JP2004509146A5 - - Google Patents
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- Publication number
- JP2004509146A5 JP2004509146A5 JP2002528263A JP2002528263A JP2004509146A5 JP 2004509146 A5 JP2004509146 A5 JP 2004509146A5 JP 2002528263 A JP2002528263 A JP 2002528263A JP 2002528263 A JP2002528263 A JP 2002528263A JP 2004509146 A5 JP2004509146 A5 JP 2004509146A5
- Authority
- JP
- Japan
- Prior art keywords
- fenofibrate
- dosage form
- amount
- composition
- fibrate
- 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.)
- Pending
Links
- 229960002297 fenofibrate Drugs 0.000 description 98
- YMTINGFKWWXKFG-UHFFFAOYSA-N fenofibrate Chemical compound C1=CC(OC(C)(C)C(=O)OC(C)C)=CC=C1C(=O)C1=CC=C(Cl)C=C1 YMTINGFKWWXKFG-UHFFFAOYSA-N 0.000 description 98
- 238000000034 method Methods 0.000 description 76
- 239000000203 mixture Substances 0.000 description 76
- 150000003904 phospholipids Chemical class 0.000 description 51
- 239000002552 dosage form Substances 0.000 description 41
- 229940125753 fibrate Drugs 0.000 description 34
- 239000011859 microparticle Substances 0.000 description 34
- 239000004094 surface-active agent Substances 0.000 description 31
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 21
- 239000004067 bulking agent Substances 0.000 description 21
- 238000002844 melting Methods 0.000 description 19
- 230000008018 melting Effects 0.000 description 19
- 239000008194 pharmaceutical composition Substances 0.000 description 18
- 239000007787 solid Substances 0.000 description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 17
- 239000002245 particle Substances 0.000 description 16
- 239000008280 blood Substances 0.000 description 15
- 210000004369 blood Anatomy 0.000 description 15
- 239000003826 tablet Substances 0.000 description 15
- 239000010419 fine particle Substances 0.000 description 13
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 11
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 11
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 11
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 11
- 229930006000 Sucrose Natural products 0.000 description 11
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 11
- 239000000600 sorbitol Substances 0.000 description 11
- 239000005720 sucrose Substances 0.000 description 11
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 10
- 229930195725 Mannitol Natural products 0.000 description 10
- 239000000594 mannitol Substances 0.000 description 10
- 235000010355 mannitol Nutrition 0.000 description 10
- 241000124008 Mammalia Species 0.000 description 9
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 9
- 239000008365 aqueous carrier Substances 0.000 description 9
- 239000000725 suspension Substances 0.000 description 9
- 239000002775 capsule Substances 0.000 description 8
- 150000001720 carbohydrates Chemical class 0.000 description 8
- 235000014633 carbohydrates Nutrition 0.000 description 8
- 239000006185 dispersion Substances 0.000 description 8
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 7
- 239000005715 Fructose Substances 0.000 description 7
- 229930091371 Fructose Natural products 0.000 description 7
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 description 7
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 7
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 7
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 7
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 7
- 239000008121 dextrose Substances 0.000 description 7
- 150000002016 disaccharides Chemical class 0.000 description 7
- 150000002402 hexoses Chemical class 0.000 description 7
- 239000008101 lactose Substances 0.000 description 7
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 7
- 150000002772 monosaccharides Chemical class 0.000 description 7
- 150000002972 pentoses Chemical class 0.000 description 7
- 150000004043 trisaccharides Chemical class 0.000 description 7
- 239000000811 xylitol Substances 0.000 description 7
- 235000010447 xylitol Nutrition 0.000 description 7
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 7
- 229960002675 xylitol Drugs 0.000 description 7
- 229910019142 PO4 Inorganic materials 0.000 description 6
- BPHQZTVXXXJVHI-UHFFFAOYSA-N dimyristoyl phosphatidylglycerol Chemical compound CCCCCCCCCCCCCC(=O)OCC(COP(O)(=O)OCC(O)CO)OC(=O)CCCCCCCCCCCCC BPHQZTVXXXJVHI-UHFFFAOYSA-N 0.000 description 6
- 238000000265 homogenisation Methods 0.000 description 6
- 239000012943 hotmelt Substances 0.000 description 6
- 239000010452 phosphate Substances 0.000 description 6
- 239000000843 powder Substances 0.000 description 6
- 239000003381 stabilizer Substances 0.000 description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 5
- 239000004518 granules dosage form Substances 0.000 description 5
- 239000006186 oral dosage form Substances 0.000 description 5
