CN1226583A - 固体剂型的制备 - Google Patents
固体剂型的制备 Download PDFInfo
- Publication number
- CN1226583A CN1226583A CN 98125899 CN98125899A CN1226583A CN 1226583 A CN1226583 A CN 1226583A CN 98125899 CN98125899 CN 98125899 CN 98125899 A CN98125899 A CN 98125899A CN 1226583 A CN1226583 A CN 1226583A
- Authority
- CN
- China
- Prior art keywords
- acid
- binder
- polymer
- multipolymer
- vinyl
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000007909 solid dosage form Substances 0.000 title abstract 3
- 239000000203 mixture Substances 0.000 claims abstract description 66
- 229920003023 plastic Polymers 0.000 claims abstract description 13
- 239000004033 plastic Substances 0.000 claims abstract description 13
- 239000000654 additive Substances 0.000 claims abstract description 8
- 238000000034 method Methods 0.000 claims description 35
- 238000009472 formulation Methods 0.000 claims description 24
- 229920005596 polymer binder Polymers 0.000 claims description 20
- 239000002491 polymer binding agent Substances 0.000 claims description 20
- 239000007787 solid Substances 0.000 claims description 15
- JBKVHLHDHHXQEQ-UHFFFAOYSA-N epsilon-caprolactam Chemical compound O=C1CCCCCN1 JBKVHLHDHHXQEQ-UHFFFAOYSA-N 0.000 claims description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 13
- 239000002552 dosage form Substances 0.000 claims description 12
- 238000001125 extrusion Methods 0.000 claims description 12
- 230000004927 fusion Effects 0.000 claims description 10
- 150000002148 esters Chemical class 0.000 claims description 9
- 229920001519 homopolymer Polymers 0.000 claims description 9
- 229920002554 vinyl polymer Polymers 0.000 claims description 9
- 230000002650 habitual effect Effects 0.000 claims description 8
- 230000000996 additive effect Effects 0.000 claims description 7
- 150000001732 carboxylic acid derivatives Chemical class 0.000 claims description 7
- 241001465754 Metazoa Species 0.000 claims description 6
- 239000000178 monomer Substances 0.000 claims description 6
- 150000001875 compounds Chemical class 0.000 claims description 5
- 239000003814 drug Substances 0.000 claims description 5
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 claims description 5
- 239000002304 perfume Substances 0.000 claims description 5
- 150000003839 salts Chemical class 0.000 claims description 5
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical group OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 4
- OFOBLEOULBTSOW-UHFFFAOYSA-N Malonic acid Chemical compound OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims description 4
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims description 4
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 4
- 150000001408 amides Chemical class 0.000 claims description 4
- 235000013305 food Nutrition 0.000 claims description 4
- 229910052799 carbon Inorganic materials 0.000 claims description 3
- 125000004432 carbon atom Chemical group C* 0.000 claims description 3
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 2
- 150000001735 carboxylic acids Chemical class 0.000 claims description 2
- 150000002825 nitriles Chemical class 0.000 claims description 2
