HRP20211092T1 - Farmaceutske kompozicije antagonista 5-ht6 - Google Patents
Farmaceutske kompozicije antagonista 5-ht6 Download PDFInfo
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- HRP20211092T1 HRP20211092T1 HRP20211092TT HRP20211092T HRP20211092T1 HR P20211092 T1 HRP20211092 T1 HR P20211092T1 HR P20211092T T HRP20211092T T HR P20211092TT HR P20211092 T HRP20211092 T HR P20211092T HR P20211092 T1 HRP20211092 T1 HR P20211092T1
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- methyl
- bromophenyl
- piperazinyl
- sulfonyl
- methoxy
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- 239000008194 pharmaceutical composition Substances 0.000 title claims 13
- 229940124801 5-HT6 antagonist Drugs 0.000 title 1
- 239000003751 serotonin 6 antagonist Substances 0.000 title 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 claims 13
- 239000000314 lubricant Substances 0.000 claims 13
- XKDCUJBWVGDNSH-UHFFFAOYSA-N 1-(2-bromophenyl)sulfonyl-5-methoxy-3-[(4-methylpiperazin-1-yl)methyl]indole;methanesulfonic acid;hydrate Chemical compound O.CS(O)(=O)=O.CS(O)(=O)=O.C12=CC(OC)=CC=C2N(S(=O)(=O)C=2C(=CC=CC=2)Br)C=C1CN1CCN(C)CC1 XKDCUJBWVGDNSH-UHFFFAOYSA-N 0.000 claims 12
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid group Chemical group C(CC(O)(C(=O)O)CC(=O)O)(=O)O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 12
- 239000003085 diluting agent Substances 0.000 claims 11
- 239000007884 disintegrant Substances 0.000 claims 10
- 239000000203 mixture Substances 0.000 claims 9
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 8
- 239000011230 binding agent Substances 0.000 claims 7
- 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 6
- 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 6
- 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 6
- 239000012535 impurity Substances 0.000 claims 6
- 229960001375 lactose Drugs 0.000 claims 6
- 239000008101 lactose Substances 0.000 claims 6
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 4
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical group O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 4
- 229960000913 crospovidone Drugs 0.000 claims 4
- 235000019359 magnesium stearate Nutrition 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
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 4
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 4
- 229940069328 povidone Drugs 0.000 claims 4
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims 3
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 3
- 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 3
- 229930195725 Mannitol Natural products 0.000 claims 3
- 229920002472 Starch Polymers 0.000 claims 3
- 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 3
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 claims 3
- 229940075614 colloidal silicon dioxide Drugs 0.000 claims 3
- 229960001681 croscarmellose sodium Drugs 0.000 claims 3
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims 3
- 235000019700 dicalcium phosphate Nutrition 0.000 claims 3
- 229940095079 dicalcium phosphate anhydrous Drugs 0.000 claims 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 3
- 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 3
- 239000000905 isomalt Substances 0.000 claims 3
- 235000010439 isomalt Nutrition 0.000 claims 3
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims 3
