CN110475545A - 用于控制释放生物活性剂的可注射和可生物降解的聚合物制剂 - Google Patents
用于控制释放生物活性剂的可注射和可生物降解的聚合物制剂 Download PDFInfo
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Abstract
本公开涉及用于将生物活性剂试剂递送至目标部位的可注射制剂,该可注射制剂包括基于三亚甲基碳酸酯(TMC)的可生物降解的聚合物,其具有摩尔分数的聚乳酸(PLA)和/或聚乙醇酸(PGA)。可以将诸如聚乙二醇(PEG)的赋形剂添加到制剂中以降低注射力和/或调节生物活性剂的释放。用于可注射制剂的合适的可生物降解的聚合物包括D,L‑PLA:TMC,D‑PLA:TMC,L‑PLA:TMC,TMC:PLA:PGA及其变体。另外,TMC和PLA的共聚物以及TMC:PLA:PGA三元共聚物可以形成为纳米颗粒,并用可注射的可交联聚乙二醇体系递送到目标部位。在至少一个实施方式中,可注射制剂用于治疗眼病。
Description
技术领域
本公开一般涉及可注射药物递送系统,并且更具体地涉及可生物降解的可注射聚合物制剂,其允许在目标部位延长或持续释放生物活性剂以实现期望的治疗效果。
背景技术
存在多种急性和慢性病症,例如眼病、癌症和炎性疾病(例如,克罗恩病),其可以用生物活性剂和其他小分子治疗。例如,如果不治疗,一些眼病可能导致部分或甚至完全视力丧失。一种突出的慢性眼病是与年龄相关的黄斑变性(ARMD),这是老年人失明的主要原因。治疗ARMD是眼后段疾病,需要长期药物治疗。局部施用的治疗例如眼滴剂在治疗眼后段的疾病方面是无效的,因为滴剂不能显著地穿透眼睛并将生物活性剂递送到目标部位。使用常规针头和注射器直接注射到眼睛中以递送生物制剂已经成功,但需要专业培训和/或多次注射以完成治疗。
因此,希望最大程度地减少将治疗有效量的药物递送到眼组织部位以治疗和/或治愈疾病所需的眼部注射治疗的次数和/或频率。还希望最大程度地减少注射治疗至除眼睛以外的组织部位,包括心脏,肾脏或肝脏,以及例如皮下注射以治疗和/或治愈疾病所需的的次数和/或频率。
发明内容
一个实施方式涉及持续释放制剂,其包括(1)具有三亚甲基碳酸酯(TMC)和聚丙交酯(PLA)的重复单元的可注射的生物可吸收共聚物,(2)至少0.5重量%的药学上可接受的赋形剂,(3)1,2,3-三乙酰氧基丙烷,和(4)生物活性剂。生物活性剂可以掺入可注射的生物可吸收共聚物中。在至少一个实施方式中,赋形剂可以是聚乙二醇、泊洛沙姆(polyxamer)或聚乙烯醇。共聚物可以是重量比为55:45的L-PLA和TMC,重量比为55:45的D-PLA和TMC,或重量比为50:50的D,L-PLA和TMC。另外,该制剂具有120N或更低的滑动力。此外,生物活性剂从可注射生物可吸收共聚物中释放的半衰期大于30天。
另一个实施方式涉及用于治疗眼科疾病的持续释放制剂,其包括(1)可注射的生物可吸收共聚物纳米颗粒,其包括三亚甲基碳酸酯(TMC)和聚丙交酯(PLA)和(2)可交联的聚乙二醇(PEG)。共聚物可具有75:25的PLA:TMC比率。该制剂还可包含溶剂。在至少一个实施方式中,溶剂可以是1,2,3-三乙酰氧基丙烷、柠檬酸乙酰基三丁酯、柠檬酸三乙酯、柠檬酸三丁酯或柠檬酸乙酰基三乙酯。另外,该制剂具有120N或更低的滑动力。生物活性剂包封在纳米颗粒中,并且从纳米颗粒中释放的半衰期大于30天。
另一个实施方式涉及可注射的生物活性剂持续释放制剂,其包括可生物降解的聚合物和掺入所述可生物降解的聚合物中的生物活性剂,所述可生物降解的聚合物包含具有三亚甲基碳酸酯(TMC)的重复单元的共聚物。制剂还可包含赋形剂和/或溶剂。在至少一个实施方式中,赋形剂可以是聚乙二醇、泊洛沙姆或聚乙烯醇,溶剂可以是1,2,3-三乙酰氧基丙烷、柠檬酸乙酰基三丁酯、柠檬酸三乙酯、柠檬酸三丁酯或柠檬酸乙酰基三乙酯。该制剂的滑动力小于约120N。该共聚物可包括重量比为55:45的L-PLA和TMC,重量比为55:45的D-PLA和TMC,或重量比为50:50的D,L-PLA和TMC。在示例性实施方式中,在80%的共聚物降解时,80%的生物活性剂已释放。
另一个实施方式涉及可注射的生物活性剂持续释放制剂,其包括可生物降解的聚合物和掺入所述可生物降解的聚合物中的生物活性剂,所述可生物降解的聚合物包含具有三亚甲基碳酸酯(TMC)的重复单元的嵌段共聚物。制剂还可包含赋形剂和/或溶剂。在至少一个实施方式中,赋形剂可以是聚乙二醇、泊洛沙姆或聚乙烯醇,溶剂可以是1,2,3-三乙酰氧基丙烷、柠檬酸乙酰基三丁酯、柠檬酸三乙酯、柠檬酸三丁酯或柠檬酸乙酰基三乙酯。该制剂具有120N或更低的滑动力。在一些实施方式中,共聚物可包括重量比为55:45的L-PLA和TMC,重量比为55:45的D-PLA和TMC,或重量比为50:50的D,L-PLA和TMC。在示例性实施方式中,在释放持续时间内,生物活性剂的保留活性大于90%。
另一个实施方式涉及可注射的生物活性剂持续释放制剂,其包括可生物降解的聚合物和掺入所述可生物降解的聚合物中的生物活性剂,所述可生物降解的聚合物包含具有三亚甲基碳酸酯(TMC)的重复单元的共聚物。该共聚物具有无定形链段和结晶链段。制剂还可包含赋形剂和/或溶剂。在至少一个实施方式中,赋形剂可以是聚乙二醇、泊洛沙姆或聚乙烯醇,溶剂可以是1,2,3-三乙酰氧基丙烷、柠檬酸乙酰基三丁酯、柠檬酸三乙酯、柠檬酸三丁酯或柠檬酸乙酰基三乙酯。该制剂具有120N或更低的滑动力。在一些实施方式中,共聚物可包括重量比为55:45的L-PLA和TMC,重量比为55:45的D-PLA和TMC,或重量比为50:50的D,L-PLA和TMC。
另一个实施方式涉及持续释放制剂,其包括:可注射的生物可吸收聚合物,其包含基于三亚甲基碳酸酯(TMC)的聚合物;药学上可接受的赋形剂;溶剂,其选自1,2,3-三乙酰氧基丙烷、柠檬酸乙酰基三丁酯、柠檬酸三乙酯、柠檬酸三丁酯和柠檬酸乙酰基三乙酯;和生物活性剂。基于TMC的聚合物包含a)包含三亚甲基碳酸酯和丙交酯的重复单元的共聚物,和/或b)聚丙交酯(PLA),(TMC),聚乙醇酸(PGA)三元共聚物,其中三元共聚物包含3-19重量%的PGA,其中PLA:TMC的重量比为3.25:1至0.75:1。生物活性剂从所述可注射的生物可吸收聚合物中释放的半衰期可大于30天。共聚物可具有无定形链段和结晶链段。赋形剂可选自聚乙二醇、泊洛沙姆和聚乙烯醇。该制剂可具有120N或更低的滑动力。共聚物可包含45至60重量%的PLA和40至55重量%的TMC。在一些方面中,共聚物包含重量比为55:45的L-PLA和TMC,重量比为55:45的D-PLA和TMC,或重量比为50:50的D,L-PLA和TMC。三元共聚物的数均分子量可以为25,000至40,000g/mol。三元共聚物的特性粘度可以为0.90至1.2dL/g。生物活性剂可以掺入所述可注射的生物可吸收聚合物中。持续释放制剂可以是体内或原位的延迟释放制剂。可以将制剂注射到组织部位中,并且当注射时,制剂在组织部位中形成固体/凝胶结构,其允许生物活性剂的延迟释放。
另一个实施方式涉及持续释放制剂,其包含:可注射的生物可吸收聚合物纳米颗粒、可交联的聚乙二醇和包封在所述纳米颗粒中的生物活性剂。所述聚合物纳米颗粒包含基于三亚甲基碳酸酯(TMC)的聚合物。基于TMC的聚合物包含:a)包含三亚甲基碳酸酯和丙交酯的重复单元的共聚物,和/或b)聚丙交酯(PLA)、(TMC)、聚乙醇酸(PGA)三元共聚物,其中三元共聚物包含3-19重量%的PGA,其中PLA:TMC的重量比为3.25:1至0.75:1。生物活性剂从所述纳米颗粒中释放的半衰期可大于30天。共聚物可包含60至90重量%的PLA和10至40重量%的TMC。共聚物可具有75:25的PLA:TMC重量比。三元共聚物的数均分子量可以为25,000至40,000g/mol。三元共聚物的特性粘度可以为0.90至1.2dL/g。生物活性剂可以包封到所述可注射的生物可吸收聚合物中。持续释放制剂可以是体内或原位的延迟释放制剂。可以将制剂注射到组织部位中,并且当注射时,制剂在组织部位中形成固体/凝胶结构,其允许生物活性剂的延迟释放。
附图简要说明
包括附图以提供对本公开的进一步理解,并且附图被纳入并构成本说明书的一部分,其例示实施方式,并且与描述一起用于解释本公开的原理。
图1是描绘实施例1的L-PLA:TMC(55:45)制剂(实心三角形)、实施例2的L-PLA:TMC(55:45)制剂(实心圆形)、PLGA低MW制剂(来自赢创工业公司(Evonik Industries)的RS752S,实心菱形)和PLGA高MW制剂(来自赢创工业公司的RS756S,实心方形)的随时间释放的牛血清白蛋白(BSA)的累积质量百分数的图示。所有曲线均基于BSA的理论负载。
图2是描绘具有1重量%PEG(实心圆形)和5重量%PEG(实心方形)的实施例1的L-PLA:TMC(55:45)制剂,具有1重量%PEG(实心菱形)和5重量%PEG(实心方形)的实施例2的L-PLA:TMC(55:45)制剂,具有1重量%PEG(空心方形)和5重量%PEG(空心菱形)的PLGA高MW制剂(来自赢创工业公司的RS756S)的随时间释放的牛血清白蛋白(BSA)的累积质量百分数的图示。所有曲线均基于BSA的理论负载。
图3是描绘含有0重量%PEG(实心圆形)、1重量%PEG(实心方形)、3重量%PEG(实心三角形)和5重量%PEG(实心菱形)的L-PLA:TMC 75:25制剂的随时间释放的牛血清白蛋白(BSA)的累积质量百分数的图示。所有曲线均基于BSA的理论负载。
图4是在20,000X拍摄的L-PLA:TMC重量比为75:25的纳米颗粒的扫描电子显微照片。
图5是在20,000X拍摄的BSA包封微球的扫描电子显微照片。
图6是描绘从D/L-PLA:TMC:PGA和PEG体系中释放BSA的图示。
图7是描绘从DLTG/波罗泽玛(Polozemar)体系中的BSA释放分布的图示。
图8是描绘从D/L-PLA:TMC:PGA和L-PLA:TMC掺混物中释放BSA的图示。
图9是描绘PEG微粒洗脱的图示。
图10是描绘PLGA,PLA:TMC:PLGA和具有PLA:TMC的交联PEG的90天植入期间的标准化平均IOP的图示。
具体实施方式
本领域的技术人员应容易理解,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,而是有可能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。应注意术语“基于TMC的共聚物”,“共聚物”和“聚合物”可在本文中互换使用。另外,术语“三元共聚物”和“TMC:PLA:PGA”可以在本文中互换和共同使用。三元共聚物也可以是基于TMC的。如本文所用,“基于TMC的聚合物”是指具有最少20重量%(wt%)的三亚甲基碳酸酯的共聚物或三元共聚物。