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 3
- 239000013589 supplement Substances 0.000 claims 2
- YIWUKEYIRIRTPP-UHFFFAOYSA-N 2-ethylhexan-1-ol Chemical compound CCCCC(CC)CO YIWUKEYIRIRTPP-UHFFFAOYSA-N 0.000 claims 1
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 claims 1
- 125000001931 aliphatic group Chemical group 0.000 claims 1
- 150000005690 diesters Chemical class 0.000 claims 1
- 150000002763 monocarboxylic acids Chemical class 0.000 claims 1
- 229920001567 vinyl ester resin Polymers 0.000 claims 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 claims 1
- 238000002156 mixing Methods 0.000 abstract description 18
- 239000011230 binding agent Substances 0.000 abstract description 11
- 239000004480 active ingredient Substances 0.000 abstract description 8
- 229920001577 copolymer Polymers 0.000 abstract description 2
- JWYVGKFDLWWQJX-UHFFFAOYSA-N 1-ethenylazepan-2-one Chemical compound C=CN1CCCCCC1=O JWYVGKFDLWWQJX-UHFFFAOYSA-N 0.000 abstract 1
- -1 polyethylene Polymers 0.000 description 33
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 14
- 238000002360 preparation method Methods 0.000 description 14
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 11
- 239000002253 acid Substances 0.000 description 10
- 239000003826 tablet Substances 0.000 description 10
- 239000000463 material Substances 0.000 description 9
- 239000002904 solvent Substances 0.000 description 9
- 239000000126 substance Substances 0.000 description 9
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 8
- 239000003795 chemical substances by application Substances 0.000 description 8
- 238000006116 polymerization reaction Methods 0.000 description 8
- 229920002678 cellulose Polymers 0.000 description 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 239000002245 particle Substances 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- 241000196324 Embryophyta Species 0.000 description 5
- XTXRWKRVRITETP-UHFFFAOYSA-N Vinyl acetate Chemical compound CC(=O)OC=C XTXRWKRVRITETP-UHFFFAOYSA-N 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 239000003960 organic solvent Substances 0.000 description 5
- 229940117958 vinyl acetate Drugs 0.000 description 5
- 229940088594 vitamin Drugs 0.000 description 5
- 229930003231 vitamin Natural products 0.000 description 5
- 235000013343 vitamin Nutrition 0.000 description 5
- 239000011782 vitamin Substances 0.000 description 5
- 150000003722 vitamin derivatives Chemical class 0.000 description 5
- GHOKWGTUZJEAQD-ZETCQYMHSA-N (D)-(+)-Pantothenic acid Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCC(O)=O GHOKWGTUZJEAQD-ZETCQYMHSA-N 0.000 description 4
- HRPVXLWXLXDGHG-UHFFFAOYSA-N Acrylamide Chemical compound NC(=O)C=C HRPVXLWXLXDGHG-UHFFFAOYSA-N 0.000 description 4
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 4
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 4
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 4
- PVNIIMVLHYAWGP-UHFFFAOYSA-N Niacin Chemical compound OC(=O)C1=CC=CN=C1 PVNIIMVLHYAWGP-UHFFFAOYSA-N 0.000 description 4
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 4
- 239000001913 cellulose Substances 0.000 description 4
- 235000010980 cellulose Nutrition 0.000 description 4
