CN1213316A - 放射性核素及放射性医药品的聚合物输送 - Google Patents

放射性核素及放射性医药品的聚合物输送 Download PDF

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CN1213316A
CN1213316A CN97192965A CN97192965A CN1213316A CN 1213316 A CN1213316 A CN 1213316A CN 97192965 A CN97192965 A CN 97192965A CN 97192965 A CN97192965 A CN 97192965A CN 1213316 A CN1213316 A CN 1213316A
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理查德·D·莱维特
路易斯·Z·阿维拉
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    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
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Abstract

本文公开了使用局部沉积聚合物储存剂作为放射性核素和放射性医药品固定化和局部输送的赋形剂。放射性核素是经由物理或化学方法以其元素形式、无机化合物、或接在较大分子或掺入到聚合物中的形式掺入的。可以采用辅助构造来控制释放速率。可以使用已被用于局部放射治疗的标准放射核素例如碘、铱、镭、铯、钇或其他元素的放射性核素。

Description

放射性核素及放射性医药品的聚合物输送
本发明背景技术
本发明涉及改良的局部放射性治疗方法，及完成所述局部放射性治疗所用的装置和组合物。
辐射已被用于癌症治疗及控制多种部位中的局部痊愈如防止过份的伤疤形成或减少淋巴渗入和增生。最近，使用辐射来抑制冠状动脉或周围动脉血管造形术后的再狭窄。经由使用掺入到血管移植片固定模中的放射性物质进行间质照射，用装着放射性来源的插管进行辐射剂输送以及外加辐射束辐射治疗等都是已知的。
上述这些措施都有缺点。在经由体外辐射束输送辐射时，会遇到将反照射限于想要影响到的组织的常见问题。此外，经常必须将剂量分开因而患者必须到医院一次以上。若要经由插管或其他暂时安装的医学装置来输送辐射时，则从装置出来的辐射输送速率必须较高。活性来源通常需要小心地遮蔽，即使是使用相当“软”的辐射例如β射线，也是一样。若在相同手术例如气球血管造形术或心旁通中施用时，会使已是复杂且危险的程序变得更为复杂。在永久性植入装置，或因提供结构支承而在长时期后必定被侵蚀掉的生物可分解性装置上输送辐射时，会因为需要限制施给组织的总输送剂量，同时提供足以达到所需效果的初始剂量而严重地限制放射性同位素的选择。再者，重复给用(如果需要的话)不易达到。
本发明的目的为提出一种改良的局部放射治疗方法以用于治愈或减轻医学病症。
本发明概述
将局部沉积的生物可分解聚合物储存剂用作为赋形剂，用于放射性核素或放射性医药品的固定化和局部输送。放射性核素是经由物理或化学方法以其元素形式，无机化合物形式，或接在较大分子上或掺入到聚合物中的形式掺入的。可以采用辅助构造来控制释放速率。较佳的储存剂是用生物可分解的物质制成的，对其加以选择以便在施用部位所遇到的状况下以已知速率降解。所述储存剂优选为流动性，或能够被变成流动性者，使其可以在使用最少侵入性手段之下以顺畅方式沉积在部位上。此等物质的例子有可在体温下再固化的熔融聚合物，及可在沉积部位聚合的可聚合物质。所述储存剂可视需要提供以控制放射性化合物释出速率的手段。这些手段可包括掺入放射性化合物的微粒子。
