ZA200407411B - Sustained release formulation of tramadol. - Google Patents
Sustained release formulation of tramadol. Download PDFInfo
- Publication number
- ZA200407411B ZA200407411B ZA200407411A ZA200407411A ZA200407411B ZA 200407411 B ZA200407411 B ZA 200407411B ZA 200407411 A ZA200407411 A ZA 200407411A ZA 200407411 A ZA200407411 A ZA 200407411A ZA 200407411 B ZA200407411 B ZA 200407411B
- Authority
- ZA
- South Africa
- Prior art keywords
- tramadol
- dosage form
- xanthan gum
- release
- tablet
- Prior art date
Links
- TVYLLZQTGLZFBW-ZBFHGGJFSA-N (R,R)-tramadol Chemical compound COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-ZBFHGGJFSA-N 0.000 title claims description 68
- 229960004380 tramadol Drugs 0.000 title claims description 67
- TVYLLZQTGLZFBW-GOEBONIOSA-N tramadol Natural products COC1=CC=CC([C@@]2(O)[C@@H](CCCC2)CN(C)C)=C1 TVYLLZQTGLZFBW-GOEBONIOSA-N 0.000 title claims description 63
- 239000000203 mixture Substances 0.000 title claims description 36
- 238000013268 sustained release Methods 0.000 title claims description 16
- 239000012730 sustained-release form Substances 0.000 title claims description 16
- 238000009472 formulation Methods 0.000 title description 23
- 239000002552 dosage form Substances 0.000 claims description 46
- 239000000230 xanthan gum Substances 0.000 claims description 33
- 229940082509 xanthan gum Drugs 0.000 claims description 33
- 229920001285 xanthan gum Polymers 0.000 claims description 33
- 235000010493 xanthan gum Nutrition 0.000 claims description 33
- 239000004615 ingredient Substances 0.000 claims description 17
- 239000011159 matrix material Substances 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 14
- 150000003839 salts Chemical class 0.000 claims description 14
- PPKXEPBICJTCRU-XMZRARIVSA-N (R,R)-tramadol hydrochloride Chemical compound Cl.COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 PPKXEPBICJTCRU-XMZRARIVSA-N 0.000 claims description 10
- 239000006186 oral dosage form Substances 0.000 claims description 10
- 229960003107 tramadol hydrochloride Drugs 0.000 claims description 10
- 238000007907 direct compression Methods 0.000 claims description 8
- 238000000576 coating method Methods 0.000 claims description 7
- 238000002156 mixing Methods 0.000 claims description 7
- 239000011248 coating agent Substances 0.000 claims description 6
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 239000007787 solid Substances 0.000 claims description 4
- 230000000873 masking effect Effects 0.000 claims description 3
- 235000019640 taste Nutrition 0.000 claims description 3
- QCQCHGYLTSGIGX-GHXANHINSA-N 4-[[(3ar,5ar,5br,7ar,9s,11ar,11br,13as)-5a,5b,8,8,11a-pentamethyl-3a-[(5-methylpyridine-3-carbonyl)amino]-2-oxo-1-propan-2-yl-4,5,6,7,7a,9,10,11,11b,12,13,13a-dodecahydro-3h-cyclopenta[a]chrysen-9-yl]oxy]-2,2-dimethyl-4-oxobutanoic acid Chemical group N([C@@]12CC[C@@]3(C)[C@]4(C)CC[C@H]5C(C)(C)[C@@H](OC(=O)CC(C)(C)C(O)=O)CC[C@]5(C)[C@H]4CC[C@@H]3C1=C(C(C2)=O)C(C)C)C(=O)C1=CN=CC(C)=C1 QCQCHGYLTSGIGX-GHXANHINSA-N 0.000 claims description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 22
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 22
- 239000003826 tablet Substances 0.000 description 22
- 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 description 13
- 239000008101 lactose Substances 0.000 description 13
- 235000019359 magnesium stearate Nutrition 0.000 description 11
- 239000000377 silicon dioxide Substances 0.000 description 10
- 235000012239 silicon dioxide Nutrition 0.000 description 9
- 238000013270 controlled release Methods 0.000 description 7
- 239000000945 filler Substances 0.000 description 7
- 239000000314 lubricant Substances 0.000 description 7
- 239000000463 material Substances 0.000 description 7
- 239000004480 active ingredient Substances 0.000 description 5
- 238000004090 dissolution Methods 0.000 description 5
- 239000003623 enhancer Substances 0.000 description 5
- 239000000546 pharmaceutical excipient Substances 0.000 description 5
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 3
- 238000007906 compression Methods 0.000 description 3
- 230000006835 compression Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000004014 plasticizer Substances 0.000 description 3
- 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 2
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 description 2
