剂靶向CTLA-4，例如，抗体，例如，易普利姆玛或tremelimumab。
在某些这些实施方案中，免疫检查点抑制剂靶向PD1或PD-L1，例如，纳武单抗、lambroizumab或BMS-936559。
在某些实施方案中，所述病况是粘膜炎，亦称为口腔炎，其可因为化学疗法或放射疗法(单独或组合)以及通过暴露于放射疗法的背景外的放射引起的损伤而发生。当单独或组合使用时可诱导粘膜炎的化学治疗剂包括但不限于，铂、顺铂、卡铂、奥沙利铂、氮芥、环磷酰胺、苯丁酸氮芥、硫唑嘌呤、巯嘌呤、长春新碱、长春碱、长春瑞滨、长春地辛、依托泊苷和替尼泊苷、紫杉醇、多西他赛、伊立替康、托泊替康、安吖啶、依托泊苷、磷酸依托泊苷、替尼泊苷、5-氟尿嘧啶、亚叶酸、甲氨蝶呤、吉西他滨、紫杉烷、亚叶酸、丝裂霉素C、替加氟-尿嘧啶、伊达比星、氟达拉滨、米托蒽醌、异环磷酰胺和多柔比星。其它试剂包括mTOR (雷帕霉素的哺乳动物靶标)的抑制剂，包括但不限于雷帕霉素、依维莫司、temsirolimus和deforolimus。
在某些实施方案中，所述病况是葡萄膜炎，其是葡萄膜的炎症(例如，前葡萄膜炎，例如，虹膜睫状体炎或虹膜炎；中间葡萄膜炎(亦称为扁平部睫状体炎)；后葡萄膜炎；或脉络膜视网膜炎，例如，泛-葡萄膜炎)。
本公开内容预期单一疗法方案以及组合疗法方案二者。
在一些实施方案中，单一疗法包括给予(例如，局部(topically)和局部(locally))受试者有效量的本文任何地方定义的化学实体(例如，显示作为线粒体解偶联剂的活性的化合物或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺或其药学上可接受的盐和/或水合物和/或共结晶；例如，化合物，例如氯硝柳胺类似物或其药学上可接受的盐和/或水合物和/或共结晶)，但不包括给予其它治疗剂(例如，活性化合物，例如，公开于美国专利8,148,328的肽，其通过引用以其整体结合到本文中)。
在一些实施方案中，本文所述的方法可进一步包括给予第二治疗剂或方案。
在某些实施方案中，在与化学实体接触或给予化学实体之前(例如，之前约1小时，或之前约6小时，或之前约12小时，或之前约24小时，或之前约48小时，或之前约1周，或之前约1个月)，第二治疗剂或方案被给予受试者。
在其它实施方案中，大约与化学实体接触或给予化学实体同时，第二治疗剂或方案被给予受试者。通过实例的方式，第二治疗剂或方案和化学实体在相同剂型中同时提供给受试者。作为另一个实例，第二治疗剂或方案和化学实体在分开的剂型中同时提供给受试者。
在仍其它实施方案中，在与化学实体接触或给予化学实体之后(例如，之后约1小时，或之后约6小时，或之后约12小时，或之后约24小时，或之后约48小时，或之后约1周，或之后约1个月)，第二治疗剂或方案被给予受试者。
在某些实施方案中，第二治疗剂是化学治疗性免疫调节剂，例如，免疫检查点抑制剂，其可以是本文任何地方定义的。在其它实施方案中，第二治疗剂或方案是在GI道中局部起作用的一种或多种抗炎剂或免疫调节剂。在其它实施方案中，第二治疗剂或方案是5-ASA(和相关的递送系统)、抗-SMAD7反义物、口服配制的抗-TNF、抗-整联蛋白、柳氮磺吡啶、巴柳氮、类固醇、硫唑嘌呤和甲氨蝶呤。在进一步的实施方案中，第二治疗剂或方案是放射或手术。
在某些实施方案中，第二治疗剂是铂、顺铂、卡铂、奥沙利铂、氮芥、环磷酰胺、苯丁酸氮芥、硫唑嘌呤、巯嘌呤、长春新碱、长春碱、长春瑞滨、长春地辛、依托泊苷和替尼泊苷、紫杉醇、多西他赛、伊立替康、托泊替康、安吖啶、依托泊苷、磷酸依托泊苷、替尼泊苷、5-氟尿嘧啶、亚叶酸、甲氨蝶呤、吉西他滨、紫杉烷、亚叶酸、丝裂霉素C、替加氟-尿嘧啶、伊达比星、氟达拉滨、米托蒽醌、异环磷酰胺和多柔比星。其它试剂包括mTOR (雷帕霉素的哺乳动物靶标)的抑制剂，包括但不限于雷帕霉素、依维莫司、temsirolimus和deforolimus。
在仍其它实施方案中，第二治疗剂可选自上述列出的那些(参见美国专利7,927,613，其通过引用以其整体结合到本文中)。
在一些实施方案中，本文所述的方法进一步包括鉴定需要这样的治疗的受试者(例如，患者)的步骤(例如，通过活检、内窥镜检查或本领域已知的其它常规方法)。
在一些实施方案中，本文所述的化学实体、方法和组合物可给予某些治疗抵抗的患者群体，例如，对用抗-TNFα疗法(例如，Humira、Enbrel、Remicade、Cimzia、Simponi、Enbrel、黄嘌呤衍生物，例如己酮可可碱和丁氨苯丙酮；(R)-DOI、TCB-2、LSD和LA-SS-Az)的治疗无反应或抵抗的群体。在某些实施方案中，患者正经历和/或已经历用抗-TNFα疗法(例如，Humira、Enbrel、Remicade、Cimzia、Simponi、Enbrel、黄嘌呤衍生物，例如己酮可可碱和丁氨苯丙酮；(R)-DOI、TCB-2、LSD和LA-SS-Az)的治疗。
为了进一步说明本发明，包括以下实施例。实施例当然不应解释为特别限制本发明。这些实施例在权利要求的范围内的变化在本领域技术人员的范围内，和认为落入本文所述和要求保护的发明的范围内。读者将认识到，获得本公开内容和本领域的技能的技术人员能够制备和使用本发明，无需穷举实施例。
实施例
实施例1：氯硝柳胺从氧化磷酸化Jurkat T细胞解偶联线粒体呼吸。
目标。为了使用亲脂阳离子染料四甲基罗丹明甲基酯(TMRM)，在Jurkat T细胞中测量氯硝柳胺对线粒体跨膜电位的剂量反应作用。
模型。Jurkat T细胞模型通常用于体外研究化合物对T细胞的可能影响。该细胞系允许研究调节T细胞线粒体功能和存活的刺激和机制。作为T细胞，Jurkat具有淋巴细胞外观和在悬浮培养中复制。它们包含呼吸线粒体和因此可评价对线粒体解偶联剂例如氯硝柳胺的响应。解偶联通过检测跨线粒体内膜的电化学梯度的下降(ΔΨm)鉴定和定量，该下降与氧化磷酸化的相应增加无关。检测ΔΨm的变化的实验通过包括其中将一定浓度的寡霉素加入以不可逆地抑制F1F0-ATP酶和阻断氧化磷酸化以证实ΔΨm的下降代表解偶联(因为其不依赖于线粒体氧化磷酸化的增加而发生)的条件进行。
细胞培养。Jurkat T细胞购自美国典型培养物保藏中心 (Manassas，VA)和根据来自供应商的说明书传代培养。实验前，细胞在含有10% FBS-HI、50个单位的青霉素/mL和50μg链霉素/mL的RPMI 1640中培养和在实验设置前维持在对数期。细胞在37 °C在5% CO2潮湿培养箱中生长。生长培养基通过加入50 mL的热灭活的FBS和5 mL的青霉素/链霉素至500mL DMEM制备。该培养基在4 °C下储存。使用前，将培养基在水浴中温热至37 °C。Jurkat细胞以5x104个细胞/mL的初始密度接种在24-孔板中。在加入处理之前使细胞生长18小时。
用氯硝柳胺处理。将氯硝柳胺溶于二甲基亚砜(DMSO)和加入培养基以达到500、100、50、10、5或1 μM的浓度。将寡霉素溶于DMSO，然后以10 μL加入试验孔，以达到1 μL的终浓度。样品在37 °C孵育60分钟。然后将溶于DMSO的TMRM以10 μL加入试验孔，以达到5 μM的终浓度和允许在37°C孵育另外30 min。仅媒介对照(替换氯硝柳胺)与每个实验同时运行。提供560 nm激发和590 nm发射检测的流式细胞仪用于定量TMRM荧光。
测量线粒体膜电位变化(ΔΨm)。TMRM具有超过其它阳离子染料的优点，因为其可选择性地进入线粒体和随膜电位增加而可逆积聚。已显示TMRM在线粒体中积聚受其膜电位驱动。此外，因为疏水特征减少，该探针显示与细胞的电位非依赖性结合，其是其它探针见到的1/10至1/20。TMRM已描述为用于动态和原位定量测量的最佳荧光染料之一，因为其被肝细胞和线粒体快速和可逆摄取。
线粒体膜电位的相对减少的计算。在寡霉素存在下相对于仅媒介阴性对照，对所有浓度的氯硝柳胺计算中值荧光强度。然后计算每个处理样品与对照样品平均数的荧光强度比率作为ΔΨm的相对减少的度量。对于统计学比较，计算95%置信区间和用该比率的平均值作图。通过利用95%置信区间，以标称5%水平设定I类误差的概率。
结果。相对于阴性对照，氯硝柳胺显示在Jurkat细胞中剂量相关的ΔΨm减少，其中5 μM和其上的浓度的氯硝柳胺显著减少(p<0.05)。
实施例2：在分离自人肠的固有层的T细胞中氯硝柳胺从氧化磷酸化解偶联线粒体呼吸
目标。本实验的目标是确定氯硝柳胺是否可在分离自人肠固有层的T细胞中以类似于在Jurkat T细胞中观察的效果的方式直接降低线粒体跨膜电位。
模型。T细胞部分地包含人肠的固有层单核细胞(LPMC)，其介导生理学和病理学过程，包括炎性肠病。LPMC可分离自人组织活检。分离后，在适合的培养条件下LPMC T细胞保持离体存活允许离体实验的一段时间。这些细胞可用于研究调节其线粒体功能和存活的机制。它们包含呼吸线粒体和因此可评价其对线粒体解偶联剂例如氯硝柳胺的反应。该细胞模型结合阻断氧化磷酸化的寡霉素和TMRM使用，以监测如实施例1所述的ΔΨm。
细胞分离和培养。细胞获自具有正常胃肠组织的区域或具有中等至严重克罗恩病(CD)、溃疡性结肠炎(UC)或乳糜泻的人的小肠或大肠或直肠的活检样本。为了分离固有层单核细胞(LPMC)，将样本在Hank平衡盐溶液(HBSS)中初始洗涤，然后切成0.5-cm段，和在含有1 mM DTT的预温热HBSS中在37 °C搅拌孵育15分钟。除去上清液和样品用HBSS搅拌洗涤5分钟两次。样品在含有5mM EDTA的预温热的HBSS中搅拌孵育30分钟。除去上清液和样品用HBSS搅拌洗涤5分钟三次。然后组织进一步在37 °C在含有2 mg/mL Liberase和0.01 μg/mLDNase I的RPMI 1640中消化1小时，同时搅拌。消化后，收集悬浮的单核细胞和以400g离心10分钟。在HBS中两次洗涤后，将沉淀物重悬浮于40% Percoll溶液和在Percoll溶液上方分层(100%、60%、40%和30% Percoll/HBSS)。将管以400g离心25分钟，和收集在60%–40%Percoll层界面处的LPMC。将分离的细胞计数和使用0.1%锥虫蓝检查存活力(存活力范围86%-94%)。用HBSS将细胞洗出Percoll和以1 x 106个细胞/mL的浓度重悬浮于补充有10%热灭活的FBS、1% L-谷氨酰胺、100 U/mL青霉素和100 mg/mL链霉素的RPMI 1640，并接种到96-孔培养板(200000个细胞/孔) (Nat Protoc. 2007;2(10):2307-11)。
