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US20030007928A1 - Polymer based radionuclide containing particulate material - Google Patents

Polymer based radionuclide containing particulate material Download PDF

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Publication number
US20030007928A1
US20030007928A1 US10/173,496 US17349602A US2003007928A1 US 20030007928 A1 US20030007928 A1 US 20030007928A1 US 17349602 A US17349602 A US 17349602A US 2003007928 A1 US2003007928 A1 US 2003007928A1
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United States
Prior art keywords
particulate material
radionuclide
yttrium
polymeric matrix
material according
Prior art date
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Abandoned
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US10/173,496
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English (en)
Inventor
Bruce Gray
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Sirtex Medical Pty Ltd
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Individual
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Filing date
Publication date
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Assigned to SIRTEX MEDICAL LIMITED reassignment SIRTEX MEDICAL LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GRAY, BRUCE NATHANIEL
Publication of US20030007928A1 publication Critical patent/US20030007928A1/en
Assigned to SIRTEX MEDICAL LIMITED reassignment SIRTEX MEDICAL LIMITED ASSIGNEE ADDRESS CHANGE Assignors: SIRTEX MEDICAL LIMITED
Priority to US11/743,530 priority Critical patent/US20070253898A1/en
Priority to US12/712,843 priority patent/US20100215571A1/en
Priority to US13/968,921 priority patent/US20140099255A1/en
Priority to US16/280,171 priority patent/US11097021B2/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/1241—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules particles, powders, lyophilizates, adsorbates, e.g. polymers or resins for adsorption or ion-exchange resins
    • A61K51/1244—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules particles, powders, lyophilizates, adsorbates, e.g. polymers or resins for adsorption or ion-exchange resins microparticles or nanoparticles, e.g. polymeric nanoparticles
    • A61K51/1251—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules particles, powders, lyophilizates, adsorbates, e.g. polymers or resins for adsorption or ion-exchange resins microparticles or nanoparticles, e.g. polymeric nanoparticles micro- or nanospheres, micro- or nanobeads, micro- or nanocapsules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04—Organic compounds
    • A61K51/06—Macromolecular compounds, carriers being organic macromolecular compounds, i.e. organic oligomeric, polymeric, dendrimeric molecules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/12—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules
    • A61K51/1241—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by a special physical form, e.g. emulsion, microcapsules, liposomes, characterized by a special physical form, e.g. emulsions, dispersions, microcapsules particles, powders, lyophilizates, adsorbates, e.g. polymers or resins for adsorption or ion-exchange resins
    • A61K51/1255—Granulates, agglomerates, microspheres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Definitions

