RU2016147009A - Композиции с пролонгированным высвобождением в виде суспензии - Google Patents
Композиции с пролонгированным высвобождением в виде суспензии Download PDFInfo
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- RU2016147009A RU2016147009A RU2016147009A RU2016147009A RU2016147009A RU 2016147009 A RU2016147009 A RU 2016147009A RU 2016147009 A RU2016147009 A RU 2016147009A RU 2016147009 A RU2016147009 A RU 2016147009A RU 2016147009 A RU2016147009 A RU 2016147009A
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- RU
- Russia
- Prior art keywords
- suspension
- sustained release
- pharmaceutically acceptable
- suspension composition
- cellulose
- Prior art date
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- 239000000725 suspension Substances 0.000 title claims 29
- 230000007774 longterm Effects 0.000 title 1
- 238000013268 sustained release Methods 0.000 claims 17
- 239000012730 sustained-release form Substances 0.000 claims 17
- -1 e.g. Chemical compound 0.000 claims 16
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- 239000000126 substance Substances 0.000 claims 4
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- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 1
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- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 claims 1
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 claims 1
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- KQKPFRSPSRPDEB-UHFFFAOYSA-N sumatriptan Chemical compound CNS(=O)(=O)CC1=CC=C2NC=C(CCN(C)C)C2=C1 KQKPFRSPSRPDEB-UHFFFAOYSA-N 0.000 claims 1
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- DOMXUEMWDBAQBQ-WEVVVXLNSA-N terbinafine Chemical compound C1=CC=C2C(CN(C\C=C\C#CC(C)(C)C)C)=CC=CC2=C1 DOMXUEMWDBAQBQ-WEVVVXLNSA-N 0.000 claims 1
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- OKUCEQDKBKYEJY-UHFFFAOYSA-N tert-butyl 3-(methylamino)pyrrolidine-1-carboxylate Chemical compound CNC1CCN(C(=O)OC(C)(C)C)C1 OKUCEQDKBKYEJY-UHFFFAOYSA-N 0.000 claims 1
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- 150000003522 tetracyclines Chemical class 0.000 claims 1
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- LLPOLZWFYMWNKH-UHFFFAOYSA-N trans-dihydrocodeinone Natural products C1C(N(CCC234)C)C2CCC(=O)C3OC2=C4C1=CC=C2OC LLPOLZWFYMWNKH-UHFFFAOYSA-N 0.000 claims 1
- 150000003626 triacylglycerols Chemical class 0.000 claims 1
- 229940001496 tribasic sodium phosphate Drugs 0.000 claims 1
- 125000005591 trimellitate group Chemical class 0.000 claims 1
- FQCQGOZEWWPOKI-UHFFFAOYSA-K trisalicylate-choline Chemical compound [Mg+2].C[N+](C)(C)CCO.OC1=CC=CC=C1C([O-])=O.OC1=CC=CC=C1C([O-])=O.OC1=CC=CC=C1C([O-])=O FQCQGOZEWWPOKI-UHFFFAOYSA-K 0.000 claims 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 1
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- GXPHKUHSUJUWKP-UHFFFAOYSA-N troglitazone Chemical compound C1CC=2C(C)=C(O)C(C)=C(C)C=2OC1(C)COC(C=C1)=CC=C1CC1SC(=O)NC1=O GXPHKUHSUJUWKP-UHFFFAOYSA-N 0.000 claims 1
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- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 claims 1
- 229960004688 venlafaxine Drugs 0.000 claims 1
- PNVNVHUZROJLTJ-UHFFFAOYSA-N venlafaxine Chemical compound C1=CC(OC)=CC=C1C(CN(C)C)C1(O)CCCCC1 PNVNVHUZROJLTJ-UHFFFAOYSA-N 0.000 claims 1
- 229960001722 verapamil Drugs 0.000 claims 1
- 229960001729 voglibose Drugs 0.000 claims 1
- 239000000080 wetting agent Substances 0.000 claims 1
- 235000010447 xylitol Nutrition 0.000 claims 1
- 239000000811 xylitol Substances 0.000 claims 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 1
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- 239000005019 zein Substances 0.000 claims 1
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- HBOMLICNUCNMMY-XLPZGREQSA-N zidovudine Chemical compound O=C1NC(=O)C(C)=CN1[C@@H]1O[C@H](CO)[C@@H](N=[N+]=[N-])C1 HBOMLICNUCNMMY-XLPZGREQSA-N 0.000 claims 1
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims 1
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Claims (45)
1. Суспензионная композиция с пролонгированным высвобождением, включающая:
(a) множество имеющих покрытие ядер, включающих:
(i) ядро, включающее активный ингредиент; и
(ii) нанесенный на ядро слой покрытия, включающий один или более полимеров, регулирующих высвобождение;
(b) суспендирующую основу, причем суспендирующая основа создает гипертоническую среду, препятствующую существенному изменению профиля высвобождения посредством растворения in vitro суспензионных композиций с пролонгированным высвобождением при хранении композиций в течение по меньшей мере семи суток.
