DK2575778T3 - Farmaceutiske sammensætninger af co-krystaller af tramadol og coxiber - Google Patents
Farmaceutiske sammensætninger af co-krystaller af tramadol og coxiber Download PDFInfo
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- DK2575778T3 DK2575778T3 DK11723885.7T DK11723885T DK2575778T3 DK 2575778 T3 DK2575778 T3 DK 2575778T3 DK 11723885 T DK11723885 T DK 11723885T DK 2575778 T3 DK2575778 T3 DK 2575778T3
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/415—1,2-Diazoles
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- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
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- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- C07C59/00—Compounds having carboxyl groups bound to acyclic carbon atoms and containing any of the groups OH, O—metal, —CHO, keto, ether, groups, groups, or groups
- C07C59/40—Unsaturated compounds
- C07C59/58—Unsaturated compounds containing ether groups, groups, groups, or groups
- C07C59/64—Unsaturated compounds containing ether groups, groups, groups, or groups containing six-membered aromatic rings
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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
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/05—Phenols
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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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/18—Sulfonamides
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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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/415—1,2-Diazoles
- A61K31/4162—1,2-Diazoles condensed with heterocyclic ring systems
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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
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
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Claims (15)
1. Farmaceutisk sammensætning omfattende en co-krystal af (rac)-tramadol-HCI - celecoxib (1:1) og mindst en opløselighedsforstærkerpolymer; hvor opløselighedsforstærkerpolymeren er udvalgt blandt polyvinylcaprolac-tam-polyvinylacetat-polyethylenglycol-podningscopolymer eller blandt copovidon, povidon, cyclodextrin, polyethylenglycol og lauroyl-macrogol-32-glycerider EP.
2. Farmaceutisk sammensætning ifølge krav 1, hvor opløselighedsforstær-kerpolymeren er udvalgt blandt polyvinylcaprolactam-polyvinylacetat-polyethylenglycol-podningscopolymer eller andre hydrofile polymerer udvalgt blandt copovidon eller povidon.
3. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 eller 2, hvor opløselighedsforstærkerpolymeren er polyvinylcaprolactam-polyvinylacetat-polyethylenglycol-podningscopolymer.
4. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 eller 2, hvor opløselighedsforstærkerpolymeren er copolymer-copovidon.
5. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 4, hvor indholdet af opløselighedsforstærkerpolymer anvendt i sammensætningen ligger mellem 2-50 vægt-%, fortrinsvis mellem 8-12 vægt-% eller ca. 8 vægt-%.
6. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 5, som er i en form udvalgt blandt tablet, pulverkapsler, eller formuleret ved tørgranulering, opslæmninger og tørrulle-sammenpresning, fortrinsvis i form af en tablet, mest fortrinsvis i form af en tablet, der kan opnås ved en direkte komprimeringsproces.
7. Farmaceutisk sammensætning ifølge krav 1 i form af en tablet omfattende en co-krystal af (rac)-tramadol-HCI - celecoxib (1:1) og mindst en opløselighedsforstærkerpolymer, som kan opnås ved en direkte komprimeringspro- ces.
8. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 7, som yderligere omfatter mindst en overfladeaktiv polymer.
9. Farmaceutisk sammensætning ifølge krav 8, hvor den overfladeaktive polymer er udvalgt blandt mikroindkapslet polysorbat 80, mikroindkapslet poly-oxyl 40 - hydrogeneret ricinusolie og natriumlaurylsulphat.
10. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 9, omfattende mindst en yderligere farmaceutisk acceptabel excipiens som et fyldstof, et opløsningsmiddel og/eller et smøremiddel.
11. Farmaceutisk sammensætning ifølge krav 10, hvor fyldstoffet er udvalgt blandt sukkerarter såsom xylitol, sorbitol, isomalt, erythritol, saccharose, fructose, dextrose, mest fortrinsvis spraytørret mannitol og lactose-familie eller fra uopløselige fyldstoffer som calciumphosphat, calciumcarbonat eller mi-krokrystallinske celluloser som MCC 102 (90 pm) og MCC 200 (200 pm) eller andre forbindelser såsom silicificeret mikrokrystallin eller sammensætninger indeholdende mikrokrystallinsk cellulose, kolloidal siliciumdioxid, natriumsti-velsesglycolat og natriumstearylfumarat, fortrinsvis er udvalgt blandt sukkerarter såsom xylitol, sorbitol, isomalt, erythritol, saccharose, fructose, dextrose, mest fortrinsvis spraytørret mannitol og lactose-familie eller fra mikrokrystallinsk cellulose, mest fortrinsvis er udvalgt blandt spraytørret mannitol og mikrokrystallinsk cellulose.
