CN116457020A - 不含脂肪酸颗粒的制剂、方法和预填充注射装置 - Google Patents
不含脂肪酸颗粒的制剂、方法和预填充注射装置 Download PDFInfo
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Abstract
本公开涉及不含脂肪酸颗粒的预填充注射装置和相关治疗制剂及方法。治疗制剂可以随着时间推移或在经受加速老化条件时保持不含脂肪酸颗粒或基本不含脂肪酸颗粒。
Description
技术领域
本公开一般涉及预填充注射装置,尤其涉及不含脂肪酸颗粒的预填充注射装置和相关治疗制剂以及方法。
背景技术
预填充注射装置的功能是储存和递送治疗制剂,所述治疗制剂包括药物和/或生物制剂。预填充注射装置通常为制药行业节省成本,并可以改进药物递送的安全性、便利性和有效性。生物药物是一类重要的药物,其可能会增加包括注射器和自动注射机的预填充注射装置的使用。随着越来越多的药物、特别是生物药物被用于预填充注射装置的递送,传统预填充技术的使用遇到了各种挑战。
一个挑战是,硅酮(例如,硅油)和/或其它液体润滑剂的使用。通常,硅酮在塞部和筒体之间提供液体密封。虽然传统上使用硅酮来确保使驱动预填充注射装置所需的力最小化,但使用硅酮作为润滑剂会带来污染风险。例如,硅酮可能污染注射装置中的药物或生物制剂。此外,硅酮可能随着药物注射至患者。硅酮可能是生物药物特别关注的问题,因为其会导致某些蛋白质聚集,从而使生物药物无法用于注射。
另一挑战是使用聚山梨醇酯和/或含有脂肪酸酯的其它表面活性剂。通常,表面活性剂降低了蛋白质对硅油的吸附作用和/或降低界面张力。然而,该表面活性剂可能产生不期望的颗粒,包括脂肪酸颗粒。该过程可以在具有脂肪酶活性的生物药物制剂中被催化。实践中,这些脂肪酸颗粒可能与细菌污染难以区分,从而使治疗制剂无法使用。
因此,需要不含脂肪酸颗粒的制剂、方法和预填充注射装置。
概述
本公开涉及不含脂肪酸酯的预填充注射装置和相关治疗制剂和方法。治疗制剂可以随着时间推移或在经受加速老化条件时保持不含脂肪酸颗粒或基本不含脂肪酸颗粒。
根据一个示例(“示例1”),提供一种预填充注射装置,其包括塞部、筒体、在塞部和筒体中至少一个上的固体润滑剂、以及治疗制剂,所述预填充注射装置不含或基本不含液体润滑剂,所述治疗制剂具有脂肪酶活性且包含至少约1mg/ml的一种或多种活性药理学试剂,其中,治疗制剂不含或基本不含脂肪酸颗粒。
根据另一个示例(“示例2”),提供一种减少脂肪酸颗粒的方法,所述方法包括:将具有脂肪酶活性且包含至少约1mg/ml的一种或多种活性药理学试剂的治疗制剂纳入预填充注射装置中,所述预填充注射装置包括塞部、筒体以及在塞部和筒体中至少一个上的固体润滑剂,所述预填充注射装置不含或基本不含液体润滑剂,其中治疗制剂不含或基本不含表面活性剂。
根据另一个示例(“示例3”),提供一种减少脂肪酸颗粒注射到对象中的方法,所述方法包括:将治疗有效量的治疗制剂从预填充注射装置给予对象,所述预填充注射装置包括塞部、筒体以及在塞部和筒体中至少一个上的固体润滑剂,所述预填充注射装置不含或基本不含液体润滑剂,所述治疗制剂不含或基本不含表面活性剂,并且所述治疗制剂具有脂肪酶活性且包含至少约1mg/ml的一种或多种活性药理学试剂。
根据另一个示例(“示例4”),提供一种胃肠外制剂,其包含至少约1mg/ml的一种或多种活性药理学试剂,其中,当在2℃至8℃储存至少约1年时,所述制剂具有脂肪酶活性,并且不含或基本不含脂肪酸颗粒。
根据另一个示例(“示例5”),提供一种预填充注射装置,其包括塞部、筒体、在塞部和筒体中至少一个上的固体润滑剂、以及治疗制剂,所述预填充注射装置不含或基本不含液体润滑剂,所述治疗制剂具有脂肪酶活性且包含至少约1mg/ml的一种或多种活性药理学试剂,其中,至少一种治疗制剂不含或基本不含表面活性剂。
上述示例仅是示例,不应被理解为限制或以其他方式缩小通过本公开以其它方式提供的发明概念的任意范围。虽然公开了多个示例,但根据显示并描述示例性示例的以下详细描述,其它实施方式将对本领域技术人员变得明显。因此,认为附图和详细描述被认为本质上是说明性的,而不是本质上是限制性的。
附图简要说明
将参考以下的非限制性附图更好地理解本发明,其中:
图1是示例性预填充注射器的正视图,所述注射器包括筒体、具有塞部的柱塞、针和治疗制剂;
图2是图1的塞部的局部剖视图,所述塞部具有至少部分被固体润滑剂覆盖的弹性体;
图3是另一塞部的局部剖视图,所述塞部具有弹性体、中间多孔层和固体润滑剂;以及
图4是图1的治疗制剂的示意图。
具体实施方式
定义和术语
本公开并不意味着以限制性的方式来阅读。例如,本申请中使用的术语应该在本领域归属于这些术语的含义的上下文中广义地进行阅读。
对于不精确的术语,术语“约”和“大约”可以互换使用,表示测量值包括所述测量值并且还包括合理接近所述测量值的任何测量值。如相关领域的普通技术人员所理解和容易确定的,与所述测量值合理接近的测量值与所述测量值的偏差相当小。例如,此类偏差可能归因于测量误差、测量和/或制造设备校准的差异、读数和/或设置测量中的人为错误、与其他组件相关的测量差异而进行的微调以优化性能和/或结构参数,特定实现场景、人或机器对对象的不精确调整和/或操纵等。如果确定相关领域的普通技术人员不容易确定这种合理的小差异的值,则术语“约”和“大约”可以理解为表示所述值的正负10%。
对各实施方式的描述
本领域的技术人员应理解,可通过构造以实施所需作用的任何数量的方法和设备来实现本公开内容的各个方面。还应注意,本文参考的附图不一定是按比例绘制,并且可能进行放大以说明本公开的各个方面,就此而言,附图不应视为限制性的。
I.预填充注射器
图1显示了药物注射装置(例如,注射器)10,其可以进行预填充以用于存储至少一种治疗制剂60并将其递送给患者。示例性注射器10包括筒体20、具有塞部40的柱塞30和刺穿元件(例如针)50,其各自在下文中进行进一步描述。注射器10是具有路厄系统(Luersystem)(未示出)的“无针”装置,其也在本公开的范围内。在本公开范围内的其它合适的药物注射装置包括:例如,自动注射机和可注射笔。
注射器10的筒体20包含治疗制剂60,并且包括面向患者的远端22、背向患者的近端24以及向内面向液体治疗制剂60的内表面26。筒20可以由硬的材料形成,例如,玻璃材料(如,硼硅酸盐玻璃)、陶瓷材料、一种或多种聚合材料(例如,聚丙烯、聚乙烯、以及它们的共聚物)、金属材料、塑性材料(例如,环烯烃聚合物和环烯烃共聚物)、以及它们的组合。在一些实施方式中,在递送至使用者时,筒体20已经预填充有治疗制剂60。筒体20可以包含约0.5mL至约20mL的治疗制剂60,但是注射器10也可以适当地按比例缩放至更小的剂量或更大的多剂量。
注射器10的柱塞30在筒体20内可往复移动,以通过移动塞部40来填充或排出治疗制剂60。柱塞30包括从筒体20的近端24延伸的头部32。塞部40连接至柱塞30的靠近筒体20远端22和针50的相对端。如图1所示的示意性塞部40通过一个或多个密封肋形部41、41接触筒体20的内表面26,虽然塞部40上可以存在任意数量的密封肋形部和/或无密封肋形部。
如图1所示,塞部40可以相对于治疗制剂60位于筒体20的预定位置处。治疗制剂60具有液体高度H1,其取决于筒体20中治疗制剂60的体积。塞部40可以位于治疗制剂60上方的预定塞部高度或“顶空”H2处,这可以从治疗制剂60的顶表面至塞部40的最接近的密封肋形部41测得。可以选择顶空H2以控制塞部40和治疗制剂60之间的筒体20中的空气量。在一些实施方式中,顶空H2小于约25mm、小于约23mm、小于约21mm、小于约19mm、小于约17mm、小于约15mm、小于约13mm、小于约10mm、小于约8mm、小于约5mm、小于约3mm、小于约2mm、小于约1mm、或小于约0.5mm。顶空体积可以通过如下来计算:将顶空高度H2乘以筒体20的内部横截面面积,减去塞部40的任意体积,其延伸经过塞部40的密封肋形部41向着治疗制剂60延伸。使顶空H2最小化以减少或避免注射器10中治疗制剂60聚集可能是有利的。
塞部40应具有低空气和液体渗透性,以在填充或排出治疗制剂60时使筒体20内的液体泄漏以及塞部40和筒体20内表面26之间的空气引入最小化。以此方式,塞部40可以抵抗筒体20中的细菌污染。塞部40还应具有相对于筒体20的低摩擦滑动性,以方便筒体20内的治疗制剂60填充和排出。在一些实施方式中,塞部40和筒体20之间的滑动力可以小于15N、小于10N或小于5N。塞部40在下文部分II中进行进一步说明。
注射器10的针50连接至筒体20的远端22。针50构造成通过按压柱塞30刺穿患者的皮肤并将治疗制剂60注射至患者体内。在针50是可拆卸的情况下,当将针50连接至筒体20和/或将针50从筒体20脱开时,应注意将筒体20中的任何细菌污染降至最低。
注射器10的内部(不包括针50,如下文所述)不含液体润滑剂(即“无润滑剂”)或基本不含液体润滑油(即“基本无润滑剂”)。具体来说,注射器10的筒体20和塞部40不含或基本不含硅酮(例如,硅油或硅脂)。如本文所用,短语“不含润滑剂”和“不含液体润滑剂”是指,无论是有意的还是无意的,筒体20和塞部40不含有任意类型的液体润滑剂(即0皮克(pg)的润滑剂),或者只含任何已知测量设备或方法都无法检测到的痕迹量液体润滑剂。短语“基本不含润滑剂”和“基本不含液体润滑剂”是指筒体20和塞部40含有不明显但可测量量的液体润滑剂,例如约5μg或更少、约4μg或更少、约3μg或更少、约2μg或更少或者约1μg或更少。在一些实施方式中,液体润滑剂存在于筒体20和/或塞部40上,其量为0μg至约5μg、约1μg至约5μg、约2μg至约5μg、约3μg至约5μg或约4μg至约5μg。不存在或基本不存在液体润滑剂可以使用气相色谱(GC)质谱法、电感耦合等离子体(ICP)质谱法和/或在注射用水(WFI)暴露于完全组装的注射器(例如玻璃筒体20和塞部40以及可选地至少一种治疗化合物)之后在WFI中测量的筒体20中的颗粒量等进行测量。在一些实施方式中,当在WFI中进行测量时,对于尺寸大于10pm的颗粒而言,筒体20中颗粒量可以为小于约600个颗粒/毫升,或者对于尺寸大于25pm的颗粒而言,可以为小于60个颗粒/毫升。如上所述,注射器10的针50可以具有润滑剂,以便于插入患者皮肤中,而不会影响注射器10的其余部分能够“不含润滑剂”或“基本不含润滑剂”。
II.注射器塞部
接下来参见图2,塞部40进行更详细地显示,并且包括至少部分被固体润滑剂46覆盖的弹性体44。固体润滑剂46可以设计成提供与筒体20(图1)的低摩擦系数、顺应性、低可提取物和可浸出物(特别是低金属离子可提取物和可浸出物)和/或针对弹性体44中的任何可提取物及可浸出物的良好阻隔性。
塞部40的弹性体44可以包括任意合适的弹性体,例如,丁基橡胶、溴化丁基橡胶、氯化丁基橡胶、硅酮、腈、苯乙烯丁二烯、聚氯丁二烯、乙烯-丙烯-二烯、含氟弹性体、以及它们的组合。在其它实施方式中,塞部40可以由非弹性材料构成,例如塑料(例如聚丙烯、聚碳酸酯和聚乙烯)、热塑性材料和含氟聚合物材料,例如乙烯-(全氟乙烯丙烯)共聚物(EFEP)、聚偏二氟乙烯(PVDF)和全氟烷氧基聚合物树脂(PFA)。
塞部40的固体润滑剂46可以包括低摩擦系数聚合物层,相对于筒体20的玻璃,该低摩擦系数聚合物层可以具有约0.08至约0.8的摩擦系数。固体润滑剂46可以由含氟聚合物构成,包括但不限于:聚四氟乙烯(PTFE)、膨胀型聚四氟乙烯(ePTFE)、致密化ePTFE以及它们的共聚物及组合。用作固体润滑剂46的其他材料包括但不限于:氟化乙烯丙烯(FEP)、乙烯-四氟乙烯(ETFE)、聚氟乙烯、聚偏二氟乙烯(例如,聚(偏二氟乙烯-共-四氟乙烯)(VDF-共-TFE)、聚(偏二氟乙烯-共-三氟乙烯)(VDE-共-TrFE))、全氟丙基乙烯基醚、全氟烷氧基聚合物、聚乙烯(例如,膨胀型超高分子量聚乙烯(eUHMWPE))、聚丙烯、聚对二甲苯(PPX)、聚乳酸(PLA)、聚L-乳酸(PLLA)、聚D-乳酸(PDLA)、以及它们的共聚物及组合,如果需要,其可以膨胀。应理解,如本文所述的固体润滑剂46可以在塞部40和筒体20中的至少一个上、覆盖或至少部分覆盖塞部40和筒体20中的至少一个。
图2的塞部40可以通过由致密化ePTFE薄膜热成型为固体润滑剂46,然后将弹性体44模塑(例如,注塑成型、压缩成型)到热成型的固体润滑剂46上来制造。在另一实施方式中,图2的塞部40可以通过直接成型工艺制造,其中,将固体润滑剂46的片材与用于弹性体44的材料一起放置在经加热的模具中,从而同时硫化弹性体44(如果适用)并形成塞部40。用化学蚀刻、等离子体处理、电晕处理、粗糙化等对固体润滑剂46进行预处理或后处理以改进固体润滑剂46与弹性体44的结合也在本公开的范围内。
接下来参见图3,显示了另一塞部40’,并且用相似的附图标记表示相似的元件。塞部40’包括弹性体44’和固体润滑剂46’(也称为阻隔层)、以及中间多孔层48’。多孔层48’可以包括ePTFE、或其它多孔膨胀型和有利地原纤化含氟聚合物或由其形成。相邻的弹性体44’和/或固体润滑剂46’可以至少部分地渗入中间多孔层48’,并且可以控制渗入程度以实现所需应用需要的强度、韧性、顺应性和稳定性。
图3的塞部40’可以通过如下制造:形成多孔层48’,涂覆、层压、吸收或以其他方式将固体润滑剂46’施加到多孔层48’上和/或施加到多孔层48’中,以产生多层或复合薄膜,然后将弹性体44’模塑(例如,注塑成型、压缩成型)到薄膜上,使得弹性体44’至少部分地渗透多孔层48’的孔。用化学蚀刻、等离子体处理、电晕处理、粗糙化等对固体润滑剂46’和/或多孔层48’进行预处理或后处理以改进固体润滑剂46’与弹性体44’的结合也在本公开的范围内。
III.治疗制剂
治疗制剂60示意性显示在图4中。治疗制剂60具有“脂肪酶活性”,意味着治疗制剂60含有一种或多种能够将脂肪酸酯水解为游离脂肪酸的脂肪酶。脂肪酶活性可以通过脂肪酸滴定或其他合适的技术来测量。一种合适的脂肪酶活性试验包括:使4-甲基伞形基油酸酯(4-methylumbelliferyl oleate)(4MuO)脂肪酶底物水解以产生荧光4-甲基伞形酮(4Mu)产物,并通过荧光发射来检测4Mu产物(Jahn等人,“测量脂解活性以支持管理脂肪酶介导的聚山梨醇酯降解的工艺改进”(Measuring Lipolytic Activity to SupportProcess Improvements to Manage Lipase-Mediated Polysorbate Degradation),PharmRes.2020;37(6):118)。其他合适的脂肪酶活性试验包括:用罗丹明B络合并检测所释放的脂肪酸、或使脂肪酶底物4-硝基苯基棕榈酸酯或4-硝基苯基丁酸酯反应并检测释出的显色反应产物4-硝基苯酚(4Np)。
