HRP20090614T1 - Stabilizirane superzasićene krute otopine steroidnih lijekova - Google Patents
Stabilizirane superzasićene krute otopine steroidnih lijekova Download PDFInfo
- Publication number
- HRP20090614T1 HRP20090614T1 HR20090614T HRP20090614T HRP20090614T1 HR P20090614 T1 HRP20090614 T1 HR P20090614T1 HR 20090614 T HR20090614 T HR 20090614T HR P20090614 T HRP20090614 T HR P20090614T HR P20090614 T1 HRP20090614 T1 HR P20090614T1
- Authority
- HR
- Croatia
- Prior art keywords
- steroid molecule
- solvent
- acetate
- drospirenone
- steroid
- Prior art date
Links
- 239000003814 drug Substances 0.000 title 1
- 229940079593 drug Drugs 0.000 title 1
- 239000006104 solid solution Substances 0.000 title 1
- 230000003637 steroidlike Effects 0.000 title 1
- 150000003431 steroids Chemical class 0.000 claims abstract 18
- 239000002904 solvent Substances 0.000 claims abstract 12
- 239000002131 composite material Substances 0.000 claims abstract 10
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract 6
- 239000000843 powder Substances 0.000 claims abstract 5
- 238000000034 method Methods 0.000 claims 8
- -1 conjugated estrogens Chemical compound 0.000 claims 6
- METQSPRSQINEEU-UHFFFAOYSA-N dihydrospirorenone Natural products CC12CCC(C3(CCC(=O)C=C3C3CC33)C)C3C1C1CC1C21CCC(=O)O1 METQSPRSQINEEU-UHFFFAOYSA-N 0.000 claims 5
- 229960004845 drospirenone Drugs 0.000 claims 5
- METQSPRSQINEEU-HXCATZOESA-N drospirenone Chemical compound C([C@]12[C@H]3C[C@H]3[C@H]3[C@H]4[C@@H]([C@]5(CCC(=O)C=C5[C@@H]5C[C@@H]54)C)CC[C@@]31C)CC(=O)O2 METQSPRSQINEEU-HXCATZOESA-N 0.000 claims 5
- WWYNJERNGUHSAO-XUDSTZEESA-N (+)-Norgestrel Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 WWYNJERNGUHSAO-XUDSTZEESA-N 0.000 claims 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical group CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 4
- RJKFOVLPORLFTN-LEKSSAKUSA-N Progesterone Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 RJKFOVLPORLFTN-LEKSSAKUSA-N 0.000 claims 4
- MUMGGOZAMZWBJJ-DYKIIFRCSA-N Testostosterone Chemical compound O=C1CC[C@]2(C)[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 MUMGGOZAMZWBJJ-DYKIIFRCSA-N 0.000 claims 4
- 150000002148 esters Chemical class 0.000 claims 4
- 229960004400 levonorgestrel Drugs 0.000 claims 4
- 229940053934 norethindrone Drugs 0.000 claims 4
- VIKNJXKGJWUCNN-XGXHKTLJSA-N norethisterone Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 VIKNJXKGJWUCNN-XGXHKTLJSA-N 0.000 claims 4
- 229960000417 norgestimate Drugs 0.000 claims 4
- KIQQMECNKUGGKA-NMYWJIRASA-N norgestimate Chemical compound O/N=C/1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(OC(C)=O)C#C)[C@@H]4[C@@H]3CCC2=C\1 KIQQMECNKUGGKA-NMYWJIRASA-N 0.000 claims 4
- BFPYWIDHMRZLRN-UHFFFAOYSA-N 17alpha-ethynyl estradiol Natural products OC1=CC=C2C3CCC(C)(C(CC4)(O)C#C)C4C3CCC2=C1 BFPYWIDHMRZLRN-UHFFFAOYSA-N 0.000 claims 2
- VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 claims 2