用试验材料处理。按照实施例1所述的方案。此外，在37°C与TMRM孵育30分钟期间，另外加入缀合至FITC (494 nm激发和521 nm检测发射)的抗-CD3单克隆抗体。
T细胞中ΔΨm的测量和变化的计算。为了在LPMC中明确区分T细胞与其它细胞，使用用FITC标记的抗-CD3单克隆抗体。该抗体特别结合在T细胞上选择性表达的人CD3抗原。LPMC T细胞通过由FITC-抗-CD3抗体标记产生的521 nm的荧光发射首先确定。测量在T细胞群体中在590 nm检测的TMRM的荧光强度。计算TMRM信号的中值荧光强度。然后计算每个处理的样品与对照样品平均数的中值荧光强度的比率作为ΔΨm相对减少的度量。对于统计学比较，计算95%置信区间和用该比率的平均值作图。
结果。相对于阴性对照，在人LPMC T细胞中，氯硝柳胺诱导剂量相关的ΔΨm减少，其中5 μM和更高的浓度的氯硝柳胺显著减少(p<0.05)。
实施例3：氯硝柳胺以导致线粒体解偶联的浓度诱导LPMC T细胞的死亡。
目标。本实验的目标是确定在LPMC中解偶联线粒体的浓度的氯硝柳胺是否诱导细胞死亡。
模型。使用实施例2所述的人LPMC模型。
细胞分离和培养。细胞分离和培养程序详述于实施例2。
用氯硝柳胺处理。将氯硝柳胺溶于二甲基亚砜(DMSO)和加入培养基以达到500、100、50、10、5或1 μM的浓度。样品在37 °C孵育60分钟。培养的细胞与DMSO (阴性对照)孵育，或用人单克隆抗–FAS-激活抗体(阳性对照，终浓度1 μg/mL)或一定浓度的氯硝柳胺在37 °C刺激24小时。处理后，将细胞暴露于1 µM 7AAD，然后在37°C孵育另外60分钟。活细胞和死细胞通过流式细胞仪计数，使用FACSVerse细胞仪装置以激发和测量在适合的波长下7-AAD的发射荧光。
检测活和死的细胞。7-AAD不包括在活细胞中，但自由进入死细胞，其中在与细胞DNA相互作用后其经历谱移。因此，死细胞被7-AAD选择性标记，导致其用647 nm的最大发射的检测。使用该试剂允许活细胞和死细胞被同时计数。为了在LPMC中明确区分T细胞与其它细胞，使用用FITC (494 nm激发与521 nm检测发射)标记的抗-CD3单克隆抗体。该抗体特别结合在T细胞上选择性表达的人CD3抗原。细胞存活力和死亡在T细胞中通过在由抗-CD3FITC标记的细胞中测量7-AAD荧光特别测定。
T细胞死亡的计算。通过FITC-抗-CD3抗体荧光，在按实施例2所述首先定义的T细胞群体中特别测量在647 nm检测的7-AAD的荧光强度。在每个实验中，7-AAD荧光强度值(低于该值时检出>95%的未处理对照(活) T细胞)被用作切点，以计算存活力。使用该切点，对于各条件计算在>10,000个体细胞的样品中死细胞的分数，和表示为平均值。对于统计学比较，计算95%置信区间和用平均值作图。
结果。氯硝柳胺显示LPMC T细胞死亡的剂量相关增加。相对于仅媒介的阴性对照，5 μM和更高的浓度的氯硝柳胺显著增加死亡(p<0.05)。低于5 μM的浓度不能诱导T细胞死亡。在LPMC中比较氯硝柳胺相关的T细胞死亡和氯硝柳胺相关的解偶联的剂量反应关系。这些剂量关系的重叠性质指示氯硝柳胺诱导的线粒体解偶联和细胞死亡之间的关系。
实施例4：氯硝柳胺是在小鼠中炎性肠病的有效治疗。
目标。本实验的目标是在结肠炎的啮齿动物模型中确定氯硝柳胺是否是有效治疗。
模型。TNBS诱导的结肠炎是炎性肠病(IBD)的常用的实验模型。TNBS (三硝基苯磺酸)是以灌肠剂的形式与乙醇组合直肠给予小鼠或大鼠的化学品，其破坏粘膜屏障和通过在肠内使蛋白半抗原化诱导结肠炎，导致它们变成免疫细胞的潜在靶标。TNBS-诱导的结肠炎的严重性在很大程度上取决于施加的剂量和使用的动物品系。在慢性复发性形式的模型中，动物通过递增TNBS的结肠内剂量致敏。在生命期间通过重量减少监测疾病。结肠样本的组织学用于在研究终止时确定疾病严重性(Gastroenterology. 2003 Dec;125(6):1750-61；Inflamm Bowel Dis. 2006 Oct;12(10):995-9.)。
小鼠品系和饲养。C57BL/6J雌性小鼠(9-周龄)由Jackson购买，和在无特定病原体设施中在通气笼中在范围68-74 °F的温度下饲养，其中日间12小时光周期。食物和水自由提供。在开始实验前，动物适应当地微生物群7天。细胞分离和培养程序如实施例2所述。
诱导结肠炎的条件。为了进行复发性半抗原诱导的结肠炎的研究，4个递增剂量的TNBS/50%乙醇通过插入直肠的3.5Fr导管以每周间隔给予轻度麻醉的小鼠。导管头插入肛外缘附近4 cm，和150 μL的液体缓慢灌注至结肠，之后以每周间隔经直肠将小鼠固定在垂直位置30秒。第一和第二剂量是0.5 mg TNBS，而第三和第四剂量是0.75和1 mg TNBS。对照组使用相同的程序每周给予50%乙醇。动物氯硝柳胺溶于水和以1、3、10、30、100 mg/kg以每日间隔通过插入直肠的3.5Fr导管给予至轻度麻醉的小鼠。对照小鼠使用相同的程序给予水。
疾病的临床评价。为临床评价结肠炎，每日记录动物重量、腹泻(0=没有；1=存在)、直肠脱出(0=没有；1=存在)和粪便中血液的存在(0=没有；1=存在)。
疾病的组织学评价。对于组织学分析，将组织在OCT中固定，切成切片，和用H&E染色。个体小鼠的组织学评分通过对样品不知情的病理学家进行，和在结肠的显微横切片上的炎症程度半定量分级为0-4。在指定死亡时间从小鼠取出的组织固定在10%福尔马林溶液中，在石蜡中包埋，切成组织切片和用苏木精和伊红染色。使用不同的标准例如淋巴细胞侵润的存在、隐窝的伸长和/或变形、明显的溃疡和肠壁增厚，检查染色的切片的结肠炎证据。结肠的显微横切片上的炎症程度被分级为0-4，如下：0：无炎症证据；1：低水平的淋巴细胞侵润，其中在<10%高倍视野(hpf=高倍视野)中见到侵润，观察到无结构变化；2：中等淋巴细胞侵润，其中在<10-25% hpf中见到侵润，隐窝伸长，肠壁增厚，其不延伸超过粘膜层；3：高水平的淋巴细胞侵润，其中在<25-50% hpf中见到侵润，肠壁增厚，其延伸超过粘膜层；4：显著程度的淋巴细胞侵润，其中在>50% hpf中见到侵润，高血管密度，隐窝伸长与变形，透壁肠壁增厚与溃疡(J Exp Med. 1995 Nov 1;182(5):1281-90；Current ProtocolImmunology 15.19 DOI: 10.1002/0471142735.im1519s49)。
治疗效果的计算。对于统计学比较，用GaphPrism软件计算双向Anova检验与Bonferroni校正。
结果。氯硝柳胺显示结肠炎临床评分和组织学评分的剂量相关减少。相对于媒介对照，3 mg/kg和更高的治疗剂量的氯硝柳胺显著减少临床和组织学评分(p<0.05)。
实施例5：在小鼠中氯硝柳胺的治疗剂量与超过10:1的结肠:血浆暴露比有关。
目标。本实验的目标是在直肠给予氯硝柳胺的小鼠中确定血浆和结肠浓度和计算结肠:血浆暴露。
模型。小鼠用作有效模型以使治疗反应与可在血液(血清或血浆级分)和组织中测量的药物浓度关联，以确定经设计以提供结肠局部给予(与系统吸收相反)的治疗策略的有效性。通过在其中观察到对结肠炎的治疗反应的小鼠品系中测量试验试剂浓度，可得到关于局部结肠递送是否产生药物暴露的高结肠:血浆比率和足够的结肠浓度的试验试剂的结论，以解释治疗效果不依赖于对试验试剂的吸收和系统暴露。
小鼠。9周龄C57BL/6J雌性小鼠自Jackson购买和在特定无病原体设施中在通气笼中在范围68-74 °F的温度下饲养，其中日间12小时光周期。食物和水自由提供。在开始实验前，动物适应当地微生物群7天。
氯硝柳胺给予。将氯硝柳胺溶于水和以3 mg/kg单剂量通过插入直肠的3.5Fr导管给予轻度麻醉的小鼠。
药代动力学研究设计。在氯硝柳胺给予后0.25、0.5、1、2、4、8、16小时，从3只小鼠/时间点收集血浆和结肠样本，高效液相色谱用于测量氯硝柳胺和其代谢物的组织浓度。
血浆和结肠比率的计算。将氯硝柳胺结肠浓度(mg/mg)和氯硝柳胺血浆浓度(mg/mL)的平均浓度作图和计算比率。
结果。氯硝柳胺显示结肠:血浆暴露比超过10:1。
实施例6：对结肠炎治疗性的剂量的氯硝柳胺导致在小鼠中与线粒体解偶联有关的结肠暴露水平。
目标。为了确定氯硝柳胺结肠暴露是否与诱导线粒体解偶联的氯硝柳胺浓度有关。
模型。实施例2和5的结果一起使用。实施例2定义了氯硝柳胺浓度和线粒体解偶联之间的剂量反应关系。使用实施例5的药代动力学数据，测定结肠中的最大氯硝柳胺浓度。该浓度与剂量反应数据直接比较以确定有效暴露是否足以在结肠中诱导线粒体解偶联。
氯硝柳胺给予。将氯硝柳胺溶于水和以1或3 mg/kg通过插入直肠的3.5Fr导管给予单剂量至轻度麻醉的小鼠。
药代动力学研究设计。在氯硝柳胺给予后0.25、0.5、1、2、4、8和16小时，从3只小鼠/时间点/组收集结肠样本，高压液相色谱用于测量氯硝柳胺和其代谢物的组织浓度。
靶标覆盖度的计算。计算结肠浓度对比时间曲线下的平均面积(AUC)和峰浓度，并作图和曲线。Y轴表示氯硝柳胺浓度(μM)，而X轴表示时间。为了评价靶标覆盖度，该图包括在其中氯硝柳胺在固有层T细胞中诱导线粒体解偶联的水平处的水平线。
结果。以低于最大功效(例如1 mg/kg)的剂量，氯硝柳胺在结肠中不达到5μM浓度。以治疗剂量3 mg/kg，氯硝柳胺达到结肠峰浓度>5μM。因为5μM是能够在固有层T细胞中诱导线粒体解偶联超过50%的氯硝柳胺浓度，该数据指示有效暴露导致氯硝柳胺的结肠浓度与线粒体解偶联有关，证实治疗机制与线粒体解偶联有关。
图1. 氯硝柳胺诱导来自活性IBD的固有层T细胞的细胞死亡。来自IBD受试者的LPMC (固有层单核细胞)分离自肉眼可见的发炎肠区域和用DMSO或氯硝柳胺(10 μM)处理16小时。固有层T细胞(CD3+)的细胞死亡通过流式细胞术测量7-AAD染色测定。
图2包括表明当直肠给予(局部)而非通过腹膜内注射(系统)给予时，氯硝柳胺在溃疡性结肠炎的鼠TNBS模型中显示稳健功效的图和图像。
实施例7：共结晶的合成
A) L-脯氨酸(35.2 mg)和氯硝柳胺(100 mg)在含有钢球的钢管中混合。向该混合物加入5滴乙醇。将样品研磨15分钟，之后共结晶转化基本上完成。
