JP2018534254A5 - - Google Patents
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- Publication number
- JP2018534254A5 JP2018534254A5 JP2018515438A JP2018515438A JP2018534254A5 JP 2018534254 A5 JP2018534254 A5 JP 2018534254A5 JP 2018515438 A JP2018515438 A JP 2018515438A JP 2018515438 A JP2018515438 A JP 2018515438A JP 2018534254 A5 JP2018534254 A5 JP 2018534254A5
- Authority
- JP
- Japan
- Prior art keywords
- hydroxyvitamin
- cinacalcet
- region
- pharmaceutically acceptable
- compound
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- VDHAWDNDOKGFTD-MRXNPFEDSA-N cinacalcet Chemical compound N([C@H](C)C=1C2=CC=CC=C2C=CC=1)CCCC1=CC=CC(C(F)(F)F)=C1 VDHAWDNDOKGFTD-MRXNPFEDSA-N 0.000 claims 31
- 229960003315 cinacalcet Drugs 0.000 claims 31
- 235000021318 Calcifediol Nutrition 0.000 claims 27
- 239000008194 pharmaceutical composition Substances 0.000 claims 26
- -1 25-hydroxyvitamin D compound Chemical class 0.000 claims 22
- 150000003839 salts Chemical class 0.000 claims 20
- 208000013038 Hypocalcemia Diseases 0.000 claims 16
- 230000000705 hypocalcaemia Effects 0.000 claims 16
- 238000000034 method Methods 0.000 claims 16
- 239000003795 chemical substances by application Substances 0.000 claims 13
- 239000000203 mixture Substances 0.000 claims 9
- 239000002775 capsule Substances 0.000 claims 8
- JWUBBDSIWDLEOM-XHQRYOPUSA-N (3e)-3-[(2e)-2-[1-(6-hydroxy-6-methylheptan-2-yl)-7a-methyl-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol Chemical compound C1CCC2(C)C(C(CCCC(C)(C)O)C)CCC2\C1=C\C=C1/CC(O)CCC1=C JWUBBDSIWDLEOM-XHQRYOPUSA-N 0.000 claims 7
- 238000013270 controlled release Methods 0.000 claims 7
- 229940079593 drug Drugs 0.000 claims 6
- 239000003814 drug Substances 0.000 claims 6
- 239000011159 matrix material Substances 0.000 claims 6
- JWUBBDSIWDLEOM-NQZHSCJISA-N 25-hydroxy-3 epi cholecalciferol Chemical compound C1([C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](CCCC(C)(C)O)C)=CC=C1C[C@H](O)CCC1=C JWUBBDSIWDLEOM-NQZHSCJISA-N 0.000 claims 4
- 208000037147 Hypercalcaemia Diseases 0.000 claims 4
- 239000002246 antineoplastic agent Substances 0.000 claims 4
- 229940041181 antineoplastic drug Drugs 0.000 claims 4
- 239000011248 coating agent Substances 0.000 claims 4
- 238000000576 coating method Methods 0.000 claims 4
- 238000000502 dialysis Methods 0.000 claims 4
- 238000009472 formulation Methods 0.000 claims 4
- 230000000148 hypercalcaemia Effects 0.000 claims 4
- 208000030915 hypercalcemia disease Diseases 0.000 claims 4
