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Method for obtaining a 2-18F-fluor-2-deoxy-D-glucose (18F-FDG) - solution

A technology of 18F-FDG and glucose, which is applied in the field of obtaining 2-18F-fluoro-2-deoxy-D-glucose (18F-FDG) solution, can solve the problem of limiting the service life of the compound, reducing the radiochemical purity of the compound, incompatibility, etc. question

Inactive Publication Date: 2005-07-27
MALLINCKRODT INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the radiochemical purity of the compound is significantly reduced by standard autoclaving procedures, and such compounds will not comply with European and US Pharmacopoeia regulations
In addition, after synthesis, due to radiolysis and the half-life of radioisotopes 18 F-FDG rapidly loses its radiochemical purity, which limits the useful life of the compound

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Embodiment 1: at pH4.5-5.5 to 18 F-FDG solution is autoclaved

[0014] 3 experimental rounds were conducted to study the use of weakly acid-buffered 18 Radiochemical purity of F-fluoro-2-deoxy-glucose (FDG) solutions compared to unbuffered solutions in saline.

[0015] After production, dilute with salt water 18 F-fluoro-deoxy-glucose (FDG) solution to a radioactivity concentration of 3 mCi / ml at ART (Activity Refeence Time) (t=0). After 2 hours of production, 0.5 ml of 18 A vial of F-fluoro-deoxy-glucose (FDG) solution, mixed with 0.1 ml of buffer (10 mM), was then autoclaved.

[0016] Table 1 shows the different buffered 18 Radiochemical purity of F-fluoro-deoxy-glucose (FDG) solutions after autoclaving at 134 °C for 5 min. Using KAVO Sterimaster TM Directly after autoclaving.

[0017] Table 1

[0018] 18 Radiochemical purity of F-FDG (%)

[0019] All test buffers achieved high radiochemical purity relative to the unbuffered reference sample N...

Embodiment 2

[0020] Example 2: Low pH range (pH2-3) 18 Autoclaving of F-FDG solution

[0021] 2 rounds of experiments were conducted to study the use of weak acid buffered to pH 2-3 18 Radiochemical purity of F-fluoro-deoxy-glucose (FDG) solutions.

[0022] with salt water 18 F-fluoro-deoxy-glucose (FDG) solutions were diluted directly after production to a radiochemical purity of 3 mCi / ml at ART (12:00h). After 2 hours of production, 0.5 ml of 18 A vial of F-fluoro-deoxy-glucose (FDG) solution mixed with 0.1 ml of buffer (100 mM) was then autoclaved.

[0023] buffer

[0024] All test buffers exhibited high radiochemical purity compared to the unbuffered reference sample NaCl / pH 6.2. A 2-3% reduction was observed with weakly acid buffered samples compared to the control sample (9% reduction in radiochemical purity). For all buffers (ascorbic acid, citric acid, acetic acid), there was no significant reduction in radiochemical purity compared to non-autoclaved samples (Table ...

Embodiment 3

[0025] Example 3: 18 Radiation decomposition of F-FDG

[0026] Measured over a period of approximately 8.5 hours 18 Radioactivity concentration of F-FDG. The radioactivity concentration at ART (t=0) was 3 mCi / ml.

[0027] 2 buffers were tested and compared to a reference sample in 0.9% NaCl / pH 6.9. The first buffer is citrate buffer pH 4.5 and the second buffer is ascorbic acid buffer pH 4.5. Five determinations of the radiochemical purity of the samples were performed in intervals. The results are shown in Table 3.

[0028] buffer / pH

[0029] Radiolysis was reduced in both test buffers compared to the 0.9% NaCl sample. The greatest reduction was observed when using ascorbic acid buffer. After 8.5 hours there was only a 2% loss of activity. 4% and 6% for citrate buffer and 0.9% NaCl, respectively. It was concluded that after adding ascorbic acid or citrate buffer, compared with no buffer, 18 F-FDG is more stable.

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PUM

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Abstract

The invention relates to a method for improving one or more physical / chemical characteristics, like reduced radiolysis of and the ability to autoclave, a <18>F-fluor-deoxy-glucose (<18>F-FDG)-solution, which method comprises the steps of a) provision of a <18>F-fluor-deoxy-glucose (<18>F-FDG)-solution, and b) addition of at least one buffer based on a weak acid to the <18>F-fluor-deoxy-glucose (<18>F-FDG)-solution. The invention also relates to a method for preparing a sterile <18>F-fluor-deoxy-glucose (<18>F-FDG)-solution by autoclaving said <18>F-fluor-deoxy-glucose (FDG)-solution.

Description

field of invention [0001] The present invention relates to obtaining 2-[ 18 F]-fluoro-2-deoxy-D-glucose (18F-FDG) solution method (also described as 18 F-fluoro-deoxy-glucose or 18 F-FDG) solutions, which have improved physicochemical properties, i.e. radiochemical stability, so that they can be sterile, 18 F-FDG solution. technical background [0002] In recent years, in the field of nuclear medicine, compounds 18 F-FDG, in addition to its important uses in cardiology and neurology, has also been shown to be useful in detecting cancerous tissue that cannot be detected by conventional methods, or in correcting misdiagnosis of these diseases. This takes advantage of a fundamental change that occurs in cells when they become malignant; cancer cells lose their ability to efficiently convert glucose into energy. As a result, they require up to 20 to 50 times more glucose. [0003] 18 F-FDG is usually prepared using a fully automatic synthesizer. Because the compound need...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K51/04A61K51/12
CPCC07B59/001A61K51/121A61K51/0491C07B63/04A61P43/00A61K51/04A61K51/12
Inventor 彼得勒斯·S·克鲁伊杰赫克托·H·奈特卡斯特罗
Owner MALLINCKRODT INC
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