上述实例意指说明而非限制本发明。用于实现所述发明的其它方法包括用研钵和研杵研磨、共磨、浆液转化和两种组分的溶液浓缩。
本领域技术人员将理解，类似的共结晶可从D-脯氨酸和从L-和D-脯氨酸的混合物例如其外消旋混合物产生。
B) L-脯氨酸(35.2 mg)和氯硝柳胺(100 mg)在含有钢球的钢管中混合。向该混合物加入5滴丙二醇。将样品研磨15分钟，之后共结晶转化基本上完成。
C) 咪唑(20.8 mg)和氯硝柳胺(100 mg)在含有钢球的钢管中混合。向该混合物加入5滴乙醇。将样品研磨15分钟，之后共结晶转化基本上完成。
上述实例意指说明而非限制本发明。用于实现所述发明的其它方法包括用研钵和研杵研磨、共磨、浆液转化和两种组分的溶液浓缩。
实施例8：灌肠剂制剂组分的制备
下表11所示的液体载体根据以下程序制备。将4-羟基苯甲酸丙酯和4-羟基苯甲酸甲酯溶于热水。将溶液冷却至室温，和加入另外的水以补偿由于在前一步骤中发生的蒸发导致的水损失。加入钠盐和搅拌溶解10分钟(pH: 6.5 – 7.5)。甲基纤维素和聚维酮使用涡轮式混合器分散(9000 rpm，30’)。使制剂静置数小时以除去泡沫。通常，液体载体的制剂不贮存和直接使用。然而，当贮存时，液体载体在500 mL聚乙烯瓶中贮存。液体载体显示表11所示的性质。
表11
表12显示的湿法制粒制剂按照以下程序制备。将内相成分合并和在高剪切颗粒机中混合。粒化溶液从水和指定试剂制备。将该溶液加入内相的混合物，导致形成颗粒。一旦颗粒形成和干燥，将外相成分加入干燥颗粒。得到的湿法制粒制剂可使用常规程序悬浮在上述液体载体中。
表12
实施例9：作为灌肠剂直肠给予的氯硝柳胺混悬剂在溃疡性结肠炎的小鼠模型中具有功效。
目标：本实验的目标是确定作为灌肠剂直肠给予结肠炎小鼠的氯硝柳胺混悬剂是否减少疾病活性。
模型：直肠内给予三硝基苯磺酸(TNBS)至小鼠导致结肠炎。TNBS引发细胞介导的免疫反应和在肠中诱导透壁炎症，其形态学和组织病理学特征类似于人炎性肠病。TNBS诱导弥散性结肠炎症，特征为白细胞侵润增加、水肿和溃疡。特别报道了给予TNBS与Th1-介导的免疫反应的显著活化有关，其表现为细胞因子例如干扰素-γ (IFN-γ)、肿瘤坏死因子-α (TNF-α)和白细胞介素-17A (IL-17A)的增加以及CD4+T细胞的密集侵润。TNBS模型的疾病活性可通过体重损失来检测，结肠组织病理学评价显示炎性损伤的证据和在结肠组织中检出的促炎细胞因子的证据。
动物和治疗：TNBS结肠炎的研究在8-12周龄的雄性Balb/c小鼠(JacksonLaboratories，种系编号000651)中进行。为诱导结肠炎，将2.5 mg的TNBS (Sigma-Aldrich，Milan，Italy)/50%乙醇通过插入直肠的3.5F导管给予轻度麻醉的小鼠。导管头插入肛外缘附近4 cm，和将150 μL的流体缓慢灌输至结肠，之后将小鼠固定在垂直位置30秒。在第0天将小鼠暴露于TNBS或50%乙醇媒介(EtOH)。TNBS或EtOH暴露的小鼠随后经直肠不给予任何试剂、给予用于氯硝柳胺的媒介(磷酸盐缓冲盐水)或氯硝柳胺灌肠剂混悬剂(0.03；3；30 mg/kg，如所示的) (通过给予150ul体积的以在磷酸盐缓冲盐水中的4、0.4、0.04 mg/ml氯硝柳胺混悬剂(Sigma-Aldrich)制备的氯硝柳胺混悬剂)。在第1天和第2天给予氯硝柳胺或仅媒介。每日记录重量变化和在研究结束时收集组织用于组织学研究和RNA分析。
组织病理学：对于组织学分析，将组织在10%中性缓冲的福尔马林溶液中固定，在石蜡中包埋，切成组织切片，并用苏木精和伊红(H&E)染色。对于TNBS-诱导的结肠炎，检查染色的切片的结肠炎证据，和通过考虑急性和慢性炎性浸润的存在、隐窝伸长和/或变形、明显的溃疡和肠壁增厚，指定结肠炎评分(0-5)。
RNA提取、cDNA制备和用于细胞因子检测的实时PCR：
RNA使用Trizol试剂根据制造商的说明书(Invitrogen，Carlsbad，CA)从治疗小鼠的新鲜粘膜样品提取。将恒定量的RNA (1 mg/样品)反转录成cDNA，和其使用基于sybergreen的PCR(Bio-Rad，Hercules，CA)，使用PCR条件和适合特异性检测IL-17A、IFN-γ和TNF-α的引物序列扩增。β-肌动蛋白用作持家基因以确定相对表达。基因表达使用ΔΔCt算法计算。
结果和结论 – 如图4A显示的，在第1和2天以剂量30 mg/kg直肠给予的氯硝柳胺混悬剂导致由于TNBS诱导的结肠炎而初始损失的体重的恢复。在未治疗或媒介对照治疗的小鼠中没有重量恢复。
如图4B显示的，基于结肠活检的H&E分析，与媒介对照治疗的小鼠或接受TNBS和未接受其它治疗的小鼠相比，在第1和2天以剂量30 mg/kg直肠给予的氯硝柳胺混悬剂导致显著更低的结肠炎评分。
图4C证实在肠活检组织中通过实时PCR检测的炎性细胞因子的表达。与未接受TNBS的EtOH对照动物相比，在媒介存在下的TNBS暴露增加TNFa、IFNy和IL-17A的表达。相对于用作持家基因以标准化的β-肌动蛋白的RNA的表达，以0.03、3.0和30 mg/kg体重直肠给予的氯硝柳胺剂量依赖性降低各细胞因子的RNA的水平。
结果支持了以下结论：直肠给予的氯硝柳胺混悬剂治疗在人炎性肠病的小鼠模型中的结肠炎，其概括了人疾病的特征，包括通过T细胞的结肠侵润和促炎细胞因子表达增加。对直肠给予的氯硝柳胺混悬剂的治疗反应包括促炎细胞因子基因表达的剂量依赖性调节。总之，这些结果例证了直肠给予氯硝柳胺混悬剂是结肠的炎性疾病的疗法的主张。
实施例10：氯硝柳胺减少分离自人肠的固有层的T细胞的促炎潜力。
目标：本实验的目标是确定氯硝柳胺是否直接降低分离自作为活检从溃疡性结肠炎(UC)的人取样的固有层的人T细胞的促炎潜力。
模型：人肠的固有层单核细胞(LPMC)部分地由T细胞包含，其介导病理学过程，包括炎性肠病。LPMC可分离自人肠组织活检。分离后，在适合的条件下LPMC T细胞保持离体存活允许离体实验的一段时间。这些细胞可用于研究试验试剂是否影响其促炎细胞因子(包括干扰素-γ (IFN)、肿瘤坏死因子-α (TNF)和白细胞介素 17A (IL-17A))的生产，以确定试验试剂是否影响介导炎性肠病(包括UC)的促炎细胞因子。
细胞分离和培养：细胞从具有中等至严重UC的区域获自人的结肠活检样本。对于固有层单核细胞(LPMC)的分离，样本在Hank平衡盐溶液(HBSS)中初始洗涤，然后切成0.5-cm块，和在含有1 mM DTT的预温热的HBSS中在37°C搅拌孵育15分钟。除去上清液和样品用HBSS搅拌洗涤5分钟两次。样品在含有5mM EDTA的预温热的HBSS中搅拌孵育30分钟。除去上清液和样品用HBSS搅拌洗涤5分钟三次。组织然后在37°C在含有2 mg/ml Liberase和0.01ug/ml DNase I的RPMI 1640中进一步消化1小时，同时搅拌。消化后，收集悬浮的单核细胞和以400g离心10分钟。在HBS中两次洗涤后，将沉淀物重悬浮于40% Percoll溶液和在Percoll溶液的上方分层(100%、60%、40%和30% Percoll/HBSS)。将管以400g离心25分钟，和收集在60%–40% Percoll层界面处的LPMC。将分离的细胞计数和使用0.1%锥虫蓝检查存活力(存活力范围86%-94%)。用HBSS将细胞洗出Percoll和以浓度1 x 106个细胞/mL重悬浮于补充有10%热灭活的FBS、1% L-谷氨酰胺、100 U/mL青霉素和100 mg/mL链霉素的RPMI1640，并接种于96-孔培养板(200000个细胞/孔) (Nat Protoc. 2007;2(10):2307-11)。
用试验材料氯硝柳胺处理 – 将氯硝柳胺(购自Sigma)溶于二甲基亚砜(DMSO)和加入培养基以达到5μM的浓度。将样品在37°C孵育24 h。仅媒介对照(替换氯硝柳胺)同时运行。
测量促炎细胞因子。按上述用氯硝柳胺或媒介对照处理后，LPMC用PMA (10 ng/mL)、伊屋诺霉素(1 µg/mL)和布雷菲德菌素A (10 µg/mL；eBioscience，San Diego，CA)刺激。5 h后，细胞用以下Ab染色：抗–CD3-PerCP (1∶50，终稀释度，BD Biosciences，SanJose，CA)，并用1%甲醛固定20′。随后，细胞用0.5%皂苷/1% BSA FACS缓冲液渗透和用以下Ab染色：抗–IFN-γ–PE (1:50，终稀释度；克隆XMG1.2，BD Biosciences)、抗–IL-17A–APC(1:50，终稀释度，克隆eBio17B7 Affymetrix eBioscience)、抗-TNF-PEcy7 (1:50，终稀释度，克隆MP6-XT22 Affymetrix)。来自BD Biosciences的适合的同种型匹配对照包括在所有实验中。流式细胞仪FACSVerse流式细胞仪和FACSSuite软件[BD Biosciences]用于分析结果。
结果和结论 - 相对于仅媒介阴性对照，5 μM的氯硝柳胺导致产生促炎细胞因子(包括TNF、IFN和IL-17A)的人LPMC T细胞的减少(图5)。
实施例11：使用在直肠粘膜中产生可检测和显著大于相应的血浆氯硝柳胺浓度的氯硝柳胺浓度的制剂给予氯硝柳胺
兔(新西兰白KBL兔(New Zealand White KBL Rabbit) (SPF：无特定病原体)，未经过任何实验程序，Charles River Laboratories S.p.A. Italia.- 仅使用雄性)用单剂量的含有硬脂酸镁和胶体二氧化硅的氯硝柳胺混悬剂(98.5%氯硝柳胺、1%二氧化硅胶体水合物和0.5%硬脂酸镁 – 用研钵和研杵手动压碎，然后通过60目(250 um)筛分，然后悬浮于实施例8所述的液体载体)以指定的剂量水平治疗。给药后，在指定的时间点获得血液样品和直肠粘膜。参见表13和14。
表13
表14 – 1小时后的氯硝柳胺直肠浓度(ng/ml)
| 受试者669 | 受试者670 | 均值 | Std dev |
| 12.3 | 32.8 | 22.55 | 14.4957 |
给药后1小时，与3.93 ng/ml (stdev 1.37)的血浆浓度相比，直肠给予氯硝柳胺(7.5mg)产生22.55 ng/ml (stdev 14.49)的平均直肠氯硝柳胺浓度。该差异意味着1 hr时氯硝柳胺的直肠浓度是血浆浓度的超过5倍。