- JWUBBDSIWDLEOM-UHFFFAOYSA-N 25-Hydroxycholecalciferol Natural products C1CCC2(C)C(C(CCCC(C)(C)O)C)CCC2C1=CC=C1CC(O)CCC1=C JWUBBDSIWDLEOM-UHFFFAOYSA-N 0.000 claims 2
- DNHCHRGCTVRAFT-JEHIOXJOSA-N 3-[(7r,8r,9s,10r,13s,14s,17r)-17-hydroxy-10,13-dimethyl-3-oxo-7-propyl-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-17-yl]propanoic acid Chemical compound C1C[C@]2(C)[C@@](CCC(O)=O)(O)CC[C@H]2[C@@H]2[C@H](CCC)CC3=CC(=O)CC[C@]3(C)[C@H]21 DNHCHRGCTVRAFT-JEHIOXJOSA-N 0.000 claims 2
- JBXXREPMUABISH-RGKMBJPFSA-N 3-[(7r,8r,9s,10r,13s,14s,17r)-17-hydroxy-7-methoxycarbonyl-10,13-dimethyl-3-oxo-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-17-yl]propanoic acid Chemical compound C1C[C@]2(C)[C@@](CCC(O)=O)(O)CC[C@H]2[C@@H]2[C@H](C(=O)OC)CC3=CC(=O)CC[C@]3(C)[C@H]21 JBXXREPMUABISH-RGKMBJPFSA-N 0.000 claims 2
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 claims 2
- 235000021318 Calcifediol Nutrition 0.000 claims 2
- ITRJWOMZKQRYTA-RFZYENFJSA-N Cortisone acetate Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)COC(=O)C)(O)[C@@]1(C)CC2=O ITRJWOMZKQRYTA-RFZYENFJSA-N 0.000 claims 2
- WUVPAYPBMZMHJO-IMNLCBETSA-N Dicirenone Chemical compound C([C@@H]1[C@]2(C)CC[C@@H]3[C@@]4(C)CCC(=O)C=C4C[C@H]([C@@H]13)C(=O)OC(C)C)C[C@@]21CCC(=O)O1 WUVPAYPBMZMHJO-IMNLCBETSA-N 0.000 claims 2
- RSEPBGGWRJCQGY-RBRWEJTLSA-N Estradiol valerate Chemical compound C1CC2=CC(O)=CC=C2[C@@H]2[C@@H]1[C@@H]1CC[C@H](OC(=O)CCCC)[C@@]1(C)CC2 RSEPBGGWRJCQGY-RBRWEJTLSA-N 0.000 claims 2
- BFPYWIDHMRZLRN-SLHNCBLASA-N Ethinyl estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 BFPYWIDHMRZLRN-SLHNCBLASA-N 0.000 claims 2
- IMONTRJLAWHYGT-ZCPXKWAGSA-N Norethindrone Acetate Chemical compound C1CC2=CC(=O)CC[C@@H]2[C@@H]2[C@@H]1[C@@H]1CC[C@](C#C)(OC(=O)C)[C@@]1(C)CC2 IMONTRJLAWHYGT-ZCPXKWAGSA-N 0.000 claims 2
- ICTXHFFSOAJUMG-SLHNCBLASA-N Norethynodrel Chemical compound C1CC(=O)CC2=C1[C@H]1CC[C@](C)([C@](CC3)(O)C#C)[C@@H]3[C@@H]1CC2 ICTXHFFSOAJUMG-SLHNCBLASA-N 0.000 claims 2
- MECHNRXZTMCUDQ-UHFFFAOYSA-N Vitamin D2 Natural products C1CCC2(C)C(C(C)C=CC(C)C(C)C)CCC2C1=CC=C1CC(O)CCC1=C MECHNRXZTMCUDQ-UHFFFAOYSA-N 0.000 claims 2
- FBRAWBYQGRLCEK-UHFFFAOYSA-N [17-(2-chloroacetyl)-9-fluoro-10,13,16-trimethyl-3,11-dioxo-7,8,12,14,15,16-hexahydro-6h-cyclopenta[a]phenanthren-17-yl] butanoate Chemical compound C1CC2=CC(=O)C=CC2(C)C2(F)C1C1CC(C)C(C(=O)CCl)(OC(=O)CCC)C1(C)CC2=O FBRAWBYQGRLCEK-UHFFFAOYSA-N 0.000 claims 2
- 229960002535 alfacalcidol Drugs 0.000 claims 2
- OFHCOWSQAMBJIW-AVJTYSNKSA-N alfacalcidol Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)C[C@H](O)C1=C OFHCOWSQAMBJIW-AVJTYSNKSA-N 0.000 claims 2
- 229960002537 betamethasone Drugs 0.000 claims 2
- UREBDLICKHMUKA-DVTGEIKXSA-N betamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-DVTGEIKXSA-N 0.000 claims 2
- 229960004311 betamethasone valerate Drugs 0.000 claims 2
