JP6537498B2 - 撮像造影用組成物及びキット - Google Patents
撮像造影用組成物及びキット Download PDFInfo
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- JP6537498B2 JP6537498B2 JP2016514435A JP2016514435A JP6537498B2 JP 6537498 B2 JP6537498 B2 JP 6537498B2 JP 2016514435 A JP2016514435 A JP 2016514435A JP 2016514435 A JP2016514435 A JP 2016514435A JP 6537498 B2 JP6537498 B2 JP 6537498B2
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- TUNFSRHWOTWDNC-HKGQFRNVSA-N tetradecanoic acid Chemical compound CCCCCCCCCCCCC[14C](O)=O TUNFSRHWOTWDNC-HKGQFRNVSA-N 0.000 description 1
- DZKXJUASMGQEMA-UHFFFAOYSA-N tetradecyl tetradecanoate Chemical compound CCCCCCCCCCCCCCOC(=O)CCCCCCCCCCCCC DZKXJUASMGQEMA-UHFFFAOYSA-N 0.000 description 1
- TXEYQDLBPFQVAA-UHFFFAOYSA-N tetrafluoromethane Chemical compound FC(F)(F)F TXEYQDLBPFQVAA-UHFFFAOYSA-N 0.000 description 1
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 1
- ABZLKHKQJHEPAX-UHFFFAOYSA-N tetramethylrhodamine Chemical compound C=12C=CC(N(C)C)=CC2=[O+]C2=CC(N(C)C)=CC=C2C=1C1=CC=CC=C1C([O-])=O ABZLKHKQJHEPAX-UHFFFAOYSA-N 0.000 description 1
- MPLHNVLQVRSVEE-UHFFFAOYSA-N texas red Chemical compound [O-]S(=O)(=O)C1=CC(S(Cl)(=O)=O)=CC=C1C(C1=CC=2CCCN3CCCC(C=23)=C1O1)=C2C1=C(CCC1)C3=[N+]1CCCC3=C2 MPLHNVLQVRSVEE-UHFFFAOYSA-N 0.000 description 1
- 229910052716 thallium Inorganic materials 0.000 description 1
- BKVIYDNLLOSFOA-UHFFFAOYSA-N thallium Chemical compound [Tl] BKVIYDNLLOSFOA-UHFFFAOYSA-N 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 150000003573 thiols Chemical class 0.000 description 1
- 229960001196 thiotepa Drugs 0.000 description 1
- RZWIIPASKMUIAC-VQTJNVASSA-N thromboxane Chemical compound CCCCCCCC[C@H]1OCCC[C@@H]1CCCCCCC RZWIIPASKMUIAC-VQTJNVASSA-N 0.000 description 1
- FRNOGLGSGLTDKL-UHFFFAOYSA-N thulium atom Chemical compound [Tm] FRNOGLGSGLTDKL-UHFFFAOYSA-N 0.000 description 1
- 229960001312 tiaprofenic acid Drugs 0.000 description 1
- 229960004605 timolol Drugs 0.000 description 1
- KSBAEPSJVUENNK-UHFFFAOYSA-L tin(ii) 2-ethylhexanoate Chemical compound [Sn+2].CCCCC(CC)C([O-])=O.CCCCC(CC)C([O-])=O KSBAEPSJVUENNK-UHFFFAOYSA-L 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- 229960000984 tocofersolan Drugs 0.000 description 1
- AOBORMOPSGHCAX-DGHZZKTQSA-N tocofersolan Chemical compound OCCOC(=O)CCC(=O)OC1=C(C)C(C)=C2O[C@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C AOBORMOPSGHCAX-DGHZZKTQSA-N 0.000 description 1
- 229930003799 tocopherol Natural products 0.000 description 1
- 239000011732 tocopherol Substances 0.000 description 1
- 125000002640 tocopherol group Chemical class 0.000 description 1
- 235000019149 tocopherols Nutrition 0.000 description 1
- 229960000303 topotecan Drugs 0.000 description 1
- UCFGDBYHRUNTLO-QHCPKHFHSA-N topotecan Chemical compound C1=C(O)C(CN(C)C)=C2C=C(CN3C4=CC5=C(C3=O)COC(=O)[C@]5(O)CC)C4=NC2=C1 UCFGDBYHRUNTLO-QHCPKHFHSA-N 0.000 description 1
- 229910052723 transition metal Inorganic materials 0.000 description 1
- 150000003624 transition metals Chemical class 0.000 description 1