实施例12：氯硝柳胺在分离自人肠的固有层的T细胞中降低线粒体膜电位
目标– 本实验的目标是确定氯硝柳胺是否可在分离自人肠固有层的T细胞中直接降低线粒体跨膜电位。
模型- 人肠的固有层单核细胞(LPMC)部分地由T细胞包含，其介导生理学和病理学过程，包括炎性肠病。LPMC可分离自人组织活检。分离后，在适合的条件下LPMC T细胞保持离体存活允许离体实验的一段时间。这些细胞可用于研究调节其线粒体功能和存活的机制。它们包含呼吸线粒体和因此可评价其对试验试剂的响应。通过检测跨线粒体内膜的电化学梯度的下降(ΔΨm)鉴定和量化解偶联。
细胞分离和培养– 细胞从具有中等至严重克罗恩病(CD)的胃肠组织的区域获自人的小肠或大肠或直肠的活检样本。对于分离固有层单核细胞(LPMC)，样本在Hank平衡盐溶液(HBSS)中初始洗涤，然后切成0.5-cm块，和在含有1 mM DTT的预温热的HBSS中在37°C搅拌孵育15分钟。除去上清液和样品用HBSS搅拌洗涤5分钟两次。样品在含有5mM EDTA的预温热的HBSS中搅拌孵育30分钟。除去上清液和样品用HBSS搅拌洗涤5分钟三次。组织然后在含有2 mg/ml Liberase和0.01 ug/ml DNase I的RPMI 1640中在37°C进一步消化1小时，同时搅拌。消化后，收集悬浮的单核细胞和以400g离心10分钟。在HBS中两次洗涤后，将沉淀物重悬浮于40% Percoll溶液和在Percoll溶液的上方分层(100%、60%、40%和30% Percoll/HBSS)。将管以400g离心25分钟，和收集在60%–40% Percoll层界面处的LPMC。将分离的细胞计数和使用0.1%锥虫蓝检查存活力(存活力范围86%-94%)。用HBSS将细胞洗出Percoll和以浓度1 x 106个细胞/mL重悬浮于补充有10%热灭活的FBS、1% L-谷氨酰胺、100 U/mL青霉素和100 mg/mL链霉素的RPMI 1640，并接种于96-孔培养板(200000个细胞/孔) (NatProtoc. 2007;2(10):2307-11)。
用试验材料氯硝柳胺处理 – 将氯硝柳胺(购自Sigma)溶于二甲基亚砜(DMSO)和加入培养基以达到5μM的浓度。样品在37°C孵育60 min。JC-1购自Thermo FisherScientific，溶于DMSO，然后加入试验孔以达到10 µg/ml的终浓度和允许在370C孵育另外30 min。仅媒介对照(替换氯硝柳胺)同时运行。流式细胞仪FACSVerse流式细胞仪和FACSSuite软件[BD Biosciences]用于定量CD45+CD3+细胞中的JC-1荧光。
测量线粒体膜电位变化(ΔΨm)。JC-1是广泛使用的线粒体膜电位指示剂。JC-1具有超过其它阳离子染料的优点，因为其显示在线粒体中电位依赖性积聚，通过从绿色(~525nm)至红色(~590 nm)的荧光发射移位指示。因此，线粒体去极化通过红色/绿色荧光强度比的减少指示。电位敏感性颜色移位归因于红色荧光J-聚集体的浓度依赖性形成。
在T细胞中测量和计算ΔΨm的变化- 为了在LPMC中明确区别T细胞与其它细胞，LPMC用抗-CD45和抗-CD3抗体染色。用PerCP-Cyanine5.5 (Ex488 Em695)标记的抗-CD45单克隆抗体购自Ebioscience (克隆2D1)；用eFluor® 450 (Ex405 Em455)标记的抗-CD3单克隆抗体购自Ebioscience (克隆OKT3)。抗-CD45抗体结合人CD45抗原，其在除了循环红细胞和血小板之外的所有生血细胞中表达。抗-CD3抗体特异性结合人CD3抗原，其在T细胞上选择性表达。LPMC CD45+CD3+ T细胞通过其从用eFluor® 450-抗-CD3抗体和PerCP-Cyanine5.5 -抗-CD3抗体标记的荧光发射首先确定。然后测量在CD45+CD3+ T细胞群体中在~525 nm和~590 nm检测的JC-1的荧光强度。
结果和结论 - 相对于阴性对照，5 μM的氯硝柳胺导致在人LPMC T细胞中ΔΨm减少(参见图6)。
已描述了本发明的许多实施方案。然而将理解，在不脱离本发明的精神和范围的情况下可进行各种修改。因此，其它实施方案在随附权利要求的范围内。
Claims (239)
1.用于诱导受试者的胃肠道(GI)中的一种或多种T细胞的细胞死亡的方法，所述方法包括使一种或多种T细胞与有效量的线粒体解偶联剂或其药学上可接受的盐和/或水合物接触。
2.权利要求1的方法，其中诱导一种或多种T细胞的细胞死亡包括诱导一种或多种T细胞的坏死或凋亡。
3.权利要求1的方法，其中一种或多种T细胞包括一种或多种活化T细胞。
4.权利要求3的方法，其中一种或多种活化T细胞的每一种独立地选自：
CD45+CD3+TCRαβ+CD62L- ;
CD45+CD3+ TCRαβ+CD62L-CCR7-;
CD45+CD3+ TCRαβ+CD62L-CD69+;
CD45+CD3+ TCRαβ+CD62L-CD69+PD-1+;
CD45+CD3+TCRαβ+CD62L-CTLA4+;
CD45+CD3+ TCRαβ+CD62L-PD-1++CTLA4+;
CD45+CD3+TCRγδ+CD62L-;
CD45+CD3+TCRγδ+CD62L-CCR7-;
CD45+CD3+TCRγδ+CD62L-CD69+;
CD45+CD3+ TCRγδ+CD62L-CD69+PD-1+；
CD45+CD3+CD62L- TCRγδ+CTLA4+；和
CD45+CD3+ TCRγδ+CD62L-PD-1++CTLA4+。
5. 权利要求1的方法，其中一种或多种T细胞存在于肠上皮内和/或固有层内和/或派尔集合淋巴结(PP)内和/或GALT (肠相关淋巴样组织)内和/或肠粘膜内和/或肠粘膜下层内和/或肠肌层内和/或肠浆膜内。
6.权利要求1的方法，其中一种或多种T细胞包括一种或多种肠向性T细胞。
7.权利要求6的方法，其中一种或多种肠向性T细胞的每一种独立地表达一种或多种肠归巢受体，所述受体选自：
CD3+CCR9+;
CD3+α4+或CD3+β7+;
CD3+α4+ β7+;
CD3+β1+;
CD3+α4+ β1+;
CD3+LFA1;
CD3+CCR4+；和
CD3+CCR10+。
8.用于治疗具有与一种或多种T细胞在受试者的胃肠道(GI)处不受调节的(例如异常的或提高的)募集和/或贮留有关的病况的受试者的方法，所述方法包括使一种或多种T细胞与有效量的线粒体解偶联剂或其药学上可接受的盐和/或水合物接触。
9. 权利要求8的方法，其中一种或多种T细胞存在于肠上皮内和/或固有层内和/或派尔集合淋巴结(PP)内和/或GALT (肠相关淋巴样组织)内和/或肠粘膜内和/或肠粘膜下层内和/或肠肌层内和/或肠浆膜内。
10.权利要求8的方法，其中一种或多种T细胞包括一种或多种活化T细胞。
11.权利要求10的方法，其中一种或多种活化T细胞的每一种独立地选自：
CD45+CD3+TCRαβ+CD62L- ;
CD45+CD3+ TCRαβ+CD62L-CCR7-;
CD45+CD3+ TCRαβ+CD62L-CD69+;
CD45+CD3+ TCRαβ+CD62L-CD69+PD-1+;
CD45+CD3+TCRαβ+CD62L-CTLA4+;
CD45+CD3+ TCRαβ+CD62L-PD-1++CTLA4+;
CD45+CD3+TCRγδ+CD62L-;
CD45+CD3+TCRγδ+CD62L-CCR7-;
CD45+CD3+TCRγδ+CD62L-CD69+;
CD45+CD3+ TCRγδ+CD62L-CD69+PD-1+；
CD45+CD3+CD62L- TCRγδ+CTLA4+；和
CD45+CD3+ TCRγδ+CD62L-PD-1++CTLA4+。
12.权利要求8的方法，其中一种或多种T细胞包括一种或多种肠向性T细胞。
13.权利要求12的方法，其中一种或多种肠向性T细胞的每一种独立地表达一种或多种肠归巢受体，所述受体选自：
CD3+CCR9+;
CD3+α4+或CD3+β7+;
CD3+α4+ β7+;
CD3+β1+;
CD3+α4+ β1+;
CD3+LFA1;
CD3+CCR4+；和
CD3+CCR10+。
14.用于治疗具有与一种或多种T细胞在受试者的胃肠道(GI)中不受调节的(例如异常的或提高的)活化有关的病况的受试者的方法，所述方法包括使一种或多种活化T细胞与有效量的线粒体解偶联剂或其药学上可接受的盐和/或水合物接触。
15. 权利要求14的方法，其中一种或多种活化T细胞存在于肠上皮内和/或固有层内和/或派尔集合淋巴结(PP)内和/或GALT (肠相关淋巴样组织)内和/或肠粘膜内和/或肠粘膜下层内和/或肠肌层内和/或肠浆膜内。
16.权利要求14的方法，其中一种或多种活化T细胞的每一种独立地选自：
CD45+CD3+TCRαβ+CD62L-;
CD45+CD3+ TCRαβ+CD62L-CCR7-;
CD45+CD3+ TCRαβ+CD62L-CD69+;
CD45+CD3+ TCRαβ+CD62L-CD69+PD-1+;
CD45+CD3+TCRαβ+CD62L-CTLA4+;
CD45+CD3+ TCRαβ+CD62L-PD-1++CTLA4+;
CD45+CD3+TCRγδ+CD62L-;
CD45+CD3+TCRγδ+CD62L-CCR7-;
CD45+CD3+TCRγδ+CD62L-CD69+;
CD45+CD3+ TCRγδ+CD62L-CD69+PD-1+；
CD45+CD3+CD62L- TCRγδ+CTLA4+；和
CD45+CD3+ TCRγδ+CD62L-PD-1++CTLA4+。
17.权利要求14的方法，其中一种或多种活化T细胞包含一种或多种活化肠向性T细胞。
18.权利要求17的方法，其中一种或多种活化肠向性T细胞的每一种独立地表达一种或多种肠归巢受体，所述受体选自：
CD3+CCR9+;
CD3+α4+或CD3+β7+;
CD3+α4+ β7+;
CD3+β1+;
CD3+α4+ β1+;
CD3+LFA1;
CD3+CCR4+；和
CD3+CCR10+。
19.权利要求8-13中任一项的方法，其中有效量是足以诱导一种或多种T细胞的至少一种的细胞死亡的量。
