FI109451B - Menetelmä lääkeaineen annosteluvälineen valmistamiseksi, joka tuottaa in situ ja vapauttaa kontrolloidusti lääkedispersion - Google Patents

Info

Publication number

FI109451B

FI109451B FI943011A FI943011A FI109451B FI 109451 B FI109451 B FI 109451B FI 943011 A FI943011 A FI 943011A FI 943011 A FI943011 A FI 943011A FI 109451 B FI109451 B FI 109451B

Authority

FI

Finland

Prior art keywords

polymer

core

water

agent

coating

Prior art date

1991-12-27

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• 239000006185 dispersion Substances 0.000 title claims abstract description 21
• 239000003814 drug Substances 0.000 title claims description 54
• 229940079593 drug Drugs 0.000 title claims description 53
• 238000000034 method Methods 0.000 title claims description 49
• 230000008569 process Effects 0.000 title claims description 20
• 238000011065 in-situ storage Methods 0.000 title claims description 5
• 238000002360 preparation method Methods 0.000 title claims description 3
• 229920000642 polymer Polymers 0.000 claims abstract description 94
• 239000003795 chemical substances by application Substances 0.000 claims abstract description 56
• 238000000576 coating method Methods 0.000 claims abstract description 48
• 239000002245 particle Substances 0.000 claims abstract description 47
• 239000011248 coating agent Substances 0.000 claims abstract description 44
• 230000009286 beneficial effect Effects 0.000 claims abstract description 34
• 230000036571 hydration Effects 0.000 claims abstract description 33
• 238000006703 hydration reaction Methods 0.000 claims abstract description 33
• -1 polymethylenes Polymers 0.000 claims description 34
• 239000000203 mixture Substances 0.000 claims description 33
• XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
• 229920006217 cellulose acetate butyrate Polymers 0.000 claims description 16
• RYMZZMVNJRMUDD-UHFFFAOYSA-N SJ000286063 Natural products C12C(OC(=O)C(C)(C)CC)CC(C)C=C2C=CC(C)C1CCC1CC(O)CC(=O)O1 RYMZZMVNJRMUDD-UHFFFAOYSA-N 0.000 claims description 15
• 239000000463 material Substances 0.000 claims description 15
• 229960002855 simvastatin Drugs 0.000 claims description 15
• RYMZZMVNJRMUDD-HGQWONQESA-N simvastatin Chemical compound C([C@H]1[C@@H](C)C=CC2=C[C@H](C)C[C@@H]([C@H]12)OC(=O)C(C)(C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1 RYMZZMVNJRMUDD-HGQWONQESA-N 0.000 claims description 15
• 150000003839 salts Chemical class 0.000 claims description 14
• FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 claims description 12
• 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 claims description 11
• 239000008101 lactose Substances 0.000 claims description 11
• PCZOHLXUXFIOCF-UHFFFAOYSA-N Monacolin X Natural products C12C(OC(=O)C(C)CC)CC(C)C=C2C=CC(C)C1CCC1CC(O)CC(=O)O1 PCZOHLXUXFIOCF-UHFFFAOYSA-N 0.000 claims description 9
• 229960004844 lovastatin Drugs 0.000 claims description 9
• PCZOHLXUXFIOCF-BXMDZJJMSA-N lovastatin Chemical compound C([C@H]1[C@@H](C)C=CC2=C[C@H](C)C[C@@H]([C@H]12)OC(=O)[C@@H](C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1 PCZOHLXUXFIOCF-BXMDZJJMSA-N 0.000 claims description 9
• QLJODMDSTUBWDW-UHFFFAOYSA-N lovastatin hydroxy acid Natural products C1=CC(C)C(CCC(O)CC(O)CC(O)=O)C2C(OC(=O)C(C)CC)CC(C)C=C21 QLJODMDSTUBWDW-UHFFFAOYSA-N 0.000 claims description 9
• DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims description 8
• 239000001069 triethyl citrate Substances 0.000 claims description 8
• VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims description 8
• 235000013769 triethyl citrate Nutrition 0.000 claims description 8
• NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 7
• CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 7
• 229930006000 Sucrose Natural products 0.000 claims description 7
• 239000002471 hydroxymethylglutaryl coenzyme A reductase inhibitor Substances 0.000 claims description 7
• 239000005720 sucrose Substances 0.000 claims description 7
• 238000002156 mixing Methods 0.000 claims description 6
• 239000004014 plasticizer Substances 0.000 claims description 6
• SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 5
• 229940121710 HMGCoA reductase inhibitor Drugs 0.000 claims description 5
• 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 5
• 239000002253 acid Substances 0.000 claims description 5
• 229920002301 cellulose acetate Polymers 0.000 claims description 5
• 239000008108 microcrystalline cellulose Substances 0.000 claims description 5
• 229940016286 microcrystalline cellulose Drugs 0.000 claims description 5
• 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 5
• 239000004800 polyvinyl chloride Substances 0.000 claims description 5
• WXZMFSXDPGVJKK-UHFFFAOYSA-N pentaerythritol Chemical compound OCC(CO)(CO)CO WXZMFSXDPGVJKK-UHFFFAOYSA-N 0.000 claims description 4
• 229920000915 polyvinyl chloride Polymers 0.000 claims description 4
• 239000001856 Ethyl cellulose Substances 0.000 claims description 3
• ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 3
