JP2000502691A - 生物接着性固形剤形 - Google Patents
生物接着性固形剤形Info
- Publication number
- JP2000502691A JP2000502691A JP09524032A JP52403297A JP2000502691A JP 2000502691 A JP2000502691 A JP 2000502691A JP 09524032 A JP09524032 A JP 09524032A JP 52403297 A JP52403297 A JP 52403297A JP 2000502691 A JP2000502691 A JP 2000502691A
- Authority
- JP
- Japan
- Prior art keywords
- tablets
- lubricant
- tablet
- forming polymer
- stearyl fumarate
- 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.)
- Granted
Links
- 239000000227 bioadhesive Substances 0.000 title claims abstract description 18
- 239000007909 solid dosage form Substances 0.000 title abstract description 7
- 239000000203 mixture Substances 0.000 claims abstract description 46
- 239000000314 lubricant Substances 0.000 claims abstract description 21
- 238000000034 method Methods 0.000 claims abstract description 17
- -1 alkyl fumarate Chemical compound 0.000 claims abstract description 16
- 229920000642 polymer Polymers 0.000 claims abstract description 15
- 239000004480 active ingredient Substances 0.000 claims abstract description 12
- 229920000881 Modified starch Polymers 0.000 claims abstract description 7
- 239000003513 alkali Substances 0.000 claims abstract description 4
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims abstract description 4
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 3
- 239000003826 tablet Substances 0.000 claims description 46
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 24
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims description 16
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims description 16
- 239000008187 granular material Substances 0.000 claims description 13
- 239000007935 oral tablet Substances 0.000 claims description 13
- MCCACAIVAXEFAL-UHFFFAOYSA-N 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole;nitric acid Chemical compound O[N+]([O-])=O.ClC1=CC(Cl)=CC=C1COC(C=1C(=CC(Cl)=CC=1)Cl)CN1C=NC=C1 MCCACAIVAXEFAL-UHFFFAOYSA-N 0.000 claims description 12
- 229960005040 miconazole nitrate Drugs 0.000 claims description 12
- 239000000377 silicon dioxide Substances 0.000 claims description 12
- 229920002125 Sokalan® Polymers 0.000 claims description 9
- 239000011159 matrix material Substances 0.000 claims description 9
- 229920002261 Corn starch Polymers 0.000 claims description 7
- 235000019759 Maize starch Nutrition 0.000 claims description 7
- 229940096978 oral tablet Drugs 0.000 claims description 7
- 229940031663 carbomer-974p Drugs 0.000 claims description 6
- 239000002552 dosage form Substances 0.000 claims description 6
- 238000009472 formulation Methods 0.000 claims description 5
- 239000004584 polyacrylic acid Substances 0.000 claims description 5
- 238000002360 preparation method Methods 0.000 claims description 4
- 229960005294 triamcinolone Drugs 0.000 claims description 4
- GFNANZIMVAIWHM-OBYCQNJPSA-N triamcinolone Chemical compound O=C1C=C[C@]2(C)[C@@]3(F)[C@@H](O)C[C@](C)([C@@]([C@H](O)C4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 GFNANZIMVAIWHM-OBYCQNJPSA-N 0.000 claims description 4
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims description 3
- 229960001631 carbomer Drugs 0.000 claims description 3
- 238000002156 mixing Methods 0.000 claims description 3
- 229920003133 pregelled starch Polymers 0.000 claims description 3
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 2
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims description 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 2