  • This invention relates to a particulate material that comprises a polymer, particularly a polymer and a radionuclide, to a method for the production thereof, and to methods for the use of this particulate material.
  • this invention relates to microspheres which comprise a polymer and a radionuclide such as radioactive yttrium, and to the use of these microspheres in the treatment of cancer in humans and other mammals.
  • the particulate material of this invention is designed to be administered into the arterial blood supply of an organ to be treated, whereby it becomes entrapped in the small blood vessels of the target organ and irradiates it.
  • An alternate form of administration is to inject the polymer based particulate material directly into the target organ or a solid tumour to be treated.
  • the particulate material of the present invention therefore has utility in the treatment of various forms of cancer and tumours, but particularly in the treatment of primary and secondary cancer of the liver and the brain. It is to be understood that the particulate material of the invention is not limited to radioactive microspheres, but may be extended to other radioactive polymeric particles which are suitable for use in the treatment methods described herein.
  • SIRT Selective Internal Radiation Therapy
  • the radiation is delivered preferentially to the cancer within the target organ.
  • the radiation is slowly and continually delivered as the radionuclide decays.
  • vasoactive substances such as Angiotensin-2
  • microspheres or other small particles When microspheres or other small particles are administered into the arterial blood supply of a target organ, it is desirable to have them of a size, shape and density that results in the optimal homogeneous distribution within the target organ. If the microspheres or small particles do not distribute evenly, and as a function of the absolute arterial blood flow, then they may accumulate in excessive numbers in some areas and cause focal areas of excessive radiation. It has been shown that microspheres of approximately 25-50 micron in diameter have the best distribution characteristics when administered into the arterial circulation of the liver (Meade, V. et al.; Distribution of different sized microspheres in experimental hepatic tumours. Europ. J. Cancer & Clin. Oncol. 1987, 23:23-41).
  • the radiation emitted should be of high energy and short range. This ensures that the energy emitted will be deposited into the tissues immediately around the particulate material and not into tissues which are not the target of the radiation treatment. In this treatment mode, it is desirable to have high energy but short penetration beta-radiation which will confine the radiation effects to the immediate vicinity of the particulate material.
  • radionuclides that can be incorporated into microspheres that can be used for SIRT.
  • Y-90 the unstable isotope of yttrium
  • Yttrium-90 decays with a half life of 64 hours, while emitting a high energy pure beta radiation.
  • radionuclides may also be used in place of yttrium-90 of which the isotopes of holmium, samarium, iodine, iridium, phosphorus, rhenium are some examples.
  • Ceramic particles have been produced that are either coated with or contain radionuclides. However, the presence of other radioactive substances that are not required for the radiation treatment of the target tissue, has then unwanted and deleterious radiation effects may occur. It is therefore desirable to have particulate material of such a composition that it only contains the single desired radionuclide.
  • a radioactive microsphere comprising a biologically compatible glass material containing a beta- or gamma-radiation emitting radioisotope such as yttrium-90 distributed throughout the glass.
  • These microspheres are solid glass and contain the element yttrium-89 that can be activated to the radionuclide yttrium-90 by placing the microspheres in a neutron beam.
  • These glass microspheres have several disadvantages including being of a higher specific gravity than is desirable and containing other elements such as alumina and silica which are activated to undesirable radionuclides when placed in a neutron beam.
  • the present invention provides a particulate material having a diameter in the range of from 5 to 200 microns comprising a polymeric matrix and a stably incorporated radionuclide.
  • the invention provides a process for the production of a particulate material having a diameter in the range of from 5 to 200 microns comprising the step of combining a polymeric matrix and a radionuclide for a time and under conditions sufficient to stably incorporate the radionuclide in the matrix to produce a particulate material having a diameter in the range of from 5 to 200 microns.
  • the present invention provides a method of radiation therapy of a patient, which comprises administration to the patient of a particulate material having a diameter in the range of from 5 to 200 microns comprising a polymeric matrix and a stably incorporated radionuclide.
  • the present invention also provides for the use of particulate material having a diameter in the range of from 5 to 200 microns comprising a polymeric matrix and a stably incorporated radionuclide in the radiation therapy of a patient.
  • references to the radionuclide being stably incorporated into particulate material or polymeric matrix are to be understood as referring to incorporation of the radionuclide so that it does not substantially leach out of the particulate material under physiological conditions such as in the patient or in storage.
  • the radionuclide is incorporated by precipitation into a polymeric matrix.
  • the leaching of radionuclides from the polymeric matrix can cause non-specific radiation of the patient and damage surrounding tissue.
  • the amount of leaching is less than 5%, more preferably less than 4%, 3%, 2%, 1% or 0.4%.
  • the radionuclide can be stably incorporated into the polymeric matrix by precipitating it as an insoluble salt.
  • the radionuclide used is yttrium-90 the yttrium is preferably precipitated as a phosphate salt.
  • the present invention also extends to precipitation of the radionuclide as other insoluble salts including, for example, carbonate and bicarbonate salts.
  • the radionuclide which is incorporated into the polymeric matrix in accordance with the present invention is preferably yttrium-90, but may also be any other suitable radionuclide which can be precipitated in solution, of which the isotopes of holmium, samarium, iodine, phosphorous, iridium and rhenium are some examples.
  • the particulate material is a microsphere.
  • microsphere is used in this specification as an example of a particulate material, it is not intended to limit the invention to microspheres, as the person skilled in the art will appreciate that the shape of the particulate material while preferably without sharp edges or points that could damage the patients arteries or catch in unintended locations, is not limited to spheres. Nor should the term microsphere be limited to spheres.
