EA010290B1 - Таблетки циталопрама гидробромида - Google Patents
Таблетки циталопрама гидробромида Download PDFInfo
- Publication number
- EA010290B1 EA010290B1 EA200600932A EA200600932A EA010290B1 EA 010290 B1 EA010290 B1 EA 010290B1 EA 200600932 A EA200600932 A EA 200600932A EA 200600932 A EA200600932 A EA 200600932A EA 010290 B1 EA010290 B1 EA 010290B1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- particle size
- range
- active ingredient
- average particle
- microns
- Prior art date
Links
- CPELXLSAUQHCOX-UHFFFAOYSA-N Hydrogen bromide Chemical compound Br CPELXLSAUQHCOX-UHFFFAOYSA-N 0.000 title 1
- 239000002245 particle Substances 0.000 claims abstract description 71
- WIHMBLDNRMIGDW-UHFFFAOYSA-N 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3h-2-benzofuran-5-carbonitrile;hydron;bromide Chemical compound [Br-].O1CC2=CC(C#N)=CC=C2C1(CCC[NH+](C)C)C1=CC=C(F)C=C1 WIHMBLDNRMIGDW-UHFFFAOYSA-N 0.000 claims abstract description 70
- 229960000584 citalopram hydrobromide Drugs 0.000 claims abstract description 66
- 239000004480 active ingredient Substances 0.000 claims abstract description 55
- 238000000034 method Methods 0.000 claims abstract description 49
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 40
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 40
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 39
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 39
- 238000007907 direct compression Methods 0.000 claims abstract description 37
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 26
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 37
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 33
- 239000008240 homogeneous mixture Substances 0.000 claims description 28
- 238000004519 manufacturing process Methods 0.000 claims description 26
- 239000000203 mixture Substances 0.000 claims description 25
- WSEQXVZVJXJVFP-HXUWFJFHSA-N (R)-citalopram Chemical compound C1([C@@]2(C3=CC=C(C=C3CO2)C#N)CCCN(C)C)=CC=C(F)C=C1 WSEQXVZVJXJVFP-HXUWFJFHSA-N 0.000 claims description 24
- 229960001653 citalopram Drugs 0.000 claims description 24
- 235000019359 magnesium stearate Nutrition 0.000 claims description 19
- 239000000126 substance Substances 0.000 claims description 16
- 239000000377 silicon dioxide Substances 0.000 claims description 15
- 239000011248 coating agent Substances 0.000 claims description 14
- 238000000576 coating method Methods 0.000 claims description 14
- 235000012239 silicon dioxide Nutrition 0.000 claims description 13
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 7
- 239000008101 lactose Substances 0.000 claims description 7
- 239000007787 solid Substances 0.000 claims description 5
- -1 isobenzofurancarbonitrile hydrobromide Chemical compound 0.000 claims description 2
- 229910002055 micronized silica Inorganic materials 0.000 claims 3
- 238000001694 spray drying Methods 0.000 claims 2
- 125000001255 4-fluorophenyl group Chemical group [H]C1=C([H])C(*)=C([H])C([H])=C1F 0.000 claims 1
- 125000002147 dimethylamino group Chemical group [H]C([H])([H])N(*)C([H])([H])[H] 0.000 claims 1
- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 claims 1
- 239000003826 tablet Substances 0.000 abstract description 118
- 239000007941 film coated tablet Substances 0.000 abstract description 8
- 238000002360 preparation method Methods 0.000 abstract description 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 10
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 10
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 10
- 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 10
- 239000000725 suspension Substances 0.000 description 10
- 238000005507 spraying Methods 0.000 description 9
- 238000004090 dissolution Methods 0.000 description 8
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 6
- 239000000843 powder Substances 0.000 description 6
- 239000008213 purified water Substances 0.000 description 6
- 238000003756 stirring Methods 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 238000005550 wet granulation Methods 0.000 description 6
- 230000032798 delamination Effects 0.000 description 5
- 239000008187 granular material Substances 0.000 description 5
- 239000004615 ingredient Substances 0.000 description 5
- 229960001375 lactose Drugs 0.000 description 5
- 238000007908 dry granulation Methods 0.000 description 4
- 229910001220 stainless steel Inorganic materials 0.000 description 4
- 239000010935 stainless steel Substances 0.000 description 4
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 239000000945 filler Substances 0.000 description 3
- 239000000314 lubricant Substances 0.000 description 3
- 238000005461 lubrication Methods 0.000 description 3
- 239000004408 titanium dioxide Substances 0.000 description 3
- 238000005303 weighing Methods 0.000 description 3
- 102100024452 DNA-directed RNA polymerase III subunit RPC1 Human genes 0.000 description 2
- 101000689002 Homo sapiens DNA-directed RNA polymerase III subunit RPC1 Proteins 0.000 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 229940066010 citalopram 40 mg Drugs 0.000 description 2
- 229940075614 colloidal silicon dioxide Drugs 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007796 conventional method Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000002349 favourable effect Effects 0.000 description 2
