RU2008140039A - Способ получения твердой дисперсии активного ингредиента - Google Patents
Способ получения твердой дисперсии активного ингредиента Download PDFInfo
- Publication number
- RU2008140039A RU2008140039A RU2008140039/15A RU2008140039A RU2008140039A RU 2008140039 A RU2008140039 A RU 2008140039A RU 2008140039/15 A RU2008140039/15 A RU 2008140039/15A RU 2008140039 A RU2008140039 A RU 2008140039A RU 2008140039 A RU2008140039 A RU 2008140039A
- Authority
- RU
- Russia
- Prior art keywords
- mixing
- zone
- item
- extruder
- worm
- Prior art date
Links
- 239000004480 active ingredient Substances 0.000 title claims abstract 7
- 239000007962 solid dispersion Substances 0.000 title claims abstract 5
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims abstract 35
- 238000002156 mixing Methods 0.000 claims abstract 23
- 238000011068 loading method Methods 0.000 claims abstract 7
- 238000006073 displacement reaction Methods 0.000 claims abstract 4
- 239000011159 matrix material Substances 0.000 claims abstract 4
- 239000003795 chemical substances by application Substances 0.000 claims 5
- 229920000642 polymer Polymers 0.000 claims 3
- 239000000654 additive Substances 0.000 claims 2
- 239000000178 monomer Substances 0.000 claims 2
- 229920002554 vinyl polymer Polymers 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 1
- 230000000996 additive effect Effects 0.000 claims 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims 1
- 238000003490 calendering Methods 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 229920003086 cellulose ether Polymers 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- 239000007884 disintegrant Substances 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 238000001125 extrusion Methods 0.000 claims 1
- 239000000945 filler Substances 0.000 claims 1
- 238000011049 filling Methods 0.000 claims 1
- 239000007888 film coating Substances 0.000 claims 1
- 238000009501 film coating Methods 0.000 claims 1
- 150000004676 glycans Chemical class 0.000 claims 1
- 238000000227 grinding Methods 0.000 claims 1
- 229920001519 homopolymer Polymers 0.000 claims 1
- 238000001746 injection moulding Methods 0.000 claims 1
- 150000002632 lipids Chemical class 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 239000000314 lubricant Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 238000000465 moulding Methods 0.000 claims 1
- QJGQUHMNIGDVPM-UHFFFAOYSA-N nitrogen group Chemical group [N] QJGQUHMNIGDVPM-UHFFFAOYSA-N 0.000 claims 1
- 229920001542 oligosaccharide Polymers 0.000 claims 1
- 150000002482 oligosaccharides Polymers 0.000 claims 1
- 239000001301 oxygen Substances 0.000 claims 1
- 229910052760 oxygen Inorganic materials 0.000 claims 1
- 239000008180 pharmaceutical surfactant Substances 0.000 claims 1
- 239000004014 plasticizer Substances 0.000 claims 1
- -1 poly (hydroxyl acids Chemical class 0.000 claims 1
- 229920000233 poly(alkylene oxides) Polymers 0.000 claims 1
- 229920000058 polyacrylate Polymers 0.000 claims 1
- 229920000193 polymethacrylate Polymers 0.000 claims 1
- 229920005862 polyol Polymers 0.000 claims 1
- 150000003077 polyols Chemical class 0.000 claims 1
- 229920001282 polysaccharide Polymers 0.000 claims 1
- 239000005017 polysaccharide Substances 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 239000006104 solid solution Substances 0.000 claims 1
- 239000003381 stabilizer Substances 0.000 claims 1
- 239000001993 wax Substances 0.000 claims 1
- 238000003754 machining Methods 0.000 abstract 1
Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
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- A—HUMAN NECESSITIES
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- 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
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- B29B7/482—Mixing; Kneading continuous, with mechanical mixing or kneading devices with movable mixing or kneading devices rotary with more than one shaft with intermeshing devices, e.g. screws provided with screw parts in addition to other mixing parts, e.g. paddles, gears, discs
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- B29B7/38—Mixing; Kneading continuous, with mechanical mixing or kneading devices with movable mixing or kneading devices rotary
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- B29C48/405—Intermeshing co-rotating screws
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29C48/41—Intermeshing counter-rotating screws
