FDA批准的第一个3D打印处方药面市

2016-03-26 佚名生物谷

Aprecia药物公司宣布，第一个利用3D打印技术被FDA批准的处方药产品SPRITAM速溶片（左乙拉西坦）正式上市，用于治疗癫痫病发作。去年8月，SPRITAM得到了FDA的上市批准。一、药品实现快速溶解，解决吞药难的问题总部位于宾夕法尼亚的Aprecia制药公司，是全球唯一开发出3D打印药物的制药公司。粉液三维打印技术打印技术是麻省理工学院在20世纪80年代开发的技术。这种技术使

Aprecia药物公司宣布，第一个利用3D打印技术被FDA批准的处方药产品SPRITAM速溶片（左乙拉西坦）正式上市，用于治疗癫痫病发作。去年8月，SPRITAM得到了FDA的上市批准。

一、药品实现快速溶解，解决吞药难的问题

总部位于宾夕法尼亚的Aprecia制药公司，是全球唯一开发出3D打印药物的制药公司。粉液三维打印技术打印技术是麻省理工学院在20世纪80年代开发的技术。这种技术使用水溶性液体把多层的粉状物粘合在一起形成三维结构。

Aprecia收购了麻省理工学院3D打印技术在药物中的应用，进而开发了ZipDose技术平台，不再使用传统的压片技术，而是采用一层一层的打印来制造药物。只要一小口水，不到10秒的时间就可以快速溶解，为病患带来了新的口服体验。在Aprecia药物公司发布的对比视频中可以看到，普通的OTC药片的溶解速度要40多秒，而SPRITAM用4秒的时间就完成了这一过程。

SPRITAM现在可以辅助治疗局部突发性，肌阵挛性和大部分强直阵挛性癫痫发作。2013年，就有近三百万人生活在美国的人患有癫痫病。现在，每年都会有大约15万的新增病例。因为癫痫病发作的时候，吞咽困难，所以解决吞咽问题一直是制药商的一大难题。跟据美国的网上调查发现，受访中的40%到50%的美国人，即使没有患癫痫病的人，也存在吞噬药品困难的情况。

Aprecia的首席执行官 Don Wetherhold表示：“当我们试图把3D技术运用到处方药的生产的时候，我们需要考虑到药品的形式是不是真正符合病患的需要，这是非常重要的。SPRITAM是我们转变癫痫病用药方式产品中的第一个，我们会为病人和护理人员提供更多的治疗选择。”

二、打破传统剂量限制，最高剂量达1000毫克

传统的可溶性药品剂量范围受到压缩或者模型技术的大幅度限制，而以3D打印为基础的ZipDose技术并不依赖于此。ZipDose可以在保持快速溶解的同时达到最高1000毫克的药剂量。标准化、商业化生产的SPRITAM有有四个剂量单位的优势，包括250毫克，500毫克，750毫克1000毫克。

三、3D打印引领医疗新革命

现在，3D打印技术在医学领域的应用正变得越来越普遍，特别是在体外医疗器械，3D打印植入体，3D打印细胞和器官方面都有长足的进步。3D打印处方药或许只是个开始，在未来，随着科技的提高，我们完全可以根据个人身体状况的不同打印剂量不同的药片，或者说根据我们的喜好打印成不同的有趣的形状，实现个性化用药。

康奈尔大学机械工程与计算机科学技术教授胡迪·利普森就提出了一个“3D打印生命阶梯”的概念，即把身体各部位排列成一个阶梯。阶梯底层是无生命的假肢；中层是简单的活性组织如骨骼与软骨；再往上是静脉和皮肤；最靠近阶梯顶层的是复杂且关键的器官，如心脏、肝脏和大脑；生命阶梯的顶层将是完整的生命单位—也许有一天将会是具备完整功能的人造生命形式。

相关会议推荐

2016（第二届）医用3D打印高峰论坛: 设计材料应用

会议时间：2016.04.07-2016.04.08 会议地点：常州

会议详情： http://www.bioon.com/z/2016med3d/

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2016-04-29 bugit

#FDA批准#

0 0
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2016-03-30 三毛坨

姐姐斤斤计较

107 0
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2016-03-30 三毛坨

iii哦

115 0
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2016-03-30 三毛坨

啦啦啦

93 0
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2016-03-30 三毛坨

了啦啦啦啦

186 0
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2016-03-30 三毛坨

啦啦啦啦老婆

109 0
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2016-03-30 三毛坨

Niubia

79 0
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2016-03-30 三毛坨

牛逼啊

125 0
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2016-03-30 三毛坨

不能那你呢

112 0
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2016-03-28 ms9833124466084992

#3D#

31 0

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