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United States Patent (19) 11 Patent Number: 5,885,547 Gray (45) Date of Patent: Mar 23, 1999

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United States Patent (19) 11 Patent Number: 5,885,547 Gray (45) Date of Patent: Mar 23, 1999 USOO5885547A United States Patent (19) 11 Patent Number: 5,885,547 Gray (45) Date of Patent: Mar 23, 1999 54) PARTICULATE MATERIAL 4,290,847 9/1981 Johnson et al. ............................. 176/1 4,303,433 12/1981 Torobin .......... ... 6.5/21.4 75 Inventor: Bruce Nathaniel Gray, Claremont, 4,340,642 7/1982 Netting et al. 428/402 Australia 4,349,456 9/1982 Sowman ......... ... 252/317 4,411,847 10/1983 Netting et al. .............................. 264/7 4,547,468 10/1985 Jones et al. ............................... 5O1/33 73 Assignee: Paragon Medical Ltd., West Perth 4,772,511 9/1988 Wood et al. ............................ 428/325 Western, Australia 4,789,501 12/1988 Day et al. ............................... 252/645 21 Appl. No.: 676,381 4,874,726 10/1989 Kleeb et al. ............................ 501/124 4.889,707 12/1989 Day et al. ... ... 424/1.11 22 PCT Filed: Jan. 20, 1995 5,011,677 4/1991 Day et al. ... ... 424/1.11 5,011,797 4/1991 Day et al. ................................. 5O1/33 86 PCT No.: PCT/AU95/00027 5,039,326 8/1991 Day et al. ... ... 424/1.11 S371 Date: Sep. 23, 1996 5,302,369 4/1994 Day et al. .............................. 424/1.29 S 102(e) Date: Sep. 23, 1996 FOREIGN PATENT DOCUMENTS 0182131 5/1986 European Pat. Off.. 87 PCT Pub. No.: WO95/1984.1 O369638 5/1990 European Pat. Off.. 2073589 10/1981 United Kingdom. PCT Pub. Date:Jul. 27, 1995 WO 8602093 4/1986 WIPO. 30 Foreign Application Priority Data WO 9314788 8/1993 WIPO. Jan. 21, 1994 AU Australia ............................... 54724/24 Primary Examiner JoséG. Dees (51) Int. Cl. ............................................... A61K 51/00 ASSistant Examiner-Dameron Jones 52 U.S. C. ... 424/1.37; 424/1.11; 424/1.29; Attorney, Agent, or Firm-Baker & Botts, L.L.P. 424/1.33; 424/1.65 57 ABSTRACT 58 Field of Search ................................... 424/1.11, 1.29, 424/1.33, 1.37, 1.65, 9.1, 9.321, 9.323, A particulate material which comprises hollow or cup 9.36, 9.4, 9.42, 9.5, 400, 450, 455, 458 shaped ceramic microSpheres having a diameter in the range of from 5 to 200 microns. The material may comprise a beta 56) References Cited or gamma-emitting radionuclide and be used in Selective internal radiation therapy (SIRT) of various forms of cancer U.S. PATENT DOCUMENTS and tumours. 3,365,315 1/1968 Beck et al. ................................ 106/40 4,039,480 8/1977 Watson et al. .......................... 252/455 10 Claims, No Drawings 5,885,547 1 2 PARTICULATE MATERIAL blood flow, then they may accumulate in excessive numbers in Some areas and cause focal areas of excessive radiation. This application is a 371 of PCT/AU95/00027 filed Jan. It has been shown that microspheres of approximately 25-50 20, 1995. micron in diameter have the best distribution characteristics when administered into the arterial circulation of the liver FIELD OF THE INVENTION (Meade, V. et al.; Distribution of different sized micro This invention relates to a particulate material which Spheres in experimental hepatic tumours. Europ. J. Cancer comprises Small hollow or cup-shaped ceramic particles & Clin. Oncol. 1987, 23:23–41). (hereinafter referred to as “microspheres'), to a process for If the microSpheres or Small particles do not contain the production thereof, and to methods for the use of this Sufficient ionising radiation, then an excessive number will particulate material. be required to deliver the required radiation dose to the In one particular aspect, this invention relates to hollow or target organ. It has been shown that if large numbers of cup-shaped ceramic microSpheres which consist of or com microSpheres are administered into the arterial Supply of the prise a radioactive material, and to the use of these radio liver, then they accumulate in and block the Small arteries active microSpheres in the treatment of cancer in humans 15 leading to the tumour, rather than distribute evenly in the and other mammals. In this aspect, the radioactive micro capillaries and precapillary arterioles of the tumour. Spheres are designed to be administered into the arterial Therefore, it is desirable to use the minimum number of blood Supply of the organ to be treated, whereby they microspheres that will provide an even distribution in the become entrapped in the Small blood vessels of the target vascular network of the tumour circulation. organ and irradiate it. An alternate form of administration is Similarly if the microSpheres or Small particles are too to inject the radioactive microSpheres directly into the dense or heavy, then they will not distribute evenly in the tumour to be treated. target organ and will accumulate in excessive concentrations The particulate material of the present invention therefore in parts of the liver that do not contain the cancer. It has been has utility in the treatment of various forms of