图4的治疗制剂60包括一种或多种活性药理学试剂62,更具体地说,活性生物药物试剂(biopharmaceuticals agent)。活性剂62可用于处理炎症性疾病,包括但不限于:类风湿性关节炎(RA)、银屑病、炎性肠病(IBD)和眼部炎性疾病。活性剂62包括但不限于:蛋白质、抗体、细胞因子、生长因子、凝血因子、蛋白酶、激酶、磷酸酶、疫苗、肽、小干扰RNA(siRNA)、小干扰DNA(siDNA)、信使RNA(mRNA)、适体和/或它们的组合。活性剂62可以至少约1mg/ml的浓度存在于治疗制剂60中,例如浓度为约1mg/ml至约200mg/ml、约10mg/ml至约200mg/ml、约20mg/ml至约200mg/ml、约40mg/ml至约200mg/ml、约60mg/ml至约200mg/ml、约80mg/ml至约200mg/ml、约100mg/ml至约200mg/ml、约120mg/ml至约200mg/ml和/或约150mg/ml至约200mg/ml。具体活性剂62见述于下文部分IV。
图4的治疗制剂60还包括能够在注射期间将活性剂62递送到患者的载剂(vehicle)64(例如,溶剂、稀释剂)。合适的溶剂包括:例如,水、乙酸、丙二醇、乙二醇、聚乙二醇、苯甲酸苄酯和它们的组合。
治疗制剂60还可以包括一种或多种赋形剂。赋形剂可以构造为保护、支持或增强可加工性、稳定性、无菌性、生物利用度、产物识别、有效性、递送和/或储存完整性。
一种赋形剂是缓冲剂66,包括例如磷酸盐(例如,磷酸盐缓冲盐水(PBS))、乙酸盐、组氨酸和Tris(三羟甲基氨基甲烷)。缓冲剂66的pH可以为约4.0至约9.5、约4.5至约9.0、约5.0至约8.5、约5.5至约8.0、约5.5至约7.5、约5.5至约7.0和/或约5.5至约6.5。
另一种赋形剂是稳定剂68,包括:例如,糖(如蔗糖、海藻糖、麦芽糖和乳糖)、多元醇(例如甘露醇、山梨醇和甘油)和氨基酸盐(例如组氨酸、精氨酸和甘氨酸)。治疗制剂60中糖的浓度可以为0重量%至约15重量%、约0.1重量%至约15重量%、约1重量%至约15重量%、约1.5重量%至约10重量%、约2重量%至约10重量%、约3重量%至约10重量%和/或约5重量%至约10重量%。治疗制剂60中多元醇的浓度可以为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。治疗制剂60中氨基酸盐的浓度可以为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
图4的治疗制剂60不含表面活性剂(即“无表面活性剂”)或基本不含表面活性剂(即,“基本无表面活性剂”)。具体来说,治疗制剂60不含或基本不含聚山梨醇酯表面活性剂,包括:聚山梨醇酯20、聚山梨醇酯40、聚山梨醇酯60、聚山梨醇酯80和/或它们的组合。该表面活性剂通常用于降低表面张力和/或界面张力,并且防止治疗物质吸附到表面和/或界面上。如本文所用,短语“无表面活性剂”和“不含表面活性剂”是指,无论是有意的还是无意的,治疗制剂60不含有任意类型的表面活性剂(即0重量%的表面活性剂),或者只含任何已知测量设备或方法都无法检测到的痕迹量表面活性剂。短语“基本无表面活性剂”和“基本不含表面活性剂”是指治疗制剂60含有少量但可测量量的表面活性剂,例如约0.1重量%或更低、约0.075重量%或更低、约0.05重量%或更低、约0.025重量%或更低、约0.01重量%或更低、约0.005重量%或更低、或约0.001重量%或更低。在某些实施方式中,治疗制剂60中表面活性剂的浓度可以为0重量%至约0.1重量%、0重量%至约0.075重量%、0重量%至约0.05重量%、0重量%至约0.025重量%、0重量%至约0.01重量%、0重量%至约0.005重量%和/或0重量%至约0.001重量%。
图4的治疗制剂60也不含脂肪酸颗粒(即“无脂肪酸颗粒”)或基本不含脂肪酸颗粒(即,“基本无脂肪酸颗粒”)。如本文所用,短语“无脂肪酸颗粒”和“不含脂肪酸颗粒”是指,无论是有意的还是无意的,治疗制剂60不含有任意类型的脂肪酸颗粒(即0个颗粒),或者只含任何已知测量设备或方法都无法检测到的过小的脂肪酸颗粒。术语“基本无脂肪酸颗粒”和“基本不含脂肪酸颗粒”是指治疗制剂60包含不明显但可测量数量的脂肪酸颗粒。对于尺寸大于25微米的脂肪酸颗粒,治疗制剂60可以包含约600个颗粒或更少,约300个颗粒或更少,约100个颗粒或更少,约20个颗粒或更少,约5个颗粒或更少,约2个颗粒或更少,或约1个颗粒。对于尺寸大于10微米的脂肪酸颗粒,治疗制剂60可以包含约6000个颗粒或更少,约3000个颗粒或更少,约1000个颗粒或更少,约200个颗粒或更少,约50个颗粒或更少,约20个颗粒或更少,或约10个颗粒或更少。眼部应用可能需要较低的脂肪酸颗粒数,而较高的脂肪酸颗粒数可适用于其他应用。这些脂肪酸颗粒数可以通过在灯箱中视觉检查来获得,例如Seidenader V90-T、微流成像(MFI)或其他合适的技术。
治疗制剂60可以随着时间推移而保持不含脂肪酸颗粒或基本不含脂肪酸颗粒。例如,当在2℃至8℃下储存约1年、约2年、约3年或更长时间时,治疗制剂60可以保持不含脂肪酸颗粒或基本不含脂肪酸颗粒。
治疗制剂60还可以在经受较高温度或加速老化条件时保持不含脂肪酸颗粒或基本不含脂肪酸颗粒。例如,治疗制剂60还可以在加热至40℃2个月或更久、然后冷却至5℃至少24小时时保持不含脂肪酸颗粒或基本不含脂肪酸颗粒。
IV.活性剂
如上文所述,治疗制剂60包括一种或多种活性剂62,所述活性剂可以包括生物分子,如,蛋白质、抗体、细胞因子、生长因子、凝血因子、蛋白酶、激酶、磷酸酶、疫苗、肽、小干扰RNA(siRNA)、小干扰DNA(siDNA)、信使RNA(mRNA)、适体和/或它们的任意组合。例如,治疗制剂60可以包括以下活性剂62中的一种或多种:
对蛋白质目标或基因所制定的抗体、反义、RNA干扰或基因治疗的示例:毛细血管扩张性共济失调突变、肿瘤蛋白p53、检查点激酶2、乳腺癌易感性蛋白、双链断裂修复蛋白、DNA修复蛋白RAD50、Nibrin、p53结合蛋白、DNA损伤检查点蛋白介质、H2A组蛋白家族成员X、微脑磷脂(Microcephalin)、C-末端结合蛋白1、染色体蛋白质1A的结构维持;酯酶;磷酸酶;离子通道的示例包括但不限于:配体门控离子通道、电压门控离子通道;生长因子的示例包括但不限于:神经生长因子(NGF)、血管内皮生长因子(VEGF)、血小板衍生生长因子(PDGF)、C-fos诱导生长因子(FIGF)、血小板活化因子(PAF)、转化生长因子β(TGF-β),b,一种形态发生蛋白(BMP)、激活素、抑制素、成纤维细胞生长因子(FGF)、粒细胞集落刺激因子(G-CSF)、粒细胞-巨噬细胞集落刺激因子(GM-CSF)、胶质细胞系衍生神经营养因子(GDNF)、生长分化因子-9(GDF9)、表皮生长因子(EGF)、转化生长因子-α(TGF-α)、生长因子(KGF)、迁移刺激因子(MSF)、肝细胞生长因子样蛋白(FIGFLP)、肝细胞生长因子(FIGF)、肝癌衍生生长因子(FIDGF)、胰岛素样生长因子;G蛋白连接受体(GPCR)的示例包括但不限于:腺苷受体家族、肾上腺素受体家族、血管紧张素II受体、爱佩琳(Apelin)受体、血管加压素受体家族、脑特异性血管生成抑制剂家族、缓激肽受体家族、铃蟾肽受体家族、补体成分3a受体1、补体成分5a受体1、降钙素受体家族、降钙素受体样家族、钙敏感受体、胆囊收缩素A受体(CCK1)、胆囊收缩素B受体(CCK2)、趋化因子(CC基序)受体家族、鞘氨醇1-磷酸受体家族、琥珀酸受体、胆碱能受体家族。趋化因子样受体家族、大麻素受体家族、促肾上腺皮质激素释放激素受体家族、前列腺素D2受体、趋化因子C-X3-C受体家族、趋化因子(CXC基序)受体家族、伯基特淋巴瘤受体、趋化因子(CXC基序)受体家族、半胱氨酰白三烯受体2(CYSLT2)、趋化因子受体(FY)、多巴胺受体家族、G蛋白连接受体183(GPR183)、溶血磷脂酸受体家族、内皮素受体家族、凝血因子II(凝血酶)受体家族、游离脂肪酸受体家族、甲酰肽受体家族、卵泡刺激素受体(FSFIR)、γ-氨基丁酸(GABA)B受体、甘丙肽受体家族、胰高血糖素受体、生长激素释放激素受体(GFHRFH)、胃生长激素促分泌素(Ghrelin)受体(ghrelin)、生长激素促分泌素受体1b(GHSR1b)、胃抑制多肽受体(GIP)、胰高血糖素样肽受体家族、促性腺激素释放激素受体(GnRH)、焦谷氨酰化(pyroglutamylated)RF酰胺肽受体(QRFPR)、G蛋白连接胆汁酸受体1(GPBA)、羟基羧酸受体家族、溶血磷脂酸受体4(LPA4)溶血磷脂酸受体5(GPR92)、G蛋白连接受体79假基因(GPR79)、羟基羧酸受体1(FHCA1)、G蛋白连接受体(C5L2、FFA4、FFA4、FFA4、GPER、GPR1、GPR101、GPR107、GPR119、GPR12、GPR123、GPR132、GPR135、GPR139、GPR141、GPR142、GPR143、GPR146、GPR148、GPR149、GPR15、GPR150、GPR151、GPR152、GPR157、GPR161、GPR162、GPR17、GPR171、GPR173、GPR176、GPR18、GPR182、GPR20、GPR22、GPR25、GPR26、GPR27、GPR3、GPR31、GPR32、GPR35、GPR37L1、GPR39、GPR4、GPR45、GPR50、GPR52、GPR55、GPR6、GPR61、GPR65、GPR75、GPR78、GPR83、GPR84、GPR85、GPR88、GPR97、TM7SF1)、代谢型谷氨酸受体家族、胃泌素释放肽受体(BB2)、食欲素受体家族、组胺受体家族、5-羟色胺受体家族、KISS1衍生肽受体(亲吻促动素(kisspeptin))、富含亮氨酸的rep含有G蛋白连接受体家族、水平促性腺激素受体(LFH)、白三烯B4受体(BLT1)、腺苷酸环化酶激活多肽1受体1(mPAC1)、胃动素受体、黑皮质素受体家族、黑色素浓缩激素受体1(MCH1)、神经肽Y1受体(Y1)、神经肽Y2受体(NPY2R)、阿片受体家族、催产素受体(OT)、P2Y嘌呤受体12(mP2Y12)、P2Y嘌呤受体6(P2Y6)、胰多肽受体家族、血小板活化因子受体家族、前列腺素E受体家族、前列腺素类IP1受体(IP1)、MAS相关GPR、成员家族、视紫红质(Rhodopsin)、松弛素家族肽受体家族、生长抑素受体家族、速激肽受体家族、褪黑素受体家族、尾加压素受体家族、血管活性肠肽受体1(mVPAC1)、神经调节肽B受体(BB1)、神经调节肽U受体1(NMU1)、神经肽B/W受体家族、神经肽FF受体1(NPFF1)、神经肽S受体1(NPS受体)、神经肽Y受体家族、神经降压素受体1(NTS1)、视蛋白5(OPN5)、阿片类受体样受体(NOP)、氧代花青素(OXE)受体1(OXE)、氧代戊二酸(α-酮戊二酸)受体1(OXGR1)、嘌呤能受体家族、嘧仪能受体家族、催乳素释放激素受体(PRRP)、前动力蛋白受体家族、血小板活化受体(PAF)、前列腺素F受体家族、前列腺素12(前列环素)受体家族、甲状旁腺激素受体家族、毒蕈碱4(rM4)、前列腺素DP2受体(rGPR44)、前动力蛋白受体家族、松弛素家族肽受体家族、分泌素受体(促胰液素)、平滑(Smoothened)、卷曲类受体(Smoothened)、微量胺相关受体家族、速激肽家族、血栓素A2受体(TP)、促甲状腺激素释放激素受体(TRH1)、甲状腺刺激素受体(TSFI);蛋白激酶的示例包括但不限于:AP2相关激酶、智人ABL原癌基因1-非受体酪氨酸蛋白激酶家族、c-abl致癌基因1受体酪氨酸激酶家族、v-abl阿贝尔森鼠白血病病毒致癌基因同源物2、激活素A受体家族、伴侣蛋白-bd复合物同源物(S.pombe)的ABC1活性(ADCK3)、含aarF结构域激酶4(ADCK4)、v-akt鼠胸腺瘤病毒致癌基因同源家族、间变性淋巴瘤受体酪氨酸激酶家族、蛋白激酶A家族、蛋白激酶B家族、含有锚蛋白重复和激酶结构域的1(ANKK1)、NUAK家族-SNF1样激酶、丝裂原活化蛋白激酶家族极光激酶(aurora kinase)A(AURKA)、极光激酶B(AURKB)、极光激酶C(AURKC)、AXL受体酪氨酸激酶(AXL)、BMP2诱导型激酶(BIKE)、B淋巴酪氨酸激酶(BLK)、骨形态发生蛋白受体家族、BMX非受体酪氨酸激酶(BMX)、v-raf鼠肉瘤病毒致癌基因同源物B1(BRAF)、蛋白酪氨酸激酶6(BRK)、BR丝氨酸/苏氨酸激酶家族、布鲁顿丙种球蛋白血症酪氨酸激酶(BTK)、钙/钙调蛋白依赖性蛋白激酶家族、细胞周期蛋白依赖性激酶家族、细胞周期蛋白依赖性激酶样家族、CHK1检查点同源物(S.pombe)(CHEK1)、CHK2检查点同源物(S.pombe)(CHEK2)、胰岛素受体、同种型A(INSR)、胰岛素受体、同种型B(INSR)、rho-相互作用丝氨酸/苏氨酸激酶(CIT)、v-kit哈地-朱克曼4猫肉瘤病毒致癌基因同源物(KIT)、CDC样激酶家族-肝细胞生长因子受体(MET)、原癌基因酪氨酸蛋白激酶受体、集落刺激因子家族受体、c-src酪氨酸激酶(CSK)、酪蛋白激酶家族、巨核细胞相关酪氨酸激酶(CTK)、死亡相关蛋白激酶家族、双皮质激酶家族、盘状蛋白结构域受体酪氨酸激酶、营养不良肌强直蛋白-蛋白激酶(DMPK)、双特异性酪氨酸-(Y)-磷酸化调节激酶家族、表皮生长因子受体家族、真核翻译起始因子2-α激酶1(EIF2AK1)、EPH受体家族、肝配蛋白A型受体家族、肝配蛋白B型受体家族、v-erb-b2成红细胞白血病病毒致癌基因同源家族、丝裂原-激活的蛋白激酶家族、内质网到核信号传导1(ERN1)、PTK2蛋白酪氨酸激酶2(FAK)、fer(fps/fes相关)酪氨酸激酶(FER)、猫肉瘤基因(FES)、成纤维细胞生长因子受体家族、加德纳-拉希德猫肉瘤病毒(v-fgr)致癌基因同源物(FGR)、fms相关酪氨酸激酶家族、Fms相关酪氨酸激酶家族、fyn相关激酶(FRK)、与SRC相关的FYN癌基因、细胞周期蛋白G相关激酶(GAK)、真核翻译起始因子2α激酶、生长激素受体、G蛋白连接受体激酶1(GRK1)、G蛋白连接受体激酶家族、糖原合成酶激酶家族、生殖细胞相关的2(单激酶)(FIASPIN)、造血细胞激酶(FICK)、同源域相互作用蛋白激酶家族、有丝分裂原-活化蛋白激酶家族、激素上调Neu相关激酶(FIUNK)、肠细胞(MAK样)激酶(ICK)、胰岛素样生长因子1受体(IGF1 R)、保守的螺旋-环-螺旋无处不在激酶(IKK-α)、B细胞中κ轻链多肽基因增强子抑制剂-激酶β家族、胰岛素受体(I NSR)、胰岛素受体相关受体(INS