20.权利要求19的方法，其中有效量是足以诱导一种或多种T细胞的至少一种的坏死或凋亡的量。
21.权利要求14-18中任一项的方法，其中有效量是足以诱导一种或多种活化T细胞的至少一种的细胞死亡的量。
22.权利要求22的方法，其中有效量是足以诱导一种或多种活化T细胞的至少一种的坏死或凋亡的量。
23.权利要求8-22中任一项的方法，其中所述病况是炎性肠病。
24.权利要求23的方法，其中炎性肠病是克罗恩病或溃疡性结肠炎。
25.权利要求23的方法，其中炎性肠病是医源性自身免疫性结肠炎。
26.权利要求25的方法，其中医源性自身免疫性结肠炎选自由一种或多种化学治疗剂诱导的结肠炎、由继承性细胞疗法的治疗诱导的结肠炎和伴随一种或多种同种异体免疫疾病(例如急性或慢性移植物抗宿主病)的结肠炎。
27.权利要求26的方法，其中医源性自身免疫性结肠炎是由一种或多种化学治疗剂诱导的结肠炎。
28.权利要求27的方法，其中一种或多种化学治疗剂的至少一种是化学治疗性免疫调节剂。
29.权利要求28的方法，其中化学治疗性免疫调节剂是免疫检查点抑制剂。
30. 权利要求29的方法，其中免疫检查点抑制剂靶向选自以下的免疫检查点受体：CTLA-4、PD-1、PD-L1、PD-1 – PD-L1、PD-1 – PD-L2、白细胞介素-2 (IL-2)、吲哚胺2,3-加双氧酶(IDO)、IL-10、转化生长因子-β (TGFβ)、T细胞免疫球蛋白和粘蛋白3 (TIM3或HAVCR2)、半乳凝素9 – TIM3、磷脂酰丝氨酸– TIM3、淋巴细胞活化基因3蛋白(LAG3)、MHCII类– LAG3、4-1BB–4-1BB配体、OX40–OX40配体、GITR、GITR配体– GITR、CD27、CD70-CD27、TNFRSF25、TNFRSF25–TL1A、CD40L、CD40–CD40配体、HVEM–LIGHT–LTA、HVEM、HVEM – BTLA、HVEM – CD160、HVEM – LIGHT、HVEM–BTLA–CD160、CD80、CD80 – PDL-1、PDL2 – CD80、CD244、CD48 – CD244、CD244、ICOS、ICOS–ICOS配体、B7-H3、B7-H4、VISTA、TMIGD2、HHLA2–TMIGD2、包括BTNL2的嗜乳脂蛋白、Siglec家族、TIGIT和PVR家族成员、KIRs、ILTs和LIRs、NKG2D和NKG2A、MICA和MICB、CD244、CD28、CD86 – CD28、CD86 – CTLA、CD80 – CD28、CD39、CD73 腺苷–CD39–CD73、CXCR4–CXCL12、磷脂酰丝氨酸、TIM3、磷脂酰丝氨酸– TIM3、SIRPA–CD47、VEGF、Neuropilin、CD160、CD30和CD155。
31. 权利要求29的方法，其中免疫检查点抑制剂选自：Urelumab、PF-05082566、MEDI6469、TRX518、Varlilumab、CP-870893、Pembrolizumab (PD1)、纳武单抗(PD1)、Atezolizumab (旧称MPDL3280A) (PDL1)、MEDI4736 (PD-L1)、Avelumab (PD-L1)、PDR001(PD1)、BMS-986016、MGA271、Lirilumab、IPH2201、Emactuzumab、INCB024360、Galunisertib、Ulocuplumab、BKT140、Bavituximab、CC-90002、贝伐单抗和MNRP1685A和MGA271。
32.权利要求30的方法，其中免疫检查点抑制剂靶向CTLA-4。
33.权利要求32的方法，其中免疫检查点抑制剂是抗体。
34.权利要求33的方法，其中抗体是易普利姆玛或tremelimumab。
35.权利要求30的方法，其中免疫检查点抑制剂靶向PD1或PD-L1。
36.权利要求35的方法，其中免疫检查点抑制剂选自纳武单抗、lambroizumab和BMS-936559。
37.权利要求8-22中任一项的方法，其中所述病况选自粘膜炎、乳糜泻、肠易激综合征、胶原性结肠炎、淋巴细胞性结肠炎、显微结肠炎、放射性小肠炎、类风湿性关节炎、狼疮、葡萄膜炎、硬皮病、银屑病、皮肤T-细胞淋巴瘤、急性移植物抗宿主病和慢性移植物抗宿主病。
38.权利要求37的方法，其中所述病况选自狼疮、硬皮病、银屑病和皮肤T-细胞淋巴瘤。
39.权利要求37的方法，其中所述病况是类风湿性关节炎、急性移植物抗宿主病或慢性移植物抗宿主病。
40.权利要求1-39中任一项的方法，其中所述剂具有少于约20%的口服生物利用度(F)。
41.权利要求1-39中任一项的方法，其中所述剂具有少于约5%的口服生物利用度(F)。
42.权利要求1-39中任一项的方法，其中所述剂具有少于约2%的口服生物利用度(F)。
43.权利要求1-39中任一项的方法，其中所述剂具有少于约1%的口服生物利用度(F)。
44. 权利要求1-39中任一项的方法，其中所述剂具有在20°C少于约0.01 g/mL的水溶解度。
45.权利要求1-39中任一项的方法，其中所述剂具有低的药物渗透性。
46. 权利要求1-39中任一项的方法，其中所述剂是BCS II类药物。
47. 权利要求1-39中任一项的方法，其中所述剂是BCS IV类药物。
48.权利要求1-39中任一项的方法，其中所述剂是氯硝柳胺或其药学上可接受的盐或水合物；或氯硝柳胺类似物或其药学上可接受的盐或水合物。
49.权利要求1-39中任一项的方法，其中所述剂是氯硝柳胺或其药学上可接受的盐或水合物。
50.权利要求1-49中任一项的方法，包括给予受试者包含所述剂和一种或多种药学上可接受的赋形剂的药物组合物。
51.权利要求50的方法，其中在给予后，所述剂在GI道中的局部浓度高于所述剂在血浆室中的浓度。
52.权利要求51的方法，其中在给予后，所述剂在GI道中的局部浓度是所述剂在血浆室中的浓度的至少10倍。
53.权利要求51或52的方法，其中所述剂在血浆室中经历首过代谢。
54.权利要求51或52的方法，其中所述剂的至少一些存在于上部GI道中。
55.权利要求54的方法，其中所述剂的至少一些存在于胃中。
56.权利要求51或52的方法，其中所述剂的至少一些存在于下部GI道中。
57.权利要求56的方法，其中所述剂的至少一些存在于大肠中。
58.权利要求57的方法，其中所述剂的至少一些存在于结肠中。
59.权利要求58的方法，其中所述剂的至少一些存在于升结肠和/或横结肠和/或末端结肠中。
60.权利要求51或52的方法，其中所述剂的至少一些存在于小肠中。
61.权利要求51或23的方法，其中所述剂的至少一些存在于升结肠和/或横结肠和/或末端结肠和/或小肠和/或胃中。
62.权利要求51-61中任一项的方法，其中所述剂是权利要求40-49中任一项所要求保护的试剂。
63.权利要求51-62中任一项的方法，其中所述组合物适合于局部给予至GI道。
64.权利要求63的方法，其中所述组合物适合于直肠给予。
65.权利要求34的方法，其中所述组合物作为灌肠剂、栓剂或直肠泡沫剂给予。
66.权利要求51-62中任一项的方法，其中所述组合物适合于口服给予。
67.权利要求66的方法，其中所述组合物作为片剂、丸剂或漱口剂给予。
68.权利要求66或67的方法，其中所述组合物进一步包含一个或多个在化学上和/或结构上使组合物易于递送所述剂至胃的组分。
69.权利要求66或67的方法，其中所述组合物进一步包含一个或多个在化学上和/或结构上使组合物易于递送所述剂至下部GI的组分。
70.权利要求69的方法，其中所述组合物进一步包含一个或多个在化学上和/或结构上使组合物易于递送所述剂至升结肠和/或横结肠和/或末端结肠和/或小肠的组分。
71. 权利要求50-70中任一项的方法，其中所述剂以约0.01 mg/Kg至约10 mg/Kg的剂量给予。
72. 权利要求50-70中任一项的方法，其中所述剂以约0.1 mg/Kg至约10 mg/Kg的剂量给予。
73. 权利要求50-70中任一项的方法，其中所述剂以约1 mg/Kg至约10 mg/Kg的剂量给予。
74.权利要求1-73中任一项的方法，其中所述方法进一步包括给予第二治疗剂或方案。
75.权利要求74的方法，其中在与线粒体解偶联剂接触或给予线粒体解偶联剂之前，将第二治疗剂或方案给予受试者。
76.权利要求74的方法，其中大约与线粒体解偶联剂接触或给予线粒体解偶联剂同时将第二治疗剂或方案给予受试者。
77.权利要求76的方法，其中以同一剂型同时将第二治疗剂或方案和线粒体解偶联剂提供给受试者。
78.权利要求76的方法，其中以分开的剂型同时将第二治疗剂或方案和线粒体解偶联剂提供给受试者。
79.权利要求74的方法，其中在与所述组合物接触或给予所述组合物后将第二治疗剂或方案给予受试者。
80.权利要求74-79中任一项的方法，其中第二治疗剂是化学治疗性免疫调节剂。
81.权利要求80的方法，其中化学治疗性免疫调节剂是免疫检查点抑制剂。
82. 权利要求81的方法，其中免疫检查点抑制剂靶向选自以下的免疫检查点受体：CTLA-4、PD-1、PD-L1、PD-1 – PD-L1、PD-1 – PD-L2、白细胞介素-2 (IL-2)、吲哚胺2,3-加双氧酶(IDO)、IL-10、转化生长因子-β (TGFβ)、T细胞免疫球蛋白和粘蛋白3 (TIM3或HAVCR2)、半乳凝素9 – TIM3、磷脂酰丝氨酸– TIM3、淋巴细胞活化基因3蛋白(LAG3)、MHCII类– LAG3、4-1BB–4-1BB配体、OX40–OX40配体、GITR、GITR配体– GITR、CD27、CD70-CD27、TNFRSF25、TNFRSF25–TL1A、CD40L、CD40–CD40配体、HVEM–LIGHT–LTA、HVEM、HVEM – BTLA、HVEM – CD160、HVEM – LIGHT、HVEM–BTLA–CD160、CD80、CD80 – PDL-1、PDL2 – CD80、CD244、CD48 – CD244、CD244、ICOS、ICOS–ICOS配体、B7-H3、B7-H4、VISTA、TMIGD2、HHLA2–TMIGD2、包括BTNL2的嗜乳脂蛋白、Siglec家族、TIGIT和PVR家族成员、KIRs、ILTs和LIRs、NKG2D和NKG2A、MICA和MICB、CD244、CD28、CD86 – CD28、CD86 – CTLA、CD80 – CD28、CD39、CD73 腺苷–CD39–CD73、CXCR4–CXCL12、磷脂酰丝氨酸、TIM3、磷脂酰丝氨酸– TIM3、SIRPA–CD47、VEGF、Neuropilin、CD160、CD30和CD155。
