EA021792B1 - Твердый препарат, растворяющийся во рту - Google Patents

Info

Publication number

EA021792B1

EA021792B1 EA201071054A EA201071054A EA021792B1 EA 021792 B1 EA021792 B1 EA 021792B1 EA 201071054 A EA201071054 A EA 201071054A EA 201071054 A EA201071054 A EA 201071054A EA 021792 B1 EA021792 B1 EA 021792B1

Authority

EA

Eurasian Patent Office

Prior art keywords

granules

active ingredient

pharmaceutically active

small granules

polymer

Prior art date

2008-03-11

Links

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• Global Dossier
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• 238000002360 preparation method Methods 0.000 title claims abstract description 193
• 239000007787 solid Substances 0.000 title claims abstract description 101
• 239000008187 granular material Substances 0.000 claims abstract description 723
• 239000004480 active ingredient Substances 0.000 claims abstract description 232
• 229920000642 polymer Polymers 0.000 claims abstract description 229
• 239000011247 coating layer Substances 0.000 claims abstract description 65
• 238000013270 controlled release Methods 0.000 claims abstract description 59
• 239000000654 additive Substances 0.000 claims abstract description 25
• 230000000996 additive effect Effects 0.000 claims abstract description 16
• 238000000576 coating method Methods 0.000 claims description 292
• 239000011248 coating agent Substances 0.000 claims description 290
• 239000010410 layer Substances 0.000 claims description 270
• 229920001577 copolymer Polymers 0.000 claims description 103
• 239000003814 drug Substances 0.000 claims description 76
• 229940079593 drug Drugs 0.000 claims description 74
• -1 carboxymethylethyl Chemical group 0.000 claims description 70
• 229920002678 cellulose Polymers 0.000 claims description 70
• 235000010980 cellulose Nutrition 0.000 claims description 69
• 239000001913 cellulose Substances 0.000 claims description 67
• 239000002245 particle Substances 0.000 claims description 60
• 239000000843 powder Substances 0.000 claims description 60
• 238000000034 method Methods 0.000 claims description 59
• 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 58
• 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 58
• DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical group CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims description 47
• 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 47
• 235000013769 triethyl citrate Nutrition 0.000 claims description 47
• 229960003943 hypromellose Drugs 0.000 claims description 46
• 239000001069 triethyl citrate Substances 0.000 claims description 46
• VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims description 46
• 239000000126 substance Substances 0.000 claims description 32
• 230000001747 exhibiting effect Effects 0.000 claims description 30
• 229920003145 methacrylic acid copolymer Polymers 0.000 claims description 30
• 239000002253 acid Substances 0.000 claims description 28
• 238000004090 dissolution Methods 0.000 claims description 28
• 229940117841 methacrylic acid copolymer Drugs 0.000 claims description 25
• 239000004014 plasticizer Substances 0.000 claims description 20
• 150000003839 salts Chemical class 0.000 claims description 20
• 150000005846 sugar alcohols Chemical class 0.000 claims description 18
• MJIHNNLFOKEZEW-UHFFFAOYSA-N lansoprazole Chemical compound CC1=C(OCC(F)(F)F)C=CN=C1CS(=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-UHFFFAOYSA-N 0.000 claims description 14
• XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 claims description 14
• 239000001856 Ethyl cellulose Substances 0.000 claims description 13
• 229920001249 ethyl cellulose Polymers 0.000 claims description 13
• 229910017053 inorganic salt Inorganic materials 0.000 claims description 13
• 235000019325 ethyl cellulose Nutrition 0.000 claims description 12
• 229960003174 lansoprazole Drugs 0.000 claims description 12
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• 229920001800 Shellac Polymers 0.000 claims description 10
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• ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 claims description 10
• 229940113147 shellac Drugs 0.000 claims description 10
• 235000013874 shellac Nutrition 0.000 claims description 10
• 229920000639 hydroxypropylmethylcellulose acetate succinate Polymers 0.000 claims description 9
• IWVKTOUOPHGZRX-UHFFFAOYSA-N methyl 2-methylprop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.COC(=O)C(C)=C IWVKTOUOPHGZRX-UHFFFAOYSA-N 0.000 claims description 9
• 230000015556 catabolic process Effects 0.000 claims description 7
• 210000002784 stomach Anatomy 0.000 claims description 7
• 229920000623 Cellulose acetate phthalate Polymers 0.000 claims description 6
• GAMPNQJDUFQVQO-UHFFFAOYSA-N acetic acid;phthalic acid Chemical compound CC(O)=O.OC(=O)C1=CC=CC=C1C(O)=O GAMPNQJDUFQVQO-UHFFFAOYSA-N 0.000 claims description 6
• 229940081734 cellulose acetate phthalate Drugs 0.000 claims description 6
• NZEXUPLJXSDMCK-UHFFFAOYSA-N methyl 2-methylprop-2-enoate;methyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound COC(=O)C=C.CC(=C)C(O)=O.COC(=O)C(C)=C NZEXUPLJXSDMCK-UHFFFAOYSA-N 0.000 claims description 6
• 238000013268 sustained release Methods 0.000 claims description 6
• 239000012730 sustained-release form Substances 0.000 claims description 6
• 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims description 5
• CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims description 3