- 239000003112 inhibitor Substances 0.000 claims 4
- 208000005770 Secondary Hyperparathyroidism Diseases 0.000 claims 3
- 208000020832 chronic kidney disease Diseases 0.000 claims 3
- 150000001875 compounds Chemical class 0.000 claims 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims 3
- 239000000825 pharmaceutical preparation Substances 0.000 claims 3
- 239000001993 wax Substances 0.000 claims 3
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims 2
- KJKIIUAXZGLUND-ICCVIKJNSA-N 25-hydroxyvitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](\C=C\[C@H](C)C(C)(C)O)C)=C\C=C1\C[C@@H](O)CCC1=C KJKIIUAXZGLUND-ICCVIKJNSA-N 0.000 claims 2
- AOJJSUZBOXZQNB-TZSSRYMLSA-N Doxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-TZSSRYMLSA-N 0.000 claims 2
- 206010020707 Hyperparathyroidism primary Diseases 0.000 claims 2
- 208000000821 Parathyroid Neoplasms Diseases 0.000 claims 2
- 201000000981 Primary Hyperparathyroidism Diseases 0.000 claims 2
- QANQWUQOEJZMLL-PKLMIRHRSA-N cinacalcet hydrochloride Chemical compound Cl.N([C@H](C)C=1C2=CC=CC=C2C=CC=1)CCCC1=CC=CC(C(F)(F)F)=C1 QANQWUQOEJZMLL-PKLMIRHRSA-N 0.000 claims 2
- 230000000694 effects Effects 0.000 claims 2
- 150000002632 lipids Chemical class 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 208000026045 malignant tumor of parathyroid gland Diseases 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- NDMPLJNOPCLANR-UHFFFAOYSA-N 3,4-dihydroxy-15-(4-hydroxy-18-methoxycarbonyl-5,18-seco-ibogamin-18-yl)-16-methoxy-1-methyl-6,7-didehydro-aspidospermidine-3-carboxylic acid methyl ester Natural products C1C(CC)(O)CC(CC2(C(=O)OC)C=3C(=CC4=C(C56C(C(C(O)C7(CC)C=CCN(C67)CC5)(O)C(=O)OC)N4C)C=3)OC)CN1CCC1=C2NC2=CC=CC=C12 NDMPLJNOPCLANR-UHFFFAOYSA-N 0.000 claims 1
- AOJJSUZBOXZQNB-VTZDEGQISA-N 4'-epidoxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-VTZDEGQISA-N 0.000 claims 1
- NMUSYJAQQFHJEW-KVTDHHQDSA-N 5-azacytidine Chemical compound O=C1N=C(N)N=CN1[C@H]1[C@H](O)[C@H](O)[C@@H](CO)O1 NMUSYJAQQFHJEW-KVTDHHQDSA-N 0.000 claims 1
- WYWHKKSPHMUBEB-UHFFFAOYSA-N 6-Mercaptoguanine Natural products N1C(N)=NC(=S)C2=C1N=CN2 WYWHKKSPHMUBEB-UHFFFAOYSA-N 0.000 claims 1
- STQGQHZAVUOBTE-UHFFFAOYSA-N 7-Cyan-hept-2t-en-4,6-diinsaeure Natural products C1=2C(O)=C3C(=O)C=4C(OC)=CC=CC=4C(=O)C3=C(O)C=2CC(O)(C(C)=O)CC1OC1CC(N)C(O)C(C)O1 STQGQHZAVUOBTE-UHFFFAOYSA-N 0.000 claims 1
- 229940122361 Bisphosphonate Drugs 0.000 claims 1
- 108010006654 Bleomycin Proteins 0.000 claims 1