RR)、白细胞介素-1受体相关激酶家族、IL2诱导型T细胞激酶(ITK)、Janus激酶家族、激酶插入域受体、v-kit哈地-朱克曼4猫肉瘤病毒致癌基因同源物、淋巴细胞特异性蛋白酪氨酸激酶(LCK)、LIM结构域激酶家族、丝氨酸/苏氨酸激酶家族富含亮氨酸的重复激酶家族、v-yes-1山口肉瘤病毒相关致癌基因同源物(LYN)、雄性生殖细胞相关激酶(MAK)、MAP/微管亲和调节激酶家族、微管相关丝氨酸/苏氨酸激酶家族、母体胚胎亮氨酸拉链激酶、c-mer原型-癌基因酪氨酸激酶(MERTK)、符合原癌基因(肝细胞生长因子受体)、MAP激酶相互作用丝氨酸/苏氨酸激酶家族、肌球蛋白轻链激酶家族、混合谱系激酶结构域蛋白同种型、CDC42结合蛋白激酶家族、丝氨酸/苏氨酸激酶家族、巨噬细胞刺激1受体(c-met相关酪氨酸激酶)(MST1R)、雷帕霉素(丝氨酸/苏氨酸激酶)(MTOR)、肌肉-骨骼-受体酪氨酸激酶(MUSK)、肌球蛋白轻链的机制靶点激酶家族、NIMA(从未在有丝分裂基因a中)相关激酶家族、丝氨酸/苏氨酸蛋白激酶NIM1(NIM1)、nemo样激酶(NLK)、氧化应激反应1(OSR1)、p21蛋白(Cdc42/Rac)激活的激酶家族、含有PAS结构域的丝氨酸/苏氨酸激酶、血小板衍生生长因子受体家族、3-磷酸肌醇依赖性蛋白激酶-1(PDPK1)、钙依赖性蛋白激酶1、磷酸化酶激酶γ家族、磷脂酰肌醇4,5-二磷酸3-激酶、磷酸肌醇-3-激酶家族、磷脂酰肌醇4-激酶家族、磷酸肌醇激酶、含有FYVE指、Pim-1致癌基因(PIM1)、pim-2致癌基因(PIM2)、pim-3致癌基因(PIM3)、磷脂酰肌醇-4-磷酸5-激酶家族、磷脂酰肌醇-5-磷酸4-激酶家族蛋白激酶、膜相关酪氨酸/苏氨酸1(PKMYT1)、蛋白激酶N家族、polo样激酶家族、蛋白激酶C家族、蛋白激酶D家族、cGMP依赖性蛋白激酶家族、真核翻译起始因子2-α激酶2(PRKR)、X连锁蛋白激酶(PRKX)、催乳素受体(PRLR)、PRP4前mRNA加工因子4同源物B(酵母)(PRP4)、PTK2B蛋白酪氨酸激酶2β(PTK2B)、SIK家族激酶3(QSK)、v-raf-1鼠白血病病毒致癌基因同源物1(RAF1)、神经营养酪氨酸激酶受体类型家族、受体(TNFRSF)-相互作用的丝氨酸-苏氨酸激酶家族、双丝氨酸/苏氨酸和酪氨酸蛋白激酶(RIPK5)、Rho-相关的、含有卷曲螺旋的蛋白激酶家族、c-ros癌基因1、受体t酪氨酸激酶(ROS1)、核糖体蛋白S6激酶家族、SFI3结合域激酶1(SBK1)、血清/糖皮质激素调节激酶家族、推定的非特征性丝氨酸/苏氨酸蛋白激酶(Sugen激酶110)(SgK110)、盐诱导型激酶家族、SNF相关激酶(SNRK)、src相关激酶、SFRS蛋白激酶家族、脾酪氨酸激酶(SYK)、TAO激酶家族、TANK结合激酶1(TBK1)、tec蛋白酪氨酸激酶(TEC)、睾丸特异性激酶1(TESK1)、转化生长因子、β受体家族、酪氨酸激酶与免疫球蛋白样和EGF样结构域1(TIE1)、TEK酪氨酸激酶、内皮细胞(TIE2)、血管生成素-1受体(Tie2)、凌乱类似激酶家族、TRAF2和NCK相互作用激酶(TNIK)、非受体酪氨酸激酶家族、TNNI3相互作用激酶(TNNI3K)、瞬时受体电位阳离子通道、睾丸特异性丝氨酸激酶家族、TTK蛋白激酶(TTK)、TXK酪氨酸激酶(TXK)、酪氨酸激酶2(TYK2)、TYR03蛋白酪氨酸激酶(TYR03)、unc-51样激酶家族、磷脂酰肌醇3-激酶、牛痘相关激酶2(VRK2)、WEE1同系物家族、WNK赖氨酸缺乏蛋白激酶家族、v-yes-1山口肉瘤病毒致癌基因同源物1(YES)、含有无菌α基序和亮氨酸拉链的激酶AZK(ZAK)、ζ-链(TCR)相关蛋白激酶70kDa(ZAP70);核激素受体的示例包括但不限于:雄激素受体(AR)、雌激素相关受体α(ESRRA)、雌激素受体1(ESR1)、核受体亚家族1-H组-成员4(NR1 H4)、核受体亚家族3-C组-成员1(糖皮质激素受体)(NR3C1)、核受体亚家族1-H组-成员3(肝X受体α)(NR1H3)、核受体亚家族1-H组-成员2(肝X受体β)(NR1H2)、核受体亚家族1-H组-成员2(肝X受体β)(NR1H2)、核受体亚家族3-C组-成员2(矿物质皮质激素受体)(NR3C2)、过氧化物酶体增殖物激活受体α(PPARA)、过氧化物酶体增殖物激活受体γ(PPARG)、过氧化物酶体增殖物激活受体δ(PPARD)、孕激素受体α(PGR)、孕激素受体β(PGR)、维甲酸受体-α(RARA)、维甲酸受体-β(RARB)、维甲酸X受体-α(RXRA)、类视黄醇X受体-γ(RXRG)、甲状腺激素受体-α(THRA)、甲状腺激素受体-β(THRB)、维甲酸相关孤儿受体、肝X受体、法呢醇X受体、维生素D受体、孕烷X受体、组成型雄甾烷受体、肝细胞核因子4、雌激素受体、雌激素相关受体、糖皮质激素受体、神经生长因子诱导的B、生殖细胞核因子;表观遗传目标(Epigenetic target)的示例包括但不限于:ATPase家族AAA结构域蛋白2(ATAD2A)、ATP酶家族-含有2B结构域的AAA(ATAD2B)、含有ATP酶家族AAA结构域-2B(ATAD2B)、与锌指结构域相邻的布罗莫结构域-1A(BAZ1A)、与锌指结构域相邻的布罗莫结构域-1B(BAZ1B)、与锌指结构域相邻的布罗莫结构域-2A(BAZ2A)、与锌指结构域相邻的布罗莫结构域-2A(BAZ2A)、与锌指结构域相邻的布罗莫结构域-2B(BAZ2B)、含布罗莫结构域的蛋白1(BRD1)、含布罗莫结构域的蛋白2-第1溴布罗莫结构域(BRD2)、含布罗莫结构域的蛋白2-第1和第2布罗莫结构域(BRD2)、含布罗莫结构域的蛋白2同种型1-布罗莫结构域2(BRD2(2))、含布罗莫结构域蛋白3-布罗莫结构域1(BRD3(1))、含布罗莫结构域蛋白3-第1布罗莫结构域(BRD3)、含布罗莫结构域的蛋白3-第1和第2布罗莫结构域(BRD3)、含布罗莫结构域的蛋白3-布罗莫结构域2(BRD3(2))、含布罗莫结构域的蛋白质4-第1布罗莫结构域(BRD4)、含布罗莫结构域的蛋白4同种型长-布罗莫结构域1和2(BRD4(1-2))、含布罗莫结构域蛋白4同种型长-布罗莫结构域2(BRD4(2))、含布罗莫结构域的蛋白4同种型短(BRD4(全长-短-同种型(full-length-short-iso.)))、含布罗莫结构域的蛋白7(BRD7)、含布罗莫结构域的8-布罗莫结构域1(BRD8(1))、含布罗莫结构域的8-布罗莫结构域2(BRD8(2))、含布罗莫结构域的蛋白9同种型1(BRD9)、含有布罗莫结构域的睾丸特异性第1布罗莫结构域(BRDT)、含有布罗莫结构域的睾丸特异性第1和第2布罗莫结构域(BRDT)、布罗莫结构域睾丸特异性蛋白同种型b-布罗莫结构域2(BRDT(2))、含布罗莫结构域和PHD指-1(BRPF1)、含布罗莫结构域和PHD指-3(BRPF3)、含布罗莫结构域和PHD指-3(BRPF3)、含布罗莫结构域和WD重复-3-第2布罗莫结构域(BRWD3(2))、猫眼综合征关键区域蛋白2(CECR2)、CREB结合蛋白(CREBBP)、E1A结合蛋白p300(EP300)、EP300(EP300)、核小体重塑因子亚基BPTF同种型1(FALZ)、核小体重塑因子亚基BPT(FALZ)、常染色质组蛋白-赖氨酸N-甲基转移酶2(EHMT2)、组蛋白乙酰转移酶-KAT2A(GCN5L2)、常染色质组蛋白-赖氨酸N-甲基转移酶1(EHMT1)、组蛋白-赖氨酸N-甲基转移酶MLL(MLL)、多溴(Polybromo)1-第1布罗莫结构域(PB1(1))、多溴1-第2布罗莫结构域(PB1(2))、多溴1-布罗莫结构域2(PBRM1(2))、多溴1-布罗莫结构域5(PBRM1(5))、组蛋白乙酰转移酶KAT2B(PCAF)、PH-相互作用蛋白-第1布罗莫结构域(PHIP(1))、PH-相互作用蛋白-第2布罗莫结构域(PHIP(2))、蛋白激酶C结合蛋白质1(PRKCBP1)、蛋白质精氨酸N-甲基转移酶3(PRMT3)、SWI/SNF相关-基质相关-染色质的肌动蛋白依赖性调节因子-亚家族a-成员2(SMARCA2)、SWI/SNF相关-基质相关-染色质的肌动蛋白依赖性调节因子-亚家族a-成员4(SMARCA4)、核体蛋白-SP110(SP110)、核体蛋白-SP140(SP140)、转录起始因子TFIID亚基1(TAF1(1-2))、TAF1 RNA聚合酶II-TATA盒结合蛋白(TBP)相关因子-250kDa-布罗莫结构域2(TAF1(2))、转录起始因子TFIID亚基1样-第1布罗莫结构域(TAF1 L(1))、转录起始因子TFIID亚基1样-第2布罗莫结构域(TAF1 L(2))、含有三联基序的24(TRIM24(Bromo.))、含有三联基序的24(TRIM24(PFID-Bromo.))、E3泛素-蛋白质连接酶TRIM33(TRIM33)、含有三联基序的33(TRIM33(PFID-Bromo))、WD重复9-第1布罗莫结构域(WDR9(1))、WD重复9-第2布罗莫结构域(WDR9(2));膜转运蛋白包括但不限于:ATP结合盒(ABC)超家族,溶质载体(SLC)超家族,多药耐药蛋白1(P-糖蛋白),有机阴离子转运蛋白1和蛋白质如EAAT3、EAAC1、EAAT1、GLUT1、GLUT2、GLUT9、GLUT10、rBAT、AE1、NBC1、KNBC、CHED2、BTR1、NABC1、CDPD、SGLT1、SGLT2、NIS、CHT1、NET、DAT、GLYT2、CRTR、BOAT1、SIT1、XT3、y+LAT1、BAT1、NHERF1、NHE6、ASBT、DMT1、DCT1、NRAMP2、NKCC2、NCC、KCC3、NACT、MCT1、MCT8、MCT12、SLD、VGLUT3、THTR1、THTR2、PIT2、GLVR2、OCTN2、URAT1、NCKX1、NCKX5、CIC、PiC、ANT1、ORNT1、AGC1、ARALAR、希特林(Citrin)、STLN2、aralar2、TPC、MUP1、MCPHA、CACT、GC1、PHC、DTD、CLD、DRA、PDS、普雷斯廷(Prestin)、TAT1、FATP4、ENT3、ZnT2、ZnT10、AT1、NPT2A、NPT2B、HHRH、CST、CDG2F、UGAT、UGTL、UGALT、UGT1、UGT2、FUCT1、CDG2C、NST、PAT2、G6PT1、SPX4、ZIP4、LIV4、ZIP13、LZT-Hs9、FPN1、MTP1、IREG1、RHAG、AIM1、PCFT、FLVCR1、FLVCR2、RFT1、RFT2、RFT3、OATP1 B1、OATP1B3、OATP2A1;结构蛋白包括但不限于:微管蛋白、热休克蛋白、微管稳定蛋白、癌蛋白18、史特夫敏(stathmin)、驱动蛋白-8和驱动蛋白-14家族、Kip3、Kif18A;蛋白酶包括但不限于:ADAM(解整合素和金属蛋白酶)家族;信号转导中的其他分子目标包括但不限于:细胞分裂周期25同源物A(CDC25A)、叉头框03(forkhead box 03)、B细胞抑制剂中κ轻多肽基因增强子的核因子、α(NFKBIA)、核因子(红细胞衍生2)样2(NFE2L2)、利尿钠肽受体A(NPR1)、肿瘤坏死因子受体超家族、成员11a(TNFRSF11A)、v-rel网状内皮组织病毒致癌基因同源物A(禽)(RELA)、甾醇调节元件结合转录因子2(SREBF2)、CREB调节的转录共激活因子1(CRTC1)、CREB调节的转录共激活因子2(CRTC2)、X-盒结合蛋白1(XBP1)、连环蛋白(钙粘蛋白相关蛋白)、β1(CTNNB1),以及它们的组合。
已知的生物制剂的示例包括但不限于:阿布辛格斯(Abbosynagis)、阿贝格(Abegrin)、安挺乐(Actemra)、AFP-Cide、安托瓦(Antova)、阿尔泽拉(Arzerra)、奥瑞西斯(Aurexis)、阿瓦斯丁(Avastin)、本利斯塔(Benlysta)、百克沙(Bexxar)、布隆特斯(Blontress)、博萨特亚(Bosatria)、坎帕斯(Campath)、CEA-Cide、CEA-Scan、赛妥珠单抗(Cimzia)、斯朗达(Cyramza)、依可拓拔(Ektomab)、爱必妥(Erbitux)、福比例新特(FibriScint)、格子佤(Gazyva)、赫塞汀(Flerceptin)、hPAM4-Cide、FlumaSPECT、HuMax-CD4、HuMax-EGFr、修美乐(Humira)、HuZAF、海步瑞西科(Hybri-ceaker)、Ilaris、因迪马斯(Indimacis)-125、卡达西拉(Kadcyla)、勒门特达(Lemtrada)、勒可阿瑞斯(LeukArrest)、勒克斯阚(LeukoScan)、雷珠单抗(Lucentis)、林福木恩(Lymphomun)、林福斯堪(LymphoScan)、林福斯特(LymphoStat)-B、迈巴斯拉(MabThera)、米克葛巴(Mycograb)、Mylotarg、密斯金(Myoscint)、纽特斯派克(NeutroSpec)、纽曼士接(Numax)、诺维恩(Nuvion)、奥密塔克(Omnitarg)、欧珀地蔚(Opdivo)、欧斯科隆(Orthoclone)OKT3、欧瓦瑞克(OvaRex)、潘诺瑞克(Panorex)、罗利亚(Prolia)、帕洛斯塔斯科(Prostascint)、瑞体肤(Raptiva)、瑞米凯德(Remicade)、瑞默瓦波(Removab)、仁卡勒斯(Rencarex)、芮泊罗(ReoPro)、锐宿母(Rexomun)、瑞图宣(Rituxan)、若安挺乐(RoActemra)、斯克提木(Scintimun)、欣普尼(Simponi)、丝穆勒科特(Simulect)、索利斯(Soliris)、喜达诺(Stelara)、辛格斯(Synagis)、塔科特斯(Tactress)、瑟拉克米(Theracim)、瑟拉金(Theragyn)、撕拉洛克(Theraloc)、提萨布里(Tysabri)、维克替比(Vectibix)、魏璐马(Verluma)、索雷尔(Xolair)、易唯一(Yervoy)、赛尼哌(Zenapax)、和泽娃灵(Zevalin),或它们的组合。