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 2
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims description 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- 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 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 2
- 235000019422 polyvinyl alcohol Nutrition 0.000 claims description 2
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 2
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 2
- 239000002775 capsule Substances 0.000 claims 1
- 238000007493 shaping process Methods 0.000 claims 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 17
- 238000005550 wet granulation Methods 0.000 description 11
- BYBLEWFAAKGYCD-UHFFFAOYSA-N Miconazole Chemical compound ClC1=CC(Cl)=CC=C1COC(C=1C(=CC(Cl)=CC=1)Cl)CN1C=NC=C1 BYBLEWFAAKGYCD-UHFFFAOYSA-N 0.000 description 10
- 238000000748 compression moulding Methods 0.000 description 10
- 229960002509 miconazole Drugs 0.000 description 10
- 238000007906 compression Methods 0.000 description 7
- 235000019441 ethanol Nutrition 0.000 description 7
- WLAMNBDJUVNPJU-UHFFFAOYSA-N 2-methylbutyric acid Chemical compound CCC(C)C(O)=O WLAMNBDJUVNPJU-UHFFFAOYSA-N 0.000 description 6
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 6
- 238000013268 sustained release Methods 0.000 description 6
- 239000012730 sustained-release form Substances 0.000 description 6
- 230000035587 bioadhesion Effects 0.000 description 5
- 230000006835 compression Effects 0.000 description 5
- 239000000843 powder Substances 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 240000008042 Zea mays Species 0.000 description 4
- 235000016383 Zea mays subsp huehuetenangensis Nutrition 0.000 description 4
- 235000002017 Zea mays subsp mays Nutrition 0.000 description 4
- 238000004090 dissolution Methods 0.000 description 4
- 238000001035 drying Methods 0.000 description 4
- 238000000338 in vitro Methods 0.000 description 4
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- 210000004877 mucosa Anatomy 0.000 description 4
- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 description 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 210000004195 gingiva Anatomy 0.000 description 3
- 239000003921 oil Substances 0.000 description 3
- 239000011734 sodium Substances 0.000 description 3
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-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
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 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 2
- ZBBHBTPTTSWHBA-UHFFFAOYSA-N Nicardipine Chemical compound COC(=O)C1=C(C)NC(C)=C(C(=O)OCCN(C)CC=2C=CC=CC=2)C1C1=CC=CC([N+]([O-])=O)=C1 ZBBHBTPTTSWHBA-UHFFFAOYSA-N 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 239000012790 adhesive layer Substances 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
- 239000007975 buffered saline Substances 0.000 description 2
- 239000010630 cinnamon oil Substances 0.000 description 2
- MYSWGUAQZAJSOK-UHFFFAOYSA-N ciprofloxacin Chemical compound C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 MYSWGUAQZAJSOK-UHFFFAOYSA-N 0.000 description 2
- OROGSEYTTFOCAN-DNJOTXNNSA-N codeine Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC OROGSEYTTFOCAN-DNJOTXNNSA-N 0.000 description 2
- WHBIGIKBNXZKFE-UHFFFAOYSA-N delavirdine Chemical compound CC(C)NC1=CC=CN=C1N1CCN(C(=O)C=2NC3=CC=C(NS(C)(=O)=O)C=C3C=2)CC1 WHBIGIKBNXZKFE-UHFFFAOYSA-N 0.000 description 2
