WO2004059661A1 - Generateur de rubidium-82 a partir d'un support de sodium nonatitanate, et procedes de separation pour la recuperation de strontium-82 sur des cibles irradiees - Google Patents

Generateur de rubidium-82 a partir d'un support de sodium nonatitanate, et procedes de separation pour la recuperation de strontium-82 sur des cibles irradiees Download PDF

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WO2004059661A1
WO2004059661A1 PCT/US2002/041676 US0241676W WO2004059661A1 WO 2004059661 A1 WO2004059661 A1 WO 2004059661A1 US 0241676 W US0241676 W US 0241676W WO 2004059661 A1 WO2004059661 A1 WO 2004059661A1
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rubidium
strontium
sodium
nonatitanate
solution
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PCT/US2002/041676
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English (en)
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Paul Sylvester
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Lynntech, Inc.
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Priority to AU2002368529A priority Critical patent/AU2002368529A1/en
Priority to PCT/US2002/041676 priority patent/WO2004059661A1/fr
Publication of WO2004059661A1 publication Critical patent/WO2004059661A1/fr

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    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21G—CONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES
    • G21G4/00—Radioactive sources
    • G21G4/04—Radioactive sources other than neutron sources
    • G21G4/06—Radioactive sources other than neutron sources characterised by constructional features
    • G21G4/08—Radioactive sources other than neutron sources characterised by constructional features specially adapted for medical application

Definitions

  • This invention relates to the selective separation of strontium-82 from other radioisotopes, such as those resulting from an irradiated molybdenum target, and in the manufacture of a rubidium-82 generator.
  • Positron ( ⁇ +) emitters are particularly useful in the study of metabolic processes because the positron-electron annihilation reaction produces a pair of gamma rays with an energy level of 511 keV travelling in opposite directions.
  • PET Positron Emission Tomography
  • rubidium is an analogue of potassium, and consequently enters the body's large potassium pool, which has a comparatively slow turnover.
  • the tracer's uptake in tissue reflects the rate of delivery, i.e. blood flow, and thus 82Rb rapidly builds up in the heart. This can be used, for example, to study blood-brain barrier leakage and heart muscle perfusion.
  • the generators that are currently available use hydrous tin oxide to immobilize the 82Sr and allow the elution of 82Rb by saline or other appropriate eluant.
  • the parent 82Sr is generated by the proton irradiation of rubidium, rubidium chloride or molybdenum targets followed by dissolution and processing to isolate the 82Sr.
  • the demand for 82Rb generators has grown so great that there is a need to reduce processing times and to increase the yield of 82Sr from processed targets.
  • One method of improving the supply of 82Sr is to improve the processes used to extract 82Sr from irradiated targets.
  • Current methods utilize organic ion exchange or chelating resins to extract very low levels of strontium from dissolved targets containing molar concentrations of inert ions.
  • a satisfactory separation of 82Sr from the target materials and other radioisotopes generated during the irradiation procedure requires multiple treatment steps due to the relatively low affinity and low selectivity of the organic ion exchange resins for 82Sr.
  • 82Sr is produced by the proton irradiation of molybdenum metal, rubidium metal and rubidium chloride targets.
  • the irradiation process also produces a range of other radioactive isotopes (e.g. 88Y, 88Zr, 85Sr) and as a consequence, a series of carefully designed separation procedures have been designed to separate the desired 82Sr from other radioisotopes and inactive species present.
  • the primary method used to separate 82Sr is by a series of ion exchange and selective elution steps. Typically, AG 50 W-X8 ion exchange resin is used to separate 82Sr from dissolved targets.
  • this resin is relatively non- selective and will absorb numerous polyvalent cations (e.g., 88Y) in addition to the desired 82Sr. Consequently, multiple separation steps are required to isolate 82Sr f om the other isotopes present.
  • polyvalent cations e.g., 88Y
  • 82Rb can be conveniently supplied to physicians in the form of a generator in which the parent 82Sr is immobilized on an ion exchange material and the 82Rb eluted when required. This means that 82Rb PET can be performed at clinical facilities where a typical generator may last several months before the yield of 82Rb diminishes below a usable level.