已知的单克隆抗体的示例包括但不限于:3F8、8H9、阿巴莫单抗、阿昔单抗、阿比特珠单抗(Abituzumab)、阿布鲁单抗(Abrilumab)、阿克托单抗(Actoxumab)、阿达木单抗、阿德木单抗、阿德堪单抗(Aducanumab)、阿非西维单抗(Afasevikumab)、阿非莫单抗、阿夫土珠单抗、培阿珠单抗、ALD518、ALD403、阿仑珠单抗、阿利库单抗(Alirocumab)、阿妥莫单抗喷替酸盐、阿玛土西单抗(Amatuximab)、AMG 334、马安那莫单抗(Anatumomab mafenatox)、安妥单抗(Anetumab ravtansine)、安弗露单抗(Anifrolumab)、安鲁珠单抗、阿泊珠单抗、阿西莫单抗、阿斯万卡单抗(Ascrinvacumab)、阿塞珠单抗、阿特立珠单抗(Atezolizumab)、阿替奴单抗(Atinumab)、阿替珠单抗、阿托木单抗、阿维鲁单抗(Avelumab)、巴匹珠单抗、巴利昔单抗、巴维妥昔单抗(Bavituximab)、贝妥莫单抗(Bectumomab)、贝戈罗单抗(Begelomab)、贝利木单抗、苯那利珠单抗(Benralizumab)、柏替木单抗(Bertilimumab)、贝索单抗(Besilesomab)、贝伐单抗、贝兹托单抗(Bezlotoxumab)、比西单抗(Biciromab)、拜马单抗、拜莫克珠单抗(Bimekizumab)、比伐妥珠单抗(Bivatuzumab mertansine)、比勒斯单抗(Bleselumab)、博纳吐单抗、布隆土单抗、布罗锁珠单抗(Blosozumab)、博库斯珠单抗(Bococizumab)、布拉兹库单抗(Brazikumab)、布妥昔单抗、布拉吉单抗、布罗芦单抗、布罗鲁珠单抗(Brolucizumab)、波替妥珠单抗(Brontictuzumab)、布洛苏单抗(Burosumab)、卡比萊珠单抗(Cabiralizumab)、卡纳努单抗(Canakinumab)、莫坎妥珠单抗(Cantuzumabmertansine)、莫坎妥珠单抗罗夫坦辛(Cantuzumab ravtansine)、卡帕齐珠单抗(Caplacizumab)、卡波米单抗喷地肽(capromab pendetide)、卡路单抗(Carlumab)、卡罗图西单抗(Carotuximab)、卡妥索单抗、cBR96-多柔比星免疫连接物、卡德丽珠单抗(Cedelizumab)、克果图珠单抗(Cergutuzumab amunaleukin)、赛妥珠单抗、西妥昔单抗、泊西他妥珠单抗(Citatuzumab bogatox)、西妥木单抗、克拉杂单抗(Clazakizumab)、克乐诺西单抗(Clenoliximab)、替坦司可利妥珠单抗、克锥特珠单抗(Codrituzumab)、克托西单抗(Coltuximab ravtansine)、可那木单抗(Conatumumab)、可丝珠单抗(Concizumab)、CR6261、克仁珠单抗(Crenezumab)、克洛特单抗(Crotedumab)、达西珠单抗、达利珠单抗、达鲁妥珠单抗(Dalotuzumab)、达皮罗珠单抗(Dapirolizumab pegol)、达托木单抗、德克特单抗(Dectrekumab)、德姆茨单抗(Demcizumab)、地宁图珠单抗(Denintuzumab mafodotin)、地诺单抗、地帕西珠单抗(Depatuxizumabmafodotin)、地罗西单抗(Derlotuximabbiotin)、地莫单抗(Detumomab)、定妥昔单抗(Dinutuximab)、地达夫单抗(Diridavumab)、冬麻罗单抗(Domagrozumab)、阿托度单抗(Dorlimomab aritox)、多兹图单抗(Drozitumab)、度立凸单抗(Duligotumab)、度丕卢单抗(Dupilumab)、度夫芦单抗(Durvalumab)、度司荼单抗(Dusigitumab)、伊克麦昔单抗(Ecromeximab)、依库珠单抗、埃巴单抗(Edobacomab)、依决洛单抗、依法珠单抗、依芬古单抗、依德卢单抗(Eldelumab)、依格珠单抗(Elgemtumab)、依罗珠单抗(Elotuzumab)、依西莫单抗(Elsilimomab)、依麻特珠单抗(Emactuzumab)、依米特珠单抗(Emibetuzumab)、依米西珠单抗(Emicizumab)、恩凡珠单抗(Enavatuzumab)、恩夫图单抗(Enfortumab vedotin)、PEG化恩莫单抗(Enlimomabpegol)、恩波妥珠单抗(Enoblituzumab)、恩诺珠单抗(Enokizumab)、恩提库单抗(Enoticumab)、恩昔妥昔单抗(Ensituximab)、恩皮莫单抗(Epitumomab cituxetan)、依帕珠单抗、厄恩诺单抗(Erenumab)、厄利珠单抗(Erlizumab)、艾土马单抗(Ertumaxomab)、伊塔木单抗(Etaracizumab)、伊特利珠单抗(Etrolizumab)、依凡纳单抗(Evinacumab)、依罗库单抗(Evolocumab)、艾韦单抗(Exbivirumab)、法索单抗(Fanolesomab)、法拉莫单抗(Faralimomab)、伐尔妥珠单抗(Farletuzumab)、法斯单抗、FBTA05、泛维珠单抗(Felvizumab)、菲兹诺单抗(Fezakinumab)、菲巴珠单抗(Fibatuzumab)、菲拉特珠单抗(Ficlatuzumab)、弗吉妥姆单抗(Figitumumab)、弗瑞单抗(Firivumab)、弗兰单抗(Flanvotumab)、弗乐提单抗(Fletikumab)、冯特利珠单抗(Fontolizumab)、芙拉单抗(Foralumab)、夫瑞单抗(Foravirumab)、弗瑞索单抗(Fresolimumab)、弗兰单抗(Fulranumab)、富图希单抗(Futuximab)、加坎珠单抗(Galcanezumab)、加利昔单抗(Galiximab)、加尼单抗(Ganitumab)、甘腾纳单抗(Gantenerumab)、加维莫单抗(Gavilimomab)、吉妥珠单抗奥佐米星、格弗珠单抗(Gevokizumab)、吉瑞妥昔单抗(Girentuximab)、戈姆妥姆单抗(Glembatumumab vedotin)、戈利木单抗、戈米利单抗、固塞单抗(Guselkumab)、艾巴利珠单抗、替伊莫单抗(Ibritumomab tiuxetan)、伊库克单抗(Icrucumab)、伊达瑞珠单抗(Idarucizumab)、伊戈伏单抗(Igovomab)、IMA-638、IMAB362、尹马鲁单抗(Imalumab)、英西单抗(imciromab)、尹戈妥珠单抗(Imgatuzumab)、尹卡单抗(Inclacumab)、尹达西单抗(Indatuximab ravtansine)、英杜斯妥单抗(Indusatumabvedotin)、英彼利珠单抗(Inebilizumab)、英夫利昔单抗、伊诺莫单抗(Inolimomab)、因诺珠单抗(Inotuzumab ozogamicin)、因特姆单抗(Intetumumab)、伊皮木单抗(Ipilimumab)、伊拉土木单抗(Iratumumab)、伊撒西单抗(Isatuximab)、伊利珠单抗(Itolizumab)、伊希珠单抗(Ixekizumab)、克里希单抗、拉贝珠单抗(Labetuzumab)、兰波单抗(Lambrolizumab)、兰波利珠单抗(Lampalizumab)、兰纳德单抗(Lanadelumab)、兰德珠单抗(Landogrozumab)、拉普特西单抗(Laprituximab emtansine)、LBR101/PF0442g7429、罗氏单抗、来马索单抗(Lemalesomab)、棱德里珠单抗(Lendalizumab)、棱西单抗(Lenzilumab)、乐德木单抗(Lerdelimumab)、来沙木单抗、利韦单抗、利伐特珠单抗(Lifastuzumab vedotin)、利格里珠单抗(Ligelizumab)、立罗妥单抗(Lilotomab satetraxetan)、林妥珠单抗、利瑞单抗(Lirilumab)、罗德西珠单抗(Lodelcizumab)、洛克弗单抗(Lokivetmab)、罗瓦妥珠单抗(Lorvotuzumab mertansin)、鲁卡妥姆单抗(Lucatumumab)、鲁利珠单抗(Lulizumabpegol)、鲁昔单抗、鲁姆妥珠单抗(Lumretuzumab)、LY2951742、马帕木单抗、马格西单抗(Margetuximab)、马斯利莫单抗(Maslimomab)、马妥珠单抗、马维珠单抗、美泊利单抗、美替木单抗(Metelimumab)、米拉珠单抗(Milatuzumab)、敏特单抗(Minretumomab)、米弗西单抗(Mirvetuximab soravtansine)、米妥莫单抗、莫加木珠单抗、莫纳利珠单抗(Monalizumab)、莫洛利单抗(Morolimumab)、莫维珠单抗、莫昔妥木单抗(Moxetumomabpasudotox)、莫罗单抗-CD3、纳考洛单抗(Nacolomabtafenatox)、纳米洛单抗(Namilumab)、纳布妥木单抗(Naptumomab estafenatox)、纳鲁西单抗(Naratuximab emtansine)、纳鲁特单抗(Narnatumab)、那他珠单抗、那西珠单抗(Navicixizumab)、纳弗单抗(Navivumab)、奈巴库单抗、奈昔单抗、奈莫利珠单抗(Nemolizumab)、奈瑞莫单抗(Nerelimomab)、奈弗库单抗(Nesvacumab)、尼妥珠单抗、尼莫单抗(Nivolumab)、诺非单抗(Nofetumomabmerpentan)、奥比托西单抗(Obiltoxaximab)、阿托珠单抗、奥卡拉珠单抗、奥克利珠单抗(Ocrelizumab)、奥度莫单抗(Odulimomab)、奥法木单抗、欧妥单抗(Olaratumab)、欧罗单抗(Olokizumab)、奥马珠单抗、欧那妥珠单抗(Onartuzumab)、欧特西珠单抗(Ontuxizumab)、欧皮西单抗(Opicinumab)、莫奥珠单抗(Oportuzumab monatox)、奥戈伏单抗、奥特库单抗(Orticumab)、奥利昔珠单抗(Otelixizumab)、奥特托珠单抗(Otlertuzumab)、奥昔卢单抗(Oxelumab)、奥赞珠单抗(Ozanezumab)、欧拉丽珠单抗(Ozoralizumab)、帕吉昔单抗、帕利珠单抗、帕莫乐单抗(Pamrevlumab)、帕尼单抗、潘可单抗(Pankomab)、帕诺库单抗(Panobacumab)、帕萨妥珠单抗(Parsatuzumab)、帕考珠单抗、帕束妥昔珠单抗(Pasotuxizumab)、帕特利珠单抗(Pateclizumab)、帕特妥单抗(Patritumab)、派姆单抗(Pembrolizumab)、排姆妥姆单抗(Pemtumomab)、排乐珠单抗(Perakizumab)、帕妥珠单抗(Pertuzumab)、培克珠单抗、匹狄立珠单抗(Pidilizumab)、匹伐珠单抗(Pinatuzumabvedotin)、并妥木单抗(Pintumomab)、帕拉库单抗(Placulumab)、帕洛利珠单抗(Plozalizumab)、泊加丽珠单抗(Pogalizumab)、波拉妥珠单抗(Polatuzumabvedotin)、泊纳珠单抗(Ponezumab)、泊洛利珠单抗(Prezalizumab)、普立昔单抗(Priliximab)、普特夏西单抗(Pritoxaximab)、普林木单抗(Pritumumab)、PRO 140、秋丽珠单抗(Quilizumab)、雷克妥木单抗(Racotumomab)、雷德妥单抗(Radretumab)、瑞非单抗(Rafivirumab)、拉潘西珠单抗(Ralpancizumab)、雷莫芦单抗(Ramucirumab)、兰尼单抗、瑞西巴库单抗(Raxibacumab)、瑞凡珠单抗(Refanezumab)、瑞加韦单抗(Regavirumab)、瑞利珠单抗(Reslizumab)、利妥木单抗、利诺库单抗(Rinucumab)、利散珠单抗(Risankizumab)、利妥昔单抗、利巴珠单抗(Rivabazumab pegol)、罗妥木单抗(Robatumumab)、洛乐杜单抗(Roledumab)、罗姆珠单抗(Romosozumab)、荣塔里珠单抗(Rontalizumab)、罗弗皮珠单抗(Rovalpituzumab tesirine)、罗维珠单抗(Rovelizumab)、卢利珠单抗(Ruplizumab)、沙斯妥珠单抗(Sacituzumabgovitecan)、萨摩利珠单抗(Samalizumab)、萨皮利珠单抗(Sapelizumab)、萨里单抗(Sarilumab)、沙妥莫单抗喷地肽(satumomab pendetide)、苏金单抗、色瑞班妥单抗(Seribantumab)、色托西单抗(Setoxaximab)、司韦单抗(Sevirumab)、SGN-CD19A、SGN-CD33A、西罗珠单抗(Sibrotuzumab)、西法木单抗、希妥昔单抗(Siltuximab)、希特珠单抗(Simtuzumab)、西利珠单抗(Siplizumab)、希鲁库单抗(Sirukumab)、索非妥珠单抗(Sofituzumabvedotin)、苏兰珠单抗(Solanezumab)、索利特单抗(Solitomab)、森纳西珠单抗(Sonepcizumab)、森图珠单抗(Sontuzumab)、司他芦单抗(Stamulumab)、硫索单抗(Sulesomab)、苏珠单抗(Suvizumab)、它布鲁单抗(Tabalumab)、它卡斯珠单抗(Tacatuzumab tetraxetan)、塔道珠单抗(Tadocizumab)、他利珠单抗(Talizumab)、它木弗单抗(Tamtuvetmab)、它尼珠单抗(Tanezumab)、泰普利莫单抗(Taplitumomab paptox)、它瑞妥单抗(Tarextumab)、太妃珠单抗(Tefibazumab)、阿替莫单抗(Telimomab aritox)、特纳妥姆单抗(Tenatumomab)、替奈昔单抗(Teneliximab)、替利珠单抗、特普妥姆单抗(Teprotumumab)、特西多单抗(Tesidolumab)、特托罗单抗(Tetulomab)、特则培单抗(Tezepelumab)、TGN1412、替西木单抗(Ticilimumab)、替卡妥珠(Tigatuzumab)、替卓珠单抗(Tildrakizumab)、替莫单抗(Timolumab)、替索托单抗(Tisotumab vedotin)、TNX-650、托珠单抗、托利珠单抗(Toralizumab)、托萨托单抗(Tosatoxumab)、托西莫单抗(Tositumomab)、托韦妥单抗(Tovetumab)、川隆单抗(Tralokinumab)、曲妥珠单抗(Trastuzumab)、曲妥珠单抗埃姆他辛(Trastuzumabemtansine)、TRBS07、曲加利珠单抗(Tregalizumab)、曲美木单抗(Tremelimumab)、曲弗单抗(Trevogrumab)、西莫白介素单抗(Tucotuzumab celmoleukin)、妥韦单抗(Tuvirumab)、乌立妥昔单抗(Ublituximab)、乌克普鲁单抗(Ulocuplumab)、乌鲁单抗(Urelumab)、乌托珠单抗(Urtoxazumab)、优特金单抗(Ustekinumab)、乌托米单抗(Utomilumab)、维达西单抗(Vadastuximab talirine)、凡多珠单抗(Vandortuzumab vedotin)、凡提单抗(Vantictumab)、凡诺西珠单抗(Vanucizumab)、瓦帕西单抗(Vapaliximab)、瓦利芦单抗(Varlilumab)、瓦特里珠单抗(Vatelizumab)、维多珠单抗、维妥珠单抗、维帕莫单抗(Vepalimomab)、维森克单抗(Vesencumab)、维斯利珠单抗(Visilizumab)、弗巴利珠单抗(Vobarilizumab)、弗洛昔单抗(Volociximab)、沃斯妥珠单抗(Vorsetuzumab mafodotin)、伏妥莫单抗(Votumumab)、疝托珠单抗(Xentuzumab)、扎木单抗(Zanolimumab)、扎鲁木单抗(Zalutumumab)、扎木单抗、扎昔单抗(Zatuximab)、齐拉木单抗(Ziralimumab)和阿佐莫单抗(Zolimomab aritox),或它们的组合。