本公开涉及用于将生物活性剂试剂递送至目标部位的可注射制剂,该可注射制剂包括基于三亚甲基碳酸酯(TMC)的可生物降解的聚合物,其具有摩尔分数的聚乳酸(PLA)和/或聚乙醇酸(PGA)。可以将诸如聚乙二醇(PEG)的赋形剂添加到制剂中以降低注射力和/或调节生物活性剂的释放。另外,TMC和PLA的共聚物以及TMC、PLA和PGA的三元共聚物可以形成为纳米颗粒并用可注射的可交联聚乙二醇体系递送到目标部位。在至少一个实施方式中,可注射制剂用于治疗眼病。
可注射制剂包括的共聚物可以是包括三亚甲基碳酸酯(TMC)单体的基于TMC的共聚物。该共聚物可具有大于20,000g/mol的数均分子量和大于约2重量%的溶解度。适合与TMC一起使用的共聚单体包括但不限于:L-乳酸共聚单体,产生聚(L,乳酸-TMC),下文中称为“L-PLA:TMC”;D-乳酸共聚单体,产生聚(D,乳酸–TMC),下文中称为“D-PLA:TMC”;以及L-乳酸和D-乳酸和TMC的共聚单体,产生聚(DL,乳酸-TMC),下文中称为“D,L-PLA:TMC”。乳酸和乙醇酸共聚单体和TMC可用于制备三元共聚物,聚(乳酸和乙醇酸-TMC),下文称为“PLA:PGA:TMC”。共聚物的D-PLA与TMC的重量比可为55%比45%(55:45)或75%比25%(75:25),L-PLA与TMC的重量比可为55%比45%(55:45)或75%比25%(75:25),D,L-PLA与TMC的重量比可为50%比50%(50:50)或75%比25%(75:25)(均基于重量)。在一些方面,共聚物可包含45至60重量%的PLA和40至55重量%的TMC。
可注射制剂可包括代替共聚物或除共聚物之外的三元共聚物。三元共聚物可包含3-19重量%的PGA,并且PLA:TMC重量比可为3.25:1至0.75:1。三元共聚物的D-PLA与TMC的重量比可为3.25:1至0.75:1,L-PLA与TMC的重量比可为3.25:1至0.75:1,或D,L-PLA与TMC的重量比可为3.25:1至0.75:1。三元共聚物的数均分子量可以为25,000至40,000g/mol。基于TMC的共聚物和PLA:TMC:PGA三元共聚物均是稳定的,且具有生物相容性,例如与眼睛生物相容,并且可以通过小规格针(例如,25-30规格)注射。
一旦聚合物合成完成,可将聚合的共聚物或三元共聚物加入可注射的溶液中。在示例性实施方式中,共聚物或三元共聚物是可注射液体的形式,其在体内固化。用于将可生物降解的基于TMC的聚合物和PLA:TMC:PGA三元共聚物置于溶液中的溶剂的合适实例包括但不限于生物相容性溶剂,例如三乙酸甘油酯(1,2,3-三乙酰氧基丙烷)、柠檬酸乙酰基三丁酯、柠檬酸三乙酯、柠檬酸三丁酯和柠檬酸乙酰基三乙酯。本领域技术人员应理解,在本公开的范围内提及“一种”或“该”溶剂旨在包括可使用至少一种溶剂的范围。在某些情况下,可以施加热量以将共聚物溶解在溶液中。加热PLA:TMC共聚物以提高溶解度通常是不理想的,因为升高的温度可能导致聚合物的降解增加。尽管基于TMC的共聚物在加热至100℃时发生一些降解,但在100℃下的降解不足以排除本文所述的PLA:TMC共聚物用于可注射制剂中。
在一些实施方式中,添加赋形剂以降低注射力和/或调节生物活性剂的释放。在一些实施方式中,赋形剂在制剂中的含量为可注射制剂的至少1重量%或至少5重量%。示例性赋形剂包括生物相容性赋形剂。实例包括但不限于聚乙二醇(PEG)、泊洛沙姆和聚乙烯醇(PVA)。例如,添加PEG使得可注射制剂能够以较低的滑动力注射。增加可注射制剂中PEG的含量可显著降低滑动力。在一些方面中,特别是对于三元共聚物,赋形剂可以0至3重量%,例如0.001至3重量%或1.5至2.3重量%存在。在一些实施方式中,制剂可以120N或更低的滑动力注射,并且在其他实施方式中,可以小于约100N的滑动力注射。
本领域技术人员应理解,在本公开的范围内提及“一种”或“该”生物活性剂旨在包括将至少一种生物活性剂掺入可注射制剂中的范围。如本文所用的“生物活性剂”意在包括为患者提供治疗益处的部分或化合物。用于可注射制剂的生物活性剂的实例包括但不限于,用于湿性黄斑变性的生物活性剂,诸如贝伐单抗雷珠单抗阿柏西普以及用于非出血性黄斑退化的潜在生物活性剂,诸如拉帕单抗(lampalizumab)。抗炎糖皮质激素如地塞米松和氟轻松(fluocinolone acetonide)也可以或替代地包括在可注射制剂中。本文公开了另外的生物活性剂。
在使用中,可注射制剂(即,基于TMC的共聚物或PLA:TMC:PGA三元共聚物,生物活性剂和任选的赋形剂)可以注射到组织床中,在此处其形成固体物质。该物质可以是固体凝胶,例如,不是液体、溶液或分散体形式。在一些方面,一旦可注射制剂被注射,制剂包埋在组织床内。如本文所述,注射和随后形成固体物质可以允许释放生物活性剂,例如延迟释放。这允许释放在体内或原位进行。组织床可以在眼睛中,但不限于眼睛。可注射制剂可以注射到其中的组织床的其他实例包括但不限于心脏、肾脏、肝脏和皮下组织。在一个实施方式中,基于TMC的可注射制剂可以是可注射液体的形式,其固化,例如嵌入眼内。固化的物质或固体凝胶结构(本文有时称为储库)随时间表现出体内生物相容性和耐受性。有利地,可注射制剂可以用小规格针(例如,25-30规格)注射到组织床(例如,眼睛)中。基于TMC的共聚物或三元共聚物充当释放剂,用于控制生物活性剂从储库中的释放。因此,随着基于TMC的聚合物生物降解,生物活性剂随时间释放到周围组织床中。可以配制可注射制剂,使得生物活性剂随时间缓慢释放,或者其可以具有初始低水平的释放,然后是更高水平的释放。或者,可能需要具有初始爆发释放,然后持续释放剩余部分的生物活性剂以用于治疗。应注意,在可注射制剂中包含赋形剂可提高生物活性剂的释放速率。例如,加入或包含在可注射制剂中的PEG的质量分数越大,生物活性剂从聚合物物质中释放的越快。
设计可生物降解的可注射聚合物制剂以允许在目标部位延长或持续释放生物活性剂以实现所需的治疗效果。期望生物活性剂以治疗潜在疾病的方式释放。因此,生物活性剂可以在数天、数周或数月的时间内从基于TMC的共聚物或三元共聚物中释放。在一个实施方式中,生物活性剂从生物可吸收共聚物中释放的半衰期大于约30天。在其他实施方式中,生物活性剂释放的半衰期大于约6个月或大于约一年。
在另一个实施方式中,PLA:TMC共聚物或PLA:TMC:PGA三元共聚物可以形成基本上为球形的纳米颗粒。如本文所用,“基本上球形”是指表示球形或接近球形的纳米颗粒。纳米颗粒可用于通过胞饮作用和吞噬作用的过程来细胞间递送生物活性剂。另外,TMC链段可以充当生物活性剂的佐剂以改善其性能。图4是重量比为75:25的L-PLA:TMC聚合物的示例性纳米颗粒的SEM。
由PLA和TMC的共聚物或PLA:TMC:PGA的三元共聚物形成的纳米颗粒可以包含在可注射的可交联聚乙二醇(PEG)体系中。在这样的实施方式中,可以使用双注射器装置。例如,纳米颗粒和PEG-胺(pH 9.0)的混合物可以包含在一个注射器的筒内,而PEG-琥珀酰亚胺基戊二酸酯(pH 4.0)的溶液可以包含在另一个注射器的筒内。注射器彼此连接,使得每个筒内的物质可以同时或几乎同时注入。在注射时,两个筒的物质混合并产生刚性水凝胶,其中捕获有纳米颗粒。不希望受理论限制,据信在某些情况下,这种组合凝胶和纳米颗粒的体系提供了一种情况,其中凝胶用于隐藏纳米颗粒避开宿主的免疫细胞和/或可能引起负响应的体内的其他级联反应。
除了上面公开的那些之外,本公开的可注射制剂可以与生物活性剂组合使用,所述生物活性剂包括但不限于药物和生物制剂,例如凝血因子,细胞因子,表观遗传蛋白家族,生长因子,激素,肽,信号转导分子及其突变;还包括氨基酸,疫苗和/或其组合。生物活性剂还包括对上述生物制剂及其靶受体产生的抗体、反义、RNA干扰及其突变。其他生物活性剂包括基因治疗,原代和胚胎干细胞。生物活性剂中还包括对蛋白激酶、酯酶、磷酸酶、离子通道、蛋白酶、结构蛋白、膜转运蛋白、核激素受体和/或其组合产生的抗体、反义、RNA干扰。另外,应理解,如本文所述的生物活性剂的组合被认为在本公开的范围内。
凝血因子的实例包括但不限于:纤维蛋白原、凝血酶原、因子I、因子V、因子X、因子VII、因子VIII、因子XI、因子XIII、蛋白C、血小板、促凝血酶原激酶和VIIa的辅因子。
细胞因子的实例包括但不限于:淋巴因子、白细胞介素、趋化因子、单核因子、干扰素和集落刺激因子。
表观遗传蛋白家族的实例包括但不限于:含ATP酶家族AAA结构域的蛋白2(ATAD2A),含ATP酶家族-AAA结构域的2B(ATAD2B),含ATP酶家族AAA结构域的-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)),含布罗莫结构域的蛋白3-布罗莫结构域1(BRD3(1)),含布罗莫结构域的蛋白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)),含布罗莫结构域的蛋白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-异)),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),含布罗莫结构域的睾丸特异性-第1布罗莫结构域(BRDT),含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指的-1(BRPF1),含布罗莫结构域和PHD指的-3(BRPF3),含布罗莫结构域和PHD指的-3(BRPF3),含布罗莫结构域和WD重复的3–第2布罗莫结构域(BRWD3(2)),猫眼综合征临界区蛋白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(Euchromatic histone)-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),多布罗莫1-第1布罗莫结构域(PB1(1)),多布罗莫1-第2布罗莫结构域(PB1(2)),多布罗莫1-布罗莫结构域2(PBRM1(2)),多布罗莫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1(PRKCBP1),蛋白精氨酸N-甲基转移酶3(PRMT3),SWI/SNF相关-基质相关-肌动蛋白依赖性染色质调节因子-亚家族a-成员2(SMARCA2),SWI/SNF相关-基质相关-肌动蛋白依赖性染色质调节因子-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(TAF1L(1)),转录起始因子TFIID亚基1-样-第2布罗莫结构域(TAF1L(2)),含三联基序的24(TRIM24(布罗莫)),含三联基序的24(TRIM24(PHD-布罗莫)),E3泛素-蛋白连接酶TRIM33(TRIM33),含三联基序的33(TRIM33(PHD-布罗莫)),WD重复9-第1布罗莫结构域(WDR9(1)),和WD重复9-第2布罗莫结构域(WDR9(2))。
