OA12883A - Lasofoxifene tablet and its coating. - Google Patents
Lasofoxifene tablet and its coating. Download PDFInfo
- Publication number
- OA12883A OA12883A OA1200500007A OA1200500007A OA12883A OA 12883 A OA12883 A OA 12883A OA 1200500007 A OA1200500007 A OA 1200500007A OA 1200500007 A OA1200500007 A OA 1200500007A OA 12883 A OA12883 A OA 12883A
- Authority
- OA
- OAPI
- Prior art keywords
- phenyl
- cellulose
- sodium
- tablet
- active
- Prior art date
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- GXESHMAMLJKROZ-IAPPQJPRSA-N lasofoxifene Chemical compound C1([C@@H]2[C@@H](C3=CC=C(C=C3CC2)O)C=2C=CC(OCCN3CCCC3)=CC=2)=CC=CC=C1 GXESHMAMLJKROZ-IAPPQJPRSA-N 0.000 title claims abstract description 33
- 229960002367 lasofoxifene Drugs 0.000 title abstract description 30
- 238000000576 coating method Methods 0.000 title abstract description 10
- 239000011248 coating agent Substances 0.000 title abstract description 9
- 239000000203 mixture Substances 0.000 claims abstract description 99
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 61
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 32
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 28
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 27
- 150000001875 compounds Chemical class 0.000 claims description 33
- 239000003085 diluting agent Substances 0.000 claims description 27
- 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 claims description 21
- 239000008101 lactose Substances 0.000 claims description 20
- 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 claims description 19
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 19
- 239000007884 disintegrant Substances 0.000 claims description 19
- 239000000945 filler Substances 0.000 claims description 19
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 17
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 17
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 17
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 17
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 17
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 17
- 239000000651 prodrug Substances 0.000 claims description 17
- 229940002612 prodrug Drugs 0.000 claims description 17
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 15
- 229960001681 croscarmellose sodium Drugs 0.000 claims description 15
- 239000000314 lubricant Substances 0.000 claims description 14
- -1 dextrates Chemical compound 0.000 claims description 11
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 10
- 239000002775 capsule Substances 0.000 claims description 8
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 8
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 8
- 239000000454 talc Substances 0.000 claims description 8
- 229910052623 talc Inorganic materials 0.000 claims description 8
- 229940033134 talc Drugs 0.000 claims description 8
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 7
- 239000001913 cellulose Substances 0.000 claims description 7
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 7
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 7
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 7
- 229920000609 methyl cellulose Polymers 0.000 claims description 7
- 235000010981 methylcellulose Nutrition 0.000 claims description 7
- 239000001923 methylcellulose Substances 0.000 claims description 7
- 229920001223 polyethylene glycol Polymers 0.000 claims description 7
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 6
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims description 6
- 229920002472 Starch Polymers 0.000 claims description 6
- 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 claims description 6
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 6