- 238000004627 transmission electron microscopy Methods 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- 150000003626 triacylglycerols Chemical class 0.000 description 1
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- ZIBGPFATKBEMQZ-UHFFFAOYSA-N triethylene glycol Chemical compound OCCOCCOCCO ZIBGPFATKBEMQZ-UHFFFAOYSA-N 0.000 description 1
- 230000001960 triggered effect Effects 0.000 description 1
- XPCLMLKCZNYPDS-YEUCEMRASA-N trimethyl-[(z)-2-[(z)-octadec-9-enoyl]-4-oxohenicos-12-enyl]azanium Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)CC(C[N+](C)(C)C)C(=O)CCCCCCC\C=C/CCCCCCCC XPCLMLKCZNYPDS-YEUCEMRASA-N 0.000 description 1
- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 1
- 229910052721 tungsten Inorganic materials 0.000 description 1
- 239000010937 tungsten Substances 0.000 description 1
- HFTAFOQKODTIJY-UHFFFAOYSA-N umbelliferone Natural products Cc1cc2C=CC(=O)Oc2cc1OCC=CC(C)(C)O HFTAFOQKODTIJY-UHFFFAOYSA-N 0.000 description 1
- ORHBXUUXSCNDEV-UHFFFAOYSA-N umbelliferone Chemical compound C1=CC(=O)OC2=CC(O)=CC=C21 ORHBXUUXSCNDEV-UHFFFAOYSA-N 0.000 description 1
- 150000004670 unsaturated fatty acids Chemical group 0.000 description 1
- JFALSRSLKYAFGM-UHFFFAOYSA-N uranium(0) Chemical compound [U] JFALSRSLKYAFGM-UHFFFAOYSA-N 0.000 description 1
- 150000003673 urethanes Chemical class 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- LEONUFNNVUYDNQ-UHFFFAOYSA-N vanadium atom Chemical compound [V] LEONUFNNVUYDNQ-UHFFFAOYSA-N 0.000 description 1
- 239000005526 vasoconstrictor agent Substances 0.000 description 1
- KDQAABAKXDWYSZ-PNYVAJAMSA-N vinblastine sulfate Chemical compound OS(O)(=O)=O.C([C@H](C[C@]1(C(=O)OC)C=2C(=CC3=C([C@]45[C@H]([C@@]([C@H](OC(C)=O)[C@]6(CC)C=CCN([C@H]56)CC4)(O)C(=O)OC)N3C)C=2)OC)C[C@@](C2)(O)CC)N2CCC2=C1NC1=CC=CC=C21 KDQAABAKXDWYSZ-PNYVAJAMSA-N 0.000 description 1
- 229960004982 vinblastine sulfate Drugs 0.000 description 1
- 229960002110 vincristine sulfate Drugs 0.000 description 1
- AQTQHPDCURKLKT-JKDPCDLQSA-N vincristine sulfate Chemical compound OS(O)(=O)=O.C([C@@H](C[C@]1(C(=O)OC)C=2C(=CC3=C([C@]45[C@H]([C@@]([C@H](OC(C)=O)[C@]6(CC)C=CCN([C@H]56)CC4)(O)C(=O)OC)N3C=O)C=2)OC)C[C@@](C2)(O)CC)N2CCC2=C1NC1=CC=CC=C21 AQTQHPDCURKLKT-JKDPCDLQSA-N 0.000 description 1
- 229960005212 vindesine sulfate Drugs 0.000 description 1
- 229960002166 vinorelbine tartrate Drugs 0.000 description 1
- GBABOYUKABKIAF-IWWDSPBFSA-N vinorelbinetartrate Chemical compound C1N(CC=2C3=CC=CC=C3NC=22)CC(CC)=C[C@H]1C[C@]2(C(=O)OC)C1=CC(C23[C@H]([C@@]([C@H](OC(C)=O)[C@]4(CC)C=CCN([C@H]34)CC2)(O)C(=O)OC)N2C)=C2C=C1OC GBABOYUKABKIAF-IWWDSPBFSA-N 0.000 description 1
- NLVXSWCKKBEXTG-UHFFFAOYSA-N vinylsulfonic acid Chemical compound OS(=O)(=O)C=C NLVXSWCKKBEXTG-UHFFFAOYSA-N 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 150000003732 xanthenes Chemical class 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 229910052727 yttrium Inorganic materials 0.000 description 1
- VWQVUPCCIRVNHF-UHFFFAOYSA-N yttrium atom Chemical compound [Y] VWQVUPCCIRVNHF-UHFFFAOYSA-N 0.000 description 1
- 229950009268 zinostatin Drugs 0.000 description 1