- SNHRLVCMMWUAJD-SUYDQAKGSA-N betamethasone valerate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CO)(OC(=O)CCCC)[C@@]1(C)C[C@@H]2O SNHRLVCMMWUAJD-SUYDQAKGSA-N 0.000 claims 2
- 229960004436 budesonide Drugs 0.000 claims 2
- JWUBBDSIWDLEOM-DTOXIADCSA-N calcidiol Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](CCCC(C)(C)O)C)=C\C=C1\C[C@@H](O)CCC1=C JWUBBDSIWDLEOM-DTOXIADCSA-N 0.000 claims 2
- 229960004361 calcifediol Drugs 0.000 claims 2
- 229960005084 calcitriol Drugs 0.000 claims 2
- 235000020964 calcitriol Nutrition 0.000 claims 2
- 239000011612 calcitriol Substances 0.000 claims 2
- GMRQFYUYWCNGIN-NKMMMXOESA-N calcitriol Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@@H](CCCC(C)(C)O)C)=C\C=C1\C[C@@H](O)C[C@H](O)C1=C GMRQFYUYWCNGIN-NKMMMXOESA-N 0.000 claims 2
- 229940086673 canrenoate Drugs 0.000 claims 2
- PBKZPPIHUVSDNM-WNHSNXHDSA-M canrenoate Chemical compound O=C1CC[C@]2(C)[C@H]3CC[C@](C)([C@](CC4)(O)CCC([O-])=O)[C@@H]4[C@@H]3C=CC2=C1 PBKZPPIHUVSDNM-WNHSNXHDSA-M 0.000 claims 2
- UJVLDDZCTMKXJK-WNHSNXHDSA-N canrenone Chemical compound C([C@H]1[C@H]2[C@@H]([C@]3(CCC(=O)C=C3C=C2)C)CC[C@@]11C)C[C@@]11CCC(=O)O1 UJVLDDZCTMKXJK-WNHSNXHDSA-N 0.000 claims 2
- 229960005057 canrenone Drugs 0.000 claims 2
- 229960004703 clobetasol propionate Drugs 0.000 claims 2
- CBGUOGMQLZIXBE-XGQKBEPLSA-N clobetasol propionate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)CCl)(OC(=O)CC)[C@@]1(C)C[C@@H]2O CBGUOGMQLZIXBE-XGQKBEPLSA-N 0.000 claims 2
- 229960005465 clobetasone butyrate Drugs 0.000 claims 2
- 229940035811 conjugated estrogen Drugs 0.000 claims 2
- 229960003290 cortisone acetate Drugs 0.000 claims 2
- 229960003843 cyproterone Drugs 0.000 claims 2
- DUSHUSLJJMDGTE-ZJPMUUANSA-N cyproterone Chemical compound C1=C(Cl)C2=CC(=O)[C@@H]3C[C@@H]3[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)C)(O)[C@@]1(C)CC2 DUSHUSLJJMDGTE-ZJPMUUANSA-N 0.000 claims 2
- 229960004976 desogestrel Drugs 0.000 claims 2
- RPLCPCMSCLEKRS-BPIQYHPVSA-N desogestrel Chemical compound C1CC[C@@H]2[C@H]3C(=C)C[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 RPLCPCMSCLEKRS-BPIQYHPVSA-N 0.000 claims 2
- 229960003957 dexamethasone Drugs 0.000 claims 2
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims 2
- 229950001803 dicirenone Drugs 0.000 claims 2
- 238000004090 dissolution Methods 0.000 claims 2
- 229960001208 eplerenone Drugs 0.000 claims 2
- JUKPWJGBANNWMW-VWBFHTRKSA-N eplerenone Chemical compound C([C@@H]1[C@]2(C)C[C@H]3O[C@]33[C@@]4(C)CCC(=O)C=C4C[C@H]([C@@H]13)C(=O)OC)C[C@@]21CCC(=O)O1 JUKPWJGBANNWMW-VWBFHTRKSA-N 0.000 claims 2
- 229960002061 ergocalciferol Drugs 0.000 claims 2
- 229960005309 estradiol Drugs 0.000 claims 2
- 229930182833 estradiol Natural products 0.000 claims 2
- 229960004766 estradiol valerate Drugs 0.000 claims 2
- 229960002568 ethinylestradiol Drugs 0.000 claims 2
- 229960002941 etonogestrel Drugs 0.000 claims 2
- GCKFUYQCUCGESZ-BPIQYHPVSA-N etonogestrel Chemical compound O=C1CC[C@@H]2[C@H]3C(=C)C[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 GCKFUYQCUCGESZ-BPIQYHPVSA-N 0.000 claims 2