  • an ion exchange material must exhibit a high affinity for strontium but a low affinity for rubidium, allowing the 82Rb daughter to be eluted f om a column containing immobilized 82Sr.
  • Generators have been proposed that were based on a number of separation media including Chelex 100, A1 2 0 3 , Sb(V) hexacyanoferrate, polyantimonic acid, titanium vanadate and hydrated tin(IV) oxide, with the hydrated tin(IV) oxide being the most widely used.
  • the present invention provides a method of chemically isolating strontium-82 from proton-irradiated molybdenum targets. This comprises dissolving the molybdenum metal target containing the strontium-82, adjusting the pH of the dissolved molybdenum target solution to an alkaline pH, removing precipitates from the solution, and then absorbing the strontium-82 from the solution onto a support comprising sodium nonatitanate. Sodium nonatitanate can also be applied to the efficient recovery of strontium-82 from alkaline RbCl solutions produced during the processing of proton-irradiated rubidium metal and rubidium chloride targets.
  • the present invention also provides a rubidium-82 generator, comprising a strontium- 82 support medium comprising sodium nonatitanate.
  • the sodium nonatitanate is characterized by a strontium selectivity greater than 250,000 mL/g at an alkaline pH, and/or the sodium nonatitanate is characterized by a rubidium selectivity less than 100 mL/g at an alkaline pH. More preferably, the sodium nonatitanate is characterized by a strontium rubidium separation factor greater than 1,000, and even more preferably greater than 100,000.
  • the rubidium-82 generator is prepared by a process comprising: preparing sodium nonatitanate from titanium isopropoxide and aqueous sodium hydroxide; heating the sodium nonatitanate at a temperature between 100°C and 250°C for a period between 12 hours and 2 weeks; and absorbing strontium-82 on the sodium nonatitanate from an aqueous solution comprising strontium-82 and a soluble sodium salt, wherein the sodium salt concentration is between 0.1 and 1 molar. It is also preferred that the titanium isopropoxide and the aqueous sodium hydroxide solution are provided at a sodium hydroxide to titanium isopropoxide molar ratio of greater than 0.44, but preferably providing a large molar excess of sodium hydroxide.
  • the sodium hydroxide to titanium isopropoxide molar ratio is preferably between 1 and 10, more preferably between 2 and 6, and most preferably about 4.
  • the invention provides a process for preparing a solution containing rubidium-82.
  • the process comprises providing a solution containing strontium-82 at a pH between 10 and 14, absorbing the strontium-82 from the solution onto a sodium nonatitanate support medium, and eluting rubidium-82 from the sodium nonatitanate support medium with a solvent.
  • the solvent is preferably selected from the group consisting of water and saline solutions. More particularly, the solvent may be an aqueous solution having a sodium chloride concentration between 0.001 molar and 1 molar, preferably between 0.2 molar and 1 molar.
  • the solvent may also be a pharmaceutical grade isotonic saline and buffer solution.
  • the present invention provides improved sodium nonatitanate compositions, a method using the composition for recovery of 82Sr from irradiated targets, and a method using the composition for generating 82Rb.
  • the sodium nonatitanate materials of the invention are far more selective at separating strontium from solutions derived from the dissolution of irradiated target materials than current ion exchange resins used in the production of 82Sr.
  • the present invention reduces the number of processing steps required, and thus leads to a decrease in target processing times and a reduction in the cost of the 82Sr product. Waste generation and disposal are also decreased.
  • the sodium nonatitanate of the present invention has been found to have a very low affinity for rubidium in addition to an exceptionally high affinity for strontium, making it ideal for use as a replacement for the hydrous tin dioxide used in current 82Rb generators.
  • Sodium nonatitanate materials of this type will both improve the recovery of 82Sr and lead to a safer, more effective 82Rb generator system for clinical applications.
  • Sodium nonatitanate, Na Ti 9 O 20 .xH 2 O is an inorganic ion exchange material that has been used for the removal of 90Sr from neutral and alkaline nuclear wastes.
  • the sodium nonatitanate of the present invention has a number of advantages over conventional organic ion exchange resins (e.g., Chelex 100) that include: very high selectivity for trace levels of strontium in the presence of molar concentrations of other ions at alkaline pH; very low affinity for rubidium; excellent radiation, chemical and thermal stability so that there is no release of contaminants (e.g.