聚合物储存剂的使用，提供了一种将放射性源的能源固定化在身体内，所述部位能用较低侵入性外科程序例如用插管或腹腔镜检查进入的遥远部位上的方法。辐射的持续期和总剂量可以经由放射性核素的选择、聚合物降解速率的控制、及控制放射性核素从储存剂释出的速率等的组合予以控制。在聚合物降解及/或放射性核素释出之后，以尿和粪便而从体内排出，此可以经由服用有利于排泄的医药剂帮助促成。例如在碘放射性核素的情况中，可以经由系统地给用非放射性碘化合物例如碘化钠或虚戈耳氏液(Lugol’s Solution)而阻断甲状腺对放射性碘或碘化合物的吸取而帮助其排泄。本发明详述
聚合物储存剂提供了一种将放射性药剂送到要治疗的局部疾病部位的方法，以用于例如防止血管造形术后的再狭窄。所述方法比其他局部辐射输送方法在所有应用中都具有优点，原因在于可经由选用不同物理半衰期的放射性核素来改变辐照的持续期和强度，及可经由加速或滞缓放射性核素的聚合物基质的释放速率而控制生物半衰期之故。如此提供了一种不需要物理去除植入的放射性核素即可控制局部辐射剂量的方法。如此可以在身体内的可经由较低侵入性程序或插管例如到冠状动脉或肿瘤动脉供给的插管接近的任何部位上施加放射性。此亦可促成间质相入放射治疗的应用，同时减少在使用其他目前可用的局部放射治疗法时有时是不可避免的对操作员的辐射。聚合物
形成储存剂所用的聚合物必须是生物可降解的，亦即必须可在储存剂施用部位的条件下分解成可由正常代谢功能及/或排泄而去除掉的小分子者。一方面，所述聚合物可在身体状态下慢慢地溶解，例如某些poloxamers，如pluronicTM F-68(一种BASF所售的聚乙二醇-聚氧化乙烯嵌段共聚物)，其可在体温下胶凝并在数天内而慢慢地溶解。于另一方面，可用温度来变更聚合物的流动性。例如，可以经由加热或冷却来熔融聚合物(例如PluronicsTM)后，将聚合物施加到部位，聚合物在所述部位上会再固化。也可以经由其他已知的凝聚手段促成储存剂形成，例如用离子使聚合物进行配位(如，钙与海藻酸盐)，直接凝聚数种聚合物(如，聚谷氨酸与聚赖氨酸)，及经由扩散去除非水溶剂分子使聚合物排溶(exsolvation)。
聚合物中的可降解键联包括酯、原碳酸酯、酐、酰胺和肽、缩醛、磷氮烯键联和席夫碱加合物。形成适当酯键联的例子包括羟基酸，例如乳酸、乙醇酸、羟基丁酸、戊酰乳酸和羟基己酸。形成酐的例子包括草酸、丙二酸、丁二酸、戊二酸、己二酸、辛二酸、壬二酸、癸二酸、顺丁烯二酸、反丁烯二酸和天冬氨酸。碳酸酯形成性化合物的例子包括三亚甲基碳酸酯。
另一方面，聚合物可为原地(in situ)可交联者。所述交联可经任何适当化学手段完成。若化学交联后，聚合物及形成的键联这一必须是生物可分解者。生物可分解的键联包括席夫碱、酸酐、二硫化物、和缩醛。不必生物可分解的其他键联的例子包括环氧基(环氧乙烷基)、氨基甲酸乙酯、酯、醚，酰胺和砜。包含碳-碳双键的键联可以经由各种手段形成，包括乙烯系不饱和基的聚合。它们可包括(甲基)丙烯酰基、乙烯基、烯丙基、苯乙烯基、肉桂酰基、和烯基。此等反应可以经由热、化学、辐射性或光化学等手段引发。已知大部分化学可交联基团和分子倾向于在放射物质存在中交联且优选在应用之前才与放射性物质混合。
再一方面，生物可分解聚合物是溶解在水以外的溶剂内(“有机”溶剂，广义地视为包括任何生物相容性非水溶剂)并沉积在部位上，且在有机溶剂从所述部位放散掉时沉淀而形成储存剂。所述有机溶剂必须不会对所述部位所在组织造成不当的伤害。其依要处理的组织和病况而变异。于许多应用中，适用者可为乙醇、异丙醇、矿物油、植物油，和液体(聚)硅氧烷。