- 239000000975 dye Substances 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 4
- 238000004898 kneading Methods 0.000 description 4
- 150000002632 lipids Chemical class 0.000 description 4
- XNGIFLGASWRNHJ-UHFFFAOYSA-N phthalic acid Chemical compound OC(=O)C1=CC=CC=C1C(O)=O XNGIFLGASWRNHJ-UHFFFAOYSA-N 0.000 description 4
- 239000006187 pill Substances 0.000 description 4
- YBJHBAHKTGYVGT-ZKWXMUAHSA-N (+)-Biotin Chemical compound N1C(=O)N[C@@H]2[C@H](CCCCC(=O)O)SC[C@@H]21 YBJHBAHKTGYVGT-ZKWXMUAHSA-N 0.000 description 3
- UHOVQNZJYSORNB-UHFFFAOYSA-N Benzene Chemical compound C1=CC=CC=C1 UHOVQNZJYSORNB-UHFFFAOYSA-N 0.000 description 3
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 3
- 239000001856 Ethyl cellulose Substances 0.000 description 3
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 3
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 239000004902 Softening Agent Substances 0.000 description 3
- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 description 3
- ZMANZCXQSJIPKH-UHFFFAOYSA-N Triethylamine Chemical compound CCN(CC)CC ZMANZCXQSJIPKH-UHFFFAOYSA-N 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 3
- WPYMKLBDIGXBTP-UHFFFAOYSA-N benzoic acid Chemical class OC(=O)C1=CC=CC=C1 WPYMKLBDIGXBTP-UHFFFAOYSA-N 0.000 description 3
- OZVBMTJYIDMWIL-AYFBDAFISA-N bromocriptine Chemical compound C1=CC(C=2[C@H](N(C)C[C@@H](C=2)C(=O)N[C@]2(C(=O)N3[C@H](C(N4CCC[C@H]4[C@]3(O)O2)=O)CC(C)C)C(C)C)C2)=C3C2=C(Br)NC3=C1 OZVBMTJYIDMWIL-AYFBDAFISA-N 0.000 description 3
- 229920001249 ethyl cellulose Polymers 0.000 description 3
- 235000019325 ethyl cellulose Nutrition 0.000 description 3
- 239000000194 fatty acid Substances 0.000 description 3
- 235000011187 glycerol Nutrition 0.000 description 3
- 125000005908 glyceryl ester group Chemical group 0.000 description 3
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 3
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 3
- 229910052500 inorganic mineral Inorganic materials 0.000 description 3
- 229920000609 methyl cellulose Polymers 0.000 description 3
- 239000001923 methylcellulose Substances 0.000 description 3
- 239000011707 mineral Substances 0.000 description 3
- 235000010755 mineral Nutrition 0.000 description 3
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 description 3
- 235000005152 nicotinamide Nutrition 0.000 description 3
- 239000011570 nicotinamide Substances 0.000 description 3
- WXZMFSXDPGVJKK-UHFFFAOYSA-N pentaerythritol Chemical compound OCC(CO)(CO)CO WXZMFSXDPGVJKK-UHFFFAOYSA-N 0.000 description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 3
- 239000006104 solid solution Substances 0.000 description 3
- 239000011720 vitamin B Chemical group 0.000 description 3
- 235000019156 vitamin B Nutrition 0.000 description 3
- 239000001993 wax Substances 0.000 description 3
- KWGRBVOPPLSCSI-WPRPVWTQSA-N (-)-ephedrine Chemical compound CN[C@@H](C)[C@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WPRPVWTQSA-N 0.000 description 2
- PHIQHXFUZVPYII-ZCFIWIBFSA-N (R)-carnitine Chemical compound C[N+](C)(C)C[C@H](O)CC([O-])=O PHIQHXFUZVPYII-ZCFIWIBFSA-N 0.000 description 2
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 description 2
