公开(公告)号：US08333952B2

公开(公告)日：2012-12-18

申请号：US12565544

申请日：2009-09-23

申请人： Ronald Nutt ,  Anthony M. Giamis ,  Aaron McFarland

发明人： Ronald Nutt ,  Anthony M. Giamis ,  Aaron McFarland

IPC分类号： A61K51/00 ,  A61M36/14

CPC分类号： A61K51/0491 ,  B01J19/004 ,  B01J19/0093 ,  B01J2219/00788 ,  B01J2219/00873 ,  B01J2219/00891 ,  B01J2219/00905

摘要： A microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography (PET). The radiopharmaceutical production system includes a reaction vessel that receives a radioisotope from an accelerator or other radioisotope generator. Organic and aqueous reagents are introduced into the reaction vessel, and the mixture is heated to synthesize a solution of a pre-selected radiopharmaceutical. The radiopharmaceutical solution is purified by passing the solution through a solid phase extraction column and a filter. The synthesis process produces per run a quantity of radiopharmaceutical approximately equal to, but not less than, one (1) unit dose of a radiopharmaceutical, reducing waste and allowing for the production of radiopharmaceutical on an as-needed basis. The synthesis process allows for the production of biomarker radiopharmaceuticals on site and close to the location where the unit dose will be administered to the patient. On-site, as-needed production of radiopharmaceuticals in small doses reduces the time between the synthesis of the radiopharmaceutical and the administration of that radiopharmaceutical, thereby minimizing the loss of active isotopes through decay and allowing the production of lesser amounts of radioisotopes overall.

摘要翻译： 一种微流体放射性药物生产系统和用于在正电子发射断层摄影（PET）中使用的放射性药物生物标志物的大约一个但不少于一个单位剂量的放射性药物生物标志物合成的方法。 放射性药物生产系统包括从加速器或其他放射性同位素发生器接收放射性同位素的反应容器。 将有机和含水试剂引入反应容器中，并加热混合物以合成预先选择的放射性药物的溶液。 通过使溶液通过固相萃取柱和过滤器来纯化放射性药物溶液。 合成过程每次产生大约等于但不小于一（1）个单位剂量的放射性药物的放射性药物的量，减少浪费并允许根据需要生产放射性药物。 合成过程允许在现场生产标记放射性药物并且靠近给予患者的单位剂量的位置。 现场按需要的小剂量放射性药物的生产减少放射性药物的合成和放射性药物的给药之间的时间，从而通过衰减使活性同位素的损失最小化，并允许整体产生较少量的放射性同位素。

公开(公告)号：US20110070160A1

公开(公告)日：2011-03-24

申请号：US12565544

申请日：2009-09-23

申请人： Ronald Nutt ,  Anthony M. Giamis ,  Aaron McFarland

发明人： Ronald Nutt ,  Anthony M. Giamis ,  Aaron McFarland

IPC分类号： G21C1/00 ,  A61K51/04

CPC分类号： A61K51/0491 ,  B01J19/004 ,  B01J19/0093 ,  B01J2219/00788 ,  B01J2219/00873 ,  B01J2219/00891 ,  B01J2219/00905

摘要： A microfluidic radiopharmaceutical production system and process for synthesizing per run approximately, but not less than, one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography (PET). The radiopharmaceutical production system includes a reaction vessel that receives a radioisotope from an accelerator or other radioisotope generator. Organic and aqueous reagents are introduced into the reaction vessel, and the mixture is heated to synthesize a solution of a pre-selected radiopharmaceutical. The radiopharmaceutical solution is purified by passing the solution through a solid phase extraction column and a filter. The synthesis process produces per run a quantity of radiopharmaceutical approximately equal to, but not less than, one (1) unit dose of a radiopharmaceutical, reducing waste and allowing for the production of radiopharmaceutical on an as-needed basis. The synthesis process allows for the production of biomarker radiopharmaceuticals on site and close to the location where the unit dose will be administered to the patient. On-site, as-needed production of radiopharmaceuticals in small doses reduces the time between the synthesis of the radiopharmaceutical and the administration of that radiopharmaceutical, thereby minimizing the loss of active isotopes through decay and allowing the production of lesser amounts of radioisotopes overall.

摘要翻译： 一种微流体放射性药物生产系统和用于在正电子发射断层摄影（PET）中使用的放射性药物生物标志物的大约一个但不少于一个单位剂量的放射性药物生物标志物合成的方法。 放射性药物生产系统包括从加速器或其他放射性同位素发生器接收放射性同位素的反应容器。 将有机和含水试剂引入反应容器中，并加热混合物以合成预先选择的放射性药物的溶液。 通过使溶液通过固相萃取柱和过滤器来纯化放射性药物溶液。 合成过程每次产生大约等于但不小于一（1）个单位剂量的放射性药物的放射性药物的量，减少浪费并允许根据需要生产放射性药物。 合成过程允许在现场生产标记放射性药物并且靠近给予患者的单位剂量的位置。 现场按需要的小剂量放射性药物的生产减少放射性药物的合成和放射性药物的给药之间的时间，从而通过衰减使活性同位素的损失最小化，并允许整体产生较少量的放射性同位素。