12. Farmaceutisk sammensætning ifølge krav 10 eller 11, hvor smøremidlet er udvalgt blandt stearylfumarat, magnesiumstearat, talkum, hydrofil røget silica, fortrinsvis er udvalgt blandt stearylfumarat og talkum, og/eller hvor opløsningsmidlet er udvalgt blandt crospovidon, croscarmellose-natrium, natriumstivelsesglycolat, pregelatineret stivelse, stivelse, polacrilin-kalium, lavsubstitueret hydroxypropylcellulose (L-HPC), calcium-carboxymethylcellulose, alginsyre, fortrinsvis er crospovidon.
13. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 12, hvor co-krystallen af (rac)-tramadol-HCI og celecoxib (1:1) er kendeteg net ved, at den udviser et pulverrøntgendiffraktionsmønster med peaks [2Θ] ved 7,1, 9,3, 10,2, 10,7, 13,6, 13,9, 14.1, 15,5, 16,1, 16,2, 16,8, 17,5, 18,0, 19,0, 19,5, 19,9, 20,5, 21,2, 21,3, 21,4, 21,8, 22,1, 22,6, 22,7, 23,6, 24,1, 24,4, 25,2, 26,1, 26,6, 26,8, 27,4, 27,9, 28,1, 29,1, 29,9, 30,1, 31,1, 31,3, 31,7, 32,5, 32,8, 34,4, 35,0, 35,8, 36,2 og 37,2[°|, idet 20-værdierne er opnået under anvendelse af kobberstråling (Cukcm 1,54060Å); og/eller hvor co-krystallen af (rac)-tramadol-HCI og celecoxib (1:1) er kendetegnet ved, at den udviser et Fourier Transform Infrarød-mønster med absorptionsbånd ved 3481,6 (m), 3133,5 (m), 2923,0 (m), 2667,7 (m), 1596,0 (m), 1472,4 (m), 1458,0 (m), 1335,1 (m), 1288,7 (m), 1271,8 (m), 1168,7 (s), 1237,3 (m), 1168,7 (s), 1122,6 (s), 1100,9 (m), 1042,2 (m), 976,8 (m), 844,6 (m), 820,1 (m), 786,5 (m) 625,9 (m) cm'1; og/eller kendetegnet ved, at co-krystallen af (rac)-tramadol-HCI og celecoxib (1:1) har en orthorhombisk enhedscelle med følgende dimensioner: a = 11,0323(7) Å b = 18,1095(12) Å c = 17,3206(12) Å; og/eller kendetegnet ved, at det endotermiske skarpe peak, der svarer til smeltepunktet af co-krystallen af (ra^-tramadol-HCI og celecoxib (1:1) indtræder ved 164 °C.
14. Fremgangsmåde til fremstilling af en oral farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 13, omfattende trinnene: (a) blanding af co-krystallen af (rac)-tramadol-HCI - celecoxib (1:1) med mindst en opløselighedsforstærkerpolymer og eventuelt et eller flere fyldstoffer, opløsningsmidler eller overfladeaktive polymerer eller en hvilken som helst kombination deraf; (b) eventuelt tilsætning af mindst et smøremiddel; (c) direkte komprimering af blandingen fra trin (a) eller den smurte blanding fra trin (b) til en tablet.
15. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 13 til anvendelse ved behandling af smerte, fortrinsvis akut smerte, kronisk smerte, neuropatisk smerte, nociceptiv smerte, mild og svær til moderat smerte, hyperalgesi, smerte, der er relateret til central sensibilisering, allodyni eller cancersmerte, herunder diabetisk neuropati eller diabetisk perifer neu- ropati og osteoarthritis, fibromyalgi; reumatoid artritis, ankyloserende spondylitis, frossen skulder eller ischias.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP10384002A EP2392319A1 (en) | 2010-06-04 | 2010-06-04 | Pharmaceutical compositions of co-crystals of tramadol and coxibs |
PCT/EP2011/002749 WO2011151080A1 (en) | 2010-06-04 | 2011-06-03 | Pharmaceutical compositions of co-crystals of tramadol and coxibs |
Publications (1)
Publication Number | Publication Date |
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DK2575778T3 true DK2575778T3 (da) | 2017-04-18 |
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Application Number | Title | Priority Date | Filing Date |
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DK11723885.7T DK2575778T3 (da) | 2010-06-04 | 2011-06-03 | Farmaceutiske sammensætninger af co-krystaller af tramadol og coxiber |
Country Status (32)
Country | Link |
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US (1) | US8846744B2 (da) |
EP (3) | EP2392319A1 (da) |
JP (1) | JP5800016B2 (da) |
KR (1) | KR101556700B1 (da) |
CN (1) | CN102946871B (da) |
AR (1) | AR081774A1 (da) |
AU (1) | AU2011260608B2 (da) |
BR (1) | BR112012030704A2 (da) |
CA (1) | CA2798090C (da) |
CO (1) | CO6660469A2 (da) |
CY (1) | CY1118813T1 (da) |
DK (1) | DK2575778T3 (da) |
EC (1) | ECSP13012368A (da) |
ES (1) | ES2622192T3 (da) |
HR (1) | HRP20170594T1 (da) |
HU (1) | HUE033999T2 (da) |
IL (1) | IL222731A (da) |
LT (1) | LT2575778T (da) |
MX (1) | MX351507B (da) |
MY (1) | MY156859A (da) |
NZ (1) | NZ603457A (da) |
PL (1) | PL2575778T3 (da) |
PT (1) | PT2575778T (da) |
RS (1) | RS55878B1 (da) |
RU (1) | RU2567843C2 (da) |
SG (1) | SG185385A1 (da) |
SI (1) | SI2575778T1 (da) |
TN (1) | TN2012000515A1 (da) |
TW (1) | TWI508722B (da) |
UA (1) | UA109661C2 (da) |
WO (1) | WO2011151080A1 (da) |
ZA (1) | ZA201208767B (da) |
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Publication number | Priority date | Publication date | Assignee | Title |
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EP2177215A1 (en) * | 2008-10-17 | 2010-04-21 | Laboratorios Del. Dr. Esteve, S.A. | Co-crystals of tramadol and NSAIDs |
EP2311446A1 (en) * | 2009-10-16 | 2011-04-20 | Laboratorios Del. Dr. Esteve, S.A. | Compositions comprising Tramadol and Celecoxib in the treatment of pain |
WO2014138881A1 (en) * | 2013-03-12 | 2014-09-18 | Patheon, Inc. | Drug delivery system |
US20180104197A9 (en) | 2014-05-01 | 2018-04-19 | Sun Pharmaceutical Industries Limited | Extended release liquid compositions of metformin |
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AU2015254875A1 (en) | 2014-05-01 | 2016-11-17 | Sun Pharmaceutical Industries Limited | Extended release suspension compositions |
US9962336B2 (en) | 2014-05-01 | 2018-05-08 | Sun Pharmaceutical Industries Limited | Extended release suspension compositions |
PL3137057T3 (pl) * | 2014-05-01 | 2021-04-06 | Sun Pharmaceutical Industries Ltd | Kompozycje ciekłe metforminy o przedłużonym uwalnianiu |
RU2017106010A (ru) | 2014-07-30 | 2018-08-28 | Сан Фармасьютикал Индастриз Лимитед | Двухкамерная упаковка |
WO2016046693A1 (en) * | 2014-09-25 | 2016-03-31 | Nathwani Sandeep Vinodkumar | A co-processed pharmaceutical excipient |
CN104276960B (zh) * | 2014-09-26 | 2016-09-28 | 安徽省逸欣铭医药科技有限公司 | 盐酸他喷他多和塞来昔布共晶及其组合物和制备方法 |