- GAGWJHPBXLXJQN-UORFTKCHSA-N Capecitabine Chemical compound C1=C(F)C(NC(=O)OCCCCC)=NC(=O)N1[C@H]1[C@H](O)[C@H](O)[C@@H](C)O1 GAGWJHPBXLXJQN-UORFTKCHSA-N 0.000 claims 1
- GAGWJHPBXLXJQN-UHFFFAOYSA-N Capecitabine Natural products C1=C(F)C(NC(=O)OCCCCC)=NC(=O)N1C1C(O)C(O)C(C)O1 GAGWJHPBXLXJQN-UHFFFAOYSA-N 0.000 claims 1
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 claims 1
- UHDGCWIWMRVCDJ-CCXZUQQUSA-N Cytarabine Chemical compound O=C1N=C(N)C=CN1[C@H]1[C@@H](O)[C@H](O)[C@@H](CO)O1 UHDGCWIWMRVCDJ-CCXZUQQUSA-N 0.000 claims 1
- 229940123780 DNA topoisomerase I inhibitor Drugs 0.000 claims 1
- 229940124087 DNA topoisomerase II inhibitor Drugs 0.000 claims 1
- HTIJFSOGRVMCQR-UHFFFAOYSA-N Epirubicin Natural products COc1cccc2C(=O)c3c(O)c4CC(O)(CC(OC5CC(N)C(=O)C(C)O5)c4c(O)c3C(=O)c12)C(=O)CO HTIJFSOGRVMCQR-UHFFFAOYSA-N 0.000 claims 1
- 102400000932 Gonadoliberin-1 Human genes 0.000 claims 1
- 102100024025 Heparanase Human genes 0.000 claims 1
- 101500026183 Homo sapiens Gonadoliberin-1 Proteins 0.000 claims 1
- 102000010638 Kinesin Human genes 0.000 claims 1
- 108010063296 Kinesin Proteins 0.000 claims 1
- FBOZXECLQNJBKD-ZDUSSCGKSA-N L-methotrexate Chemical compound C=1N=C2N=C(N)N=C(N)C2=NC=1CN(C)C1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 FBOZXECLQNJBKD-ZDUSSCGKSA-N 0.000 claims 1
- 229940124761 MMP inhibitor Drugs 0.000 claims 1
- 101710181812 Methionine aminopeptidase Proteins 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 102000029749 Microtubule Human genes 0.000 claims 1
- 108091022875 Microtubule Proteins 0.000 claims 1
- 101100335081 Mus musculus Flt3 gene Proteins 0.000 claims 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
- ZDZOTLJHXYCWBA-VCVYQWHSSA-N N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 claims 1
- 229930012538 Paclitaxel Natural products 0.000 claims 1
- 102000004160 Phosphoric Monoester Hydrolases Human genes 0.000 claims 1
- 108090000608 Phosphoric Monoester Hydrolases Proteins 0.000 claims 1
- 108091000080 Phosphotransferase Proteins 0.000 claims 1
- 229920002675 Polyoxyl Polymers 0.000 claims 1
- 102000001708 Protein Isoforms Human genes 0.000 claims 1
- 108010029485 Protein Isoforms Proteins 0.000 claims 1
- 229940127361 Receptor Tyrosine Kinase Inhibitors Drugs 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- 229920002472 Starch Polymers 0.000 claims 1
- 239000000365 Topoisomerase I Inhibitor Substances 0.000 claims 1
- 239000000317 Topoisomerase II Inhibitor Substances 0.000 claims 1