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- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
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Abstract
1. Способ получения твердой дисперсии активного ингредиента, который включает загрузку активного ингредиента и матрицеобразующего агента в экструдер и получение однородного экструдата, где экструдер включает, по меньшей мере, два вращающихся вала (2), где каждый из валов (2) несет множество обрабатывающих элементов, расположенных аксиально друг за другом, где обрабатывающие элементы образуют ! (i) зону загрузки и перемещения (А), ! (ii) по меньшей мере, одну зону смешивания (В) и ! (iii) зону выгрузки (Е), ! где обрабатывающие элемент(ы), образующие зону смешивания (В), содержит(ат) смешивающий элемент (11, 12, 13), который основан на червячном элементе. ! 2. Способ по п.1, где смешивающий элемент (11, 12, 13) имеет канавки в спиральной нарезке червяка червячного элемента. ! 3. Способ по п.1 или 2, где смешивающий элемент не имеет плоской поверхности с нормалью, параллельной и противоположной общему направлению движения. ! 4. Способ по п.1 или 2, где смешивающий элемент (11, 12, 13) не имеет поверхности, которая перпендикулярна общему направлению движения. !5. Способ по п.1 или 2, где смешивающий элемент (11, 12, 13) не имеет примыкающих поверхностей, которые перпендикулярны общему направлению движения. ! 6. Способ по п.1 или 2, где смешивающий элемент (11, 12, 13) имеет множество концентрических кольцевых зон (16; 25), образованных желобками, выточенными в червячном элементе. ! 7. Способ по п.1 или 2, где обрабатывающие элементы дополнительно содержат, по крайней мере, один элемент противодавления (14). ! 8. Способ по п.7, где элемент противодавления (14) расположен по направлению движения к зоне смешивания (D). ! 9. Способ по п.1 или 2, где валы (2) вращаются в одном направлении. !10.
Claims (26)
1. Способ получения твердой дисперсии активного ингредиента, который включает загрузку активного ингредиента и матрицеобразующего агента в экструдер и получение однородного экструдата, где экструдер включает, по меньшей мере, два вращающихся вала (2), где каждый из валов (2) несет множество обрабатывающих элементов, расположенных аксиально друг за другом, где обрабатывающие элементы образуют
(i) зону загрузки и перемещения (А),
(ii) по меньшей мере, одну зону смешивания (В) и
(iii) зону выгрузки (Е),
где обрабатывающие элемент(ы), образующие зону смешивания (В), содержит(ат) смешивающий элемент (11, 12, 13), который основан на червячном элементе.
2. Способ по п.1, где смешивающий элемент (11, 12, 13) имеет канавки в спиральной нарезке червяка червячного элемента.
3. Способ по п.1 или 2, где смешивающий элемент не имеет плоской поверхности с нормалью, параллельной и противоположной общему направлению движения.
4. Способ по п.1 или 2, где смешивающий элемент (11, 12, 13) не имеет поверхности, которая перпендикулярна общему направлению движения.
5. Способ по п.1 или 2, где смешивающий элемент (11, 12, 13) не имеет примыкающих поверхностей, которые перпендикулярны общему направлению движения.
6. Способ по п.1 или 2, где смешивающий элемент (11, 12, 13) имеет множество концентрических кольцевых зон (16; 25), образованных желобками, выточенными в червячном элементе.
7. Способ по п.1 или 2, где обрабатывающие элементы дополнительно содержат, по крайней мере, один элемент противодавления (14).
8. Способ по п.7, где элемент противодавления (14) расположен по направлению движения к зоне смешивания (D).
9. Способ по п.1 или 2, где валы (2) вращаются в одном направлении.
10. Способ по п.1 или 2, где валы (2) вращаются в противоположных направлениях.
11. Способ по п.1 или 2, где обрабатывающие элементы образуют
(i) зону загрузки и перемещения (А),
(ii) первую зону смешивания (В),
(iii) промежуточную зону перемещения (С),
(iv) вторую зону смешивания (D) и
(v) зону выгрузки (Е).
12. Способ по п.11, где обрабатывающие элементы дополнительно содержат элемент противодавления (14), расположенный по направлению движения и рядом со второй зоной смешивания (D).
13. Способ по п.1, где, по крайней мере, часть матрицеобразующего агента загружают в бункер экструдера и, по крайней мере, один компонент, выбранный из
(i) оставшегося матрицеобразующего агента,
(ii) активного ингредиента,
(iii) добавки и
(iv) их сочетаний,
вводят в экструдер через отверстие (8) в цилиндре экструдера (1), расположенного против направления движения от зоны смешивания (В).
