HRP20140780T4 - Amorfni i kristalinični oblik genz 112638 hemitartrata kao inhibitor glukozilceramid sintaze - Google Patents
Amorfni i kristalinični oblik genz 112638 hemitartrata kao inhibitor glukozilceramid sintaze Download PDFInfo
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- HRP20140780T4 HRP20140780T4 HRP20140780TT HRP20140780T HRP20140780T4 HR P20140780 T4 HRP20140780 T4 HR P20140780T4 HR P20140780T T HRP20140780T T HR P20140780TT HR P20140780 T HRP20140780 T HR P20140780T HR P20140780 T4 HRP20140780 T4 HR P20140780T4
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- hemitartrate
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- 102000044956 Ceramide glucosyltransferases Human genes 0.000 title claims 2
- 108091000114 ceramide glucosyltransferase Proteins 0.000 title claims 2
- 229960002856 eliglustat Drugs 0.000 title 1
- KUBARPMUNHKBIQ-VTHUDJRQSA-N eliglustat tartrate Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O.C([C@@H](NC(=O)CCCCCCC)[C@H](O)C=1C=C2OCCOC2=CC=1)N1CCCC1.C([C@@H](NC(=O)CCCCCCC)[C@H](O)C=1C=C2OCCOC2=CC=1)N1CCCC1 KUBARPMUNHKBIQ-VTHUDJRQSA-N 0.000 title 1
- 239000003112 inhibitor Substances 0.000 title 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 18
- 150000003839 salts Chemical class 0.000 claims 18
- 239000000945 filler Substances 0.000 claims 13
- 238000000634 powder X-ray diffraction Methods 0.000 claims 7
- 239000011230 binding agent Substances 0.000 claims 6
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 claims 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 claims 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 4
- 229920000881 Modified starch Polymers 0.000 claims 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 4
- 229920002472 Starch Polymers 0.000 claims 4
- 229930006000 Sucrose Natural products 0.000 claims 4
- 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 4
- 229940049654 glyceryl behenate Drugs 0.000 claims 4
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 4
- 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 4
- 229960001021 lactose monohydrate Drugs 0.000 claims 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims 4
- 239000008107 starch Substances 0.000 claims 4
- 235000019698 starch Nutrition 0.000 claims 4
- 239000000126 substance Substances 0.000 claims 4
- 239000005720 sucrose Substances 0.000 claims 4
- 239000003795 chemical substances by application Substances 0.000 claims 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 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical group 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 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 2
- 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 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 2
- 108010010803 Gelatin Proteins 0.000 claims 2
- SQUHHTBVTRBESD-UHFFFAOYSA-N Hexa-Ac-myo-Inositol Natural products CC(=O)OC1C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C1OC(C)=O SQUHHTBVTRBESD-UHFFFAOYSA-N 0.000 claims 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 241000209149 Zea Species 0.000 claims 2
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 claims 2
- 235000002017 Zea mays subsp mays Nutrition 0.000 claims 2
- 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 2
- 229960004977 anhydrous lactose Drugs 0.000 claims 2
- 239000001506 calcium phosphate Substances 0.000 claims 2
- 229910000389 calcium phosphate Inorganic materials 0.000 claims 2
- 235000011010 calcium phosphates Nutrition 0.000 claims 2
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 2
- 235000013539 calcium stearate Nutrition 0.000 claims 2
- 239000008116 calcium stearate Substances 0.000 claims 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 2
- -1 copolyvidone Polymers 0.000 claims 2
- 235000005822 corn Nutrition 0.000 claims 2
- 229920000159 gelatin Polymers 0.000 claims 2
- 239000008273 gelatin Substances 0.000 claims 2
- 235000019322 gelatine Nutrition 0.000 claims 2
- 235000011852 gelatine desserts Nutrition 0.000 claims 2
- 239000008172 hydrogenated vegetable oil Substances 0.000 claims 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 2