公开(公告)号：US20110070158A1

公开(公告)日：2011-03-24

申请号：US12565552

申请日：2009-09-23

申请人： Ronald Nutt ,  Anthony M. Giamis ,  Aaron McFarland

发明人： Ronald Nutt ,  Anthony M. Giamis ,  Aaron McFarland

IPC分类号： A61K51/04 ,  B01J19/00 ,  G01N21/59 ,  G01N30/00

CPC分类号： A61K51/0491 ,  G01N21/25 ,  G01N21/59 ,  G01N21/80

摘要： A sample card and automated quality control module for a radiopharmaceutical synthesis system for conducting quality control tests on approximately one (1) unit dose of a radiopharmaceutical biomarker for use in positron emission tomography. The sample card and quality control module allow operators to conduct quality control tests in reduced time using micro-scale test samples from the radiopharmaceutical solution. The sample card works in conjunction with a microfluidic radiopharmaceutical synthesis system to collect samples of radiopharmaceutical solution on the scale of 5-20 microliters per sample. The sample card then interacts with the quality control module to feed the samples into a number of test vessels, where the samples undergo a number of automated quality control tests.

摘要翻译： 用于放射性药物合成系统的样品卡和自动质量控制模块，用于对大约一（1）个单位剂量的用于正电子发射断层扫描的放射性药物生物标志物进行质量控制测试。 样品卡和质量控制模块允许操作员使用来自放射性药物溶液的微量测试样品在缩短的时间内进行质量控制测试。 样品卡与微流体放射性药物合成系统一起工作，以每个样品5-20微升的规模收集放射性药物溶液样品。 样品卡然后与质量控制模块进行交互，以将样品进料到多个测试容器中，其中样品进行许多自动质量控制测试。

公开(公告)号：US08937287B2

公开(公告)日：2015-01-20

申请号：US13451295

申请日：2012-04-19

申请人： Anthony M. Giamis

发明人： Anthony M. Giamis

IPC分类号： G01J1/42

CPC分类号： G01N30/62 ,  G01N2030/77

摘要： A self-referencing radiation detector to test the radiochemical purity of a sample radiopharmaceutical solution. In some embodiments, the self-referencing radiation detector measures the radioactivity of a sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through a high performance liquid chromatography column. The radiation detector then measures the radioactivity of each separated molecularly distinct species from the high performance liquid chromatography column. The radiochemical purity of the sample radiopharmaceutical solution is calculated by comparing the measured radioactivity of separated molecularly distinct species from said high performance liquid chromatography column to the measured radioactivity of the sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through the high performance liquid chromatography column.

摘要翻译： 一种自参照辐射检测器，用于测试样品放射性药物溶液的放射化学纯度。 在一些实施例中，自参照辐射检测器在样品放射性药物溶液通过高效液相色谱柱之前测量样品放射性药物溶液的放射性。 然后，辐射检测器测量每个分离的分子不同物种与高效液相色谱柱的放射性。 样品放射性药物溶液的放射化学纯度通过将样品放射性药物溶液通过高效液相色谱柱而将样品放射性药物溶液的样品放射性物质与所述高效液相色谱柱分离的分子不同物质的放射性进行比较来计算， 。

公开(公告)号：US20130277566A1

公开(公告)日：2013-10-24

申请号：US13451295

申请日：2012-04-19

申请人： Anthony M. Giamis

发明人： Anthony M. Giamis

IPC分类号： G01N21/84 ,  G01T1/00

CPC分类号： G01N30/62 ,  G01N2030/77

摘要： A self-referencing radiation detector to test the radiochemical purity of a sample radiopharmaceutical solution. In some embodiments, the self-referencing radiation detector measures the radioactivity of a sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through a high performance liquid chromatography column. The radiation detector then measures the radioactivity of each separated molecularly distinct species from the high performance liquid chromatography column. The radiochemical purity of the sample radiopharmaceutical solution is calculated by comparing the measured radioactivity of separated molecularly distinct species from said high performance liquid chromatography column to the measured radioactivity of the sample radiopharmaceutical solution before the sample radiopharmaceutical solution is passed through the high performance liquid chromatography column.

摘要翻译： 一种自参照辐射检测器，用于测试样品放射性药物溶液的放射化学纯度。 在一些实施例中，自参照辐射检测器在样品放射性药物溶液通过高效液相色谱柱之前测量样品放射性药物溶液的放射性。 然后，辐射检测器测量每个分离的分子不同物种与高效液相色谱柱的放射性。 样品放射性药物溶液的放射化学纯度通过将样品放射性药物溶液通过高效液相色谱柱而将样品放射性药物溶液的样品放射性物质与所述高效液相色谱柱分离的分子不同物质的放射性进行比较来计算， 。