  • the particulate material is substantially spherical, but need not be regular or symmetrical in shape.
  • the polymeric matrix is partially cross linked.
  • the present invention provides a particulate material as described above in which the polymeric matrix is an ion exchange resin, particularly a cation exchange resin.
  • the ion exchange resin comprises a partially cross linked aliphatic polymer, including polystyrene.
  • a particularly preferred cation exchange resin is the styrene/divinylbenzene copolymer resin commercially available under the trade name Aminex 50W-X4 (Biorad, Hercules, Calif.). However, there are many other commercially available cation exchange resins which are suitable.
  • the particulate material is preferably low density, more particularly a density below 3.0 g/cc, even more preferably below 2.8 g/cc, 2.5 g/cc, 2.3 g/cc, 2.2 g/cc or 2.0 g/cc.
  • the ideal particle for injection into the blood stream would have a very narrow size range with a SD of less than 5%, so as to assist in even distribution of the microspheres within the target organ, particularly within the liver and would be sized in the range 5-200 micron preferably 15-100 micron and preferably 20-50 micron, and most preferably 30-35 micron.
  • the particulate material manufactured so that the suspending solution has a pH less than 9. If the pH is greater than 9 then this may result in irritation of the blood vessels when the suspension is injected into the artery or target organ.
  • the pH is less than 8.5 or 8.0 and more preferably less than 7.5.
  • the present invention particularly provides a method for the production of a radioactive particulate material comprising a polymeric matrix as described above, characterised by the steps of:
  • the method of the present invention is carried out by firstly irradiating yttria (yttrium oxide) in a neutron beam to activate yttria to the isotope yttrium-90.
  • the yttrium-90 oxide is then solubilised, for example as yttrium-90 sulphate solution.
  • the ion exchange resin is preferably provided in the form of an aqueous slurry of microspheres of ion exchange resin having a particle size 30 to 35 microns, and the yttrium-90 sulphate solution is added to the slurry to absorb the yttrium-90 into the ion exchange resin microspheres.
  • the yttrium-90 is precipitated as a phosphate salt, for example by addition of tri-sodium phosphate solution, to stably incorporate the yttrium-90 into the microspheres.
  • the particulate material may be combined with a solution of the radionuclide or the salt of the radionuclide may be combined with the particulate matter, in a solution suitable for solubilising the radionuclide.
  • Alternate sources of yttrium-90 may be used in the production of these microspheres.
  • a highly pure source of yttrium-90 may be obtained by extracting yttrium-90 from a parent nuclide and using this extracted yttrium-90 as the source of the soluble yttrium salt that is then incorporated into the polymeric matrix of the microspheres.
  • the microspheres may be washed to remove any un-precipitated or loosely adherent radionuclide.
  • the present invention provides a suspension of the required pH by precipitating the yttrium with a tri-sodium phosphate solution at a concentration containing at least a three-fold excess of phosphate ion, but not exceeding a 30-fold excess of phosphate ion, and then washing the microspheres with de-ionised water.
  • Another approach which ensures that the pH of the microsphere suspension is in the desired range is to wash the resin with a phosphate buffer solution of the desired pH.
  • the present invention also provides a method of radiation therapy of a human or other mammalian patient that comprises administration to the patient of particulate material as described above.
  • administration may be by any suitable means and preferably by delivery to the relevant artery.
  • administration is preferably by laparotomy to expose the hepatic artery or by insertion of a catheter into the hepatic artery via the femoral, or brachial artery.
  • Pre or co-administration of another agent may prepare the tumour for receipt of the particulate material, for example a vasioactive substance, such as angiotension-2 to redirect arterial blood flow into the tumour. Delivery of the particulate matter may be by single or multiple doses, until the desired level of radiation is reached.
  • Yttrium (90Y) labelled microspheres are made in the form of a sterile, pyrogen free suspension of resin beads labelled with yttrium (90Y) phosphate.
  • the resin beads consist of sulphuric acid groups attached to a styrene divinylbenzene copolymer lattice.
  • Yttrium oxide is irradiated to produce yttrium-90 from the nuclear reaction Y-89 (n, ⁇ ) Y-90.
  • Yttrium-90 has a half life of 64 hours.
  • the yttrium (90Y) oxide is then dissolved in 0.1M sulphuric acid with gentle heating and stirring to form a clear, colourless solution of yttrium (90Y) sulphate.
  • Symmetrical microspheres of ion exchange resin (Aminex 50W-X4 cation exchange resin; supplied by ‘Bio-Rad Cat # 1474313’) with a diameter of approximately 30 to 35 microns are added to water (Water for injections BP) to form a slurry that is then transferred into a reaction vessel.
  • Yttrium (90Y) sulphate solution is added to the reaction vessel and the mixture stirred at a speed sufficient to ensure homogeneity to absorb the yttrium (90Y) solution into the resin-based microspheres.
  • Tri-sodium phosphate solution (1.25% w/v) is then added to the reaction vessel with further stirring to precipitate the radionuclide as yttrium (90Y) phosphate.
  • microspheres are then washed with a phosphate buffer solution until the pH of the wash solution is less than 9 and preferable less than 8.5. Following washing of the microspheres with water (Water for Injection BP), the microspheres are resuspended and diluted (if necessary) with water (Water for Injections BP) to give a light brown suspension having an activity of 3000 MBq ⁇ 10%.
  • Water for Injection BP Water for Injection BP
  • the resin-based yttrium microspheres produced by the above method have 0.01-0.4% unbound or unprecipitated 90Y when tested in the following leaching test:
  • a 5 ⁇ /L sample is diluted with water to 5 mL, adjusted to pH 7.0 and agitated in a water bath at 37° C. for 20 minutes.
  • a 100 ⁇ L sample is counted for beta emission in a Geiger-Müller counter.
  • Another representative 100 ⁇ L sample is filtered through a 0.22 ⁇ m filter and the filtrate counted for beta emission in the Geiger-Müller counter.
  • the percent unbound 90Y is calculated by:
  • SIRT Selective Internal Radiation Therapy
  • tumour response by objective parameters including reduction in tumour volume and serial estimations of serum carcino-embryonic antigen (CEA) levels, is an acceptable index of the ability of the treatment to alter the biological behaviour of the tumour.
  • CEA serum carcino-embryonic antigen