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 6
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 6
- 239000008107 starch Substances 0.000 claims description 6
- 235000019698 starch Nutrition 0.000 claims description 6
- 239000002202 Polyethylene glycol Substances 0.000 claims description 5
- 239000003921 oil Substances 0.000 claims description 5
- 235000019198 oils Nutrition 0.000 claims description 5
- 235000019814 powdered cellulose Nutrition 0.000 claims description 5
- 229920003124 powdered cellulose Polymers 0.000 claims description 5
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 4
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 4
- 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 claims description 4
- 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 claims description 4
- 229930195725 Mannitol Natural products 0.000 claims description 4
- 229920000881 Modified starch Polymers 0.000 claims description 4
- 229930006000 Sucrose Natural products 0.000 claims description 4
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 4
- 239000011575 calcium Substances 0.000 claims description 4
- 229910052791 calcium Inorganic materials 0.000 claims description 4
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 4
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 4
- 235000010980 cellulose Nutrition 0.000 claims description 4
- 229920002678 cellulose Polymers 0.000 claims description 4
- 239000008121 dextrose Substances 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 claims description 4
- 239000005720 sucrose Substances 0.000 claims description 4
- 229960000540 polacrilin potassium Drugs 0.000 claims description 3
- WVWZXTJUCNEUAE-UHFFFAOYSA-M potassium;1,2-bis(ethenyl)benzene;2-methylprop-2-enoate Chemical compound [K+].CC(=C)C([O-])=O.C=CC1=CC=CC=C1C=C WVWZXTJUCNEUAE-UHFFFAOYSA-M 0.000 claims description 3
- 239000008109 sodium starch glycolate Substances 0.000 claims description 3
- 229920003109 sodium starch glycolate Polymers 0.000 claims description 3
- 229940079832 sodium starch glycolate Drugs 0.000 claims description 3
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 2
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims description 2
- 229920002261 Corn starch Polymers 0.000 claims description 2
- 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 claims description 2
- 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 claims description 2
- FEWJPZIEWOKRBE-LWMBPPNESA-L D-tartrate(2-) Chemical compound [O-]C(=O)[C@@H](O)[C@H](O)C([O-])=O FEWJPZIEWOKRBE-LWMBPPNESA-L 0.000 claims description 2
- 229920002307 Dextran Polymers 0.000 claims description 2
- 239000004375 Dextrin Substances 0.000 claims description 2
- 229920001353 Dextrin Polymers 0.000 claims description 2
- 229920002774 Maltodextrin Polymers 0.000 claims description 2
- 239000005913 Maltodextrin Substances 0.000 claims description 2
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 2
- 235000021355 Stearic acid Nutrition 0.000 claims description 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 2
- 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 claims description 2
- 229960003563 calcium carbonate Drugs 0.000 claims description 2
- 229910000019 calcium carbonate Inorganic materials 0.000 claims description 2
- 235000010216 calcium carbonate Nutrition 0.000 claims description 2
- 229940095672 calcium sulfate Drugs 0.000 claims description 2
- 235000011132 calcium sulphate Nutrition 0.000 claims description 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims description 2
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims description 2
- 239000008120 corn starch Substances 0.000 claims description 2
- 229940096516 dextrates Drugs 0.000 claims description 2