83. 权利要求81的方法，其中免疫检查点抑制剂选自：Urelumab、PF-05082566、MEDI6469、TRX518、Varlilumab、CP-870893、Pembrolizumab (PD1)、纳武单抗(PD1)、Atezolizumab (旧称MPDL3280A) (PDL1)、MEDI4736 (PD-L1)、Avelumab (PD-L1)、PDR001(PD1)、BMS-986016、MGA271、Lirilumab、IPH2201、Emactuzumab、INCB024360、Galunisertib、Ulocuplumab、BKT140、Bavituximab、CC-90002、贝伐单抗和MNRP1685A和MGA271。
84.权利要求83的方法，其中免疫检查点抑制剂靶向CTLA-4。
85.权利要求84的方法，其中免疫检查点抑制剂是抗体。
86.权利要求85的方法，其中抗体是易普利姆玛或tremelimumab。
87.权利要求83的方法，其中免疫检查点抑制剂靶向PD1或PD-L1。
88.权利要求87的方法，其中免疫检查点抑制剂选自纳武单抗、lambroizumab和BMS-936559。
89.权利要求74-79中任一项的方法，其中第二治疗方案是放射。
90.用于治疗受试者的自身免疫性结肠炎(或其一种或多种症状)的方法，所述方法包括局部(topically)和局部(locally)给予有效量的线粒体膜解偶联剂(例如氯硝柳胺)或其药学上可接受的盐和/或水合物至受试者的GI道。
91.用于治疗受试者的病况(或其一种或多种症状)的方法，所述病况选自乳糜泻、肠易激综合征、胶原性结肠炎、淋巴细胞性结肠炎、显微结肠炎、放射性小肠炎、类风湿性关节炎、狼疮、硬皮病、银屑病、皮肤T-细胞淋巴瘤、急性移植物抗宿主病和慢性移植物抗宿主病，所述方法包括局部(topically)和局部(locally)给予有效量的线粒体膜解偶联剂(例如氯硝柳胺)或其药学上可接受的盐和/或水合物至受试者的GI道和/或皮肤。
92.权利要求1-91中任一项的方法，其中受试者是人。
93. 用于诱导受试者的胃肠道(GI)中的一种或多种T细胞的细胞死亡的方法，所述方法包括使一种或多种T细胞与有效量的共结晶接触，所述共结晶包含(i) 线粒体解偶联剂或其药学上可接受的盐和/或水合物；和(ii) 一种或多种药学上可接受的共形成物。
94.权利要求93的方法，其中诱导一种或多种T细胞的细胞死亡包括诱导一种或多种T细胞的坏死或凋亡。
95.权利要求93的方法，其中一种或多种T细胞包括一种或多种活化T细胞。
96.权利要求95的方法，其中一种或多种活化T细胞的每一种独立地选自：
CD45+CD3+TCRαβ+CD62L- ;
CD45+CD3+ TCRαβ+CD62L-CCR7-;
CD45+CD3+ TCRαβ+CD62L-CD69+;
CD45+CD3+ TCRαβ+CD62L-CD69+PD-1+;
CD45+CD3+TCRαβ+CD62L-CTLA4+;
CD45+CD3+ TCRαβ+CD62L-PD-1++CTLA4+;
CD45+CD3+TCRγδ+CD62L-;
CD45+CD3+TCRγδ+CD62L-CCR7-;
CD45+CD3+TCRγδ+CD62L-CD69+;
CD45+CD3+ TCRγδ+CD62L-CD69+PD-1+；
CD45+CD3+CD62L- TCRγδ+CTLA4+；和
CD45+CD3+ TCRγδ+CD62L-PD-1++CTLA4+。
97. 权利要求93的方法，其中一种或多种T细胞存在于肠上皮内和/或固有层内和/或派尔集合淋巴结(PP)内和/或GALT (肠相关淋巴样组织)内和/或肠粘膜内和/或肠粘膜下层内和/或肠肌层内和/或肠浆膜内。
98.权利要求93的方法，其中一种或多种T细胞包括一种或多种肠向性T细胞。
99.权利要求98的方法，其中一种或多种肠向性T细胞的每一种独立地表达一种或多种肠归巢受体，所述受体选自：
CD3+CCR9+;
CD3+α4+或CD3+β7+;
CD3+α4+ β7+;
CD3+β1+;
CD3+α4+ β1+;
CD3+LFA1;
CD3+CCR4+；和
CD3+CCR10+。
100. 用于治疗具有与受试者的胃肠道(GI)处的一种或多种T细胞的不受调节的(异常的、提高的)募集和/或贮留有关的病况的受试者的方法，所述方法包括使一种或多种T细胞与有效量的共结晶接触，所述共结晶包含(i) 线粒体解偶联剂或其药学上可接受的盐和/或水合物；和(ii) 一种或多种药学上可接受的共形成物。
101. 权利要求100的方法，其中一种或多种T细胞存在于肠上皮内和/或固有层内和/或派尔集合淋巴结(PP)内和/或GALT (肠相关淋巴样组织)内和/或肠粘膜内和/或肠粘膜下层内和/或肠肌层内和/或肠浆膜内。
102.权利要求100的方法，其中一种或多种T细胞包括一种或多种活化T细胞。
103.权利要求102的方法，其中一种或多种活化T细胞的每一种独立地选自：
CD45+CD3+TCRαβ+CD62L- ;
CD45+CD3+ TCRαβ+CD62L-CCR7-;
CD45+CD3+ TCRαβ+CD62L-CD69+;
CD45+CD3+ TCRαβ+CD62L-CD69+PD-1+;
CD45+CD3+TCRαβ+CD62L-CTLA4+;
CD45+CD3+ TCRαβ+CD62L-PD-1++CTLA4+;
CD45+CD3+TCRγδ+CD62L-;
CD45+CD3+TCRγδ+CD62L-CCR7-;
CD45+CD3+TCRγδ+CD62L-CD69+;
CD45+CD3+ TCRγδ+CD62L-CD69+PD-1+；
CD45+CD3+CD62L- TCRγδ+CTLA4+；和
CD45+CD3+ TCRγδ+CD62L-PD-1++CTLA4+。
104.权利要求100的方法，其中一种或多种T细胞包括一种或多种肠向性T细胞。
105.权利要求104的方法，其中一种或多种肠向性T细胞的每一种独立地表达一种或多种肠归巢受体，所述受体选自：
CD3+CCR9+;
CD3+α4+或CD3+β7+;
CD3+α4+ β7+;
CD3+β1+;
CD3+α4+ β1+;
CD3+LFA1;
CD3+CCR4+；和
CD3+CCR10+。
106. 用于治疗具有与受试者的胃肠道(GI)中的一种或多种T细胞的不受调节的(异常的、提高的)活化有关的病况的受试者的方法，所述方法包括使一种或多种活化T细胞与有效量的共结晶接触，所述共结晶包含(i) 线粒体解偶联剂或其药学上可接受的盐和/或水合物；和(ii) 一种或多种药学上可接受的共形成物。
107. 权利要求106的方法，其中一种或多种活化T细胞存在于肠上皮内和/或固有层内和/或派尔集合淋巴结(PP)内和/或GALT (肠相关淋巴样组织)内和/或肠粘膜内和/或肠粘膜下层内和/或肠肌层内和/或肠浆膜内。
108.权利要求106的方法，其中一种或多种活化T细胞的每一种独立地选自：
CD45+CD3+TCRαβ+CD62L- ;
CD45+CD3+ TCRαβ+CD62L-CCR7-;
CD45+CD3+ TCRαβ+CD62L-CD69+;
CD45+CD3+ TCRαβ+CD62L-CD69+PD-1+;
CD45+CD3+TCRαβ+CD62L-CTLA4+;
CD45+CD3+ TCRαβ+CD62L-PD-1++CTLA4+;
CD45+CD3+TCRγδ+CD62L-;
CD45+CD3+TCRγδ+CD62L-CCR7-;
CD45+CD3+TCRγδ+CD62L-CD69+;
CD45+CD3+ TCRγδ+CD62L-CD69+PD-1+；
CD45+CD3+CD62L- TCRγδ+CTLA4+；和
CD45+CD3+ TCRγδ+CD62L-PD-1++CTLA4+。
109.权利要求106的方法，其中一种或多种活化T细胞包括一种或多种活化肠向性T细胞。
110.权利要求109的方法，其中一种或多种活化肠向性T细胞的每一种独立地表达一种或多种肠归巢受体，所述受体选自：
CD3+CCR9+;
CD3+α4+或CD3+β7+;
CD3+α4+ β7+;
CD3+β1+;
CD3+α4+ β1+;
CD3+LFA1;
CD3+CCR4+；和
CD3+CCR10+。
111.权利要求100-105中任一项的方法，其中有效量是足以诱导一种或多种T细胞的至少一种的细胞死亡的量。
112.权利要求111的方法，其中有效量是足以诱导一种或多种T细胞的至少一种的坏死或凋亡的量。
113.权利要求106-110中任一项的方法，其中有效量是足以诱导一种或多种活化T细胞的至少一种的细胞死亡的量。
114.权利要求113的方法，其中有效量是足以诱导一种或多种活化T细胞的至少一种的坏死或凋亡的量。
115. 用于治疗有需要的受试者的特征为异常炎性反应的病况(或其一种或多种症状)的方法，包括给予受试者有效量的共结晶，所述共结晶包含(i) 线粒体解偶联剂或其药学上可接受的盐和/或水合物；和(ii) 一种或多种药学上可接受的共形成物。
116.权利要求100-115中任一项的方法，其中所述病况是炎性肠病。
117.权利要求116的方法，其中炎性肠病是克罗恩病。
118.权利要求116的方法，其中炎性肠病是自身免疫性结肠炎。
119.权利要求118的方法，其中自身免疫性结肠炎选自溃疡性结肠炎、由一种或多种化学治疗剂诱导的结肠炎、由继承性细胞疗法的治疗诱导的结肠炎、伴随一种或多种同种异体免疫疾病(例如移植物抗宿主病)的结肠炎和放射性小肠炎。
120.权利要求119的方法，其中自身免疫性结肠炎是由一种或多种化学治疗剂诱导的结肠炎。
121.权利要求120的方法，其中一种或多种化学治疗剂的至少一种是化学治疗性免疫调节剂。
122.权利要求121的方法，其中化学治疗性免疫调节剂是免疫检查点抑制剂。