- JXLYSJRDGCGARV-WWYNWVTFSA-N Vinblastine Natural products O=C(O[C@H]1[C@](O)(C(=O)OC)[C@@H]2N(C)c3c(cc(c(OC)c3)[C@]3(C(=O)OC)c4[nH]c5c(c4CCN4C[C@](O)(CC)C[C@H](C3)C4)cccc5)[C@@]32[C@H]2[C@@]1(CC)C=CCN2CC3)C JXLYSJRDGCGARV-WWYNWVTFSA-N 0.000 claims 1
- 229930003316 Vitamin D Natural products 0.000 claims 1
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 claims 1
- RTJVUHUGTUDWRK-CSLCKUBZSA-N [(2r,4ar,6r,7r,8s,8ar)-6-[[(5s,5ar,8ar,9r)-9-(3,5-dimethoxy-4-phosphonooxyphenyl)-8-oxo-5a,6,8a,9-tetrahydro-5h-[2]benzofuro[6,5-f][1,3]benzodioxol-5-yl]oxy]-2-methyl-7-[2-(2,3,4,5,6-pentafluorophenoxy)acetyl]oxy-4,4a,6,7,8,8a-hexahydropyrano[3,2-d][1,3]d Chemical compound COC1=C(OP(O)(O)=O)C(OC)=CC([C@@H]2C3=CC=4OCOC=4C=C3[C@@H](O[C@H]3[C@@H]([C@@H](OC(=O)COC=4C(=C(F)C(F)=C(F)C=4F)F)[C@@H]4O[C@H](C)OC[C@H]4O3)OC(=O)COC=3C(=C(F)C(F)=C(F)C=3F)F)[C@@H]3[C@@H]2C(OC3)=O)=C1 RTJVUHUGTUDWRK-CSLCKUBZSA-N 0.000 claims 1
- 238000010521 absorption reaction Methods 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- 239000000556 agonist Substances 0.000 claims 1
- 229940100198 alkylating agent Drugs 0.000 claims 1
- 239000002168 alkylating agent Substances 0.000 claims 1
- SHGAZHPCJJPHSC-YCNIQYBTSA-N all-trans-retinoic acid Chemical compound OC(=O)\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C SHGAZHPCJJPHSC-YCNIQYBTSA-N 0.000 claims 1
- 239000003242 anti bacterial agent Substances 0.000 claims 1
- 230000002280 anti-androgenic effect Effects 0.000 claims 1
- 230000001772 anti-angiogenic effect Effects 0.000 claims 1
- 229940046836 anti-estrogen Drugs 0.000 claims 1
- 230000001833 anti-estrogenic effect Effects 0.000 claims 1
- 230000000340 anti-metabolite Effects 0.000 claims 1
- 230000001028 anti-proliverative effect Effects 0.000 claims 1
- 230000000259 anti-tumor effect Effects 0.000 claims 1
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- 239000007864 aqueous solution Substances 0.000 claims 1
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- 229960002756 azacitidine Drugs 0.000 claims 1
- VSRXQHXAPYXROS-UHFFFAOYSA-N azanide;cyclobutane-1,1-dicarboxylic acid;platinum(2+) Chemical compound [NH2-].[NH2-].[Pt+2].OC(=O)C1(C(O)=O)CCC1 VSRXQHXAPYXROS-UHFFFAOYSA-N 0.000 claims 1
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- 150000004663 bisphosphonates Chemical class 0.000 claims 1
- 229960001561 bleomycin Drugs 0.000 claims 1