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US10/173,496 2000-10-25 2002-06-17 Polymer based radionuclide containing particulate material Abandoned US20030007928A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US11/743,530 US20070253898A1 (en) 2000-10-25 2007-05-02 Polymer based radionuclide containing particulate material
US12/712,843 US20100215571A1 (en) 2000-10-25 2010-02-25 Polymer based radionuclide containing particulate material
US13/968,921 US20140099255A1 (en) 2000-10-25 2013-08-16 Polymer based radionuclide containing particulate material
US16/280,171 US11097021B2 (en) 2000-10-25 2019-02-20 Polymer based radionuclide containing particulate material

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
AUPR0983 2000-10-25
AUPR0983A AUPR098300A0 (en) 2000-10-25 2000-10-25 Polymer based radionuclide containing microspheres
PCT/AU2001/001370 WO2002034300A1 (fr) 2000-10-25 2001-10-25 Radionuclide a base de polymere contenant une matiere particulaire

Related Parent Applications (1)

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PCT/AU2001/001370 Continuation WO2002034300A1 (fr) 2000-10-25 2001-10-25 Radionuclide a base de polymere contenant une matiere particulaire

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US11/743,530 Continuation US20070253898A1 (en) 2000-10-25 2007-05-02 Polymer based radionuclide containing particulate material

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US10/173,496 Abandoned US20030007928A1 (en) 2000-10-25 2002-06-17 Polymer based radionuclide containing particulate material
US11/743,530 Abandoned US20070253898A1 (en) 2000-10-25 2007-05-02 Polymer based radionuclide containing particulate material
US12/712,843 Abandoned US20100215571A1 (en) 2000-10-25 2010-02-25 Polymer based radionuclide containing particulate material
US13/968,921 Abandoned US20140099255A1 (en) 2000-10-25 2013-08-16 Polymer based radionuclide containing particulate material
US16/280,171 Expired - Lifetime US11097021B2 (en) 2000-10-25 2019-02-20 Polymer based radionuclide containing particulate material

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Application Number Title Priority Date Filing Date
US11/743,530 Abandoned US20070253898A1 (en) 2000-10-25 2007-05-02 Polymer based radionuclide containing particulate material
US12/712,843 Abandoned US20100215571A1 (en) 2000-10-25 2010-02-25 Polymer based radionuclide containing particulate material
US13/968,921 Abandoned US20140099255A1 (en) 2000-10-25 2013-08-16 Polymer based radionuclide containing particulate material
US16/280,171 Expired - Lifetime US11097021B2 (en) 2000-10-25 2019-02-20 Polymer based radionuclide containing particulate material

Country Status (6)

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US (5) US20030007928A1 (fr)
EP (1) EP1333866A4 (fr)
JP (1) JP4229699B2 (fr)
AU (2) AUPR098300A0 (fr)
CA (1) CA2426602C (fr)
WO (1) WO2002034300A1 (fr)

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US20030233150A1 (en) * 2002-03-29 2003-12-18 George Bourne Tissue treatment
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US8173176B2 (en) 2004-03-30 2012-05-08 Boston Scientific Scimed, Inc. Embolization
US8414927B2 (en) 2006-11-03 2013-04-09 Boston Scientific Scimed, Inc. Cross-linked polymer particles
US8425550B2 (en) 2004-12-01 2013-04-23 Boston Scientific Scimed, Inc. Embolic coils
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US20150273089A1 (en) * 2012-09-17 2015-10-01 Bruce N. Gray Method of treating cancer
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US10804000B2 (en) * 2016-05-18 2020-10-13 The Regents Of The University Of California High efficiency continuous-flow production of radioisotopes
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