- 229960001021 lactose monohydrate Drugs 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 0.000 claims 3
- 239000008109 sodium starch glycolate Substances 0.000 claims 3
- 229940079832 sodium starch glycolate Drugs 0.000 claims 3
- 229920003109 sodium starch glycolate Polymers 0.000 claims 3
- 239000008107 starch Substances 0.000 claims 3
- 229940032147 starch Drugs 0.000 claims 3
- 235000019698 starch Nutrition 0.000 claims 3
- ZAMOUSCENKQFHK-UHFFFAOYSA-N Chlorine atom Chemical compound [Cl] ZAMOUSCENKQFHK-UHFFFAOYSA-N 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- 239000000460 chlorine Substances 0.000 claims 2
- 229910052801 chlorine Inorganic materials 0.000 claims 2
- GWCYPEHWIZXYFZ-UHFFFAOYSA-N masupirdine Chemical compound C12=CC(OC)=CC=C2N(S(=O)(=O)C=2C(=CC=CC=2)Br)C=C1CN1CCN(C)CC1 GWCYPEHWIZXYFZ-UHFFFAOYSA-N 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 239000002775 capsule Substances 0.000 claims 1
- 239000008119 colloidal silica Substances 0.000 claims 1
- 239000012738 dissolution medium Substances 0.000 claims 1
- 239000012748 slip agent Substances 0.000 claims 1
- 239000002904 solvent Substances 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/2004—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
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Claims (12)
1. Farmaceutska kompozicija s trenutnim oslobađanjem, koja u 100 mas.%, sadrži:
a) od 2% do 60% 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil]-1H-indol ili njegovu farmaceutski prihvatljivu sol;
b) od 36% do 97% jednog ili ukupno dva razrjeđivača; naznačeno time da je razrjeđivač odabran iz grupe koja obuhvaća mikrokristalnu celulozu, laktozu monohidrat, dvobazni kalcij fosfat, laktozu, laktozu hidrat, anhidrat laktoze, manitol, škrob i izomalt;
c) od 0.5% do 2% lubrikanta; naznačeno time da je lubrikant magnezij stearat;
d) od 0.5% do 1% sredstva za klizanje; naznačeno time da je sredstvo za klizanje koloidni silicij dioksid;
e) 0% do 10% sredstva za vezivanje; naznačeno time da je sredstvo za vezivanje odabrano iz grupe koju čine povidon ili hidroksipropil metilceluloza;
f) 0% do 5% sredstva za raspadanje; naznačeno time da je sredstvo za raspadanje odabrano između krospovidona, natrij škrob glikolata i natrij kroskarmeloze; i
g) 0% do 2% regulatora kiselosti; naznačeno time da je regulator kiselosti limunska kiselina.
2. Farmaceutska kompozicija s trenutnim oslobađanjem prema patentnom zahtjevu 1, naznačena time što navedena kompozicija u 100 mas.% sadrži:
(a) od 2% do 60% 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil]-1H-indol dimezilat monohidrata;
(b) od 36% do 97% jednog ili ukupno dva razrjeđivača; naznačeno time da je razrjeđivač odabran iz grupe koja obuhvaća mikrokristalnu celulozu, laktozu monohidrat, dvobazni kalcij fosfat, laktozu, hidrat laktoze, anhidrat laktoze, manitol, škrob i izomalt;
(c) od 0.5% do 2% lubrikanta; naznačeno time da je lubrikant magnezij stearat;
(d) od 0.5% do 1% sredstva za klizanje; naznačeno time da je sredstvo za klizanje koloidni silicij dioksid;
(e) 0% do 10% sredstva za vezivanje; naznačeno time da je sredstvo za vezivanje odabrano iz grupe koju čine povidon ili hidroksipropil metilceluloza;
(f) 0% do 5% sredstva za raspadanje; naznačeno time da je sredstvo za raspadanje odabrano između krospovidona, natrij škrob glikolata i natrij kroskarmeloze, i
(g) 0% do 2% regulatora kiselosti; naznačeno time da je regulator kiselosti limunska kiselina.