- OYVAGSVQBOHSSS-UAPAGMARSA-O bleomycin A2 Chemical compound N([C@H](C(=O)N[C@H](C)[C@@H](O)[C@H](C)C(=O)N[C@@H]([C@H](O)C)C(=O)NCCC=1SC=C(N=1)C=1SC=C(N=1)C(=O)NCCC[S+](C)C)[C@@H](O[C@H]1[C@H]([C@@H](O)[C@H](O)[C@H](CO)O1)O[C@@H]1[C@H]([C@@H](OC(N)=O)[C@H](O)[C@@H](CO)O1)O)C=1N=CNC=1)C(=O)C1=NC([C@H](CC(N)=O)NC[C@H](N)C(N)=O)=NC(N)=C1C OYVAGSVQBOHSSS-UAPAGMARSA-O 0.000 claims 1
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- 229960004562 carboplatin Drugs 0.000 claims 1
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- 235000021466 carotenoid Nutrition 0.000 claims 1
- 150000001747 carotenoids Chemical class 0.000 claims 1
- 229960004316 cisplatin Drugs 0.000 claims 1
- DQLATGHUWYMOKM-UHFFFAOYSA-L cisplatin Chemical compound N[Pt](N)(Cl)Cl DQLATGHUWYMOKM-UHFFFAOYSA-L 0.000 claims 1
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- 229960004397 cyclophosphamide Drugs 0.000 claims 1
- 229960000684 cytarabine Drugs 0.000 claims 1
- STQGQHZAVUOBTE-VGBVRHCVSA-N daunorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(C)=O)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 STQGQHZAVUOBTE-VGBVRHCVSA-N 0.000 claims 1
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- 229960001904 epirubicin Drugs 0.000 claims 1
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- VJJPUSNTGOMMGY-MRVIYFEKSA-N etoposide Chemical compound COC1=C(O)C(OC)=CC([C@@H]2C3=CC=4OCOC=4C=C3[C@@H](O[C@H]3[C@@H]([C@@H](O)[C@@H]4O[C@H](C)OC[C@H]4O3)O)[C@@H]3[C@@H]2C(OC3)=O)=C1 VJJPUSNTGOMMGY-MRVIYFEKSA-N 0.000 claims 1
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- 125000005456 glyceride group Chemical group 0.000 claims 1
- YQEMORVAKMFKLG-UHFFFAOYSA-N glycerine monostearate Natural products CCCCCCCCCCCCCCCCCC(=O)OC(CO)CO YQEMORVAKMFKLG-UHFFFAOYSA-N 0.000 claims 1
- SVUQHVRAGMNPLW-UHFFFAOYSA-N glycerol monostearate Natural products CCCCCCCCCCCCCCCCC(=O)OCC(O)CO SVUQHVRAGMNPLW-UHFFFAOYSA-N 0.000 claims 1
- XLXSAKCOAKORKW-AQJXLSMYSA-N gonadorelin Chemical compound C([C@@H](C(=O)NCC(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1[C@@H](CCC1)C(=O)NCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1N=CNC=1)NC(=O)[C@H]1NC(=O)CC1)C1=CC=C(O)C=C1 XLXSAKCOAKORKW-AQJXLSMYSA-N 0.000 claims 1
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- 125000000400 lauroyl group Chemical group O=C([*])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 claims 1
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- NRUKOCRGYNPUPR-QBPJDGROSA-N teniposide Chemical compound COC1=C(O)C(OC)=CC([C@@H]2C3=CC=4OCOC=4C=C3[C@@H](O[C@H]3[C@@H]([C@@H](O)[C@@H]4O[C@@H](OC[C@H]4O3)C=3SC=CC=3)O)[C@@H]3[C@@H]2C(OC3)=O)=C1 NRUKOCRGYNPUPR-QBPJDGROSA-N 0.000 claims 1