组合物中所包含的生物可分解性聚合物和任何溶剂或佐剂对于治疗目的而言必须更具充足的生物相容性。生物相容性物质应为其植入引起很少或不会引起组织反应，且即使有任何反应时反应的程度和持续期有限。依施用部位而定，其刺激程度是可容忍的，或为会被诱出的。例如，多种聚合物在皮肤上或在消化道内皆有最低的刺激性，而只有少数聚合的可在腹膜内被接受。许多种高生物相容性(最低刺激性)物质皆为非离子性物质且在施用后，含有很少的反应性或潜在反应性基团。这些物质的较佳例子为聚(氧化烯)，例如聚乙二醇，poloxamers,meroxapols等。
经由适当生物分解性聚合物的局部沉积(通常在沉积时与放射性物质组合)所形成的储存剂，将被构造成在所述储存剂的生物降解中以已知且可预测的方式释出所述放射性物质。放射性衰变效应和控制释放效应的组合决定沉积到靶组织内的总能量。有许多手段是已知可用来控制物质从储存剂的释放速率的。这些手段包含物质经过固体聚合物扩散；物质从聚合物或聚合物所形成的凝胶中的孔洞扩散出；在间格(compartment)破裂时物质爆出；因聚合物侵蚀使物质曝露到环境中；物质从使聚合物保持在定位中的固体形式内慢慢的溶解出；固体聚合物、聚合物涂层或凝胶的降解对物质释放的扩散限制；从接到聚合物上或接到包含在聚合物之内或之上的载体上的可分解性键联将物质释出；及使物质与聚合物或包含在聚合物之中或之上的载体物质之间的可逆性缔合去结合(de-bonding)。可以使用这些手段的组合来得到最佳释放型态。例如，可以将小的经放射标记的分子包埋在可降解性微球体之中，再经由扩散和微球体的降解的组合使物质从其中慢慢地释出。所述微球体转而可被原位形成的聚合物凝胶持留在治疗部位上，其本身则提供最微小的扩散屏障及逐渐地降解。凝胶和微球体相对降解速率的选择会影响给到治疗部位的总辐射剂量。如本文所用者，微球体包括微粒子、微胶囊、脂质体，脂质粒子，及其他具类似尺寸和功能的调配物。放射性物质
任何放射性物质都可以使用。可以使用已用于局部放射治疗的标准放射性核素，例如碘、铱、镭、铯、钇或其他元素的放射性核素。
较佳的放射性核素在组织中的粒度范围与要治疗的组织层所具厚度一致。有关粒度范围的资料是易于取得的。例如，已知14C(碳-14)源的能量中约有90％会被吸收在约最近70微米的组织内，且对于硫-35和磷-33也有类似的距离，因这些核素的发射粒子与14C所发射的粒子是相似的(β粒子)且具相似能量之故。更高能β粒子具有更长的范围，例如磷-32所发射的粒子，其最大范围约一公分因而可用来治疗较厚的肿瘤，或具有几毫米厚中间层的血管。非常高能量的发射，不论是β粒子或其他形式的粒子，通常较不适当，因其放射可能从身体透射出因而引起屏蔽问题。
放射性同位素必须以医药可接受的形式给用。所述形式必须是生物相容者，如上文所说明的。所述形式也必须能够在与控制局部输送所用工具组合之下在施用部位持留一段经控制的时间。例如，所述放射同位素可为元素、无机化合物、有机化合物或接在较大分子例如聚合物上的形式。于最后情况中，其可掺入到主链基中；作为侧基，较佳者为经共价键结的；或为一配位基，经结合到聚合物上的适当结合基上。结合基可为非生物结合基，例如金属离子的螯合剂；或生物结合基，例如用于生物素的亲事素。同样地，所述聚合物可为生物物质，例如蛋白质、多醣或核酸；或其可为人工合成物，例如聚烷二醇或聚(甲基)丙烯酸酯。将离子固定化在凝胶内
放射性离子可以直接固定化在凝胶内。在一实施方案中，其可局部地转变成低溶解度盐形式，例如经由适当的盐(例如磷酸钙)，或为聚合物上的配体，或为结合到生物分子的辅助因子予以沉淀。