cancer and shown that Solid heavy microSpheres distribute poorly tumours, but particularly in the treatment of primary and 25 within the parenchyma of the liver when injected into the Secondary cancer of the liver and the brain. It is, however, arterial Supply of the liver. This, in turn, decreases the to be understood that this invention is not limited to micro effective radiation reaching the cancer in the target organ, Spheres of radioactive material, and extends to microSpheres which decreases the ability of the radioactive microSpheres of other ceramic materials which are Suitable for use in the to kill the tumour cells. In contrast, lighter microSpheres process described herein. with a specific gravity of the order of 2.0 distribute well within the liver (Burton, M. A. et al.; Selective International BACKGROUND OF THE INVENTION Radiation Therapy; Distribution of radiation in the liver. Many previous attempts have been made to locally Europ. J. Cancer Clin. Oncol. 1989, 25:1487–1491). administer radioactive materials to patients with cancer as a 35 For radioactive microSpheres to be used Successfully for form of therapy. In Some of these, the radioactive materials the treatment of cancer, the radiation emitted from the have been incorporated into Small particles, Seeds, wires and microSpheres should be of high energy and short range. This Similar related configurations that can be directly implanted ensures that the energy emitted from the microSpheres will into the cancer. In other approaches, the radioactive mate be deposited into the tissues immediately around the micro rials have been formulated into microSpheres of regular size 40 Spheres and not into tissueS which are not the target of the for injection into the arterial blood Supply of the target radiation treatment. There are many radionuclides that can organ. When radioactive particles or microSpheres are be incorporated into microspheres that can be used for SIRT. administered into the blood Supply of the target organ, the Of particular suitability for use in this form of treatment are technique has become known as Selective Internal Radiation the unstable isotopes of yttrium (Y-90) and phosphorous Therapy (SIRT). Generally, the main form of application of 45 (P-32), although other isotopes Such as iodine can also be SIRT has been its use to treat cancers in the liver. used. Yttrium-90 is the unstable isotope of yttrium-89 which There are many potential advantages of SIRT over can be manufactured by placing the Stable yttrium-89 in a conventional, external beam radiotherapy. Firstly, the radia neutron beam. The yttrium-90 that is generated decays with tion is delivered preferentially to the cancer within the target a half life of 64 hours, while emitting a high energy pure beta radiation. organ. Secondly, the radiation is slowly and continually 50 delivered as the radionuclide decays. Thirdly, by manipu If the microSpheres contain other radioactive Substances lating the arterial blood Supply with vasoactive Substances that are not required for the radiation treatment of the target (Such as Angiotensin-2), it is possible to enhance the per tissue, then unwanted and deleterious radiation effects may centage of radioactive microSpheres that go to the cancerous occur. It is therefore desirable to have microSpheres of Such part of the organ, as opposed to the healthy normal tissues. 55 a composition that they only contain the Single desired This has the effect of preferentially increasing the radiation radionuclide. In this treatment mode, it is desirable to have dose to the cancer while maintaining the radiation dose to microSpheres that emit high energy but short penetration the normal tissues at a lower level (Burton, M. A. et al.; beta-radiation which will confine the radiation effects to the Effect of Angiotensin-2 on blood flow in the transplanted immediate vicinity of the microSpheres. For this purpose, sheep Squamous cell carcinoma. Europ. J. Cancer Clin. 60 yttrium-90 is the preferred radionuclide, although other Oncol. 1988, 24(8): 1373–1376). radionuclides such as P-32 are also Suitable. When microSpheres or other Small particles are adminis Therefore, the ideal microSpheres for use in this treatment tered into the arterial blood Supply of a target organ, it is mode will consist only of yttria, have a low density relative desirable to have them of a size, shape and density that to pure yttria, be in the size range of from 20-80 micron, and results in the optimal homogeneous distribution within the 65 be stable So that no material leaches from the microSpheres target organ. If the microSpheres or Small particles do not when administered into the body of a human or other distribute evenly, and as a function of the absolute arterial mammalian patient. 5,885,547 3 4 In the earliest clinical use of yttrium-90-containing Preferably, the process for the production of the particu microSpheres, the yttrium was incorporated into a polymeric late material comprises the steps of (i) grinding or otherwise matrix that was formulated into microspheres.
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