TW200418525A - Coated pharmaceutical tablets containing Tibolone - Google Patents

Coated pharmaceutical tablets containing Tibolone Download PDF

Info

Publication number: TW200418525A
Authority: TW; Taiwan
Prior art keywords: coating; sugar; film; tablets; tablet
Prior art date: 2002-11-20

Application number

TW092131416A

Other languages

English (en)

Chinese (zh)

Inventor

Haan Pieter De

Lare Cornelis Elisabeth Johannus Van

Original Assignee

Akzo Nobel Nv

Priority date (The priority date 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 date listed.)

2002-11-20

Filing date

2003-11-10

Publication date

2004-10-01

2003-11-10 Application filed by Akzo Nobel Nv filed Critical Akzo Nobel Nv

2004-10-01 Publication of TW200418525A publication Critical patent/TW200418525A/zh

Links

WZDGZWOAQTVYBX-XOINTXKNSA-N tibolone Chemical compound C([C@@H]12)C[C@]3(C)[C@@](C#C)(O)CC[C@H]3[C@@H]1[C@H](C)CC1=C2CCC(=O)C1 WZDGZWOAQTVYBX-XOINTXKNSA-N 0.000 title abstract description 9
229960001023 tibolone Drugs 0.000 title abstract description 8
239000007888 film coating Substances 0.000 claims abstract description 50
238000009501 film coating Methods 0.000 claims abstract description 50
235000000346 sugar Nutrition 0.000 claims abstract description 41
238000000576 coating method Methods 0.000 claims abstract description 39
239000011248 coating agent Substances 0.000 claims abstract description 36
238000009495 sugar coating Methods 0.000 claims abstract description 20
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 abstract description 13
229930006000 Sucrose Natural products 0.000 claims abstract description 13
239000005720 sucrose Substances 0.000 claims abstract description 12
230000000087 stabilizing effect Effects 0.000 claims abstract description 6
PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 15
238000000034 method Methods 0.000 claims description 13
108010010803 Gelatin Proteins 0.000 claims description 11
229920000159 gelatin Polymers 0.000 claims description 11
235000019322 gelatine Nutrition 0.000 claims description 11
235000011852 gelatine desserts Nutrition 0.000 claims description 11
239000008273 gelatin Substances 0.000 claims description 10
239000002202 Polyethylene glycol Substances 0.000 claims description 7
229920001223 polyethylene glycol Polymers 0.000 claims description 7
235000011187 glycerol Nutrition 0.000 claims description 6
239000004014 plasticizer Substances 0.000 claims description 6
229920003086 cellulose ether Polymers 0.000 claims description 5
229920002554 vinyl polymer Polymers 0.000 claims description 5
MTHSVFCYNBDYFN-UHFFFAOYSA-N diethylene glycol Chemical compound OCCOCCO MTHSVFCYNBDYFN-UHFFFAOYSA-N 0.000 claims 3
239000000126 substance Substances 0.000 claims 2
ZOXJGFHDIHLPTG-UHFFFAOYSA-N Boron Chemical compound [B] ZOXJGFHDIHLPTG-UHFFFAOYSA-N 0.000 claims 1
229910052796 boron Inorganic materials 0.000 claims 1
239000007857 degradation product Substances 0.000 abstract description 10
238000006317 isomerization reaction Methods 0.000 abstract description 7
101000764229 Rattus norvegicus Mitochondrial import receptor subunit TOM40 homolog Proteins 0.000 abstract 1
239000003826 tablet Substances 0.000 description 69
239000000203 mixture Substances 0.000 description 22
239000006185 dispersion Substances 0.000 description 17
HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 12
230000015572 biosynthetic process Effects 0.000 description 11
239000000454 talc Substances 0.000 description 11
229910052623 talc Inorganic materials 0.000 description 11
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 11
GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 10
229960004793 sucrose Drugs 0.000 description 10
DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 9
239000007941 film coated tablet Substances 0.000 description 9
229920002472 Starch Polymers 0.000 description 7
239000013612 plasmid Substances 0.000 description 7
239000000843 powder Substances 0.000 description 7
239000008107 starch Substances 0.000 description 7
235000019698 starch Nutrition 0.000 description 7
VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 6
239000008199 coating composition Substances 0.000 description 6
239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 6
235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 6
229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 6
235000019359 magnesium stearate Nutrition 0.000 description 6
239000000047 product Substances 0.000 description 6
238000007789 sealing Methods 0.000 description 6
239000008298 dragée Substances 0.000 description 5
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 description 5
239000010410 layer Substances 0.000 description 5
239000008213 purified water Substances 0.000 description 5
239000007940 sugar coated tablet Substances 0.000 description 5
239000004408 titanium dioxide Substances 0.000 description 5
239000003981 vehicle Substances 0.000 description 5
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 4
UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 4