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- MNRILEROXIRVNJ-UHFFFAOYSA-N tioguanine Chemical compound N1C(N)=NC(=S)C2=NC=N[C]21 MNRILEROXIRVNJ-UHFFFAOYSA-N 0.000 claims 1
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- 229960001727 tretinoin Drugs 0.000 claims 1
- 229960000653 valrubicin Drugs 0.000 claims 1
- ZOCKGBMQLCSHFP-KQRAQHLDSA-N valrubicin Chemical compound O([C@H]1C[C@](CC2=C(O)C=3C(=O)C4=CC=CC(OC)=C4C(=O)C=3C(O)=C21)(O)C(=O)COC(=O)CCCC)[C@H]1C[C@H](NC(=O)C(F)(F)F)[C@H](O)[C@H](C)O1 ZOCKGBMQLCSHFP-KQRAQHLDSA-N 0.000 claims 1
- 229960003048 vinblastine Drugs 0.000 claims 1
- JXLYSJRDGCGARV-XQKSVPLYSA-N vincaleukoblastine Chemical compound 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 JXLYSJRDGCGARV-XQKSVPLYSA-N 0.000 claims 1
- 229960004528 vincristine Drugs 0.000 claims 1
- OGWKCGZFUXNPDA-XQKSVPLYSA-N vincristine Chemical compound C([N@]1C[C@@H](C[C@]2(C(=O)OC)C=3C(=CC4=C([C@]56[C@H]([C@@]([C@H](OC(C)=O)[C@]7(CC)C=CCN([C@H]67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)C[C@@](C1)(O)CC)CC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-XQKSVPLYSA-N 0.000 claims 1
- OGWKCGZFUXNPDA-UHFFFAOYSA-N vincristine Natural products C1C(CC)(O)CC(CC2(C(=O)OC)C=3C(=CC4=C(C56C(C(C(OC(C)=O)C7(CC)C=CCN(C67)CC5)(O)C(=O)OC)N4C=O)C=3)OC)CN1CCC1=C2NC2=CC=CC=C12 OGWKCGZFUXNPDA-UHFFFAOYSA-N 0.000 claims 1
- 229960004355 vindesine Drugs 0.000 claims 1
- UGGWPQSBPIFKDZ-KOTLKJBCSA-N vindesine Chemical compound C([C@@H](C[C@]1(C(=O)OC)C=2C(=CC3=C([C@]45[C@H]([C@@]([C@H](O)[C@]6(CC)C=CCN([C@H]56)CC4)(O)C(N)=O)N3C)C=2)OC)C[C@@](C2)(O)CC)N2CCC2=C1N=C1[C]2C=CC=C1 UGGWPQSBPIFKDZ-KOTLKJBCSA-N 0.000 claims 1
- 229960002066 vinorelbine Drugs 0.000 claims 1
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Claims (27)
- 25-ヒドロキシビタミンD化合物を含む第１の領域及び低カルシウム血症のリスクを高める薬剤（任意でシナカルセト又はその医薬的に許容される塩）を含む第２の領域を含む、経口投与用医薬製剤。
- 第１の領域が第２の領域と物理的に区別され、ここで前記第１の領域及び第２の領域は少なくとも１つのカプセル殻で分離されているか又は個別チャンバー内に収容されていてもよく、及び／又は、第１の領域の組成が第２の領域の組成と異なる、請求項１に記載の医薬製剤。
- 25-ヒドロキシビタミンD化合物を含む第１の領域が医薬的に許容される賦形剤をさらに含むか、又は低カルシウム血症のリスクを高める薬剤を含む第２の領域が医薬的に許容される賦形剤をさらに含むか、又は第１及び第２の両領域がそれぞれ医薬的に許容される賦形剤をさらに含む、請求項１又は２に記載の医薬製剤。
- a)25-ヒドロキシビタミンD化合物と遊離可能に結合し、かつ制御可能に25-ヒドロキシビタミンD化合物を放出するマトリックスを第１の領域内に含み、前記マトリックスは、低カルシウム血症のリスクを高める薬剤を含む第２の領域をさらに含んでもよい、及び/又は、
b)25-ヒドロキシビタミンD化合物、制御放出剤、乳化剤、吸収増強剤、及び安定剤を含む第１の領域を含むワックスマトリックスを含み、前記ワックスマトリックスは、低カルシウム血症のリスクを高める薬剤を含む第２の領域をさらに含んでもよい、