- CDAISMWEOUEBRE-GPIVLXJGSA-N inositol Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](O)[C@@H]1O CDAISMWEOUEBRE-GPIVLXJGSA-N 0.000 claims 2
- 229960000367 inositol Drugs 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 229960001855 mannitol Drugs 0.000 claims 2
- 229920001206 natural gum Polymers 0.000 claims 2
- 229920001223 polyethylene glycol Polymers 0.000 claims 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 claims 2
- 235000010413 sodium alginate Nutrition 0.000 claims 2
- 239000000661 sodium alginate Substances 0.000 claims 2
- 229940005550 sodium alginate Drugs 0.000 claims 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims 2
- 239000011780 sodium chloride Substances 0.000 claims 2
- 229960002668 sodium chloride Drugs 0.000 claims 2
- 239000000600 sorbitol Substances 0.000 claims 2
- 239000006188 syrup Substances 0.000 claims 2
- 235000020357 syrup Nutrition 0.000 claims 2
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims 2
- 208000024720 Fabry Disease Diseases 0.000 claims 1
- 208000015872 Gaucher disease Diseases 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000002708 enhancing effect Effects 0.000 claims 1
- 150000002339 glycosphingolipids Chemical class 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
Classifications
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- 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
- A61K31/33—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
- A61K31/4025—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 not condensed and containing further heterocyclic rings, e.g. cromakalim
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
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- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D319/00—Heterocyclic compounds containing six-membered rings having two oxygen atoms as the only ring hetero atoms
- C07D319/10—1,4-Dioxanes; Hydrogenated 1,4-dioxanes
- C07D319/14—1,4-Dioxanes; Hydrogenated 1,4-dioxanes condensed with carbocyclic rings or ring systems
- C07D319/16—1,4-Dioxanes; Hydrogenated 1,4-dioxanes condensed with carbocyclic rings or ring systems condensed with one six-membered ring
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- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D319/00—Heterocyclic compounds containing six-membered rings having two oxygen atoms as the only ring hetero atoms
- C07D319/10—1,4-Dioxanes; Hydrogenated 1,4-dioxanes
- C07D319/14—1,4-Dioxanes; Hydrogenated 1,4-dioxanes condensed with carbocyclic rings or ring systems
- C07D319/16—1,4-Dioxanes; Hydrogenated 1,4-dioxanes condensed with carbocyclic rings or ring systems condensed with one six-membered ring
- C07D319/18—Ethylenedioxybenzenes, not substituted on the hetero ring
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- C07D405/00—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom
- C07D405/02—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings
- C07D405/06—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings linked by a carbon chain containing only aliphatic carbon atoms
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Claims (24)
1. Farmaceutski pripravak naznačen time što sadrži hemitartratnu sol spoja prikazanog sa slijedećom strukturnom formulom:
[image]
i farmaceutski prihvatljiv nosač ili sredstvo za razrjeđivanje, pri čemu je najmanje 70% težinski soli kristalinično.
2. Farmaceutski pripravak prema zahtjevu 1, naznačen time što je najmanje 70% težinski soli u jednom kristaliničnom obliku.
3. Farmaceutski pripravak prema zahtjevu 1 ili zahtjevu 2, naznačen time što je najmanje 99% težinski soli kristalinično.
4. Farmaceutski pripravak prema bilo kojem zahtjevu od 1 do 3, naznačen time što je najmanje 99% težinski u jednom kristaliničnom obliku.
5. Farmaceutski pripravak prema bilo kojem zahtjevu od 1 do 4, naznačen time što je hemitartratna sol odabrana od D-hemitartrata, L-hemitartrata, hemimezovinske kiseline ili racemskog D,L-hemitartrata.
6. Farmaceutski pripravak prema bilo kojem zahtjevu od 1 do 5, naznačen time što je hemitartratna sol L-hemitartrat.
7. Farmaceutski pripravak prema zahtjevu 2 ili zahtjevu 4, naznačen time što je najmanje 70% težinski soli u jednom kristaliničnom obliku - Obliku A.
