RU2006118801A - Композиции и лекарственные формы для усиления всасывания габапентина и прегабалина - Google Patents
Композиции и лекарственные формы для усиления всасывания габапентина и прегабалина Download PDFInfo
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- RU2006118801A RU2006118801A RU2006118801/15A RU2006118801A RU2006118801A RU 2006118801 A RU2006118801 A RU 2006118801A RU 2006118801/15 A RU2006118801/15 A RU 2006118801/15A RU 2006118801 A RU2006118801 A RU 2006118801A RU 2006118801 A RU2006118801 A RU 2006118801A
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- pregabalin
- gabapentin
- complex
- dosage form
- transport
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
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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
- A61K31/66—Phosphorus compounds
- A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
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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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
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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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
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- A61K31/28—Compounds containing heavy metals
- A61K31/295—Iron group metal compounds
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/54—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
- A61K47/541—Organic ions forming an ion pair complex with the pharmacologically or therapeutically active agent
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- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/58—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
- A61K47/585—Ion exchange resins, e.g. polystyrene sulfonic acid resin
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
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Claims (24)
1. Вещество, состоящее из габапентина или прегабалина и транспортной части, при этом указанный габапентин или прегабалин и указанная транспортная часть образуют комплекс.
2. Вещество по п.1, в котором указанная транспортная часть представляет собой алкилсульфатную соль, имеющую от 6 до 12 атомов углерода.
3. Вещество по п.2, в котором указанная алкилсульфатная соль представляет собой лаурилсульфатную соль.
4. Композиция, содержащая
комплекс, состоящий из габапентина или прегабалина и транспортной части, и
фармацевтически приемлемый носитель;
при этом указанная композиция всасывается в нижних отделах желудочно-кишечного тракта по меньшей мере в 5 раз лучше, чем габапентин или прегабалин.
5. Композиция по п. 4, в которой указанная транспортная часть представляет собой алкилсульфатную соль, имеющую от 6 до 12 атомов углерода.
6. Композиция по п.5, в которой указанная алкилсульфатная соль представляет собой лаурилсульфатную соль.
7. Лекарственная форма, содержащая композицию по п.4.
8. Лекарственная форма, содержащая вещество по п.1.
9. Лекарственная форма по п.8, которая представляет собой осмотическую лекарственную форму.
10. Лекарственная форма по п.9, состоящая из (i) выталкивающего слоя; (ii) лекарственного слоя, содержащего комплекс габапентин-транспортная часть или комплекс прегабалин-транспортная часть; (iii) полупроницаемой стенки, расположенной вокруг выталкивающего слоя и лекарственного слоя; и (iv) выходного отверстия.
11. Лекарственная форма по п.9, состоящая из (i) полупроницаемой стенки, расположенной вокруг осмотической композиции комплекса габапентин-транспортная часть или комплекса прегабалин-транспортная часть, осмагента и осмополимера; и (ii) выходного отверстия.
12. Лекарственная форма по п.9, которая обеспечивает суммарную суточную дозу от 200 до 3600 мг.
13. Улучшенная лекарственная форма, включающая габапентин или прегабалин, которая представляет собой лекарственную форму, содержащую комплекс габапентина или прегабалина и транспортной части, связанных посредством сильной ионной связи.
14. Улучшенная лекарственная форма по п.13, в которой указанная транспортная часть представляет собой алкилсульфатную соль, имеющую от 6 до 12 атомов углерода.
15. Улучшенная лекарственная форма по п.14, в которой указанная алкилсульфатная соль представляет собой лаурилсульфатную соль.
16. Способ введения габапентина или прегабалина, включающий введение вещества по п.1 пациенту, который в этом нуждается.
17. Способ по п.16, в котором указанное введение осуществляют посредством перорального введения.
18. Способ изготовления комплекса габапентина или прегабалина и транспортной части, включающий
предоставление габапентина или прегабалина;
предоставление транспортной части;
объединение габапентина или прегабалина и транспортной части в присутствии растворителя, имеющего диэлектрическую постоянную меньше, чем у воды;
при этом указанное объединение приводит к образованию комплекса габапентина или прегабалина и транспортной части.
19. Способ по п.18, в котором указанное объединение включает (i) объединение габапентина или прегабалина и транспортной части в водном растворителе, (ii) добавление указанного растворителя, имеющего диэлектрическую постоянную меньше, чем у воды, к водному растворителю, и (iii) выделение указанного комплекса из указанного растворителя.
20. Способ по п.18, в котором указанное объединение включает контактирование в растворителе, имеющем диэлектрическую постоянную по меньшей мере в два раза меньше, чем диэлектрическая постоянная воды.
21. Способ по п.20, в котором указанный растворитель выбран из группы, состоящей из метанола, этанола, ацетона, бензола, метиленхлорида и четыреххлористого углерода.
22. Способ улучшения всасывания габапентина или прегабалина в желудочно-кишечном тракте, включающий
предоставление комплекса, состоящего из габапентина или прегабалина и транспортной части; и
введение комплекса пациенту.
23. Способ по п.22, в котором улучшенное всасывание включает улучшенное всасывание в нижних отделах желудочно-кишечного тракта.
24. Способ по п.22, в котором улучшенное всасывание включает улучшенное всасывание в верхних отделах желудочно-кишечного тракта.
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US51625903P | 2003-10-31 | 2003-10-31 | |
US60/516,259 | 2003-10-31 | ||
US51950903P | 2003-11-12 | 2003-11-12 | |
US60/519,509 | 2003-11-12 |
Publications (1)
Publication Number | Publication Date |
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RU2006118801A true RU2006118801A (ru) | 2007-12-10 |
Family
ID=34556123
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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RU2006118801/15A RU2006118801A (ru) | 2003-10-31 | 2004-10-29 | Композиции и лекарственные формы для усиления всасывания габапентина и прегабалина |
Country Status (14)
Country | Link |
---|---|
US (6) | US20060094782A9 (ru) |
EP (6) | EP1677759A1 (ru) |
JP (6) | JP2007509973A (ru) |
KR (6) | KR20060103440A (ru) |
AU (4) | AU2004285533A1 (ru) |
BR (1) | BRPI0416138A (ru) |
CA (6) | CA2543185A1 (ru) |
EC (1) | ECSP066535A (ru) |
IL (4) | IL175194A0 (ru) |
MA (1) | MA28140A1 (ru) |
MX (1) | MXPA06004960A (ru) |
NO (4) | NO20062512L (ru) |
RU (1) | RU2006118801A (ru) |
WO (6) | WO2005041927A1 (ru) |
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