• 150000007513 acids Chemical class 0.000 claims description 3
• 229920001249 ethyl cellulose Polymers 0.000 claims description 3
• 235000019325 ethyl cellulose Nutrition 0.000 claims description 3
• 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 claims description 2
• 229910019142 PO4 Inorganic materials 0.000 claims description 2
• TUZYXOIXSAXUGO-UHFFFAOYSA-N Pravastatin Natural products C1=CC(C)C(CCC(O)CC(O)CC(O)=O)C2C(OC(=O)C(C)CC)CC(O)C=C21 TUZYXOIXSAXUGO-UHFFFAOYSA-N 0.000 claims description 2
• 239000003085 diluting agent Substances 0.000 claims description 2
• 235000021317 phosphate Nutrition 0.000 claims description 2
• 229920001495 poly(sodium acrylate) polymer Polymers 0.000 claims description 2
• 229960002965 pravastatin Drugs 0.000 claims description 2
• 239000011734 sodium Substances 0.000 claims description 2
• 229910052708 sodium Inorganic materials 0.000 claims description 2
• NNMHYFLPFNGQFZ-UHFFFAOYSA-M sodium polyacrylate Chemical compound [Na+].[O-]C(=O)C=C NNMHYFLPFNGQFZ-UHFFFAOYSA-M 0.000 claims description 2
• 235000000346 sugar Nutrition 0.000 claims description 2
• 150000008163 sugars Chemical class 0.000 claims description 2
• 239000004094 surface-active agent Substances 0.000 claims description 2
• 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 claims 6
• 238000004132 cross linking Methods 0.000 claims 4
• UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 2
• 238000007580 dry-mixing Methods 0.000 claims 2
• 238000005469 granulation Methods 0.000 claims 2
• 230000003179 granulation Effects 0.000 claims 2
• 229910052739 hydrogen Inorganic materials 0.000 claims 2
• 239000001257 hydrogen Substances 0.000 claims 2
• 239000001488 sodium phosphate Substances 0.000 claims 2
• 235000011008 sodium phosphates Nutrition 0.000 claims 2
• RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical class [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims 2
• PYGXAGIECVVIOZ-UHFFFAOYSA-N Dibutyl decanedioate Chemical compound CCCCOC(=O)CCCCCCCCC(=O)OCCCC PYGXAGIECVVIOZ-UHFFFAOYSA-N 0.000 claims 1
• 102400001190 Vastatin Human genes 0.000 claims 1
• 101800000422 Vastatin Proteins 0.000 claims 1
• 239000000427 antigen Substances 0.000 claims 1
• 102000036639 antigens Human genes 0.000 claims 1
• 108091007433 antigens Proteins 0.000 claims 1
• 230000000593 degrading effect Effects 0.000 claims 1
• 229940031954 dibutyl sebacate Drugs 0.000 claims 1
• 239000012535 impurity Substances 0.000 claims 1
• 150000003013 phosphoric acid derivatives Chemical class 0.000 claims 1
• TUZYXOIXSAXUGO-PZAWKZKUSA-N pravastatin Chemical compound C1=C[C@H](C)[C@H](CC[C@@H](O)C[C@@H](O)CC(O)=O)[C@H]2[C@@H](OC(=O)[C@@H](C)CC)C[C@H](O)C=C21 TUZYXOIXSAXUGO-PZAWKZKUSA-N 0.000 claims 1
• 235000015424 sodium Nutrition 0.000 claims 1
• 239000011162 core material Substances 0.000 description 68
• 239000003826 tablet Substances 0.000 description 49
• CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical compound CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 description 26
• OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 18
• 239000004615 ingredient Substances 0.000 description 15
• HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 14
• 229960000905 indomethacin Drugs 0.000 description 13
• YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 12
• 239000002552 dosage form Substances 0.000 description 12
• LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 11
• WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 11
• 230000015572 biosynthetic process Effects 0.000 description 11
• 239000000126 substance Substances 0.000 description 11
• 239000013543 active substance Substances 0.000 description 10
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• CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 9
• 241001465754 Metazoa Species 0.000 description 9
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• 239000008187 granular material Substances 0.000 description 8
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• 238000010330 laser marking Methods 0.000 description 7
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• 235000019359 magnesium stearate Nutrition 0.000 description 6
• 239000008363 phosphate buffer Substances 0.000 description 6
• 229940069328 povidone Drugs 0.000 description 6
• NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 6
• 239000007921 spray Substances 0.000 description 6
• HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 6
• 238000009792 diffusion process Methods 0.000 description 5
• NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 5
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• 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 2
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• VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 2
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• WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 2
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