于一较佳实施方案中，放射性离子经由螯合而固定化在凝胶内。螯合剂可共价地固定化在凝胶内。经共价键联的螯合剂(“主体”)转而可固定化金属离子(“客体”)。
可聚合的大分子或小分子可经合成而具有连接到主链上的恰当螯合剂。适当分子的例子为在其中央主链(例如，聚氧化烯，如聚乙二醇(PEG)，或聚丙二醇/聚乙二醇(PPO/PEO))的一端具有螯合剂，其可视需要经由间隔基(spacer group)例如羟基酸而与主链相连。所述PEG主链的另一端具有一可聚合键，有或无间隔基。如此需要具有两个或更多个可官能化末端的主链。主链的存在是视情况而定的；螯合基可以直接偶合到一反应性基团例如丙烯酰基、烯丙基或乙烯基上，其可参与凝胶的形成。
螯合剂(“主体”)的一例子为多氮杂巨环cyclam 1.4,8,11-四氮杂环十四烷，已知其可与一种医用的金属离子Tc=99m(“客体”)形成热力学和动力学稳定的配合物。
“客体”的一例子为锝-99m(technetium-99m)，一种供医用的γ-发射体，其只发射γ-辐射，具有低辐射能及只有6小时的短半衰期。Tc-99m可以用来以闪烁照相术(scintigraphy)监测生理变化，该技术为大部分医院所用的一种高敏感性的基于γ-辐射的技术。
这些载着螯合剂的巨大单体可以用其溶液形式输送并用可聚合交联剂使其“胶凝”在靶部位中(例如，用生物可分解的间隔基将丙烯酸酯端基联结到PEG上所形成的PEG)。可使所得水凝胶的降解和其他物理性质达到所欲的规格。
这些凝胶的重要性在于：
1．此等水凝胶可在原位(in situ)形成且可带有γ-发射体或其他医事可用的同位素供各种医学应用所用。
2．由于各种螯合剂的数据库可从文献取得，因此可以直接地找到恰当的螯合剂以选择性地将特殊金属离子固定化在水凝胶内。
3．这种概念的其他可能应用包括医学上有用核素的局部化输送或固定化，生理有益(及治疗性)金属离子或其他带电荷物种的局部化输送。医学应用
此种技术的应用包括肿瘤、癌症和其他不良生长(如粥瘤，乳头)的局部治疗；创疤或愈痕的抑制以防止过份的创疤形成或瘢痕瘤形成；手术造成的导管的维护，例如在青光眼滤过程序后的巩膜愈合的抑制；纤维变性和囊形成的防止；及血管造形术后再狭窄的防止。应用方法
局部储存剂可以用数种方法中的任一法放置在要治疗的部位。对于外部应用，可将预先形成的储存剂加上并用恰当的黏着剂固定。外部应用也需要恰当的手段以防止放射性物质的移动。对于内部应用，将储存剂形成用聚合物(优选与放射性物质和任何所需赋形剂、辅助物质和药物输送工具相组合)典型地以流动形式经由输送装置施用到施用部位，及促成或使其在所述部位固化。输送装置可包括经皮工具例如插管、导管、和针；或经由自然或外科造成的开口或暂时开口，例如用套针包括注射筒、刷、垫或刷所造成的开口而施加的工具。类似的手段也用来施加从流体聚合物材料形成储存剂所需的任何刺激物。例如，可经由光纤或类似腹腔镜的装置将光带到远方部位以促成储存剂中的聚合反应，或可以使用类似于储存剂形成性混合物所用的工具来施用化学品。剂量控制
所述方法提供三种控制输送到某一部位的总剂量而同时控制对身体其他部位的辐照的方式。第一种，可改变同位素的总量。第二种，可选择用同们素的半衰期，此举提供所加剂量的上限。第三种，可以控制局部输送储存剂中的放射性同位素的寿命。
例如，若放射性同位素为一巨大分子时，储存剂可为凝胶，且巨大分子从凝胶的释出速率可通过将凝胶作得足够稠密使得所述巨分子只在凝胶降解时才释出而予以控制。此等凝胶是已知的；例如，Hubbell etal.的美国专利第5,410,016号中所述的即可适用。