- 235000019425 dextrin Nutrition 0.000 claims description 2
- 235000019700 dicalcium phosphate Nutrition 0.000 claims description 2
- 229940095079 dicalcium phosphate anhydrous Drugs 0.000 claims description 2
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims description 2
- 229960001031 glucose Drugs 0.000 claims description 2
- 229940075507 glyceryl monostearate Drugs 0.000 claims description 2
- FETSQPAGYOVAQU-UHFFFAOYSA-N glyceryl palmitostearate Chemical compound OCC(O)CO.CCCCCCCCCCCCCCCC(O)=O.CCCCCCCCCCCCCCCCCC(O)=O FETSQPAGYOVAQU-UHFFFAOYSA-N 0.000 claims description 2
- 229940046813 glyceryl palmitostearate Drugs 0.000 claims description 2
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims description 2
- 229940035034 maltodextrin Drugs 0.000 claims description 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 2
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 claims description 2
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 2
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 2
- 229920001983 poloxamer Polymers 0.000 claims description 2
- 235000010413 sodium alginate Nutrition 0.000 claims description 2
- 239000000661 sodium alginate Substances 0.000 claims description 2
- 229940005550 sodium alginate Drugs 0.000 claims description 2
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 2
- 239000004299 sodium benzoate Substances 0.000 claims description 2
- 235000010234 sodium benzoate Nutrition 0.000 claims description 2
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 2
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- 239000008117 stearic acid Substances 0.000 claims description 2
- 229960004274 stearic acid Drugs 0.000 claims description 2
- 235000019731 tricalcium phosphate Nutrition 0.000 claims description 2
- 239000000811 xylitol Substances 0.000 claims description 2
- 235000010447 xylitol Nutrition 0.000 claims description 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 2
- 229960002675 xylitol Drugs 0.000 claims description 2
- 239000011701 zinc Substances 0.000 claims description 2
- 229910052725 zinc Inorganic materials 0.000 claims description 2
- 229960005069 calcium Drugs 0.000 claims 2
- 229940032147 starch Drugs 0.000 claims 2
- UMKXSOXZAXIOPJ-UHFFFAOYSA-N 5,6,7,8-tetrahydro-2-naphthol Chemical compound C1CCCC2=CC(O)=CC=C21 UMKXSOXZAXIOPJ-UHFFFAOYSA-N 0.000 claims 1
- PTHCMJGKKRQCBF-UHFFFAOYSA-N Cellulose, microcrystalline Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC)C(CO)O1 PTHCMJGKKRQCBF-UHFFFAOYSA-N 0.000 claims 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- 239000004698 Polyethylene Substances 0.000 claims 1
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims 1
- 229960002086 dextran Drugs 0.000 claims 1
- 229940071676 hydroxypropylcellulose Drugs 0.000 claims 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims 1
- 229920000573 polyethylene Polymers 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
- 235000015424 sodium Nutrition 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 abstract description 23
- 238000004519 manufacturing process Methods 0.000 abstract description 16
- 239000001087 glyceryl triacetate Substances 0.000 abstract description 12
- 235000013773 glyceryl triacetate Nutrition 0.000 abstract description 12
- 229960002622 triacetin Drugs 0.000 abstract description 12
- 238000009513 drug distribution Methods 0.000 abstract description 2
- 239000004480 active ingredient Substances 0.000 abstract 2
- 238000000034 method Methods 0.000 description 31
- 239000003826 tablet Substances 0.000 description 30
- 239000002552 dosage form Substances 0.000 description 25
- 230000008569 process Effects 0.000 description 22
- 238000002156 mixing Methods 0.000 description 21