- ADEBPBSSDYVVLD-UHFFFAOYSA-N donepezil Chemical compound O=C1C=2C=C(OC)C(OC)=CC=2CC1CC(CC1)CCN1CC1=CC=CC=C1 ADEBPBSSDYVVLD-UHFFFAOYSA-N 0.000 description 2
- RRAFCDWBNXTKKO-UHFFFAOYSA-N eugenol Chemical compound COC1=CC(CC=C)=CC=C1O RRAFCDWBNXTKKO-UHFFFAOYSA-N 0.000 description 2
- 239000012467 final product Substances 0.000 description 2
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- ASUTZQLVASHGKV-JDFRZJQESA-N galanthamine Chemical compound O1C(=C23)C(OC)=CC=C2CN(C)CC[C@]23[C@@H]1C[C@@H](O)C=C2 ASUTZQLVASHGKV-JDFRZJQESA-N 0.000 description 2
- JYGXADMDTFJGBT-VWUMJDOOSA-N hydrocortisone Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 JYGXADMDTFJGBT-VWUMJDOOSA-N 0.000 description 2
- 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 2
- 239000010410 layer Substances 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 239000002609 medium Substances 0.000 description 2
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- LOUPRKONTZGTKE-LHHVKLHASA-N quinidine Chemical compound C([C@H]([C@H](C1)C=C)C2)C[N@@]1[C@H]2[C@@H](O)C1=CC=NC2=CC=C(OC)C=C21 LOUPRKONTZGTKE-LHHVKLHASA-N 0.000 description 2
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- 229910052708 sodium Inorganic materials 0.000 description 2
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 2
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- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 description 2
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- REQCZEXYDRLIBE-UHFFFAOYSA-N procainamide Chemical compound CCN(CC)CCNC(=O)C1=CC=C(N)C=C1 REQCZEXYDRLIBE-UHFFFAOYSA-N 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 229960003598 promazine Drugs 0.000 description 1
- XXPDBLUZJRXNNZ-UHFFFAOYSA-N promethazine hydrochloride Chemical compound Cl.C1=CC=C2N(CC(C)N(C)C)C3=CC=CC=C3SC2=C1 XXPDBLUZJRXNNZ-UHFFFAOYSA-N 0.000 description 1
- AQHHHDLHHXJYJD-UHFFFAOYSA-N propranolol Chemical compound C1=CC=C2C(OCC(O)CNC(C)C)=CC=CC2=C1 AQHHHDLHHXJYJD-UHFFFAOYSA-N 0.000 description 1
- WQGWDDDVZFFDIG-UHFFFAOYSA-N pyrogallol Chemical compound OC1=CC=CC(O)=C1O WQGWDDDVZFFDIG-UHFFFAOYSA-N 0.000 description 1
- 229960001404 quinidine Drugs 0.000 description 1
- YREYEVIYCVEVJK-UHFFFAOYSA-N rabeprazole Chemical compound COCCCOC1=CC=NC(CS(=O)C=2NC3=CC=CC=C3N=2)=C1C YREYEVIYCVEVJK-UHFFFAOYSA-N 0.000 description 1
- 229960004157 rabeprazole Drugs 0.000 description 1
- 229960003401 ramipril Drugs 0.000 description 1
- HDACQVRGBOVJII-JBDAPHQKSA-N ramipril Chemical compound C([C@@H](C(=O)OCC)N[C@@H](C)C(=O)N1[C@@H](C[C@@H]2CCC[C@@H]21)C(O)=O)CC1=CC=CC=C1 HDACQVRGBOVJII-JBDAPHQKSA-N 0.000 description 1
- VMXUWOKSQNHOCA-LCYFTJDESA-N ranitidine Chemical compound [O-][N+](=O)/C=C(/NC)NCCSCC1=CC=C(CN(C)C)O1 VMXUWOKSQNHOCA-LCYFTJDESA-N 0.000 description 1
- 229960000620 ranitidine Drugs 0.000 description 1
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- GWHQHAUAXRMMOT-MBANBULQSA-N rivastigmine tartrate Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O.CCN(C)C(=O)OC1=CC=CC([C@H](C)N(C)C)=C1 GWHQHAUAXRMMOT-MBANBULQSA-N 0.000 description 1
- 235000002020 sage Nutrition 0.000 description 1
- 238000013341 scale-up Methods 0.000 description 1
- 229960002646 scopolamine Drugs 0.000 description 1
- STECJAGHUSJQJN-FWXGHANASA-N scopolamine Chemical compound C1([C@@H](CO)C(=O)O[C@H]2C[C@@H]3N([C@H](C2)[C@@H]2[C@H]3O2)C)=CC=CC=C1 STECJAGHUSJQJN-FWXGHANASA-N 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 230000001624 sedative effect Effects 0.000 description 1
- IYETZZCWLLUHIJ-UTONKHPSSA-N selegiline hydrochloride Chemical compound [Cl-].C#CC[NH+](C)[C@H](C)CC1=CC=CC=C1 IYETZZCWLLUHIJ-UTONKHPSSA-N 0.000 description 1
