CN101340897A - 兰索拉唑口腔崩解片剂 - Google Patents
兰索拉唑口腔崩解片剂 Download PDFInfo
- Publication number
- CN101340897A CN101340897A CNA200580052347XA CN200580052347A CN101340897A CN 101340897 A CN101340897 A CN 101340897A CN A200580052347X A CNA200580052347X A CN A200580052347XA CN 200580052347 A CN200580052347 A CN 200580052347A CN 101340897 A CN101340897 A CN 101340897A
- Authority
- CN
- China
- Prior art keywords
- tablet
- oral cavity
- cavity disintegration
- sub
- disintegration tablet
- 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.)
- Pending
Links
- 229960003174 lansoprazole Drugs 0.000 title claims description 40
- 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 title claims description 40
- 239000006191 orally-disintegrating tablet Substances 0.000 title abstract description 4
- 239000003826 tablet Substances 0.000 claims abstract description 204
- 239000003814 drug Substances 0.000 claims abstract description 125
- 229940079593 drug Drugs 0.000 claims abstract description 60
- 210000000214 mouth Anatomy 0.000 claims description 86
- 239000002253 acid Substances 0.000 claims description 69
- 239000002702 enteric coating Substances 0.000 claims description 62
- 238000009505 enteric coating Methods 0.000 claims description 62
- 239000010410 layer Substances 0.000 claims description 60
- 239000003513 alkali Substances 0.000 claims description 58
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 54
- 238000000576 coating method Methods 0.000 claims description 41
- 239000003381 stabilizer Substances 0.000 claims description 26
- 239000000203 mixture Substances 0.000 claims description 20
- 238000000034 method Methods 0.000 claims description 15
- 238000009826 distribution Methods 0.000 claims description 14
- 235000012222 talc Nutrition 0.000 claims description 14
- 239000004014 plasticizer Substances 0.000 claims description 13
- 239000000454 talc Substances 0.000 claims description 13
- 229910052623 talc Inorganic materials 0.000 claims description 13
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 12
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 12
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 12
- 229920001577 copolymer Polymers 0.000 claims description 11
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-UHFFFAOYSA-N 0.000 claims description 8
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 6
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims description 6
- 229940117841 methacrylic acid copolymer Drugs 0.000 claims description 6
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical group O.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 WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 claims description 4
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical group [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 4
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 claims description 4
- 229920002472 Starch Polymers 0.000 claims description 4
- 229920002678 cellulose Polymers 0.000 claims description 4
- 239000001913 cellulose Substances 0.000 claims description 4
- 230000036571 hydration Effects 0.000 claims description 4
- 238000006703 hydration reaction Methods 0.000 claims description 4
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims description 4
- 239000001095 magnesium carbonate Substances 0.000 claims description 4
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims description 4
- 229910052710 silicon Inorganic materials 0.000 claims description 4
- 239000010703 silicon Substances 0.000 claims description 4
- 238000005507 spraying Methods 0.000 claims description 4
- 239000008107 starch Substances 0.000 claims description 4
- 235000019698 starch Nutrition 0.000 claims description 4
- 239000004575 stone Substances 0.000 claims description 4
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 3
- 229920002261 Corn starch Polymers 0.000 claims description 3
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 claims description 3
- 239000003153 chemical reaction reagent Substances 0.000 claims description 3
- 239000007891 compressed tablet Substances 0.000 claims description 3
- 239000008120 corn starch Substances 0.000 claims description 3
- 239000004408 titanium dioxide Substances 0.000 claims description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 2
- 229910000019 calcium carbonate Inorganic materials 0.000 claims description 2