123. 权利要求122的方法，其中免疫检查点抑制剂靶向选自以下的免疫检查点受体：CTLA-4、PD-1、PD-L1、PD-1 – PD-L1、PD-1 – PD-L2、白细胞介素-2 (IL-2)、吲哚胺2,3-加双氧酶(IDO)、IL-10、转化生长因子-β (TGFβ)、T细胞免疫球蛋白和粘蛋白3 (TIM3或HAVCR2)、半乳凝素9 – TIM3、磷脂酰丝氨酸– TIM3、淋巴细胞活化基因3蛋白(LAG3)、MHCII类– LAG3、4-1BB–4-1BB配体、OX40–OX40配体、GITR、GITR配体– GITR、CD27、CD70-CD27、TNFRSF25、TNFRSF25–TL1A、CD40L、CD40–CD40配体、HVEM–LIGHT–LTA、HVEM、HVEM – BTLA、HVEM – CD160、HVEM – LIGHT、HVEM–BTLA–CD160、CD80、CD80 – PDL-1、PDL2 – CD80、CD244、CD48 – CD244、CD244、ICOS、ICOS–ICOS配体、B7-H3、B7-H4、VISTA、TMIGD2、HHLA2–TMIGD2、包括BTNL2的嗜乳脂蛋白、Siglec家族、TIGIT和PVR家族成员、KIRs、ILTs和LIRs、NKG2D和NKG2A、MICA和MICB、CD244、CD28、CD86 – CD28、CD86 – CTLA、CD80 – CD28、CD39、CD73 腺苷–CD39–CD73、CXCR4–CXCL12、磷脂酰丝氨酸、TIM3、磷脂酰丝氨酸– TIM3、SIRPA–CD47、VEGF、Neuropilin、CD160、CD30和CD155。
124. 权利要求122的方法，其中免疫检查点抑制剂选自：Urelumab、PF-05082566、MEDI6469、TRX518、Varlilumab、CP-870893、Pembrolizumab (PD1)、纳武单抗(PD1)、Atezolizumab (旧称MPDL3280A) (PDL1)、MEDI4736 (PD-L1)、Avelumab (PD-L1)、PDR001(PD1)、BMS-986016、MGA271、Lirilumab、IPH2201、Emactuzumab、INCB024360、Galunisertib、Ulocuplumab、BKT140、Bavituximab、CC-90002、贝伐单抗和MNRP1685A和MGA271。
125.权利要求123的方法，其中免疫检查点抑制剂靶向CTLA-4。
126.权利要求125的方法，其中免疫检查点抑制剂是抗体。
127.权利要求126的方法，其中抗体是易普利姆玛或tremelimumab。
128.权利要求123的方法，其中免疫检查点抑制剂靶向PD1或PD-L1。
129.权利要求128的方法，其中免疫检查点抑制剂选自纳武单抗、lambroizumab和BMS-936559。
130.权利要求100-115中任一项的方法，其中所述病况选自粘膜炎、乳糜泻、肠易激综合征、胶原性结肠炎、淋巴细胞性结肠炎、显微结肠炎、放射性小肠炎、类风湿性关节炎、狼疮、葡萄膜炎、硬皮病、银屑病、皮肤T-细胞淋巴瘤、急性移植物抗宿主病和慢性移植物抗宿主病。
131.权利要求130的方法，其中所述病况选自乳糜泻、肠易激综合征、胶原性结肠炎、淋巴细胞性结肠炎、显微结肠炎、放射性小肠炎、狼疮、硬皮病、银屑病和皮肤T-细胞淋巴瘤。
132.权利要求130的方法，其中所述病况是类风湿性关节炎、急性移植物抗宿主病或慢性移植物抗宿主病。
133.权利要求93-132中任一项的方法，其中共结晶具有少于约20%的口服生物利用度(F)。
134.权利要求93-132中任一项的方法，其中共结晶具有少于约5%的口服生物利用度(F)。
135.权利要求93-132中任一项的方法，其中共结晶具有少于约2%的口服生物利用度(F)。
136.权利要求93-132中任一项的方法，其中共结晶具有少于约1%的口服生物利用度(F)。
137. 权利要求93-132中任一项的方法，其中共结晶具有在20°C少于约0.01 g/mL的水溶解度。
138.权利要求93-132中任一项的方法，其中共结晶具有低的药物渗透性。
139. 权利要求93-132中任一项的方法，其中所述剂是BCS II类药物。
140. 权利要求93-132中任一项的方法，其中所述剂是BCS IV类药物。
141.权利要求93-132中任一项的方法，其中所述剂是氯硝柳胺或其药学上可接受的盐或水合物；或氯硝柳胺类似物或其药学上可接受的盐或水合物。
142.权利要求141的方法，其中所述剂是具有下式的化合物或其药学上可接受的盐和/或水合物：
其中R1、R2、R5、R6、R7、R8、R9、R10、R11和R12独立地选自H、卤素、NO2、CF3、OH、酰基、CN、C1-C10烷基(优选地C1-C3烷基)和C1-C10杂烷基(优选地C1-C3杂烷基)；和其中R3是C=O，和R4是NH；或R3是NH，和R4是C=O，其中R1、R2、R5、R6、R7、R8、R9、R10、R11和R12的至少一个不是H。
143.权利要求142的方法，其中R1、R2、R10、R11和R12中的两个独立地选自卤素、NO2、CF3、OH、酰基、CN、C1-C10烷基(优选地C1-C3烷基)和C1-C10杂烷基(优选地C1-C3杂烷基)，和其它的是H；和R5、R6、R7、R8和R9中的两个独立地选自卤素、NO2、CF3、OH、酰基、CN、C1-C10烷基(优选地C1-C3烷基)和C1-C10杂烷基(优选地C1-C3杂烷基)，和其它的是H。
144.权利要求142的方法，其中所述剂是具有下式的化合物或其药学上可接受的盐和/或水合物：
其中R1、R2、R3、R4和R5中的一个或多个是卤素、NO2、CF3、OH、酰基、CN、C1-C10烷基(优选地C1-C3烷基)或C1-C10杂烷基(优选地C1-C3杂烷基)；和其它的是氢。
145.权利要求141-144中任一项的方法，其中所述剂是氯硝柳胺或其药学上可接受的盐或水合物。
146.权利要求141-144中任一项的方法，其中所述剂是氯硝柳胺类似物或其药学上可接受的盐或水合物。
147.权利要求146的方法，其中所述剂选自表1-6或其药学上可接受的盐和/或水合物。
148.权利要求93-147中任一项的方法，其中一种或多种药学上可接受的共形成物的至少一种可在共结晶中与所述剂形成一个或多个氢键。
149.权利要求93-147中任一项的方法，其中一种或多种药学上可接受的共形成物的至少一种包含选自以下的一个或多个官能团：醚、硫醚、羟基、巯基、醛、酮、硫酮、硝酸酯、磷酸酯、硫代磷酸酯、酯、硫酯、硫酸酯、羧酸、膦酸、次膦酸、磺酸、酰氨基、伯胺、仲胺、氨、叔氨基、sp2氨基、硫氰酸酯、氨腈、肟、腈、重氮基、卤代烷基、硝基、杂环、杂芳环、环氧化物、过氧化物和氧肟酸。
150.权利要求93-147中任一项的方法，其中一种或多种药学上可接受的共形成物的至少一种选自咖啡因、尿素、对氨基苯甲酸、茶碱、苯甲酸苄酯和烟酰胺。
151.权利要求93-147中任一项的方法，其中一种或多种药学上可接受的共形成物的至少一种是第二API。
152.权利要求93-147中任一项的方法，其中一种或多种药学上可接受的共形成物的至少一种是氯硝柳胺或其药学上可接受的盐和/或水合物。
153.权利要求93-147中任一项的方法，其中一种或多种药学上可接受的共形成物的至少一种是氯硝柳胺类似物或其药学上可接受的盐和/或水合物。
154. 权利要求93-147中任一项的方法，其中共结晶包含(i) 氯硝柳胺或氯硝柳胺类似物；和(ii) 氯硝柳胺的药学上可接受的盐和/或水合物；或 氯硝柳胺类似物的药学上可接受的盐和/或水合物。
155. 权利要求93-147中任一项的方法，其中共结晶包含(i) 氯硝柳胺；和(ii) 氯硝柳胺的药学上可接受的盐和/或水合物；或氯硝柳胺类似物的氯硝柳胺的药学上可接受的盐和/或水合物。
156. 权利要求93-147中任一项的方法，其中共结晶包含(i) 氯硝柳胺或氯硝柳胺类似物；和(ii) 第二API。
157. 权利要求93-147中任一项的方法，其中共结晶包含(i) 氯硝柳胺的药学上可接受的盐和/或水合物；或氯硝柳胺类似物的氯硝柳胺的药学上可接受的盐和/或水合物；和(ii) 第二API。
158. 权利要求93-147中任一项的方法，其中共结晶包含(i) 氯硝柳胺；和(ii) 第二API。
159.权利要求93-147中任一项的方法，其中在共结晶中所述剂与一种或多种药学上可接受的共形成物的每一种的比率是化学计量的。
160.权利要求93-147中任一项的方法，其中在共结晶中所述剂与一种或多种药学上可接受的共形成物的每一种的比率是非化学计量的。
161.权利要求93-160中任一项的方法，其中共结晶作为包含共结晶和一种或多种药学上可接受的赋形剂的药物组合物给予。
162.权利要求161的方法，其中在给予后，所述剂在GI道中的局部浓度高于所述剂在血浆室中的浓度。
163.权利要求162的方法，其中在给予后，所述剂在GI道中的局部浓度为所述剂在血浆室中的浓度的约10倍。
164.权利要求162或163的方法，其中所述剂在血浆室中经历首过代谢。
165.权利要求162或163的方法，其中所述剂的至少一些存在于上部GI道中。
166.权利要求165的方法，其中所述剂的至少一些存在于胃中。
167.权利要求162或163的方法，其中所述剂的至少一些存在于下部GI道中。
168.权利要求167的方法，其中所述剂的至少一些存在于大肠中。
169.权利要求168的方法，其中所述剂的至少一些存在于结肠中。
170.权利要求169的方法，其中所述剂的至少一些存在于升结肠和/或横结肠和/或末端结肠中。
171.权利要求162或163的方法，其中所述剂的至少一些存在于小肠中。
172.权利要求162或163的方法，其中所述剂的至少一些存在于升结肠和/或横结肠和/或末端结肠和/或小肠和/或胃中。
173.权利要求161-172中任一项的方法，其中所述组合物适合于局部给予至GI道。
174.权利要求173的方法，其中所述组合物适合于直肠给予。
175.权利要求174的方法，其中所述组合物作为灌肠剂、栓剂或直肠泡沫剂给予。
176.权利要求161-172中任一项的方法，其中所述组合物适合于口服给予。
177.权利要求176的方法，其中所述组合物作为片剂、丸剂或漱口剂给予。
178.权利要求176或177的方法，其中所述组合物进一步包含一个或多个在化学上和/或结构上使组合物易于递送所述剂至胃的组分。