- SYWHXTATXSMDSB-GSLJADNHSA-N fludrocortisone acetate Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1CC[C@@](C(=O)COC(=O)C)(O)[C@@]1(C)C[C@@H]2O SYWHXTATXSMDSB-GSLJADNHSA-N 0.000 claims 2
- 229960003336 fluorocortisol acetate Drugs 0.000 claims 2
- SIGSPDASOTUPFS-XUDSTZEESA-N gestodene Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](C=C4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 SIGSPDASOTUPFS-XUDSTZEESA-N 0.000 claims 2
- 229960005352 gestodene Drugs 0.000 claims 2
- HCFSGRMEEXUOSS-JXEXPEPMSA-N medrogestone Chemical compound C1=C(C)C2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)C)(C)[C@@]1(C)CC2 HCFSGRMEEXUOSS-JXEXPEPMSA-N 0.000 claims 2
- 229960000606 medrogestone Drugs 0.000 claims 2
- PSGAAPLEWMOORI-PEINSRQWSA-N medroxyprogesterone acetate Chemical compound C([C@@]12C)CC(=O)C=C1[C@@H](C)C[C@@H]1[C@@H]2CC[C@]2(C)[C@@](OC(C)=O)(C(C)=O)CC[C@H]21 PSGAAPLEWMOORI-PEINSRQWSA-N 0.000 claims 2
- 229960002985 medroxyprogesterone acetate Drugs 0.000 claims 2
- CPHJTSJQUQZOLJ-ISIDMKFXSA-N mespirenone Chemical compound C([C@]12[C@H]3C[C@H]3[C@@H]3[C@]1(C)CC[C@@H]1[C@@]4(C)C=CC(=O)C=C4C[C@H]([C@@H]31)SC(=O)C)CC(=O)O2 CPHJTSJQUQZOLJ-ISIDMKFXSA-N 0.000 claims 2
- 229950008481 mespirenone Drugs 0.000 claims 2
- 238000002156 mixing Methods 0.000 claims 2
- 229960001652 norethindrone acetate Drugs 0.000 claims 2
- 229960005205 prednisolone Drugs 0.000 claims 2
- OIGNJSKKLXVSLS-VWUMJDOOSA-N prednisolone Chemical compound O=C1C=C[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 OIGNJSKKLXVSLS-VWUMJDOOSA-N 0.000 claims 2
- 229960004618 prednisone Drugs 0.000 claims 2
- XOFYZVNMUHMLCC-ZPOLXVRWSA-N prednisone Chemical compound O=C1C=C[C@]2(C)[C@H]3C(=O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 XOFYZVNMUHMLCC-ZPOLXVRWSA-N 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 229960003387 progesterone Drugs 0.000 claims 2
- 239000000186 progesterone Substances 0.000 claims 2
- OHZWNMVYJJTNKU-VAFIVCJBSA-N prorenoate Chemical compound C12=CC(=O)CC[C@]2(C)[C@H]2CC[C@](C)([C@](CC3)(O)CCC(O)=O)[C@@H]3[C@@H]2[C@@H]2[C@H]1C2 OHZWNMVYJJTNKU-VAFIVCJBSA-N 0.000 claims 2
- RRHHMFQGHCFGMH-LAPLKBAYSA-N prorenone Chemical compound C([C@H]1[C@H]2[C@@H]([C@]3(CCC(=O)C=C3[C@H]3C[C@H]32)C)CC[C@@]11C)C[C@@]11CCC(=O)O1 RRHHMFQGHCFGMH-LAPLKBAYSA-N 0.000 claims 2
- LXMSZDCAJNLERA-ZHYRCANASA-N spironolactone Chemical compound C([C@@H]1[C@]2(C)CC[C@@H]3[C@@]4(C)CCC(=O)C=C4C[C@H]([C@@H]13)SC(=O)C)C[C@@]21CCC(=O)O1 LXMSZDCAJNLERA-ZHYRCANASA-N 0.000 claims 2
- 229960002256 spironolactone Drugs 0.000 claims 2
- NZUIUYWHFPQZBH-HXCATZOESA-N spirorenone Chemical compound C([C@]12[C@H]3C[C@H]3[C@H]3[C@H]4[C@@H]([C@]5(C=CC(=O)C=C5[C@@H]5C[C@@H]54)C)CC[C@@]31C)CC(=O)O2 NZUIUYWHFPQZBH-HXCATZOESA-N 0.000 claims 2
- 229950004131 spirorenone Drugs 0.000 claims 2
- 229960003604 testosterone Drugs 0.000 claims 2