US10238803B2 (en) | 2016-05-02 | 2019-03-26 | Sun Pharmaceutical Industries Limited | Drug delivery device for pharmaceutical compositions |
US10369078B2 (en) | 2016-05-02 | 2019-08-06 | Sun Pharmaceutical Industries Limited | Dual-chamber pack for pharmaceutical compositions |
WO2018031577A1 (en) * | 2016-08-09 | 2018-02-15 | Autotelic Llc | Fixed dose combination for pain relief without edema |
DE102016012746A1 (de) | 2016-10-25 | 2018-04-26 | WindplusSonne GmbH | Vorprodukte zur Herstellung von porösen, mineralischen Leichtbaumaterialien, Verfahren zur Herstellung von porösen, mineralischen Leichtbaumaterialien und ihre Verwendung |
AU2017376257A1 (en) * | 2016-12-14 | 2019-06-13 | Druggability Technologies Ip Holdco Limited | Pharmaceutical composition containing celecoxib |
CN107595792A (zh) * | 2017-11-06 | 2018-01-19 | 刘丽 | 一种盐酸他喷他多塞来昔布片剂及其制备方法 |
CN110101673A (zh) * | 2019-05-07 | 2019-08-09 | 安徽金太阳生化药业有限公司 | 一种盐酸曲马多分散片的制备方法 |
BR112021020893A2 (pt) * | 2019-05-14 | 2022-04-19 | Esteve Pharmaceuticals Sa | Uso de cocristais de tramadol e celecoxib para o tratamento de dor, ao mesmo tempo que reduzindo a suscetibilidade a abuso do tramadol |
CN112007024A (zh) * | 2019-05-28 | 2020-12-01 | 江苏恒瑞医药股份有限公司 | 艾瑞昔布与曲马多联合在制备治疗疼痛的药物中的用途 |
CN115251264B (zh) * | 2022-08-05 | 2023-11-21 | 齐鲁工业大学 | 含桑叶提取物的共结晶粉末功能性饮料及其制备方法 |
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WO2000051685A1 (en) * | 1999-03-01 | 2000-09-08 | Ortho-Mcneil Pharmaceutical, Inc. | Composition comprising a tramadol material and a selective cox-2 inhibitor drug |
DE10014588A1 (de) * | 2000-03-27 | 2001-10-04 | Basf Ag | Wirkstoffhaltige Schwimmformen enthaltend Polyvinylacetat und Polyvinylpyrrolidon, deren Verwendung und Herstellung |
US20030105141A1 (en) * | 2001-04-17 | 2003-06-05 | Ping Gao | Finely self-emulsifiable pharmaceutical composition |
EP1478366B1 (en) * | 2002-02-19 | 2008-12-03 | Adcock Ingram Limited | Pharmaceutical combinations of meloxicam, codeine phosphate and paracetamol |
JP2005154334A (ja) * | 2003-11-25 | 2005-06-16 | Toa Yakuhin Kk | アズレンスルホン酸塩水溶液剤 |
DE102006044694A1 (de) * | 2006-09-22 | 2008-03-27 | Krewel Meuselbach Gmbh | Perorale feste Schmerzmittelzubereitung |
WO2008085674A1 (en) * | 2007-01-04 | 2008-07-17 | Transform Pharmaceuticals, Inc. | Pharmaceutical compositions comprising celecoxib co-crystals |
CN101254180B (zh) * | 2008-03-28 | 2010-11-10 | 辽宁正鑫药物研究有限公司 | 一种内容物为半固体组合物的尼莫地平胶囊剂及制备方法 |
EP2177215A1 (en) | 2008-10-17 | 2010-04-21 | Laboratorios Del. Dr. Esteve, S.A. | Co-crystals of tramadol and NSAIDs |
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2010
- 2010-06-04 EP EP10384002A patent/EP2392319A1/en not_active Withdrawn
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2011
- 2011-06-03 CA CA2798090A patent/CA2798090C/en active Active
- 2011-06-03 US US13/701,192 patent/US8846744B2/en active Active
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- 2011-06-03 AU AU2011260608A patent/AU2011260608B2/en active Active
- 2011-06-03 JP JP2013512793A patent/JP5800016B2/ja active Active
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- 2011-06-03 KR KR1020127033847A patent/KR101556700B1/ko active IP Right Grant
- 2011-06-03 UA UAA201300099A patent/UA109661C2/uk unknown
- 2011-06-03 EP EP11723885.7A patent/EP2575778B1/en active Active
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- 2011-06-03 DK DK11723885.7T patent/DK2575778T3/da active
- 2011-06-03 WO PCT/EP2011/002749 patent/WO2011151080A1/en active Application Filing
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- 2011-06-03 EP EP16203254.4A patent/EP3158994A1/en not_active Withdrawn
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