HRP20040322A2 - Flashmelt oral dosage formulation - Google Patents
Flashmelt oral dosage formulationInfo
- Publication number
- HRP20040322A2 HRP20040322A2 HRP20040322A HRP20040322A2 HR P20040322 A2 HRP20040322 A2 HR P20040322A2 HR P20040322 A HRP20040322 A HR P20040322A HR P20040322 A2 HRP20040322 A2 HR P20040322A2
- Authority
- HR
- Croatia
- Prior art keywords
- dosage form
- weight
- percent
- fast
- total weight
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims description 72
- 238000009472 formulation Methods 0.000 title description 8
- 239000002552 dosage form Substances 0.000 claims description 188
- 229960004372 aripiprazole Drugs 0.000 claims description 82
- 239000000378 calcium silicate Substances 0.000 claims description 78
- 235000012241 calcium silicate Nutrition 0.000 claims description 78
- 229910052918 calcium silicate Inorganic materials 0.000 claims description 78
- OYACROKNLOSFPA-UHFFFAOYSA-N calcium;dioxido(oxo)silane Chemical compound [Ca+2].[O-][Si]([O-])=O OYACROKNLOSFPA-UHFFFAOYSA-N 0.000 claims description 75
- 239000003814 drug Substances 0.000 claims description 65
- CEUORZQYGODEFX-UHFFFAOYSA-N Aripirazole Chemical compound ClC1=CC=CC(N2CCN(CCCCOC=3C=C4NC(=O)CCC4=CC=3)CC2)=C1Cl CEUORZQYGODEFX-UHFFFAOYSA-N 0.000 claims description 61
- 229940079593 drug Drugs 0.000 claims description 61
- 239000002270 dispersing agent Substances 0.000 claims description 56
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 54
- 229960000913 crospovidone Drugs 0.000 claims description 54
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 54
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 54
- 239000003795 chemical substances by application Substances 0.000 claims description 39
- 229920002785 Croscarmellose sodium Polymers 0.000 claims description 31
- -1 deskinolone Chemical compound 0.000 claims description 30
- 239000008187 granular material Substances 0.000 claims description 29
- 239000011230 binding agent Substances 0.000 claims description 25
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical group O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 23
- 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 22
- 229960001681 croscarmellose sodium Drugs 0.000 claims description 22
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 22
- 238000009826 distribution Methods 0.000 claims description 18
- 239000005909 Kieselgur Substances 0.000 claims description 9
- 229910021485 fumed silica Inorganic materials 0.000 claims description 9
- 239000005995 Aluminium silicate Substances 0.000 claims description 8
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 claims description 8
- 235000012211 aluminium silicate Nutrition 0.000 claims description 8
- UWFFNDSXSPUNTR-UHFFFAOYSA-N aluminum magnesium silicic acid trihydroxy(oxido)silane silicate Chemical compound [Mg+2].[Al+3].O[Si](O)(O)O.O[Si](O)(O)[O-].[O-][Si]([O-])([O-])[O-] UWFFNDSXSPUNTR-UHFFFAOYSA-N 0.000 claims description 8
- 229960005168 croscarmellose Drugs 0.000 claims description 8
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims description 8
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 claims description 8
- 239000000454 talc Substances 0.000 claims description 8
- 229910052623 talc Inorganic materials 0.000 claims description 8
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 6
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims description 6
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 6
- 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 claims description 5