- 239000000126 substance Substances 0.000 description 5
- MUPFEKGTMRGPLJ-RMMQSMQOSA-N Raffinose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 MUPFEKGTMRGPLJ-RMMQSMQOSA-N 0.000 description 4
- MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 description 4
- 238000001816 cooling Methods 0.000 description 4
- 150000002632 lipids Chemical class 0.000 description 4
- 239000000546 pharmaceutical excipient Substances 0.000 description 4
- 125000002467 phosphate group Chemical group [H]OP(=O)(O[H])O[*] 0.000 description 4
- MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 description 4
- 238000000527 sonication Methods 0.000 description 4
- 239000011248 coating agent Substances 0.000 description 3
- 238000000576 coating method Methods 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 235000009200 high fat diet Nutrition 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 239000003960 organic solvent Substances 0.000 description 3
- 230000000087 stabilizing effect Effects 0.000 description 3
- 235000010469 Glycine max Nutrition 0.000 description 2
- JLPULHDHAOZNQI-JLOPVYAASA-N [(2r)-3-hexadecanoyloxy-2-[(9e,12e)-octadeca-9,12-dienoyl]oxypropyl] 2-(trimethylazaniumyl)ethyl phosphate Chemical class CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCC\C=C\C\C=C\CCCCC JLPULHDHAOZNQI-JLOPVYAASA-N 0.000 description 2
- 229940063823 fenofibrate 100 mg Drugs 0.000 description 2
- 229940020402 fenofibrate 134 mg Drugs 0.000 description 2
- 229940053392 fenofibrate 150 mg Drugs 0.000 description 2
- 229940020404 fenofibrate 160 mg Drugs 0.000 description 2
- 229940020832 fenofibrate 200 mg Drugs 0.000 description 2
- 229940060593 fenofibrate 50 mg Drugs 0.000 description 2
- 229940020823 fenofibrate 67 mg Drugs 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 2
- WTJKGGKOPKCXLL-RRHRGVEJSA-N phosphatidylcholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCC=CCCCCCCCC WTJKGGKOPKCXLL-RRHRGVEJSA-N 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 239000008223 sterile water Substances 0.000 description 2
- 239000008227 sterile water for injection Substances 0.000 description 2
- 125000000647 trehalose group Chemical group 0.000 description 2
- 241000282412 Homo Species 0.000 description 1
- 208000035150 Hypercholesterolemia Diseases 0.000 description 1
- 208000031226 Hyperlipidaemia Diseases 0.000 description 1
- 238000000498 ball milling Methods 0.000 description 1
- 229940020407 fenofibrate 54 mg Drugs 0.000 description 1
- 239000007941 film coated tablet Substances 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 208000006575 hypertriglyceridemia Diseases 0.000 description 1
- 238000010902 jet-milling Methods 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 238000003801 milling Methods 0.000 description 1
- 238000004062 sedimentation Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US23418600P | 2000-09-20 | 2000-09-20 | |
| US24176100P | 2000-10-20 | 2000-10-20 | |
| PCT/US2001/012826 WO2002024193A1 (en) | 2000-09-20 | 2001-04-20 | Stabilised fibrate microparticles |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2004509146A JP2004509146A (ja) | 2004-03-25 |
| JP2004509146A5 true JP2004509146A5 (enExample) | 2008-07-03 |
Family
ID=26927654
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2002528263A Pending JP2004509146A (ja) | 2000-09-20 | 2001-04-20 | 安定化フィブレート微粒子 |
Country Status (10)
| Country | Link |
|---|---|
| US (2) | US20020058065A1 (enExample) |
| EP (1) | EP1320362B1 (enExample) |
| JP (1) | JP2004509146A (enExample) |
| AT (1) | ATE522211T1 (enExample) |
| AU (2) | AU2001255515A1 (enExample) |
| CA (1) | CA2423336C (enExample) |
| ES (1) | ES2372746T3 (enExample) |
| NZ (1) | NZ525231A (enExample) |
| TW (1) | TWI354568B (enExample) |
| WO (1) | WO2002024193A1 (enExample) |
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-
2001
- 2001-04-20 TW TW090109549A patent/TWI354568B/zh not_active IP Right Cessation
- 2001-04-20 JP JP2002528263A patent/JP2004509146A/ja active Pending
- 2001-04-20 CA CA2423336A patent/CA2423336C/en not_active Expired - Fee Related
- 2001-04-20 WO PCT/US2001/012826 patent/WO2002024193A1/en not_active Ceased
- 2001-04-20 ES ES01928684T patent/ES2372746T3/es not_active Expired - Lifetime
- 2001-04-20 EP EP01928684A patent/EP1320362B1/en not_active Expired - Lifetime
- 2001-04-20 AT AT01928684T patent/ATE522211T1/de not_active IP Right Cessation
- 2001-04-20 US US09/838,541 patent/US20020058065A1/en not_active Abandoned
- 2001-04-20 AU AU2001255515A patent/AU2001255515A1/en not_active Abandoned
- 2001-04-20 NZ NZ525231A patent/NZ525231A/en not_active IP Right Cessation
-
2003
- 2003-05-19 US US10/440,368 patent/US20030194442A1/en not_active Abandoned
-
2007
- 2007-05-01 AU AU2007201953A patent/AU2007201953B2/en not_active Ceased
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