- 229910052726 zirconium Inorganic materials 0.000 description 1
- 239000002076 α-tocopherol Substances 0.000 description 1
- 235000004835 α-tocopherol Nutrition 0.000 description 1
- PAPBSGBWRJIAAV-UHFFFAOYSA-N ε-Caprolactone Chemical compound O=C1CCCCCO1 PAPBSGBWRJIAAV-UHFFFAOYSA-N 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
- A61B6/48—Diagnostic techniques
- A61B6/481—Diagnostic techniques involving the use of contrast agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/04—X-ray contrast preparations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/04—X-ray contrast preparations
- A61K49/0433—X-ray contrast preparations containing an organic halogenated X-ray contrast-enhancing agent
- A61K49/0438—Organic X-ray contrast-enhancing agent comprising an iodinated group or an iodine atom, e.g. iopamidol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/04—X-ray contrast preparations
- A61K49/0433—X-ray contrast preparations containing an organic halogenated X-ray contrast-enhancing agent
- A61K49/0442—Polymeric X-ray contrast-enhancing agent comprising a halogenated group
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/04—X-ray contrast preparations
- A61K49/0433—X-ray contrast preparations containing an organic halogenated X-ray contrast-enhancing agent
- A61K49/0447—Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is a halogenated organic compound
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/04—X-ray contrast preparations
- A61K49/0433—X-ray contrast preparations containing an organic halogenated X-ray contrast-enhancing agent
- A61K49/0447—Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is a halogenated organic compound
- A61K49/0452—Solutions, e.g. for injection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/04—X-ray contrast preparations
- A61K49/0433—X-ray contrast preparations containing an organic halogenated X-ray contrast-enhancing agent
- A61K49/0447—Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is a halogenated organic compound
- A61K49/0457—Semi-solid forms, ointments, gels, hydrogels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/04—X-ray contrast preparations
- A61K49/0433—X-ray contrast preparations containing an organic halogenated X-ray contrast-enhancing agent
- A61K49/0447—Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is a halogenated organic compound
- A61K49/0476—Particles, beads, capsules, spheres
- A61K49/0485—Nanoparticles, nanobeads, nanospheres, nanocapsules, i.e. having a size or diameter smaller than 1 micrometer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/06—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations
- A61K49/18—Nuclear magnetic resonance [NMR] contrast preparations; Magnetic resonance imaging [MRI] contrast preparations characterised by a special physical form, e.g. emulsions, microcapsules, liposomes
- A61K49/1806—Suspensions, emulsions, colloids, dispersions
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Radiology & Medical Imaging (AREA)
- Medical Informatics (AREA)
- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