生长因子的实例包括但不限于: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),骨形态发生蛋白(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(HGFLP)、肝细胞生长因子(HGF)、肝癌衍生生长因子(HDGF)和胰岛素样生长因子。
激素的实例包括但不限于:氨基酸衍生的(如褪黑素和甲状腺素),促甲状腺素释放激素,加压素,胰岛素,生长激素,糖蛋白激素,促黄体激素,促卵泡激素,促甲状腺激素,类二十烷酸,花生四烯酸,脂毒素,前列腺素,类固醇,雌激素,睾酮,皮质醇和孕激素。
蛋白质和肽以及信号转导分子的实例包括但不限于: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损伤检查点蛋白介导,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,细胞分裂周期25同源物A(CDC25A),叉头框O3(forkhead box O3),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β1(钙粘蛋白相关蛋白或CTNNB1)。
G蛋白偶联受体(GPCR)的实例包括但不限于: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(C-C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(C-X-C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蛋白偶联受体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(FSHR)、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(GHRH)、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(pyrogluta mylated)RF酰胺肽受体(QRFPR)、G蛋白偶联胆汁酸受体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蛋白偶联受体79假基因(GPR79)、羟基羧酸受体1(HCA1)、G蛋白偶联受体(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))、含亮氨酸重复的G蛋白偶联受体家族、水平促性腺激素受体(LH)、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(视紫红质)、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、嘧啶能受体家族、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I2(前列环素)受体家族、甲状旁腺激素受体家族、毒蕈碱乙酰胆碱受体(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(平滑受体)、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)和甲状腺刺激素受体(TSH)。
核激素受体的实例包括但不限于: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(NR1H4)、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。
膜转运蛋白的实例包括但不限于: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、B0AT1、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、压力素(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、OATP1B1、OATP1B3和OATP2A1。
结构蛋白的实例包括但不限于: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和Kif18A。
蛋白酶的实例包括但不限于:ADAM(解整合素和金属蛋白酶)家族。
蛋白激酶的实例包括但不限于: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-bc1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激酶激酶家族极光激酶(aurorakinase)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、双皮质激素家族、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蛋白偶联受体激酶1(GRK1)、G蛋白偶联受体激酶家族、糖原合成酶激酶家族、生殖细胞相关的2(单激酶)(HASPIN)、造血细胞激酶(HCK)、同源域相互作用蛋白激酶家族、有丝分裂原-活化蛋白激酶激酶激酶激酶家族、激素上调Neu相关激酶(HUNK)、肠细胞(MAK样)激酶(ICK)、胰岛素样生长因子1受体(IGF1R)、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(INSR)、胰岛素受体相关受体(INSRR)、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如微管相关丝氨酸/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、SH3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)如TAO激酶家族、TANK结合激酶1(TBK1)如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)、凌乱样激酶家族、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)、TYRO3蛋白酪氨酸正弦激酶(TYRO3)、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)和ζ-链(TCR)相关蛋白激酶70kDa(ZAP70)。
其他已知生物制剂的非限制性实例包括但不限于:阿布辛格斯(Abbosynagis)、阿贝格(Abegrin)、安挺乐(Actemra)、AFP-Cide、安托瓦(Antova)、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)、Campath、CEA-Cide、CEA-Scan、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(Herceptin)、hPAM4-Cide、HumaSPECT、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、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)、Vectibix、魏璐马(Verluma)、索雷尔(Xolair)、易唯一(Yervoy)、Zenapax、和泽娃灵(Zevalin)以及它们的组合。
已知的单克隆抗体的非限制性实例包括但不限于: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(Anatumomabmafenatox)、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(Cantuzumab mertansine)、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(capromabpendetide)、卡路单抗(Carlumab)、卡罗图西单抗(Carotuximab)、卡妥索单抗、cBR96-多柔比星免疫偶联物、卡德丽珠单抗(Cedelizumab)、克果图珠单抗(Cergutuzumabamunaleukin)、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(Depatuxizumab mafodotin)、地罗西单抗(Derlotuximab artiox)、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(Enlimomab pegol)、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)、LBR-101/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(Nacolomab tafenatox)、纳米洛单抗(Namilumab)、纳布妥木单抗(Naptumomab estafenatox)、纳鲁西单抗(Naratuximabemtansine)、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(Nofetumomab merpentan)、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(Pinatuzumab vedotin)、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(Sacituzumab govitecan)、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(Sofituzumab vedotin)、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),以及它们的组合。
