LV10182B - Memantine-containing solid pharmaceutical dosage forms having an extended two-stage release profile and production thereof - Google Patents
Memantine-containing solid pharmaceutical dosage forms having an extended two-stage release profile and production thereof Download PDFInfo
- Publication number
- LV10182B LV10182B LVP-93-1013A LV931013A LV10182B LV 10182 B LV10182 B LV 10182B LV 931013 A LV931013 A LV 931013A LV 10182 B LV10182 B LV 10182B
- Authority
- LV
- Latvia
- Prior art keywords
- water
- casein
- insoluble
- salt
- soluble
- Prior art date
Links
- 239000007787 solid Substances 0.000 title claims abstract description 13
- 229960004640 memantine Drugs 0.000 title claims abstract description 12
- BUGYDGFZZOZRHP-UHFFFAOYSA-N memantine Chemical compound C1C(C2)CC3(C)CC1(C)CC2(N)C3 BUGYDGFZZOZRHP-UHFFFAOYSA-N 0.000 title claims abstract 4
- 239000002552 dosage form Substances 0.000 title abstract description 17
- 238000004519 manufacturing process Methods 0.000 title abstract description 8
- BECPQYXYKAMYBN-UHFFFAOYSA-N casein, tech. Chemical compound NCCCCC(C(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(CC(C)C)N=C(O)C(CCC(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(C(C)O)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(COP(O)(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(N)CC1=CC=CC=C1 BECPQYXYKAMYBN-UHFFFAOYSA-N 0.000 claims abstract description 61
- 239000000203 mixture Substances 0.000 claims abstract description 59
- 108010076119 Caseins Proteins 0.000 claims abstract description 33
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 27
- 150000003839 salts Chemical class 0.000 claims abstract description 26
- 239000005018 casein Substances 0.000 claims abstract description 21
- 235000021240 caseins Nutrition 0.000 claims abstract description 21
- 239000004480 active ingredient Substances 0.000 claims abstract description 15
- 238000000034 method Methods 0.000 claims abstract description 15
- 108010033929 calcium caseinate Proteins 0.000 claims abstract description 12
- 102000011632 Caseins Human genes 0.000 claims description 30
- 229940088598 enzyme Drugs 0.000 claims description 28
- 108090000790 Enzymes Proteins 0.000 claims description 27
- 102000004190 Enzymes Human genes 0.000 claims description 27
- 239000003814 drug Substances 0.000 claims description 21
- 150000001768 cations Chemical class 0.000 claims description 16
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 16
- 238000007906 compression Methods 0.000 claims description 11
- 230000006835 compression Effects 0.000 claims description 11
- 229940080237 sodium caseinate Drugs 0.000 claims description 9
- 108010019160 Pancreatin Proteins 0.000 claims description 7
- 108090000284 Pepsin A Proteins 0.000 claims description 7
- 102000057297 Pepsin A Human genes 0.000 claims description 7
- 229940055695 pancreatin Drugs 0.000 claims description 7
- 229940111202 pepsin Drugs 0.000 claims description 7
- 239000000126 substance Substances 0.000 claims description 7
- 238000005469 granulation Methods 0.000 claims description 5
- 230000003179 granulation Effects 0.000 claims description 5
- 238000002360 preparation method Methods 0.000 claims description 5
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 claims description 2
- 229910001424 calcium ion Inorganic materials 0.000 claims 1
- 125000002091 cationic group Chemical group 0.000 claims 1
- 229940125368 controlled substance Drugs 0.000 claims 1
- 239000000599 controlled substance Substances 0.000 claims 1
- 238000001125 extrusion Methods 0.000 claims 1
- 239000011343 solid material Substances 0.000 claims 1
- 239000011159 matrix material Substances 0.000 abstract description 18
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 abstract description 3
- 239000011734 sodium Substances 0.000 abstract description 3
- 229910052708 sodium Inorganic materials 0.000 abstract description 3
- 229940071162 caseinate Drugs 0.000 description 42