- Pathology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Nanotechnology (AREA)
- Dispersion Chemistry (AREA)
- Biophysics (AREA)
- High Energy & Nuclear Physics (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Description
処方物は、体内への注射、又は生検に限定されるわけではないが、生検などの外科的医療行為で使用される細い針を用いた注射に適用されることが望ましい。ヒドロゲル又はゲルを形成する処方物の注射前の粘度は、処方物を患者に非経口投与することが可能である等の、適切な粘度にすることが可能である。
造影剤は、ヨウ素化化合物等のX線不透過性物質などの有機X線造影剤を用いて得ることが可能で、ガドリニウムなどのMRI剤のキレート、及び/又は銅64などのPET画像診断剤のキレートと結合してもよく、更に固体の無機粒子と結合してもよい。キレート剤は、DOTA、EDTA、又はDTPAであってもよく、非共有結合にてゲル形成成分中に取り込まれたり、あるいは共有結合にてゲル形成成分に凝集したりする可能性がある。結合した造影剤は、望ましくは、少なくともCT画像診断法により可視であるべきである。望ましい造影剤は、ポリマー、又はグルコース若しくはスクロース、あるいは他のオリゴ糖の誘導体などの糖類分子などのヨウ素化化合物である。固体粒子は、例えばX線照射をブロックするあるいは弱めることが可能な化合物などの1つ又はそれ以上のX線造影剤を含んでいてもよく、又はこれらから構成されていてもよい。そのような化合物としては、周期表に定義されている、遷移金属、希土類金属、アルカリ金属、アルカリ土類金属、他の金属などがある。金属又はアルカリ金属は、酸化されていなくても、あるいは既に酸化状態にあってもよい。これらの酸化状態としては、一価の陽イオン、二価の陽イオン、三価の陽イオン、四価の陽イオン、五価の陽イオン、六価の陽イオン、及び七価の陽イオンなどがある。
固体粒子は、様々な他の成分を更に含んでいてもよい。有用な固体粒子とは、リポソーム、ポリマーソーム、デンドリマー、水溶性の架橋性ポリマー、及びそのような固体粒子を含むミセル、並びに、被覆されていない若しくは被覆された金属粒子、被覆されていない若しくは被覆された固体金属塩などである。本明細書で用いられている、「被覆された」固体粒子には、シェル、固体コア材周辺の表面被覆などがある。シェル又は表面被覆は、共有結合、非共有結合、又は共有結合と非共有結合の両方により、コア材と結合することが可能である。代表的なシェル若しくは表面被覆を本明細書に記載する。一実施形態において、固体粒子は、コア表面粒子に非共有結合又は共有結合により結合したポリマー表面被覆を含んでいる。ポリマーは、ホモポリマー、共重合体、ブロック共重合体、又はグラフト共重合体、又は合成又は天然のデンドリマー型共重合体であってもよく、これらに限定されるものではない。一般的に、ポリマー被覆には、例えば5,000ダルトンといった通常2,000〜70,000ダルトンの分子量のポリエチレングリコール(PEG)、通常2,000〜1,000,000ダルトンの分子量のデキストラン、及び/又は通常2,000〜1,000,000ダルトンの分子量のヒアルロン酸が含まれる。ポリマーは、ポリマー構造全体が負に帯電し、効率的な被覆を可能にする正に帯電したナノサイズ粒子表面との静電相互作用を可能にする方法により、通常、ブロック共重合体として結合している。特定の実施形態において、固体粒子には、例えば、約1,000、2,000、3,000、5,000、及び10,000ダルトンの平均分子量をそれぞれ有するPEG処方である、共役なPEG1000、PEG2000、PEG3000、PEG5000、又はPEG10000などがあるが、これらに限定されるものではない。更なる実施形態において、固体粒子には、例えば、約1,000、2,000、3,000、5,000、及び10,000ダルトンの平均分子量をそれぞれ有するPNIPAM処方である、共役なPNIPAM1000、PNIPAM2000、PNIPAM3000、PNIPAM5000、又はPNIPAM10000などがあるが、これらに限定されるものではない。一実施形態において、固体粒子とは、シェル、又は脂質単分子層及び/若しくは1つ又はそれ以上の脂質二分子層などの脂質層、及び無機粒子を含む粒子コアを含む表面被覆などである。本発明の目的用の表面被覆脂質とは、例えば、脂肪酸、中性脂肪、リン脂質、糖脂質、セラミド、スフィンゴ脂質、脂肪族アルコール、及びステロイドなどである。これらに限定されるものではないが、固体粒子の具体例には、PEG被覆又はペグ化(PEGylated)された国際公開第2007/129791号、及びKim et al(2007)「Invest.Radiol」(2007,42,797−806)に記載された金のナノロッドを用いて合成された金のナノサイズ粒子、Rabin(2006)「Nat.Mater」(2006,5,188−122)に記載されたポリマー被覆されたビスマス硫化物のナノサイズ粒子、Haba et al(2007)「Langmuir」(2007,23,5243−5246)、及びKojima et al(2010)「Bioconjugate Chem」(2010,21,1559−1564)に記載されたリン酸カルシウムリポソーム・コアシェルナノ組成物、CT画像診断用に封入された金のナノサイズ粒子を伴うPAMAMのデンドリマー、及び当該技術分野において既知であるX線造影剤を含む他の固体粒子がある。本発明の特定の実施形態において、ナノサイズ粒子のシェルには、1,2−ジステアロイル−sn−グリセロ−3−ホスホコリン(DSPC)「A」、コレステロール「B」、1,2−ジステアロイル−sn−グリセロ−3−ホスホエタノールアミン−N−[メトキシ(ポリエチレングリコール)−2000](DSPE−PEG−2000)「C」、及び1,2−ジステアロイル−sn−グリセロ−3−ホスホエタノールアミン−N−[メトキシ(ポリエチレングリコール)−2000]−TATE(DSPE−PEG−2000−RGD)「D」が含まれ、そのモル比A:B:C:Dに関して、Aは45〜65、Bは35〜45、Cは5〜13、Dは0〜3で選択され、A+B+C+D=100となる。
本発明に係るナノサイズ粒子は、疑似球状、球状、又は棒状などの非球状であってもよい。好適なナノ粒子とは、最大50μmのサイズ、好ましくは最大5μmのサイズを有する粒子である。
好適なゲル形成成分には、エステル化された単糖類などの誘導体化された単糖類、エステル化されたポリオール、ポリマー、脂質、ペプチド、タンパク質、低分子量のゲル化剤、及び非水溶性の高粘度液体キャリア物質などの誘導体化されたポリオール、並びにこれらの組み合わせなどの有機成分により構成されるものなどがあるが、これらに限定されるものではない。
