SK285440B6 - Farmaceutický preparát obsahujúci aktívnu látku topiramát, postup tvorby tohto farmaceutického preparátu a použitie tohto preparátu - Google Patents
Farmaceutický preparát obsahujúci aktívnu látku topiramát, postup tvorby tohto farmaceutického preparátu a použitie tohto preparátu Download PDFInfo
- Publication number
- SK285440B6 SK285440B6 SK1306-2000A SK13062000A SK285440B6 SK 285440 B6 SK285440 B6 SK 285440B6 SK 13062000 A SK13062000 A SK 13062000A SK 285440 B6 SK285440 B6 SK 285440B6
- Authority
- SK
- Slovakia
- Prior art keywords
- topiramate
- beads
- core particles
- coating
- pharmaceutical preparation
- Prior art date
Links
- KJADKKWYZYXHBB-XBWDGYHZSA-N Topiramic acid Chemical compound C1O[C@@]2(COS(N)(=O)=O)OC(C)(C)O[C@H]2[C@@H]2OC(C)(C)O[C@@H]21 KJADKKWYZYXHBB-XBWDGYHZSA-N 0.000 title claims abstract description 72
- 229960004394 topiramate Drugs 0.000 title claims abstract description 67
- 238000000034 method Methods 0.000 title claims abstract description 33
- 239000013543 active substance Substances 0.000 title claims abstract description 20
- 239000000825 pharmaceutical preparation Substances 0.000 title claims abstract description 17
- 230000008569 process Effects 0.000 title claims abstract description 17
- 239000000203 mixture Substances 0.000 claims abstract description 53
- 239000011248 coating agent Substances 0.000 claims abstract description 39
- 238000000576 coating method Methods 0.000 claims abstract description 39
- 235000019640 taste Nutrition 0.000 claims abstract description 37
- 239000007771 core particle Substances 0.000 claims abstract description 31
- 230000000873 masking effect Effects 0.000 claims abstract description 24
- 239000002245 particle Substances 0.000 claims abstract description 18
- 238000001035 drying Methods 0.000 claims abstract description 13
- 239000011324 bead Substances 0.000 claims description 71
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 38
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 37
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 37
- 229940069328 povidone Drugs 0.000 claims description 35
- 238000002360 preparation method Methods 0.000 claims description 35
- 235000000346 sugar Nutrition 0.000 claims description 26
- 229920002301 cellulose acetate Polymers 0.000 claims description 18
- 239000008194 pharmaceutical composition Substances 0.000 claims description 17
- 239000003814 drug Substances 0.000 claims description 14
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- 239000003085 diluting agent Substances 0.000 claims description 9
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- 206010010904 Convulsion Diseases 0.000 claims description 3
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- 206010012601 diabetes mellitus Diseases 0.000 claims description 2
- 239000002775 capsule Substances 0.000 description 27
- 235000013305 food Nutrition 0.000 description 22
- 238000009472 formulation Methods 0.000 description 20
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 19
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 18
- 239000003826 tablet Substances 0.000 description 18
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- 239000007788 liquid Substances 0.000 description 14
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- 239000000725 suspension Substances 0.000 description 13
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- 239000001856 Ethyl cellulose Substances 0.000 description 3
- 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 3
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- PSSHGMIAIUYOJF-XBWDGYHZSA-N [(3as,5ar,8ar,8bs)-2,2,7,7-tetramethyl-5,5a,8a,8b-tetrahydrodi[1,3]dioxolo[4,5-a:5',3'-d]pyran-3a-yl]methanol Chemical compound C1O[C@@]2(CO)OC(C)(C)O[C@H]2[C@@H]2OC(C)(C)O[C@@H]21 PSSHGMIAIUYOJF-XBWDGYHZSA-N 0.000 description 2
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- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
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- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 description 1
- SXLHPBDGZHWKSX-UHFFFAOYSA-N 1-(5-amino-2-hydroxyphenyl)ethanone Chemical compound CC(=O)C1=CC(N)=CC=C1O SXLHPBDGZHWKSX-UHFFFAOYSA-N 0.000 description 1
- 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 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
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- 235000019739 Dicalciumphosphate Nutrition 0.000 description 1
- 229920003134 Eudragit® polymer Polymers 0.000 description 1
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- 150000001298 alcohols Chemical class 0.000 description 1
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- 150000004781 alginic acids Chemical class 0.000 description 1
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- SNAAJJQQZSMGQD-UHFFFAOYSA-N aluminum magnesium Chemical compound [Mg].[Al] SNAAJJQQZSMGQD-UHFFFAOYSA-N 0.000 description 1
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- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 description 1
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- 230000005484 gravity Effects 0.000 description 1
- XLSMFKSTNGKWQX-UHFFFAOYSA-N hydroxyacetone Chemical compound CC(=O)CO XLSMFKSTNGKWQX-UHFFFAOYSA-N 0.000 description 1
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- 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
- 239000008101 lactose Substances 0.000 description 1
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- 239000000463 material Substances 0.000 description 1