- 239000000243 solution Substances 0.000 description 18
- 229960001375 lactose Drugs 0.000 description 16
- 239000000546 pharmaceutical excipient Substances 0.000 description 13
- CSNNHWWHGAXBCP-UHFFFAOYSA-L Magnesium sulfate Chemical compound [Mg+2].[O-][S+2]([O-])([O-])[O-] CSNNHWWHGAXBCP-UHFFFAOYSA-L 0.000 description 12
- 238000009472 formulation Methods 0.000 description 12
- 229920000642 polymer Polymers 0.000 description 10
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 9
- 239000003086 colorant Substances 0.000 description 9
- 229940079593 drug Drugs 0.000 description 9
- 239000003814 drug Substances 0.000 description 9
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 8
- 238000005550 wet granulation Methods 0.000 description 8
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 7
- 239000000463 material Substances 0.000 description 7
- 239000002245 particle Substances 0.000 description 7
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 6
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 238000009826 distribution Methods 0.000 description 6
- 238000007908 dry granulation Methods 0.000 description 6
- 229910052943 magnesium sulfate Inorganic materials 0.000 description 6
- 235000019341 magnesium sulphate Nutrition 0.000 description 6
- 239000003605 opacifier Substances 0.000 description 6
- 239000004014 plasticizer Substances 0.000 description 6
- 239000000047 product Substances 0.000 description 6
- 238000003756 stirring Methods 0.000 description 6
- 238000005469 granulation Methods 0.000 description 5
- 230000003179 granulation Effects 0.000 description 5
- 239000010410 layer Substances 0.000 description 5
- 230000003647 oxidation Effects 0.000 description 5
- 238000007254 oxidation reaction Methods 0.000 description 5
- 230000003389 potentiating effect Effects 0.000 description 5
- 239000000843 powder Substances 0.000 description 5
- 239000007787 solid Substances 0.000 description 5
- 239000000126 substance Substances 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 238000005160 1H NMR spectroscopy Methods 0.000 description 4
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 description 4
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 4
- 239000008186 active pharmaceutical agent Substances 0.000 description 4
- 239000011230 binding agent Substances 0.000 description 4
- 238000006243 chemical reaction Methods 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 239000003937 drug carrier Substances 0.000 description 4
- 229940088679 drug related substance Drugs 0.000 description 4
- 239000012535 impurity Substances 0.000 description 4
- 229960001021 lactose monohydrate Drugs 0.000 description 4
- 239000007788 liquid Substances 0.000 description 4
- 239000012044 organic layer Substances 0.000 description 4
- 230000002829 reductive effect Effects 0.000 description 4
- 239000007916 tablet composition Substances 0.000 description 4
- 239000004408 titanium dioxide Substances 0.000 description 4
- 238000009827 uniform distribution Methods 0.000 description 4
- INEHJXCWEVNEDZ-LUDNRVPPSA-N (2s,3s)-2,3-dihydroxybutanedioic acid;(5r,6s)-6-phenyl-5-[4-(2-pyrrolidin-1-ylethoxy)phenyl]-5,6,7,8-tetrahydronaphthalen-2-ol Chemical compound OC(=O)[C@@H](O)[C@H](O)C(O)=O.C1([C@@H]2[C@@H](C3=CC=C(C=C3CC2)O)C=2C=CC(OCCN3CCCC3)=CC=2)=CC=CC=C1 INEHJXCWEVNEDZ-LUDNRVPPSA-N 0.000 description 3
- HJOOGTROABIIIU-UHFFFAOYSA-N 1-[2-[4-(6-methoxy-2-phenyl-3,4-dihydronaphthalen-1-yl)phenoxy]ethyl]pyrrolidine;hydrochloride Chemical compound Cl.C1CC2=CC(OC)=CC=C2C(C=2C=CC(OCCN3CCCC3)=CC=2)=C1C1=CC=CC=C1 HJOOGTROABIIIU-UHFFFAOYSA-N 0.000 description 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- RWRDLPDLKQPQOW-UHFFFAOYSA-N Pyrrolidine Chemical compound C1CCNC1 RWRDLPDLKQPQOW-UHFFFAOYSA-N 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 230000015572 biosynthetic process Effects 0.000 description 3