(1)注射可能なように、投与前、系はゾル状態であるべきである。ゾル状態は、小さいニードルヘッドにより、患者の苦痛を和らげ、挿入手順を簡潔化することを可能にするために、十分低粘度、通常は20℃において10Pa・s(10,000cP)未満、好ましくは2Pa・s(2,000cP)未満、(又は、その代わりに5℃で10Pa・s(10,000cP)未満、好ましくは2Pa・s(2,000cP)未満)であるべきである。
(2)化学的架橋、物理的結合、又は水和のいずれかによるゲル化が、注入後に開始する、又は完了すること。
(3)ゲルは生分解可能である、あるいは制御期間内に徐々に溶解可能であるべきであり、生成物は通常の経路で、除去/分泌されるべきである。
(4)ポリマー自体及び分解可能な生成物は、生体適合的であるべきである。同様に、架橋剤や開始剤などの添加物を添加するならば、それらも生体適合的であるべきである。
(5)ゲルは、細胞/組織接着特性を潜在的に有してもよい。
(6)ゲルが、例えば炎症などの免疫応答などの副作用を生じさせるべきでない。
1つの実施形態において、ゲル形成系は、10〜65℃の範囲、好ましくは35〜40℃の範囲の温度への応答により、ゲルを形成する。
他の実施形態において、ゲル形成系は、1μm〜500mmの範囲、好ましくは1〜50mm又は50〜200mmの範囲のイオン強度の変化への応答により、ゲルを形成する。
更に別の実施形態においては、ゲル形成系は、pHの変化に応答するゲルの形成を受ける。ゲル形成系は、例えばpHの範囲が6〜8で、35〜40℃の温度といった、pHと温度の変化の組み合わせに応答するゲルの形成を任意に受ける。
更に別の実施形態においては、ゲル形成系は、酵素活性に応答するゲルの形成を受ける。
更に他の実施形態において、ゲル形成系では、例えば化学的共有結合によるゲル形成系の架橋によってゲルを形成する分子又はX線照射などの開始剤との接触に応答して、ゲルを形成する。
更に別の実施形態においては、ゲル形成系は、水和に応答するゲルの形成を受ける。そのようなゲル形成系の例としては、i)国際公開第2006/075123号、ii)「Adv.Drug Delivery Rev」(2001,47,229−250)、iii)米国特許出願第2007/0092560号及び本明細書で参照されるから選択されるものがあるが、これらに限定されるものではない。中性ジアシル脂質及び/又はトコフェロール及び/又は生体適合性のある酸素を含有した低粘度有機溶媒中に可溶なリン脂質で構成される処方物は、例えば、これらに限定されるものではないが、血管外液、細胞外液、間質液、又は血漿などの水溶液との接触などの水和により、液晶相構造を形成してもよい。他の系としては、非水系に溶解性のあるスクロース酢酸イソブチル(SAIB)などの高粘度液体キャリア物質などが挙げられる。そのようなシステムは、本発明に記載される固体粒子と混合させ、その後非経口注射させることが可能であり、そのため、X線画像診断法を含む1つ又は複数の画像診断法により可視化できる注入可能な造影剤として機能する。
更に別の実施形態において、上記のゲル形成系のいずれも、これらに限定させるものではないが、アクリレート、メタクリレート、アクリルアミド、メタアクリルアミド、ビニルエーテル、スチリル、エポキシド、マレイン酸誘導体、ジエン、置換されたジエン、チオール、アルコール、アミン、ヒドロキシアミン、カルボン酸、カルボン酸無水物、カルボン酸ハロゲン化物、アルデヒド、ケトン、イソシアネート、スクシンイミド、カルボン酸ヒドラジド、グリシジルエーテル、シロキサン、アルコキシシラン、アルキン、アジド、2’−ピリジルジチオール、フェニルグリオキサール、ヨード、マレイミド、イミドエステル、ジブロモプロピオン酸塩、及びブロモ酢酸などのハロゲン化酢酸などの、1つ又はそれ以上の架橋可能なグループを導入することにより、更に機能化される。
他の実施形態において、ゲル形成系は、キレートイオンとして知られるキレート試薬で構成される。現在知られている、又は後に発見される、イオンのキレート試薬は、本発明の品目に用いられる可能性がある。金属イオン(例えば、Gd3+あるいはCu2+)キレート剤の例としては、拡張ポルフィリンとポルフィリン様誘導体、DOTA、DTPA、AngioMARKTM(DTPAキレートで官能化された骨格)、DTPA−BMA(DTPAの天然のビス−メチルアミド誘導体)、及びHP−D03A(DOTA様大環状化合物で、1つのキレートアームがヒドロキシルプロピル基と置換されたもの)などがあるが、これらに限定されるものではない。他のキレートとしては、DPDP(TeslaScan(商標))や、デフェロキサミン(例えば、Fe3+やZr4+)などがあるが、これらに限定されるものではない。
処方物には、α−シクロデキストリン、β−シクロデキストリン及び/又はγ−シクロデキストリン、及び他の誘導体などの、他の成分などが更に含まれてもよい。そのような成分は、ゲル形成系、及びナノサイズ粒子とホスト−ゲスト錯体を形成してもよく、こうして、ゲルの形成を助け、粒子の結合プロファイルを変化させることが可能である(「Adv.Drug Delivery Rev」2008,60,1000−1017)。他の大変興味深い実施形態において、ゲル形成系は、PEG−PHB−PEGトリブロック共重合体、α−シクロデキストリン、及びPEG被覆された固体ナノサイズ粒子を基としている。そのような処方物において、α−シクロデキストランは、PEG−PHB−PEGトリブロック共重合体のPEGブロックと、PHB中間ブロックとの間で疎水相互作用により結合するPEG被覆された固体ナノサイズ粒子の両方と包接錯体を形成することが可能であり、粒子の結合プロファイルを変化させるα−シクロデキストリン相互作用により、強化された固体ナノサイズ粒子の保持により、強力なヒドロゲルを形成する。
注入前の処方物の粘度は、20℃において、好ましくは10Pa・s(10,000cP)未満、特に好ましくは2Pa・s(2,000cP)未満である。その代わり、注入前の処方物の粘度は、5℃において、通常は2Pa・s(2,000cP)未満である。
本発明は、上記処方物を、哺乳動物の体のコンピュータ断層撮影法(CT)などの特異的組織マーカーとして、X線画像診断法で使用することも可能にする。
本発明には、シリンジと、前述のシリンジの開口端部に適用され、体内の注射若しくはこれに限定されるものではないが生検などの外科的医療行為に使用する針と、本明細書で上記に既定の組成物と、を備えるキットを更に含む。一実施形態において、処方物は、内部又は前述のシリンジ内に保持される。
本発明は、動物体又は人体のX線画像を記録する方法も提供し、この方法は、
(a)X線画像診断により検出可能なヨウ素化化合物などの有機X線造影剤を含む注射の前に、均質液体である有機ゲル形成系を含む処方物を準備するステップと、
(b)処方物を被験体に投与するステップと、
(c)コンピュータ断層撮影(CT)画像又は2次元X線画像などのX線ベースの画像を記録するステップと、含む。