請求項１〜３のいずれか１項に記載の医薬製剤。 - 25-ヒドロキシビタミンD化合物、約20wt%のパラフィン、約20wt%〜約25wt%のグリセロールモノステアラート、約10wt%の、ラウロイルマクロゴールグリセリドとラウロイルポリオキシルグリセリドの混合物、約30wt%〜約35wt%の鉱油、及び約10wt%〜約15wt%のヒドロキシルプロピルメチルセルロースを含む第１の領域を含むマトリックスを含み、ワックスマトリックスは、低カルシウム血症のリスクを高める薬剤を含む第２の領域をさらに含んでもよい、請求項１〜４のいずれか１項に記載の医薬製剤。
- a)低カルシウム血症のリスクを高める薬剤を含む第２の領域が第１のカプセル殻中に配置され、25-ヒドロキシビタミンD化合物を含む第１の領域が第２のカプセル殻中に配置され、前記第２のカプセル殻は、前記第１のカプセル殻内に配置されている、及び/又は、
b)低カルシウム血症のリスクを高める薬剤が顆粒形態にある、及び/又は、
c)製剤が、25-ヒドロキシビタミンD化合物を含む第１の領域を含むコア領域と、低カルシウム血症のリスクを高める薬剤を含む第２の領域を含む外側領域とを含む、及び/又は、
d)低カルシウム血症のリスクを高める薬剤を含む第２の領域が、コーティング内に配置されている、及び/又は、
e)コーティングが、少なくとも１つのノンパレイユ上に配置されている、
請求項１〜５のいずれか１項に記載の医薬製剤。 - 低カルシウム血症のリスクを高める薬剤を含む第２の領域がコーティング内に配置され、前記コーティングが少なくとも１つのノンパレイユ上に配置されている、１〜５のいずれか１項に記載の医薬製剤であって、
１つ以上のコーティングされたノンパレイユが、非水溶液中で25-ヒドロキシビタミンD化合物を含む第１の領域とブレンドされ、前記ブレンドはカプセル殻内に配置されており、
25-ヒドロキシビタミンD化合物を含む第１の領域が、２チャンバーカプセルの第１のチャンバー中に配置されていてもよく、１つ以上のコーティングされたノンパレイユが、２チャンバーカプセルの第２のチャンバー中に配置されていてもよい、
前記医薬製剤。 - 25-ヒドロキシビタミンD化合物が、
a)25-ヒドロキシビタミンD2、25-ヒドロキシビタミンD3、又はその組合せである、及び/又は、
b)25-ヒドロキシビタミンD 3 である、及び/又は、
c)約1mcg〜約1000mcgの量で存在する、及び/又は、
d)約1mcg〜約100mcgの量で存在する、
請求項１〜７のいずれか１項に記載の医薬製剤。 - 低カルシウム血症のリスクを高める薬剤が、
a)約1mg〜約100mgの量で存在する、及び/又は、
b)シナカルセト又はその医薬的に許容される塩を含み、
前記シナカルセト又はその医薬的に許容される塩がシナカルセトHClを含んでもよい、
請求項１〜８のいずれか１項に記載の医薬製剤。 - さらに崩壊剤を、任意で約1wt%〜10wt%の量で、含む、請求項１〜９のいずれか１項に記載の医薬製剤。
- 低カルシウム血症のリスクを高める薬剤を含む第２の領域が、約10質量%〜約40質量%のシナカルセト又はその医薬的に許容される塩、約45質量%〜約85質量%の少なくとも1種の希釈剤、及び約1質量%〜約10質量%の少なくとも1種の崩壊剤を含み、約1質量%〜約5質量%の少なくとも1種の結合剤をさらに含んでもよく、ここで、質量百分率は前記領域の総質量に対するものである、請求項１〜１０のいずれか１項に記載の医薬製剤。
- 低カルシウム血症のリスクを高める薬剤を含む領域が下記：
(a)約10質量%〜約40質量%のシナカルセト又はその医薬的に許容される塩；
(b)約40質量%〜約75質量%の微結晶性セルロース；
(c)約5質量%〜約35質量%のデンプン；
(d)約1質量%〜約10質量%のクロスポビドン；
(e)約0.05質量%〜約1.5質量%のコロイド状二酸化ケイ素；及び
(f)約0.05質量%〜約1.5質量%のステアリン酸マグネシウム
を含み；ここで、質量百分率は前記領域の総質量に対するものである、請求項１〜１０のいずれか１項に記載の医薬製剤。 - シナカルセト又はその医薬的に許容される塩による療法を受けている患者の医原性低カルシウム血症及び続発性副甲状腺機能亢進症を管理する方法で使用するための、請求項１〜１２のいずれか１項に記載の医薬製剤。
- 患者の治療方法で使用するための25-ヒドロキシビタミンD及びシナカルセトを含む医薬組成物であって、前記方法が下記：
(i)透析を受けている患者の慢性腎臓病における続発性副甲状腺機能亢進症の治療方法であって、調節放出による有効量の25-ヒドロキシビタミンD化合物及び1日360mg未満の量の有効用量のシナカルセト又はその医薬的に許容される塩を前記患者に投与することを含み、ここで、シナカルセトの前記有効量は、前記25-ヒドロキシビタミンD投与がない場合のシナカルセトの有効用量に比べて低減した用量である前記方法；又は
(ii)副甲状腺癌を有する患者の高カルシウム血症の治療方法であって、調節放出による有効量の25-ヒドロキシビタミンD化合物及び1日360mg未満の量の有効用量のシナカルセト又はその医薬的に許容される塩を前記患者に投与することを含み、ここで、シナカルセト又はその医薬的に許容される塩の前記有効量は、前記25-ヒドロキシビタミンD投与がない場合のシナカルセトの有効用量に比べて低減した用量である前記方法;又は