为病毒性疾病研发的疫苗的实例包括但不限于: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、和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、和内脏利什曼病疫苗;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、和溶瘤病毒药剂(Talimogene laherparepvec)(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(FluarixQuadrivalent)、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(FluMistQuadrivalent)、伏必灵(Fluvirin)、四价弗露倧(Fluzone Quadrivalent)、弗露倧(Fluzone)、高剂量弗露倧和皮肤内弗露倧(Fluzone High-Dose and FluzoneIntradermal)、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。
可注射药物的实例包括但不限于: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(Caverject Impulse)、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(LIORESAL INTRATHECAL))、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)、美容用Botox(注射用Ona肉毒杆菌素(OnabotulinumtoxinA))、BR3-FC、Bravelle(尿促卵泡素注射剂)、溴苄乙铵(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)、坎帕斯(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)、戊酸雌二醇(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)、葡萄糖/电解质、葡萄糖和氯化钠注射剂(0.9%氯化钠中的葡萄糖5%)、葡萄糖、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(ProHance)、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(Havrix)、Hectorol注射剂(度骨化醇(Doxercalciferol)注射剂)、何德浩途径抑制剂(HedgehogPathway Inhibitor)、肝素、赫赛汀、hG-CSF、优泌乐(Humalog)、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(Idarubicin Hydrochloride)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)、注射用肉毒素A(IncobotulinumtoxinA,Xeomin)、殷克雷斯(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)、怡万之(Invanz)(厄他培南注射剂)、善思达(Invega Sustenna)(棕榈酸帕利哌酮缓释剂(Paliperidone PalmitateExtended-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%葡萄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(Brevital Sodium))、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(Depo Medrol))、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脂质体注射剂(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)、多种电解质和葡萄糖注射剂、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(Alglucosidasealfa))、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Tc99m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%常规人胰岛素注射剂)、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和葡萄糖(维弗乐塑料容器50中的多种电解质和葡萄糖注射剂)、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%葡萄糖注射剂(葡萄糖中的林格(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(SystemicHedgehog 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、庚酸睾酮、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(Triptorelin Pamoate for Injectable 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(肉毒素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。
以下提供非限制性实施例。
实施例
聚合物合成
根据“可吸收DL-丙交酯三亚甲基碳酸酯共聚酯的分析和表征(Analysis andcharacterization of resorbable DL-lactide trimethylene carbonatecopolyesters)”,Journal of Material Science:Materials in Medicine 4(1993)第381-88页中描述的方法合成实施例中鉴定的生物可吸收聚合物。
实施例1
该实施例描述了共聚物L-PLA:TMC,其重量比为55:45。表1显示了该实施例中组合物的表征数据。
用六氟异丙醇(HFIP)作为萃取溶剂,使用Cannon MiniPV-HX自动粘度计测量特性粘度(IV)。对于该实施例,IV(HFIP)=1.07dL/g。
实施例2
该实施例描述了共聚物L-PLA:TMC,其重量比为55:45。表1显示了该实施例中组合物的表征数据。
用六氟异丙醇(HFIP)作为萃取溶剂,使用Cannon MiniPV-HX自动粘度计测量特性粘度(IV)。对于该实施例,IV(HFIP)=1.36dL/g。
实施例3
该实施例描述了共聚物D,L-PLA:TMC,其重量比为50:50。表1显示了该实施例中组合物的表征数据。
用氯仿(CHCl3)作为萃取溶剂,使用Cannon MiniPV-HX自动粘度计测量特性粘度。对于该实施例,IV(CHCl3)=0.933dL/g,聚合物的玻璃化转变温度确定为7.2℃。
实施例4
该实施例描述了共聚物L-PLA:TMC,其重量比为75:25。表1显示了以纯化样品形式的该实施例中组合物的表征数据,且T=150MIN。为了获得纯化的样品,将共聚物以2-5重量%溶解在氯仿(CHCl3)中并在10x异丙醇(IPA)中沉淀,然后真空干燥。
用六氟异丙醇(HFIP)作为萃取溶剂,使用Cannon MiniPV-HX自动粘度计测量特性粘度(IV)。对于该实施例,IV(HFIP)=1.349dL/g,聚合物的玻璃化转变温度确定为32.95℃。
实施例5
该实施例是以表格形式描述表1中的实施例1-4的聚合物组成特征的概述。
表1
实施例6
该实施例描述了基于TMC的聚合物在各种溶剂中的溶解度表征。
三乙酸甘油酯、柠檬酸三乙酯、2-乙酰基柠檬酸三乙酯,柠檬酸三丁酯、苯甲酸丁酯和O-乙酰基柠檬酸三丁酯用于测试如实施例1和2中所述的PLA:TMC共聚物的溶解度。在室温下这些PLA:TMC共聚物不能溶于任何溶剂。当将混合物加热至100℃时,共聚物溶解在三乙酸甘油酯中,直至溶液中有7.5重量%的聚合物。当加热至100℃时,在柠檬酸三乙酯和2-乙酰基柠檬酸三乙酯中,共聚物分别溶解到溶液中有5重量%的聚合物。即使将混合物加热至100℃,共聚物似乎也不溶于或几乎不溶于柠檬酸三丁酯、苯甲酸丁酯和O-乙酰基柠檬酸三丁酯。
获得实施例3和4中的PLA:TMC共聚物在三乙酸甘油酯中的溶解度。确定两种共聚物在室温下的溶解度为溶液中有7.5重量%的聚合物。
实施例7
该实施例证明了本文所述的TMC-聚合物制剂的可注射性。
在25ml玻璃瓶中,将如上文实施例3中所述的D,L-PLA:TMC 50:50溶于11g三乙酸甘油酯(圣路易斯的西格玛-奥德里奇公司(Sigma-Aldrich,St.Louis))中,通过将混合物保持在带有磁力搅拌棒的搅拌盘上,获得约6%的溶液。由该储备溶液,添加含有不同添加量的分子量为400的聚(乙二醇)(PEG)(圣路易斯的西格玛-奥德里奇公司)的制剂,产生基于总重量计的0重量%、1重量%和5重量%PEG的溶液。
使用配备有27G1/2英寸薄壁针头和约0.96μl溶液的Schott未硅化的SyriQ注射器,在TA XT Plus质构分析仪上以200mm/分钟的速度测量注射力相对于位移的关系。在测试之前将填充的注射器保持24小时以使得溶液与注射器塞充分接触。
所有力相对于位移的数据均是平坦的,在其最大力附近具有大致相同的值。利用最大力之后的数据来确定平均滑动力。分别测定0重量%,1重量%和5重量%PEG的平均滑动力为104N,103N和98N。这表明PEG浓度对滑动力有明显影响,增加PEG则滑行力下降。