2. Суспензионная композиция с пролонгированным высвобождением, включающая:
(a) множество имеющих покрытие ядер, включающих:
(i) ядро, включающее активный ингредиент; и
(ii) нанесенный на ядро слой покрытия, включающий один или более полимеров, регулирующих высвобождение;
(b) суспендирующую основу;
при этом композиция отличается тем, что имеет отношение осмоляльностей, составляющее по меньшей мере приблизительно 1, и профиль высвобождения при растворении in vitro суспензионных композиций с пролонгированным высвобождением по существу не изменяется после хранения в течение по меньшей мере семи суток.
3. Суспензионная композиция с пролонгированным высвобождением по п. 1 или 2, в которой суспендирующая основа включает вещество, изменяющее осмотическое давление среды.
4. Суспензионная композиция с пролонгированным высвобождением по п. 1 или 2, отличающаяся тем, что композиция представляет собой суспензию или ресуспендируемый (восстанавливаемый) порошок для получения суспензии.
5. Суспензионная композиция с пролонгированным высвобождением по п. 1 или 2, в которой активный ингредиент послойно нанесен на инертную частицу с образованием ядра.
6. Суспензионная композиция с пролонгированным высвобождением по п. 5, в которой инертная частица выбрана из группы, включающей зерна нонпарель,
сферу из микрокристаллической целлюлозы, гранулу гидроортофосфата (двузамещенного ортофосфата) кальция, гранулу маннита, гранулу оксида кремния, крупинку винной кислоты или крупинку на основе воска.
7. Суспензионная композиция с пролонгированным высвобождением по п. 3, в которой вещество, изменяющее осмотическое давление среды, выбрано из группы, включающей углеводы, такие как ксилит, маннит, сорбит, арабиноза, рибоза, ксилоза, глюкоза, фруктоза, манноза, галактоза, сахароза, мальтоза, лактоза, декстроза и раффиноза; водорастворимые соли неорганических кислот, такие как хлорид магния, сульфат магния, сульфат калия, хлорид лития, хлорид натрия, хлорид калия, гидрофосфат лития, гидрофосфат натрия, гидрофосфат калия, дигидрофосфат лития, дигидрофосфат натрия, дигидрофосфат калия и трехосновный фосфат натрия; водорастворимые соли органических кислот, такие как ацетат натрия, ацетат калия, сукцинат магния, бензоат натрия, цитрат натрия и аскорбат натрия; водорастворимые аминокислоты, такие как глицин, лейцин, аланин, метионин; мочевину или ее производные; пропиленгликоль; глицерин; полиэтиленоксид; ксантановую камедь; гидроксипропилметилцеллюлозу; или смеси перечисленных соединений.
8. Суспензионная композиция с пролонгированным высвобождением по п. 1, в которой регулирующий высвобождение полимер выбран из группы, включающей полимер, свойства которого зависят от рН, полимер, свойства которого не зависят от рН, или их смеси.
9. Суспензионная композиция с пролонгированным высвобождением по п. 8, в которой полимер, свойства которого зависят от рН, выбран из группы, включающей акриловые сополимеры, такие как сополимеры метакриловой кислоты и метилметакрилата, например, Eudragit® L 100 и Eudragit® S 100, сополимеры метакриловой кислоты и этилакрилата, например, Eudragit® L 100-55 и Eudragit® L 30 D-55, сополимеры диметиламиноэтилметакрилата, бутилметакрилата и метилметакрилата, например, Eudragit® Е 100, Eudragit® Е РО, сополимеры метилакрилата, метакриловой кислоты и октилакрилата, сополимеры стирола и акриловой кислоты, сополимеры стирола, акриловой кислоты и бутилакрилата, и сополимер этилакрилата и метакриловой кислоты; ацетатфталат целлюлозы; ацетатсукцинаты целлюлозы; фталаты гидроксиалкилцеллюлозы, такие как фталат гидроксипропилметилцеллюлозы; ацетатсукцинаты гидроксиалкилцеллюлозы, такие как ацетатсукцинат гидроксипропилметилцеллюлозы; винилацетатфталаты; винилацетатсукцинат; ацетаттримеллитат целлюлозы; производные поливинила, такие как поливинилацетатфталат, фталат поливинилового спирта,
поливинилбутилатфталат и фталат поливинилацетоацеталя; зеин; шеллак; или их смеси.