14. Способ по п.13, где, по крайней мере, один компонент вводят в экструдер в месте, близком к месту соединения зоны загрузки и перемещения и зоны смешивания (В).
15. Способ по п.13 или 14, где, по крайней мере, один компонент является жидким или сжиженным.
16. Способ по п.13 или 14, где, по крайней мере, один компонент содержит фармацевтически приемлемое поверхностно-активное вещество.
17. Способ по п.13 или 14, где активный ингредиент диспергирован в полимере в состоянии твердого раствора.
18. Способ по п.13 или 14, где матрицеобразующий агент содержит фармацевтически приемлемый полимер.
19. Способ по п.18, где фармацевтически приемлемый полимер выбирают из группы, включающей
гомополимеры N-виниллактамов,
сополимеры N-виниллактама и одного или более сомономеров, выбранных из азотсодержащих мономеров и кислородсодержащих мономеров,
сложные эфиры целлюлозы и простые эфиры целлюлозы,
оксиды высокомолекулярных полиалкиленоксидов,
полиакрилаты и полиметакрилаты,
олиго- и полисахариды,
поли(гидроксильные кислоты) или их смеси.
20. Способ по п.13 или 14, где матрицеобразующий агент содержит соединение, выбранное из полиолов, восков и липидов.
21. Способ по п.13 или 14, дополнительно включающий загрузку в экструдер, по крайней мере, одной добавки, выбранной из группы, включающей регуляторы потока, смазывающие агенты, наполнители, дезинтеграторы, пластификаторы, стабилизаторы или консерванты.
22. Способ по п.1 или 13, где экструдат формуют непосредственно в лекарственную форму.
23. Способ по п.22, где формование проводят каландрованием, литьем под давлением или экструзией профилированных изделий.
24. Способ по п.22, дополнительно включающий измельчение отвержденного экструдата.
25. Способ по п.24, дополнительно включающий прессование указанной твердой дисперсии в таблетку или заполнение капсулы указанной твердой дисперсией.
26. Способ по п.25, дополнительно включающий нанесение пленочного покрытия на таблетку.
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Application Number | Priority Date | Filing Date | Title |
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US78139806P | 2006-03-10 | 2006-03-10 | |
EP06004999.6 | 2006-03-10 | ||
US60/781,398 | 2006-03-10 | ||
EP06004999A EP1832281A1 (en) | 2006-03-10 | 2006-03-10 | Process for producing a solid dispersion of an active ingredient |
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Publication Number | Publication Date |
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RU2008140039A true RU2008140039A (ru) | 2010-04-20 |
RU2448688C2 RU2448688C2 (ru) | 2012-04-27 |
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Application Number | Title | Priority Date | Filing Date |
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RU2008140040/15A RU2442568C2 (ru) | 2006-03-10 | 2007-03-12 | Улучшенный способ получения твердой дисперсии активного ингредиента |
RU2008140039/15A RU2448688C2 (ru) | 2006-03-10 | 2007-03-12 | Устройство для получения твердой дисперсии активного ингредиента |
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RU2008140040/15A RU2442568C2 (ru) | 2006-03-10 | 2007-03-12 | Улучшенный способ получения твердой дисперсии активного ингредиента |
Country Status (20)
Country | Link |
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US (4) | US20090302493A1 (ru) |
EP (5) | EP1832281A1 (ru) |
JP (3) | JP5670023B2 (ru) |
KR (2) | KR101417892B1 (ru) |
CN (2) | CN101400341B (ru) |
AT (1) | ATE531359T1 (ru) |
AU (2) | AU2007224486B2 (ru) |
BR (2) | BRPI0708709A2 (ru) |
CA (2) | CA2644035C (ru) |
CY (1) | CY1112273T1 (ru) |
DK (2) | DK1996164T3 (ru) |
ES (2) | ES2425176T3 (ru) |
HK (3) | HK1215188A1 (ru) |
MX (2) | MX2008011041A (ru) |
PL (2) | PL1996164T3 (ru) |
PT (1) | PT1996163E (ru) |
RU (2) | RU2442568C2 (ru) |
SI (1) | SI1996163T1 (ru) |
WO (2) | WO2007104747A2 (ru) |
ZA (2) | ZA200808564B (ru) |
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