实施例8
该实施例证明了与常规PLGA聚合物相比,本文所述的基于TMC的共聚物的较低注射力。
在25ml玻璃瓶中,将从德国赢创工业公司购买的RG 756S,即聚(D,L-丙交酯-共-乙交酯)溶于11g三乙酸甘油酯(圣路易斯的西格玛-奥德里奇公司)中,通过将混合物保持在带有磁力搅拌棒的搅拌盘上,获得约6%的溶液。由该储备溶液,添加含有不同添加量的分子量为400的聚(乙二醇)(PEG)(圣路易斯的西格玛-奥德里奇公司)的制剂,产生基于总重量计的0重量%和5重量%PEG的溶液。
使用配备有27G1/2英寸薄壁针头和约0.96μl溶液的Schott未硅化的SyriQ注射器,在TA XT Plus质构分析仪(汉密尔顿,马萨诸塞州)上以200mm/分钟的速度测量注射力相对于位移的关系。在测试之前将填充的注射器保持24小时以使得溶液与注射器塞充分接触。
所有力相对于位移的数据均是平坦的,在其最大力附近具有大致相同的值。利用最大力之后的数据来确定平均滑动力。分别测定0重量%和5重量%PEG的平均滑动力为117N和113N。这表明PEG浓度对滑动力有明显影响,增加PEG则滑行力下降。
实施例9
该实施例证明了本文所述的基于TMC的共聚物作为液体通过小规格针头注射器注射并在组织床内作为单一物质固化的能力。
在25ml玻璃瓶中,将如上文实施例1中所述的L-PLA:TMC 55:45溶于12g三乙酸甘油酯(圣路易斯的西格玛-奥德里奇公司)中,通过将混合物保持在带有磁力搅拌棒的搅拌盘上并加热到100℃,获得约7.5%的溶液。由该储备溶液,添加含有不同添加量的分子量为4,500的聚(乙二醇)(PEG)(新泽西州新不伦瑞克的光谱化学MFG公司(Spectrum ChemicalMFG Corp.,New Brunswick,NJ))的制剂,产生基于总重量计的1重量%和5重量%PEG的溶液。一种模型蛋白生物活性剂牛血清白蛋白(BSA)也以1.5重量%的含量与含聚合物的溶液一起配制。用研钵和研杵研磨粗BSA粉末,并使用45μm分子筛筛分。在室温下将BSA微粒加入到聚合物溶液中,然后混合。
通过约100μl的玻璃体内注射(IVI)将每种制剂递送到死后的动物受试者的眼中。将27号针头插入眼睛上侧部分的巩膜中,并从1ml注射器注射聚合物制剂。
在注射后数小时内,收集眼睛并将每只眼睛浸入其自己的标记的戴维森(Davidson)溶液容器中至少一小时。在初始浸泡之后,用手术刀在每只眼睛的侧面形成小开口,以便于玻璃体和视网膜的彻底固定。进行额外的眼内脂肪和肌肉组织修剪,并将每只眼睛重新浸入戴维森溶液中24-48小时。
在将每只眼睛对分以提供对玻璃体的清晰视野后,用低倍显微镜目视检查每只眼睛。每次注射都显示不透明的球状聚合物物质,从而证明制剂已固化并作为单一物质保留在眼睛中。
实施例10
该实施例证明了本文所述的基于TMC的共聚物作为液体通过小规格针头注射器注射并在组织床内作为单一物质固化的能力,并显示体内生物相容性和耐受性随时间的变化。
如实施例7中所述制备如实施例4中所述的共聚物L-PLA:TMC 75:25和如实施例3中所述的D,L-PLA:TMC 50:50,以产生具有5重量%PEG的6%聚合物溶液。将每种溶液无菌地通过0.2μm无菌过滤器处理至1ml注射器中。每个注射器含有约200μl制剂。
将聚合物制剂递送到动物受试者的眼睛中,并且每只眼睛仅接受单次注射。将27号针头插入眼睛上侧部分的巩膜中,并注射约100μl聚合物。聚合物制剂注射的寿命期约为30天。大约每周测量眼压(IOP)。
对于所有试验,如预期的,术后即刻测量的IOP比基线高得多(大于300%)。通过注射,眼睛中增加了更多的总体积,从而增加了眼压。IOP的即刻升高在约30分钟内恢复到正常值。对于所有接受注射的眼睛,在眼睛内可看到聚合物制剂。大约每周进行IOP检查,并确定所有值均在正常范围内。初始注射时IOP增加的消退在一定程度上证明了生物相容性和耐受性。
检查眼睛并获得眼压(IOP)。取出时,将眼睛轻轻取出,进行大体检查,并在戴维森溶液中固定至少24小时。固定后,处理眼睛进行组织学分析。
目视检查显示所有眼睛均在正常的解剖学考虑范围内,未观察到异常。在组织修剪时,在玻璃体内识别出半透明聚合物的圆形聚集体。
在显微镜下,通过检查组织学切片,所有评估的眼睛区域都在正常范围内,未观察到异常。在组织学处理期间,大部分玻璃体未被保存,因此,不能直接检查玻璃体内的聚合物制剂体系。
由于组织处理过程中玻璃体液的丧失,无法评估/评价玻璃体液内的任何炎症。然而,在视网膜内未鉴定出活跃和转移的炎性细胞群。通过视网膜迁移到玻璃体液是炎性细胞进入的途径。
总之,该实施例的发现证明了玻璃体中注入的聚合物的可接受的安全性,而没有发现风险。总的来说,这表明生物相容性和耐受性。
实施例11
该实施例比较了使用本文所述的基于TMC的共聚物制剂(不含PEG)与PLGA制剂(不含PEG)的模型蛋白生物活性剂的控制释放。
在该实施例中,牛血清白蛋白(BSA)获自西格玛生命科学公司(Sigma LifeScience)(密苏里州圣路易斯市),作为模型蛋白生物活性剂。在该实施例中使用的共聚物是如实施例1中所述的L-PLA:TMC 55:45和如实施例2中所述的L-PLA:TMC 55:45。
为了制备L-PLA:TMC聚合物储备溶液,将约1.9g实施例1的L-PLA:TMC聚合物溶于23.2g三乙酸甘油酯中。将该混合物在搅拌的同时保持在约100℃2小时,得到均匀溶液。用研钵和研杵研磨粗BSA粉末,并使用45μm筛进行筛分。在室温下将0.37g筛分的BSA微粒物质加入到聚合物溶液中并混合。最终制剂由7.5重量%聚合物和1.5重量%BSA组成。在将制剂转移到具有16号针头的1ml注射器中之前,再次短暂搅拌制剂以确保均匀性。将约50μl制剂注入13ml玻璃试管中,该试管中含有3ml 1x PBS,其具有0.01%w/v聚山梨醇酯20和0.02%w/v叠氮化钠。注入后,形成单一的制剂储库。聚合物储库的重量通过制剂注入前后称重玻璃管之间的重量差来确定。
用实施例2的L-PLA:TMC重复上述步骤,得到由7.5重量%聚合物和1.5重量%BSA组成的混合物。在将制剂转移到具有16号针头的1ml注射器中之前,再次短暂搅拌制剂以确保均匀性。将约50μl制剂注入13ml玻璃试管中,该试管中含有3ml 1x PBS,其具有0.01%w/v聚山梨醇酯20和0.02%w/v叠氮化钠。注入后,形成单一的制剂储库。聚合物储库的重量通过制剂注入前后称重玻璃管之间的重量差来确定。
类似地,使用市售的高分子量PLGA聚合物(RS756S,来自德国赢创工业公司)和低分子量PLGA聚合物(RS752S,来自德国赢创工业公司)作为对照。最终制剂由7.5重量%聚合物和1.5重量%BSA组成。在不加热聚合物的情况下制备这些制剂。
在周期性时间段,收集,保留和更新3ml PBS溶液。通过利用赛默科技公司(ThermoScientific)(伊利诺斯州罗克福德)的Bradford测定试剂盒(prod#23209)分析保留的样品的BSA含量。
图1图示了从含以下成分的制剂释放的BSA的累积质量百分数随时间的变化:实施例1的L-PLA:TMC(实心三角形)、实施例2的L-PLA:TMC(实心圆形)、PLGA低MW(RS752S,德国赢创工业公司)(实心菱形),和PLGA高MW(RS756S,德国赢创工业公司(实心方形)。所有曲线均基于BSA理论负载。PLGA低MW的释放是一个爆发体系,大部分BSA在前几周释放,而PLGA高MW制剂显示延长的双相释放曲线。两种L-PLA:TMC制剂均与PLGA制剂不同,L-PLA:TMC制剂具有初始低释放水平,随后是更高水平的释放。这表明L-PLA:TMC制剂可以产生延长释放曲线并且不同于PLGA制剂。
实施例12
该实施例比较了使用本文所述的基于TMC的共聚物制剂(含PEG)与PLGA制剂(含PEG)的模型蛋白生物活性剂的控制释放。
在该实施例中,牛血清白蛋白(BSA)获自西格玛生命科学公司(密苏里州圣路易斯市),作为模型蛋白生物活性剂。在该实施例中使用的共聚物是如实施例1中所述的L-PLA:TMC 55:45和如实施例2中所述的L-PLA:TMC 55:45。该实施例中的所有制剂含有1重量%或5重量%的PEG。
为了使用实施例1的L-PLA:TMC共聚物制备L-PLA:TMC聚合物储备溶液,将1g该L-PLA:TMC聚合物溶于12g三乙酸甘油酯中。将该混合物加热到约100℃并搅拌2小时,直到得到均匀溶液。当将聚合物溶液冷却至50℃时,将0.14g PEG(Spectrum,Mw=4.6K Da)加入到聚合物溶液中并搅拌直至获得含有1重量%PEG的均匀溶液。为了得到含有5重量%PEG的聚合物溶液,将0.71g PEG(Spectrum,Mw=4.6K Da)加入到聚合物溶液中并搅拌直至获得均匀溶液。将BSA薄片研磨并使用45μm分子筛进行筛分。在冷却至室温后,将0.2g BSA微粒加入到聚合物溶液中。最终混合物含有7.5重量%的聚合物,1重量%或5重量%的PEG,和1.5重量%的BSA。将混合物再次搅拌,然后装入配有16号针头的1ml注射器中。将约50μl混合物注入13ml玻璃试管中,该试管中含有3ml 1x PBS,其具有0.01%w/v聚山梨醇酯20和0.02%w/v叠氮化钠。在PBS溶液中形成聚合物储库。通过在注入聚合物混合物之前和之后称重玻璃管来计算聚合物储库的重量。
用实施例2的L-PLA:TMC重复上述步骤,得到含有7.5重量%聚合物,1重量%或5重量%PEG,和1.5重量%BSA的混合物。将约50μl混合物注入13ml玻璃试管中,该试管中含有3ml 1x PBS,其具有0.01%w/v聚山梨醇酯20和0.02%w/v叠氮化钠。在PBS溶液中形成聚合物储库。通过在注入聚合物混合物之前和之后称重玻璃管来计算聚合物储库的重量。
类似地,使用市售的高分子量PLGA聚合物(RS756S,来自德国赢创工业公司)和低分子量PLGA聚合物(RS752S,来自德国赢创工业公司)作为对照。最终PLGA制剂由7.5重量%聚合物和1.5重量%BSA组成。在不加热聚合物的情况下制备这些制剂。
在周期性时间段,收集,保留和更新3ml PBS溶液。通过利用赛默科技公司(伊利诺斯州罗克福德)的Bradford测定试剂盒(prod#23209)分析保留的样品的BSA含量。图2图示了以下制剂随时间释放的BSA的累积质量百分数:具有1重量%PEG(实心圆形)和5重量%PEG(实心方形)的L-PLA:TMC(实施例1)的制剂;具有1重量%PEG(实心三角形)和5重量%PEG(实心菱形)的L-PLA:TMC(实施例2)的制剂,和具有1重量%PEG(空心方形)和5重量%PEG(空心菱形)的PLGA高MW(RS756S,德国赢创工业公司)的制剂。所有曲线均基于理论负载。