- 239000007888 film coating Substances 0.000 description 2
- 238000009501 film coating Methods 0.000 description 2
- 238000005469 granulation Methods 0.000 description 2
- 230000003179 granulation Effects 0.000 description 2
- 239000000594 mannitol Substances 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- 238000002156 mixing Methods 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 description 1
- 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 1
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 description 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
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 239000004372 Polyvinyl alcohol Substances 0.000 description 1
- 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 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000000935 antidepressant agent Substances 0.000 description 1
- 239000003831 antifriction material Substances 0.000 description 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000010419 fine particle Substances 0.000 description 1
- 239000003979 granulating agent Substances 0.000 description 1
- 238000001033 granulometry Methods 0.000 description 1
- 229960001021 lactose monohydrate Drugs 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- QSHDDOUJBYECFT-UHFFFAOYSA-N mercury Chemical compound [Hg] QSHDDOUJBYECFT-UHFFFAOYSA-N 0.000 description 1
- 229910052753 mercury Inorganic materials 0.000 description 1
- 238000005453 pelletization Methods 0.000 description 1
- 239000008177 pharmaceutical agent Substances 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 238000009490 roller compaction Methods 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000002303 tibia Anatomy 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
Landscapes
- Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| HU0303790A HU227491B1 (en) | 2003-11-25 | 2003-11-25 | Tablet containing citalopram hydrogen bromide |
| PCT/HU2004/000110 WO2005051374A1 (en) | 2003-11-25 | 2004-11-24 | Tablets of citalopram hydrobromide |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EA200600932A1 EA200600932A1 (ru) | 2006-10-27 |
| EA010290B1 true EA010290B1 (ru) | 2008-08-29 |
Family
ID=89981808
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA200600932A EA010290B1 (ru) | 2003-11-25 | 2004-11-24 | Таблетки циталопрама гидробромида |
Country Status (9)
| Country | Link |
|---|---|
| EP (1) | EP1694321A1 (bg) |
| BG (1) | BG109587A (bg) |
| CZ (1) | CZ2006376A3 (bg) |
| EA (1) | EA010290B1 (bg) |
| HU (1) | HU227491B1 (bg) |
| PL (1) | PL379864A1 (bg) |
| SK (1) | SK50532006A3 (bg) |
| UA (1) | UA83094C2 (bg) |
| WO (1) | WO2005051374A1 (bg) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TWI347942B (en) * | 2005-06-22 | 2011-09-01 | Lundbeck & Co As H | Crystalline base of escitalopram and orodispersible tablets comprising escitalopram base |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001080619A2 (en) * | 2000-08-10 | 2001-11-01 | H. Lundbeck A/S | Pharmaceutical composition containing citalopram |
| WO2002053133A1 (en) * | 2001-01-05 | 2002-07-11 | H. Lundbeck A/S | Pharmaceutical composition containing citalopram |
| US6607751B1 (en) * | 1997-10-10 | 2003-08-19 | Intellipharamaceutics Corp. | Controlled release delivery device for pharmaceutical agents incorporating microbial polysaccharide gum |
-
2003
- 2003-11-25 HU HU0303790A patent/HU227491B1/hu unknown
-
2004
- 2004-11-24 SK SK5053-2006A patent/SK50532006A3/sk not_active Application Discontinuation
- 2004-11-24 EA EA200600932A patent/EA010290B1/ru not_active IP Right Cessation
- 2004-11-24 PL PL379864A patent/PL379864A1/pl not_active Application Discontinuation
- 2004-11-24 CZ CZ20060376A patent/CZ2006376A3/cs unknown
- 2004-11-24 WO PCT/HU2004/000110 patent/WO2005051374A1/en active Application Filing
- 2004-11-24 UA UAA200607053A patent/UA83094C2/ru unknown
- 2004-11-24 EP EP04798748A patent/EP1694321A1/en not_active Withdrawn
-
2006
- 2006-06-23 BG BG109587A patent/BG109587A/bg unknown
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6607751B1 (en) * | 1997-10-10 | 2003-08-19 | Intellipharamaceutics Corp. | Controlled release delivery device for pharmaceutical agents incorporating microbial polysaccharide gum |
| WO2001080619A2 (en) * | 2000-08-10 | 2001-11-01 | H. Lundbeck A/S | Pharmaceutical composition containing citalopram |
| WO2002053133A1 (en) * | 2001-01-05 | 2002-07-11 | H. Lundbeck A/S | Pharmaceutical composition containing citalopram |
Also Published As
| Publication number | Publication date |
|---|---|
| HUP0303790A2 (hu) | 2005-08-29 |
| SK50532006A3 (sk) | 2006-09-07 |
| HUP0303790A3 (en) | 2005-09-28 |
| EP1694321A1 (en) | 2006-08-30 |
| HU0303790D0 (en) | 2004-03-01 |
| CZ2006376A3 (cs) | 2006-10-11 |
| UA83094C2 (en) | 2008-06-10 |
| PL379864A1 (pl) | 2006-11-27 |
| BG109587A (bg) | 2006-12-29 |
| EA200600932A1 (ru) | 2006-10-27 |
| WO2005051374A1 (en) | 2005-06-09 |
| HU227491B1 (en) | 2011-07-28 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM4A | Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s) |
Designated state(s): AM AZ BY KZ KG MD TJ TM |
|
| MM4A | Lapse of a eurasian patent due to non-payment of renewal fees within the time limit in the following designated state(s) |
Designated state(s): RU |