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 30
- 239000013543 active substance Substances 0.000 description 20
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 description 18
- 229940079593 drug Drugs 0.000 description 18
- 238000009472 formulation Methods 0.000 description 18
- 235000019359 magnesium stearate Nutrition 0.000 description 15
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 13
- 239000012530 fluid Substances 0.000 description 11
- 230000002496 gastric effect Effects 0.000 description 11
- 239000003826 tablet Substances 0.000 description 11
- 239000002609 medium Substances 0.000 description 10
- LPHGQDQBBGAPDZ-UHFFFAOYSA-N Isocaffeine Natural products CN1C(=O)N(C)C(=O)C2=C1N(C)C=N2 LPHGQDQBBGAPDZ-UHFFFAOYSA-N 0.000 description 9
- 229960001948 caffeine Drugs 0.000 description 9
- VJEONQKOZGKCAK-UHFFFAOYSA-N caffeine Natural products CN1C(=O)N(C)C(=O)C2=C1C=CN2C VJEONQKOZGKCAK-UHFFFAOYSA-N 0.000 description 9
- 238000004090 dissolution Methods 0.000 description 9
- 238000013265 extended release Methods 0.000 description 9
- LDDHMLJTFXJGPI-UHFFFAOYSA-N memantine hydrochloride Chemical group Cl.C1C(C2)CC3(C)CC1(C)CC2(N)C3 LDDHMLJTFXJGPI-UHFFFAOYSA-N 0.000 description 9
- 230000000694 effects Effects 0.000 description 8
- 239000000243 solution Substances 0.000 description 8
- 229910002012 Aerosil® Inorganic materials 0.000 description 7
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- -1 alginic acid salts Chemical class 0.000 description 6
- 239000011575 calcium Substances 0.000 description 6
- 239000012738 dissolution medium Substances 0.000 description 6
- 210000000936 intestine Anatomy 0.000 description 6
- 210000002784 stomach Anatomy 0.000 description 6
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 5
- 229960005069 calcium Drugs 0.000 description 5
- 229910052791 calcium Inorganic materials 0.000 description 5
- 238000013270 controlled release Methods 0.000 description 5
- 239000008187 granular material Substances 0.000 description 5
- 230000000968 intestinal effect Effects 0.000 description 5
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 4
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 4
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- 239000001110 calcium chloride Substances 0.000 description 4
- 229960002713 calcium chloride Drugs 0.000 description 4
- 229910001628 calcium chloride Inorganic materials 0.000 description 4
- 235000011148 calcium chloride Nutrition 0.000 description 4
- 229960001680 ibuprofen Drugs 0.000 description 4
- 235000018102 proteins Nutrition 0.000 description 4
- 102000004169 proteins and genes Human genes 0.000 description 4
- 108090000623 proteins and genes Proteins 0.000 description 4
- 239000007909 solid dosage form Substances 0.000 description 4
- 239000007916 tablet composition Substances 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 4
- 229910002016 Aerosil® 200 Inorganic materials 0.000 description 3
- JZUFKLXOESDKRF-UHFFFAOYSA-N Chlorothiazide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC2=C1NCNS2(=O)=O JZUFKLXOESDKRF-UHFFFAOYSA-N 0.000 description 3
- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 3
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 3
- 239000000654 additive Substances 0.000 description 3
- FUFJGUQYACFECW-UHFFFAOYSA-L calcium hydrogenphosphate Chemical compound [Ca+2].OP([O-])([O-])=O FUFJGUQYACFECW-UHFFFAOYSA-L 0.000 description 3
- 159000000007 calcium salts Chemical class 0.000 description 3
- 235000019700 dicalcium phosphate Nutrition 0.000 description 3
- 230000037406 food intake Effects 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 239000008188 pellet Substances 0.000 description 3
- UCTWMZQNUQWSLP-VIFPVBQESA-N (R)-adrenaline Chemical compound CNC[C@H](O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-VIFPVBQESA-N 0.000 description 2
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-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