为病毒性疾病研发的疫苗的示例包括但不限于:甲型肝炎疫苗、乙型肝炎疫苗、戊型肝炎疫苗、HPV疫苗、流感疫苗、流行性乙型脑炎疫苗、MMR疫苗、MMRV疫苗、脊髓灰质炎疫苗、狂犬病疫苗、轮状病毒疫苗、水痘疫苗、带状疱疹疫苗、天花疫苗、黄热病疫苗、腺病毒疫苗、柯萨奇B病毒疫苗、巨细胞病毒疫苗、人类登革热疫苗、人类东部马脑炎病毒疫苗、埃博拉疫苗、肠道病毒71疫苗、爱泼斯坦巴尔疫苗、丙型肝炎疫苗、艾滋病疫苗、人用HTLV-1T淋巴细胞白血病疫苗、马尔堡病毒疫苗、诺如病毒疫苗、人体呼吸道合胞病毒疫苗、严重急性呼吸道综合征(SARS)疫苗、人用西尼罗河病毒疫苗;细菌性疾病的示例包括但不限于:炭疽疫苗、DPT疫苗、Q热疫苗、Hib疫苗、结核病(BCG)疫苗、脑膜炎球菌疫苗、伤寒疫苗、肺炎球菌结合疫苗、肺炎球菌多糖疫苗、霍乱疫苗、龋疫苗、埃立克体病疫苗、麻风疫苗、莱姆病疫苗、金黄色葡萄球菌疫苗、化脓性链球菌疫苗、梅毒疫苗、土拉菌病疫苗、鼠疫耶尔森氏菌疫苗;寄生虫病的示例包括但不限于:疟疾疫苗、血吸虫病疫苗、恰加丝病疫苗、钩虫疫苗、人用盘尾丝虫病河盲症疫苗、锥虫病疫苗、内脏利什曼病疫苗;非感染性疾病的示例包括但不限于:阿尔茨海默病淀粉样蛋白疫苗、乳腺癌疫苗、卵巢癌疫苗、前列腺癌疫苗、溶瘤病毒药剂(Talimogenelaherparepvec)(T-VEC);疫苗还包括但不限于以下商品名称:ACAM2000、ActHIB、阿德萨(Adacel)、阿福洛利(Afluria)、四价阿福洛利(AFLURIAQUADRIVALENT)、阿格里夫(Agriflu)、BCG疫苗、BEXSERO、百思拉霞(Biothrax)、卜思特(Boostrix)、希瑞适(Cervarix)、康福熙(Comvax)、达忒瑟(DAPTACEL)、德克发(DECAVAC)、英格里希(Engerix)-B、复立达(FLUAD)、福禄立适(Fluarix)、四价福禄立适(Fluarix Quadrivalent)、弗露博洛克(Flublok)、弗露希腊(Flucelvax)、四价弗露希腊(FlucelvaxQuadrivalent)、弗露拉法(FluLaval)、弗露米斯特(FluMist)、四价弗露米斯特(FluMist Quadrivalent)、伏必灵(Fluvirin)、四价弗露倧(FluzoneQuadrivalent)、弗露倧(Fluzone)、高剂量弗露倧和皮肤内弗露倧(Fluzone High-Dose and Fluzone Intradermal)、加德西(Gardasil)、加德西9、贺福立适(Havrix)、贺新立适(Hiberix)、印法克斯(Imovax)、英芬立适(Infanrix)、IPOL、依稀罗(Ixiaro)、JE-Vax、KINRIX、美那克查(Menactra)、门西比克(MenHibrix)、美诺门(Menomune)-A/C/Y/W-135、门福鸥(Menveo)、M-M-R II、M-M-Vax、帕迪丽(Pediarix)、PedvaxHIB、蓬塔克(Pentacel)、纽莫法(Pneumovax)23、珀利弗科思(Poliovax)、沛儿(Prevnar)、沛儿13、普罗栝达(ProQuad)、阔达丝(Quadracel)、四价(Quadrivalent)、拉布维特(RabAvert)、瑞抗必发(Recombivax)HB、罗特律(ROTARIX)、罗塔特克(RotaTeq)、特尼微克(TENIVAC)、TICE BCG、特培达(Tripedia)、川膜倍(TRUMENBA)、Twinrix、TYPHIM Vi、VAQTA、瓦瑞法克(Varivax)、瓦克罗(Vaxchora)、维弗提(Vivotif)、YF-Vax、伏带疹(Zostavax)、以及它们的组合。
可注射药物的示例包括但不限于:阿巴弗(Ablavar)(钆磷维塞三钠(Gadofosveset Trisodium)注射剂)、阿巴瑞克储库剂(奥巴里德宝(Abarelix Depot))、肉毒素A型(Abo肉毒杆菌毒素(Abobotulinumtoxin A))注射剂(丽舒妥(Dysport))、ABT-263、ABT-869、ABX-EFG、阿西托品(Accretropin)(生长激素(Somatropin)注射剂)、Acetadote(乙酰胺半胱氨酸(Acetylcysteine)注射剂)、乙酰唑胺注射剂(AcetazolamideInjection)、乙酰半胱氨酸注射剂(Acetadote)、安挺乐(托珠单抗注射剂)、Acthrel(注射用三氟乙酸绵羊可的瑞林(Corticorelin Ovine Triflutate))、奥克图门(Actummune)、阿替普酶(Activase)、注射用阿昔洛韦(Acyclovir)(佐韦瑞克斯(Zovirax)注射剂)、阿德萨(Adacel)、阿达木单抗、Adenoscan(腺苷注射剂)、腺苷注射剂(Adenoscan)、阿德那克里克(Adrenaclick)、AdreView(用于静脉注射使用的碘1123苄胍(lobenguane 1123)注射剂)、阿福洛利(Afluria)、Ak-Fluor(荧光素注射剂)、Aldurazyme(拉罗尼酶(Laronidase))、阿糖苷酶注射剂(Ceredase)、阿尔肯尔(Alkeran)注射剂(盐酸美法仑注射剂)、注射用别嘌醇钠(Aloprim)、Aloprim(注射用别嘌醇钠)、前列地尔(Alprostadil)、Alsuma(舒马普坦注射剂)、ALTU-238、氨基酸注射剂、美乐欣(Aminosyn)、阿匹朱(Apidra)、阿普斯特(Apremilast)、注射用前列地尔双腔系统(CaverjectImpulse)、AMG 009、AMG 076、AMG102、AMG 108、AMG 114、AMG 162、AMG 220、AMG 221、AMG 222、AMG 223、AMG 317、AMG 379、AMG 386、AMG 403、AMG 477、AMG 479、AMG 517、AMG 531、AMG 557、AMG 623、AMG 655、AMG706、AMG 714、AMG 745、AMG 785、AMG 811、AMG 827、AMG 837、AMG 853、AMG 951、胺碘酮盐酸注射剂(盐酸胺碘酮注射剂)、异戊巴比妥钠注射剂(阿米妥钠)、阿米妥钠(异戊巴比妥钠注射剂)、阿那白滞素(Anakinra)、Aβ抗体(Anti-Abeta)、β7抗体(Anti-Beta7)、β20抗体(Anti-Beta20)、CD4抗体(Anti-CD4)、CD20抗体(Anti-CD20)、CD40抗体(Anti-CD40)、IFNα抗体(Anti-IFNalpha)、IL13抗体(Anti-IL13)、OX40L抗体(Anti-OX40L)、oxLDS抗体(Anti-oxLDS)、NGF抗体(Anti-NGF)、NRP1抗体(Anti-NRP1)、Arixtra(戊聚糖钠)、Amphadase(透明质酸酶注射剂)、Ammonul(苯乙酸钠和苯甲酸钠注射剂)、阿诺普克斯(Anaprox)、Anzemet注射剂(甲磺酸多拉司琼注射剂)、阿匹朱(赖谷胰岛素[rDNA来源]注射剂)、Apomab、Aranesp(阿法达贝泊汀)、Argatroban(阿加曲班注射剂)、盐酸精氨酸注射剂(R-Gene 10、曲安西龙(Aristocort)、己曲安奈德(Aristospan)、三氧化二砷注射剂(Trisenox)、盐酸阿替卡因(Articane HCl)和肾上腺素注射剂(Septocaine)、Arzerra(奥法木单抗注射剂)、Asclera(聚多卡醇注射剂)、阿特伦(Ataluren)、阿特伦-DMD、阿替洛尔(Atenolol)注射剂(天诺敏I.V.注射剂(Tenormin I.V.Injection))、苯磺酸阿曲库铵注射剂(阿曲库铵苯磺酸盐注射剂)、阿瓦斯丁(Avastin)、埃扎可坦(Azactam)注射剂(噻肟单胺菌素(Aztreonam)注射剂)、阿奇霉素(希舒美注射剂)、噻肟单胺菌素注射剂(埃扎可坦注射剂)、巴氯芬注射剂(尚有鞘内注射液(LIORESALINTRATHECAL))、抑菌水(Bacteriostatic Water)(注射用抑菌水)、巴氯芬注射剂(尚有鞘内注射液)、油安瓶中的巴尔(Bal in Oil Ampules)(二巯基丙醇(Dimercarprol)注射剂)、百禾B(BayHepB)、百特(BayTet)、本纳注(Benadryl)、盐酸苯达莫司汀注射剂(Treanda)、甲磺酸苯扎托品注射剂(Cogentin)、倍他米松可注射悬浮液(倍他米松磷酸酯钠(Celestone Soluspan))、百克沙、比西林(Bicillin)C-R 900/300(盘尼西林G苄星青霉素和盘尼西林G普鲁卡因注射剂)、博莱霉素(Blenoxane)(硫酸博莱霉素注射剂)、硫酸博来霉素注射剂(Blenoxane)、Boniva注射剂(伊班膦酸钠(Ibandronate Sodium)注射剂)、Botox Cosmetic(注射用Ona肉毒杆菌素(OnabotulinumtoxinA))、BR3-FC、Bravelle(尿促卵泡素注射剂)、Bretylium(溴苄铵注射剂)、甲己炔巴比妥钠(BrevitalSodium)(注射用美索比妥钠)、贝利新(Brethine)、贝利百西(Briobacept)、BTT-1023、盐酸布比卡因、艾塞那肽(Byetta)、Ca-DTPA(喷替酸钙钠注射剂)、卡巴他赛注射剂(Jevtana)、咖啡因生物碱(Caffeine Alkaloid)(咖啡因和苯甲酸钠注射剂)、骨化三醇注射剂(罗钙全(Calcitrol))、罗钙全(骨化三醇注射剂)、氯化钙(氯化钙注射剂10%)、依地酸钙钠(乙二胺四乙酸二钠钙注射剂)、Campath(阿仑单抗(Altemtuzumab))、Camptosar注射剂(盐酸伊立替康)、卡纳努单抗注射剂(Ilaris)、硫酸卷曲霉素(Capastat Sulfate)(注射用卷曲霉素(Capreomycin))、注射用卷曲霉素(硫酸卷曲霉素)、Cardiolite(注射用锝Tc99司他比准备试剂盒(Prep kit for Technetium Tc99 Sestamibi))、Carticel、Cathflo、注射用头孢唑啉和右旋糖(头孢唑啉(Cefazolin)注射剂)、盐酸头孢吡肟、头孢噻肟、头孢三嗪(Ceftriaxone)、思而赞(Cerezyme)、卡尼特(Carnitor)注射剂、凯威捷(Caverject)、倍他米松磷酸酯钠、赛里西欧(Celsior)、Cerebyx(磷苯妥英钠(Fosphenytoin Sodium)注射剂)、Ceredase(阿糖苷酶注射剂)、Ceretec(锝Tc99m依沙美肟(Exametazime)注射剂)、赛妥珠单抗、CF-101、氯霉素琥珀酸钠(琥珀酸钠氯霉素注射剂)、琥珀酸钠氯霉素注射剂(氯霉素琥珀酸钠)、考来胶(Cholestagel)(盐酸考来维仑)、绒毛膜促性腺激素(Choriogonadotropin)α注射剂(Ovidrel)、Cimzia、Cisplatin(顺氯氨铂注射剂)、Clolar(氯法拉滨注射剂)、克罗米酚柠檬酸盐(Clomiphine Citrate)、可乐定注射剂(Duraclon)、Cogentin(甲磺酸苄托品注射剂)、粘菌素(Colistimethate)注射剂(Coly-Mycin M)、Coly-Mycin M(粘菌素注射剂)、康帕斯(Compath)、盐酸考尼伐坦注射剂(Vaprisol)、注射用结合雌激素(妊马雌酮(Premarin)注射剂)、克帕松(Copaxone)、注射用三氟乙酸绵羊可的瑞林(Acthrel)、Corvert(富马酸伊布利特(Ibutilide Fumarate)注射剂)、库比星(Cubicin)(达托霉素注射剂)、CF-101、Cyanokit(注射用羟钴胺素)、阿糖胞苷脂质体(CytarabineLiposome)注射剂(DepoCyt)、氰钻胺、Cytovene(丙氧鸟苷)、D.H.E.45、达西珠单抗、Dacogen(地西他滨注射剂)、达替肝素(Dalteparin)、丹曲林IV(注射用丹曲林钠)、注射用丹曲林钠(丹曲林IV)、达托霉素注射剂(库比星(Cubicin))、达尔贝激素(Darbepoietin)α、DDAVP注射剂(乙酸去氨加压素注射剂)、Decavax、地西他滨注射剂(Dacogen)、无水乙醇(无水乙醇注射剂)、德尼单抗注射剂(Prolia)、庚酸睾酮(Delatestryl)、去甲肾上腺素(Delestrogen)、达特肝素钠(Delteparin Sodium)、的帕肯(Depacon)(丙戊酸钠注射剂)、德普梅德尔(醋酸甲泼尼龙可注射悬浮液)、DepoCyt(阿糖胞苷脂质体注射剂)、DepoDur(硫酸吗啡XR脂质体(Morphine Sulfate XR Liposome)注射剂)、乙酸去氨加压素注射剂(DDAVP注射剂)、德普(Depo)-雌二醇、德普-普维拉(Provera)104mg/ml、德普-普维拉150mg/ml、德普-睾酮、注射用敌拉造可散、仅静脉输注(Totect)、右旋糖/电解质、右旋糖和氯化钠注射剂(0.9%氯化钠中的右旋糖5%)、右旋糖、地西泮注射剂(安定注射剂)、地高辛注射剂(拉诺辛注射剂)、双氢吗啡(Dilaudid)-HP(盐酸二氢吗啡酮注射剂)、二巯基丙醇注射剂(油安瓶中的巴尔)、苯海拉明注射剂(苯那君(Benadryl)注射剂)、双嘧达莫注射剂(潘生丁注射剂)、DMOAD、注射用多西他赛(Taxotere)、甲磺酸多拉司琼注射剂(Anzemet注射剂)、Doribax(注射用多利培南)、注射用多利培南(Doribax)、度骨化醇(Doxercalciferol)注射剂(Hectorol注射剂)、Doxil(盐酸阿霉素脂质体(Doxorubicin Hcl Liposome)注射剂)、盐酸阿霉素脂质体注射剂(Doxil)、Duraclon(可乐亭注射剂)、硫酸吗啡(Duramorph)(吗啡注射剂)、Dysport(Abo肉毒杆菌毒素A注射剂)、艾卡拉肽注射剂(Kalbitor)、EC-萘普生(甲氧萘丙酸(naproxen))、乙二胺四乙酸钙二钠注射剂(依地酸二钠钙)、Edex(注射用前列地)、英格里希(Engerix)、滕喜龙注射剂(依酚氯铵(Enlon))、酒石酸伊利果斯(Eliglustat Tartate)、乐沙定(奥沙利铂注射剂)、易梦德(Emend)注射剂(福沙吡坦二甲葡胺(Fosaprepitant Dimeglumine)注射剂)、依那普利注射剂(埃那拉普利尔制剂(Enalaprilat)注射剂)、依酚氯铵(滕喜龙(Edrophonium)注射剂)、依诺肝素钠(Enoxaparin Sodium)注射剂(Lovenox)、Eovist(钆塞酸二钠(Gadoxetate Disodium)注射剂)、Enbrel(依那西普(etanercept))、依诺肝素(Enoxaparin)、依皮瑟(Epicel)、肾上腺素(Epinepherine)、肾上腺素笔(Epipen)、初级肾上腺素笔(Epipen Jr.)