- 229920002472 Starch Polymers 0.000 description 2
- 230000000202 analgesic effect Effects 0.000 description 2
- 239000008119 colloidal silica Substances 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 239000000975 dye Substances 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 2
- 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 2
- 238000000338 in vitro Methods 0.000 description 2
- 230000036407 pain Effects 0.000 description 2
- 239000000049 pigment Substances 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 description 2
- 235000019422 polyvinyl alcohol Nutrition 0.000 description 2
- 230000002035 prolonged effect Effects 0.000 description 2
- 235000019698 starch Nutrition 0.000 description 2
- 235000000346 sugar Nutrition 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 239000004408 titanium dioxide Substances 0.000 description 2
- 239000005995 Aluminium silicate Substances 0.000 description 1
- 206010010774 Constipation Diseases 0.000 description 1
- 206010022998 Irritability Diseases 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 241000124008 Mammalia Species 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 229940127450 Opioid Agonists Drugs 0.000 description 1
- 208000004756 Respiratory Insufficiency Diseases 0.000 description 1
- 206010038678 Respiratory depression Diseases 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000000556 agonist Substances 0.000 description 1
- 235000012211 aluminium silicate Nutrition 0.000 description 1
- 125000003277 amino group Chemical group 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 229940035676 analgesics Drugs 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- OGBUMNBNEWYMNJ-UHFFFAOYSA-N batilol Polymers CCCCCCCCCCCCCCCCCCOCC(O)CO OGBUMNBNEWYMNJ-UHFFFAOYSA-N 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- 230000037058 blood plasma level Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000010668 complexation reaction Methods 0.000 description 1
- 238000012790 confirmation Methods 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 125000000753 cycloalkyl group Chemical group 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 239000012458 free base Substances 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 229920001477 hydrophilic polymer Polymers 0.000 description 1
- 238000005213 imbibition Methods 0.000 description 1
- 238000012625 in-situ measurement Methods 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 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
- 229960001375 lactose Drugs 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 239000000014 opioid analgesic Substances 0.000 description 1
- 230000008058 pain sensation Effects 0.000 description 1
- 150000002989 phenols Chemical class 0.000 description 1
- 239000008363 phosphate buffer Substances 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 229960001866 silicon dioxide Drugs 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- -1 sugars Chemical compound 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
- 239000012049 topical pharmaceutical composition Substances 0.000 description 1
- 231100000027 toxicology Toxicity 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
-
- 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
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP02076130 | 2002-03-22 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ZA200407411B true ZA200407411B (en) | 2005-08-31 |
Family
ID=28051804
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ZA200407411A ZA200407411B (en) | 2002-03-22 | 2004-09-15 | Sustained release formulation of tramadol. |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US20060018962A1 (es) |
| EP (1) | EP1490036A1 (es) |
| JP (1) | JP2005537221A (es) |
| KR (1) | KR20050009983A (es) |
| CN (1) | CN1642532A (es) |
| AU (1) | AU2003215671A1 (es) |
| CA (1) | CA2479252A1 (es) |
| IL (1) | IL164077A0 (es) |
| MX (1) | MXPA04009256A (es) |
| PL (1) | PL374350A1 (es) |
| RU (1) | RU2336864C2 (es) |
| WO (1) | WO2003080031A1 (es) |
| ZA (1) | ZA200407411B (es) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060172006A1 (en) * | 2003-10-10 | 2006-08-03 | Vincent Lenaerts | Sustained-release tramadol formulations with 24-hour clinical efficacy |
| US8168228B2 (en) * | 2003-10-17 | 2012-05-01 | Sandoz Ag | Antibiotic clarithromycin micropellet compositions |