- 229930195725 Mannitol Natural products 0.000 claims description 5
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 5
- 229960000980 entecavir Drugs 0.000 claims description 5
- YXPVEXCTPGULBZ-WQYNNSOESA-N entecavir hydrate Chemical compound O.C1=NC=2C(=O)NC(N)=NC=2N1[C@H]1C[C@H](O)[C@@H](CO)C1=C YXPVEXCTPGULBZ-WQYNNSOESA-N 0.000 claims description 5
- 239000000594 mannitol Substances 0.000 claims description 5
- 235000010355 mannitol Nutrition 0.000 claims description 5
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 5
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 5
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 5
- WDLWHQDACQUCJR-ZAMMOSSLSA-N (6r,7r)-7-[[(2r)-2-azaniumyl-2-(4-hydroxyphenyl)acetyl]amino]-8-oxo-3-[(e)-prop-1-enyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate Chemical compound C1([C@@H](N)C(=O)N[C@H]2[C@@H]3N(C2=O)C(=C(CS3)/C=C/C)C(O)=O)=CC=C(O)C=C1 WDLWHQDACQUCJR-ZAMMOSSLSA-N 0.000 claims description 4
- XUBOMFCQGDBHNK-JTQLQIEISA-N (S)-gatifloxacin Chemical compound FC1=CC(C(C(C(O)=O)=CN2C3CC3)=O)=C2C(OC)=C1N1CCN[C@@H](C)C1 XUBOMFCQGDBHNK-JTQLQIEISA-N 0.000 claims description 4
- 239000002947 C09CA04 - Irbesartan Substances 0.000 claims description 4
- 229920000881 Modified starch Polymers 0.000 claims description 4
- 229960002580 cefprozil Drugs 0.000 claims description 4
- 229960003923 gatifloxacin Drugs 0.000 claims description 4
- YCPOHTHPUREGFM-UHFFFAOYSA-N irbesartan Chemical compound O=C1N(CC=2C=CC(=CC=2)C=2C(=CC=CC=2)C=2[N]N=NN=2)C(CCCC)=NC21CCCC2 YCPOHTHPUREGFM-UHFFFAOYSA-N 0.000 claims description 4
- 229960002198 irbesartan Drugs 0.000 claims description 4
- 239000000463 material Substances 0.000 claims description 4
- 229920003109 sodium starch glycolate Polymers 0.000 claims description 4
- 239000008109 sodium starch glycolate Substances 0.000 claims description 4
- 229940079832 sodium starch glycolate Drugs 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
- 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 3
- 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 3
- 239000001506 calcium phosphate Substances 0.000 claims description 3
- 229910000389 calcium phosphate Inorganic materials 0.000 claims description 3
- 235000011010 calcium phosphates Nutrition 0.000 claims description 3
- FAKRSMQSSFJEIM-RQJHMYQMSA-N captopril Chemical compound SC[C@@H](C)C(=O)N1CCC[C@H]1C(O)=O FAKRSMQSSFJEIM-RQJHMYQMSA-N 0.000 claims description 3
- 229960000830 captopril Drugs 0.000 claims description 3
- 238000007906 compression Methods 0.000 claims description 3
- 230000006835 compression Effects 0.000 claims description 3
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 3
- 229920001249 ethyl cellulose Polymers 0.000 claims description 3
- 239000008101 lactose Substances 0.000 claims description 3
- LVRLSYPNFFBYCZ-VGWMRTNUSA-N omapatrilat Chemical compound C([C@H](S)C(=O)N[C@H]1CCS[C@H]2CCC[C@H](N2C1=O)C(=O)O)C1=CC=CC=C1 LVRLSYPNFFBYCZ-VGWMRTNUSA-N 0.000 claims description 3
- 229950000973 omapatrilat Drugs 0.000 claims description 3
- 229960002965 pravastatin Drugs 0.000 claims description 3
- 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 description 3
- 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 claims description 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 claims 4
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims 2
- 238000007580 dry-mixing Methods 0.000 claims 1
- 239000011159 matrix material Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 description 73
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 64
- 238000010438 heat treatment Methods 0.000 description 57
