RU2006114690A - Составы пантопразола, состоящие из множества частиц - Google Patents
Составы пантопразола, состоящие из множества частицInfo
- Publication number
- RU2006114690A RU2006114690A RU2006114690/15A RU2006114690A RU2006114690A RU 2006114690 A RU2006114690 A RU 2006114690A RU 2006114690/15 A RU2006114690/15 A RU 2006114690/15A RU 2006114690 A RU2006114690 A RU 2006114690A RU 2006114690 A RU2006114690 A RU 2006114690A
- Authority
- RU
- Russia
- Prior art keywords
- pantoprazole
- particles
- core
- insulating coating
- multiple particles
- Prior art date
Links
- 239000002245 particle Substances 0.000 title claims 38
- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical compound COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 title claims 34
- 239000000203 mixture Substances 0.000 title claims 6
- 229960005019 pantoprazole Drugs 0.000 claims 35
- 238000000576 coating method Methods 0.000 claims 14
- 239000011248 coating agent Substances 0.000 claims 13
- 239000002702 enteric coating Substances 0.000 claims 9
- 238000009505 enteric coating Methods 0.000 claims 9
- 238000000034 method Methods 0.000 claims 9
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 4
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 4
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 3
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 3
- 229960000913 crospovidone Drugs 0.000 claims 3
- 229960003943 hypromellose Drugs 0.000 claims 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 3
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 3
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 3
- 239000000126 substance Substances 0.000 claims 3
- 239000004094 surface-active agent Substances 0.000 claims 3
- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims 2
- 150000002734 metacrylic acid derivatives Chemical class 0.000 claims 2
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims 2
- -1 pantoprazole compound Chemical class 0.000 claims 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
- 229920000136 polysorbate Polymers 0.000 claims 2
- 229950008882 polysorbate Drugs 0.000 claims 2
- 229920000053 polysorbate 80 Polymers 0.000 claims 2
- 229940068968 polysorbate 80 Drugs 0.000 claims 2
- 150000003839 salts Chemical class 0.000 claims 2
- 239000000725 suspension Substances 0.000 claims 2
- 239000000454 talc Substances 0.000 claims 2
- 229910052623 talc Inorganic materials 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 229920003138 Eudragit® L 30 D-55 Polymers 0.000 claims 1
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 229920001688 coating polymer Polymers 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- GDCRSXZBSIRSFR-UHFFFAOYSA-N ethyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.CCOC(=O)C=C GDCRSXZBSIRSFR-UHFFFAOYSA-N 0.000 claims 1
- 238000001125 extrusion Methods 0.000 claims 1
- 239000011888 foil Substances 0.000 claims 1
- 230000002496 gastric effect Effects 0.000 claims 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 1
- 229920003130 hypromellose 2208 Polymers 0.000 claims 1
- 229940031707 hypromellose 2208 Drugs 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 230000007935 neutral effect Effects 0.000 claims 1
- 239000006186 oral dosage form Substances 0.000 claims 1
- 239000003002 pH adjusting agent Substances 0.000 claims 1
- 229910000029 sodium carbonate Inorganic materials 0.000 claims 1
- 238000005563 spheronization Methods 0.000 claims 1
- 239000001069 triethyl citrate Substances 0.000 claims 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims 1
- 235000013769 triethyl citrate Nutrition 0.000 claims 1
Classifications
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
-
- 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
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
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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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Plural Heterocyclic Compounds (AREA)
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Claims (30)
1. Множественные частицы пантопразола, обладающие сниженным высвобождением в условиях желудка и быстрым высвобождением при нейтральном pH, где каждая из указанных множественных частиц содержит сферическое ядро, содержащее пантопразол, или его энантиомер, или его соль, или гидрат, по меньшей мере одно поверхностно-активное вещество, по меньшей мере одно вещество, ускоряющее распад, и от приблизительно 1% до приблизительно 2% мас./мас. воды, первичное изолирующее покрытие на сферическом ядре, кишечно-растворимое покрытие на ядре, причем указанное кишечно-растворимое покрытие включает сополимер метакриловой кислоты и метакрилатов в количестве от приблизительно от 15 до приблизительно 45% мас./мас. каждой из множественных частиц, и
где указанные множественные частицы с покрытием имеют средний размер приблизительно 1 мм в диаметре.
2. Множественные частицы пантопразола по п.1, дополнительно включающие завершающее изолирующее покрытие, нанесенное на кишечно-растворимое покрытие.
3. Множественные частицы пантопразола по п.2, где завершающее изолирующее покрытие составляет приблизительно от 0,1 до 10 мас.% множественных частиц.
4. Множественные частицы пантопразола по п.2 или 3, где завершающее изолирующее покрытие содержит гидроксипропилметилцеллюлозу (гипромеллозу).
5. Множественные частицы пантопразола по п.1, где указанное первичное изолирующее покрытие составляет приблизительно от 2 до 4% мас./мас. массы ядра без покрытия.
6. Множественные частицы пантопразола по любому из пп.1-3, 5, где первичное изолирующее покрытие содержит гипромеллозу.