• 229940126409 proton pump inhibitor Drugs 0.000 claims description 3
• 239000000612 proton pump inhibitor Substances 0.000 claims description 3
• IYKJEILNJZQJPU-UHFFFAOYSA-N acetic acid;butanedioic acid Chemical compound CC(O)=O.OC(=O)CCC(O)=O IYKJEILNJZQJPU-UHFFFAOYSA-N 0.000 claims description 2
• NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 2
• GZVJYLVCUMGZOK-UHFFFAOYSA-N C(C)(=O)OC.C(C=C)(=O)O Chemical compound C(C)(=O)OC.C(C=C)(=O)O GZVJYLVCUMGZOK-UHFFFAOYSA-N 0.000 claims 1
• MJIHNNLFOKEZEW-RUZDIDTESA-N dexlansoprazole Chemical group CC1=C(OCC(F)(F)F)C=CN=C1C[S@@](=O)C1=NC2=CC=CC=C2N1 MJIHNNLFOKEZEW-RUZDIDTESA-N 0.000 claims 1
• 229960003568 dexlansoprazole Drugs 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
• 230000002035 prolonged effect Effects 0.000 claims 1
• 238000004519 manufacturing process Methods 0.000 abstract description 226
• 238000005266 casting Methods 0.000 abstract description 3
• 239000000594 mannitol Substances 0.000 description 163
• 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 161
• 229930195725 Mannitol Natural products 0.000 description 159
• 235000010355 mannitol Nutrition 0.000 description 159
• 239000011257 shell material Substances 0.000 description 157
• 239000000243 solution Substances 0.000 description 151
• 239000000203 mixture Substances 0.000 description 129
• UQSXHKLRYXJYBZ-UHFFFAOYSA-N Iron oxide Chemical compound [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 108
• 210000000214 mouth Anatomy 0.000 description 99
• XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 87
• 239000003826 tablet Substances 0.000 description 84
• 239000007921 spray Substances 0.000 description 80
• VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 74
• 239000011162 core material Substances 0.000 description 74
• HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 70
• 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 69
• 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 69
• 239000001863 hydroxypropyl cellulose Substances 0.000 description 67
• 239000008213 purified water Substances 0.000 description 66
• 150000001875 compounds Chemical class 0.000 description 55
• 238000006467 substitution reaction Methods 0.000 description 53
• 238000005507 spraying Methods 0.000 description 49
• 239000006185 dispersion Substances 0.000 description 46
• 125000001424 substituent group Chemical group 0.000 description 46
• 239000011812 mixed powder Substances 0.000 description 45
• 239000000454 talc Substances 0.000 description 40
• 229910052623 talc Inorganic materials 0.000 description 40
• 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 38
• 229940068968 polysorbate 80 Drugs 0.000 description 38
• 229920000053 polysorbate 80 Polymers 0.000 description 38
• YQEMORVAKMFKLG-UHFFFAOYSA-N glycerine monostearate Natural products CCCCCCCCCCCCCCCCCC(=O)OC(CO)CO YQEMORVAKMFKLG-UHFFFAOYSA-N 0.000 description 37
• SVUQHVRAGMNPLW-UHFFFAOYSA-N glycerol monostearate Natural products CCCCCCCCCCCCCCCCC(=O)OCC(O)CO SVUQHVRAGMNPLW-UHFFFAOYSA-N 0.000 description 37
• 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 37
• 235000019359 magnesium stearate Nutrition 0.000 description 35
• GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 31
• OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 31
• KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 29
• 239000003795 chemical substances by application Substances 0.000 description 24
• 238000009792 diffusion process Methods 0.000 description 24
• GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 22
• 239000000796 flavoring agent Substances 0.000 description 22
• 239000008101 lactose Substances 0.000 description 22
• 239000002702 enteric coating Substances 0.000 description 20
• 238000009505 enteric coating Methods 0.000 description 20
• 238000005469 granulation Methods 0.000 description 19
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• WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 18
• ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 18
• 235000019634 flavors Nutrition 0.000 description 16
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• ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 description 15
• 239000001095 magnesium carbonate Substances 0.000 description 15
• 229910000021 magnesium carbonate Inorganic materials 0.000 description 15
• 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 description 15
• 229920000523 polyvinylpolypyrrolidone Polymers 0.000 description 15
• VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 14
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• 125000003545 alkoxy group Chemical group 0.000 description 13
• 125000000217 alkyl group Chemical group 0.000 description 12
• PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 11
• 230000000694 effects Effects 0.000 description 11
• 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 description 10
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• URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 10
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• FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 description 8
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• 125000002252 acyl group Chemical group 0.000 description 5
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• 125000004070 6 membered heterocyclic group Chemical group 0.000 description 3
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• 235000005979 Citrus limon Nutrition 0.000 description 3
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