- 238000000034 method Methods 0.000 description 37
- 239000004615 ingredient Substances 0.000 description 32
- 235000019359 magnesium stearate Nutrition 0.000 description 32
- 239000013078 crystal Substances 0.000 description 26
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 25
- 238000004519 manufacturing process Methods 0.000 description 12
- 238000002156 mixing Methods 0.000 description 10
- 230000008901 benefit Effects 0.000 description 9
- 230000008569 process Effects 0.000 description 8
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 7
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 description 6
- 229940124447 delivery agent Drugs 0.000 description 6
- 238000001228 spectrum Methods 0.000 description 6
- 238000004090 dissolution Methods 0.000 description 5
- 238000004806 packaging method and process Methods 0.000 description 5
- 238000002360 preparation method Methods 0.000 description 5
- IAZDPXIOMUYVGZ-WFGJKAKNSA-N Dimethyl sulfoxide Chemical compound [2H]C([2H])([2H])S(=O)C([2H])([2H])[2H] IAZDPXIOMUYVGZ-WFGJKAKNSA-N 0.000 description 4
- 239000003125 aqueous solvent Substances 0.000 description 4
- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 description 4
- 239000000796 flavoring agent Substances 0.000 description 4
- 235000013355 food flavoring agent Nutrition 0.000 description 4
- 235000003599 food sweetener Nutrition 0.000 description 4
- 238000000227 grinding Methods 0.000 description 4
- 238000000634 powder X-ray diffraction Methods 0.000 description 4
- 238000000425 proton nuclear magnetic resonance spectrum Methods 0.000 description 4
- 210000002784 stomach Anatomy 0.000 description 4
- 239000003765 sweetening agent Substances 0.000 description 4
- 235000019640 taste Nutrition 0.000 description 4
- 229920003084 Avicel® PH-102 Polymers 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 description 3
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 3
- 150000008064 anhydrides Chemical class 0.000 description 3
- 239000002585 base Substances 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 238000007908 dry granulation Methods 0.000 description 3
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- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 3
- 239000006186 oral dosage form Substances 0.000 description 3
- 239000000047 product Substances 0.000 description 3
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- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
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- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 2
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- JHLNERQLKQQLRZ-UHFFFAOYSA-N calcium silicate Chemical compound [Ca+2].[Ca+2].[O-][Si]([O-])([O-])[O-] JHLNERQLKQQLRZ-UHFFFAOYSA-N 0.000 description 2
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- 239000008122 artificial sweetener Substances 0.000 description 1
- 235000021311 artificial sweeteners Nutrition 0.000 description 1
- 125000003118 aryl group Chemical group 0.000 description 1
- 239000000605 aspartame Substances 0.000 description 1
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 description 1
- 229960003438 aspartame Drugs 0.000 description 1
- 235000012206 bottled water Nutrition 0.000 description 1
- 239000007894 caplet Substances 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 235000014633 carbohydrates Nutrition 0.000 description 1
- 235000010980 cellulose Nutrition 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229940046978 chlorpheniramine maleate Drugs 0.000 description 1