10. Суспензионная композиция с пролонгированным высвобождением по п. 8, в которой полимер, свойства которого не зависят от рН, выбран из группы, включающей целлюлозные полимеры, такие как этилцеллюлоза, метил целлюлоза, гидроксиэтилцеллюлоза, гидроксипропилцеллюлоза, гидроксиэтилметилцеллюлоза, гидроксипропилметилцеллюлоза и карбоксиметилцеллюлоза; акриловые сополимеры, такие как сополимеры метакриловой кислоты, например, Eudragit® RS, Eudragit® RL, Eudragit® NE 30 D; ацетат целлюлозы; производные полиэтилена, например, полиэтиленгликоль и полиэтиленоксид; поливиниловый спирт; поливинилацетат; камеди, например, гуаровая камедь, камедь бобов рожкового дерева, трагакантовая камедь, каррагенан, альгиновая кислота, гуммиарабик, аравийская камедь, геллановая камедь и ксантановая камедь; триглицериды; воски, например, Compritol®, Lubritab® и Gelucires®; липиды; жирные кислоты или их соли/производные; смесь поливинилацетата и поливинилпирролидона, например, Kollidon® SR; или смеси перечисленных веществ.
11. Суспензионная композиция с пролонгированным высвобождением по п. 1, в которой активный ингредиент выбран из группы, включающей метформин, акарбозу, миглитол, воглибоз, репаглинид, натеглинид, глибенкламид, глимепирид, глипизид, гликлазид, хлорпропамид, толбутамид, фенформин, алоглиптин, ситаглиптин, линаглиптин, саксаглиптин, розиглитазон, пиоглитазон, троглитазон, фараглитазар, энглитазон, дарглитазон, изаглитазон, зорглитазон, лираглутид, мураглитазар, пелиглитазар, тезаглитазар, канаглифлозин, дапаглифлозин, ремоглифлозин, серглифлозин, верапамил, альбутерол, сальметерол, ацебутолол, соталол, пеницилламин, норфлоксацин, ципрофлоксацин, офлоксацин, левофлоксацин, моксифлоксацин, тровафлоксацин, гатифлоксацин, цефиксим, цефдинир, цефпрозил, цефадроксил, цефуроксим, цефподоксим, тетрациклин, демеклоциклина гидрохлорид, амоксициллин, клавуланат калия, азитромицин, лозартан, ирбесартан, эпросартан, валсартан, ирбесартан, дилтиазем, изосорбида мононитрат, ранолазин, пропафенон, гидроксимочевину, гидрокодон, делавирдин, пентозана полисульфат, абакавир, амантадин, ацикловир, ганцикловир, валацикловир, валганцикловир, саквинавир, идинавир, нелфинавир, ламивудин, диданозин, зидовудин, набуметон, целекоксиб, мефенамовую кислоту, напроксен, пропоксифен, циметидин, ранитидин, албендазол, мебендазол, тиобендазол, пиразинамид, празиквантел, хлорпромазин, суматриптан, бупропион, аминобензоат, пиридостигмина бромид, калия хлорид, ниацин, токайнид, кветиапин,
фексофенадин, сертралин, хлорфенирамин, рифампин, метенамин, нефазодон, модафинил, метаксалон, морфин, севеламер, карбонат лития, флекаинида ацетат, симетикон, метилдопа, хлортиазид, метирозин, прокаинамид, энтакапон, метопролол, пропанолола гидрохлорид, хлорзоксазон, толметин, трамадол, бепридил, фенитоин, габапентин, флуконазол, тербинафин, аторвастатин, доксепин, рифабутин, месаламин, этидронат, нитрофурантоин, холин-магний трисалицилат, теофиллин, низатидин, метокарбамол, микофенолята мофетил, толкапон, тиклопидин, капецитабин, орлистат, колесевелам, меперидин, гидроксихлорохин, гвайфенезин, гуанфацин, амиодарон, хинидин, атомоксетин, фелбамат, псевдоэфедрин, карисопродол, венлафаксин, этодолак, хондроитин, лансопразол, пантопразол, эзомепразол, декслансопразол, дексметилфенидат, метилфенидат, оксибутират натрия или изотретиноин.