3. Farmaceutske kompozicije s trenutnim oslobađanjem, prema patentnom zahtjevu 1 ili patentnom zahtjevu 2, naznačene time, što je sastav kompozicije u 100 mas.% izabran iz grupe koju čine:
1) (a) od 2% do 3% 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil] -1H-indol dimezilat monohidrata, (b) od 95% do 97% razrjeđivača, (c) 1% lubrikanta i (d) 0.5% sredstva za klizanje;
2) (a) od 11% do 38% 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil] -1H-indol dimezilat monohidrata, (b) od 61% do 87% jednog ili ukupno dva razrjeđivača, (c) 1% lubrikanta, (d) 0.5 % sredstva za klizanje, (e) 2% sredstva za raspadanje i (f) 1% regulatora kiselosti;
3) (a) od 24% do 38% 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil]-1H-indol dimezilat monohidrata (b) od 61% do 72% jednog ili ukupno dva razrjeđivača, (c) od 1% do 1.25% lubrikanta, (d) 0.5% sredstva za klizanje i (e) 2% sredstva za raspadanje;
4) (a) od 37% do 51% 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil] -1H-indol dimezilat monohidrata, (b) od 45% do 60% razrjeđivača, (c) 1% lubrikanta, (d) 0.5% sredstva za klizanje, (e) 2% otapala i (f) 1% regulatora kiselosti;
5) (a) od 36% do 60% 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil] -1H-indol dimezilat monohidrata, (b) od 36% do 62% razrjeđivača, (c) od 0.5% do 1% lubrikanta, (d) 0.5% sredstva za klizanje i (e) 2% sredstva za raspadanje; i
6) (a) od 11% do 38% 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil]-1H-indol dimezilat monohidrata; (b) od 61% do 72% razrjeđivača; (c) od 2% do 5% sredstva za vezivanje; (d) 1% lubrikanta; (e) 0.5 % sredstva za klizanje i (f) od 2% do 4% sredstva za raspadanje.
4. Farmaceutska kompozicija s trenutnim oslobađanjem prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, što je doza 1-[(2-bromfenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil) metil]-1H-indola ili njegove farmaceutski prihvatljive soli od 5 mg do 200 mg.
5. Farmaceutska kompozicija s trenutnim oslobađanjem prema bilo kojem od patentnih zahtjeva 1 do 4, naznačena time, što je kompozicija u obliku tablete ili kapsule.
6. Farmaceutska kompozicija s trenutnim oslobađanjem prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, što kompozicija sadrži:
i) manje od 0.5% nečistoća klora;
ii) manje od 0.5% drugih nečistoća;
iii) manje od 1% ukupnih nečistoća.
7. Farmaceutska kompozicija s trenutnim oslobađanjem prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, što je pročišćenost 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil]-1 H-indol dimezilat monohidrata, 99.3%.
8. Farmaceutska kompozicija s trenutnim oslobađanjem prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, što kompozicija sadrži:
i) 99.3% pročišćenog 1-[(2-bromfenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil] -1 H-indol dimezilat monohidrata;
ii) manje od 0.5% nečistoća klora;
iii) manje od 0.5% drugih nečistoća;
iv) manje od 1% ukupne nečistoće.
9. Farmaceutska kompozicija s trenutnim oslobađanjem, prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, što se 1- [(2- bromofenil)sulfonil]-5-metoksi-3- [(4-metil-1-piperazinil) metil] -1H-indol dimezilat monohidrat oslobađa od 85% do 100% u roku od 30 minuta, kada se testira s rotirajućom lopaticom pri 100 okreta/min u 900 ml medija za otapanje, 0.1 N klorovodoničnoj kiselini ili vodi na 37 ° C.
10. Farmaceutska kompozicija s trenutnim oslobađanjem prema patentnom zahtjevu 5, naznačena time, što navedena smjesa u 100 mas.% sadrži:
(a) od 2% do 60% 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil] -1H-indol dimezilat monohidrata;
(b) od 36% do 97% jednog ili ukupno dva razrjeđivača; naznačeno time da je razrjeđivač odabran iz grupe koja obuhvaća mikrokristalnu celulozu, laktoza monohidrat, dvobazni kalcij fosfat, laktozu, hidrat laktoze, anhidrat laktoze, manitol, škrob i izomalt;
(c) od 0.5% do 2% lubrikanta; naznečeno time da je lubrikant magnezij stearat;
(d) od 0.5% do 1% sredstva za klizanje; naznačeno time da je sredstvo za klizanje koloidni silicij dioksid;
(e) 0% do 10% sredstva za vezivanje; naznačeno time da je sredstvo za vezivanje odabrano iz grupe koja obuhvaća povidon ili hidroksipropil metilcelulozu;
(f) 0% do 5% sredstva za raspadanje; naznačeno time da je sredstvo za raspadanje odabrano između krospovidona, natrij škrob glikolata i natrij kroskarmeloze; i
(g) 0% do 2% regulatora kiselosti; naznačeno time da je regulator kiselosti limunska kiselina.