- 230000001680 brushing effect Effects 0.000 description 3
- 239000000969 carrier Substances 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 238000001914 filtration Methods 0.000 description 3
- 239000011521 glass Substances 0.000 description 3
- 229950010500 lasofoxifene tartrate Drugs 0.000 description 3
- 229940095743 selective estrogen receptor modulator Drugs 0.000 description 3
- 239000000333 selective estrogen receptor modulator Substances 0.000 description 3
- 230000001225 therapeutic effect Effects 0.000 description 3
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- 150000005846 sugar alcohols Polymers 0.000 description 1
- 238000009495 sugar coating Methods 0.000 description 1
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- LSNNMFCWUKXFEE-UHFFFAOYSA-L sulfite Chemical class [O-]S([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-L 0.000 description 1
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- 239000004094 surface-active agent Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 229940095064 tartrate Drugs 0.000 description 1
- 150000003567 thiocyanates Chemical class 0.000 description 1
- 235000010215 titanium dioxide Nutrition 0.000 description 1
- 229910052905 tridymite Inorganic materials 0.000 description 1
- RIOQSEWOXXDEQQ-UHFFFAOYSA-O triphenylphosphanium Chemical compound C1=CC=CC=C1[PH+](C=1C=CC=CC=1)C1=CC=CC=C1 RIOQSEWOXXDEQQ-UHFFFAOYSA-O 0.000 description 1
- 239000012808 vapor phase Substances 0.000 description 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
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Classifications
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- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Physical Education & Sports Medicine (AREA)
- Endocrinology (AREA)
- Rheumatology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Reproductive Health (AREA)
- Urology & Nephrology (AREA)
- Child & Adolescent Psychology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
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| US39509002P | 2002-07-10 | 2002-07-10 |
Publications (1)
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| OA12883A true OA12883A (en) | 2006-09-15 |
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Family Applications (1)
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| EP (1) | EP1534248B1 (de) |
| JP (2) | JP4446446B2 (de) |
| KR (1) | KR100782693B1 (de) |
| CN (1) | CN100344278C (de) |
| AP (1) | AP2005003201A0 (de) |
| AR (1) | AR040434A1 (de) |
| AT (1) | ATE550017T1 (de) |
| AU (1) | AU2003247017B2 (de) |
| BR (1) | BR0312563A (de) |
| CA (1) | CA2489407C (de) |
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| DK (1) | DK1534248T3 (de) |
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| EC (1) | ECSP055528A (de) |
| ES (1) | ES2395123T3 (de) |
| HN (1) | HN2003000206A (de) |
| HR (1) | HRP20041196A2 (de) |
| IL (2) | IL165746A0 (de) |
| IS (1) | IS7594A (de) |
| MA (1) | MA27318A1 (de) |
| MX (1) | MXPA05000394A (de) |
| NO (1) | NO20050018L (de) |
| NZ (1) | NZ537278A (de) |
| OA (1) | OA12883A (de) |
| PA (1) | PA8576201A1 (de) |
| PE (1) | PE20040104A1 (de) |
| PL (1) | PL374913A1 (de) |
| PT (1) | PT1534248E (de) |
| SI (1) | SI1534248T1 (de) |
| TN (1) | TNSN05006A1 (de) |
| TW (1) | TW200406222A (de) |
| UY (1) | UY27886A1 (de) |
| WO (1) | WO2004006895A1 (de) |
| ZA (1) | ZA200410196B (de) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PA8576201A1 (es) * | 2002-07-10 | 2004-05-26 | Pfizer Prod Inc | Composicion farmaceutica que tiene una distribucion y potencia uniforme de farmaco |