- 229920003084 Avicel® PH-102 Polymers 0.000 description 2
- 239000001828 Gelatine Substances 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
- 235000010443 alginic acid Nutrition 0.000 description 2
- 229920000615 alginic acid Polymers 0.000 description 2
- 230000000202 analgesic effect Effects 0.000 description 2
- BLFLLBZGZJTVJG-UHFFFAOYSA-N benzocaine Chemical compound CCOC(=O)C1=CC=C(N)C=C1 BLFLLBZGZJTVJG-UHFFFAOYSA-N 0.000 description 2
- 230000002051 biphasic effect Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 229910000019 calcium carbonate Inorganic materials 0.000 description 2
- 229960003563 calcium carbonate Drugs 0.000 description 2
- 239000004227 calcium gluconate Substances 0.000 description 2
- 229960004494 calcium gluconate Drugs 0.000 description 2
- 235000013927 calcium gluconate Nutrition 0.000 description 2
- MKJXYGKVIBWPFZ-UHFFFAOYSA-L calcium lactate Chemical compound [Ca+2].CC(O)C([O-])=O.CC(O)C([O-])=O MKJXYGKVIBWPFZ-UHFFFAOYSA-L 0.000 description 2
- 239000001527 calcium lactate Substances 0.000 description 2
- 229960002401 calcium lactate Drugs 0.000 description 2
- 235000011086 calcium lactate Nutrition 0.000 description 2
- 229940078480 calcium levulinate Drugs 0.000 description 2
- ZCCIPPOKBCJFDN-UHFFFAOYSA-N calcium nitrate Chemical compound [Ca+2].[O-][N+]([O-])=O.[O-][N+]([O-])=O ZCCIPPOKBCJFDN-UHFFFAOYSA-N 0.000 description 2
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
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- 239000007888 film coating Substances 0.000 description 2
- 238000009501 film coating Methods 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 229920000159 gelatin Polymers 0.000 description 2
- 235000019322 gelatine Nutrition 0.000 description 2
- 229960002003 hydrochlorothiazide Drugs 0.000 description 2
- 238000011065 in-situ storage Methods 0.000 description 2
- 238000010348 incorporation Methods 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 239000011777 magnesium Substances 0.000 description 2
- 229910052749 magnesium Inorganic materials 0.000 description 2
- 235000001055 magnesium Nutrition 0.000 description 2
- 229940091250 magnesium supplement Drugs 0.000 description 2
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- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 description 2
- XQYZDYMELSJDRZ-UHFFFAOYSA-N papaverine Chemical compound C1=C(OC)C(OC)=CC=C1CC1=NC=CC2=CC(OC)=C(OC)C=C12 XQYZDYMELSJDRZ-UHFFFAOYSA-N 0.000 description 2
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- WWYNJERNGUHSAO-XUDSTZEESA-N (+)-Norgestrel Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](CC)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 WWYNJERNGUHSAO-XUDSTZEESA-N 0.000 description 1
- WHTVZRBIWZFKQO-AWEZNQCLSA-N (S)-chloroquine Chemical compound ClC1=CC=C2C(N[C@@H](C)CCCN(CC)CC)=CC=NC2=C1 WHTVZRBIWZFKQO-AWEZNQCLSA-N 0.000 description 1
- TWBNMYSKRDRHAT-RCWTXCDDSA-N (S)-timolol hemihydrate Chemical compound O.CC(C)(C)NC[C@H](O)COC1=NSN=C1N1CCOCC1.CC(C)(C)NC[C@H](O)COC1=NSN=C1N1CCOCC1 TWBNMYSKRDRHAT-RCWTXCDDSA-N 0.000 description 1
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- JWDYCNIAQWPBHD-UHFFFAOYSA-N 1-(2-methylphenyl)glycerol Chemical compound CC1=CC=CC=C1OCC(O)CO JWDYCNIAQWPBHD-UHFFFAOYSA-N 0.000 description 1
- OKMWKBLSFKFYGZ-UHFFFAOYSA-N 1-behenoylglycerol Chemical compound CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO OKMWKBLSFKFYGZ-UHFFFAOYSA-N 0.000 description 1
- BFPYWIDHMRZLRN-UHFFFAOYSA-N 17alpha-ethynyl estradiol Natural products OC1=CC=C2C3CCC(C)(C(CC4)(O)C#C)C4C3CCC2=C1 BFPYWIDHMRZLRN-UHFFFAOYSA-N 0.000 description 1
- GCKMFJBGXUYNAG-UHFFFAOYSA-N 17alpha-methyltestosterone Natural products C1CC2=CC(=O)CCC2(C)C2C1C1CCC(C)(O)C1(C)CC2 GCKMFJBGXUYNAG-UHFFFAOYSA-N 0.000 description 1
- FLPJVCMIKUWSDR-UHFFFAOYSA-N 2-(4-formylphenoxy)acetamide Chemical compound NC(=O)COC1=CC=C(C=O)C=C1 FLPJVCMIKUWSDR-UHFFFAOYSA-N 0.000 description 1