- 229960001380 cimetidine Drugs 0.000 description 1
- CCGSUNCLSOWKJO-UHFFFAOYSA-N cimetidine Chemical compound N#CNC(=N/C)\NCCSCC1=NC=N[C]1C CCGSUNCLSOWKJO-UHFFFAOYSA-N 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 238000005056 compaction Methods 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 235000009508 confectionery Nutrition 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 239000003218 coronary vasodilator agent Substances 0.000 description 1
- 239000000850 decongestant Substances 0.000 description 1
- 229940124581 decongestants Drugs 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 239000007857 degradation product Substances 0.000 description 1
- 239000002274 desiccant Substances 0.000 description 1
- 238000000113 differential scanning calorimetry Methods 0.000 description 1
- GXGAKHNRMVGRPK-UHFFFAOYSA-N dimagnesium;dioxido-bis[[oxido(oxo)silyl]oxy]silane Chemical compound [Mg+2].[Mg+2].[O-][Si](=O)O[Si]([O-])([O-])O[Si]([O-])=O GXGAKHNRMVGRPK-UHFFFAOYSA-N 0.000 description 1
- HNPSIPDUKPIQMN-UHFFFAOYSA-N dioxosilane;oxo(oxoalumanyloxy)alumane Chemical compound O=[Si]=O.O=[Al]O[Al]=O HNPSIPDUKPIQMN-UHFFFAOYSA-N 0.000 description 1
- 229960000520 diphenhydramine Drugs 0.000 description 1
- PCHPORCSPXIHLZ-UHFFFAOYSA-N diphenhydramine hydrochloride Chemical compound [Cl-].C=1C=CC=CC=1C(OCC[NH+](C)C)C1=CC=CC=C1 PCHPORCSPXIHLZ-UHFFFAOYSA-N 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 238000007922 dissolution test Methods 0.000 description 1
- 239000002934 diuretic Substances 0.000 description 1
- 229940030606 diuretics Drugs 0.000 description 1
- DLNKOYKMWOXYQA-UHFFFAOYSA-N dl-pseudophenylpropanolamine Natural products CC(N)C(O)C1=CC=CC=C1 DLNKOYKMWOXYQA-UHFFFAOYSA-N 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 239000003937 drug carrier Substances 0.000 description 1
- 238000009506 drug dissolution testing Methods 0.000 description 1
- 230000004064 dysfunction Effects 0.000 description 1
- 230000001856 erectile effect Effects 0.000 description 1
- 229960004667 ethyl cellulose Drugs 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 229960002490 fosinopril Drugs 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- XUBOMFCQGDBHNK-UHFFFAOYSA-N gatifloxacin Chemical compound FC1=CC(C(C(C(O)=O)=CN2C3CC3)=O)=C2C(OC)=C1N1CCNC(C)C1 XUBOMFCQGDBHNK-UHFFFAOYSA-N 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000001056 green pigment Substances 0.000 description 1
- 229920001903 high density polyethylene Polymers 0.000 description 1
- 239000004700 high-density polyethylene Substances 0.000 description 1
- 239000008240 homogeneous mixture Substances 0.000 description 1
- 229940126904 hypoglycaemic agent Drugs 0.000 description 1
- 229960001680 ibuprofen Drugs 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 150000002576 ketones Chemical class 0.000 description 1
- 229960001375 lactose Drugs 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- RDOIQAHITMMDAJ-UHFFFAOYSA-N loperamide Chemical compound C=1C=CC=CC=1C(C=1C=CC=CC=1)(C(=O)N(C)C)CCN(CC1)CCC1(O)C1=CC=C(Cl)C=C1 RDOIQAHITMMDAJ-UHFFFAOYSA-N 0.000 description 1
- 239000000391 magnesium silicate Substances 0.000 description 1
- 229940099273 magnesium trisilicate Drugs 0.000 description 1
- 229910000386 magnesium trisilicate Inorganic materials 0.000 description 1
- 235000019793 magnesium trisilicate Nutrition 0.000 description 1
- 239000000845 maltitol Substances 0.000 description 1
- 235000010449 maltitol Nutrition 0.000 description 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 description 1
- 229940035436 maltitol Drugs 0.000 description 1