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims 2
- 235000015112 vegetable and seed oil Nutrition 0.000 claims 2
- 239000008158 vegetable oil Substances 0.000 claims 2
- MECHNRXZTMCUDQ-RKHKHRCZSA-N vitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)/C=C/[C@H](C)C(C)C)=C\C=C1\C[C@@H](O)CCC1=C MECHNRXZTMCUDQ-RKHKHRCZSA-N 0.000 claims 2
- 235000001892 vitamin D2 Nutrition 0.000 claims 2
- 239000011653 vitamin D2 Substances 0.000 claims 2
- 229910021486 amorphous silicon dioxide Inorganic materials 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 238000001704 evaporation Methods 0.000 claims 1
- 230000008020 evaporation Effects 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 239000006187 pill Substances 0.000 claims 1
- 238000001953 recrystallisation Methods 0.000 claims 1
- 239000012047 saturated solution Substances 0.000 claims 1
- 239000000243 solution Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 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
- A61K9/08—Solutions
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- 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
-
- 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
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
- A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
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Abstract
Praškasti kompozit, naznačen time, da sadrži steroidnu molekulu; i amorfni silicijev dioksid koji ima specifičnu površinu od najmanje 250 m2/g; gdje je steroidna molekula otopljena u otapalu apsorbiranom na površinu amorfnog silicijevog dioksida i gdje je steroidna molekula prisutna u otapalu u superzasićenoj koncentraciji. Patent sadrži još 12 patentnih zahtjeva.
Claims (13)
1. Praškasti kompozit, naznačen time, da sadrži steroidnu molekulu; i amorfni silicijev dioksid koji ima specifičnu površinu od najmanje 250 m2/g; gdje je steroidna molekula otopljena u otapalu apsorbiranom na površinu amorfnog silicijevog dioksida i gdje je steroidna molekula prisutna u otapalu u superzasićenoj koncentraciji.
2. Kompozit prema zahtjevu 1, naznačen time, da je steroidna molekula izabran iz skupine koja se sastoji od estradiola i njegovih estera, etinil estradiola, konjugiranih estrogena, testosterona i njegovih estera, ciproterona, drospirenona, etonogestrela, desogestrela, gestodena, levonorgestrela, noretisterona, norgestimata, noretindrona, noretindron acetata, noretinodrela, norgestimata, norgestrela, medrogestona, medroksiprogesteron acetata, progesterona, spironolaktona, eplerenona, kanrenoata, kanrenona, dicirenona, meksrenoata, prorenoata, epostena, mespirenona, oksprenoata, spirorenona, spiroksanona, prorenona, azoprisnila, becimetazon dipropionata, betametazona, betametazon valerata, budesonida, klobetazol propionata, klobetazon butirata, kortizon acetata, deksametazona, fludrokortizon acetata, prednizolona, prednizona, alfakalcidola, kalcifediola, kalciferola ili kalcitriola.