8. Farmaceutski pripravak prema zahtjevu 2 ili zahtjevu 4, naznačen time što je jedan kristalinični oblik naznačen time što ima:
(a) najmanje jedan glavni vrh kod difrakcije x-zraka na prahu pri kutovima 2θ od 5.1°, 6.6°, 10.7°, 11.0°, 15.9°, i 21.7°;
(b) najmanje dva glavna vrha kod difrakcije x-zraka na prahu pri kutovima 2θ od 5.1°, 6.6°, 10.7°, 11.0°, 15.9°, i 21.7°;
(c) najmanje tri glavna vrha kod difrakcije x-zraka na prahu pri kutovima 5.1°, 6.6°, 10.7°, 11.0°, 15.9°, i 21.7°;
(d) najmanje četiri glavna vrha kod difrakcije x-zraka na prahu pri kutovima 2θ od 5.1 °, 6.6°, 10.7°, 11.0°, 15.9°, i 21.7°; ili
(e) glavni vrh kod difrakcije x-zraka na prahu pri kutovima 2θ od 5.1 °, 6.6°, 10.7°, 11.0°, 15.9°, i 21.7°.
9. Farmaceutski pripravak prema zahtjevu 2 ili zahtjevu 4, pri čemu je jedan kristalinični oblik naznačen time što ima vrhove difrakcije x-zraka na prahu pri kutovima 2θ od 5.1°, 6.6°, 10.7°, 11.0°, 13.3°, 15.1°, 15.9°, 16.5°, 17.6°, 18.6°, 18.7°, 19.0°, 20.2°, 21.7° i 23.5°.
10. Farmaceutski pripravak prema zahtjevu 2 ili zahtjevu 4, pri čemu je jedan kristalinični oblik naznačen time što ima uzorak difrakcije x-zraka na prahu prema slici 1.
11. Farmaceutski pripravak naznačen time što sadrži:
hemitartratnu sol kako je definirana u bilo kojem zahtjevu od 1 do 10:
najmanje jedno u vodi topivo punilo;
najmanje jedno punilo netopivo u vodi;
najmanje jedno vezivno sredstvo; i
najmanje jedno sredstvo za povećanje skliskosti.
12. Farmaceutski pripravak prema zahtjevu 11, naznačen time što:
(a) u vodi topivo punilo je odabrano iz skupine koja sadrži bezvodnu laktozu, laktozu monohidrat, manitol, natrijev klorid, šećer u prahu, sorbitol, saharozu, inozitol i preželatinizirani škrob;
(b) punilo netopivo u vodi je odabrano iz skupine koja sadrži mikrokristalnu celulozu, kalcijev fosfat i škrob;
(c) vezivno sredstvo je odabrano iz skupine koja sadrži preželatinizirani škrob, natrijevu karboksimetil celulozu, hidroksipropil celulozu, hidroksipropil metil celulozu, polivinil pirolidon, kopolividon, želatinu, prirodne gume, škrobnu pastu, saharozu, kukuruzni sirup, polietilen glikole i natrijev alginat; ili
(d) sredstvo za povećanje skliskosti je odabrano iz skupine koja sadrži hidrogenirano biljno ulje, kalcijev stearat, te gliceril behenat.
13. Farmaceutski pripravak prema zahtjevu 11, naznačen time što:
u vodi topivo punilo je odabrano iz skupine koja sadrži bezvodnu laktozu, laktozu monohidrat, manitol, natrijev klorid, šećer u prahu, sorbitol, saharozu, inozitol i preželatinizirani škrob;
punilo netopivo u vodi je odabrano iz skupine koja sadrži mikrokristalnu celulozu, kalcijev fosfat i škrob;
vezivno sredstvo je odabrano iz skupine koja sadrži preželatinizirani škrob, natrijevu karboksimetil celulozu, hidroksipropil celulozu, hidroksipropil metil celulozu, polivinil pirolidon, kopolividon, želatinu, prirodne gume, škrobnu pastu, saharozu, kukuruzni sirup, polietilen glikole i natrijev alginat; i
sredstvo za povećanje skliskosti je odabrano iz skupine koja sadrži hidrogenirano biljno ulje, kalcijev stearat, te gliceril behenat.