QAQJMLQRFWZOBN-LAUBAEHRSA-N L-ascorbyl-6-palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](O)[C@H]1OC(=O)C(O)=C1O QAQJMLQRFWZOBN-LAUBAEHRSA-N 0.000 description 4
239000011786 L-ascorbyl-6-palmitate Substances 0.000 description 4
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 4
235000010385 ascorbyl palmitate Nutrition 0.000 description 4
239000003814 drug Substances 0.000 description 4
230000000694 effects Effects 0.000 description 4
239000004615 ingredient Substances 0.000 description 4
239000008101 lactose Substances 0.000 description 4
229920000642 polymer Polymers 0.000 description 4
239000007787 solid Substances 0.000 description 4
239000007921 spray Substances 0.000 description 4
239000002671 adjuvant Substances 0.000 description 3
229910000019 calcium carbonate Inorganic materials 0.000 description 3
239000003086 colorant Substances 0.000 description 3
229940079593 drug Drugs 0.000 description 3
239000003937 drug carrier Substances 0.000 description 3
238000009472 formulation Methods 0.000 description 3
238000005259 measurement Methods 0.000 description 3
-1 nonpareils Substances 0.000 description 3
229920000058 polyacrylate Polymers 0.000 description 3
235000013772 propylene glycol Nutrition 0.000 description 3
239000002904 solvent Substances 0.000 description 3
230000006641 stabilisation Effects 0.000 description 3
238000011105 stabilization Methods 0.000 description 3
150000008163 sugars Chemical class 0.000 description 3
239000001069 triethyl citrate Substances 0.000 description 3
VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 3
235000013769 triethyl citrate Nutrition 0.000 description 3
CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 2
229920003134 Eudragit® polymer Polymers 0.000 description 2
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 2
235000021355 Stearic acid Nutrition 0.000 description 2
DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 description 2
239000008135 aqueous vehicle Substances 0.000 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 description 2
108010052008 colla corii asini Proteins 0.000 description 2
FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 description 2
150000002148 esters Chemical class 0.000 description 2
239000008103 glucose Substances 0.000 description 2
238000004128 high performance liquid chromatography Methods 0.000 description 2
239000007788 liquid Substances 0.000 description 2
QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 2
OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 2
235000019645 odor Nutrition 0.000 description 2
229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
239000001267 polyvinylpyrrolidone Substances 0.000 description 2
235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
229920001592 potato starch Polymers 0.000 description 2
229910052704 radon Inorganic materials 0.000 description 2
SYUHGPGVQRZVTB-UHFFFAOYSA-N radon atom Chemical compound [Rn] SYUHGPGVQRZVTB-UHFFFAOYSA-N 0.000 description 2
239000002356 single layer Substances 0.000 description 2
239000007909 solid dosage form Substances 0.000 description 2
239000008117 stearic acid Substances 0.000 description 2
235000019640 taste Nutrition 0.000 description 2
URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 2
IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 1
FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 description 1
NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 1
235000010919 Copernicia prunifera Nutrition 0.000 description 1
244000180278 Copernicia prunifera Species 0.000 description 1
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 1
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 1
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 1
LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
239000001856 Ethyl cellulose Substances 0.000 description 1
229920003139 Eudragit® L 100 Polymers 0.000 description 1
229920003136 Eudragit® L polymer Polymers 0.000 description 1
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 1
229930091371 Fructose Natural products 0.000 description 1
239000005715 Fructose Substances 0.000 description 1
UXDDRFCJKNROTO-UHFFFAOYSA-N Glycerol 1,2-diacetate Chemical compound CC(=O)OCC(CO)OC(C)=O UXDDRFCJKNROTO-UHFFFAOYSA-N 0.000 description 1
229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 description 1
235000010643 Leucaena leucocephala Nutrition 0.000 description 1
240000007472 Leucaena leucocephala Species 0.000 description 1
229930195725 Mannitol Natural products 0.000 description 1
CERQOIWHTDAKMF-UHFFFAOYSA-M Methacrylate Chemical compound CC(=C)C([O-])=O CERQOIWHTDAKMF-UHFFFAOYSA-M 0.000 description 1
229920000881 Modified starch Polymers 0.000 description 1
239000004372 Polyvinyl alcohol Substances 0.000 description 1
239000004373 Pullulan Substances 0.000 description 1
229920001218 Pullulan Polymers 0.000 description 1
DHXVGJBLRPWPCS-UHFFFAOYSA-N Tetrahydropyran Chemical compound C1CCOCC1 DHXVGJBLRPWPCS-UHFFFAOYSA-N 0.000 description 1
YZCKVEUIGOORGS-NJFSPNSNSA-N Tritium Chemical compound [3H] YZCKVEUIGOORGS-NJFSPNSNSA-N 0.000 description 1
TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 1
239000002313 adhesive film Substances 0.000 description 1