  • sodium nonatitanate powder can be manufactured into pellets appropriate for column operations.
  • Other chemically related sodium titanate materials suitable for use in the same manner as the aforementioned sodium nonatitanate (Na Ti 9 0 2 o-xH 2 0) include other titanate materials exhibiting high Sr affinity and low Rb affinity, including Sr-Treat (available from Selion Oy) and monosodium titanate (available from Boulder Scientific) It is also anticipated that analogous zirconates may exhibit similar properties.
  • the invention also provides important improvements in the processing of irradiated targets to recover 82Sr.
  • Sodium nonatitanate has a much greater affinity for 82Sr than currently used ion exchange resins, and a low affinity for other radioactive isotopes. Consequently, the use of sodium nonatitanate greatly simplifies the extraction process by reducing the number of separation steps that are required to produce chemically pure 82Sr. Thus, targets can be processed more rapidly and the recovery of 82Sr improved. Improved isotope selectivity may also facilitate the isolation of other useful isotopes from the targets, leading to greater payback from target processing operations.
  • sodium nonatitanate may be used as a direct replacement for hydrous tin dioxide in the 82Rb generator, it is also possible to use sodium nonatitanate in the form of a disposable add-on filter that could be used to trap any 82Sr that is leached from the generator during the production of 82Rb.
  • the first step in preparing a 82Rb generator is to load the parent 82Sr onto the sodium nonatitanate material and place the ion exchange material into a suitable column. It is essential that sufficient time be allowed for the 82Sr to be absorbed by the sodium nonatitanate material in order to maximize the loading of the parent radioisotope per gram of ion exchange material.
  • Sodium nonatitanate should be loaded with 82Sr before being placed in an ion exchange column, to avoid preferential loading of the 82Sr on the top of the ion exchange column rather than uniformly throughout the material. This high concentration of radioactivity on a very small volume may result in undesirable radiolytic problems. Although sodium nonatitanate has been shown to be highly resistant to radiation damage, it is considered prudent to avoid any potential problems.
  • Sodium nonatitanate (NaTi) was synthesized hydrothermally as follows. 77.5 g of titanium isopropoxide was added to 84.35 g of a 50 wt.% solution of NaOH with vigorous stirring and 60 mL of deionized water was added. The resultant gel was heated at approximately 108°C for 3 hours, transferred to a hydrothermal pressure vessel with an additional 90 mL of deionized water, and heated at either 170°C or 200°C for times ranging from 21 hours to 1 week. After the allotted time, the materials were filtered, washed with ethanol to remove residual base and dried at 60°C. The mass of sodium nonatitanate produced was approximately 31 g. Each sample was characterized using x-ray powder diffraction (XRD). The reaction is outlined in Equation 1.
  • the crystallinity of the material was shown to be dependent upon the reaction time and temperature, with the most crystalline materials being produced after 1 week of hydrothermal treatment (200°C for 7 days). Samples that received no hydrothermal treatment, or only a few days, were virtually amorphous with only a few very broad reflections visible on the XRD pattern.
  • the theoretical cation exchange capacity (CEC) of sodium nonatitanate is quite high and has a value of 4.74 meq/g, which compares favorably with organic ion exchange resins.
  • titanium salts that could be used to manufacture sodium nonatitanate include titanium tetrachloride, TiCl , and titanium sulfate, TiOS0 .xH 2 S0 4 .yH 2 0.
  • hydrolysis of these salts leads to the generation of hydrochloric acid and sulfuric acid, respectively, and thus additional base is required during the hydrothermal process.
  • the final product also needed to be exliaustively washed to remove residual sodium chloride or sodium sulfate. Consequently, titanium isopropoxide (which hydrolyzes to form propanol) is the preferred starting material because the final product is free from additional sodium salts.
  • Chelex 100 (Na+) BioRad. Chelating resin None. Used as received. (50 - 100 Mesh) with iminodiacetic acid functionality.
  • Hydrous Si0 2 Synthesized in house Acetic acid hydrolysis of tetraethyl orthosilicate. Washed with H 2 0 Hydrous Ti0 2 Synthesized in house Hydrolysis of titanium isopropoxide. Washed with H 2 0
  • Hydrous Zr0 2 Synthesized in house ZrOCl 2 + NaOH. Washed with deionized water.