、依帕珠单抗、爱必妥(Erbitux)、厄他培南(Ertapenem)注射剂(怡万之(Invanz))、红细胞生成素(Erythropoieten)、必需氨基酸注射剂(Nephramine)、环戊酸雌二醇(EstradiolCypionate)、戊酸雌二醇(Estradiol Valerate)、依那西普、艾塞那肽注射剂(百泌达(Byetta))、艾佛特(Evlotra)、半乳糖苷酶(Fabrazyme)(阿达西达瑟(Adalsidase)β)、法莫替丁注射剂、FDG(氟代脱氧葡萄糖F18注射剂)、芙拉和莫(Feraheme)(纳米氧化铁(Ferumoxytol)注射剂)、菲立磁四代(Feridex I.V.)(氧化铁纳米微粒(Ferumoxides)可注射溶液)、费提娜(Fertinex)、氧化铁纳米微粒可注射溶液(菲立磁四代)、纳米氧化铁注射剂(芙拉和莫)、甲硝唑(Flagyl)注射剂(灭滴灵(Metronidazole)注射剂)、福禄立适(Fluarix)、氟拉达拉(Fludara)(磷酸氟达拉滨)、氟脱氧葡萄糖F18注射剂(FDG)、荧光素注射剂(Ak-Fluor)、弗丽丝汀AQ筒(Follistim AQ Cartridge)(促卵泡素β注射剂)、促卵泡素α注射剂(Gonal-f RFF)、促卵泡素β注射剂(弗丽丝汀AQ筒)、弗洛婷(Folotyn)(静脉注射用普拉曲沙溶液)、磺达肝癸钠(Fondaparinux)、Forteo(特立帕肽(rDNA来源)注射剂)、弗丝麻亭(Fostamatinib)、福沙吡坦二甲葡胺(Fosaprepitant Dimeglumine)注射剂(Emend注射剂)、膦甲酸钠注射剂(Foscavir)、Foscavir(膦甲酸钠注射剂)、磷苯妥英钠注射剂(Cerebyx)、磷丙泊酚钠注射剂(Lusedra)、法安明(Fragmin)、Fuzeon(恩夫韦肽(enfuvirtide))、GA101、钆贝葡胺注射剂(Multihance)、钆磷维塞三钠注射剂(Ablavar)、钆特醇(Gadoteridol)注射溶液(ProFlance)、钆弗塞胺(Gadoversetamide)注射剂(OptiMARK)、伽岛二钠(Gadoxetate Disodium)注射剂(Eovist)、加尼瑞克(Ganirelix)(醋酸加尼瑞克注射剂)、加德西(Gardasil)、GC1008、GDFD、注射用吉妥珠单抗奥唑米星(Gemtuzumab Ozogamicin)(Mylotarg)、基因重组人生长激素(Genotropin)、庆大霉素注射剂、GENZ-112638、戈利木单抗注射剂(欣普尼(Simponi)注射剂)、Gonal-f RFF(促卵泡素α注射剂)、盐酸格拉司琼(康泉(Kytril)注射剂)、硫酸庆大霉素、醋酸格拉替雷、胰高血糖素(Glucagen)、胰高血糖素(Glucagon)、HAE1、Haldol(氟哌啶醇注射剂)、贺福立适(Flavrix)、Flectorol注射剂(度骨化醇(Doxercalciferol)注射剂)、何德浩途径抑制剂(Fledgehog Pathway Inhibitor)、肝素、赫赛汀、hG-CSF、优泌乐(Flumalog)、人类生长激素、优猛茁(Humatrope)、喜码士(HuMax)、喜美康(Humegon)、修美乐(Humira)、优泌林(Humulin)、伊班膦酸钠注射剂(Boniva注射剂)、布洛芬赖氨酸盐注射剂(NeoProfen)、布洛芬赖氨酸盐注射剂(Corvert)、伊达米星(Idamycin)PFS(盐酸伊达比星(IdarubicinHydrochloride)注射剂)、盐酸伊达比星注射剂(伊达米星PFS)、Ilaris(卡纳努单抗注射剂)、注射用亚胺培南和西司他丁(Primaxin I.V.)、依米彻(Imitrex)、注射用inco肉毒杆菌毒素(Incobotulinumtoxin)A(Xeomin)、Increlex(美卡舍明(Mecasermin)[rDNA来源]注射剂)、消炎痛(Indocin)IV(吲哚美辛注射剂)、吲哚美辛注射剂(消炎痛IV)、英芬立适(Infanrix)、亭扎肝素(Innohep)、胰岛素(Insulin)、门冬胰岛素[rDNA来源]注射剂(NovoLog)、甘精胰岛素[rDNA来源]注射剂(Lantus)、赖谷胰岛素[rDNA来源]注射剂(阿匹朱)、注射用干扰素α-2b重组体(Intron A)、Intron A(注射用干扰素α-2b重组体)、Invanz(厄他培南注射剂)、善思达(Invega Sustenna)(棕榈酸帕利哌酮缓释剂(Paliperidone Palmitate Extended-Release)可注射悬浮液)、Invirase(甲磺酸沙奎那韦)、静脉输注用途的碘苄胍1123注射剂(AdreView)、碘普罗胺注射剂(优维显(Ultravist))、碘佛醇注射剂(安射力(Optiray)注射剂)、Iplex(美卡舍明林菲培[rDNA来源]注射剂)、依皮法克(Iprivask)、盐酸伊立替康(Camptosar注射剂)、蔗糖铁注射剂(Venofer)、Istodax(注射用罗米地辛)、依曲康唑注射剂(斯皮仁诺注射剂)、Jevtana(卡巴他赛注射剂)、九纳西(Jonexa)、Kalbitor(艾卡拉肽注射剂)、D5NS中的KCL(在5%右旋糖和氯化钠中的氯化钾注射剂)、D5W中的KCL、NS中的KCL、口内膏(Kenalog)10注射剂(醋酸曲安奈德(Triamcinolone Acetonide)可注射悬浮液)、Kepivance(帕利夫明)、开浦兰注射剂(左乙拉西坦)、角化细胞(Keratinocyte)、KFG、激酶抑制剂、Kineret(阿那白滞素)、Kinlytic(尿激酶注射剂)、金利(Kinrix)、克诺平(氯硝安定)、Kytril注射剂(盐酸格拉司琼)、拉科酰胺片和注射剂(Vimpat)、乳酸林格氏液(Lactated Ringer's)、拉诺辛注射剂(地高辛注射剂)、注射用兰索拉唑(普托平I.V.)、兰德仕(Lantus)、亚叶酸钙(甲酰四氢叶酸钙注射剂)、朗泰(Lente)(L)、莱普亭(Leptin)、诺和平(Levemir)、乐凯沙格司亭(Leukine Sargramostim)、醋酸亮丙瑞林、左甲状腺素、左乙拉西坦(开浦兰注射剂)、依诺肝素(Lovenox)、左卡尼汀注射剂(卡尼丁注射剂)、乐西阚(Lexiscan)(瑞加德松(Regadenoson)注射剂)、尚有鞘内注射液(巴氯芬注射剂)、利拉鲁肽[rDNA]注射剂(诺和力)、依诺肝素(Lovenox)(依诺肝素钠注射剂)、雷珠单抗(Lucentis)(兰尼单抗注射剂)、卢米兹莫(Lumizyme)、Lupron(醋酸亮丙瑞林注射剂)、Lusedra(磷丙泊酚钠注射剂)、马奇(Maci)、硫酸镁(硫酸镁注射剂)、甘露醇注射剂(甘露醇IV)、麻卡因(盐酸布比卡因和肾上腺素注射剂)、马斯平(Maxipime)(注射用盐酸头孢吡肟)、锝注射剂的MDP多剂量试剂盒(锝Tc99m依沙美肟注射剂)、美卡舍明[rDNA来源]注射剂(Increlex)、美卡舍明林菲培[rDNA来源]注射剂(Iplex)、盐酸美法仑注射剂(爱克兰(Alkeran)注射剂)、氨甲蝶呤、美那克查(Menactra)、美诺孕(Menopur)(促生育素注射剂)、注射用促生育素(Repronex)、注射用美索比妥钠(甲己炔巴比妥钠(BrevitalSodium))、盐酸甲基多巴乙酯注射剂溶液(盐酸甲基多巴乙酯)、亚甲蓝(亚甲蓝注射剂)、醋酸甲泼尼龙可注射悬浮液(德普梅德尔(DepoMedrol))、梅特麦(MetMab)、甲氧氯普胺注射剂(灭吐灵(Reglan)注射剂)、麦处定(注射用尿促卵泡素)、甲硝哒唑注射剂(灭滴灵(Flagyl)注射剂)、密钙息、咪达唑仑(咪达唑仑注射剂)、米帕拉(Mimpara)(西那卡塞(Cinacalet))、米诺环素注射剂(二甲胺四环素注射剂)、二甲胺四环素注射剂(米诺环素注射剂)、米泊美生(Mipomersen)、注射用米托蒽醌浓缩剂(诺凡特龙)、吗啡注射剂(硫酸吗啡)、硫酸吗啡XR脂质体(DepoDur)、鱼肝油酸钠(鱼肝油酸钠注射剂)、莫特塞尼(Motesanib)、普乐沙福(Mozobil)(注射用皮乐霞(Plerixa))、Multihance(钆贝葡胺注射剂)、多种电解质和右旋糖注射剂、多种电解质注射剂、Mylotarg(注射用吉妥珠单抗奥唑米星)、Myozyme(α-阿葡糖苷酶(Alglucosidase alfa))、萘夫西林注射剂(萘夫西林钠)、萘夫西林钠(萘夫西林注射剂)、纳曲酮XR注射剂(Vivitrol)、萘普生(甲氧萘丙酸)、NeoProfen(布洛芬赖氨酸盐注射剂)、癸酸诺龙(Nandrol Decanoate)、甲硫酸新斯的明(甲硫酸新斯的明注射剂)、NEO-GAA、NeoTect(锝To 99m地普奥肽注射剂)、Nephramine(必需氨基酸注射剂)、Neulasta(培非格司亭)、优保津(Neupogen)(非格司亭)、诺和灵、诺和锐、倍他依泊汀(NeoRecormon)、Neutrexin(三甲曲沙葡糖醛酸脂注射剂)、NPH(N)、Nexterone(盐酸胺碘酮注射剂)、Norditropin(生长激素(Somatropin)注射剂)、生理盐水(氯化钠注射剂)、诺凡特龙(注射用米托蒽醌浓缩剂)、诺和灵70/30一诺莱特(Innolet)(70%NPH,中性精蛋白人胰岛素悬液和30%Regular,人胰岛素注射剂)、诺和锐(门冬胰岛素[rDNA来源]注射剂)、Nplate(罗米司亭)、诺折平(Nutropin)(注射用生长激素(rDNA来源))、诺折平AQ、Nutropin Depot(注射用生长激素(rDNA来源))、醋酸奥曲肽注射剂(善得定LAR)、奥克利珠单抗、奥法木单抗注射剂(Arzerra)、奥氮平缓释剂可注射悬浮液(Zyprexa Relprevv)、奥密塔克、Omnitrope(生长激素[rDNA来源]注射剂)、盐酸昂丹司琼注射剂(枢复宁注射剂)、OptiMARK(钆弗塞胺注射剂)、安射力注射剂(碘佛醇注射剂)、奥瑞希纳(Orencia)、阿维娃中的欧斯米特(Osmitrol)注射剂(阿维娃(Aviva)塑料容器250中的甘露醇注射剂)、维弗乐中的欧斯米特注射剂(维弗乐(Viaflex)塑料容器250中的甘露醇注射剂)、骨保护素(Osteoprotegrin)、Ovidrel(绒毛膜促性腺激素α注射剂)、苯唑西林(注射用苯唑西林)、奥沙利铂注射剂(乐沙定)、催产素注射剂(吡哆素)、棕榈酸帕利哌酮缓释剂可注射悬浮液(善思达)、帕米膦酸二钠注射剂(帕米磷酸钠注射剂)、静脉输注用帕尼单抗注射剂(Vectibix)、盐酸罂粟碱注射剂(罂素碱注射剂)、罂素碱注射剂(盐酸罂粟碱注射剂)、甲状旁腺素、帕立骨化醇注射剂触发瓶(Fliptop Vial)(Zemplar注射剂)、PARP抑制剂、帕迪丽(Pediarix)、PEGlntron、派罗欣(Peginterferon)、培非格司亭、苄星青霉素G和普鲁卡因青霉素G、Pentetate喷替酸钙钠注射剂(Ca-DTPA)、喷替酸锌钠注射剂(Zn-DTPA)、Pepcid注射剂(法莫替丁注射剂)、普格纳(Pergonal)、帕妥珠单抗、甲磺酰酚妥拉明(酚妥拉明注射用)、水杨酸毒扁豆碱(水杨酸毒扁豆碱(注射剂))、水杨酸毒扁豆碱(注射剂)(水杨酸毒扁豆碱)、哌拉西林和他唑巴坦注射剂(Zosyn)、吡哆素(催产素注射剂)、勃脉力(Plasma-Lyte)148(多种电解质注射剂)、勃脉力56和右旋糖(维弗乐塑料容器250中的多种电解质和右旋糖注射剂)、勃脉力(PlasmaLyte)、(注射用皮乐霞(Plerixa))普乐沙福、聚多卡醇注射剂(Asclera)、氯化钾、静脉注射用普拉曲沙溶液(Folotyn)、醋酸普兰林肽注射剂(塞米琳(Symlin))、普雷马林注射剂(注射用共轭雌激素)、注射用锝Tc-99司他比准备试剂盒(Cardiolite)、普托平I.V.(注射用兰索拉唑)、Primaxin I.V.(注射用亚胺培南和西司他丁)、前干细胞素(Prochymal)、普罗克瑞(Procrit)、黄体酮、ProHance(钆特醇注射溶液)、Prolia(德尼单抗注射剂)、盐酸普鲁米近注射剂(盐酸异丙嗪注射剂)、盐酸普萘洛尔注射剂(普萘洛尔盐酸注射剂)、葡萄糖酸奎尼丁注射剂(奎尼丁注射剂)、奎尼丁注射剂(葡萄糖酸奎尼丁注射剂)、R-Gene 10(盐酸精氨酸注射剂)、兰尼单抗注射剂(雷珠单抗(Lucentis))、盐酸雷尼替丁注射剂(Zantac注射剂)、瑞体肤(Raptiva)、Reclast(唑来膦酸注射剂)、瑞抗比力克(Recombivarix)HB、瑞加德松注射剂(乐西阚)、灭吐灵注射剂(甲氧氯普胺注射剂注射剂)、瑞米凯德、磷能解(Renagel)、Renvela(碳酸司维拉姆)、Repronex(注射用促生育素)、立妥威(Retrovir)IV(齐多夫定注射剂)、rhApo2L/TRAIL、林格氏(Ringer’s)和5%右旋糖注射剂(右旋糖中的林格(Ringer))、林格氏注射剂(林格注射剂)、瑞图宣(Rituxan)、利妥昔单抗、罗氏芬(头孢三嗪)、罗库溴铵注射剂(Zemuron)、罗扰素-A(干扰素α-2a)、Romazicon(氟马西尼)、注射用罗米地辛(Istodax)、思增(Saizen)(生长激素注射剂)、善得定LAR(醋酸奥曲肽注射剂)、硬骨素(Sclerostin)Ab、Sensipar(西那卡塞)、Sensorcaine(盐酸布比卡因注射剂)、Septocaine(盐酸阿替卡因和肾上腺素注射剂)、Serostim LQ(生长激素(rDNA来源)注射剂)、Simponi注射剂(戈利木单抗注射剂)、醋酸钠(醋酸钠注射剂)、碳酸氢钠(碳酸氢钠5%注射剂)、乳酸钠(AVIVA中的乳酸钠注射剂)、苯乙酸钠和苯甲酸钠注射剂(Ammonul)、注射用生长激素(rDNA来源)(Nutropin)、斯皮仁诺注射剂(依曲康唑注射剂)、喜达诺(Stelara)注射剂(优特金单抗)、司坦琴(Stemgen)、舒芬太尼(枸橼酸舒芬太尼(Sufentanil Citrate)注射剂)、枸橼酸舒芬太尼注射剂(舒芬太尼(Sufenta))、孙麻弗(Sumavel)、舒马曲坦注射剂(Alsuma)、塞米琳、塞米琳笔、系统性何德浩拮抗剂(Systemic Hedgehog Antagonist)、Synvisc-One(希兰G-F 20单次关节内注射剂)、埃罗替尼(Tarceva)、泰索帝(注射用多西他赛)、锝Tc 99m、注射用特拉万星(Vibativ)、替西罗莫司(Temsirolimus)注射剂(Torisel)、天诺敏I.V.