| US20040253305A1 (en) * | 2003-06-12 | 2004-12-16 | Luner Paul E. | Pharmaceutical compositions of atorvastatin |
| US20050271717A1 (en) * | 2003-06-12 | 2005-12-08 | Alfred Berchielli | Pharmaceutical compositions of atorvastatin |
| EP1871359A1 (de) * | 2005-04-07 | 2008-01-02 | Miso Sabovic | Verzögerung des alterungsprozesses und von altersbedingten erkrankungen |
| CA2607419C (en) * | 2005-04-26 | 2014-06-17 | Dainippon Sumitomo Pharma Co., Ltd. | Granular preparation containing biguanide compound |
| GB0516604D0 (en) * | 2005-08-12 | 2005-09-21 | Sandoz Ag | Rapidly dispersing/disintegrating compositions |
| EP1948179A1 (de) | 2005-11-11 | 2008-07-30 | Boehringer Ingelheim International GmbH | Chinazolin-derivate zur behandlung von krebserkrankungen |
| EP4403221A3 (de) | 2007-02-23 | 2024-10-09 | Gilead Sciences, Inc. | Modulatoren der pharmakokinetischen eigenschaften von therapeutika |
| CA2587805C (en) * | 2007-04-25 | 2014-02-18 | The Procter & Gamble Company | Improved vitamin d content uniformity in pharmaceutical dosage forms |
| CN101820863A (zh) * | 2007-10-10 | 2010-09-01 | 马林克罗特贝克公司 | 直接可压制的高功能性颗粒状微晶纤维素基赋形剂、其制备方法和用途 |
| US20100055180A1 (en) * | 2007-10-10 | 2010-03-04 | Mallinckrodt Baker, Inc. | Directly Compressible Granular Microcrystalline Cellulose Based Excipient, Manufacturing Process and Use Thereof |
| US20090274757A1 (en) * | 2008-05-01 | 2009-11-05 | Wyeth | Pharmaceutical polish formulations |
| CN103479584A (zh) | 2008-05-02 | 2014-01-01 | 吉里德科学公司 | 固体载体颗粒在改善药物制剂加工性中的应用 |
| PL2451445T3 (pl) | 2009-07-06 | 2019-09-30 | Boehringer Ingelheim International Gmbh | Sposób suszenia BIBW2992, jego soli i stałych preparatów farmaceutycznych zawierających tę substancję czynną |
| SG11201401583YA (en) * | 2011-10-17 | 2014-09-26 | Lexicon Pharmaceuticals Inc | Solid dosage forms of (s)-ethyl 2-amino-3-(4-(2-amino-6-((r)-1-(4-chloro-2-(3-methyl-1h-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate |
| CA2873961C (en) | 2012-05-14 | 2017-09-26 | Shionogi & Co., Ltd. | Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivatives |
| WO2015036512A1 (en) * | 2013-09-13 | 2015-03-19 | Bayer Pharma Aktiengesellschaft | Pharmaceutical compositions containing refametinib |
| RU2539375C1 (ru) * | 2013-11-07 | 2015-01-20 | Общество С Ограниченной Ответственностью "Валента-Интеллект" | Фармацевтическая композиция в форме таблетки и способ ее получения |
| US9242965B2 (en) | 2013-12-31 | 2016-01-26 | Boehringer Ingelheim International Gmbh | Process for the manufacture of (E)-4-N,N-dialkylamino crotonic acid in HX salt form and use thereof for synthesis of EGFR tyrosine kinase inhibitors |
| CN103830196A (zh) * | 2014-03-14 | 2014-06-04 | 王志刚 | 一种酒石酸拉索昔芬分散片及其制备方法 |
| TWI535784B (zh) | 2014-08-26 | 2016-06-01 | 財團法人工業技術研究院 | 剪切增稠配方、及包含其之複合材料 |
| CN105434444B (zh) * | 2014-09-29 | 2021-02-05 | 上海奥奇医药科技有限公司 | 一种A-失碳-5α雄甾烷化合物的口服制剂 |
| CN109789095A (zh) * | 2016-07-25 | 2019-05-21 | Ebbu 公司 | 新的大麻片剂配方和组合物及其制造方法 |
| NZ752443A (en) | 2016-10-11 | 2022-11-25 | Univ Duke | Lasofoxifene treatment of er+ breast cancer |
| CN117771239A (zh) | 2018-04-10 | 2024-03-29 | 杜克大学 | 乳腺癌的拉索昔芬治疗 |
| GB202116903D0 (en) | 2021-11-18 | 2022-01-05 | Sermonix Pharmaceuticals Inc | Lasofoxifene treatment of aromatase-resistant er+ cancer |
| CN114288258A (zh) * | 2022-02-18 | 2022-04-08 | 山东新时代药业有限公司 | 一种单硝酸异山梨酯片及其制备方法 |
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| US4182A (en) * | 1845-09-09 | Island | ||
| US4880636A (en) * | 1988-05-13 | 1989-11-14 | Franz Robert M | Film coated tablet of ranitidine HCl |
| US5552412A (en) | 1995-01-09 | 1996-09-03 | Pfizer Inc | 5-substitued-6-cyclic-5,6,7,8-tetrahydronaphthalen2-ol compounds which are useful for treating osteoporosis |