实施例13
该实施例证明了BSA作为模型蛋白生物活性剂从含有L-PLA:TMC 75:25聚合物(不需要加热来溶解)和0重量%、1重量%、3重量%或5重量%PEG的制剂的控制释放。
通过将1g如实施例4中所述的L-PLA:TMC(75:25)聚合物溶解在12g三乙酸甘油酯中来制备L-PLA:TMC(75:25)聚合物溶液。将混合物在室温下搅拌4天,得到均匀溶液。在37℃下保持L-PLA:TMC聚合物溶液的同时,在不断搅拌下加入PEG以获得具有1重量%、3重量%或5重量%PEG的制剂。将BSA薄片研磨并使用45μm分子筛进行筛分,以产生BSA微粒。然后在室温下将约0.2g BSA微粒加入上述聚合物和PEG溶液中。应注意,进行该过程以获得四种单独的制剂。最终混合物含有7.5重量%聚合物,1.5%BSA,和0重量%(不添加PEG)、1重量%、3重量%或5重量%的PEG。
将混合物再次搅拌,然后装入配有16号针头的1ml注射器中。将约50μl混合物注入13ml玻璃试管中,该试管中含有3ml 1x PBS,其具有0.01%w/v聚山梨醇酯20和0.02%w/v叠氮化钠。在PBS溶液中形成聚合物储库。通过在注入聚合物混合物之前和之后称重玻璃管来计算聚合物储库的重量。
图3图示了从含有0重量%PEG(实心圆形)、1重量%PEG(实心方形)、3重量%PEG(实心三角形)和5重量%PEG(实心菱形)的L-PLA:TMC 75:25制剂中随时间释放的牛血清白蛋白(BSA)的累积质量百分数。注意到加入到体系中的PEG的质量分数越大,BSA从聚合物储库中释放的越快。
实施例14
该实施例证明了由如本文所述的PLA和TMC的共聚物制成的纳米颗粒。
通过在室温下将0.40g L-PLA:TMC 75:25聚合物(如实施例4中所述)溶解在20ml二氯甲烷中来制备纳米颗粒。然后将约40ml的5%聚乙烯醇(奥德里奇公司(Aldrich),Mowiol 4-88)水溶液加入到有机聚合物溶液中。使用配备有1/8”锥形探针的BransonSXF150超声波仪将所得混合物超声处理2分钟。使用具有30秒开启和10秒关闭的脉冲模式,70%的振幅用于超声处理以产生乳液。另外在500rpm磁力搅拌下将100ml去离子水加入到乳液中。将乳液搅拌约1小时,然后在减压下(使用Welch,Dryfast2032泵)在室温下旋转蒸发(IKA,RV10 Basic,100rpm)处理1小时以萃取二氯甲烷。这形成硬化的颗粒,通过在4000rpm下离心8小时(Beckman GS-6KR离心机)收集这些颗粒。将颗粒再分散在去离子水中,冲洗掉残留的化学物质,并再次离心。弃去上清液以除去任何残留的聚乙烯醇。将清洁的颗粒分散在20ml去离子水中并冻干。以20,000X拍摄的冻干颗粒的扫描电子显微镜(SEM)图像显示在图4中。纳米颗粒具有球形形状并且是单个的。
实施例15
该实施例证明了可注射的交联PEG体系中包含的PLA和TMC的共聚物的纳米颗粒。
将约0.02g实施例14中所述的L-PLA:TMC 75:25聚合物纳米颗粒分散在1ml 1xPBS中,并使用Branson SXF150以70%振幅超声处理30秒。另外将0.2g 4臂PEG胺(CreativePEGWorks公司,Mw=10K)溶解在0.9ml 1XPBS中,用0.25N氢氧化钠溶液(奥德里奇公司)将其调节至PH=9.0。此外,将0.04g 4-臂PEG琥珀酰亚胺基戊二酸酯(Creative PEGWorks公司,Mw=2K)溶解在1ml 1XPBS中,用0.1N盐酸溶液(奥德里奇公司)调节到PH=4.0。然后将约100μl的L-PLA:TMC 75:25纳米颗粒分散体加入到PEG-胺溶液中并使用磁力搅拌棒充分混合。分别用0.2μm过滤器(颇尔生命科学公司(Pall Lifesciences),Acrodisc CR 25mm注射器过滤器)过滤PEG-胺颗粒溶液和PEG-SG溶液。
然后在分开的两侧用过滤的溶液填充2ml×2ml 1:1比例的双筒注射器(普拉斯帕克工业公司(Plas-Pak Industries Inc.))。将改进的尖端和针头配置连接到双筒注射器上。改进的尖端和针头配置由2mm x 8mm Element微混合器针尖(普拉斯帕克工业公司)组成,尖端的锥形部分被切除,用超级胶水将鲁尔锁尖端(科西纳(Qosina),部件号64017)粘合到剩余的尖端部分,并将27G针头装配到鲁尔部分。将溶液缓慢地从注射器中推出并立即形成具有包埋的纳米颗粒的水凝胶。用金属刮刀戳交联凝胶显示出凝胶硬度。
三元共聚物的合成
根据“可再吸收DL-丙交酯三亚甲基碳酸酯共聚酯的分析和表征(Analysis andcharacterization of resorbable DL-lactide trimethylene carbonatecopolyesters)”,材料科学杂志(Journal of Material Science):医学材料4(Materialsin Medicine 4)(1993)第381-88页中描述的方法合成实施例中鉴定的生物可吸收聚合物。
实施例16
该实施例描述了三元共聚物D/L-PLA:TMC:PGA,其重量比为67.5:22.5:10。PLA与TMC的比值为3。
用氯仿(CHCl3)作为溶剂,使用Cannon MiniPV-HX自动粘度计测量特性粘度(IV)。对于该实施例,IV(CHCl3)=1.086dL/g,聚合物的玻璃化转变温度确定为-3℃。体外降解研究表明,三元共聚物在6-8个月的时间范围内基本上降解。
实施例17
该实施例描述了三元共聚物D/L-PLA:TMC:PGA,其重量比为63.75:21.25:15。PLA与TMC的比值为3。
用氯仿(CHCl3)作为溶剂,使用Cannon MiniPV-HX自动粘度计测量特性粘度(IV)。对于该实施例,IV(CHCl3)=1.155dL/g,聚合物的玻璃化转变温度确定为-1℃。体外降解研究表明,三元共聚物在6-8个月的时间范围内基本上降解。
实施例18
该实施例描述了三元共聚物D/L-PLA:TMC:PGA,其重量比为45:45:10。PLA与TMC的比值为1。
用氯仿(CHCl3)作为溶剂,使用Cannon MiniPV-HX自动粘度计测量特性粘度。对于该实施例,IV(CHCl3)=1.093dL/g,聚合物的玻璃化转变温度确定为11.3℃。体外降解研究表明,三元共聚物在6-8个月的时间范围内基本上降解。
实施例19
该实施例描述了三元共聚物D/L-PLA:TMC:PHR PGA,其重量比为42.5:42.5:15。PLA与TMC的比值为1。
用氯仿(CHCl3)作为溶剂,使用Cannon MiniPV-HX自动粘度计测量特性粘度(IV)。对于该实施例,IV(CHCl3)=0.9576dL/g,聚合物的玻璃化转变温度确定为13.1℃。体外降解研究表明,三元共聚物在6-8个月的时间范围内基本上降解。
表2详细描述了实施例16、17、18和19中使用的三元共聚物的表征。
表2三元共聚物的表征
实施例20
该实施例描述了基于TMC的三元共聚物在三乙酸甘油酯溶剂中的溶解度表征。
三乙酸甘油酯用于测试如实施例16、17、18和19中所述的PLA:TMC:PGA三元共聚物的溶解度。在室温下,这些PLA:TMC:PGA三元共聚物在室温下在溶剂中搅拌数天后可溶于三乙酸甘油酯溶剂中。三元共聚物可以溶解在三乙酸甘油酯中,直至溶液中聚合物达到20重量%。在20重量%时,溶液变得太粘而不能通过27G针头进行注射。
实施例21
该实施例证明了本文所述的TMC-三元共聚物的三乙酸甘油酯溶液的可注射性。在25ml玻璃瓶中,将如上文实施例16和19中所述的1克D,L-PLA:TMC:PGA三元共聚物溶于12g三乙酸甘油酯(圣路易斯的西格玛-奥德里奇公司)中,通过将各混合物保持在带有磁力搅拌棒的搅拌盘上,获得约7.5重量%的聚合物溶液。将混合物在室温下搅拌几天后,得到澄清的均匀聚合物溶液。
使用配备有27G1/2英寸薄壁针头和约0.96μl溶液的Schott未硅化的SyriQ注射器,在TA XT Plus质构分析仪上以200mm/分钟的速度测量注射力相对于位移的关系。在测试之前将填充的注射器保持30分钟以使得溶液与注射器塞充分接触。
所有力相对于位移的数据均是平坦的,在其最大力附近具有大致相同的值。利用最大力之后的数据来确定平均滑动力。分别测定实施例16和19的三元共聚物的平均滑动力为98N和120N。
实施例22
该实施例证明了本文实施例16、17、18和19中所述的基于TMC的三元共聚物作为液体通过小规格针头注射器注射并在组织床内作为单一物质固化的能力。根据实施例21制备,得到溶液。
在对分以提供对玻璃体的清晰视野后,在取出的情况下用低倍显微镜检查每种制剂。每次注射都显示不透明的球状聚合物物质,从而证明制剂已固化并作为单一物质保留在眼睛中。
实施例23
该实施例描述了使用喷雾干燥方法制备微粒蛋白模型蛋白生物活性剂。
在该实施例中,牛血清白蛋白(BSA)获自西格玛生命科学公司(密苏里州圣路易斯市),作为模型蛋白生物活性剂。
为了使用喷雾干燥法制备BSA微粒,将BSA粉末(西格玛98-99%A-7906批号#:39F0001)以8重量%的浓度溶解在去离子水中。使用Buchi Model B-290迷你喷雾干燥器将溶液喷雾干燥。进口温度设定为100℃,吸气器容量为100%,转子流量计设定为40mm高度,相当于473L/小时的气体流量。氮气用作喷射空气。蠕动泵设定为30%。这导致出口温度为70℃。将喷雾干燥的BSA微粒(MS-2)收集在干净的干燥玻璃小瓶中,并储存在4℃冰箱中直至进一步使用。通过SEM检查颗粒,结果显示它们的尺寸范围为1-10um。
实施例24
该实施例比较了使用本文所述的含有0重量%、1重量%、1.5重量%、2.3重量%或3重量%PEG的基于TMC的三元共聚物制剂的模型蛋白生物活性剂的控制释放。
在该实施例中,牛血清白蛋白(BSA)获自西格玛生命科学公司(密苏里州圣路易斯市),作为模型蛋白生物活性剂。该实施例使用的三元共聚物是如实施例17所述的D/L-PLA:TMC:PGA 63.75:21.25:15。
根据实施例23,使用1重量%的BSA水溶液制备BSA微粒。通过SEM检查BSA微粒,结果显示它们的尺寸范围为1-10um。