注射剂(阿替洛尔注射剂)、特立帕肽(rDNA来源)注射剂(Forteo)、环戊丙酸睾酮、庚酸睾酮、丙酸睾酮、Tev-Tropin(生长激素,rDNA来源,注射用)、tgAAC94、氯化亚铊、茶碱、噻替派(噻替派注射剂)、Thymoglobulin(抗胸腺细胞球蛋白(兔)、适谪进(注射用促甲状腺激素α)、替卡西林钠和克拉维酸钾盖乐熙(Galaxy)(泰门汀注射剂)、帝根注射剂(可注射盐酸三甲氧苯酰胺)、泰门汀注射剂(替卡西林钠和克拉维酸钾盖乐熙)、替奈普酶(TNKase)、妥布霉素注射剂(托普霉素注射剂)、托珠单抗注射剂(安挺乐)、Torisel(替西罗莫司注射剂)、Totect(注射用右丙亚胺,仅静脉输注)、曲妥珠单抗-DM1、Travasol(氨基酸(注射剂))、Treanda(盐酸苯达莫司汀注射剂)、Trelstar(羟萘酸曲普瑞林可注射悬浮液(TriptorelinPamoate forInjectable Suspension))、醋酸曲安奈德、二醋酸去炎松、己曲安奈德可注射悬浮液(Aristospan注射剂20mg)、Triesence(醋酸曲安奈德可注射悬浮液)、可注射盐酸三甲氧苯酰胺(Tigan注射剂)、三甲曲沙葡萄糖醛酯注射剂(Neutrexin)、羟萘酸曲普瑞林可注射悬浮液(Trelstar)、呑皆克(Twinject)、Trivaris(醋酸曲安奈德可注射悬浮液)、Trisenox(三氧化二砷注射剂)、双福立适(Twinrix)、伤寒Vi疫苗(Typhoid Vi)、优维显(碘普罗胺注射剂)、注射用尿促卵泡素(麦处定)、尿激酶注射剂(Kinlytic)、优特金单抗(Stelara注射剂)、特慢胰岛素(Ultralente)(U)、安定(Valium)(地西泮)、丙戊酸钠注射剂(的帕肯)、Valtropin(生长激素注射剂)、盐酸万古霉素(盐酸万古霉素注射剂)、盐酸万古霉素注射剂(盐酸万古霉素)、Vaprisol(盐酸考尼伐坦注射剂)、VAQTA、Vasovist(用于静脉输注使用的钆磷维塞三钠注射剂)、Vectibix(静脉输注用帕尼单抗注射剂)、Venofer(蔗糖铁注射剂)、维替泊芬注射剂(Visudyne)、Vibativ(注射用特拉万星)、诺和力(Victoza)(利拉鲁肽[rDNA]注射剂)、Vimpat(拉科酰胺片和注射剂)、硫酸长春碱(硫酸长春碱注射剂)、Vincasar PFS(硫酸长春新碱注射剂)、诺和力、硫酸长春新碱(硫酸长春新碱注射剂)、Visudyne(维替泊芬注射剂)、维生素B-12、Vivitrol(纳曲酮XR注射剂)、Voluven(氯化钠中的羟乙基淀粉注射剂)、希罗达(Xeloda)、赛尼可(奥利司他)、Xeomin(inco肉毒杆菌毒素A注射用)、索雷尔(Xolair)、Zantac注射剂(盐酸雷尼替丁注射剂)、Zemplar注射剂(帕立骨化醇注射剂触发瓶)、Zemuron(罗库溴铵注射剂)、Zenapax(达利珠单抗)、泽娃灵(Zevalin)、齐多夫定注射剂(立妥威IV)、希舒美注射剂(阿奇霉素)、Zn-DTPA(喷替酸锌钠注射剂)、枢复宁注射剂(盐酸昂丹司琼注射剂)、琴果(Zingo)、注射用唑来膦酸(择泰(Zometa))、唑来膦酸注射剂(Reclast)、择泰(注射用唑来膦酸)、Zosyn(哌拉西林和他唑巴坦注射剂)、Zyprexa Relprevv(奥氮平缓释剂可注射悬浮液)和它们的组合。
上文已经中概括性地并且结合具体实施方式描述本申请的发明。对本领域的技术人员来说显而易见的是,可以在不偏离本发明的范围的情况下,对本文所述的实施方式进行各种修改和变动。因此,实施方式旨在覆盖对本发明的这些修改和变动,只要这些修改和变动在所附权利要求及其等同方案的范围之内。
预示的实施例
预示的实施例A:表面活性剂对脂肪酸颗粒形成的影响
样品制备:将在10cc小瓶中制备含有具有脂肪酶活性的酶(例如,兔肝酯酶、胰腺脂肪酶)和缓冲剂(例如,20mM组氨酸氯化物缓冲液,pH 5.5)的样品,各样品的体积约为6mL。除对照样品外,样品将含有各种类型和浓度的聚山梨醇酯表面活性剂,包括聚山梨醇酯20(PS20)、聚山梨醇酯40(PS40)、聚山梨醇酯60(PS60)和聚山梨醇酯80(PS80),如下表1所示。
表1
孵育:各样品在40℃下孵育2个月,然后在5℃下孵育至少24小时。
分析:在24小时孵育期之后,将在预定时间(如0小时、1天、2天、4天、10天、30天和60天)对各样品的脂肪酸颗粒形成进行分析。
各样品都可以在灯箱中进行目视检查,例如Seidenader V90-T。该目视检查可以在5℃和/或室温下进行。
各样品可以进行微流成像(MFI)。各样品将保持在5℃,直至MFI分析之前。
各样品还可以进行高效液相色谱(HPLC),以对保持完整的任意聚山梨醇酯表面活性剂或任何游离脂肪酸进行定量。
预示的结果:本发明人认为,在60天或更短时间后,更可能在10天或更短的时间后,在样品20-A至80-G中将可看到脂肪酸颗粒。本发明人还认为,在具有较低表面活性剂浓度(例如,20-A、40-A、60-A、80-A)的样品之前,将在具有较高表面活性剂浓度(例如,20-G、40-G、60-G、80-G)的样品中可看到脂肪酸颗粒。在不囿于理论的情况下,本发明人认为,即使在60天后,在对照样品中也不会看到脂肪酸颗粒。
预示的实施例B:顶空对搅拌诱导的蛋白质聚集的影响
样品制备:将在3cc或更大的小瓶中制备含有150mM NaCl中蛋白质(例如BSA、hGH)和缓冲剂(例如,20mM组氨酸氯化物缓冲液,pH 6)的样品。样品将具有不同蛋白质浓度(例如,1、10、50、150mg/mL)和不同PS20浓度(例如0.0重量%、0.01重量%、0.02重量%、0.04重量%、0.08重量%、0.10重量%、0.15重量%和0.30重量%)。不同体积(例如,0.5mL、1mL和3mL)的注射器将无菌填充合适量的各样品,以获得不同的顶空体积(例如0mL、0.05mL、0.1mL、0.2mL、0.5mL、1.0mL)。然后,各注射器将被加盖并密封。
搅拌:各注射器和小瓶将使用合适的搅拌器在室温下来回搅拌24小时。
分析:将对各注射器和小瓶的内容物检查颗粒和乳白色(opalescence)。各样品可以使用合适的光谱仪在400nm和500nm下以1cm的路径长度进行分析,并且样品是纯净的,0.22um过滤前和0.22um过滤后。各样品也可以使用尺寸排除色谱法(SEC)对可溶性聚集体进行分析(0.22μm过滤后)。
预示的结果:对于所有含有PS20的样品,本发明人认为,样品将在空气-水界面处具有低表面张力(由于在该界面处存在PS20),并且在搅拌后不会呈现出变化。另一方面,对于不含PS20的小瓶中的样品,本发明人认为样品将具有更高的表面张力,并且将表现出增多的乳白色,并且可能增加可溶性聚集体。然而,本发明人认为,由于空气-水界面处较高的表面张力,这种乳白色和聚集不会发生在具有低顶空体积的预填充注射器中。这表明,当注射器中顶空体积最小化时,即使没有PS20的样品在搅拌后也不会呈现出变化。
Claims (98)
1.一种预填充注射装置,其包括:
塞部;
筒体;
在塞部和筒体中至少一个上的固体润滑剂,所述预填充注射装置不含或基本不含液体润滑剂;和
具有脂肪酶活性且包含至少约1mg/ml的一种或多种活性药理学试剂的治疗制剂,
其中,治疗制剂不含或基本不含脂肪酸颗粒。
2.如权利要求1所述的预填充注射装置,其中,活性药理学试剂包括:蛋白质、抗体、细胞因子、生长因子、凝血因子、蛋白酶、激酶、磷酸酶、疫苗、肽、小干扰RNA(siRNA)、小干扰DNA(siDNA)、信使RNA(mRNA)、信使RNA(mRNA)、适体和/或它们的任意组合。
3.如权利要求1至2中任一项所述的预填充注射装置,其中,治疗制剂包含一种或多种活性药理学试剂,浓度为约1mg/ml至约200mg/ml、约10mg/ml至约200mg/ml、约20mg/ml至约200mg/ml、约40mg/ml至约200mg/ml、约60mg/ml至约200mg/ml、约80mg/ml至约200mg/ml、约100mg/ml至约200mg/ml、约120mg/ml至约200mg/ml和/或约150mg/ml至约200mg/ml。
4.如权利要求1至3中任一项所述的预填充注射装置,其中,治疗制剂不含或基本不含表面活性剂,并且,表面活性剂包括如下中的至少一种:聚山梨醇酯20、聚山梨醇酯40、聚山梨醇酯60、聚山梨醇酯80和/或它们的组合。
5.如权利要求4所述的预填充注射装置,其中,治疗制剂包含表面活性剂,浓度为0重量%至约0.1重量%、0重量%至约0.075重量%、0重量%至约0.05重量%、0重量%至约0.025重量%、0重量%至约0.01重量%、0重量%至约0.005重量%和/或0重量%至约0.001重量%。
6.如权利要求1至5中任一项所述的预填充注射装置,其中,治疗制剂包含pH为约4.0至约9.5、约4.5至约9.0、约5.0至约8.5、约5.5至约8.0、约5.5至约7.5、约5.5至约7.0和/或约5.5至约6.5的缓冲剂。
7.如权利要求1至6中任一项所述的预填充注射装置,其中,治疗制剂包含糖,浓度为0重量%至约15重量%、约0.1重量%至约15重量%、约1重量%至约15重量%、约1.5重量%至约10重量%、约2重量%至约10重量%、约3重量%至约10重量%和/或约5重量%至约10重量%。
8.如权利要求1至7中任一项所述的预填充注射装置,其中,治疗制剂包含多元醇,浓度为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
9.如权利要求1至8中任一项所述的预填充注射装置,其中,治疗制剂包含精氨酸盐,浓度为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
10.如权利要求1至9中任一项所述的预填充注射装置,其中,塞部和筒体不含或基本不含液体润滑剂硅酮。
11.如权利要求1至10中任一项所述的预填充注射装置,其中,筒体由如下材料中的至少一种制成:玻璃材料、塑料材料、陶瓷材料、金属材料和/或它们的组合。
12.如权利要求1至11中任一项所述的预填充注射装置,其中,固体润滑剂是低摩擦系数聚合物层,并且塞部包括弹性体和位于弹性体上的低摩擦系数聚合物层。
13.如权利要求12所述的预填充注射装置,其中,低摩擦系数聚合物层包括含氟聚合物。
14.如权利要求13所述的预填充注射装置,其中,低摩擦系数聚合物层的含氟聚合物是膨胀型含氟聚合物。
15.如权利要求14所述的预填充注射装置,其中,弹性体至少部分吸入低摩擦系数聚合物层的膨胀型含氟聚合物中。
16.如权利要求13所述的预填充注射装置,其中,低摩擦系数聚合物层的含氟聚合物是膨胀型聚四氟乙烯(ePTFE)。
17.如权利要求13所述的预填充注射装置,其中,低摩擦系数聚合物层的含氟聚合物包括具有阻隔层和多孔层的复合含氟聚合物薄膜,阻隔层包含选自如下中的至少一种:聚四氟乙烯(PTFE)、膨胀型聚四氟乙烯(ePTFE)、致密化ePTFE、氟化乙烯丙烯(FEP)、乙烯-四氟乙烯(ETFE)、聚氟乙烯、聚偏二氟乙烯、全氟丙基乙烯基醚、全氟烷氧基聚合物、聚乙烯、聚丙烯、聚乳酸(PLA)、聚L-乳酸(PLLA)、聚D-乳酸(PDLA)、聚对二甲苯(PPX)以及它们的共聚物和组合。
18.如权利要求1至17中任一项所述的预填充注射装置,其中,预填充注射装置中的治疗制剂包含0至约600个颗粒、0至约300个颗粒、0至约100个颗粒、0至约20个颗粒、0至约5个颗粒、0至约2个颗粒和/或0至约1个颗粒的尺寸大于25微米的脂肪酸颗粒。
19.如权利要求1至18中任一项所述的预填充注射装置,其中,预填充注射装置中的治疗制剂包含0至约6000个颗粒、0至约3000个颗粒、0至约1000个颗粒、0至约200个颗粒、0至约50个颗粒、0至约20个颗粒和/或0至约10个颗粒的尺寸大于10微米的脂肪酸颗粒。
20.如权利要求1至19中任一项所述的预填充注射装置,其中,当在2℃至8℃储存至少约1年时,治疗制剂不含或基本不含脂肪酸颗粒。
21.如权利要求20所述的预填充注射装置,其中,当在2℃至8℃储存至少约2年时,治疗制剂不含或基本不含脂肪酸颗粒。
22.如权利要求1至21中任一项所述的预填充注射装置,其中,在经受加速老化后,治疗制剂不含或基本不含脂肪酸颗粒,所述加速老化包括将治疗制剂加热至40℃,历时2个月,然后将治疗制剂冷却至5℃至少24小时。
23.一种减少脂肪酸颗粒的方法,所述方法包括:
将具有脂肪酶活性且包含至少约1mg/ml的一种或多种活性药理学试剂的治疗制剂引入预填充注射装置中,所述预填充注射装置包括:
塞部;
筒体;和
在塞部和筒体中至少一个上的固体润滑剂,所述预填充注射装置不含或基本不含液体润滑剂,
其中,治疗制剂不含或基本不含表面活性剂。
24.如权利要求23所述的方法,其中,预填充治疗装置中的治疗制剂在2℃至8℃下储存至少约1年,其中,在储存步骤后,治疗制剂不含或基本不含脂肪酸颗粒。
25.如权利要求24所述的方法,其中,储存步骤进行至少约2年。
26.如权利要求23所述的方法,所述方法包括:使治疗制剂经受加速老化,所述加速老化包括:
将预填充注射装置中的治疗制剂加热至40℃,历时2个月;以及
在加热步骤后,将治疗制剂冷却至5℃至少24小时,
其中,在加热和冷却步骤后,治疗制剂不含或基本不含脂肪酸颗粒。
27.如权利要求23至26中任一项所述的方法,其中,活性药理学试剂包括:蛋白质、抗体、细胞因子、生长因子、凝血因子、蛋白酶、激酶、磷酸酶、疫苗、肽、小干扰RNA(siRNA)、小干扰DNA(siDNA)、信使RNA(mRNA)、适体和/或它们的任意组合。
28.如权利要求23至27中任一项所述的方法,其中,治疗制剂包含一种或多种活性药理学试剂,浓度为约1mg/ml至约200mg/ml、约10mg/ml至约200mg/ml、约20mg/ml至约200mg/ml、约40mg/ml至约200mg/ml、约60mg/ml至约200mg/ml、约80mg/ml至约200mg/ml、约100mg/ml至约200mg/ml、约120mg/ml至约200mg/ml和/或约150mg/ml至约200mg/ml。
29.如权利要求23至28中任一项所述的方法,其中,治疗制剂包含表面活性剂,并且,表面活性剂选自:聚山梨醇酯20、聚山梨醇酯40、聚山梨醇酯60、聚山梨醇酯80和/或它们的组合。
30.如权利要求23至29中任一项所述的方法,其中,治疗制剂包含表面活性剂,浓度为0重量%至约0.1重量%、0重量%至约0.075重量%、0重量%至约0.05重量%、0重量%至约0.025重量%、0重量%至约0.01重量%、0重量%至约0.005重量%和/或0重量%至约0.001重量%。
31.如权利要求23至30中任一项所述的方法,其中,治疗制剂包含pH为约4.0至约9.5、约4.5至约9.0、约5.0至约8.5、约5.5至约8.0、约5.5至约7.5、约5.5至约7.0和/或约5.5至约6.5的缓冲剂。
32.如权利要求23至31中任一项所述的方法,其中,治疗制剂包含糖,浓度为0重量%至约15重量%、约0.1重量%至约15重量%、约1重量%至约15重量%、约1.5重量%至约10重量%、约2重量%至约10重量%、约3重量%至约10重量%和/或约5重量%至约10重量%。
33.如权利要求23至32中任一项所述的方法,其中,治疗制剂包含多元醇,浓度为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