- SGTNSNPWRIOYBX-UHFFFAOYSA-N 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile Chemical compound C1=C(OC)C(OC)=CC=C1CCN(C)CCCC(C#N)(C(C)C)C1=CC=C(OC)C(OC)=C1 SGTNSNPWRIOYBX-UHFFFAOYSA-N 0.000 description 2
- FSCWZHGZWWDELK-UHFFFAOYSA-N 3-(3,5-dichlorophenyl)-5-ethenyl-5-methyl-2,4-oxazolidinedione Chemical compound O=C1C(C)(C=C)OC(=O)N1C1=CC(Cl)=CC(Cl)=C1 FSCWZHGZWWDELK-UHFFFAOYSA-N 0.000 description 2
- ALYNCZNDIQEVRV-UHFFFAOYSA-N 4-aminobenzoic acid Chemical compound NC1=CC=C(C(O)=O)C=C1 ALYNCZNDIQEVRV-UHFFFAOYSA-N 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
- UIERETOOQGIECD-UHFFFAOYSA-N Angelic acid Natural products CC=C(C)C(O)=O UIERETOOQGIECD-UHFFFAOYSA-N 0.000 description 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- GHOKWGTUZJEAQD-UHFFFAOYSA-N Chick antidermatitis factor Natural products OCC(C)(C)C(O)C(=O)NCCC(O)=O GHOKWGTUZJEAQD-UHFFFAOYSA-N 0.000 description 2
- SNPLKNRPJHDVJA-ZETCQYMHSA-N D-panthenol Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCCO SNPLKNRPJHDVJA-ZETCQYMHSA-N 0.000 description 2
- ULGZDMOVFRHVEP-RWJQBGPGSA-N Erythromycin Chemical compound O([C@@H]1[C@@H](C)C(=O)O[C@@H]([C@@]([C@H](O)[C@@H](C)C(=O)[C@H](C)C[C@@](C)(O)[C@H](O[C@H]2[C@@H]([C@H](C[C@@H](C)O2)N(C)C)O)[C@H]1C)(C)O)CC)[C@H]1C[C@@](C)(OC)[C@@H](O)[C@H](C)O1 ULGZDMOVFRHVEP-RWJQBGPGSA-N 0.000 description 2
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- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 2
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 2
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- NKANXQFJJICGDU-QPLCGJKRSA-N Tamoxifen Chemical compound C=1C=CC=CC=1C(/CC)=C(C=1C=CC(OCCN(C)C)=CC=1)/C1=CC=CC=C1 NKANXQFJJICGDU-QPLCGJKRSA-N 0.000 description 2
- DOQPXTMNIUCOSY-UHFFFAOYSA-N [4-cyano-4-(3,4-dimethoxyphenyl)-5-methylhexyl]-[2-(3,4-dimethoxyphenyl)ethyl]-methylazanium;chloride Chemical compound [H+].[Cl-].C1=C(OC)C(OC)=CC=C1CCN(C)CCCC(C#N)(C(C)C)C1=CC=C(OC)C(OC)=C1 DOQPXTMNIUCOSY-UHFFFAOYSA-N 0.000 description 2
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Classifications
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- A—HUMAN NECESSITIES
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
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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
- A61K9/20—Pills, tablets, discs, rods
- 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
Abstract
通过将至少一种聚合粘结剂和至少一种活性成分与适当的惯用添加剂混合,形成塑性混合物,从而制成固体剂型,其中使用N-乙烯已内酰胺的均聚物或共聚物作为聚合粘结剂。按此方法能以简单而低成本的方式制备使活性成分快速释放的固体剂型。
Description
本发明涉及一种制备固体剂型的方法,通过将至少一种聚合粘结剂和至少一种活性成分与适当的惯用添加剂混合,形成一种塑性混合物,并经成形完成。本发明尤其涉及一种制备固体药物剂型的方法。
制备固体药物剂型(尤其是片剂)的传统方法是分批进行,它含有许多步骤。因此药物颗粒是重要的中间体。例如Bauer,Frommig和Fuhrer在《制药技术》Georg-Thieme-Verlag,292页以后揭示了可以通过干法制粒从融体得到药物剂型。记载了通过融化和震动固化,通过铸塑和粉碎或通过在喷雾塔中造粒制备固化熔融颗粒的可能性。与这些方法有关的一个问题是对于制备药物成形必须准确。产生不规则颗粒或片断使形成的形状不能与惯用的药物剂型对应,因此颗粒本身作为药物剂型并不重要。制备理想的固体药物剂型需要进行进一步的工艺步骤,如在压片机中压制。这是耗时且高成本的方法。
一段时间之前已知一种制备固体药物剂型的相当简单的连续的方法,需要将含有活性成分的聚合粘结剂的无溶剂熔体挤压,并使此压制物形成所需的药物剂型,例如在一有铸模轧辊压延机中制备,参见EP-A-240904,EP-A-337256和EP-A-358105(熔融挤压)。以此方法可以达到特定的成形。使用的聚合粘结剂尤其是N-乙烯吡咯烷酮或其共聚物,如乙烯乙酸酯。