  • the strontium selectivity of the ion exchange materials of Table 1 was evaluated in sodium chloride and rubidium chloride solutions using radiotracer techniques. Samples were evaluated using a simple batch technique to allow the rapid screening of a large number of materials over a range of ionic strengths. Blanks were run for each matrix to check for any loss of strontium during filtration or absorption of strontium onto the scintillation vials. In all solutions evaluated, strontium absorption was negligible.
  • A, initial activity in solution (counts per minute (cpm)/mL)
  • a f final activity in solution (cpm/mL)
  • v volume of solution (mL)
  • m mass of exchanger
  • the final pH of the solution was also noted. The period of 6 hours was chosen to allow equilibrium to be reached for each of the ion exchange materials. However, previous work on the titanosilicates and titanates had shown the reaction rates to be rapid with the majority of the uptake occurring in only a few minutes.
  • the concentration of the chloride solutions was varied from 1M to 0.001M to evaluate the effect of increasing Rb+ and Na+ concentrations on the uptake of Sr 2+ . All experiments were performed in duplicate, and if significant variations between duplicate samples occurred, the experiments were repeated until good agreements on the K ⁇ j values were obtained. The results are shown in Tables 2 and 3 and represented the average K d obtained, quoted to 3 significant figures.
  • Na-Clinoptilolite 8 124 3,260 36,900
  • an ion exchange material For an ion exchange material to be suitable for use in a 82Rb generator, it must have a very high selectivity for strontium to prevent any loss of 82Sr from the ion exchange column and release to the patient undergoing a PET scan. This property was clearly demonstrated in Example 2. It must also have a very low selectivity towards rubidium, thus allowing 82Rb to be released into solution as saline is passed through the 82Rb generator. Consequently, the rubidium selectivity of the ion exchange materials was evaluated in sodium chloride media following the procedure described in Example 2. The same procedure was followed using 86Rb to spike the solutions to give an activity of approximately 200,000 cpm mL. Total rubidium in solution was ⁇ 0.05 ppm. The selectivities of the materials are shown below in Table 4.
  • Hydrous tin dioxide exhibited some of the lowest rubidium affinities and was comparable with Chelex 100, the best of the nonatitanates and the hydrous zirconium dioxide. However, hydrous tin dioxide exhibited much lower strontium K d values than the nonatitanates. Therefore, nonatitanate materials are preferred because they have higher strontium rubidium separation factors. Hydrous tin dioxide also has a limited pH stability range and significant dissolution and release of absorbed strontium is likely to occur should any significant pH perturbations occur outside the range of pH 4 to pH 9. Radiation stability of hydrous tin dioxide is also limited, with particle breakdown causing current 82-Rb generators to be replaced before decay has reduced the 82-Rb below useable levels.
  • the rubidium selectivity data also indicates that AW500, potassium Pharmacosiderite and the sodium titanosilicate have a strong affinity for rubidium in a range of saline solutions. Consequently, these materials will be unsuitable for use in a 82Rb generator and have only limited applications in the processing of irradiated target materials.
  • Example 4 Sr and Rb Selectivity in 0.1M Sodium Acetate/Acetic Acid Buffer
  • some strontium and rubidium selectivity experiments were performed in a 0.1M sodium acetate / acetic acid buffer solution.
  • the final pH remained between 5.2 and 6.3, which is a more clinically acceptable pH for an 82Rb infusion.
  • Rubidium K d values remained low, as expected, following the trend observed in Table 5.
  • Strontium K values were considerably lower, with a maximum K d value of 80,000 mL/g being obtained for the sodium nonatitanate sample that was heated hydrotherrnally at 170°C for 21 hours.
  • the column can then be stripped using dilute mineral acid to recover the 82Sr and the sodium nonatitanate reused or discarded.
  • the most likely isotope to be absorbed is beryllium, because it is a Group II metal with a similar aqueous chemistry to strontium.
  • the affinity of sodium nonatitanate for Group II metals decreases in the order Sr > Ca > Mg. No data is available for beryllium, but if the trend continues, the affinity would be expected to be low. Thus, any absorbed 7Be would be readily removed by an alkaline sodium chloride (or similar) wash.