- 238000007873 sieving Methods 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- 229960002855 simvastatin Drugs 0.000 description 1
- 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 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- STFSJTPVIIDAQX-LTRPLHCISA-M sodium;(e)-4-octadecoxy-4-oxobut-2-enoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCCOC(=O)\C=C\C([O-])=O STFSJTPVIIDAQX-LTRPLHCISA-M 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 229940071138 stearyl fumarate Drugs 0.000 description 1
- NCEXYHBECQHGNR-QZQOTICOSA-N sulfasalazine Chemical compound C1=C(O)C(C(=O)O)=CC(\N=N\C=2C=CC(=CC=2)S(=O)(=O)NC=2N=CC=CC=2)=C1 NCEXYHBECQHGNR-QZQOTICOSA-N 0.000 description 1
- 229960001940 sulfasalazine Drugs 0.000 description 1
- NCEXYHBECQHGNR-UHFFFAOYSA-N sulfasalazine Natural products C1=C(O)C(C(=O)O)=CC(N=NC=2C=CC(=CC=2)S(=O)(=O)NC=2N=CC=CC=2)=C1 NCEXYHBECQHGNR-UHFFFAOYSA-N 0.000 description 1
- 229960004940 sulpiride Drugs 0.000 description 1
- KQKPFRSPSRPDEB-UHFFFAOYSA-N sumatriptan Chemical compound CNS(=O)(=O)CC1=CC=C2NC=C(CCN(C)C)C2=C1 KQKPFRSPSRPDEB-UHFFFAOYSA-N 0.000 description 1
- 229960003708 sumatriptan Drugs 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- 229960001685 tacrine Drugs 0.000 description 1
- YLJREFDVOIBQDA-UHFFFAOYSA-N tacrine Chemical compound C1=CC=C2C(N)=C(CCCC3)C3=NC2=C1 YLJREFDVOIBQDA-UHFFFAOYSA-N 0.000 description 1
- 230000009967 tasteless effect Effects 0.000 description 1
- 229960003188 temazepam Drugs 0.000 description 1
- 229960000351 terfenadine Drugs 0.000 description 1
- 229940116411 terpineol Drugs 0.000 description 1
- 239000001585 thymus vulgaris Substances 0.000 description 1
- 229960005013 tiotixene Drugs 0.000 description 1
- 229960002044 tolmetin sodium Drugs 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 229960002341 trifluperidol Drugs 0.000 description 1
- GPMXUUPHFNMNDH-UHFFFAOYSA-N trifluperidol Chemical compound C1CC(O)(C=2C=C(C=CC=2)C(F)(F)F)CCN1CCCC(=O)C1=CC=C(F)C=C1 GPMXUUPHFNMNDH-UHFFFAOYSA-N 0.000 description 1
- 239000010681 turmeric oil Substances 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 229960001722 verapamil Drugs 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
- PJVWKTKQMONHTI-UHFFFAOYSA-N warfarin Chemical compound OC=1C2=CC=CC=C2OC(=O)C=1C(CC(=O)C)C1=CC=CC=C1 PJVWKTKQMONHTI-UHFFFAOYSA-N 0.000 description 1
- 229960005080 warfarin Drugs 0.000 description 1
- JOLJIIDDOBNFHW-UHFFFAOYSA-N xanomeline Chemical compound CCCCCCOC1=NSN=C1C1=CCCN(C)C1 JOLJIIDDOBNFHW-UHFFFAOYSA-N 0.000 description 1
- 229950006755 xanomeline Drugs 0.000 description 1
- 229960000607 ziprasidone Drugs 0.000 description 1
- MVWVFYHBGMAFLY-UHFFFAOYSA-N ziprasidone Chemical compound C1=CC=C2C(N3CCN(CC3)CCC3=CC=4CC(=O)NC=4C=C3Cl)=NSC2=C1 MVWVFYHBGMAFLY-UHFFFAOYSA-N 0.000 description 1
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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Biophysics (AREA)
- Physiology (AREA)
- Hematology (AREA)
- Nutrition Science (AREA)
- Molecular Biology (AREA)
- Obesity (AREA)
- Pulmonology (AREA)
- Heart & Thoracic Surgery (AREA)
- Urology & Nephrology (AREA)
- Cardiology (AREA)