N-乙烯己内酰胺的均聚物和共聚物已被用于通常的药物剂型中。因此US3,900,559记载了一种从基质持续释放美生舍灵的剂型,它包括不溶于水的凝胶亲水性三元共聚物与作为一种组分的N-乙烯内酰胺。US 4,987,182记载了制备聚乙烯醇缩丁醛与作为活性成分的载体的聚乙烯内酰胺的混合物。WO 96/17579记载了一种片剂粘结剂,它含有N-乙烯内酰胺与多元酸的均聚物或共聚物。EP756820记载了具有增强的稳定性的含碘制剂,在其粘结剂组分中可以含有N-乙烯己内酰胺。DE 4434986A记载了N-乙烯己内酰胺的制剂。它用于制备慢速释放活性成分的制剂。DE 4327514A公开了一种不溶于水的单体与一种水溶性单体(可以是N-乙烯己内酰胺)的共聚物。此共聚物可以作为活性成分的载体,并使各组分易于结合,使控制释放成为可能。
DE 4422881记载了N-乙烯己内酰胺与疏水性共聚单体的共聚物在配制低水溶性活性成分的制剂中的应用。该制剂为溶液或分散相的形式,并具有增强的稳定性和功效。
DE 3517080记载了一种用于治疗性活性成分的传递系统的组分,此系统以具有弹性的聚合物为基础,此聚合物可以是N-乙烯内酰胺的均聚物或共聚物。这些组分用于治疗性活性成分传递系统如药用硬膏剂的活性成分贮备层中。
基于此类聚合物的剂型的不足是:对于许多应用,其释放活性成分太慢。因此,不采取进一步的措施(如将剂型粉碎以产生一较大的表面积〕就不可能制备快速释放剂型,也称为即时释放剂型。
本发明的一个目的是提供一种可以通过熔融挤压制备、并能够快速释放活性成分的剂型。
我们已发现能通过使用含有N-乙烯己内酰胺的聚合物作为聚合粘结剂达到此目的。
因此本发明涉及一种制备固体剂型的方法,即通过将至少一种聚合粘结剂,与至少一种活性成分和适当的通用添加剂混合形成塑性混合物,并经成形,从而制成固体剂型,其中使用N-乙烯己内酰胺的均聚物和/或共聚物作为聚合粘结剂。
新方法能够以一种简单而低成本的方式制备活性成分快速释放(即时释放)的固体剂型。由于N-乙烯己内酰胺聚合物在聚合物技术中仅慢速释放活性成分,各组分的塑性混合物产生具有小的表面积的致密的非多孔剂型,这将促成活性成分的慢速释放,因而活性成分的快速释放是令人惊奇的。
此处剂型代表适于作为药物、植物处理组合物、人或动物的食品和用于释放芳香剂和芳香油的所有剂型。这些包括,例如,任何形状的片剂、丸剂、颗粒剂,也包括大的剂型如立方体形、块状或柱状剂型,尤其可以用作人或动物的食品。
根据本发明得到的剂型一般含有:
a)0-99%重量份,优选0.1-60%重量(以剂型的总重量为基准)的活性成分,
b)10-100%重量份,优选40-99.9%重量份的聚合粘结剂和
c)适当的添加剂。
本发明使用的聚合粘结剂是N-乙烯己内酰胺的共聚物或均聚物。共聚物含有至少1%重量份的,优选至少10%重量份的,特别优选25%重量份的,尤其是50%重量份的N-乙烯己内酰胺单元。
作为共聚物,聚合粘结剂含有至少一种其它的共聚单体,其重量百分比为0.5-99%,优选0.5-90%,尤其优选0.5-75%,特别是0.5-50%。适宜的共聚单体优选含有3-30个碳原子的、尤其是含有3-8个碳原子的单乙烯基不饱和的羧酸,如丙烯酸、甲基丙烯酸、二甲基丙烯酸、乙基丙烯酸、马来酸、柠康酸、亚甲基丙二酸、烯丙基乙酸、乙烯基乙酸、巴豆酸、富马酸、甲基富马酸、亚甲基丁二酸及上述的二羧酸与C1-C24-链烷醇的单酯。优选丙烯酸、甲基丙烯酸、马来酸或上述羧酸的混合物。可以使用单乙烯基不饱和羧酸的游离酸,如果可能,可以使用其酸酐或者部分或全部中和的形式。优选使用碱金属或碱土金属的碱、氨或胺进行中和,如氢氧化钠、氢氧化钾、碳酸钠、碳酸钾、碳酸氢钠、氧化镁、氢氧化钙、氧化钙、氨气或氨水、三乙胺、乙醇胺、二乙醇胺、吗啉、二亚乙基三胺、或四亚乙基五胺。
适宜的聚合物的进一步的例子是上述羧酸与C1-C24-链烷醇、C2-C4-二醇、单和二-C1-C4-烷基氨基-C2-C4-链烷醇形成的酯及酰胺,这些羧酸的单和二-C1-C4-烷基酰胺和腈,如甲基丙烯酸酯、乙基丙烯酸酯、甲基异丁烯酸酯、乙基异丁烯酸酯、羟乙基丙烯酸酯、羟丙基丙烯酸酯、羟丁基丙烯酸酯、羟乙基异丁烯酸酯、羟丙基异丁烯酸酯、羟基异丁基丙烯酸酯、羟基异丁基异丁烯酸酯、马来酸一甲酯、马来酸二甲酯、马来酸一乙酯、马来酸二乙酯、2-乙基己基丙烯酸酯、2-乙基己基异丁烯酸酯、十八烷酰丙烯酸酯、十八烷酰异丁烯酸酯、二十二烷基丙烯酸酯、二十二烷基异丁烯酸酯、辛基丙烯酸酯、辛基异丁烯酸酯、丙烯酰胺、甲基丙烯酰胺、N,N-二甲基丙烯酰胺、N-叔丁基丙烯酰胺、丙烯腈、甲基丙烯腈、二甲基氨基乙基丙烯酸酯、二乙基氨基乙基丙烯酸酯、二乙基氨基乙基异丁烯酸酯及最后所述的单体与羧酸或矿酸或季铵化产物的盐。
丙烯酰胺乙二醇酸、乙烯基磺酸、烯丙基磺酸、甲基烯丙基磺酸、苯乙烯磺酸、3-丙磺基丙烯酸酯、3-丙磺基异丁烯酸酯和丙烯酰胺甲基丙烷基磺酸,和含有膦酰基的单体(如乙烯基膦酸、烯丙基膦酸和丙烯酰胺甲基丙烷基膦酸)也是适宜的共聚单体。进一步适宜的共聚单体还有N-乙烯比咯烷酮、N-乙烯咪唑、N-乙烯-2-甲基咪唑、N-乙烯-4-甲基咪唑、二烯丙基氯铵和乙烯基乙酯(如乙烯基乙酸酯和乙烯基丙酸酯),和芳香乙烯基化合物如苯乙烯。当然也能使用上述单体的混合物。
使用在聚合条件下生成自由基的化合物、通过已知方法制备均聚物和共聚物,例如用溶液聚合法,沉淀聚合法,悬浮聚合法或反向悬浮聚合法,或反向乳化聚合法。
一般在30-200℃进行聚合,优选40-110℃。适宜的引发剂是偶氮和过氧化合物以及惯用的氧化还原引发剂系统如过氧化物和还原化合物的组合物,例如,亚硫酸钠、亚硫酸氢钠、甲醛化次硫酸钠和肼。
共聚物的K值至少为7,优选10-100,尤其优选10-50。用HFikentscher,Cellulose-Chemie,13(1932)58-64和71-74记载的方法,在25℃的水溶液或有机溶剂中测定K值,根据K值的范围,溶液的浓度为0.1-5%。
除以上所述聚合粘结剂外,尤其可以使用高达粘结剂总重量30%重量份的其它粘结剂,如聚合物、共聚物、纤维素衍生物、淀粉和淀粉衍生物。适宜的例子是:
聚乙烯吡咯烷酮(PVP)、N-乙烯吡咯烷酮(NVP)和乙烯乙酸酯或乙烯丙酸酯的共聚物,乙烯乙酸酯和巴豆酸的共聚物,部分氢化的聚乙烯乙酸酯,聚乙烯醇,聚合(羟烷基丙烯酸酯),聚合(羟烷基异丁和酸酯),聚合丙烯酸酯和聚合异丁烯酸酯(Eudragit类型),甲基异丁烯酸酯和丙烯酸的共聚物,聚合丙烯酰胺,聚乙二醇,聚乙烯甲酰胺(适当时部分或全部氢化的),纤维素酯,纤维素醚(尤其是甲基纤维素和乙基纤维素),羟烷基纤维素(尤其是羟丙基纤维素),羟烷基烷基纤维素(尤其是羟丙基乙基纤维素),邻苯二甲酸纤维素酯(尤其是邻苯二甲酸纤维素乙酸酯和羟丙基甲基纤维素邻苯二甲酸酯)和甘露聚糖(尤其是半乳甘露聚糖)。其中尤其优选聚乙烯吡咯烷酮、N-乙烯吡咯烷酮(NVP)和乙烯酯的共聚物,聚合(羟烷基丙烯酸酯)、聚合(羟烷基异丁烯酸酯)、聚合丙烯酸酯和聚合异丁烯酸酯、甲基纤维素和羟烷基纤维素。
含有所有组分的总混合物中的聚合粘结剂在50-180℃(优选60-130℃)必须软化或熔融形成塑性混合物。混合物的玻璃化温度因此必须低于180℃,优选低于130℃。如果必要,用惯用的药学上可以接受的增塑辅料将其降低。增塑剂的数量不能超过粘结剂和增塑剂总重的30%,以形成不出现冷变形的储存稳定的药物剂型。然而此混合物优选不含增塑剂。
这些增塑剂的例子是:
长链醇,乙二醇,丙二醇,丙三醇,三羟甲基丙烷,三甘醇,丁二醇,戊醇如季戊四醇,己醇,聚乙二醇,聚丙二醇,聚乙/丙二醇,(聚)硅氧烷,芳香族羧酸酯(二烷基邻苯二甲酸酯、1,2,4-苯三酸酯、苯甲酸酯、对苯二甲酸酯)或脂肪族-二羧酸酯(如二烷基己二酸酯、癸二酸酯、壬二酸酯、柠檬酸和酒石酸酯),脂肪酸酯如甘油单、二、三乙酸酯或磺基琥珀酸二乙酯钠(sodium diethylsulfosuccinate)。增塑剂浓度一般为混合物总重量的0.5-15%,优选0.5-5%。
总重量可达聚合物重量的100%的惯用药学辅料,可以是,例如膨胀剂和填充剂(如硅酸盐或硅藻土),氧化镁,氧化铝,氧化钛,硬脂酸及其盐如镁盐或钙盐,甲基纤维素,羧甲基纤维素钠,滑石,蔗糖,乳糖,谷类或玉米淀粉,马铃薯粉,聚乙烯醇,浓度多为混合物总重的0.02-50%,优选0.20-20%。
润滑剂如硬脂酸铝和钙、滑石和硅酮,浓度为混合物总重量的0.1-5%,优选0.1-3%。
助流剂如动、植物脂类,尤其是其氢化形式,它们在室温为固态。这些脂类{的熔点优选50℃或更高。优选C12、C14、C16和C18脂肪酸甘油三酯。也能使用蜡,如巴西棕榈蜡。有利的是这些脂类和蜡可以单独混合,或与单和/或二甘油酯或磷脂,尤其是卵磷脂混合。单或二甘油酯优选从上述脂肪酸类衍生得到的。脂类、蜡、单、二甘油酯和/或卵磷脂的总量为各层组合物总重量的0.1-30%,优选0.1-5%。
染料,如偶氮染料,有机或无机颜料或天然染料,其中无机颜料的浓度为混合物总重量的0.001-10%,优选0.5-3%。
稳定剂如抗氧化剂、光稳定剂、过氧化氢破坏剂、自由基清除剂、抵制微生物侵袭的稳定剂。
也能加入湿润剂、防腐剂、崩解剂、吸附剂、释放剂和推进剂(参考文献,如H Sucker等《制药技术》,Thieme-Verlag,Stuttgart,1978)。
辅料包括为达到本发明目的而入的,用于制备各种活性成分固体溶液的物质。如季戊四醇和季戊四醇四乙酸酯,聚合物如聚乙烯氧化物和聚丙烯氧化物和其嵌段共聚物(泊咯沙姆),磷脂如卵磷脂,乙烯吡咯烷酮的共聚物和均聚物,表面活性剂如聚氧乙烯40硬脂酸酯,以及柠檬酸和琥珀酸、胆酸、甾醇和其它物质,如,在J.L.Ford,Pharm.Acta.Helv.,61,(1986)69-88指出的物质。
酸和碱也可以作为辅料加入以控制活性成分的溶解度(参见,如K.Thoma等,《制药工业》,51(1989)98-101)。
适宜作为辅料的唯一先决条件是其足够的热稳定性。
本发明的活性成分意指,只要在加工条件下不分解且具有生理效应的所有物质。这些尤其是药学活性成分(对于人和动物)、用于植物处理的活性成分、杀虫剂、人和动物食品的活性成分、香料和芳香油。每剂量单位活性成分的数量和浓度可以根据其活性和释放速度在一较宽的范围内改变。唯一的条件是它们应足以达到所需的效果。因此以重量计,活性成分的浓度可以在0.1-95%,优选20-80%,尤其优选30-70%。也能使用复合活性成分。本发明使用的活性成分也包括维生素和矿物质。维生素包括A族维生素、B族维生素,除B1、B2、B6、B12和烟酸和烟酰胺外,还包括具有维生素B的特性的化合物,如腺嘌呤、胆碱、泛酸、维生素H、腺苷磷酸、叶酸、乳清酸、维生素B15、肉毒碱、对氨基苯甲酸、肌醇、硫辛酸,及C、D、E、F、H、I、J、K、P族维生素。本发明使用的活性成分也包括具有治疗作用的肽。植物处理剂包括,如烯菌酮、epoxiconazole和quinmerac。
本发明新方法适用于制备以下活性成分:
醋丁洛尔、乙酰半胱氨酸、乙酰水杨酸、阿昔洛韦、阿普唑仑、阿法骨化醇、尿囊素、别嘌醇、氨溴索、阿米卡星、阿米洛利、甘氨酸、胺碘酮、阿米替林、氨氯地平、阿莫西林、氨苄西林、抗坏血酸、阿司帕坦、阿司咪唑、阿替洛尔、氯地米松、苄丝肼、盐酸苯扎铵、苯佐卡因、苯甲酸、倍他米松、苯扎贝卡、生物素、比哌立簦、比索洛尔、溴西泮、溴己新、溴隐亭、布地奈德、丁苯羟酸、丁洛地尔、丁螺环酮、咖啡因、樟脑、卡托普利、卡马西平、卡比巴多、卡铂、头孢克洛、头孢氨苄、头孢羟氨苄、头孢唑啉、头孢克肟、头孢赛肟、头孢他啶、头孢曲松、头孢呋辛、司来吉兰、氯霉素、氯己定、氯苯那敏、氯噻酮、胆碱、环孢菌素、西司他丁、西米替丁、环丙氟哌酸、西沙必利、顺铂、克红霉素、克拉维酸、氯米帕明、氯硝西泮、可乐定、克霉唑、可待因、考来烯胺、色甘酸、氰钴胺、环丙孕酮、去氧孕烯、地塞米松、右泛醇、右沙米芬、右丙氧芬、地西泮、双氯芬酸、地高辛、双氯可待因、双氢麦角胺、二氢麦角胺、地尔硫卓*、苯海拉明、双嘧达莫、安乃近、丙吡胺、多潘立酮、多巴胺、强力霉素、依那普利、麻黄碱、肾上腺素、麦角骨化醇、麦角胺、红霉素、雌二醇、炔雌醇、依托泊甙、蓝桉树、法莫替丁、非洛地平、非诺贝特、非诺特罗、芬太尼、黄素单核苷酸、氟康唑、氟桂利嗪、氟脲嘧啶、氟西汀、氟比洛芬、氟赛米、加洛帕米、吉非贝齐、庆大霉素、银杏(Gingko biloba)、灰黄霉素、愈创木酚甘油醚、氟哌啶醇、肝素、透明质酸、氢氯噻嗪、氢可酮、氢化可的松、氢吗啡酮、氢氧化异丙托品、布洛芬、亚胺培南、消炎痛、碘六醇、碘五醇、硝酸异山梨酯、单硝异山梨酯、异维甲酸、酮替芬、酮康唑、酮基布洛芬、酮咯酸、柳胺苄心定、乳果糖、卵磷脂、左肉毒碱、左旋多巴、左旋谷酰胺、左旋甲炔诺酮、甲状腺素、利多卡因、脂酶、丙咪嗪、赖诺普利、易蒙停、洛卡酮、美维洛林甲羟孕酮、薄荷醇、甲氨嘌呤、甲基强地松龙、氯普胺、倍他乐克、达克宁、速眠安、二甲胺四环素、长压定、喜克溃、吗啡、多种维生素混合物或化合物、矿物盐、N-甲基麻黄碱、萘呋胺酯、消痛灵、新霉胺、尼卡地平、麦角溴烟酯、烟酰胺、尼古丁、烟酸、硝苯地平、尼莫地平、硝西泮、尼群地平、尼扎替丁炔诺酮、诺氟沙星、甲基炔诺酮、去甲替林、制霉素、氧氟沙星、奥美拉唑、奥丹西隆、胰酶、泛醇、泛酸、扑热息痛、青霉素G、青霉素V、苯巴比妥、己酮可可碱、青霉素V钾、去氧肾上腺素、苯丙醇胺、苯妥英、炎痛喜康、多粘菌素B、聚乙烯吡咯酮、帕伐他丁、普拉西泮、哌唑嗪、强地松龙己酸酯、强地松、溴隐亭甲磺酸盐、普罗帕酮、心得安、羟丙茶碱、右旋麻黄碱、祛脂酸吡哆醇、奎宁、雷米普利、呋喃硝胺、利血平、维生素A、维生素B2、利福平、维生素P、糖精、沙丁胺醇、沙卡托宁、水杨酸、西伐他停、促生长素、索他洛尔、安体舒通、硫糖铝、舒巴克坦、磺胺恶唑、磺胺吡啶、止呕灵、三苯氧胺呋氟啶、替普瑞酮、四喃唑嗪、特布他林、丁苯哌丁醇、四环素、茶碱、呋喃硫胺、噻氯匹定、噻吗心安、止血环酸、维甲酸、去炎松缩丙酮、氨苯喋啶、甲氧苄啶、维脑路通、尿嘧啶、丙戊酸、万古霉素、维拉帕米、维生素E、亚叶酸、叠氮胸苷。
优选的活性成分是布洛芬(作为消旋体、对映体或浓缩对映体)、酮洛芬、氟比洛芬、乙酰水杨酸、维拉帕米、扑热息痛、硝苯地平或卡托普利。
为制备固体剂型,先制备组分(熔融)的塑性混合物然后使之成形。有各种混合组分并形成熔体的方法。可以在形成熔体前、过程中和/或其后进行混合。如可以先混合组分,然后熔融/或混合与熔融同时进行。经常将塑性混合物均化以使活性成分彻底分散。
然而,已证明,尤其在使用敏感的活性成分时,先将聚合粘结剂熔融,并在适当时,与通用的药物添加剂预混合,然后在完全混合器中以一很短的滞留时间混入以塑性相形式存在的敏感活性成分(均化)中。用于此目的的活性成分,可以是固体形式的或在溶液或分散相中的一或多种活性成分。
在制备过程中通常如此使用各组分。然而也可以使用其液体形式,即作为溶液,悬浮液或分散体使用。
对于组分的液体形式适宜的溶剂是水或可与水相溶的有机溶剂,或其与水的混合物。然而也能使用与水不相混溶或相混溶的有机溶剂。适宜的与水相混溶的溶剂尤其是,C1-C4-烷醇,如乙醇、异丙醇或正丙醇;多元醇如乙二醇、丙三醇和聚乙二醇。适宜的与水不相混溶的溶剂是烷烃,如戊烷或己烷;酯如乙酸乙酯或乙酸丁酯;氯代烃,如亚甲基氯;和芳香烃如甲苯和二甲苯。其它可以使用的溶剂是液体二氧化碳。