  • the current process for recovering 82Sr from irradiated rubidium metal and rubidium chloride targets requires minimal modification to facilitate the use of sodium nonatitanate. Both targets are processed following standard processing procedures to generate rubidium chloride solutions in an ammonia/aminonium chloride buffer solution. These solutions are then passed through a sodium nonatitanate column and washed with additional buffer to remove any weakly held rubidium cations. Strontium and possibly some other cationic species present will be absorbed onto the nonatitanate column, whereas rubidium cations, ammonium cations and anions will rapidly pass through the column.
  • Figure 1 clearly shows the exceptionally high affinity of the sodium nonatitanate materials in comparison with the currently utilized organic resin Chelex 100. All of the sodium nonatitanates performed equally well in the buffered rubidium target solutions indicating that the synthetic conditions are not too important when the material is being used in solutions containing high concentrations of rubidium ions. Thus, by replacing the Chelex 100 with sodium nonatitanate, a more efficient 82Sr isolation can be achieved.
  • Rubidium selectivities were low, making the sodium nonatitanate ideal as a replacement for hydrous tin dioxide in a 82Rb generator.
  • one method of 82-Sr production is via the proton spallation reaction with natural molybdenum metal targets.
  • a simulated molybdate target solution was prepared as follows. 12.5 g of molybdenum powder was carefully dissolved in 30% H 2 0 2 solution and made up to a total volume of 500 mL to produce a clear yellow solution of molybdic acid, H 2 Mo0 4 . Solid sodium hydroxide granules totaling 10.9 g were then carefully added to neutralize the solution and bring the pH to approximately 12.3. The colorless solution was then filtered to remove any precipitate.
  • This alkaline molybdate solution was spiked with either 86Rb or 89Sr and K d values determined as described previously. Separation factors for the strontium/rubidium selectivity were also calculated by dividing the strontium K by the rubidium K-d, thus allowing the relative affinities of the ion exchange materials to be directly compared. The results are illustrated below in Table 5.
  • strontium selectivity also decreased with increasing reaction time.
  • the best overall strontium/rubidium separation factor was obtained for the material that had not undergone any hydrothermal treatment. All of the materials performed better than the commercially available nonatitanate materials.
  • Rubidium selectivities were very low for all of the nonatitanates, indicating minimal rubidium absorption would occur in a column process and that any rubidium absorbed would be readily removed by a dilute saline wash.
  • the sodium titanosilicate, potassium Pharmacosiderite and AW500 exhibit selectivities for rubidium that are too high to allow their use in the selective removal of 82Sr from irradiated molybdenum targets. This high selectivity would result in some rubidium being retained on the column that would not be readily removed by a simple saline wash, thus leading to contamination of the 82Sr product with both radioactive and stable rubidium isotopes. Hydrous tin oxide was not evaluated because, due to the amphoteric nature of tin, significant dissolution would be expected at a pH in excess of 12.
  • Sodium nonatitanate has a relatively low affinity for strontium at pH values less than 6, and was not expected to exhibit any affinity for strontium from the acidic molybdate target solutions prior to the addition of sodium hydroxide.
  • K d values were determined to confirm this and to compare it with the K d values for both Chelex 100 and AG 50W-X8 under identical conditions. The data obtained is shown below in Table 6.
  • the ion exchange materials were also evaluated for their rubidium selectivity from 0.1 M NH 3 / 0. IM NH C1 buffer solution.
  • the buffer was prepared, spiked with 86Rb and the pH adjusted to approximately 9.25 with concentrated ammonia. 86Rb K d values were then determined following the method described earlier. All of the sodium nonatitanates had a K ⁇ 20 mL/g. The very low rubidium selectivity in the pure buffer is almost certainly due to competition from NH + ions for the available ion exchange sites.
  • ком ⁇ онентs include titanium isopropoxide or tetraethyl orthosilicate (TEOS) as a binder precursor.
  • TEOS tetraethyl orthosilicate
  • Example 10 - 82Sr Removal from Irradiated Targets Using Pelletized Sodium Nonatitanate A sample of sodium nonatitanate was mixed with titanium isopropoxide as a binder and the resulting paste dried at 105°C for 12 hours. The material was gently broken up using a mortar and pestle and then sieved to produce particles in the range 40 to 60 mesh. The binder content was approximately 20%. These particles were then used to assess the extraction of 89Sr from simulated target solutions.
