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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
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    2016-03-30 三毛坨

    姐姐斤斤计较

    0

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    2016-03-30 三毛坨

    iii哦

    0

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    2016-03-30 三毛坨

    啦啦啦

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1839415, encodeId=7037183941526, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Apr 29 04:00:00 CST 2016, time=2016-04-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74506, encodeId=06e3e450696, content=姐姐斤斤计较, beContent=null, objectType=article, channel=null, level=null, likeNumber=131, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74507, encodeId=2beae450794, content=iii哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74508, encodeId=0d99e4508da, content=啦啦啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74509, encodeId=6519e4509a0, content=了啦啦啦啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=213, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74510, encodeId=d885e4510aa, content=啦啦啦啦老婆, beContent=null, objectType=article, channel=null, level=null, likeNumber=133, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74503, encodeId=743fe4503cd, content=Niubia, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:43:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74504, encodeId=d2e7e45045e, content=牛逼啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:43:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74505, encodeId=0ee0e45050b, content=不能那你呢, beContent=null, objectType=article, channel=null, level=null, likeNumber=135, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:43:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1335898, encodeId=cb611335898a2, content=<a href='/topic/show?id=792612047e' target=_blank style='color:#2F92EE;'>#3D#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1204, encryptionId=792612047e, topicName=3D)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/pSGl6CJeZ2PzWxdhCtrvv4U9Q281RV8e0AKmlB5ib93DibbiaRyOzmkCdz5F04cbfX5RGOpG4dOXvuQW1fumibVeBg/132, createdBy=fc342500110, createdName=ms9833124466084992, createdTime=Mon Mar 28 01:00:00 CST 2016, time=2016-03-28, status=1, ipAttribution=)]
    2016-03-30 三毛坨

    了啦啦啦啦

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1839415, encodeId=7037183941526, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Apr 29 04:00:00 CST 2016, time=2016-04-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74506, encodeId=06e3e450696, content=姐姐斤斤计较, beContent=null, objectType=article, channel=null, level=null, likeNumber=131, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74507, encodeId=2beae450794, content=iii哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74508, encodeId=0d99e4508da, content=啦啦啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74509, encodeId=6519e4509a0, content=了啦啦啦啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=213, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74510, encodeId=d885e4510aa, content=啦啦啦啦老婆, beContent=null, objectType=article, channel=null, level=null, likeNumber=133, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74503, encodeId=743fe4503cd, content=Niubia, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:43:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74504, encodeId=d2e7e45045e, content=牛逼啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:43:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74505, encodeId=0ee0e45050b, content=不能那你呢, beContent=null, objectType=article, channel=null, level=null, likeNumber=135, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:43:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1335898, encodeId=cb611335898a2, content=<a href='/topic/show?id=792612047e' target=_blank style='color:#2F92EE;'>#3D#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1204, encryptionId=792612047e, topicName=3D)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/pSGl6CJeZ2PzWxdhCtrvv4U9Q281RV8e0AKmlB5ib93DibbiaRyOzmkCdz5F04cbfX5RGOpG4dOXvuQW1fumibVeBg/132, createdBy=fc342500110, createdName=ms9833124466084992, createdTime=Mon Mar 28 01:00:00 CST 2016, time=2016-03-28, status=1, ipAttribution=)]
    2016-03-30 三毛坨

    啦啦啦啦老婆

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1839415, encodeId=7037183941526, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Fri Apr 29 04:00:00 CST 2016, time=2016-04-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74506, encodeId=06e3e450696, content=姐姐斤斤计较, beContent=null, objectType=article, channel=null, level=null, likeNumber=131, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74507, encodeId=2beae450794, content=iii哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74508, encodeId=0d99e4508da, content=啦啦啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=117, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74509, encodeId=6519e4509a0, content=了啦啦啦啦, beContent=null, objectType=article, channel=null, level=null, likeNumber=213, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74510, encodeId=d885e4510aa, content=啦啦啦啦老婆, beContent=null, objectType=article, channel=null, level=null, likeNumber=133, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:44:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74503, encodeId=743fe4503cd, content=Niubia, beContent=null, objectType=article, channel=null, level=null, likeNumber=101, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:43:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74504, encodeId=d2e7e45045e, content=牛逼啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=153, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:43:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=74505, encodeId=0ee0e45050b, content=不能那你呢, beContent=null, objectType=article, channel=null, level=null, likeNumber=135, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=43f41674911, createdName=三毛坨, createdTime=Wed Mar 30 01:43:00 CST 2016, time=2016-03-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1335898, encodeId=cb611335898a2, content=<a href='/topic/show?id=792612047e' target=_blank style='color:#2F92EE;'>#3D#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=62, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1204, encryptionId=792612047e, topicName=3D)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/pSGl6CJeZ2PzWxdhCtrvv4U9Q281RV8e0AKmlB5ib93DibbiaRyOzmkCdz5F04cbfX5RGOpG4dOXvuQW1fumibVeBg/132, createdBy=fc342500110, createdName=ms9833124466084992, createdTime=Mon Mar 28 01:00:00 CST 2016, time=2016-03-28, status=1, ipAttribution=)]
    2016-03-30 三毛坨

    Niubia

    0

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    2016-03-30 三毛坨

    牛逼啊

    0

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    2016-03-30 三毛坨

    不能那你呢

    0

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