- IQSHMXAZFHORGY-UHFFFAOYSA-N methyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound COC(=O)C=C.CC(=C)C(O)=O IQSHMXAZFHORGY-UHFFFAOYSA-N 0.000 description 1
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- 235000012222 talc Nutrition 0.000 description 1
- 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 description 1
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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
-
- 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
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
-
- 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
-
- 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
-
- 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
- A61P25/08—Antiepileptics; Anticonvulsants
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US7677098P | 1998-03-04 | 1998-03-04 | |
| PCT/US1999/004449 WO1999044581A2 (en) | 1998-03-04 | 1999-03-01 | Pharmaceutical composition of topiramate |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| SK13062000A3 SK13062000A3 (sk) | 2001-04-09 |
| SK285440B6 true SK285440B6 (sk) | 2007-01-04 |
Family
ID=22134079
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SK1306-2000A SK285440B6 (sk) | 1998-03-04 | 1999-03-01 | Farmaceutický preparát obsahujúci aktívnu látku topiramát, postup tvorby tohto farmaceutického preparátu a použitie tohto preparátu |
Country Status (32)
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| EP (1) | EP1066027B1 (et) |
| JP (1) | JP2003530295A (et) |
| KR (1) | KR20010041592A (et) |
| CN (1) | CN100364501C (et) |
| AR (3) | AR017984A1 (et) |
| AT (1) | ATE246490T1 (et) |
| AU (1) | AU763643B2 (et) |
| BG (1) | BG64885B1 (et) |
| BR (1) | BR9908488A (et) |
| CA (1) | CA2322644C (et) |
| DE (1) | DE69910186T2 (et) |
| DK (1) | DK1066027T3 (et) |
| EA (1) | EA200000814A1 (et) |
| EE (1) | EE04175B1 (et) |
| ES (1) | ES2204109T3 (et) |
| HK (1) | HK1032009A1 (et) |
| HR (1) | HRP20000563B1 (et) |
| HU (1) | HUP0301192A3 (et) |
| ID (1) | ID26982A (et) |
| IL (2) | IL138032A0 (et) |
| MY (1) | MY125821A (et) |
| NO (1) | NO20004311L (et) |
| NZ (1) | NZ506532A (et) |
| PL (1) | PL194559B1 (et) |
| PT (1) | PT1066027E (et) |
| SK (1) | SK285440B6 (et) |
| TR (1) | TR200002541T2 (et) |
| TW (1) | TW590778B (et) |
| UA (1) | UA65607C2 (et) |
| WO (1) | WO1999044581A2 (et) |
| ZA (1) | ZA991716B (et) |
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- 1999-01-03 UA UA2000085074A patent/UA65607C2/uk unknown
- 1999-03-01 AU AU27989/99A patent/AU763643B2/en not_active Expired
- 1999-03-01 DE DE69910186T patent/DE69910186T2/de not_active Revoked
- 1999-03-01 CN CNB998035890A patent/CN100364501C/zh not_active Expired - Lifetime
- 1999-03-01 NZ NZ506532A patent/NZ506532A/en not_active IP Right Cessation
- 1999-03-01 ID IDW20001690A patent/ID26982A/id unknown
- 1999-03-01 AT AT99908594T patent/ATE246490T1/de active
- 1999-03-01 ES ES99908594T patent/ES2204109T3/es not_active Expired - Lifetime
- 1999-03-01 IL IL13803299A patent/IL138032A0/xx active IP Right Grant
- 1999-03-01 US US09/259,718 patent/US6696091B2/en not_active Expired - Lifetime
- 1999-03-01 BR BR9908488-0A patent/BR9908488A/pt not_active Application Discontinuation
- 1999-03-01 JP JP2000534184A patent/JP2003530295A/ja active Pending
- 1999-03-01 EE EEP200000503A patent/EE04175B1/et unknown
- 1999-03-01 SK SK1306-2000A patent/SK285440B6/sk not_active IP Right Cessation
- 1999-03-01 PT PT99908594T patent/PT1066027E/pt unknown
- 1999-03-01 EA EA200000814A patent/EA200000814A1/ru unknown
- 1999-03-01 TR TR2000/02541T patent/TR200002541T2/xx unknown
- 1999-03-01 DK DK99908594T patent/DK1066027T3/da active
- 1999-03-01 CA CA002322644A patent/CA2322644C/en not_active Expired - Lifetime
- 1999-03-01 EP EP99908594A patent/EP1066027B1/en not_active Revoked
- 1999-03-01 KR KR1020007009784A patent/KR20010041592A/ko not_active Application Discontinuation
- 1999-03-01 MY MYPI99000735A patent/MY125821A/en unknown
- 1999-03-01 WO PCT/US1999/004449 patent/WO1999044581A2/en active IP Right Grant
- 1999-03-01 PL PL99343894A patent/PL194559B1/pl unknown
- 1999-03-01 HU HU0301192A patent/HUP0301192A3/hu unknown
- 1999-03-03 AR ARP990100895A patent/AR017984A1/es not_active Application Discontinuation
- 1999-03-03 ZA ZA9901716A patent/ZA991716B/xx unknown
- 1999-03-26 TW TW088103263A patent/TW590778B/zh not_active IP Right Cessation
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2000
- 2000-08-23 IL IL138032A patent/IL138032A/en not_active IP Right Cessation
- 2000-08-29 BG BG104727A patent/BG64885B1/bg unknown
- 2000-08-30 HR HR20000563A patent/HRP20000563B1/xx not_active IP Right Cessation
- 2000-08-30 NO NO20004311A patent/NO20004311L/no unknown
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2001
- 2001-04-18 HK HK01102738A patent/HK1032009A1/xx not_active IP Right Cessation
-
2003
- 2003-12-30 US US10/748,764 patent/US7125560B2/en not_active Expired - Lifetime
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2005
- 2005-03-31 AR ARP050101281A patent/AR048456A2/es not_active Application Discontinuation
- 2005-03-31 AR ARP050101282A patent/AR048457A2/es not_active Application Discontinuation
-
2006
- 2006-08-25 US US11/467,298 patent/US20060286163A1/en not_active Abandoned
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2007
- 2007-10-30 US US11/927,850 patent/US20080260813A1/en not_active Abandoned
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MK4A | Patent expired |
Expiry date: 20190301 |