在各例中使用的溶剂根据将要处理的成分及其性质决定。如常常将药学活性成分用于通常溶于水的盐形式中。因此可以使用水溶性活性成分的水溶液,或优选,在粘结剂的水溶液或分散相中处理。如果所用成分的液体形式是溶于一种有机溶剂形成的,则相应的结论适用于溶于以上所述溶剂之一的活性成分。
如果需要和/或必须加入适宜的添加剂如乳化剂,适当时可以将其溶解、悬浮或分散在上述溶剂中代替熔融。然后除去溶剂,在适宜的装置(如挤压机)中形成熔体。此后的混合包括此步骤。
熔融和/或混合在用于此目的的通用装置中进行。尤其适宜的装置是在适当时可以被加热,并有一搅拌器的挤压机或容器,如捏和机(如以下提及的那些类型)。
尤其适宜的混合装置是一种用于塑料工艺中混合的装置。例如“Mischen beimHerstellen und Verabeiten von Kmststoffen”,H.Pahl,VDI-Verlag,1986记载了适宜的装置。尤其适宜的装置是挤压机以及动态和静态混合器、和搅拌器、有脱模装置的单轴搅拌器(尤其膏剂混合器)、多轴搅拌器(尤其是PDSM混合器)、固体混合器,优选混合器/捏和反应器(如,List提供的ORP CRP,AP,DTB或Krauss-Maffei提供的Reactotherm,或Buss提供的Ko-Kneter),槽状混合器和密闭式混合器,或旋转/固定系统(如IKA提供的Dispax)。
在处理敏感的活性成分的情况下,优选首先将聚合粘结剂在挤压机中熔融,然后在混合器/捏和反应器中将活性成分预混合。另一方面,使用旋转/固定系统将敏感性较低的活性成分有效地分散。
混合装置根据其设计按通常方式连续或分批进料。粉状成分可自由进料,如通过一种定量供给装置。塑性组合物可以直接从挤压机或经齿轮泵进料,在粘度和压力高的情况下后者尤其有利。可以用适宜的泵装置对液态介质进行计量。
通过将粘结剂、活性成分和适当时加入的糊状至粘性的(塑料)或流体添加剂混合和/或熔融,得到可以压制的混合物。混合物的玻璃化温度低于混合物中所有组分的分解温度。粘结剂应优选在生理介质中能溶解和膨胀者。
在此工艺中混合和熔融的步骤可以在同一装置中或两个或多个独立的操作装置中进行。预混合物可以在上述的惯用混合装置之一中制备。然后可以将此类预混合物直接进料,如,加入挤压机中,然后进行挤压,适当时加入其它成分。
在此新方法中,单螺杆压出机、交叉式螺杆压出机或其它多螺杆压出机,尤其是共转式或逆转式的双螺杆压出机可以作为挤压机使用,适当时安装捏和盘。如果必须在挤压中蒸发溶剂,挤压机一般安装蒸发部件。尤其优选的挤压机是Werner和Ptteiderer提供的ZKS系列。
根据本发明可以通过共挤压制备多层药物剂型,在这种情况下将许多种上述成分的混合物一同进料加入挤压机模具中,得到所需的多层药物剂型的层状结构。优选对于不同的层使用不同的粘结剂。
多层药物剂型优选含有2或3层。它们可以是开放式或闭合式剂型,尤其是开放式或闭合式多层片剂。
至少其中一层含有至少一种药物活性成分。另一种活性成分可以存在于另一层中。这有利于加工互不相容的两种活性成分,或能够控制活性成分的释放特性。
通过将从单个挤压机或其它用来向普通共挤压模具进料和挤压的装置得到的混合物共挤压,完成成形步骤。共挤压模具的形状根据所需药物剂型而定。适宜的模具的例子是具有平的孔口、被称为缝模,及具有圆的孔口的模具。根据所用的聚合粘结剂和所需的药物剂型设计模具。
得到的混合物优选不含溶剂,即不含水也不含有机溶剂。
作为常规,将塑性混合物进行最后成形。这样,根据模具和所需形状的不同可以得到许多不同的型材。如,如果使用挤压机,可以在一个传输带和一个滚筒之间使挤出物成形,在两个传输带之间或在两个滚筒之间成形,如EP-A-358105所记载,或在有两个铸模滚筒的压延机中进行压延,见EP-A-240904。可以通过挤压和将挤出物热或冷切制得到其它形状,如小颗粒或均匀的丸。热切制丸经常产生透镜状的剂型(片剂),直径为1-10mm,条状制丸一般产生圆柱状物,长度与直径比为1-10,直径为0.5-10mm。因此可能生成单层剂型,但使用共挤压也能产生多层剂型,如长方形片剂、包衣片剂、锭剂、丸剂。也能将产生的颗粒剂研磨成粉并以常规方法压制成片剂。可以通过Rotoform-Sandvik方法制备微型锭剂。可以将这些剂型磨圆和/或在后续工艺步骤中用惯用方法包衣。适于薄膜包衣的材料是聚丙烯酸酯,如Eudragit类;纤维素酯,如羟丙基纤维素邻苯二甲酸酯;以及纤维素醚,如乙基纤维素、羟丙基甲基纤维素或羟丙基纤维素。
在特殊情况下可以形成固体溶液。“固体溶液”一词对于本领域的技术人员是熟知的,如开始引用的文献中所述。在聚合物中的活性成分的固体剂型中,活性成分以分子形式分散于聚合物中。
以下的实施例是用来说明本发明新方法的,但不只限于此。实施例1
将520g聚乙烯己内酰胺(K值为40,在乙醇中的浓度为1%)在以下条件下与480g盐酸维拉帕米一起挤压,压制成500mg的长方形片剂。
部件1 52℃
部件2 85℃
部件3 130℃
部件4 108℃
部件5 92℃
模具 85℃
1小时后的释放为100%(USP搅槽法(改变pH))。例2
将500g 50%重量份的乙烯己内酰胺和50%重量份的乙烯吡咯烷酮的共聚物(K值为65,在水中的浓度为1%)与480g盐酸维拉帕米在如下条件下挤压,制成500mg的长方形片剂,并将其制粒。
部件1 47℃
部件2 86℃
部件3 132℃
部件4 112℃
部件5 101℃
模具 100℃
1小时后的释放为67%,2小时后的释放为100%(USP搅槽法(pH改变))。例3
将500g 50%重量份的乙烯己内酰胺和50%重量份的乙烯吡咯烷酮的共聚物(K值65,在水中的浓度为1%)与500g烯菌酮一起在如下条件下挤压,冷却并制粒。
部件1 60℃
部件2 96℃
部件3 140℃
部件4 150℃
部件5 129℃
模具 100℃
得到透明的、X-射线非晶形的、能分散在水中的颗粒。例4
将500g聚乙烯己内酰胺(K值40,在乙醇中的浓度为1%)和500gepoxyconazole一起在如下条件下挤压,冷却并压延。
部件1 60℃
部件2 90℃
部件3 120℃
部件4 135℃
部件5 120℃
模具 100℃
得到透明的、X-射线非晶形的、能分散在水中的颗粒。
Claims (10)
1.一种制备固体剂型的方法,其特征在于通过将至少一种聚合粘结剂、至少一种活性成分和适当时惯用添加剂混合以形成一种塑性混合物,并且成形,其中使用N-乙烯己内酰胺的均聚物和/或共聚物作为聚合粘结剂。
2.根据权利要求1所述的方法,其特征在于使用N-乙烯己内酰胺的均聚物作为聚合粘结剂。
3.根据权利要求1所述的方法,其特征在于使用N-乙烯己内酰胺的共聚物作为聚合粘结剂,该共聚物含有至少10%重量,尤其是至少25%重量份,特别优选至少50%重量份的N-乙烯己内酰胺单元。
4.根据权利要求1或3所述的方法,其特征在于使用N-乙烯己内酰胺的共聚物作为聚合粘结剂,该共聚物含有至少一种可共聚单体作为共聚单体,所述的可共聚单体选自:有3-30个碳原子的单乙烯基不饱和单羧酸或二羧酸;所述羧酸与C1-C24-链烷醇、C2-C4-链烷二醇和单或二-(C1-C4)-烷基氨基-C2-C4-链烷醇的二酯和单酯;所述羧酸的酰胺、单和二-(C1-C4)-烷基酰胺和腈;脂肪族C1-C18-羧酸的乙烯基酯;N-乙烯基吡咯烷酮;及它们的盐。