179.权利要求176或177的方法，其中所述组合物进一步包含一个或多个在化学上和/或结构上使组合物易于递送所述剂至下部GI的组分。
180.权利要求179的方法，其中所述组合物进一步包含一个或多个在化学上和/或结构上使组合物易于递送所述剂至升结肠和/或横结肠和/或末端结肠和/或小肠的组分。
181. 权利要求161-180中任一项的方法，其中所述剂以约0.01 mg/Kg至约10 mg/Kg的剂量给予。
182. 权利要求161-180中任一项的方法，其中所述剂以约0.1 mg/Kg至约10 mg/Kg的剂量给予。
183. 权利要求161-180中任一项的方法，其中所述剂以约1 mg/Kg至约10 mg/Kg的剂量给予。
184.权利要求93-183中任一项的方法，其中所述方法进一步包括给予第二治疗剂或方案。
185.权利要求184的方法，其中在与共结晶接触或给予共结晶之前给予第二治疗剂或方案。
186.权利要求184的方法，其中大约与共结晶接触或给予共结晶同时将第二治疗剂或方案给予受试者。
187.权利要求186的方法，其中以同一剂型同时将第二治疗剂或方案和共结晶提供给受试者。
188.权利要求186的方法，其中以分开的剂型同时将第二治疗剂或方案和共结晶提供给受试者。
189.权利要求184的方法，其中在与共结晶接触或给予共结晶后将第二治疗剂或方案给予受试者。
190.权利要求184-189中任一项的方法，其中第二治疗剂是化学治疗性免疫调节剂。
191.权利要求190的方法，其中化学治疗性免疫调节剂是免疫检查点抑制剂。
192. 权利要求191的方法，其中免疫检查点抑制剂靶向选自以下的免疫检查点受体：CTLA-4、PD-1、PD-L1、PD-1 – PD-L1、PD-1 – PD-L2、白细胞介素-2 (IL-2)、吲哚胺2,3-加双氧酶(IDO)、IL-10、转化生长因子-β (TGFβ)、T细胞免疫球蛋白和粘蛋白3 (TIM3或HAVCR2)、半乳凝素9 – TIM3、磷脂酰丝氨酸– TIM3、淋巴细胞活化基因3蛋白(LAG3)、MHCII类– LAG3、4-1BB–4-1BB配体、OX40–OX40配体、GITR、GITR配体– GITR、CD27、CD70-CD27、TNFRSF25、TNFRSF25–TL1A、CD40L、CD40–CD40配体、HVEM–LIGHT–LTA、HVEM、HVEM – BTLA、HVEM – CD160、HVEM – LIGHT、HVEM–BTLA–CD160、CD80、CD80 – PDL-1、PDL2 – CD80、CD244、CD48 – CD244、CD244、ICOS、ICOS–ICOS配体、B7-H3、B7-H4、VISTA、TMIGD2、HHLA2–TMIGD2、包括BTNL2的嗜乳脂蛋白、Siglec家族、TIGIT和PVR家族成员、KIRs、ILTs和LIRs、NKG2D和NKG2A、MICA和MICB、CD244、CD28、CD86 – CD28、CD86 – CTLA、CD80 – CD28、CD39、CD73 腺苷–CD39–CD73、CXCR4–CXCL12、磷脂酰丝氨酸、TIM3、磷脂酰丝氨酸– TIM3、SIRPA–CD47、VEGF、Neuropilin、CD160、CD30和CD155。
193. 权利要求191的方法，其中免疫检查点抑制剂选自：Urelumab、PF-05082566、MEDI6469、TRX518、Varlilumab、CP-870893、Pembrolizumab (PD1)、纳武单抗(PD1)、Atezolizumab (旧称MPDL3280A) (PDL1)、MEDI4736 (PD-L1)、Avelumab (PD-L1)、PDR001(PD1)、BMS-986016、MGA271、Lirilumab、IPH2201、Emactuzumab、INCB024360、Galunisertib、Ulocuplumab、BKT140、Bavituximab、CC-90002、贝伐单抗和MNRP1685A和MGA271。
194.权利要求193的方法，其中免疫检查点抑制剂靶向CTLA-4。
195.权利要求194的方法，其中免疫检查点抑制剂是抗体。
196.权利要求195的方法，其中抗体是易普利姆玛或tremelimumab。
197.权利要求193的方法，其中免疫检查点抑制剂靶向PD1或PD-L1。
198.权利要求197的方法，其中免疫检查点抑制剂选自纳武单抗、lambroizumab和BMS-936559。
199.权利要求74-79和184-189中任一项的方法，其中第二治疗剂是在GI道中局部起作用的一种或多种抗炎剂或免疫调节剂。
200. 权利要求74-79和184-189中任一项的方法，其中一种或多种治疗剂选自：5-ASA(和相关的递送系统)、抗-SMAD7反义物、口服配制的抗-TNF、抗-整联蛋白、柳氮磺吡啶、巴柳氮、类固醇、硫唑嘌呤、甲氨蝶呤。
201.权利要求184-189中任一项的方法，其中第二治疗方案是放射。
202. 用于在有需要的受试者中治疗特征为异常炎性反应的病理的一种或多种症状的方法，包括局部(topically)和局部(locally)给予受试者有效量的共结晶，所述共结晶包含(i) 线粒体解偶联剂(例如氯硝柳胺)或其药学上可接受的盐和/或水合物；和(ii) 一种或多种药学上可接受的共形成物。
203. 用于治疗受试者的自身免疫性结肠炎(或其一种或多种症状)的方法，所述方法包括局部(topically)和局部(locally)给予受试者有效量的共结晶，所述共结晶包含(i)线粒体解偶联剂(例如氯硝柳胺)或其药学上可接受的盐和/或水合物；和(ii) 一种或多种药学上可接受的共形成物。
204. 用于治疗受试者的病况(或其一种或多种症状)的方法，所述病况选自乳糜泻、肠易激综合征、胶原性结肠炎、淋巴细胞性结肠炎、显微结肠炎、放射性小肠炎、类风湿性关节炎、狼疮、硬皮病、银屑病、皮肤T-细胞淋巴瘤、急性移植物抗宿主病和慢性移植物抗宿主病，所述方法包括局部(topically)和局部(locally)给予受试者有效量的共结晶，所述共结晶包含(i) 线粒体解偶联剂(例如氯硝柳胺)或其药学上可接受的盐和/或水合物；和(ii) 一种或多种药学上可接受的共形成物。
205.权利要求93-204中任一项的方法，其中受试者是人。
206.权利要求37或130的方法，其中粘膜炎是口腔粘膜炎、食管粘膜炎或肠粘膜炎。
207.权利要求37或130的方法，其中所述剂或共结晶经局部给予至口腔(例如，用于治疗口腔或食管粘膜炎)。
208.权利要求37或130的方法，其中所述剂或共结晶经口服给予(例如，用于治疗肠粘膜炎)。
209.权利要求37或130的方法，其中所述剂或共结晶以适合口服给予胃肠道的剂型经口服给予。
210.权利要求37或130的方法，其中所述剂或共结晶经直肠给予用于治疗肠粘膜炎。
211.权利要求37或130的方法，其中粘膜炎通过暴露于由放射疗法导致的放射引起。
212.权利要求37或130的方法，其中粘膜炎通过暴露于在放射疗法的背景外存在的放射引起。
213.包含氯硝柳胺和L-脯氨酸的共结晶。
214. 根据权利要求213的共结晶，其中氯硝柳胺: L-脯氨酸的化学计量比率是约1:1。
215. 根据权利要求213或214的共结晶，具有X-射线粉末衍射图，其包含当使用Cu Kα放射测量时以度2θ表示的1-4个以下特征峰：9.24±0.10、12.85±0.10、16.55±0.10和20.47±0.10。
216. 根据权利要求215的共结晶，具有X-射线粉末衍射图，其包含当使用Cu Kα放射测量时以度2θ表示的1-5个以下特征峰：8.89±0.10、16.30±0.10、17.86±0.10、21.75±0.10和25.76±0.10。
217. 用于制备包含氯硝柳胺和L-脯氨酸的共结晶的方法，所述方法包括：
使氯硝柳胺与L-脯氨酸接触以形成混合物；和
任选地将溶剂加入至所述混合物。
218.权利要求217的方法，其中所述接触包括通过机械过程混合组分。
219.权利要求217的方法，其中在室温下所述溶剂不与氯硝柳胺产生溶剂合物。
220.权利要求219的方法，其中溶剂包含羟基。
221.权利要求220的方法，其中溶剂是乙醇或丙二醇。
222.权利要求213的共结晶，其中超过约90%的氯硝柳胺呈共结晶形式。
223.权利要求213的共结晶，其中超过约95%的氯硝柳胺呈共结晶形式。
224.权利要求214的共结晶，其中超过约90%的氯硝柳胺呈共结晶形式。
225.权利要求214的共结晶，其中超过约95%的氯硝柳胺呈共结晶形式。
226.包含氯硝柳胺和咪唑的共结晶。
227.根据权利要求226的共结晶，其中氯硝柳胺:咪唑的化学计量比率是约1:1。
228. 根据权利要求226或227的共结晶，具有X-射线粉末衍射图，其包含当使用Cu Kα放射测量时以度2θ表示的1-4个以下特征峰：6.06±0.10、8.06±0.10、9.26±0.10和16.22±0.10。
229. 根据权利要求228的共结晶，具有X-射线粉末衍射图，其包含当使用Cu Kα放射测量时以度2θ表示的1-4个以下特征峰：14.33±0.10、16.85±0.10、22.11±0.10和24.46 ±0.10。
230. 用于制备氯硝柳胺与咪唑的共结晶的方法，所述方法包括：
使氯硝柳胺与咪唑接触以形成混合物；和
任选地将溶剂加入至所述混合物。
231.权利要求230的方法，其中所述接触包括通过机械过程混合组分。
232.权利要求231的方法，其中在室温下所述溶剂不与氯硝柳胺产生溶剂合物。
233.权利要求232的方法，其中溶剂包含羟基。
234.权利要求233的方法，其中溶剂是乙醇或丙二醇。
235.权利要求226的共结晶，其中超过约90%的氯硝柳胺呈共结晶形式。
236.权利要求226的共结晶，其中超过约95%的氯硝柳胺呈共结晶形式。
237.权利要求227的共结晶，其中超过约90%的氯硝柳胺呈共结晶形式。
238.权利要求227的共结晶，其中超过约95%的氯硝柳胺呈共结晶形式。
239.药物制剂，包含有效量的线粒体膜解偶联剂(例如氯硝柳胺)或其药学上可接受的盐和/或水合物和/或共结晶和一种或多种药学上可接受的赋形剂，其中所述制剂适合通过灌肠剂递送。
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