- Endocrinology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.医薬的に効果的な量の有効成分、80%−98.8(重量/重量)%の予備糊化澱 粉および1%−10(重量/重量)%の親水性マトリックス形成ポリマーを含んで 成る生物接着性医薬組成物であって、組成物がさらに滑剤として0.2%−5(重 量/重量)%のアルカリC16-22アルキルフマレートを含んで成ることを特徴と する生物接着性医薬組成物。 2.滑剤が、微粉化ステアリルフマル酸ナトリウムである、請求の範囲第1項に 記載の組成物。 3.2.5−7.5(重量/重量)%の親水性マトリックス形成ポリマーを含んで成る 、請求の範囲第1項に記載の組成物。 4.ポリマーが、ポリアクリル酸(カルボマー)、ヒドロキシエチルセルロース 、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、ナト リウムカルボキシメチルセルロース、ポリビニルアルコールまたはそれらの混合 物である、請求の範囲第3項に記載の組成物。 5.さらにグライダントを含んで成る、請求の範囲第1項に記載の組成物。 6.グライダントがコロイド状無水シリカである、請求の範囲第5項に記載の組 成物。 7.全重量に基づく重量で 0.001%−10%の有効成分; 80%−99.8%のプレ−ゲル化澱粉; 1%−10%の親水性マトリックス形成ポリマー; 0.2%−5%のステアリルフマル酸ナトリウム;および 0%−1%のグライダント、 を含んで成る、請求の範囲第1項に記載の組成物。 8.請求の範囲第1項ないし第7項のいずれか1項に記載されている組成物を含 んで成り、そして錠剤として成形されている、経口、鼻内、直腸または膣内投与 に適する剤形。 9.錠剤の全重量に基づく重量で 10%の微粉硝酸ミコナゾール; 82.8%のドラム乾燥したロウ様メイズ澱粉; 2%のステアリルフマル酸ナトリウム; 5%のカルボマー 974P;および 0.2%のコロイド状無水シリカ、 を含んで成る、請求の範囲第8項に記載の口腔錠剤。 10.錠剤の全重量に基づく重量で 1%の微粉トリアムシノロン; 91.8%のドラム乾燥したロウ様メイズ澱粉; 2%のステアリルフマル酸ナトリウム; 5%のカルボマー974P;および 0.2%のコロイド状無水シリカ、 を含んで成る、請求の範囲第8項に記載の口腔錠剤。 11.錠剤またはカプセルの乾燥調製法であって、 −有効成分、予備糊化澱粉および親水性マトリックス形成ポリマーを、乾燥状態 で完全に混合し; −このように得た混合物を、シートに圧縮成形し; −シートを粒質に砕き; −粒質を、滑剤および場合によってはグライダントとブレンドし;そし て、 −ブレンドを錠剤に成形する、 工程を含んで成る上記乾燥調製法。 12.請求の範囲第11項に記載の方法により得ることができる生成物。 13.生物接着性剤形を製造するための、滑剤として0.2%−5(重量/重量) %のステアリルフマル酸ナトリウム、および80%−98.8(重量/重量)%の予備 糊化澱粉、および1%−10%の親水性マトリックス形成ポリマーの使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP95203649 | 1995-12-27 | ||
EP95203649.9 | 1995-12-27 | ||
PCT/EP1996/005884 WO1997024109A1 (en) | 1995-12-27 | 1996-12-20 | Bioadhesive solid dosage form |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2000502691A true JP2000502691A (ja) | 2000-03-07 |
JP4317264B2 JP4317264B2 (ja) | 2009-08-19 |
Family
ID=8221021
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP52403297A Expired - Lifetime JP4317264B2 (ja) | 1995-12-27 | 1996-12-20 | 生物接着性固形剤形 |
Country Status (27)
Country | Link |
---|---|
US (1) | US6303147B1 (ja) |
EP (1) | EP0869772B1 (ja) |
JP (1) | JP4317264B2 (ja) |
KR (1) | KR100459029B1 (ja) |
CN (1) | CN1146401C (ja) |
AT (1) | ATE206304T1 (ja) |
AU (1) | AU713849B2 (ja) |
BR (1) | BR9612291A (ja) |
CA (1) | CA2232152C (ja) |
CY (1) | CY2269B1 (ja) |
CZ (1) | CZ298690B6 (ja) |
DE (1) | DE69615704T2 (ja) |
DK (1) | DK0869772T3 (ja) |
EA (1) | EA000818B1 (ja) |
ES (1) | ES2164940T3 (ja) |
HK (1) | HK1015680A1 (ja) |
HU (1) | HU228350B1 (ja) |
IL (1) | IL123636A (ja) |
NO (1) | NO320015B1 (ja) |
NZ (1) | NZ325844A (ja) |
PL (1) | PL186278B1 (ja) |
PT (1) | PT869772E (ja) |
SI (1) | SI0869772T1 (ja) |
SK (1) | SK283370B6 (ja) |
TR (1) | TR199800894T2 (ja) |
WO (1) | WO1997024109A1 (ja) |
ZA (1) | ZA9610886B (ja) |
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JP2005526021A (ja) * | 2002-01-31 | 2005-09-02 | ナショナル スターチ アンド ケミカル インベストメント ホールディング コーポレイション | 多糖とポリカルボキシル化ポリマーとを含んでなる生物接着性組成物 |
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JP2009542788A (ja) * | 2006-07-12 | 2009-12-03 | コントロールド・セラピューティクス(スコットランド)・リミテッド | クリンダマイシンの塩酸塩を有する薬剤デリバリーポリマー |
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JP2005526021A (ja) * | 2002-01-31 | 2005-09-02 | ナショナル スターチ アンド ケミカル インベストメント ホールディング コーポレイション | 多糖とポリカルボキシル化ポリマーとを含んでなる生物接着性組成物 |
JP2010280711A (ja) * | 2002-01-31 | 2010-12-16 | Natl Starch & Chem Investment Holding Corp | 多糖とポリカルボキシル化ポリマーとを含んでなる生物接着性組成物 |
US9987364B2 (en) | 2002-09-27 | 2018-06-05 | Ferring B.V. | Water-swellable polymers |
JP2007063272A (ja) * | 2005-08-26 | 2007-03-15 | Natl Starch & Chem Investment Holding Corp | 粘膜デリバリー錠剤 |
US10105445B2 (en) | 2006-07-05 | 2018-10-23 | Ferring B.V. | Hydrophilic polyurethane compositions |
JP2009542788A (ja) * | 2006-07-12 | 2009-12-03 | コントロールド・セラピューティクス(スコットランド)・リミテッド | クリンダマイシンの塩酸塩を有する薬剤デリバリーポリマー |
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