5.根据权利要求4所述的方法,其特征在于其中所述的共聚单体选自单乙烯基不饱和的C3-C6-单羧酸和二羧酸以及这些羧酸与C1-C18-链烷醇和C2-C4-链烷二醇的酯。
6.根据权利要求5所述的方法,其特征在于其中所述的共聚单体选自丙烯酸,甲基丙烯酸,马来酸,丙烯酸或甲基丙烯酸与甲醇、乙醇、正丁醇、2-乙基己醇、乙烯基二醇和丙烯基二醇形成的酯,以及尤其是N-乙烯吡咯烷酮。
7.根据上述权利要求中任一权利要求所述的方法,其特征在于所用的聚合粘结剂的K值在10-100范围内。
8.根据上述权利要求中任一权利要求所述的方法,其特征在于通过将组分在挤压机中混合和/或熔融制备塑性混合物。
9.根据上述权利要求中任一权利要求所述的方法,其特征在于它可用于制备药物剂型、植物处理组合物、动物饲料添加剂和补充剂、人类食品补充剂及芳香剂和芳香油的各种剂型。
10.一种通过权利要求1-9中任一权利要求所述的方法可得到的固体剂型。
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EP (1) | EP0922462A3 (zh) |
JP (1) | JPH11228392A (zh) |
CN (1) | CN1226583A (zh) |
CA (1) | CA2253695A1 (zh) |
DE (1) | DE19753300A1 (zh) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100448432C (zh) * | 2006-10-26 | 2009-01-07 | 徐竹青 | 高溶出度尼莫地平分散片的制备方法 |
CN101258848B (zh) * | 2008-04-10 | 2011-02-09 | 浙江大学 | 含三唑磷的杀虫固体微乳剂及其制备方法 |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE19809242A1 (de) * | 1998-03-05 | 1999-09-09 | Basf Ag | Verfahren zur Herstellung von festen, sphärischen Formkörpern, enthaltend pharmazeutische Wirkstoffe in einer Bindemittelmatrix |
US7883721B2 (en) | 2001-01-30 | 2011-02-08 | Smithkline Beecham Limited | Pharmaceutical formulation |
GB0102342D0 (en) | 2001-01-30 | 2001-03-14 | Smithkline Beecham Plc | Pharmaceutical formulation |
US7842308B2 (en) | 2001-01-30 | 2010-11-30 | Smithkline Beecham Limited | Pharmaceutical formulation |
US6575013B2 (en) * | 2001-02-26 | 2003-06-10 | Lucent Technologies Inc. | Electronic odor sensor |
TW200526274A (en) | 2003-07-21 | 2005-08-16 | Smithkline Beecham Plc | Pharmaceutical formulations |
TW200539903A (en) | 2004-03-12 | 2005-12-16 | Smithkline Beecham Plc | Pharmaceutical formulations |
EP2219624A2 (en) | 2007-11-08 | 2010-08-25 | Glaxo Group Limited | Pharmaceutical formulations |
JP2014525423A (ja) * | 2011-08-30 | 2014-09-29 | ウニベルシテイト ヘント | 多層放出配合物 |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3830355A1 (de) * | 1988-09-07 | 1990-03-15 | Basf Ag | Verfahren zur herstellung von pharmazeutischen tabletten |
US5130388A (en) * | 1991-05-06 | 1992-07-14 | Isp Investments Inc. | Precipitation polymerization process |
DE4422881A1 (de) * | 1993-10-25 | 1995-04-27 | Bayer Ag | Kolloidal dispergierbare Wirkstoff-Formulierungen |
DE19603303C2 (de) * | 1996-01-25 | 1999-07-22 | Inventa Ag | Kontinuierliches Verfahren zur aktivierten anionischen Lactampolymerisation |
-
1997
- 1997-12-01 DE DE1997153300 patent/DE19753300A1/de not_active Withdrawn
-
1998
- 1998-11-27 EP EP98122620A patent/EP0922462A3/de not_active Withdrawn
- 1998-11-30 CA CA 2253695 patent/CA2253695A1/en not_active Abandoned
- 1998-11-30 CN CN 98125899 patent/CN1226583A/zh active Pending
- 1998-12-01 JP JP34168698A patent/JPH11228392A/ja not_active Withdrawn
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100448432C (zh) * | 2006-10-26 | 2009-01-07 | 徐竹青 | 高溶出度尼莫地平分散片的制备方法 |
CN101258848B (zh) * | 2008-04-10 | 2011-02-09 | 浙江大学 | 含三唑磷的杀虫固体微乳剂及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CA2253695A1 (en) | 1999-06-01 |
EP0922462A3 (de) | 1999-10-20 |
JPH11228392A (ja) | 1999-08-24 |
EP0922462A2 (de) | 1999-06-16 |
DE19753300A1 (de) | 1999-06-02 |
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