  • Strontium was quantitatively eluted from the sodium nonatitanate column of Example 10 using 6M nitric acid. Hydrochloric acid was found to be much less effective and also resulted in breakdown of the sodium nonatitanate particles and blocked the ion exchange column.

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Abstract

Cette invention concerne des compositions de sodium nonatitanate, une méthode d'utilisation de la composition pour la récupération de 82Sr sur des cibles irradiées et une méthode d'utilisation de cette composition pour la production de 82Rb. Les matériaux de sodium nonatitanate de l'invention présentent une sélectivité élevée pour la séparation du strontium de solutions dérivées de la dissolution de matériaux cibles irradiées, ce qui accélère le traitement de la cible. Par ailleurs, ces compositions n'ont qu'une très faible affinité pour le rubidium, ce qui en fait un matériau idéal comme générateur de 82Rb . Les matériaux de sodium nonatitanate de ce type améliorent la récupération de 82Sr tout en constituant un système de générateur de 82Rb plus sur et plus efficace.
PCT/US2002/041676 2002-12-30 2002-12-30 Generateur de rubidium-82 a partir d'un support de sodium nonatitanate, et procedes de separation pour la recuperation de strontium-82 sur des cibles irradiees WO2004059661A1 (fr)

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AU2002368529A AU2002368529A1 (en) 2002-12-30 2002-12-30 Rubidium-82 generator based on sodium nonatitanate support, and separation methods for the recovery of the recovery of strontium-82 from irradiated targets
PCT/US2002/041676 WO2004059661A1 (fr) 2002-12-30 2002-12-30 Generateur de rubidium-82 a partir d'un support de sodium nonatitanate, et procedes de separation pour la recuperation de strontium-82 sur des cibles irradiees

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US7862534B2 (en) 2008-06-11 2011-01-04 Bracco Diagnostics Inc. Infusion circuit subassemblies
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US9123449B2 (en) 2008-06-11 2015-09-01 Bracco Diagnostics Inc. Infusion system configurations
US9597053B2 (en) 2008-06-11 2017-03-21 Bracco Diagnostics Inc. Infusion systems including computer-facilitated maintenance and/or operation and methods of use
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Cited By (28)

* Cited by examiner, † Cited by third party
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WO2006135374A2 (fr) * 2004-07-19 2006-12-21 Lynntech, Inc. Generateur de rubidium-82 comprenant un support de nonatitanate de sodium, et procedes de separation ameliores pour la recuperation de strontium-82 a partir de cibles irradiees
WO2006135374A3 (fr) * 2004-07-19 2009-03-12 Lynntech Inc Generateur de rubidium-82 comprenant un support de nonatitanate de sodium, et procedes de separation ameliores pour la recuperation de strontium-82 a partir de cibles irradiees
US9750869B2 (en) 2008-06-11 2017-09-05 Bracco Diagnostics, Inc. Integrated strontium-rubidium radioisotope infusion systems
US9597053B2 (en) 2008-06-11 2017-03-21 Bracco Diagnostics Inc. Infusion systems including computer-facilitated maintenance and/or operation and methods of use
US9750870B2 (en) 2008-06-11 2017-09-05 Bracco Diagnostics, Inc. Integrated strontium-rubidium radioisotope infusion systems
US7862534B2 (en) 2008-06-11 2011-01-04 Bracco Diagnostics Inc. Infusion circuit subassemblies
US8708352B2 (en) 2008-06-11 2014-04-29 Bracco Diagnostics Inc. Cabinet structure configurations for infusion systems
US9114203B2 (en) 2008-06-11 2015-08-25 Bracco Diagnostics Inc. Infusion systems configurations
US9123449B2 (en) 2008-06-11 2015-09-01 Bracco Diagnostics Inc. Infusion system configurations
US9299467B2 (en) 2008-06-11 2016-03-29 Bracco Diagnostics Inc. Infusion system with radioisotope detector
US9299468B2 (en) 2008-06-11 2016-03-29 Bracco Diagnostics Inc. Radioisotope generator system including activity measurement and dose calibration
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