7. Множественные частицы пантопразола по любому из пп.1-3, 5, где поверхностно-активное вещество составляет от приблизительно 2 до приблизительно 7% массы ядра без покрытия.
8. Множественные частицы пантопразола по любому из пп.1-3, 5, где поверхностно-активное вещество представляет собой полисорбат.
9. Множественные частицы пантопразола по п.8, где полисорбат представляет собой полисорбат 80.
10. Множественные частицы пантопразола по любому из пп.1-3, 5, где кишечно-растворимое покрытие составляет от 27,5 до 48% мас./мас. множественных частиц.
11. Множественные частицы пантопразола по п.1, где кишечно-растворимое покрытие содержит приблизительно 30% мас./мас. покрытия Eudragit L 30 D-55, приблизительно 15% мас./мас. талька, приблизительно 3% триэтилцитрата и регулятор pH, причем указанные количества определяются в расчете на массу множественных частиц.
12. Множественные частицы пантопразола по любому из пп.1-3, 5, где соединение пантопразола присутствует в количестве приблизительно от 5 до 50% мас./мас. сферического ядра.
13. Множественные частицы пантопразола по любому из пп.1-3, 5, в котором ядро содержит соединение пантопразола в количестве, эквивалентном приблизительно 40 мг пантопразола на 100 мг множественных частиц без покрытия.
14. Множественные частицы пантопразола по любому из пп. 1-3, 5, где указанное сферическое ядро дополнительно содержит регулятор pH и гипромеллозу.
15. Множественные частицы пантопразола по любому из пп. 1-3, 5, где вещество, ускоряющее распад, выбрано из группы, состоящей из микрокристаллической целлюлозы и кросповидона и их смесей.
16. Множественные частицы пантопразола по п.15, где микрокристаллическая целлюлоза составляет от приблизительно 25 до приблизительно 30% массы ядра.
17. Множественные частицы пантопразола по п.15, где кросповидон составляет от приблизительно 14 до приблизительно 16% массы ядра.
18. Множественные частицы пантопразола по п.1, где сферическое ядро по существу состоит из, % мас./мас.:
19. Состав пантопразола для введения педиатрическим пациентам, причем указанный состав включает суспензию, содержащую множественные частицы пантопразола по любому из пп.1-18, и физиологически совместимую суспендирующую жидкость.
20. Капсула, содержащая множественные частицы пантопразола по любому из пп.1-19.
21. Пакет из фольги, содержащий множественные частицы пантопразола по любому из пп.1-19.
22. Способ лечения людей, которым требуется пантопразол, причем указанный способ включает стадию введения эффективной дозы множественных частиц пантопразола по любому из пп.1-19.
23. Способ получения состава пантопразола, состоящего из множества частиц, причем указанный способ включает стадии:
получения сферического ядра, содержащего пантопразол или его энантиомер, или его соль, поверхностно-активное вещество, вещество, ускоряющее распад, посредством экструзии и сферонизации, причем указанное ядро содержит от приблизительно 1 до приблизительно 2% мас./мас. воды;
нанесения первичного изолирующего покрытия на сферическое ядро, причем указанное первичное изолирующее покрытие составляет от приблизительно 1% мас./мас. до приблизительно 2% мас./мас. множественных частиц;
нанесения кишечно-растворимого покрытия на первичное изолирующее покрытие, причем указанное упомянутое кишечно-растворимое покрытие содержит сополимер метакриловой кислоты и метакрилатов в таком количестве, чтобы множественные частицы содержали 15-45% мас./мас. сухого полимера кишечно-растворимого покрытия; и
необязательного нанесения завершающего изолирующего покрытия на сферическое ядро с кишечно-растворимым покрытием, причем указанное завершающее изолирующее покрытие составляет приблизительно 1 мас.% множественных частиц,
где средний размер указанных множественных частиц не превышает приблизительно 1 мм в диаметре.
24. Способ по п.23, где сферическое ядро получают путем смешивания ингредиентов в смесителе с низким усилием сдвига при условиях низких усилий сдвига, составляющим приблизительно от 25 до 35 об/мин.
25. Способ по п.24, где условие низкого усилия сдвига представляет собой 32 об/мин.
26. Способ по п.24 или 25, где сферические ядра сушат при низкой температуре, не превышающей приблизительно 40°C, в течение от 8 до 72 ч до процента (%) потерь при высушивании (ППВ) от 3,4 до 4,3%.
27. Способ по п.23, дополнительно включающий стадию нанесения слоя талька в количестве от 0,05% мас./мас. до 0,1% мас./мас. множественных частиц.
28. Способ по п.23, где кишечно-растворимое покрытие в виде суспензии распыляют на сферическое ядро.
29. Применение множественных частиц пантопразола по любому из пп.1-19 в получении лекарственного средства.
30. Композиция, включающая пероральную лекарственную форму, содержащую эффективное количество пантопразола, состоящего из множества частиц, где после ее перорального введения пациенту отношение Cmax для пантопразола составляет от 62 до 66 нг/мл, и отношение AUC - от 89 до 94 для разовой дозы 40 мг пантопразола.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
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- 2004-09-30 GT GT200400194A patent/GT200400194A/es unknown
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