- 229960001855 mannitol Drugs 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 229960001474 meclozine Drugs 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 229910000000 metal hydroxide Inorganic materials 0.000 description 1
- 150000004692 metal hydroxides Chemical class 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 201000003152 motion sickness Diseases 0.000 description 1
- 239000004090 neuroprotective agent Substances 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 229960005489 paracetamol Drugs 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- DLNKOYKMWOXYQA-APPZFPTMSA-N phenylpropanolamine Chemical compound C[C@@H](N)[C@H](O)C1=CC=CC=C1 DLNKOYKMWOXYQA-APPZFPTMSA-N 0.000 description 1
- 229960000395 phenylpropanolamine Drugs 0.000 description 1
- 150000003016 phosphoric acids Chemical class 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229920005862 polyol Polymers 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 description 1
- 239000003306 quinoline derived antiinfective agent Substances 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
- 238000001953 recrystallisation Methods 0.000 description 1
- 210000003296 saliva Anatomy 0.000 description 1
- 229940125723 sedative agent Drugs 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- RMAQACBXLXPBSY-UHFFFAOYSA-N silicic acid Chemical compound O[Si](O)(O)O RMAQACBXLXPBSY-UHFFFAOYSA-N 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 239000008347 soybean phospholipid Substances 0.000 description 1
- 238000012430 stability testing Methods 0.000 description 1
- 229940071117 starch glycolate Drugs 0.000 description 1
- 238000007619 statistical method Methods 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 208000023516 stroke disease Diseases 0.000 description 1
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- 150000008163 sugars Chemical class 0.000 description 1
- 230000008961 swelling Effects 0.000 description 1
- 229940061354 tequin Drugs 0.000 description 1
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 238000011287 therapeutic dose Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000001685 thyroid gland Anatomy 0.000 description 1
- 238000009827 uniform distribution Methods 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
- 239000010457 zeolite Substances 0.000 description 1
Classifications
-
- 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
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Seasonings (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| HRP20040322 HRP20040322A2 (en) | 2001-10-09 | 2004-04-05 | Flashmelt oral dosage formulation |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/US2001/031530 WO2003030868A1 (en) | 2001-10-09 | 2001-10-09 | Flashmelt oral dosage formulation |
| HRP20040322 HRP20040322A2 (en) | 2001-10-09 | 2004-04-05 | Flashmelt oral dosage formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20040322A2 true HRP20040322A2 (en) | 2004-12-31 |
Family
ID=32505152
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20040322 HRP20040322A2 (en) | 2001-10-09 | 2004-04-05 | Flashmelt oral dosage formulation |
Country Status (13)
| Country | Link |
|---|---|
| EP (1) | EP1441698B1 (zh) |
| JP (1) | JP2005507397A (zh) |
| KR (1) | KR20040045499A (zh) |
| CN (1) | CN100490810C (zh) |
| BR (1) | BR0117147A (zh) |
| CA (1) | CA2462886C (zh) |
| HR (1) | HRP20040322A2 (zh) |
| HU (1) | HUP0500638A3 (zh) |
| IL (1) | IL161143A0 (zh) |
| IS (1) | IS7208A (zh) |
| MX (1) | MXPA04003346A (zh) |
| NO (1) | NO340570B1 (zh) |