- 239000008119 colloidal silica Substances 0.000 claims description 2
- 229960001021 lactose monohydrate Drugs 0.000 claims description 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 1
- 239000000654 additive Substances 0.000 claims 1
- 230000000996 additive effect Effects 0.000 claims 1
- 239000000463 material Substances 0.000 description 23
- 229960004157 rabeprazole Drugs 0.000 description 18
- YREYEVIYCVEVJK-UHFFFAOYSA-N rabeprazole Chemical compound COCCCOC1=CC=NC(CS(=O)C=2NC3=CC=CC=C3N=2)=C1C YREYEVIYCVEVJK-UHFFFAOYSA-N 0.000 description 18
- 239000006185 dispersion Substances 0.000 description 17
- 238000002360 preparation method Methods 0.000 description 14
- 229920000642 polymer Polymers 0.000 description 12
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 description 9
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 9
- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical compound COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 description 9
- 239000003795 chemical substances by application Substances 0.000 description 9
- 239000011248 coating agent Substances 0.000 description 9
- 229960004770 esomeprazole Drugs 0.000 description 9
- SUBDBMMJDZJVOS-DEOSSOPVSA-N esomeprazole Chemical compound C([S@](=O)C1=NC2=CC=C(C=C2N1)OC)C1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-DEOSSOPVSA-N 0.000 description 9
- 229960003943 hypromellose Drugs 0.000 description 9
- 229960000381 omeprazole Drugs 0.000 description 9
- 229960005019 pantoprazole Drugs 0.000 description 9
- 238000001035 drying Methods 0.000 description 8
- 239000002245 particle Substances 0.000 description 8
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 6
- 239000011162 core material Substances 0.000 description 5
- 239000002904 solvent Substances 0.000 description 5
- 150000001875 compounds Chemical class 0.000 description 4
- 210000002249 digestive system Anatomy 0.000 description 4
- 239000008187 granular material Substances 0.000 description 4
- 239000006187 pill Substances 0.000 description 4
- 239000002351 wastewater Substances 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- 150000001720 carbohydrates Chemical class 0.000 description 3
- 230000000593 degrading effect Effects 0.000 description 3
- 210000001035 gastrointestinal tract Anatomy 0.000 description 3
- -1 hydroxypropyl Chemical group 0.000 description 3
- 239000000843 powder Substances 0.000 description 3
- 238000003825 pressing Methods 0.000 description 3
- 238000009498 subcoating Methods 0.000 description 3
- 125000000185 sucrose group Chemical group 0.000 description 3
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 description 2
- 230000002378 acidificating effect Effects 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 230000008878 coupling Effects 0.000 description 2
- 238000010168 coupling process Methods 0.000 description 2
- 238000005859 coupling reaction Methods 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000012055 enteric layer Substances 0.000 description 2
- 239000000796 flavoring agent Substances 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 235000013355 food flavoring agent Nutrition 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
- 229940126701 oral medication Drugs 0.000 description 2
- 238000010298 pulverizing process Methods 0.000 description 2
- 125000006850 spacer group Chemical group 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 239000001069 triethyl citrate Substances 0.000 description 2
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 2
- 235000013769 triethyl citrate Nutrition 0.000 description 2
- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-UHFFFAOYSA-N 0.000 description 1
- HYZJCKYKOHLVJF-UHFFFAOYSA-N 1H-benzimidazole Chemical compound C1=CC=C2NC=NC2=C1 HYZJCKYKOHLVJF-UHFFFAOYSA-N 0.000 description 1
- 108010011485 Aspartame Proteins 0.000 description 1
- 239000002126 C01EB10 - Adenosine Substances 0.000 description 1
- 244000024675 Eruca sativa Species 0.000 description 1
- 235000014755 Eruca sativa Nutrition 0.000 description 1
- 108030003004 Triphosphatases Proteins 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 229960005305 adenosine Drugs 0.000 description 1
- 239000008122 artificial sweetener Substances 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
