RU2017110025A - Шипучие композиции и способы их получения и применения - Google Patents

Шипучие композиции и способы их получения и применения Download PDF

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RU2017110025A
RU2017110025A RU2017110025A RU2017110025A RU2017110025A RU 2017110025 A RU2017110025 A RU 2017110025A RU 2017110025 A RU2017110025 A RU 2017110025A RU 2017110025 A RU2017110025 A RU 2017110025A RU 2017110025 A RU2017110025 A RU 2017110025A
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acid
zone
granulation
twin
processing device
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RU2017110025A
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RU2706727C2 (ru
RU2017110025A3 (ru
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Бабу ПАДМАНАБХАН
Ракшит ШЕТТИ
Виджай КУЛКАРНИ
Химадри Сен
Инду БХУШАН
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Стирлайф Индия Прайвит Лимитед
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    • 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
    • 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
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
    • A23P10/00—Shaping or working of foodstuffs characterised by the products
    • A23P10/20—Agglomerating; Granulating; Tabletting
    • A23P10/25—Agglomeration or granulation by extrusion or by pressing, e.g. through small holes, through sieves or between surfaces
    • 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
    • A61K31/195—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]
    • A—HUMAN NECESSITIES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/385—Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
    • A—HUMAN NECESSITIES
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
    • A61K31/546—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
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Claims (34)

1. Гранулярная композиция, содержащая
безводный кислотный компонент, содержащий комбинацию части кислоты, подвергнутой расплавлению, и части кислоты, не подвергнутой расплавлению, и
безводный основный компонент, содержащий карбонатную функциональную группу, где основный компонент способен взаимодействовать с кислотным компонентом с образованием диоксида углерода; и
где безводный кислотный компонент и безводный основный компонент находятся в массовом отношении в диапазоне от 1:9 до 9:1, и композиция не содержит обязательно добавляемый гранулирующий агент.
2. Композиция по п. 1, где композиция дополнительно содержит активный фармацевтический агент, выбранный из группы, состоящей из противоинфекционного, антибактериального, антигистаминного, противозастойного, противовоспалительного, антипаразитарного, антивирусного, противогрибкового, амебицидного, трихомоноцидного средства, анальгетика, противоартритного средства, антигистаминного средства, антикоагулянта, противосудорожного средства, антидепрессанта, противодиабетического средства, противоопухолевого средства, нейролептика, гипотензивного средства, отхаркивающего средства, электролита, слабительного средства, фитофармацевтического средства, мышечного релаксанта, диуретика или их комбинаций.
3. Пористая шипучая композиция, сформированная из входящей смеси, содержащей кислоту и основание путем гранулирования входящей смеси в двухшнековом обрабатывающем устройстве, где пористая шипучая композиция содержит гранулы, сформированные с помощью in situ гранулирующего агента, где in situ гранулирующий агент представляет собой часть кислоты, причем часть кислоты представляет собой часть кислоты, которая плавится в процессе грануляции.
4. Пористая шипучая композиция по п. 3, где пористая шипучая композиция имеет пористость, по меньшей мере на 50% превышающую пористость входящей смеси.
5. Пористая шипучая композиция по п. 3 или п. 4, где пористая шипучая композиция имеет содержание удержанного диоксида углерода, составляющее по меньшей мере 90% от входящей смеси.
6. Пористая шипучая композиция по п. 3, где кислота выбрана из группы, состоящей из лимонной кислоты, винной кислоты, адипиновой кислоты, яблочной кислоты или их комбинаций.
7. Пористая шипучая композиция по п. 3, где входящая смесь дополнительно содержит один или более ингредиентов, выбранных из группы, состоящей из фармацевтических, пищевых, ветеринарных, нутрицевтических, садоводческих, бытовых, кулинарных, пестицидных, сельскохозяйственных, косметических, гербицидных, промышленных, моющих, кондитерских и вкусоароматических средств или их комбинаций.
8. Пероральная твердая дозированная форма, содержащая:
пористую шипучую композицию по п. 3, и один или более необязательных технологических эксципиентов.
9. Пероральная твердая дозированная форма по п. 8, где пористая шипучая композиция имеет пористость, по меньшей мере на 50% превышающую пористость входящей смеси.
10. Пероральная твердая дозированная форма по п. 8 или 9, где пористая шипучая композиция имеет содержание удержанного диоксида углерода, составляющее по меньшей мере 90% от входящей смеси.
11. Пероральная твердая дозированная форма по п. 8, где пероральная твердая дозированная форма выбрана из группы, состоящей из шипучей таблетки, перорального порошка, быстро распадающейся таблетки, распадающейся таблетки для перорального применения или их комбинаций.
12. Пероральная твердая дозированная форма по п. 11, где шипучая таблетка имеет время распадаемости от 20 до 90 секунд в воде при комнатной температуре приблизительно 25°С±5°С.
13. Пероральная твердая дозированная форма по п. 11 или 12, где шипучая таблетка имеет твердость по меньшей мере 3 Кп.
14. Способ получения пористых шипучих гранул, включающий
подачу входящей смеси, содержащей кислоту и основание, в двухшнековое обрабатывающее устройство;
плавление только части кислоты, служащей в качестве in situ гранулирующего агента;
гранулирование входящей смеси с образованием гранул; и
необязательно сбор гранул из двухшнекового обрабатывающего устройства.
15. Способ по п. 14, где плавления только части кислоты достигают в зоне инициации грануляции двухшнекового обрабатывающего устройства без какого-либо застоя материала, причем зона инициации грануляции состоит по существу из конвейерных элементов.
16. Способ по п. 14, где двухшнековое обрабатывающее устройство представляет собой двухшнековый экструдер с двумя шнеками, вращающимися в одном направлении.
17. Способ по п. 14, где гранулы, собранные из двухшнекового обрабатывающего устройства, имеют содержание удержанного диоксида углерода, составляющее по меньшей мере 90% от входящей смеси.
18. Двухшнековое обрабатывающее устройство для получения пористых шипучих гранул, содержащее
впускную зону для приема входящей смеси, содержащей кислоту и основание;
зону инициации грануляции для плавления только части кислоты, служащей в качестве in situ гранулирующего агента;
зону завершения грануляции для гранулирования входящей смеси; и
выпускное отверстие для выгрузки гранул,
где зона инициации грануляции и зона завершения грануляции состоят по существу из конвейерных элементов, причем зона инициации грануляции содержит нагревательные элементы для поддержания в зоне инициации грануляции температуры, достаточной для плавления только части кислоты, и в зоне завершения грануляции поддерживают более низкую температуру, чем в зоне инициации грануляции.
19. Двухшнековое обрабатывающее устройство по п. 18, дополнительно содержащее переходную зону между зоной инициации грануляции и зоной завершения грануляции, где в переходной зоне поддерживают более низкую температуру, чем в зоне инициации грануляции, и более высокую температуру, чем в зоне завершения грануляции.
20. Двухшнековое обрабатывающее устройство по п. 18, где двухшнековое обрабатывающее устройство представляет собой двухшнековый экструдер с двумя шнеками, вращающимися в одном направлении.
21. Пористые шипучие гранулы, содержащие кислоту и основание, где пористые шипучие гранулы имеют пористость, по меньшей мере на 50% превышающую пористость входящей смеси, используемой для получения гранул, и гранулы удерживают по меньшей мере 90% диоксида углерода входящей смеси.
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