3. Kompozit prema zahtjevu 2, naznačen time, da je steroidna molekula drospirenon i/ili estradiol valerat.
4. Kompozit prema zahtjevu 3, naznačen time, da je steroidna molekula drospirenon.
5. Kompozit prema bilo kojem od zahtjeva 1 do 4, naznačen time, da je otapalo etanol; djelomično sintetski triglicerid; ili biljno ulje.
6. Postupak za pripravu praškastog kompozita koji sadrži steroidnu molekulu, naznačen time, da navedeni postupak sadrži korake
c) cjelokupnog otapanja steroidne molekule u otapalu u količini koja prelazi koncentraciju zasićenja navedene steroidne molekule u otapalu; i
d) miješanje dobivene superzasićene otopine iz koraka a) sa amorfnim silicijevim dioksidom koji ima specifičnu površinu od najmanje 250 m2/g.
7. Postupak za pripravu praškastog kompozita koji sadrži steroidnu molekulu, naznačen time, da navedeni postupak sadrži korake
d) cjelokupnog otapanja steroidne molekule u otapalu u količini koja je jednaka koncentraciji zasićenja navedene steroidne molekule u otapalu; i
e) miješanje nastale zasićene otopine iz koraka a) sa amorfnim silicijevim dioksidom koji ima specifičnu površinu od najmanje 250 m2/g; i
f) isparavanje dijela otapala.
8. Postupak prema zahtjevima 6 ili 7, naznačen time, da je steroidna molekula izabrana iz grupe koja se sastoji od estradiola i njegovih estera, etinil estradiola, konjugiranih estrogena, testosterona i njegovih estera, ciproterona, drospirenona, etonogestrela, desogestrela, gestodena, levonorgestrela, noretisterona, norgestimata, noretindrona, noretindron acetata, noretinodrela, norgestimata, norgestrela, medrogestona, medroksiprogesteron acetata, progesterona, spironolaktona, eplerenona, kanrenoata, kanrenona, dicirenona, meksrenoata, prorenoata, epostena, mespirenona, oksprenoata, spirorenona, spiroksanona, prorenona, azoprisnila, becimetazon dipropionata, betametazona, betametazon valerata, budesonida, klobetazol propionata, klobetazon butirata, kortizon acetata, deksametazona, fludrokortizon acetata, prednizolona, prednizona, alfakalcidola, kalcifediola, kalciferola ili kalcitriola.
9. Postupak prema zahtjevu 8, naznačen time, da ja steroidna molekula drospirenon i/ili estradiol valerat.
10. Postupak prema bilo kojem od zahtjeva 6 do 9, naznačen time, da je otapalo etanol; djelomično sintetski triglicerid; ili biljno ulje.
11. Praškasti kompozit, naznačen time, da je dobiven pomoću postupaka definiranih u bilo kojem od zahtjeva od 6 do 10.
12. Farmaceutski dozni oblik, naznačen time, da je u obliku granula, tablete, kapsule ili pilule koja obuhvaća kompozit kao što je definiran u bilo kojem od zahtjeva od 1 do 5 ili 11.
13. Upotreba amorfnog silicijevog dioksida sa specifičnom površinom većom od 250 m2/g, naznačena time, da se ista upotrebljava za inhibiciju re-kristaliziranja steroidne molekule koja se nalazi u otapalu u superzasićenoj koncentraciji.
Applications Claiming Priority (3)
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| US55133004P | 2004-03-10 | 2004-03-10 | |
| EP04075714 | 2004-03-10 | ||
| PCT/IB2005/000748 WO2005087199A2 (en) | 2004-03-10 | 2005-03-10 | Stabilised supersaturated solid solutions of steroidal drugs |
Publications (1)
| Publication Number | Publication Date |
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| HRP20090614T1 true HRP20090614T1 (hr) | 2009-12-31 |
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| HR20090614T HRP20090614T1 (hr) | 2004-03-10 | 2009-11-16 | Stabilizirane superzasićene krute otopine steroidnih lijekova |
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