| KR20070058540A (ko) * | 2004-10-01 | 2007-06-08 | 니폰 조키 세야쿠 가부시키가이샤 | 고형 의약제제 |
| NZ565108A (en) | 2005-07-07 | 2011-10-28 | Farnam Co Inc | Sustained release pharmaceutical compositions for highly water soluble drugs |
| DK1931346T3 (da) | 2005-09-09 | 2012-10-22 | Angelini Labopharm Llc | Trazodonsammensætning til indgivelse en gang om dagen |
| AU2007232836B2 (en) | 2006-03-30 | 2012-12-06 | Nippon Zoki Pharmaceutical Co., Ltd. | Solid pharmaceutical preparation |
| US9259426B2 (en) * | 2006-07-20 | 2016-02-16 | Gilead Sciences, Inc. | 4,6-di- and 2,4,6-trisubstituted quinazoline derivatives useful for treating viral infections |
| CN101095666B (zh) * | 2007-08-14 | 2010-10-06 | 石药集团欧意药业有限公司 | 一种盐酸曲马多缓释片剂及其制备方法 |
| CN101467984B (zh) * | 2007-12-25 | 2012-05-23 | 上海医药工业研究院 | 一种曲马多鼻用凝胶剂及其制备方法和用途 |
| US20100003322A1 (en) * | 2008-07-03 | 2010-01-07 | Lai Felix S | Enteric coated hydrophobic matrix formulation |
| CN101780039A (zh) * | 2010-03-05 | 2010-07-21 | 南京海陵中药制药工艺技术研究有限公司 | 曲马多多囊泡脂质体及其制备方法 |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3652589A (en) * | 1967-07-27 | 1972-03-28 | Gruenenthal Chemie | 1-(m-substituted phenyl)-2-aminomethyl cyclohexanols |
| GB8601204D0 (en) * | 1986-01-18 | 1986-02-19 | Boots Co Plc | Therapeutic agents |
| US5292534A (en) * | 1992-03-25 | 1994-03-08 | Valentine Enterprises, Inc. | Sustained release composition and method utilizing xanthan gum and an active ingredient |
| NZ260408A (en) * | 1993-05-10 | 1996-05-28 | Euro Celtique Sa | Controlled release preparation comprising tramadol |
| DE4329794C2 (de) * | 1993-09-03 | 1997-09-18 | Gruenenthal Gmbh | Tramadolsalz enthaltende Arzneimittel mit verzögerter Wirkstofffreisetzung |
| US5399358A (en) * | 1993-11-12 | 1995-03-21 | Edward Mendell Co., Inc. | Sustained release formulations for 24 hour release of metroprolol |
| JPH08295637A (ja) * | 1995-04-27 | 1996-11-12 | Green Cross Corp:The | 口腔部局所投与剤 |
| ES2248908T7 (es) * | 1997-06-06 | 2014-11-24 | Depomed, Inc. | Formas de dosificación de fármacos por vía oral y retención gástrica para liberación continuada de fármacos altamente solubles |
| WO1999001111A1 (en) * | 1997-07-02 | 1999-01-14 | Euro-Celtique, S.A. | Stabilized sustained release tramadol formulations |
| US6607748B1 (en) * | 2000-06-29 | 2003-08-19 | Vincent Lenaerts | Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture |
| CA2423558A1 (en) * | 2000-10-03 | 2002-04-11 | Penwest Pharmaceuticals Company | Delivery system for multi-pharmaceutical active materials at various release rates |
| US20020106408A1 (en) * | 2000-12-01 | 2002-08-08 | Johnatan Bacon | Prolamin-based sustained-release compositions and delayed-onset compositions |
| WO2002085335A1 (en) * | 2001-04-18 | 2002-10-31 | Nostrum Pharmaceuticals Inc. | A novel coating for a sustained release pharmaceutical composition |
-
2003
- 2003-03-21 KR KR10-2004-7014814A patent/KR20050009983A/ko not_active Application Discontinuation
- 2003-03-21 PL PL03374350A patent/PL374350A1/xx not_active Application Discontinuation
- 2003-03-21 WO PCT/EP2003/003050 patent/WO2003080031A1/en active Application Filing
- 2003-03-21 MX MXPA04009256A patent/MXPA04009256A/es unknown
- 2003-03-21 CA CA002479252A patent/CA2479252A1/en not_active Abandoned
- 2003-03-21 EP EP03744847A patent/EP1490036A1/en not_active Withdrawn
- 2003-03-21 US US10/508,615 patent/US20060018962A1/en not_active Abandoned
- 2003-03-21 AU AU2003215671A patent/AU2003215671A1/en not_active Abandoned
- 2003-03-21 RU RU2004131213/15A patent/RU2336864C2/ru not_active IP Right Cessation
- 2003-03-21 IL IL16407703A patent/IL164077A0/xx unknown
- 2003-03-21 CN CNA038065762A patent/CN1642532A/zh active Pending
- 2003-03-21 JP JP2003577861A patent/JP2005537221A/ja not_active Withdrawn
-
2004
- 2004-09-15 ZA ZA200407411A patent/ZA200407411B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US20060018962A1 (en) | 2006-01-26 |
| AU2003215671A1 (en) | 2003-10-08 |
| EP1490036A1 (en) | 2004-12-29 |
| RU2336864C2 (ru) | 2008-10-27 |
| KR20050009983A (ko) | 2005-01-26 |
| WO2003080031A1 (en) | 2003-10-02 |
| MXPA04009256A (es) | 2005-01-25 |
| PL374350A1 (en) | 2005-10-17 |
| CN1642532A (zh) | 2005-07-20 |
| IL164077A0 (en) | 2005-12-18 |
| CA2479252A1 (en) | 2003-10-02 |
| RU2004131213A (ru) | 2005-08-10 |
| JP2005537221A (ja) | 2005-12-08 |
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