| UA51676C2 (uk) | 1995-11-02 | 2002-12-16 | Пфайзер Інк. | (-)цис-6(s)-феніл-5(r)[4-(2-піролідин-1-ілетокси)феніл]-5,6,7,8-тетрагідронафталін-2-ол d-тартрат, спосіб його одержання, спосіб лікування захворювань, що піддаються лікуванню агоністами естрогену, та фармацевтична композиція |
| TW442286B (en) * | 1996-02-28 | 2001-06-23 | Pfizer | New therapeutic uses of estrogen agonists |
| US6372457B1 (en) | 1997-01-14 | 2002-04-16 | Arkion Life Sciences Llc | Process and materials for production of glucosamine |
| KR200161927Y1 (ko) * | 1997-08-26 | 1999-12-01 | 윤종용 | 냉장고 |
| YU26700A (sh) | 1999-05-24 | 2002-06-19 | Pfizer Products Inc. | Postupak za cis-1-(2-(4-(6-metoksi-2-fenil-1,2,3,4- tetrahidronaftalen-1-il)fenoksi)etil)pirolidin |
| US6436977B1 (en) * | 1999-09-29 | 2002-08-20 | Pfizer Inc. | Dosing regimens for lasofoxifene |
| US6419956B1 (en) * | 1999-12-30 | 2002-07-16 | Ancile Pharmaceuticals | Odor-masking coating for a pharmaceutical preparation |
| EP1145719A3 (de) * | 2000-03-10 | 2001-11-14 | Pfizer Products Inc. | Verwendung von einem Ferrosalz zur Hemmung des oxidativen Abbaus von pharmazeutischen Zusammensetzungen |
| AR029538A1 (es) * | 2000-07-06 | 2003-07-02 | Wyeth Corp | Composiciones farmaceuticas de agentes estrogenicos |
| IL158390A0 (en) * | 2001-05-01 | 2004-05-12 | Pfizer Prod Inc | Method for manufacturing a low dose pharmaceutical composition |
| PA8576201A1 (es) * | 2002-07-10 | 2004-05-26 | Pfizer Prod Inc | Composicion farmaceutica que tiene una distribucion y potencia uniforme de farmaco |
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2003
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- 2003-06-30 AT AT03764059T patent/ATE550017T1/de active
- 2003-06-30 NZ NZ537278A patent/NZ537278A/en unknown
- 2003-06-30 AP AP2005003201A patent/AP2005003201A0/xx unknown
- 2003-06-30 AU AU2003247017A patent/AU2003247017B2/en not_active Ceased
- 2003-06-30 SI SI200332150T patent/SI1534248T1/sl unknown
- 2003-06-30 DK DK03764059.6T patent/DK1534248T3/da active
- 2003-06-30 ES ES03764059T patent/ES2395123T3/es not_active Expired - Lifetime
- 2003-06-30 BR BR0312563-7A patent/BR0312563A/pt not_active IP Right Cessation
- 2003-06-30 PT PT03764059T patent/PT1534248E/pt unknown
- 2003-06-30 HR HR20041196A patent/HRP20041196A2/hr not_active Application Discontinuation
- 2003-06-30 EP EP03764059A patent/EP1534248B1/de not_active Expired - Lifetime
- 2003-06-30 JP JP2004521001A patent/JP4446446B2/ja not_active Expired - Fee Related
- 2003-06-30 WO PCT/IB2003/003074 patent/WO2004006895A1/en not_active Ceased
- 2003-06-30 CN CNB038162881A patent/CN100344278C/zh not_active Expired - Fee Related
- 2003-06-30 OA OA1200500007A patent/OA12883A/en unknown
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- 2003-06-30 KR KR1020057000369A patent/KR100782693B1/ko not_active Expired - Fee Related
- 2003-06-30 EA EA200401583A patent/EA007268B1/ru not_active IP Right Cessation
- 2003-06-30 IL IL16574603A patent/IL165746A0/xx unknown
- 2003-07-01 US US10/612,679 patent/US20040057992A1/en not_active Abandoned
- 2003-07-04 TW TW092118389A patent/TW200406222A/zh unknown
- 2003-07-07 PE PE2003000682A patent/PE20040104A1/es not_active Application Discontinuation
- 2003-07-07 HN HN2003000206A patent/HN2003000206A/es unknown
- 2003-07-08 AR AR20030102454A patent/AR040434A1/es not_active Application Discontinuation
- 2003-07-08 UY UY27886A patent/UY27886A1/es not_active Application Discontinuation
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2004
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2005
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- 2005-01-10 TN TNP2005000006A patent/TNSN05006A1/fr unknown
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2006
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2012
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