一実施形態において、本方法は、統合放射線治療、及び個体中の標的組織のX線画像診断用の方法であり、ステップ(c)における画像により、標的組織が鮮明となり、
(d)体外照射放射線療法の対象を、標的組織に向けさせるためのc)で得られた標的組織の鮮明度を使用するステップを更に含む。
標的組織とは、通常、望ましくない増殖細胞を含むものである。一実施形態において、望ましくなく増殖する細胞とは、悪性細胞などの腫瘍細胞であり、個体はがんに罹患しているか、あるいはがんのリスクがある。特定の実施形態において、望ましくない細胞の増殖は、肺がん、前立腺がん、頸がん、あるいは卵巣がんと関連する。他の条件の形態、あるいは望ましくない細胞の増殖と関連する病気としては、子宮外(異所性)妊娠、視神経に近接する箇所の良性腫瘍などの脳内の良性腫瘍、例えば視床下部などホルモンを過剰分泌する小腺、神経圧迫と関連する骨と軟骨、移植の前に破壊される可能性のある血球、急性扁桃腺炎又は咽頭炎、閉塞型睡眠時無呼吸、鼻気道の閉塞、いびき、あるいはへんとう周囲膿瘍などの大きな扁桃腺と関連する条件、あるいは過形成性眼疾患又は眼内血管新生性疾患などがある。
本発明は、本明細書において上記で定義されるような処方物に、例えば本発明の生検の画像診断治療の併用で作製される針管などの組織シーラントとしての使用法も提供する。
上述のように、本発明は、局所投与用のX線造影用組成物の一実施形態で、X線造影用組成物が造影特性を示し、前述のX線造影用組成物の投与量の少なくとも60%が、X線造影用組成物を人体又は動物体に投与した時の注入点より10cm以内の場所に、24時間超残るものである。これらに限定されるものではないが、経皮注入、スコープ(気管支鏡、胃鏡、又は体内をナビゲートするのに使用される他のフレキシブルワイヤーシステム)の使用、開放創へのスプレーあるいは付着させるもの、頭蓋内注入、内部空気や流体が満たされた器官若しくは空洞(例えば、嚢、胃)、あるいは、人工的に若しくは医学的に作製された内部空洞などの他の組織への付着など、様々な可能な注入形態や注入経路が存在する。
a.ゲル形成系における有機X線造影剤を含むX線造影剤組成物を与えるステップと、
b.哺乳動物の所定の箇所に、X線造影剤組成物を投与するステップと、
c.所定の箇所を含めて少なくとも体の1箇所のX線ベースの画像を記録するステップと、を含む。
a.ゲル形成系における有機X線造影剤を含むX線造影剤組成物を与えるステップと、
b.哺乳動物の所定の標的組織に、X線造影剤組成物を投与するステップと、
c.標的組織を含む体の少なくとも一部分のX線ベースの画像を記録し、その結果、標的組織の鮮明度(鮮明画像)を与えるステップと、
d.体外照射放射線療法の対象を、標的組織に向けさせるためのc)で得られた標的組織の鮮明度を使用するステップと、を含む。
ステップ(c)及び(d)は、同時に実施される可能性があり、実施してもよい。
a.ゲル形成系における有機X線造影剤を含むX線造影剤組成物を与えるステップと、
b.哺乳動物の所定の標的組織に、X線造影剤組成物を投与するステップと、
c.標的組織を含む体の少なくとも一部分のX線ベースの画像を記録し、その結果、標的組織の解像度を与えるステップと、
d.哺乳動物の所定の標的組織に医薬品を送達させるための医薬品を更に含ませるために、b)中のX線造影剤組成物を使用するステップと、を含む。
本発明の特定の一実施形態において、標的組織には不必要に増殖する細胞が含まれ、他の特定の実施形態において、標的組織には腫瘍細胞が含まれる。
化学物質は、特に明記しない限り、Sigma−Aldrich Inc.(Brondby、Denmark)より購入した。2−(2,4,6−トリヨードフェノキシ)酢酸(3)、及び6,6’−(2,4,6−トリヨードフェノキシ)アセトキシ−イソ酪酸−スクロース(8)を、図7及び図8で示すように、2ステップ、又は4ステップで合成した。
2−(2,4,6−トリヨードフェノキシ)酢酸(3)。2,4,6−トリヨードフェノール(1)(10.00g,21.2mmol)を、窒素雰囲気下で、乾燥DMF(75mL)中に溶解させた。この溶液に、ブロモ酢酸tert−ブチル(4.20mL,28.46mmol)、及びK2CO3(8.79g,63.6mmol)を添加し、室温で一晩撹拌した。減圧で溶媒を除去し、残った黄色のオイルは、EtOAc(150mL)中に再溶解させ、MQ−H2O(3×150mL)で洗浄した。有機層を、MgSO4で乾燥させ、ろ過し、減圧で濃縮し、淡黄色のオイルであるtert−ブチル2−(2,4,6−トリヨードフェノキシ)アセテート(2)を得て、このオイルは更に精製されることなく、次のステップで使用された。2をCH2Cl2(60mL)中で溶解させ、トリフルオロ酢酸(30mL)を添加した。この混合物を、室温で1時間撹拌し、その後、減圧で溶媒を取り除き、白色の固体を得た。粗生成物を、エタノールから再結晶化し、純度の高い白色の針状の結晶(9.58g,85%(2ステップ))として、2−(2,4,6−トリヨードフェノキシ)酢酸(3)を得た。1HーNMR(300MHz,MeOD):δ 6.58(s,2H)、2.95(s,2H)。MALDI−TOF MS(DHB+Na):化学式:C8H5I3NaO3、計算された質量:552.83、観察された質量:553.08(M+Na+)。
以下の表で示されるように、徐々に増量していった6,6’−(2,4,6−トリヨードフェノキシ)アセトキ−イソ酪酸−スクロースの加わった、3つのスクロース酢酸イソブチル(SAIB)をベースとした処方物(それぞれ600mg)を調製した。
この3つは、10wt%、25wt%、又は50wt%のヨウ素化ゲル8を形成し、MQ−H2Oを含有する陰性対称を、医療用CTスキャナにより、すべて200mAs、2mm(col40×0.6mm)の条件での、異なるエネルギー、80kV、100kV、120kV、及び140kVを用いて、視覚化した。エネルギーの関数としてプロットされたハンスフィールドユニット(HU)単位で得られた造影を図10で示し、以下の表にリスト化する。1.300から10.5000HUの範囲の素晴らしい造影が観察され、これは8の重量パーセントw%と適用したエネルギーに依存している。
[材料]
化学物質は、特に明記しない限り、Sigma−Aldrich Inc.(Brondby、Denmark)より購入した。HAuCl4×3H2Oは、Wako Chemicals GmbH(Neuss、Germany)より購入し、SH−PNIPAM(MW3500,PDI=1.24)は、Polymer Source(Dorval,Canada)より購入した。