11. Farmaceutska kompozicija s trenutnim oslobađanjem prema patentnom zahtjevu 10, naznačena time, što navedena kompozicija u 100 mas. % sadrži:
(a) od 2% do 60% 1-[(2-bromofenil)sulfonil]-5-metoksi-3-[(4-metil-1-piperazinil)metil]-1H-indol dimezilat monohidrata;
(b) od 36% do 97% mikrokristalne celuloze;
(c) od 0.5% do 2% magnezij stearata;
(d) od 0.5% do 1% koloidnog silicij dioksida;
(e) 0% do 5% povidona;
(f) 0% do 4% krospovidona; i
(g) 0% do 2% limunske kiseline.
12. Farmaceutska kompozicija s trenutnim oslobađanjem prema patentnom zahtjevu 10 ili patentnom zahtjevu 11, naznačena time, što je ukupna masa kompozicije za trenutno oslobađanje od 100 mg do 600 mg.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IN201641033741 | 2016-10-03 | ||
PCT/IB2017/056009 WO2018065869A1 (en) | 2016-10-03 | 2017-09-29 | Pharmaceutical compositions of 5-ht6 antagonist |
EP17794060.8A EP3518905B1 (en) | 2016-10-03 | 2017-09-29 | Pharmaceutical compositions of 5-ht6 antagonist |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20211092T1 true HRP20211092T1 (hr) | 2021-10-15 |
Family
ID=60245136
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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HRP20211092TT HRP20211092T1 (hr) | 2016-10-03 | 2021-07-08 | Farmaceutske kompozicije antagonista 5-ht6 |
Country Status (25)
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US (1) | US20190336497A1 (hr) |
EP (1) | EP3518905B1 (hr) |
JP (1) | JP6669937B2 (hr) |
KR (1) | KR102083135B1 (hr) |
CN (1) | CN109789098A (hr) |
AU (1) | AU2017339755B2 (hr) |
BR (1) | BR112019006588A2 (hr) |
CA (1) | CA3038620C (hr) |
CY (1) | CY1124539T1 (hr) |
DK (1) | DK3518905T3 (hr) |
EA (1) | EA036235B1 (hr) |
ES (1) | ES2879675T3 (hr) |
HR (1) | HRP20211092T1 (hr) |
HU (1) | HUE055452T2 (hr) |
IL (1) | IL265662B (hr) |
LT (1) | LT3518905T (hr) |
MA (1) | MA46358B1 (hr) |
MD (1) | MD3518905T2 (hr) |
MX (1) | MX2019003815A (hr) |
PL (1) | PL3518905T3 (hr) |
PT (1) | PT3518905T (hr) |
RS (1) | RS62113B1 (hr) |
SI (1) | SI3518905T1 (hr) |
WO (1) | WO2018065869A1 (hr) |
ZA (1) | ZA201901734B (hr) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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NZ761037A (en) * | 2017-07-03 | 2022-10-28 | Suven Life Sciences Ltd | New uses of a pure 5-ht6 receptor antagonist |
Family Cites Families (3)
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NZ572186A (en) * | 2002-11-28 | 2010-02-26 | Suven Life Sciences Ltd | N-arylsulfonyl-3-substituted indoles having serotonin receptor affinity, process for their preparation and pharmaceutical composition containing them |
US20060002999A1 (en) * | 2004-06-17 | 2006-01-05 | Forest Laboratories, Inc. | Immediate release formulations of 1-aminocyclohexane compounds, memantine and neramexane |
HUE036008T2 (hu) * | 2013-12-02 | 2018-06-28 | Suven Life Sciences Ltd | Eljárás 1-[(2-brómfenil)szulfonil]-5-metoxi-3-[(4-metil-1-piperazinil)metil]-1H-indol-dimezilát-monohidrát nagyüzemi léptékben történõ elõállítására |