通过以下方式制备D/L-PLA:TMC:PGA(63.75:21.25:15)三元共聚物溶液:将如实施例17中所述的1g D/L-PLA:TMC:PGA(63.75:21.25:15)聚合物与适量的PEG(西格玛,P-3515,批号17H0551,Mw=1000)溶解在12g三乙酸甘油酯中,得到含有0重量%、1重量%、1.5重量%、2.3重量%、3重量%和5重量%PEG(西格玛,Mw=1000)的制剂。将混合物在室温下搅拌4天,得到均匀溶液。然后在室温下将约0.2g BSA微粒加入上述聚合物和PEG溶液中。应注意,进行该过程以获得5种单独的制剂。最终混合物含有7.5重量%聚合物,1.5%BSA,和0重量%(不添加PEG)、1.5重量%、2重量%、2.3重量%或3重量%的PEG。
将混合物再次搅拌,然后装入配有16号针头的1ml注射器中。将约100μl混合物注入13ml玻璃试管中,该试管中含有3ml 1x PBS,其具有0.01%w/v聚山梨醇酯20和0.02%w/v叠氮化钠。在PBS溶液中形成聚合物储库。通过在注入聚合物混合物之前和之后称重玻璃管来计算聚合物储库的重量。
图6图示了从含有0重量%PEG(实心三角形)、1.5重量%PEG(叉形)、2重量%PEG(星形)、2.3重量%PEG(实心菱形)、3重量%PEG(实心圆形)和5重量%PEG(实心方形)的D/L-PLA:TMC:PGA(63.75:21.25:15)制剂中随时间释放的牛血清白蛋白(BSA)的累积质量百分数。注意到当超过3重量%的PEG加入到体系中时,BSA在第一周内迅速释放。当PEG的总量在1.5-2.3重量%时,得到在第一周内控制释放。
实施例25
该实施例比较了使用本文所述的含有0.23重量%、0.38重量%、0.54重量%、1重量%或1.5重量%泊洛沙姆F68的基于TMC的三元共聚物制剂的模型蛋白生物活性剂的控制释放。
在该实施例中,用于该实施例的三元共聚物是如实施例17所述的D/L-PLA:TMC:PGA 63.75:21.25:15。模型蛋白生物活性剂BSA微粒与实施例24中所述的相同。
通过以下方式制备D/L-PLA:TMC:PGA(63.75:21.25:15)三元共聚物溶液:将如实施例21中所述的1g D/L-PLA:TMC:PGA(63.75:21.25:15)聚合物与适量的泊洛沙姆F68(巴斯夫(BASF),Lutrol Micro 68MP,批号#W045740,Mw=8400)溶解在12g三乙酸甘油酯中,得到含有0.23重量%、0.38重量%、0.54重量%、1重量%或1.5重量%泊洛沙姆的制剂。将混合物在室温下搅拌4天,得到均匀溶液。然后在室温下将约0.2g BSA微粒加入上述聚合物和PEG溶液中。应注意,进行该过程以获得5种单独的制剂。最终混合物含有7.5重量%聚合物,1.5%BSA,和0.23重量%、0.38重量%、0.54重量%、1重量%或1.5重量%的泊洛沙姆F68。
将混合物再次搅拌,然后装入配有16号针头的1ml注射器中。将约100μl混合物注入13ml玻璃试管中,该试管中含有3ml 1x PBS,其具有0.01%w/v聚山梨醇酯20和0.02%w/v叠氮化钠。在PBS溶液中形成聚合物储库。通过在注入聚合物混合物之前和之后称重玻璃管来计算聚合物储库的重量。
图7图示了从含有0.23重量%泊洛沙姆(实心方形)、0.38重量%泊洛沙姆(实心三角形)、0.54重量%泊洛沙姆(实心圆形)、1重量%泊洛沙姆(实心菱形)、1.5重量%泊洛沙姆(实心三角形)的D/L-PLA:TMC:PGA(63.75:21.25:15)制剂中随时间释放的牛血清白蛋白(BSA)的累积质量百分数。值得注意的是,当超过1重量%的泊洛沙姆加入到体系中时,在最初的几天内得到BSA的爆发释放,并且在一周内80%至90%的BSA释放。当泊洛沙姆的量在0.2-0.5重量%时,得到在第一周内的持续释放而没有BSA的大量爆发释放。
实施例26
该实施例比较了使用本文所述的基于TMC的共聚物和三元共聚物的掺混制剂的模型蛋白生物活性剂的控制释放。
在该实施例中,用于该实施例的三元共聚物是如实施例17所述的D/L-PLA:TMC:PGA 63.75:21.25:15。该实施例使用的共聚物是如实施例4所述的L-PLA-TMC 75:25。模型蛋白生物活性剂BSA微粒与实施例24中所述的相同。
通过以下方式制备D/L-PLA:TMC:PGA(63.75:21.25:15)三元共聚物和L-PLA:TMC75:25共聚物的掺混溶液:将总量为1g的如实施例17所述的D/L-PLA:TMC:PGA(63.75:21.25:15)聚合物和如实施例4所述的L-PLA-TMC75:25溶解在12g三乙酸甘油酯中,得到含有0重量%、25重量%、50重量%、75%或100重量%L-PLA:TMC 75:25聚合物溶液的制剂。将混合物在室温下搅拌4天,得到均匀溶液。然后在室温下将约0.2g BSA微粒加入上述聚合物溶液中。应注意,进行该过程以获得5种单独的制剂。最终混合物含有7.5重量%聚合物掺混物,1.5%BSA,和0重量%、25重量%、50重量%、75重量%或100重量%的L-PLA:TMC 75:25。
将混合物再次搅拌,然后装入配有16号针头的1ml注射器中。将约100μl混合物注入13ml玻璃试管中,该试管中含有3ml 1x PBS,其具有0.01%w/v聚山梨醇酯20和0.02%w/v叠氮化钠。在PBS溶液中形成聚合物储库。通过在注入聚合物混合物之前和之后称重玻璃管来计算聚合物储库的重量。
图8图示了从D/L-PLA:TMC:PGA(63.75:21.25:15)三元共聚物(实心菱形),L-PLA:TMC 75:25共聚物(矩形)和含有25重量%L-PLA:TMC 75:25(实心三角形)、50重量%L-PLA:TMC 75:25(实心方形)、75重量%L-PLA:TMC 75:25(实心圆形)的聚合物掺混制剂中随时间释放的牛血清白蛋白(BSA)的累积质量百分数。应注意,当在掺混物中使用超过50重量%的如实施例4中所述的共聚物L-PLA:TMC 75:25时,在前2周内观察到持续的BSA释放。
实施例27
BSA包封LT75微球
该实施例证明了由如本文所述的PLA和TMC的共聚物制成的BSA包封微球。
通过在室温下将0.50g L-PLA:TMC 75:25聚合物(如实施例4中所述)溶解在15ml二氯甲烷中来制备BSA包封微球。将1g BSA溶于10mL 1x PBS溶液中,制成浓度为100mg/mL的BSA溶液。然后将1.5mL的100mg/mL BSA溶液加入到有机聚合物溶液中。使用配备有1/8”锥形探针的Branson SXF150超声波仪将所得混合物超声处理2分钟。使用具有30秒开启和10秒关闭的脉冲模式,50%的振幅用于超声处理以产生油包水乳液。然后将约150mL的5%聚乙烯醇(奥德里奇公司,Mowiol 4-88)水溶液加入到乳液中。使用IKA T18数字均化器将所得混合物在5000rpm下均化2分钟。另外在500rpm磁力搅拌下将1L去离子水加入到乳液中。将乳液搅拌约1小时,然后在减压下(使用Welch,Dryfast2032泵)在室温下旋转蒸发(IKA,RV10 Basic,100rpm)处理1小时以除去二氯甲烷。对乳液进行离心处理,弃去上清液以除去任何残留的聚乙烯醇。将颗粒再分散在去离子水中,并再次离心。将清洁的颗粒分散在20ml去离子水中并冻干。以20,000X拍摄的冻干颗粒的扫描电子显微镜(SEM)图像显示在图5中。
通过使用二氯甲烷和THF(1:1体积比)一次然后使用THF两次、随后使用石油醚从冻干的微球中萃取BSA来检测BSA包封效率和负载量。将萃取的BSA风干,然后溶解在PBS中。由Bradford测定法测试BSA量。颗粒的包封效率为22%,BSA的负载量为6.4重量%。
实施例28
该实施例证明了本文所述的具有PEG的BSA包封TMC-共聚物微球的制剂的可注射性。称取0.04G分子量为2KDa的4-臂琥珀酰亚胺基戊二酸酯封端的聚(环氧乙烷)(PEG-SG)(Creative PEGWorks公司)和0.2G分子量为10KDa的4-臂胺封端的聚(环氧乙烷)(PEG-AM)(Creative PEGWorks公司),分别加入到两个干净的玻璃瓶中。将0.01g如实施例27中所述制备的BSA包封D,L-PLA:TMC 75:25微粒称重到第三个干净的瓶中。所有瓶都盖上带有橡胶隔垫的螺帽。然后将瓶用氮气脱气30秒并密封。通过γ辐射以9-11kGy的剂量对PEG和纳米颗粒样品进行灭菌。将通过0.1N盐酸溶液(奥德里奇公司)调节到pH=4.5的1ml 1XPBS(PBS4.5)注入PEG-SG瓶中以制备4重量%的PEG-SG溶液。将通过0.25N氢氧化钠溶液(奥德里奇公司)调节至PH=9.0的1ml 1XPBS(PBS 9.0)注入PLA-TMC纳米颗粒瓶中以分散纳米颗粒。将0.5mL的PBS 9.0注入PEG-AM瓶中以溶解PEG-AM。在获得PEG-AM的澄清溶液后,将0.5ml良好分散的PLA-TMC/PBS 9.0分散体转移到PEG-AM/PBS 9.0溶液中以制备具有10mg/mL PLA-TMC微粒的20%PEG-AM溶液。然后分别用PEG-SG溶液和PEG-AM/纳米颗粒分散体填充两个1ml注射器。每个注射器含有约200μl PEG制剂。将这些注射器组装到双注射器支架(巴克斯特(Baxter))上。将双注射器尖端连接到两个注射器上,并将27G针头安装到注射器尖端。将溶液缓慢地从注射器中推出并立即形成具有包埋的纳米颗粒的水凝胶。用金属刮刀戳交联凝胶显示出凝胶硬度。
实施例29
将如实施例28中所述制备的PEG-Am和PEG-SG溶液分别装入两个3ml注射器中并置于Baxter双注射器支架上。使用配备有27G1/2英寸薄壁针头和约0.96μl溶液的Baxter双注射器套件,在TA XT Plus质构分析仪上以200mm/分钟的速度测量注射力相对于位移的关系。
所有力相对于位移的数据均是平坦的,在其最大力附近具有大致相同的值。利用最大力之后的数据来确定平均滑动力。实施例28中可交联PEG凝胶的平均滑动力确定为79N。
实施例30
该实施例证明了从PLA和TMC的共聚物的BSA包封微球和从包含在可注射交联PEG体系中的微球中洗脱BSA。
在2mL离心管(Spin-离心管过滤器,)中,将约10mg实施例27中所述的BSA包封L-PLA:TMC 75:25聚合物微球分散在1.5ml 1xPBS中。在使用涡旋器(Vortex)将混合物摇晃1分钟后,将颗粒充分分散在PBS溶液中。然后将样品在37℃水浴中温育。