14. Farmaceutski pripravak prema zahtjevu 13, naznačen time što pripravak sadrži:
(a) 26 % tež. do 50 % tež. na bazi suhe tvari u vodi topivog punila;
(b) 8 % tež. do 32 % tež., 8 % tež. do 24 % tež. ili 12 % tež. do 20 % tež. na bazi suhe tvari punila netopivog u vodi;
(c) 2 % tež. do 6 % tež. na bazi suhe tvari vezivnog sredstva; ili
(d) 0.1 % tež. do 2 % tež. na bazi suhe tvari sredstva za povećanje skliskosti.
15. Farmaceutski pripravak prema zahtjevu 13, naznačen time što pripravak sadrži 14 % tež. do 18 % tež. na bazi suhe tvari punila netopivog u vodi.
16. Farmaceutski pripravak prema zahtjevu 13, naznačen time što pripravak sadrži:
35 % tež. do 40 % tež. hemitartratne soli;
26 % tež. do 50 % tež. u vodi topivog punila;
8 % tež. do 32 % tež. punila netopivog u vodi;
2 % tež. do 6 % tež. vezivnog sredstva; i
0.1 % tež. do 2 % tež. sredstva za povećanje skliskosti,
sve na bazi suhe tvari.
17. Farmaceutski pripravak prema zahtjevu 13, naznačen time što:
u vodi topivo punilo je laktoza monohidrat;
punilo netopivo u vodi je mikrokristalna celuloza;
vezivno sredstvo je hidroksipropil metilceluloza; i
sredstvo za povećanje skliskosti je gliceril behenat.
18. Farmaceutski pripravak prema zahtjevu 17, naznačen time što pripravak sadrži:
35 % tež. do 40 % tež. hemitartratne soli;
26 % tež. do 50 % tež. laktoza monohidrata;
8 % tež. do 32 % tež. mikrokristalne celuloze;
2 % tež. do 6 % tež. hidroksipropil metilceluloze; i
0.1 % tež. do 2 % tež. gliceril behenata,
sve na bazi suhe tvari.
19. Hemitartratna sol naznačena time što je definirana u bilo kojem zahtjevu od 1 do 10.
20. Hemitartratna sol prema zahtjevu 19 naznačena time što je za uporabu kod liječenja Gaucherove bolesti.
21. Hemitartratna sol prema zahtjevu 19 naznačena time što je za uporabu kod liječenja Fabrijeve bolesti.
22. Hemitartratna sol prema zahtjevu 19 naznačena time što je za uporabu za inhibiciju glukozilceramid sintaze ili smanjenje koncentracija glikosfingolipida kod subjekta kojemu je to potrebno.
23. Hemitartratna sol za uporabu prema bilo kojem zahtjevu od 20 do 22, naznačena time što je sol za davanje dva puta dnevno u dozi od 25 miligrama do 200 miligrama.
24. Hemitartratna sol za uporabu prema bilo kojem zahtjevu od 20 do 22, naznačena time što je sol za davanje dva puta dnevno u dozi od 50 miligrama.
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| US26474809P | 2009-11-27 | 2009-11-27 | |
| PCT/US2010/057952 WO2011066352A1 (en) | 2009-11-27 | 2010-11-24 | An amorphous and a crystalline form of genz 112638 hemitartrat as inhibitor of glucosylceramide synthase |
| EP10785289.9A EP2504332B2 (en) | 2009-11-27 | 2010-11-24 | An amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase |
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| HRP20161038TT HRP20161038T1 (hr) | 2009-11-27 | 2016-08-17 | Genz 112638 za liječenje gaucherove ili fabrijeve bolesti u kombiniranoj terapiji |
| HRP20191647 HRP20191647T1 (hr) | 2009-11-27 | 2019-09-12 | Eliglustat (genz 112638) kao inhibitor glukozilceramid sintaze za uporabu u postupku liječenja fabryjeve ili gaucherove bolesti, postupak sadrži podešavanje pojedinačne terapeutske doze metabolizmu p-450 kod pacijenta |
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| HRP20191647 HRP20191647T1 (hr) | 2009-11-27 | 2019-09-12 | Eliglustat (genz 112638) kao inhibitor glukozilceramid sintaze za uporabu u postupku liječenja fabryjeve ili gaucherove bolesti, postupak sadrži podešavanje pojedinačne terapeutske doze metabolizmu p-450 kod pacijenta |
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