| RS (1) | RS55392B1 (zh) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5279487B2 (ja) * | 2005-05-18 | 2013-09-04 | エムペックス・ファーマシューティカルズ・インコーポレーテッド | エアロゾル化フルオロキノロンおよびその使用 |
| KR100780553B1 (ko) * | 2005-08-18 | 2007-11-29 | 한올제약주식회사 | 메트포르민 서방정 및 그의 제조방법 |
| CN101322709B (zh) * | 2007-06-12 | 2011-03-02 | 成都康弘药业集团股份有限公司 | 一种含有阿立哌唑的药物组合物及其制备方法 |
| WO2010106936A1 (ja) * | 2009-03-16 | 2010-09-23 | ニプロ株式会社 | 口腔内崩壊錠 |
| WO2011049122A1 (ja) * | 2009-10-21 | 2011-04-28 | 第一三共株式会社 | プラバスタチンナトリウム口腔内速崩壊錠及びその製造方法 |
| HU1000278D0 (en) * | 2010-05-28 | 2010-07-28 | Egis Gyogyszergyar Nyilvanosan | Novel pharmaceutical use uf silicic acid |
| CN102397552B (zh) * | 2010-09-10 | 2016-06-08 | 广州自远生物科技有限公司 | 一种含喹诺酮类的药物复合制剂及其制备方法和应用 |
| JP2012121850A (ja) * | 2010-12-09 | 2012-06-28 | Otsuka Pharmaceut Co Ltd | アリピプラゾールの経口速溶性組成物 |
| CN102357086A (zh) * | 2011-11-01 | 2012-02-22 | 上海理工大学 | 一种头孢丙烯口腔崩解片 |
| KR101285008B1 (ko) * | 2012-04-18 | 2013-07-10 | 제일약품주식회사 | 저용량 엔테카비어의 경구투여 제제의 제조방법 |
| CN102670533B (zh) * | 2012-05-17 | 2017-06-16 | 浙江华海药业股份有限公司 | 稳定的阿立哌唑口腔崩解片及其制备方法 |
| CN104138382B (zh) * | 2014-08-14 | 2015-08-12 | 广州一品红制药有限公司 | 一种含盐酸左氧氟沙星的组合物 |
| JP6558530B2 (ja) * | 2015-04-20 | 2019-08-14 | 高田製薬株式会社 | アリピプラゾール医薬品製剤 |
| JP2015172084A (ja) * | 2015-07-06 | 2015-10-01 | 大塚製薬株式会社 | アリピプラゾールの経口速溶性組成物 |
| CN106913548A (zh) * | 2015-12-28 | 2017-07-04 | 药源药物化学（上海）有限公司 | 一种阿立哌唑口崩片及其制备方法 |
| JP6572257B2 (ja) * | 2017-05-16 | 2019-09-04 | 大塚製薬株式会社 | アリピプラゾールの経口速溶性組成物 |
| KR101808513B1 (ko) | 2017-06-22 | 2018-01-18 | 임철수 | 한대의본체로 다수가 사용하는 컴퓨터장치 및 그 운영방법 |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5994348A (en) * | 1995-06-07 | 1999-11-30 | Sanofi | Pharmaceutical compositions containing irbesartan |
| EP0918456A1 (en) * | 1996-07-23 | 1999-06-02 | Fmc Corporation | Disintegrant composition for dispersible solids |
| CA2311734C (en) * | 2000-04-12 | 2011-03-08 | Bristol-Myers Squibb Company | Flash-melt oral dosage formulation |
-
2001
- 2001-10-09 BR BRPI0117147-0A patent/BR0117147A/pt active Search and Examination
- 2001-10-09 CN CNB01823853XA patent/CN100490810C/zh not_active Expired - Lifetime
- 2001-10-09 KR KR10-2004-7005155A patent/KR20040045499A/ko not_active Application Discontinuation
- 2001-10-09 RS RS28404A patent/RS55392B1/sr unknown
- 2001-10-09 MX MXPA04003346A patent/MXPA04003346A/es unknown
- 2001-10-09 CA CA2462886A patent/CA2462886C/en not_active Expired - Lifetime
- 2001-10-09 HU HU0500638A patent/HUP0500638A3/hu unknown
- 2001-10-09 JP JP2003533901A patent/JP2005507397A/ja active Pending
- 2001-10-09 IL IL16114301A patent/IL161143A0/xx unknown
- 2001-10-09 EP EP01979614.3A patent/EP1441698B1/en not_active Expired - Lifetime
-
2004
- 2004-04-02 NO NO20041383A patent/NO340570B1/no not_active IP Right Cessation
- 2004-04-05 HR HRP20040322 patent/HRP20040322A2/hr not_active Application Discontinuation
- 2004-04-06 IS IS7208A patent/IS7208A/is unknown
Also Published As
| Publication number | Publication date |
|---|---|
| MXPA04003346A (es) | 2004-09-28 |
| CN100490810C (zh) | 2009-05-27 |
| NO20041383L (no) | 2004-06-01 |
| KR20040045499A (ko) | 2004-06-01 |
| RS55392B1 (sr) | 2017-03-31 |
| BR0117147A (pt) | 2006-05-09 |
| HUP0500638A3 (en) | 2008-04-28 |
| IL161143A0 (en) | 2004-08-31 |
| EP1441698A1 (en) | 2004-08-04 |
| CA2462886A1 (en) | 2003-04-17 |
| NO340570B1 (no) | 2017-05-15 |
| CN1561200A (zh) | 2005-01-05 |
| HUP0500638A2 (en) | 2007-02-28 |
| EP1441698A4 (en) | 2008-08-13 |
| IS7208A (is) | 2004-04-06 |
| CA2462886C (en) | 2013-07-30 |
| EP1441698B1 (en) | 2018-05-02 |
| JP2005507397A (ja) | 2005-03-17 |
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