34.如权利要求23至33中任一项所述的方法,其中,治疗制剂包含精氨酸盐,浓度为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
35.如权利要求23至24中任一项所述的方法,其中,塞部和筒体不含或基本不含液体润滑剂硅酮。
36.如权利要求23至35中任一项所述的方法,其中,筒体由如下材料中的至少一种制成:玻璃材料、塑料材料、陶瓷材料、金属材料和/或它们的组合。
37.如权利要求23至36中任一项所述的方法,其中,固体润滑剂是低摩擦系数聚合物层,塞部包括弹性体,并且低摩擦系数聚合物层位于弹性体上。
38.如权利要求37所述的方法,其中,低摩擦系数聚合物层包括含氟聚合物。
39.如权利要求23至38中任一项所述的方法,其中,预填充注射装置中的治疗制剂包含0至约600个颗粒、0至约300个颗粒、0至约100个颗粒、0至约20个颗粒、0至约5个颗粒、0至约2个颗粒和/或0至约1个颗粒的尺寸大于25微米的脂肪酸颗粒。
40.如权利要求23至39中任一项所述的方法,其中,预填充注射装置中的治疗制剂包含0至约6000个颗粒、0至约3000个颗粒、0至约1000个颗粒、0至约200个颗粒、0至约50个颗粒、0至约20个颗粒和/或0至约10个颗粒的尺寸大于10微米的脂肪酸颗粒。
41.一种减少脂肪酸颗粒注射到对象中的方法,所述方法包括:
将治疗有效量的治疗制剂从预填充注射装置给予对象,所述预填充注射装置包括:
塞部;
筒体;和
在塞部和筒体中至少一个上的固体润滑剂,所述预填充注射装置不含或基本不含液体润滑剂,
其中,治疗制剂不含或基本不含表面活性剂,并且
其中,治疗制剂具有脂肪酶活性且包含至少约1mg/ml的一种或多种活性药理学试剂。
42.如权利要求41所述的方法,其中,活性药理学试剂包括:蛋白质、抗体、细胞因子、生长因子、凝血因子、蛋白酶、激酶、磷酸酶、疫苗、肽、小干扰RNA(siRNA)、小干扰DNA(siDNA)、信使RNA(mRNA)、适体和/或它们的任意组合。
43.如权利要求41至42中任一项所述的方法,其中,治疗制剂包含一种或多种活性药理学试剂,浓度为约1mg/ml至约200mg/ml、约10mg/ml至约200mg/ml、约20mg/ml至约200mg/ml、约40mg/ml至约200mg/ml、约60mg/ml至约200mg/ml、约80mg/ml至约200mg/ml、约100mg/ml至约200mg/ml、约120mg/ml至约200mg/ml和/或约150mg/ml至约200mg/ml。
44.如权利要求41至43中任一项所述的方法,其中,表面活性剂包括如下中的至少一种:聚山梨醇酯20、聚山梨醇酯40、聚山梨醇酯60、聚山梨醇酯80和/或它们的组合。
45.如权利要求41至44中任一项所述的方法,其中,治疗制剂包含表面活性剂,浓度为0重量%至约0.1重量%、0重量%至约0.075重量%、0重量%至约0.05重量%、0重量%至约0.025重量%、0重量%至约0.01重量%、0重量%至约0.005重量%和/或0重量%至约0.001重量%。
46.如权利要求41至45中任一项所述的方法,其中,治疗制剂包含pH为约4.0至约9.5、约4.5至约9.0、约5.0至约8.5、约5.5至约8.0、约5.5至约7.5、约5.5至约7.0和/或约5.5至约6.5的缓冲剂。
47.如权利要求41至46中任一项所述的方法,其中,治疗制剂包含糖,浓度为0重量%至约15重量%、约0.1重量%至约15重量%、约1重量%至约15重量%、约1.5重量%至约10重量%、约2重量%至约10重量%、约3重量%至约10重量%和/或约5重量%至约10重量%。
48.如权利要求41至47中任一项所述的方法,其中,治疗制剂包含多元醇,浓度为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
49.如权利要求41至48中任一项所述的方法,其中,治疗制剂包含精氨酸盐,浓度为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
50.如权利要求41至49中任一项所述的方法,其中,塞部和筒体不含或基本不含液体润滑剂硅酮。
51.如权利要求41至50中任一项所述的方法,其中,筒体由如下材料中的至少一种制成:玻璃材料、塑料材料、陶瓷材料、金属材料和/或它们的组合。
52.如权利要求41至51中任一项所述的方法,其中,固体润滑剂是低摩擦系数聚合物层,塞部包括弹性体,并且低摩擦系数聚合物层位于弹性体上。
53.如权利要求52所述的方法,其中,低摩擦系数聚合物层包括含氟聚合物。
54.如权利要求41至53中任一项所述的方法,其中,预填充注射装置中的治疗制剂包含0至约600个颗粒、0至约300个颗粒、0至约100个颗粒、0至约20个颗粒、0至约5个颗粒、0至约2个颗粒和/或0至约1个颗粒的尺寸大于25微米的脂肪酸颗粒。
55.如权利要求41至54中任一项所述的方法,其中,预填充注射装置中的治疗制剂包含0至约6000个颗粒、0至约3000个颗粒、0至约1000个颗粒、0至约200个颗粒、0至约50个颗粒、0至约20个颗粒和/或0至约10个颗粒的尺寸大于10微米的脂肪酸颗粒。
56.如权利要求41至55中任一项所述的方法,其中,进行给予步骤以处理眼部疾病。
57.一种胃肠外制剂,其包含:
至少约1mg/ml的一种或多种活性药理学试剂,
其中,当在2℃至8℃储存至少约1年时,所述制剂具有脂肪酶活性,并且不含或基本不含脂肪酸颗粒。
58.如权利要求57所述的制剂,其中,当在2℃至8℃储存至少约2年时,所述制剂不含或基本不含脂肪酸颗粒。
59.如权利要求57至58中任一项所述的制剂,其中,活性药理学试剂包括:蛋白质、抗体、细胞因子、生长因子、凝血因子、蛋白酶、激酶、磷酸酶、疫苗、肽、小干扰RNA(siRNA)、小干扰DNA(siDNA)、信使RNA(mRNA)、适体和/或它们的组合。
60.如权利要求57至59中任一项所述的制剂,其中,所述制剂包含一种或多种活性药理学试剂,浓度为约1mg/ml至约200mg/ml、约10mg/ml至约200mg/ml、约20mg/ml至约200mg/ml、约40mg/ml至约200mg/ml、约60mg/ml至约200mg/ml、约80mg/ml至约200mg/ml、约100mg/ml至约200mg/ml、约120mg/ml至约200mg/ml和/或约150mg/ml至约200mg/ml。
61.如权利要求57至60中任一项所述的制剂,其中,治疗制剂不含或基本不含表面活性剂,并且,表面活性剂包括如下中的至少一种:聚山梨醇酯20、聚山梨醇酯40、聚山梨醇酯60、聚山梨醇酯80和/或它们的组合。
62.如权利要求61所述的制剂,其中,治疗制剂包含表面活性剂,浓度为0重量%至约0.1重量%、0重量%至约0.075重量%、0重量%至约0.05重量%、0重量%至约0.025重量%、0重量%至约0.01重量%、0重量%至约0.005重量%和/或0重量%至约0.001重量%。
63.如权利要求57至62中任一项所述的制剂,其包含pH为约4.0至约9.5、约4.5至约9.0、约5.0至约8.5、约5.5至约8.0、约5.5至约7.5、约5.5至约7.0和/或约5.5至约6.5的缓冲剂。
64.如权利要求57至63中任一项所述的制剂,其包含糖,浓度为0重量%至约15重量%、约0.1重量%至约15重量%、约1重量%至约15重量%、约1.5重量%至约10重量%、约2重量%至约10重量%、约3重量%至约10重量%和/或约5重量%至约10重量%。
65.如权利要求57至64中任一项所述的制剂,其包含多元醇,浓度为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
66.如权利要求57至65中任一项所述的制剂,其包含精氨酸盐,浓度为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
67.如权利要求57至66中任一项所述的制剂,其包含至少一种溶剂。
68.如权利要求67所述的制剂,其中,至少一种溶剂包括水、乙酸、丙二醇、乙二醇、聚乙二醇、苯甲酸苄酯和它们的组合。
69.如权利要求57至68中任一项所述的制剂,其中,预填充注射器中的制剂包含0至约600个颗粒、0至约300个颗粒、0至约100个颗粒、0至约20个颗粒、0至约5个颗粒、0至约2个颗粒和/或0至约1个颗粒的尺寸大于25微米的脂肪酸颗粒。
70.如权利要求57至69中任一项所述的制剂,其中,预填充注射器中的制剂包含0至约6000个颗粒、0至约3000个颗粒、0至约1000个颗粒、0至约200个颗粒、0至约50个颗粒、0至约20个颗粒和/或0至约10个颗粒的尺寸大于10微米的脂肪酸颗粒。
71.一种预填充注射装置,其包括:
塞部;
筒体;
在塞部和筒体中至少一个上的固体润滑剂,所述预填充注射装置不含或基本不含液体润滑剂;和
具有脂肪酶活性且包含至少约1mg/ml的一种或多种活性药理学试剂的治疗制剂,
其中,至少一种治疗制剂不含或基本不含表面活性剂。
72.如权利要求71所述的预填充注射装置,其中,活性药理学试剂包括:蛋白质、抗体、细胞因子、生长因子、凝血因子、蛋白酶、激酶、磷酸酶、疫苗、肽、小干扰RNA(siRNA)、小干扰DNA(siDNA)、信使RNA(mRNA)、适体和/或它们的任意组合。
73.如权利要求71至72中任一项所述的预填充注射装置,其中,治疗制剂包含一种或多种活性药理学试剂,浓度为约1mg/ml至约200mg/ml、约10mg/ml至约200mg/ml、约20mg/ml至约200mg/ml、约40mg/ml至约200mg/ml、约60mg/ml至约200mg/ml、约80mg/ml至约200mg/ml、约100mg/ml至约200mg/ml、约120mg/ml至约200mg/ml和/或约150mg/ml至约200mg/ml。
74.如权利要求71至73中任一项所述的预填充注射装置,其中,表面活性剂包括如下中的至少一种:聚山梨醇酯20、聚山梨醇酯40、聚山梨醇酯60、聚山梨醇酯80和/或它们的组合。
75.如权利要求71至74中任一项所述的预填充注射装置,其中,治疗制剂包含表面活性剂,浓度为0重量%至约0.1重量%、0重量%至约0.075重量%、0重量%至约0.05重量%、0重量%至约0.025重量%、0重量%至约0.01重量%、0重量%至约0.005重量%和/或0重量%至约0.001重量%。
76.如权利要求71至75中任一项所述的预填充注射装置,其中,治疗制剂包含pH为约4.0至约9.5、约4.5至约9.0、约5.0至约8.5、约5.5至约8.0、约5.5至约7.5、约5.5至约7.0和/或约5.5至约6.5的缓冲剂。
77.如权利要求71至76中任一项所述的预填充注射装置,其中,治疗制剂包含糖,浓度为0重量%至约15重量%、约0.1重量%至约15重量%、约1重量%至约15重量%、约1.5重量%至约10重量%、约2重量%至约10重量%、约3重量%至约10重量%和/或约5重量%至约10重量%。
78.如权利要求71至77中任一项所述的预填充注射装置,其中,治疗制剂包含多元醇,浓度为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
79.如权利要求71至78中任一项所述的预填充注射装置,其中,治疗制剂包含精氨酸盐,浓度为0重量%至约5重量%、约0.1重量%至约5重量%、约1重量%至约5重量%、约1.5重量%至约5重量%、约2重量%至约5重量%和/或约3重量%至约5重量%。
80.如权利要求71至79中任一项所述的预填充注射装置,其中,筒体由如下材料中的至少一种制成:玻璃材料、塑料材料、陶瓷材料、金属材料和/或它们的组合。
81.如权利要求71至80中任一项所述的预填充注射装置,其中,治疗制剂不含或基本不含脂肪酸颗粒。
82.如权利要求81所述的预填充注射装置,其中,预填充注射装置中的治疗制剂包含0至约600个颗粒、0至约300个颗粒、0至约100个颗粒、0至约20个颗粒、0至约5个颗粒、0至约2个颗粒和/或0至约1个颗粒的尺寸大于25微米的脂肪酸颗粒。
83.如权利要求81至82中任一项所述的预填充注射装置,其中,预填充注射装置中的治疗制剂包含0至约6000个颗粒、0至约3000个颗粒、0至约1000个颗粒、0至约200个颗粒、0至约50个颗粒、0至约20个颗粒和/或0至约10个颗粒的尺寸大于10微米的脂肪酸颗粒。
84.如权利要求81至83中任一项所述的预填充注射装置,其中,当在2℃至8℃储存至少约1年时,治疗制剂不含或基本不含脂肪酸颗粒。
85.如权利要求84所述的预填充注射装置,其中,当在2℃至8℃储存至少约2年时,治疗制剂不含或基本不含脂肪酸颗粒。
86.如权利要求81至85中任一项所述的预填充注射装置,其中,在经受加速老化后,治疗制剂不含或基本不含脂肪酸颗粒,所述加速老化包括将治疗制剂加热至40℃,历时2个月,然后将治疗制剂冷却至5℃至少24小时。
87.如权利要求71至86中任一项所述的预填充注射装置,其中,塞部和筒体不含或基本不含液体润滑剂硅酮。
88.如权利要求71至87中任一项所述的预填充注射装置,其中,固体润滑剂是低摩擦系数聚合物层,并且塞部包括弹性体和位于弹性体上的低摩擦系数聚合物层。
89.如权利要求88所述的预填充注射装置,其中,低摩擦系数聚合物层包括含氟聚合物。
90.如权利要求89所述的预填充注射装置,其中,低摩擦系数聚合物层的含氟聚合物是膨胀型含氟聚合物。
91.如权利要求90所述的预填充注射装置,其中,弹性体至少部分吸入低摩擦系数聚合物层的膨胀型含氟聚合物中。
92.如权利要求90至91中任一项所述的预填充注射装置,其中,低摩擦系数聚合物层的膨胀型含氟聚合物用如下中的至少一种处理进行预处理:化学蚀刻、等离子体处理、电晕和物理改性。
93.如权利要求89至92中任一项所述的预填充注射装置,其中,低摩擦系数聚合物层的含氟聚合物是膨胀型聚四氟乙烯(ePTFE)。
94.如权利要求93所述的预填充注射装置,其中,低摩擦系数聚合物层的含氟聚合物是致密化ePTFE。
95.如权利要求89至94中任一项所述的预填充注射装置,其中,低摩擦系数聚合物层的含氟聚合物包括具有阻隔层和多孔层的复合含氟聚合物薄膜,阻隔层包含选自如下中的至少一种:聚四氟乙烯(PTFE)、膨胀型聚四氟乙烯(ePTFE)、致密化ePTFE、氟化乙烯丙烯(FEP)、乙烯-四氟乙烯(ETFE)、聚氟乙烯、聚偏二氟乙烯、全氟丙基乙烯基醚、全氟烷氧基聚合物、聚乙烯、聚丙烯、聚对二甲苯(PPX)、聚乳酸(PLA)、聚L-乳酸(PLLA)、聚D-乳酸(PDLA)以及它们的共聚物和组合。
96.如权利要求71至95中任一项所述的预填充注射装置,其包括可在所述筒体内往复运动的柱塞杆,其中,塞部固定至柱塞杆的末端。
97.如权利要求71至96中任一项所述的预填充注射装置,其中,塞部和治疗制剂之间测量的顶空体积为约0.1mL或更低。
98.如权利要求97所述的预填充注射装置,其中,顶空体积为约0.05mL或更低。
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