150000001298 alcohols Chemical class 0.000 description 1
229940072056 alginate Drugs 0.000 description 1
235000010443 alginic acid Nutrition 0.000 description 1
229920000615 alginic acid Polymers 0.000 description 1
238000004458 analytical method Methods 0.000 description 1
239000003125 aqueous solvent Substances 0.000 description 1
229940009098 aspartate Drugs 0.000 description 1
235000010216 calcium carbonate Nutrition 0.000 description 1
WUKWITHWXAAZEY-UHFFFAOYSA-L calcium difluoride Chemical compound [F-].[F-].[Ca+2] WUKWITHWXAAZEY-UHFFFAOYSA-L 0.000 description 1
239000002775 capsule Substances 0.000 description 1
239000001569 carbon dioxide Substances 0.000 description 1
229910002092 carbon dioxide Inorganic materials 0.000 description 1
229920002678 cellulose Polymers 0.000 description 1
239000001913 cellulose Substances 0.000 description 1
150000001860 citric acid derivatives Chemical class 0.000 description 1
239000011247 coating layer Substances 0.000 description 1
239000007891 compressed tablet Substances 0.000 description 1
229920001577 copolymer Polymers 0.000 description 1
235000013681 dietary sucrose Nutrition 0.000 description 1
238000001035 drying Methods 0.000 description 1
BEFDCLMNVWHSGT-UHFFFAOYSA-N ethenylcyclopentane Chemical compound C=CC1CCCC1 BEFDCLMNVWHSGT-UHFFFAOYSA-N 0.000 description 1
150000002170 ethers Chemical class 0.000 description 1
235000010944 ethyl methyl cellulose Nutrition 0.000 description 1
229960005191 ferric oxide Drugs 0.000 description 1
239000012530 fluid Substances 0.000 description 1
239000010436 fluorite Substances 0.000 description 1
239000011521 glass Substances 0.000 description 1
239000003292 glue Substances 0.000 description 1
150000002314 glycerols Chemical class 0.000 description 1
239000001087 glyceryl triacetate Substances 0.000 description 1
235000013773 glyceryl triacetate Nutrition 0.000 description 1
239000008187 granular material Substances 0.000 description 1
239000001863 hydroxypropyl cellulose Substances 0.000 description 1
235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
239000012535 impurity Substances 0.000 description 1
230000003993 interaction Effects 0.000 description 1
238000011835 investigation Methods 0.000 description 1
235000013980 iron oxide Nutrition 0.000 description 1
210000001630 jejunum Anatomy 0.000 description 1
NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 description 1
235000010445 lecithin Nutrition 0.000 description 1
239000000787 lecithin Substances 0.000 description 1
229940067606 lecithin Drugs 0.000 description 1
230000007774 longterm Effects 0.000 description 1
239000011777 magnesium Substances 0.000 description 1
229940063002 magnesium palmitate Drugs 0.000 description 1
ABSWXCXMXIZDSN-UHFFFAOYSA-L magnesium;hexadecanoate Chemical compound [Mg+2].CCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCC([O-])=O ABSWXCXMXIZDSN-UHFFFAOYSA-L 0.000 description 1
239000002075 main ingredient Substances 0.000 description 1
239000000594 mannitol Substances 0.000 description 1
235000010355 mannitol Nutrition 0.000 description 1
238000004519 manufacturing process Methods 0.000 description 1
HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
229920003087 methylethyl cellulose Polymers 0.000 description 1
238000002156 mixing Methods 0.000 description 1
239000003960 organic solvent Substances 0.000 description 1
239000000546 pharmaceutical excipient Substances 0.000 description 1
125000005498 phthalate group Chemical class 0.000 description 1
229910021420 polycrystalline silicon Inorganic materials 0.000 description 1
229940068918 polyethylene glycol 400 Drugs 0.000 description 1
229920005862 polyol Polymers 0.000 description 1
150000003077 polyols Chemical class 0.000 description 1
229920005591 polysilicon Polymers 0.000 description 1
229920002451 polyvinyl alcohol Polymers 0.000 description 1
235000019422 polyvinyl alcohol Nutrition 0.000 description 1
229910052573 porcelain Inorganic materials 0.000 description 1
235000019423 pullulan Nutrition 0.000 description 1
230000001105 regulatory effect Effects 0.000 description 1
238000007873 sieving Methods 0.000 description 1
239000011734 sodium Substances 0.000 description 1
229910052708 sodium Inorganic materials 0.000 description 1
235000010199 sorbic acid Nutrition 0.000 description 1
239000004334 sorbic acid Substances 0.000 description 1
229940075582 sorbic acid Drugs 0.000 description 1
239000000600 sorbitol Substances 0.000 description 1
235000010356 sorbitol Nutrition 0.000 description 1
150000003431 steroids Chemical group 0.000 description 1
239000013589 supplement Substances 0.000 description 1
235000012222 talc Nutrition 0.000 description 1
229960002622 triacetin Drugs 0.000 description 1
229910052722 tritium Inorganic materials 0.000 description 1
239000000230 xanthan gum Substances 0.000 description 1
229920001285 xanthan gum Polymers 0.000 description 1
235000010493 xanthan gum Nutrition 0.000 description 1
229940082509 xanthan gum Drugs 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
235000010447 xylitol Nutrition 0.000 description 1
229960002675 xylitol Drugs 0.000 description 1