- FSVJFNAIGNNGKK-UHFFFAOYSA-N 2-[cyclohexyl(oxo)methyl]-3,6,7,11b-tetrahydro-1H-pyrazino[2,1-a]isoquinolin-4-one Chemical compound C1C(C2=CC=CC=C2CC2)N2C(=O)CN1C(=O)C1CCCCC1 FSVJFNAIGNNGKK-UHFFFAOYSA-N 0.000 description 1
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 description 1
- 229930008281 A03AD01 - Papaverine Natural products 0.000 description 1
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 1
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- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
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- BFPYWIDHMRZLRN-SLHNCBLASA-N Ethinyl estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 BFPYWIDHMRZLRN-SLHNCBLASA-N 0.000 description 1
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- 239000000006 Nitroglycerin Substances 0.000 description 1
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- CJCSPKMFHVPWAR-JTQLQIEISA-N alpha-methyl-L-dopa Chemical compound OC(=O)[C@](N)(C)CC1=CC=C(O)C(O)=C1 CJCSPKMFHVPWAR-JTQLQIEISA-N 0.000 description 1
- AZDRQVAHHNSJOQ-UHFFFAOYSA-N alumane Chemical class [AlH3] AZDRQVAHHNSJOQ-UHFFFAOYSA-N 0.000 description 1
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- IZMJMCDDWKSTTK-UHFFFAOYSA-N quinoline yellow Chemical compound C1=CC=CC2=NC(C3C(C4=CC=CC=C4C3=O)=O)=CC=C21 IZMJMCDDWKSTTK-UHFFFAOYSA-N 0.000 description 1
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- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
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- 239000011780 sodium chloride Substances 0.000 description 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 description 1
- VTGPMVCGAVZLQI-UHFFFAOYSA-M sodium;2-[4-(2-methylpropyl)phenyl]propanoate;dihydrate Chemical compound O.O.[Na+].CC(C)CC1=CC=C(C(C)C([O-])=O)C=C1 VTGPMVCGAVZLQI-UHFFFAOYSA-M 0.000 description 1
- 230000002048 spasmolytic effect Effects 0.000 description 1
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- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
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Classifications
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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
- A61K9/2063—Proteins, e.g. gelatin
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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
-
- 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
- A61K9/1658—Proteins, e.g. albumin, gelatin
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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
- A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
-
- 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
-
- 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
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Botany (AREA)
- Zoology (AREA)
- Psychiatry (AREA)
- Hospice & Palliative Care (AREA)
- Nutrition Science (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (7)
- LV 10182 Izgudrojuma formula 1. Cieta materiāla farmaceitiskais sastāvs, kurš zāļu veidā ir ar regulētas pamatvielas paplašinātu divpakāpju izdalīšanās profilu un kurš satur efektīvu daudzumu vismaz vienas farmaceitiski aktīvas sastāvdaļas, ieteicamāk memantīna, un kurā pamatvielu veido galvenokārt ūdenī šķīstošas kazeīna sāls, ieteicams nātrija kazeināta, un ūdenī nešķīstošas kazeīna sāls, ieteicams kalcija kazeināta, kombinācija, pie kam kopējais ūdenī šķīstošo un ūdenī nešķīstošo kazeīnac sāļu saturs sastāda 5 līdz 98 procentus no farmaceitiskā sastāva kopējā svara un visi sāļi un katjoni ir farmaceitiski pieņemami.
- 2. Farmaceitiskais sastāvs saskaņā ar l.p., kurā 10 līdz 90 svara procentus no farmaceitiskā, sastāva sastāda ūdenī šķīstošie un ūdenī nešķīstošie kazeīna sāļi.
- 3. Farmaceitiskais sastāvs saskaņā ar 2.p., kurā 30 līdz 80 svara procentus no farmaceitiskā sastāva sastāda ūdenī nešķīstošie kazeīna sāļi.un ūdenī šķīstošie kazeīna sāļi.
- 4. Farmaceitiskais sastāvs saskaņā ar l.p., kurš satur aptuveni 5 līdz 95 svara procentus ūdenī nešķīstošus kazeīna sāļus izejot no kopējā kazeīna sāļu satura.