12. Суспензионная композиция с пролонгированным высвобождением по п. 3, в которой суспендирующая основа дополнительно включает одно или более фармацевтически приемлемых вспомогательных веществ, выбранных из группы, включающей суспендирующие агенты, добавки, препятствующие слипанию, смачивающие агенты, консерванты, буферные вещества, вкусовые добавки, антиоксиданты и хелатирущие агенты.
13. Способ получения суспензионной композиции с пролонгированным высвобождением по п. 1 или 2, включающий следующие этапы:
(i) получение ядер, включающих активный ингредиент и одно или более фармацевтически приемлемых вспомогательных веществ;
(ii) растворение/диспергирование в подходящем растворителе полимера, регулирующего высвобождение, и одной или более фармацевтически приемлемых добавок, образующих покрытие;
(iii) нанесение композиции покрытия, полученной на этапе (ii), на ядра, полученные на этапе (i);
(iv) растворение одного или более веществ, изменяющих осмотическое давление среды, и фармацевтически приемлемых вспомогательных веществ в фармацевтически приемлемом носителе с образованием суспендирующей основы; и
(v) диспергирование полученных на этапе (iii) ядер с покрытием в суспендирующей основе, полученной на этапе (iv), в результате чего получают суспензионную композицию с пролонгированным высвобождением.
14. Способ получения суспензионной композиции с пролонгированным высвобождением по п. 1 или 2, который включает следующие этапы:
(A) получение порошка для суспензии, включающее следующие этапы:
(i) получение ядер, включающих активный ингредиент и одно или более фармацевтически приемлемых вспомогательных веществ;
(ii) растворение/диспергирование в подходящем растворителе полимера, регулирующего высвобождение, и одной или более фармацевтически приемлемых добавок, образующих покрытие;
(iii) нанесение композиции покрытия, полученной на этапе (ii), на ядра, полученные на этапе (i);
(iv) смешивание одного или более фармацевтически приемлемых вспомогательных веществ с имеющими покрытие ядрами, полученными на этапе (iii), с образованием порошка для суспензии;
(B) получение суспендирующей основы посредством растворения одного или более веществ, изменяющих осмотическое давление среды, и фармацевтически приемлемых вспомогательных веществ в фармацевтически приемлемом носителе; и
(C) ресуспендирование порошка для суспензии, полученного на этапе (А), в суспендирующей основе, полученной на этапе (В), в результате чего получают суспензионную композицию с пролонгированным высвобождением.
15. Способ получения суспензионной композиции с пролонгированным высвобождением по п. 1 или 2, который включает следующие этапы:
(A) получение порошка для суспензии, включающее следующие этапы:
(i) получение ядер, включающих активный ингредиент и одно или более фармацевтически приемлемых вспомогательных веществ;
(ii) растворение/диспергирование в подходящем растворителе полимера, регулирующего высвобождение, и одной или более фармацевтически приемлемых добавок, образующих покрытие;
(iii) нанесение композиции покрытия, полученной на этапе (ii), на ядра, полученные на этапе (i);
(iv) смешивание одного или более веществ, изменяющих осмотическое давление среды, и одного или более фармацевтически приемлемых вспомогательных веществ с имеющими покрытие ядрами, полученными на этапе (iii), с образованием порошка для суспензии; и
(B) ресуспендирование порошка для суспензии, полученного на этапе (А), в фармацевтически приемлемом носителе, в результате чего получают суспензионную композицию с пролонгированным высвобождением.
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PCT/IB2015/053209 WO2015166473A1 (en) | 2014-05-01 | 2015-05-01 | Extended release suspension compositions |
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EP3137060B1 (en) | 2020-11-11 |
CA3021475A1 (en) | 2017-10-26 |
JP2018517460A (ja) | 2018-07-05 |
MX2016014320A (es) | 2017-05-23 |
PL3137060T3 (pl) | 2021-03-08 |
CA2947528C (en) | 2023-09-05 |
MA44703A (fr) | 2019-02-27 |
MA44702A (fr) | 2019-02-27 |
WO2015166473A1 (en) | 2015-11-05 |
MA42001A (fr) | 2018-03-07 |
JP2017514903A (ja) | 2017-06-08 |
US9962345B2 (en) | 2018-05-08 |
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