(iii)副甲状腺摘出術を受けることができない原発性副甲状腺機能亢進症を有する患者の重症高カルシウム血症の治療方法であって、調節放出による有効量の25-ヒドロキシビタミンD化合物及び1日360mg未満の量の有効用量のシナカルセト又はその医薬的に許容される塩を前記患者に投与することを含み、ここで、シナカルセト又はその医薬的に許容される塩の前記有効量は、前記25-ヒドロキシビタミンD投与がない場合のシナカルセトの有効用量に比べて低減した用量である前記方法
である、前記医薬組成物。 - 患者が、慢性腎臓病ステージ1、2、3、4、又は5を伴っていてもよい腎機能障害を有する、請求項１４に記載の医薬組成物。
- 患者が透析を受けている、請求項１４又は１５に記載の医薬組成物。
- 患者が透析を受けていない、請求項１４又は１５に記載の医薬組成物。
- 有効量の25-ヒドロキシビタミンDが、
a)経口調節放出製剤、任意で持続放出製剤で、投与される、及び/又は、
b)シナカルセト又はその医薬的に許容される塩を含む経口製剤で同時投与される、及び/又は、
c)約100mcg〜約300mcgの範囲内である、
請求項１４〜１７のいずれか１項に記載の医薬組成物。 - 25-ヒドロキシビタミンDが、
a)25-ヒドロキシビタミンD3、25-ヒドロキシビタミンD2、又はその組合せを含む、及び/又は、
b)25-ヒドロキシビタミンD 3 を含む、及び/又は、
c)1日当たり1mcg〜1000mcgの用量で投与される、
請求項１４〜１８のいずれか１項に記載の医薬組成物。 - シナカルセト又はその医薬的に許容される塩がシナカルセトHClを含む、請求項１４〜１９のいずれか１項に記載の医薬組成物。
- 患者が、1日当たり1mg〜400mgの用量で投与されるシナカルセトを受けている、請求項１４〜２０のいずれか１項に記載の医薬組成物。
- 下記の方法で使用するための、有効量の25-ヒドロキシビタミンD化合物及び1日360mg未満の量の有効用量のシナカルセト又はその医薬的に許容される塩を含む医薬組成物：
a)透析を受けている患者の慢性腎臓病における続発性副甲状腺機能亢進症の治療方法であって、調節放出による有効量の25-ヒドロキシビタミンD化合物及び1日360mg未満の量の有効用量のシナカルセト又はその医薬的に許容される塩を前記患者に投与することを含み、ここで、シナカルセトの前記有効量は、前記25-ヒドロキシビタミンD投与がない場合のシナカルセトの有効用量に比べて低減した用量である、前記方法、又は、
b)副甲状腺癌を有する患者の高カルシウム血症の治療方法であって、調節放出による有効量の25-ヒドロキシビタミンD化合物及び1日360mg未満の量の有効用量のシナカルセト又はその医薬的に許容される塩を前記患者に投与することを含み、ここで、シナカルセト又はその医薬的に許容される塩の前記有効量は、前記25-ヒドロキシビタミンD投与がない場合のシナカルセトの有効用量に比べて低減した用量である、前記方法、又は、
c)副甲状腺摘出術を受けることができない原発性副甲状腺機能亢進症を有する患者の重症高カルシウム血症の治療方法であって、調節放出による有効量の25-ヒドロキシビタミンD化合物及び1日360mg未満の量の有効用量のシナカルセト又はその医薬的に許容される塩を前記患者に投与することを含み、ここで、シナカルセト又はその医薬的に許容される塩の前記有効量は、前記25-ヒドロキシビタミンD投与がない場合のシナカルセトの有効用量に比べて低減した用量である、前記方法。 - 1日1回、約20mg〜約25mgの範囲の初期用量のシナカルセトを含む、請求項２２に記載の医薬組成物。
- さらに抗癌薬を含む、請求項１４〜２３のいずれか１項に記載の医薬組成物。
- (a)25-ヒドロキシビタミンD化合物、(b)低カルシウム血症のリスクを高める薬剤（任意でシナカルセト又はその医薬的に許容される塩）、及び(c)抗癌薬、を含む、経口投与用医薬製剤。
- 抗癌薬が、アロマターゼ阻害薬；抗エストロゲン薬；抗アンドロゲン薬；ゴナドレリン作動薬；トポイソメラーゼI阻害薬；トポイソメラーゼII阻害薬；微小管活性薬；アルキル化薬；レチノイド、カロテノイド、又はトコフェロール；シクロオキシゲナーゼ阻害薬；MMP阻害薬；mTOR阻害薬；代謝拮抗薬；白金化合物；メチオニンアミノペプチダーゼ阻害薬；ビスホスホナート；抗増殖性抗体；ヘパラナーゼ阻害薬；Ras発癌性イソ型の阻害薬；テロメラーゼ阻害薬；プロテアソーム阻害薬；Flt-3阻害薬；Hsp90阻害薬；キネシンスピンドルタンパク質阻害薬；MEK阻害薬；抗腫瘍抗生物質；ニトロソウレア、タンパク質又は脂質キナーゼ活性を標的にする／低下させる化合物、タンパク質又は脂質ホスファターゼ活性を標的にする／低下させる化合物、抗血管新生化合物、アザシチジン、アキサチオプリン、ベバシズマブ、ブレオマイシン、カペシタビン、カルボプラチン、クロラブシル、シスプラチン、シクロホスファミド、シタラビン、ダウノルビシン、ドセタキセル、ドキシフルリジン、ドキソルビシン、エピルビシン、エトポシド、フルオロウラシル、ゲムシタビン、ヘルセプチン、イダルビシン、メクロレタミン、メルファラン、メルカプトプリン、メトトレキサート、ミトキサントロン、オキサリプラチン、パクリタキセル、タフルポシド、テニポシド、チオグアニン、レチノイン酸、バルルビシン、ビンブラスチン、ビンクリスチン、ビンデシン、ビノレルビン、及び受容体チロシンキナーゼ阻害薬を含む群の１つ以上の薬剤を含む、請求項２４に記載の医薬組成物又は請求項２５に記載の医薬製剤。
- (a)25-ヒドロキシビタミンD化合物、(b)低カルシウム血症のリスクを高める薬剤、(c)抗癌薬、及び、(d)必要とする患者に有効量の(a)、(b)及び(c)を共投与するための指示書を含む、キット。
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