- 5. Farmaceitiskais sastāvs saskaņā ar 4.p., kurā ūdenī nešķīstošo kazeīnā sāļu procentuālais saturs attiecībā pret kopējo kazeīna sāļu saturu ir aptuveni 20 līdz 70 svara procenti.
- 6. Farmaceitiskais sastāvs saskaņā ar l.p., kurā farmaceitiskais sastāvs satur enzīmu, pie kam kā enzīms var būt pankreatīns vai pepsīns vai abi kopā.
- 7. Paņēmiens cieta materiāla farmaceitiskā sastāva .izgatavošanai, kuram zāļu veidā ir regulētas pamatvielas divpakāpju izdalīšanās profils un kurš satur vismaz vienas farmaceitiski aktīvas sastāvdaļas efektīvu daudzumu un kur pamatviela sastāv galvenokārt no ūdenī šķīstošas kazeīnsāls un ūdenī nešķīstošas kazeīnsāls kombinācijas, ietver maisījuma, kurš piemaisījumā 2. satur vismaz vienu aktīvo sastāvdaļu kopā ar ūdenī šķīstošo un un ūdenī nešķīstošo kazeīna sāli vai, alternatīvi, ūdenī šķīstošas kazeīni sāls un daudzvērtīga katjona, kurš spējīgs uz vietas veidot ūdenī nešķīstošu kazeīna sāli, šķīdumu vai sāli, pie kam maisījuma kopējais ūdenī šķīstošās un ūdenī nešķīstošās kazeīna sāls daudzums gala sastāvā ir 5 līdz 98 procenti no farmaceitiskā sastāva kopējā svara un visi sāļi un katjoni ir farmaceitiski pieņemami, ieteicamāk kur ūdenī šķīstošie un ūdenī nešķīstošie kazeīna sāļi maisījumā tiek ņemti 10 līdz 90 procenti no farmaceitiskā. sastāva svara, ieteicamāk kur ūdenī šķīstošie un ūdenī nešķīstošie kazeīna sāļi maisījumā ir robežās no 30 lidz 80 procenti no farmaceitiskā sastāva svara, ieteicamāk kur aptuveni 5 līdz 95 procentus ūdenī nešķīstošās kazeīna sāls, izejot no kopējā kazeīna sāls satura, iemaisa sastāvā, ieteicamāk kur ūdenī nešķīstošās kazeīna sals procentuālais saturs attiecībā pret kopējo maisījumā ietvertās kazeīni sāls saturu ir aptuveni 20 līdz 70 svara procenti, ieteicamāk kur sastāvā iemaisītā ūdenī nešķīstošā kazeīna sāls ir kalcija kazeināts un kur ūdenī šļstošā kazeīna sāls ir nātrija kazeināts, vai kur ūdenī šķīstošu kazeīna sāli un daudzvērtīgā katjona sāli izmanto procesā, ūdenī nešķīstošās kazeīna sāls procentuālajam saturam attiecībā pret gala rezultāta kazeīna sāls saturu esot aptuveni 5 līdz 90 procenti, ietei-camāk kur katjons ir kalcija jons, ieteicamāk kur kā ūdenī šķīstošo kazeīna sāli izmanto nātrija kazeinātu, ieteicamāk kur procentuālā attiecība ir 20 līdz 70 procenti, ieteicamāk kur enzīms tiek ievadīts farmaceitiskā sastāvā, ieteicamāk kur enzīms ir pankreatīns vai pepsīns vai abi kopā, un ieteicamāk kur aktīvā! ^sastāvdaļa, kuru pievieno maisījumam, ir memantīns, saspiešanas stadiju, granulēšanu, ekstrūziju, lodīšu veidošanu vai tablešu veidošanu, ar sauso vai slapjo paņēmienu.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE4225730A DE4225730C2 (de) | 1992-08-04 | 1992-08-04 | Verfahren zur Herstellung von festen Arzneiformkörpern mit protrahierter 2-Stufen-Freisetzung |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| LV10182A LV10182A (lv) | 1994-10-20 |
| LV10182B true LV10182B (en) | 1995-04-20 |
Family
ID=6464804