すべてのガラス器具は、使用前に王水で洗浄した。クエン酸三ナトリウム(10mL,38.8mm)を、HAuCl4*3H2O(100mL,1.0mm)の還流液中に激しく撹拌しながら素早く注入した。直後に淡黄色からワインレッドへの色の変化が観察され、溶液を室温で冷却した後、還流を15分間継続した。得られたAuNPシーズ(20mL)を、HAuCl4*3H2O(2500mL,0.296mm)の沸騰液に激しく撹拌しながら加えた。その後、クエン酸三ナトリウム(11.2mL,38.8mm)を加え、混合物を30分間還流し、ワインレッドから紫色に、明らかに色が変化した。追加のクエン酸三ナトリウム(100mL,38.8mm)を安定剤として加え、混合物を更に1時間加温した。AuNP溶液を室温で冷却し、エタノール(5.0mL)中に溶解させたSH−PNIPAM3500(40mg,11.4μmol)(6分子pr/nm2 AuNP表面積)を加えた。反応混合物を、一晩室温で撹拌した(図11a)。PNIPAM被覆AuNPsを、MQ−H2Oで広範に洗浄し、遠心分離(4500rpm,45分/サイクル)により、約2.3mL(理論的に65mg AuNP/mL)まで濃縮した。クエン酸塩で安定化されたAuNPシーズ、及び精製された濃縮PNIPAM被覆AuNPは、UV−Vis(図11b)、DLS(図11c)ですべて特性評価され、ゼータ電位(図11d)が測定された。濃縮PNIPAM被覆AuNPsの[金]濃度は、内部標準として0.5pptのIrでスパイクされた5%塩酸内のAu3+標準液(1000mg/mL)を用いて、ICP−MSにより決定した。濃縮PNIPAM被覆AuNPsを、王水中に溶解し、理論的に666ppt Au3+になるまで5%塩酸で希釈した。PNIPAM被覆AuNPsの濃度は、64mg Au/mLと決定した。PNIPAM被覆AuNPsは、次に使用されるまで、5℃で保存された。
PNIPAM被覆AuNPs(上記の合成を参照)を、MQ−H2Oで、1.0mgAu/mL、2.5mgAu/mL、又は5.0mgAu/mLに希釈し、液体窒素で2分間、急速凍結させた。サンプルを一晩(p<600×10−2Pa(6.0×10−2mbar))凍結乾燥し、黒色の光沢のある粉末が得られた。凍結乾燥させたPNIPAM被覆AuNPsを、エタノール(0.50mL)中に再溶解し、2、3秒間ボルテックスした。粒子は、数秒以内に、完全に再分散され、黒色溶液が得られた。粒子の形態は、UV−Vis(図12a)、及びDLS(図12b)で評価した。PNIPAM被覆AuNPsにおいて、凝集又は不安定な性質は、凍結乾燥中、エタノール溶解中のいずれにおいても、観察されなかった。凍結乾燥した粉末は、その後、容易に保存でき、容易に減量可能であった。
化学物質は、特に明記しない限り、Sigma−Aldrich Inc.(Brondby、Denmark)より購入した。HAuCl4×3H2Oは、Wako Chemicals GmbH(Neuss,Germany)より購入し、SH−PNIPAM(MW3500,PDI=1.24)は、Polymer Source(Dorval,Canada)より購入し、MeO−PEG5000−SHは、Rapp Polymere GmbH(Tuebingen,Germany)より購入した。
ペグ化(PEGylated)されたAuNPs(PEG5000)を、SH−PEG5000を粒子含有ポリマーとして使用して、実施例2のPNIPAM被覆AuNPで示すように、調製した。ペグ化(PEGylated)された粒子は、UV−Vis(λ=539nm)、及びDLS(59.7±0.9nm)により特性評価され、濃度は、ICP−MS(82.6mg Au/mL)により決定された。
SAIB/8/エタノール(75:20:5)+3.0w% PNIPAM3500、又はPEG5000被覆AuNPで構成される処方物を、以下の表で示すように調製した。
[材料]
化学物質は、特に明記しない限り、Sigma−Aldrich Inc.(Brondby、Denmark)より購入した。HAuCl4×3H2Oは、Wako Chemicals GmbH(Neuss、Germany)より購入し、SH−PNIPAM(MW3500,PDI=1.24)は、Polymer Source(Dorval,Canada)より購入した。6,6’−(2,4,6−トリヨードフェノキシ)アセトキ−イソ酪酸−スクロース(8)は、例1に記載されているように、合成された。
AuNP合成、PNIPAM被覆、及び粒子特性評価
PNIPAM被覆AuNPsを、実施例2に記載されているように、調製した。
SAIB/8/エタノール(55:25:20)+3.0w% PNIPAM−AuNPで構成される処方物は、以下の表に示されるように、調製された。
3.0w%PNIPAM被覆AuNPs(処方物F)の入ったヨウ素化ゲル(200μL)を、MQ−H2O(10.0mL)の入ったガラスバイアル中に37℃で注入することで、調製した。小分量(1.0mL)を時間の関数として(経時的に)除去し、フレッシュなMQ−H2Oと置換した。放出されたAuNPsの量を、UV−Vis吸収と、PNIPAM被覆AuNPsに基づく標準曲線との相関から、計測した。実験を通して、PNIPAM被覆AuNPsの放出は、観察されなかった。処方物Fは、25gの皮下注射針を通して注入可能な均質な黒ずんだ色の溶液であった。
[材料]
化学物質は、特に明記しない限り、Sigma−Aldrich Inc.(Brondby、Denmark)より購入した。6,6’−(2,4,6−トリヨードフェノキシ)アセトキシ−イソ酪酸−スクロース(8)は、例1に記載されているように、合成された。
SAIB/8/エタノール(55:25:20)(350mg)で構成される処方物は、実施例1(処方物B)で記述されるように、調製された。ヨードSAIBゲル(250μL)は、ガラスビーカー中のMQ−H2O(500mL)内に注入され、超音波検査による視覚化の前に、ゲルは5日間置かれた。ヨードSAIBゲルの超音波画像診断は、以下の設定で、超音波スキャナ(BK Medical,Herleve,Denmark)を用いて実施された。Res/Hz 2/21Hz,B Gain83%、ダイナミックレンジ80dB、ノイズ除去10、ノイズ・カットオフ32。ヨードSAIBゲルは、図14に示される超音波診断法を用いて、はっきりと確認できた。
[材料]
化学物質は、特に明記しない限り、Sigma−Aldrich Inc.(Brondby、Denmark)より購入した。6,6’−(2,4,6−トリヨードフェノキシ)アセトキシ−イソ酪酸−スクロース(8)は、例1に記載されているように、合成された。健康体の雌のNMRI(Naval Medical Research Institute)のマウスを、Taconic(Borup,Denmark)より購入した。
SAIB/8/エタノール(55:25:20)(900mg)で構成される処方物は、例1(処方物B)で記述されるように調製された。
処方物B(SAIB/8/エタノール(55:25:20))を健康体の雌のNMRIマウス(n=3)に、麻酔下において皮下注射(各200μL)で投与した。
ヨウ素化ゲルは、時間をかけて、コンピュータ断層撮影(CT)により、視覚化された。画像は、MicroCAT(登録商標)II system(Siemens Medical solutions,Malvern,USA)を使用して、得られた。図15A〜図15B(24時間、及び48時間、p.i.形式で記録されたCT画像)で示されるような、処方物B(SAIB/8/エタノール(55:25:20))を用いて、優れたCT造影が得られた。