若所述放射性同位素为小分子而非大分子，而通过将其包埋在生物可侵蚀性固体物质，例如，聚交酯，聚己内酯，聚酸酐，或已聚合的生物物质如蛋白质之内而控制释放速率。然后经由穿过所述物质的扩散作用及所述物质的侵蚀的组合而释出所述小分子，其中两种作用均可调整。另外，可经由选择放射性同位素与其环境的交互作用强度而调整其释放速率，例如若分子和储存剂两者都相当地疏水的时候，所述分子会相当慢地从所述储存剂扩散出。若不能使储存剂成为疏水性物质的时候，可以将所述分子包在更疏水性的微粒子内，例如聚合物微粒子、脂质体、乳液等，后者转而可包埋在亲水性储存剂之内。
本发明将参考下列非限制性实施例予以进一步阐述。实施例1：将放射性核素固定化在介面沉积凝胶内。
在血管造形术(其可为冠状动脉或外周动脉)，或血管内移植模放置、或颈动脉移植模、或动脉切除术之后将放射性核素(125I或131I或其他放射性核素)沉积在介面水凝胶中。所掺入的放射性核素经选择而得对动脉壁可提供至少1500 cGy的总辐照量。输送剂量通过选择放射性核素的掺加量予以调整及经由选择在沉积部位具有不同持续期的水凝胶调配物而进一步控制。在沉积部位的辐照持续期可经由调整水凝胶的生物可分解部份或改变聚合物在所述部位的交联密度而予以控制。实施例2：经由导管插入法施用聚合物的局部放射治疗
局部放射治疗可以施用到可由血管导管接近的任何肿瘤。此技术特别可应用于高度血管化的肿瘤或具有单一主要动脉血管供应的肿瘤。此可提供特别适用于肾细胞癌、肝细胞瘤、肉瘤、头颈癌和中枢神经系统肿瘤治疗的方法。于此实例中，是将含有钇-90的放射性微球体掺入在供应肿瘤的动脉内沉积的水凝胶中。在微球体被固定化在沉积部位时，沉积部位中的局部肿瘤体积即被照射。于水凝胶降解时，微球体释出并再沉积于远处的微循环系统，于那里它们再次提供持续的辐射治疗。在初沉积部位的辐照可以通过调整水凝胶中的生物可分解部份或调整交联密度以控制水凝胶降解速率而予以调节。所述微球体可经选择而具有大于320小时的较长降解或消去时间，所述时间超过了被植入钇-90的5个半衰期且绝大部份的放射性衰变已经发生了。

Claims (14)

1．一种在患者体内某一部位进行的局部放射治疗方法，包括在要施用所述治疗的部位形成聚合物储存剂，其中所述储存剂包括一或多种放射性同位素以及储存剂形成性生物可分解的生物相容性聚合物材料。
2．如权利要求1所述的方法，其中所述储存剂为水凝胶。
3．如权利要求1所述的方法，其中所述储存剂为在第一流动状态施加而在施加于组织上时转变成第二较不流动性状态的固体聚合物。
4．如权利要求1所述的方法，其中所述聚合物与所述放射性同位素化学偶联。
5．如权利要求1所述的方法，其中所述聚合物是经由偶合到聚合物上的螯合剂而共轭(合)到所述放射性同位素。
6．如权利要求1所述的方法，其中所述储存剂包括有包含放射性同位素的微球体。
7．如权利要求6所述的方法，其中所述微球体能以不同于储存剂的速率被生物分解。
8．一种局部放射治疗组合物，包括与储存剂形成性物质结合着的一种或多种放射性同位素，其中所述储存剂形成性物质为生物可分解的生物相容性聚合物且可在所选部位活体内形成储存剂。
9．如权利要求8所述的组合物，其中所述储存剂为水凝胶。
10．如权利要求8所述的组合物，其中所述储存剂为在第一流动状态施加而在施加于组织上时转变成第二较不流动性状态的固体聚合物。
11．如权利要求8所述的组合物，其中所述聚合物与所述放射性同位素物化学偶联。
12．如权利要求8所述的组合物，其中所述聚合物经由偶合到聚合物上的螯合剂而共轭(合)到所述放射性同位素上。
13．如权利要求8所述的组合物，其中所述储存剂包括有包含所述放射性同位素的微球体。
14．如权利要求13所述的组合物，其中所述微球体是能以不同于储存剂的速率被生物分解。
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