将约5mg实施例27中所述的BSA包封L-PLA:TMC 75:25聚合物微球分散在已经用0.25N氢氧化钠溶液(奥德里奇公司)调节至PH=9.0的0.5ml 1xPBS中。另外将0.2g 4臂PEG胺(Creative PEGWorks公司,Mw=10K)溶解在同样调节到pH=9.0的0.5ml 1XPBS中。然后将BSA包封L-PLA:TMC75:25微球分散体加入到PEG-胺溶液中并使用磁力搅拌棒充分混合。将0.04g4-臂PEG琥珀酰亚胺基戊二酸酯(Creative PEGWorks公司,Mw=2K)溶解在1ml1XPBS中,用0.1N盐酸溶液(奥德里奇公司)调节到PH=4.0。
将两个1ml注射器(BD)组装成1:1比例的双注射器支架(Baxter),然后在分开的两侧上填充颗粒/PEG-胺和PEG-SG溶液。将双注射器尖端(Baxter)连接到双筒注射器上,并将27G针头安装到鲁尔部分上。将100uL溶液缓慢地从注射器中推出,并在含有1.5mL 1XPBS的2mL离心管(Spin-离心管过滤器,)中立即形成具有包埋微球的水凝胶。将离心管在37℃水浴中温育。
图9显示了游离BSA包封微球和包含在交联PEG凝胶中的颗粒的BSA洗脱。
实施例31
该实施例证明了基于PLGA的共聚物作为液体通过小规格针头注射器注射并在组织床内作为单一物质固化的能力,并显示一定程度的炎性反应。
在25ml玻璃瓶中,将从德国赢创工业公司购买的共聚物PLA:GA RG756 S,即聚(D,L-丙交酯-共-乙交酯)溶于11g三乙酸甘油酯(圣路易斯的西格玛-奥德里奇公司)中,通过将混合物保持在带有磁力搅拌棒的搅拌盘上,获得约6%的溶液。PLGA聚合物的分子量为76,000。将溶液无菌地通过0.2μm无菌过滤器处理至1ml注射器中。每个注射器含有约200μl制剂。
将聚合物制剂递送到动物受试者的眼睛中,并且每只眼睛仅接受单次注射。将27号针头插入眼睛上侧部分的巩膜中,并注射约100μl聚合物。聚合物制剂注射的寿命期约为90天。大约每周测量眼压(IOP)。
对于所有试验,如预期的,术后即刻测量的IOP比基线高得多。通过注射,眼睛中增加了更多的总体积,从而增加了眼压。IOP的即刻升高在约30分钟内恢复到正常值。对于所有接受注射的眼睛,在眼睛内可看到聚合物制剂。大约每周进行IOP检查,并且在图10中图示出相对于植入前的基线的平均标准化值(空心方形)。虚线曲线拟合线表示PLAG组的IOP普遍增高,并且数据点高于100%。此外,在一次观察中,用检眼镜进行目视检查显示视网膜发红,这是炎症的迹象。
在取出时,检查眼睛并获得眼压(IOP)。轻轻取出眼睛,检查并在戴维森溶液中固定至少24小时。固定后,处理眼睛进行组织学分析。
处理组织样品以产生组织学切片,并在显微镜下检查炎症。检查发现炎症。
总之,该实施例的发现证明了PLGA样品中炎症增加,如高于基线的IOP增加、视网膜发红和组织学组织反应所证明的。
实施例32
该实施例证明了本文所述的基于TMC的三元共聚物作为液体通过小规格针头注射器注射并在组织床内作为单一物质固化的能力,并显示体内生物相容性和耐受性随时间的变化。
在如实施例21所述的工作制剂中制备如实施例17中所述的三元共聚物D/L-PLA:TMC:PGA,其重量比为63.75:21.25:15。将溶液无菌地通过0.2μm无菌过滤器处理至1ml注射器中。每个注射器含有约200μl制剂。
将聚合物制剂递送到动物受试者的眼睛中,并且每只眼睛仅接受单次注射。将27号针头插入眼睛上侧部分的巩膜中,并注射约100μl聚合物。聚合物制剂注射的寿命期约为90天。大约每周测量眼压(IOP)。
对于所有试验,如预期的,术后即刻测量的IOP比基线高得多,因为随着注射,更多的总体积增加到眼睛中,因此增高了IOP。IOP的即刻升高在约30分钟内恢复到正常值。对于所有接受注射的眼睛,在眼睛内可看到聚合物制剂。大约每周进行IOP检查,并且在图10中图示出相对于植入前的基线的平均标准化值(实心圆形)。初始注射时IOP增加的消退,并保持IOP值处于或低于100%在一定程度上证明了生物相容性和耐受性。此外,在任何观察中,用检眼镜进行目视检查均未发现视网膜发红,如果观察到可能是炎症迹象。
最后一次检查眼睛,并获得眼压(IOP)。取出时,将眼睛取出,检查,并在戴维森溶液中固定至少24小时。固定后,处理眼睛进行组织学分析。
目视检查显示所有眼睛均在正常的解剖学考虑范围内,未观察到异常。在玻璃体内识别出半透明聚合物的圆形聚集体。
在显微镜下,通过检查组织学切片,所有评估的眼睛区域都进行了观察。在聚合物植入物(即固体凝胶结构)周围没有发现炎症。
总之,该实施例的发现证明了玻璃体中注入的聚合物的可接受的安全性,而没有发现风险。总体而言,这表明生物相容性和耐受性,没有炎症迹象。
实施例33
该实施例证明了本文所述的具有可交联PEG的基于TMC的聚合物纳米颗粒作为液体通过小规格针头注射器注射并在组织床内作为含有TMC纳米颗粒的交联水凝胶固化的能力,并显示体内生物相容性和耐受性随时间的变化。
如实施例28中所述制备含有可注射PLA-TMC纳米颗粒的可交联PEG溶液,得到无菌制剂。
将制剂递送到动物受试者的眼睛中,并且每只眼睛仅接受单次注射。将27号针头插入眼睛上侧部分的巩膜中,并注射约100μl PEG溶液。聚合物制剂注射的寿命期约为90天。大约每周测量眼压(IOP)。
对于所有试验,如预期的,术后即刻测量的IOP比基线高得多。通过注射,眼睛中增加了更多的总体积,从而增加了眼压。IOP的即刻升高在约30分钟内恢复到正常值。对于所有接受注射的眼睛,在眼睛内可看到聚合物制剂。大约每周进行IOP检查,并且在图10中图示出相对于植入前的基线的平均标准化值(显示为X)。IOP值保持在等于或低于100%在一定程度上证明了生物相容性和耐受性。此外,在任何观察中,用检眼镜进行目视检查均未发现视网膜发红,如果观察到可能是炎症迹象。
取出后,检查眼睛并获得眼压(IOP)。取出眼睛,检查并在戴维森溶液中固定至少24小时。固定后,处理眼睛进行组织学分析。
在显微镜下,通过检查组织学切片,所有评估的眼睛区域都进行了观察。在植入物周围注意到轻微的炎症。
总之,该实施例的发现证明了玻璃体中注入的聚合物的可接受的安全性,而没有发现风险。总的来说,这表明生物相容性和耐受性,仅有轻微炎症。
实施例34
该实施例证明了实施例4所述的基于TMC的共聚物L-PLA:TMC 75:25和本文实施例21所述的三元共聚物作为液体通过小规格针头注射器注射并在组织床内作为单一物质固化的能力。在该实施例中检查的组织床是肾脏、肝脏和心脏。根据实施例12和21制备溶液。
通过约100μl的玻璃体内注射(IVI)将每种制剂递送到死后的目标组织床中。将27号针头插入左右肾脏的颅极和尾极(四个病灶),从1毫升注射器注射100uL到肝脏(一个病灶),100uL到心脏的顶点(一个病灶)。
在注射后数小时内,收集组织并将各组织浸入其自己的标记的戴维森溶液容器中超过24小时。
在对分后,用低倍显微镜目视检查每个组织床。每次注射都显示不透明的球状固体凝胶物质,从而证明制剂已固化并作为单一物质保留。
上文中已经概括性地并且结合具体实施方式描述了本申请的发明。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精神和范围的情况下,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。
Claims (20)
1.一种持续释放制剂,其包含:
包含基于三亚甲基碳酸酯(TMC)的聚合物的可注射的生物可吸收聚合物,其中所述基于TMC的聚合物包含:
a)包含三亚甲基碳酸酯和丙交酯的重复单元的共聚物,和/或
b)聚丙交酯(PLA)、(TMC)、聚乙醇酸(PGA)三元共聚物,其中所述三元共聚物包含3-19重量%的PGA,其中PLA:TMC的重量比为3.25:1至0.75:1;
药学上可接受的赋形剂;
溶剂,其选自1,2,3-三乙酰氧基丙烷、柠檬酸乙酰基三丁酯、柠檬酸三乙酯、柠檬酸三丁酯和柠檬酸乙酰基三乙酯;和
生物活性剂。
2.如权利要求1所述的制剂,其中,所述生物活性剂具有从所述可注射的生物可吸收聚合物中释放的大于30天的半衰期。
3.如权利要求1所述的制剂,其中,所述共聚物具有无定形链段和结晶链段。
4.如权利要求1所述的制剂,其中,所述赋形剂选自聚乙二醇、泊洛沙姆和聚乙烯醇。
5.如权利要求1所述的制剂,其中,所述制剂的滑动力为120N或更低。
6.如权利要求1所述的制剂,其中,所述共聚物包含45-60重量%的PLA和40-55重量%的TMC。
7.如权利要求1所述的制剂,其中,所述共聚物包含重量比为55:45的L-PLA和TMC,重量比为55:45的D-PLA和TMC,或重量比为50:50的D,L-PLA和TMC。
8.如权利要求1所述的制剂,其中,所述三元共聚物的数均分子量为25,000克/摩尔至40,000克/摩尔。
9.如权利要求1所述的制剂,其中,所述三元共聚物的特性粘度为0.90至1.2dL/g。
10.如权利要求1所述的制剂,其中,所述生物活性剂掺入所述可注射的生物可吸收聚合物中。
11.如权利要求1所述的制剂,其中,所述持续释放制剂是体内或原位的延迟释放制剂。
12.如权利要求1所述的制剂,其中,当所述制剂被注射到组织部位中时,所述制剂在组织部位中形成固体/凝胶结构,其允许生物活性剂的延迟释放。
13.一种持续释放制剂,其包含:
包含基于三亚甲基碳酸酯(TMC)的聚合物的可注射的生物可吸收聚合物纳米颗粒,其中所述基于TMC的聚合物包含:
a)包含三亚甲基碳酸酯和丙交酯的重复单元的共聚物,和/或
b)聚丙交酯(PLA)、(TMC)、聚乙醇酸(PGA)三元共聚物,其中所述三元共聚物包含3-19重量%的PGA,其中PLA:TMC的重量比为3.25:1至0.75:1;
可交联的聚乙二醇;和
包封在所述纳米颗粒中的生物活性剂。
14.如权利要求13所述的制剂,其中,所述生物活性剂具有从所述纳米颗粒中释放的大于30天的半衰期。
15.如权利要求13所述的制剂,其中,所述共聚物包含60-90重量%的PLA和10-40重量%的TMC。
16.如权利要求13所述的制剂,其中,所述共聚物具有75:25的PLA:TMC重量比。
17.如权利要求13所述的制剂,其中,所述三元共聚物的数均分子量为25,000克/摩尔至40,000克/摩尔。
18.如权利要求13所述的制剂,其中,所述三元共聚物的特性粘度为0.90至1.2dL/g。
19.如权利要求13所述的制剂,其中,所述持续释放制剂是体内或原位的延迟释放制剂。
20.如权利要求13所述的制剂,其中,当所述制剂被注射到组织部位中时,所述制剂在组织部位中形成固体/凝胶结构,其允许生物活性剂的延迟释放。
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