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| LVP-93-1013A LV10182B (en) | 1992-08-04 | 1993-08-04 | Memantine-containing solid pharmaceutical dosage forms having an extended two-stage release profile and production thereof |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US5382601A (lv) |
| EP (1) | EP0582186B1 (lv) |
| JP (1) | JP3560244B2 (lv) |
| CN (1) | CN1086708A (lv) |
| AT (1) | ATE176866T1 (lv) |
| AU (1) | AU669731B2 (lv) |
| CA (1) | CA2141691C (lv) |
| DE (2) | DE4225730C2 (lv) |
| DK (1) | DK0582186T3 (lv) |
| ES (1) | ES2128369T3 (lv) |
| GR (1) | GR3030227T3 (lv) |
| IL (1) | IL106580A (lv) |
| LT (1) | LT3201B (lv) |
| LV (1) | LV10182B (lv) |
| MX (1) | MX9304675A (lv) |
| WO (1) | WO1994003158A1 (lv) |
| ZA (1) | ZA935614B (lv) |
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| JP2020531543A (ja) | 2017-08-24 | 2020-11-05 | アダマス ファーマ エルエルシーＡｄａｍａｓ Ｐｈａｒｍａ ＬＬＣ | アマンタジン組成物、その調製、および使用方法 |
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-
1992
- 1992-08-04 DE DE4225730A patent/DE4225730C2/de not_active Expired - Lifetime
-
1993
- 1993-07-23 US US08/096,952 patent/US5382601A/en not_active Expired - Lifetime
- 1993-07-28 ES ES93112018T patent/ES2128369T3/es not_active Expired - Lifetime
- 1993-07-28 DK DK93112018T patent/DK0582186T3/da active
- 1993-07-28 AT AT93112018T patent/ATE176866T1/de active
- 1993-07-28 DE DE59309388T patent/DE59309388D1/de not_active Expired - Lifetime
- 1993-07-28 EP EP93112018A patent/EP0582186B1/de not_active Expired - Lifetime
- 1993-08-03 IL IL106580A patent/IL106580A/en not_active IP Right Cessation
- 1993-08-03 MX MX9304675A patent/MX9304675A/es unknown
- 1993-08-03 ZA ZA935614A patent/ZA935614B/xx unknown
- 1993-08-04 CA CA002141691A patent/CA2141691C/en not_active Expired - Lifetime
- 1993-08-04 JP JP50501594A patent/JP3560244B2/ja not_active Expired - Fee Related
- 1993-08-04 LT LTIP839A patent/LT3201B/lt not_active IP Right Cessation
- 1993-08-04 AU AU47069/93A patent/AU669731B2/en not_active Expired
- 1993-08-04 LV LVP-93-1013A patent/LV10182B/en unknown
- 1993-08-04 WO PCT/EP1993/002074 patent/WO1994003158A1/en active Application Filing
- 1993-08-04 CN CN93116211A patent/CN1086708A/zh active Pending
-
1999
- 1999-05-14 GR GR990401314T patent/GR3030227T3/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| LV10182A (lv) | 1994-10-20 |
| IL106580A0 (en) | 1993-12-08 |
| LT3201B (en) | 1995-03-27 |
| IL106580A (en) | 1998-02-08 |
| JP3560244B2 (ja) | 2004-09-02 |
| ES2128369T3 (es) | 1999-05-16 |
| MX9304675A (es) | 1994-03-31 |
| WO1994003158A1 (en) | 1994-02-17 |
| GR3030227T3 (en) | 1999-08-31 |
| ZA935614B (en) | 1995-02-03 |
| EP0582186A1 (de) | 1994-02-09 |
| AU4706993A (en) | 1994-03-03 |
| CA2141691A1 (en) | 1994-02-17 |
| AU669731B2 (en) | 1996-06-20 |
| CA2141691C (en) | 2002-04-09 |
| EP0582186B1 (de) | 1999-02-24 |
| ATE176866T1 (de) | 1999-03-15 |
| DE4225730A1 (de) | 1994-02-10 |
| US5382601A (en) | 1995-01-17 |
| LTIP839A (lt) | 1994-08-25 |
| JPH07509479A (ja) | 1995-10-19 |
| DK0582186T3 (da) | 1999-09-27 |
| DE59309388D1 (de) | 1999-04-01 |
| DE4225730C2 (de) | 2003-04-30 |
| CN1086708A (zh) | 1994-05-18 |
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