[材料]
化学物質は、特に明記しない限り、Sigma−Aldrich Inc.(Brondby、Denmark)より購入した。6,6’−(2,4,6−トリヨードフェノキシ)アセトキシ−イソ酪酸−スクロース(8)は、例1に記載されているように、合成された。健康体の雌のNMRI(Naval Medical Research Institute)のマウスを、Taconic(Borup,Denmark)より購入した。
実施例1に記載されるように、a)SAIB/8/エタノール(65:15:20)(750mg)及び b)SAIB/8/エタノール(50:30:20)(750mg)で構成される処方物を調製した。
a)SAIB/8/エタノール(65:15:20)、及びb)SAIB/8/エタノール(50:30:20)の両処方物を、健康体の雌のNMRIマウス(n=2×8マウス)に、麻酔下において皮下注射(各50μL)で投与した。
ヨウ素化ゲルは、時間をかけて、コンピュータ断層撮影(CT)により、視覚化された。画像は、MicroCaT(登録商標)II system(Siemens Medical solutions,Malvern,USA)を使用して、得られた。図16A〜図Bで示されるように、a)SAIB/8/エタノール(65:15:20)、及びb)SAIB/8/エタノール(50:30:20)の両処方物を使用して、優れたCT造影が得られた。得られたCT造影は、処方物中のヨードSAIB(8)の処方量に対応することが判明した。注入後14週間で、動物は殺処分され、ゲルは皮下部分より除去された(図16C〜図16D)。ヨウ素化ゲルは、ゲルが破砕されることなく、容易に除去、移動することが可能な、定義の明確なゲルであった。更に、ヨウ素化ゲルはメスを用いて変形できるほど柔らかであった。
SAIB/8/エタノール(50:30:20)で構成されるヨウ素化ゲルのゲル化の動態を、注入後の最初の2、3時間、複数のmicro−CTスキャンによりモニタした(図17A)。これらの画像に基づき、時間の関数としてのヨウ素化ゲルの全量を、図17Bで示されるように計算した。ヨウ素化ゲルのゲル化は、ゲル集合体からのエタノールの流出によって起き、この流出は、p.i.形式において、最初に2時間以内に起き、ヨウ素化ゲルの粘度の急速な増加と、ゲルの収縮によるCT造影の約35%の増加をもたらす。
a)SAIB/8/エタノール(65:15:20)及びb)SAIB/8/エタノール(50:30:20)で構成されるヨウ素化ゲルの分解プロファイルを、14週間以上、microCTスキャンでモニタした。これらの画像に基づき、時間の関数としてのヨウ素化ゲルの全量を、図17Cで示されるように計算した。2つの処方物間での分解プロファイルの違いは観察されず、両処方物において、定常状態の分解プロファイルが観察された。95%の信頼区間で、−0.09176μL/日の体積損失が、最初のエタノールの流出段階後、両方の処方物で観察された。
[材料]
化学物質は、特に明記しない限り、Sigma−Aldrich Inc.(Brondby、Denmark)より購入した。6,6’−(2,4,6−トリヨードフェノキシ)アセトキシ−イソ酪酸−スクロース(8)は、例1に記載されているように、合成された。
SAIB/8/エタノール(55:25:20)(350mg)で構成される処方物は、実施例1(処方物B)で記述されるように調製された。
処方物B(SAIB/8/エタノール(55:25:20))を、前肢の間に肥満細胞腫のあるコンパニオン・ドッグ(アメリカン・スタッフォードシャー・テリア、9歳、34kg)に投与した。ヨードSAIBゲルを、25gの針を用いて、腫瘍内投与(500μL)した。
ヨードSAIBゲルは、コンピュータ断層撮影(CT)により視覚化された。画像は、シングルスライスのシーメンスCTスキャナ(Siemens Medical solutions,Malvern,USA)を使用して、得られた。図18(24時間、p.i.形式で記録されたCT画像)で示されるように、処方物B(SAIB/8/エタノール(55:25:20))を用いて、優れたCT造影が得られた。
Claims (8)
- 局所投与用の撮像造影用組成物であって、前記撮像造影用組成物が造影特性を示し、前記撮像造影用組成物の投与量の少なくとも60%が、前記撮像造影用組成物を人体又は動物体に投与した時の注入点より10cm以内の場所に、24時間超残り、
前記撮像造影用組成物は、投与前に液体であり、投与後にゲルへ転換する能力を有し、前記人体又は動物体に投与した後に、粘度が1,000センチポアズ(cP)を超えて増加し、
前記撮像造影用組成物は、スクロース酢酸イソブチル(SAIB)のヨウ素化誘導体を含むか、又は、スクロース酢酸イソブチル(SAIB)中にドープされたスクロース酢酸イソブチル(SAIB)のヨウ素化誘導体を含むX線造影用組成物である、撮像造影用組成物。 - 前記X線造影用組成物が、20℃で、10,000 センチポアズ(cP)未満の粘度を有する、請求項1記載の撮像造影用組成物。
- 前記X線造影用組成物は、35〜40℃の範囲の温度、 水和、 1μM〜500mMの範囲のイオン濃度、6〜8の範囲のpH、および、開始剤との接触の少なくともいずれか1つに応答してゲルを形成する、請求項1または2に記載の撮像造影用組成物。
- 前記X線造影用組成物が、放射性化合物、常磁性化合物、蛍光化合物、若しくは強磁性体化合物、又はこれらの混合物も含むか、及び/または、前記X線造影用組成物が、少なくとも1つの医薬物質も含む、請求項1〜3のいずれか1つに記載の撮像造影用組成物。
- 前記X線造影用組成物が、エタノールとスクロース酢酸イソブチル(SAIB)の混合物中で可溶化されたスクロース酢酸イソブチル(SAIB)のヨウ素化誘導体を含む、請求項1〜4のいずれか1つに撮像造影用組成物。
- 前記X線造影用組成物が、スクロース酢酸イソブチル(SAIB)のヨウ素化誘導体を含み、かつ医薬物質を含有するか、または、医薬物質を含有する粒子を含有する、請求項1〜5のいずれか1つに撮像造影用組成物。
- 組織マーカーとして、または、薬剤の制御放出組成物として放射線治療に使用される、請求項1〜6のいずれか1つに記載の撮像造影用組成物。
- シリンジと、
前記シリンジの開口端部に適用され、体内への注射、または、外科的医療行為に使用する針と、
請求項1〜7のいずれか1つに記載の撮像造影用組成物と、
を備える、キット。
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WO2021102241A1 (en) * | 2019-11-20 | 2021-05-27 | The Regents Of The University Of California | Liquid embolic material composition |
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