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Methods for multi-dose synthesis of [f-18]fddnp for clinical settings

A technology of F-18, complex, applied in the field of synthesizing 2-amino]-2-naphthyl} ethylene)-malononitrile, can solve problems such as the reduction of available dose, achieve compensation for product decay and shorten synthesis time , the effect of simplifying the synthesis process

Inactive Publication Date: 2019-06-21
RGT UNIV OF CALIFORNIA
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  • Abstract
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  • Claims
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Problems solved by technology

Third, autoradiolysis of [F-18]FDDNP could potentially occur during prepurification and HPLC purification
Shipping F-18 labeled biomarkers over relatively long geographic distances will always result in lower final available doses

Method used

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  • Methods for multi-dose synthesis of [f-18]fddnp for clinical settings
  • Methods for multi-dose synthesis of [f-18]fddnp for clinical settings
  • Methods for multi-dose synthesis of [f-18]fddnp for clinical settings

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Embodiment Construction

[0016] figure 1 Shown is the tosyloxy precursor 2-{[6-(2,2-dicyano-1-methylvinyl)-2-naphthyl](methyl)amino-}ethyl-4 -Toluenesulfonates (DDNPTs) produced biomarkers or PET tracers 2-(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthalene The radiochemical reaction of [F-18]FDDNP). After preparation or synthesis, the PET tracer [F-18]FDDNP was purified by semi-preparative high performance liquid chromatography (HPLC). Figure 2A-2B A schematic diagram of a semi-automated synthesis module 10 for the synthesis of [F-18]FDDNP is shown. The semi-automated module 10 is arranged in a "hot cell" as found in a cyclotron or other radiochemical laboratory. Hot cells are specialized enclosures for handling radioactive materials. The hot cell is vented and the radiation shielded enclosure prevents the technician or operator from being exposed to radiation from the gamma ray emitter. Various types of concrete, lead, lead glass, steel, and depleted uranium can be used as shielding mater...

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Abstract

A method of manufacturing 2-(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthyl}ethylidene)-malononitrile ([F-18]FDDNP) utilizes a semi-automated module that is used to perform fluorination, pre-purification, separation, product extraction, and formulation. The method is able to produce [F-18]FDDNP with high yields and ready for human administration under existing FDA regulations, and without the need for hazardous organic solvents such as dichloromethane (DCM), methanol (MeOH), and tetrahydrofuran (THF). The method also improves the speed with which [F-18]FDDNP can be synthesized with the method being able to generate a final product within about 90 to 100 minutes. This synthesis method is easily adaptable to FDA registered and approved automated synthesis systems.

Description

[0001] related application [0002] This application claims priority under 35 USC §119, as well as any other applicable statutes, to US Provisional Patent Application No. 62 / 419,286, filed November 8, 2016, the entire contents of which are incorporated herein by reference. technical field [0003] The technical field relates generally to the synthesis of 2-(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthyl}ethylidene)-propane using semi-automated synthesis modules Dinitrile ([F-18]FDDNP) method. This method was used to synthesize [F-18]FDDNP with high yield and short preparation time, ready for human administration. The method also introduces an anhydrous workup procedure and also does not use a combination of hazardous organic solvents that have been used in previous synthetic operations. Background technique [0004] 2-(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthyl}ethylene)-malononitrile ([F-18]FDDNP)PET Imaging has been used to classify and stage progressive...

Claims

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Application Information

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IPC IPC(8): A61K49/06A61K51/04G01N33/58G01N33/60G21H5/02
CPCC07B59/001C07C253/30C07C253/34C07C255/42C07B2200/05C07C255/34
Inventor 那吉切蒂亚尔·萨蒂亚穆尔蒂刘捷乔治·R·巴里奥
Owner RGT UNIV OF CALIFORNIA
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