- 235000010357 aspartame Nutrition 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000007931 coated granule Substances 0.000 description 1
- 229920001688 coating polymer Polymers 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- SWXVUIWOUIDPGS-UHFFFAOYSA-N diacetone alcohol Natural products CC(=O)CC(C)(C)O SWXVUIWOUIDPGS-UHFFFAOYSA-N 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 230000000977 initiatory effect Effects 0.000 description 1
- 239000003456 ion exchange resin Substances 0.000 description 1
- 229920003303 ion-exchange polymer Polymers 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 210000002231 macronucleus Anatomy 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 239000011824 nuclear material Substances 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
Images
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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/US2005/046296 WO2007078271A2 (en) | 2005-12-20 | 2005-12-20 | Lansoprazole orally disintegrating tablets |
Publications (1)
Publication Number | Publication Date |
---|---|
CN101340897A true CN101340897A (zh) | 2009-01-07 |
Family
ID=37672393
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNA200580052347XA Pending CN101340897A (zh) | 2005-12-20 | 2005-12-20 | 兰索拉唑口腔崩解片剂 |
Country Status (5)
Country | Link |
---|---|
JP (1) | JP2009519334A (ja) |
CN (1) | CN101340897A (ja) |
CA (1) | CA2630235A1 (ja) |
IL (1) | IL191523A0 (ja) |
WO (1) | WO2007078271A2 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101507718B (zh) * | 2009-03-03 | 2011-05-04 | 张登科 | 雷贝拉唑钠肠溶口崩片及其制备方法 |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8497258B2 (en) | 2005-11-12 | 2013-07-30 | The Regents Of The University Of California | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
KR20100129761A (ko) * | 2008-03-11 | 2010-12-09 | 다케다 야쿠힌 고교 가부시키가이샤 | 경구 붕해 고형 제제 |
EP2440210A4 (en) | 2009-06-12 | 2014-01-29 | Meritage Pharma Inc | METHOD FOR THE TREATMENT OF STOMACH DARM DISEASES |
SG190905A1 (en) * | 2010-12-27 | 2013-07-31 | Takeda Pharmaceutical | Orally disintegrating tablet |
CN102805737A (zh) * | 2012-09-03 | 2012-12-05 | 海南中化联合制药工业股份有限公司 | 一种兰索拉唑肠溶口崩片及其制备方法 |
CN105392486A (zh) * | 2013-05-21 | 2016-03-09 | 武田药品工业株式会社 | 口腔崩解片 |
US20170042806A1 (en) * | 2015-04-29 | 2017-02-16 | Dexcel Pharma Technologies Ltd. | Orally disintegrating compositions |
US10076494B2 (en) | 2016-06-16 | 2018-09-18 | Dexcel Pharma Technologies Ltd. | Stable orally disintegrating pharmaceutical compositions |
JP7336187B2 (ja) * | 2017-11-30 | 2023-08-31 | 日本ケミファ株式会社 | 多層構造を有する粒子状医薬組成物 |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SE9500478D0 (sv) * | 1995-02-09 | 1995-02-09 | Astra Ab | New pharmaceutical formulation and process |
US6489346B1 (en) * | 1996-01-04 | 2002-12-03 | The Curators Of The University Of Missouri | Substituted benzimidazole dosage forms and method of using same |
PT1736144E (pt) * | 1998-05-18 | 2016-02-10 | Takeda Pharmaceutical | Comprimidos de desintegração oral |
WO2004066982A1 (en) * | 2003-01-31 | 2004-08-12 | Ranbaxy Laboratories Limited | Stable oral benzimidazole compositions and processes for their preparation |
US20040265375A1 (en) * | 2003-04-16 | 2004-12-30 | Platteeuw Johannes J. | Orally disintegrating tablets |
WO2005046634A2 (de) * | 2003-11-14 | 2005-05-26 | Siegfried Generics International Ag | Magensaftresistente verabreichungsform |
US20050214371A1 (en) * | 2004-03-03 | 2005-09-29 | Simona Di Capua | Stable pharmaceutical composition comprising an acid labile drug |
US8545881B2 (en) * | 2004-04-19 | 2013-10-01 | Eurand Pharmaceuticals, Ltd. | Orally disintegrating tablets and methods of manufacture |
-
2005
- 2005-12-20 CA CA002630235A patent/CA2630235A1/en not_active Abandoned
- 2005-12-20 WO PCT/US2005/046296 patent/WO2007078271A2/en active Application Filing
- 2005-12-20 CN CNA200580052347XA patent/CN101340897A/zh active Pending
- 2005-12-20 JP JP2008545558A patent/JP2009519334A/ja active Pending
-
2008
- 2008-05-18 IL IL191523A patent/IL191523A0/en unknown
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101507718B (zh) * | 2009-03-03 | 2011-05-04 | 张登科 | 雷贝拉唑钠肠溶口崩片及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
JP2009519334A (ja) | 2009-05-14 |
WO2007078271A3 (en) | 2007-10-11 |
IL191523A0 (en) | 2008-12-29 |
CA2630235A1 (en) | 2007-07-12 |
WO2007078271A2 (en) | 2007-07-12 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20090107 |