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
- A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

TW092131416A 2002-11-20 2003-11-10 Coated pharmaceutical tablets containing Tibolone TW200418525A (en)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US42774002P	2002-11-20	2002-11-20
EP02079920		2002-11-20

Publications (1)

Publication Number	Publication Date
TW200418525A true TW200418525A (en)	2004-10-01

Family

ID=52340857

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
TW092131416A TW200418525A (en)	2002-11-20	2003-11-10	Coated pharmaceutical tablets containing Tibolone

Country Status (11)

Country	Link
EP (1)	EP1565168A1 (pl)
JP (1)	JP2006508144A (pl)
AU (1)	AU2003298290A1 (pl)
BR (1)	BR0316417A (pl)
CA (1)	CA2505485A1 (pl)
MX (1)	MXPA05005381A (pl)
NZ (1)	NZ539715A (pl)
PL (1)	PL376744A1 (pl)
RU (1)	RU2005119197A (pl)
TW (1)	TW200418525A (pl)
WO (1)	WO2004045587A1 (pl)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
EP1563833B1 (de) *	2004-02-06	2006-11-02	Helm AG	Pharmazeutische Zubereitungen mit amorphem Tibolon
WO2005084682A1 (en) *	2004-03-08	2005-09-15	Pharmaceutical Services Inc. (Psi Nv.)	Pharmaceutical composition comprising cyclodextrin complex of tibolone
CZ300465B6 (cs) *	2007-07-25	2009-05-27	Zentiva, A. S.	Zpusob výroby komprimované farmaceutické formulace s obsahem tibolonu
HUE055164T2 (hu)	2016-05-04	2021-11-29	Novalon S A	Cukoralkoholok alkalmazása Tobolon tartalmú készítményekben

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
IL123984A (en) *	1997-04-22	2004-09-27	Akzo Nobel Nv	Pharmacological dosage units containing tibolone and carrier pharmacy are acceptable
DE69702985T2 (de) *	1997-09-23	2001-02-15	Akzo Nobel N.V., Arnheim/Arnhem	Steroid enthaltende Dosierungsformen mit einer steroiddichten Umhüllung
CZ298703B6 (cs) *	1998-10-16	2007-12-27	N.V. Organon	Vysoce cistý (7alfa, 17alfa)-17-hydroxy-7-methyl-19-nor-17-pregn-5(10)-en-20-yn-3-on se zvýšenou stabilitou
JP2002068965A (ja) *	2000-08-31	2002-03-08	Teikoku Hormone Mfg Co Ltd	単層糖衣錠及びその製造方法

2003
- 2003-11-10 TW TW092131416A patent/TW200418525A/zh unknown
- 2003-11-13 JP JP2004552724A patent/JP2006508144A/ja not_active Withdrawn
- 2003-11-13 NZ NZ539715A patent/NZ539715A/en unknown
- 2003-11-13 MX MXPA05005381A patent/MXPA05005381A/es unknown
- 2003-11-13 WO PCT/EP2003/050829 patent/WO2004045587A1/en not_active Ceased
- 2003-11-13 BR BR0316417-9A patent/BR0316417A/pt not_active IP Right Cessation
- 2003-11-13 CA CA002505485A patent/CA2505485A1/en not_active Abandoned
- 2003-11-13 EP EP03796019A patent/EP1565168A1/en not_active Withdrawn
- 2003-11-13 AU AU2003298290A patent/AU2003298290A1/en not_active Abandoned
- 2003-11-13 RU RU2005119197/15A patent/RU2005119197A/ru not_active Application Discontinuation
- 2003-11-13 PL PL376744A patent/PL376744A1/pl not_active Application Discontinuation

Also Published As

Publication number	Publication date
NZ539715A (en)	2006-04-28
WO2004045587A1 (en)	2004-06-03
PL376744A1 (pl)	2006-01-09
JP2006508144A (ja)	2006-03-09
CA2505485A1 (en)	2004-06-03
BR0316417A (pt)	2005-10-11
EP1565168A1 (en)	2005-08-24
MXPA05005381A (es)	2005-08-26
AU2003298290A1 (en)	2004-06-15
RU2005119197A (ru)	2006-02-10

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