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2017
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- 2017-09-29 MD MDE20190876T patent/MD3518905T2/ro unknown
- 2017-09-29 DK DK17794060.8T patent/DK3518905T3/da active
- 2017-09-29 EP EP17794060.8A patent/EP3518905B1/en active Active
- 2017-09-29 PT PT177940608T patent/PT3518905T/pt unknown
- 2017-09-29 ES ES17794060T patent/ES2879675T3/es active Active
- 2017-09-29 RS RS20210868A patent/RS62113B1/sr unknown
- 2017-09-29 CA CA3038620A patent/CA3038620C/en active Active
- 2017-09-29 SI SI201730844T patent/SI3518905T1/sl unknown
- 2017-09-29 AU AU2017339755A patent/AU2017339755B2/en active Active
- 2017-09-29 CN CN201780059816.3A patent/CN109789098A/zh active Pending
- 2017-09-29 MX MX2019003815A patent/MX2019003815A/es unknown
- 2017-09-29 LT LTEP17794060.8T patent/LT3518905T/lt unknown
- 2017-09-29 US US16/337,685 patent/US20190336497A1/en not_active Abandoned
- 2017-09-29 EA EA201990827A patent/EA036235B1/ru unknown
- 2017-09-29 HU HUE17794060A patent/HUE055452T2/hu unknown
- 2017-09-29 BR BR112019006588A patent/BR112019006588A2/pt active Search and Examination
- 2017-09-29 PL PL17794060T patent/PL3518905T3/pl unknown
- 2017-09-29 WO PCT/IB2017/056009 patent/WO2018065869A1/en active Search and Examination
- 2017-09-29 KR KR1020197012229A patent/KR102083135B1/ko active IP Right Grant
- 2017-09-29 MA MA46358A patent/MA46358B1/fr unknown
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2019
- 2019-03-20 ZA ZA201901734A patent/ZA201901734B/en unknown
- 2019-03-27 IL IL26566219A patent/IL265662B/en active IP Right Grant
-
2021
- 2021-07-08 HR HRP20211092TT patent/HRP20211092T1/hr unknown
- 2021-07-09 CY CY20211100623T patent/CY1124539T1/el unknown
Also Published As
Publication number | Publication date |
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SI3518905T1 (sl) | 2021-11-30 |
CA3038620C (en) | 2020-05-26 |
BR112019006588A2 (pt) | 2019-07-02 |
NZ752060A (en) | 2020-09-25 |
KR20190050858A (ko) | 2019-05-13 |
WO2018065869A1 (en) | 2018-04-12 |
CN109789098A (zh) | 2019-05-21 |
PT3518905T (pt) | 2021-07-14 |
LT3518905T (lt) | 2021-08-10 |
EA201990827A1 (ru) | 2019-07-31 |
MX2019003815A (es) | 2019-08-12 |
AU2017339755A1 (en) | 2019-04-18 |
MA46358B1 (fr) | 2021-08-31 |
RS62113B1 (sr) | 2021-08-31 |
MD3518905T2 (ro) | 2021-09-30 |
EP3518905B1 (en) | 2021-04-28 |
US20190336497A1 (en) | 2019-11-07 |
ES2879675T3 (es) | 2021-11-22 |
CY1124539T1 (el) | 2022-07-22 |
AU2017339755B2 (en) | 2019-11-07 |
JP6669937B2 (ja) | 2020-03-18 |
CA3038620A1 (en) | 2018-04-12 |
KR102083135B1 (ko) | 2020-02-28 |
EA036235B1 (ru) | 2020-10-16 |
JP2019529471A (ja) | 2019-10-17 |
IL265662A (en) | 2019-05-30 |
HUE055452T2 (hu) | 2021-11-29 |
DK3518905T3 (da) | 2021-07-19 |
IL265662B (en) | 2019-11-28 |
PL3518905T3 (pl) | 2021-10-25 |
ZA201901734B (en) | 2020-11-25 |
EP3518905A1 (en) | 2019-08-07 |
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