MXPA06000524A

MXPA06000524A - Formulacion farmaceutica y metodo para tratar desordenes gastrointestinales provocados por acido.

Formulacion farmaceutica y metodo para tratar desordenes gastrointestinales provocados por acido.

Info

Publication number: MXPA06000524A
Authority: MX; Mexico
Prior art keywords: pharmaceutical formulation; proton pump; pump inhibitor; less; formulation according
Prior art date: 2003-07-18

Application number

MXPA06000524A

Other languages

English (en)

Spanish (es)

Inventor

Laura Weston

Original Assignee

Santarus Inc

Priority date

2003-07-18

Filing date

2004-07-16

Publication date

2006-08-11

2004-07-16 Application filed by Santarus Inc filed Critical Santarus Inc

2006-08-11 Publication of MXPA06000524A publication Critical patent/MXPA06000524A/es

Links

239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 153
238000000034 method Methods 0.000 title claims abstract description 43
208000018522 Gastrointestinal disease Diseases 0.000 title claims description 29
229940126409 proton pump inhibitor Drugs 0.000 claims abstract description 170
239000000612 proton pump inhibitor Substances 0.000 claims abstract description 166
239000000725 suspension Substances 0.000 claims abstract description 110
229940069428 antacid Drugs 0.000 claims abstract description 85
239000003159 antacid agent Substances 0.000 claims abstract description 85
VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims abstract description 83
230000001458 anti-acid effect Effects 0.000 claims abstract description 71
239000000843 powder Substances 0.000 claims abstract description 41
239000000375 suspending agent Substances 0.000 claims abstract description 38
239000000203 mixture Substances 0.000 claims description 128
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 claims description 65
229960000381 omeprazole Drugs 0.000 claims description 64
239000002253 acid Substances 0.000 claims description 63
239000000796 flavoring agent Substances 0.000 claims description 56
239000002245 particle Substances 0.000 claims description 54
210000002966 serum Anatomy 0.000 claims description 54
-1 dontoprazole Chemical compound 0.000 claims description 52
UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 50
239000003795 chemical substances by application Substances 0.000 claims description 48
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 47
102100021904 Potassium-transporting ATPase alpha chain 1 Human genes 0.000 claims description 43
108010083204 Proton Pumps Proteins 0.000 claims description 43
230000002401 inhibitory effect Effects 0.000 claims description 40
239000000463 material Substances 0.000 claims description 36
235000019634 flavors Nutrition 0.000 claims description 33
150000003839 salts Chemical class 0.000 claims description 31
239000000546 pharmaceutical excipient Substances 0.000 claims description 30
239000000651 prodrug Substances 0.000 claims description 30
229940002612 prodrug Drugs 0.000 claims description 30
235000017557 sodium bicarbonate Nutrition 0.000 claims description 25
229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 25
229920001285 xanthan gum Polymers 0.000 claims description 25
208000010643 digestive system disease Diseases 0.000 claims description 24
208000018685 gastrointestinal system disease Diseases 0.000 claims description 24
235000013355 food flavoring agent Nutrition 0.000 claims description 23
235000010493 xanthan gum Nutrition 0.000 claims description 23
239000000230 xanthan gum Substances 0.000 claims description 23
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238000002156 mixing Methods 0.000 claims description 20
RAXXELZNTBOGNW-UHFFFAOYSA-N imidazole Natural products C1=CNC=N1 RAXXELZNTBOGNW-UHFFFAOYSA-N 0.000 claims description 17
239000002552 dosage form Substances 0.000 claims description 15
239000012458 free base Substances 0.000 claims description 15
YREYEVIYCVEVJK-UHFFFAOYSA-N rabeprazole Chemical compound COCCCOC1=CC=NC(CS(=O)C=2NC3=CC=CC=C3N=2)=C1C YREYEVIYCVEVJK-UHFFFAOYSA-N 0.000 claims description 13
239000003826 tablet Substances 0.000 claims description 13
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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 11
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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 10
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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 claims description 10
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 10
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FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 8
FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 8
TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 8
125000003118 aryl group Chemical group 0.000 claims description 8
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HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 8
239000000600 sorbitol Substances 0.000 claims description 8
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235000010447 xylitol Nutrition 0.000 claims description 8
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HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 8
239000007910 chewable tablet Substances 0.000 claims description 7
229960004157 rabeprazole Drugs 0.000 claims description 7
CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims description 7
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244000131522 Citrus pyriformis Species 0.000 claims description 6
229940068682 chewable tablet Drugs 0.000 claims description 6
WBZFUFAFFUEMEI-UHFFFAOYSA-M Acesulfame k Chemical compound [K+].CC1=CC(=O)[N-]S(=O)(=O)O1 WBZFUFAFFUEMEI-UHFFFAOYSA-M 0.000 claims description 5
244000144730 Amygdalus persica Species 0.000 claims description 5
235000016623 Fragaria vesca Nutrition 0.000 claims description 5
240000009088 Fragaria x ananassa Species 0.000 claims description 5
235000011363 Fragaria x ananassa Nutrition 0.000 claims description 5
229920002907 Guar gum Polymers 0.000 claims description 5
HYMLWHLQFGRFIY-UHFFFAOYSA-N Maltol Natural products CC1OC=CC(=O)C1=O HYMLWHLQFGRFIY-UHFFFAOYSA-N 0.000 claims description 5
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 claims description 5
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239000000619 acesulfame-K Substances 0.000 claims description 5
125000002619 bicyclic group Chemical group 0.000 claims description 5
KWORUUGOSLYAGD-YPPDDXJESA-N esomeprazole magnesium Chemical compound [Mg+2].C([S@](=O)C=1[N-]C2=CC=C(C=C2N=1)OC)C1=NC=C(C)C(OC)=C1C.C([S@](=O)C=1[N-]C2=CC=C(C=C2N=1)OC)C1=NC=C(C)C(OC)=C1C KWORUUGOSLYAGD-YPPDDXJESA-N 0.000 claims description 5
235000010417 guar gum Nutrition 0.000 claims description 5
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229940043353 maltol Drugs 0.000 claims description 5
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235000019204 saccharin Nutrition 0.000 claims description 5
229940081974 saccharin Drugs 0.000 claims description 5
239000000901 saccharin and its Na,K and Ca salt Substances 0.000 claims description 5
NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims description 4
PSIREIZGKQBEEO-UHFFFAOYSA-N 2-(1h-benzimidazol-2-ylsulfinylmethyl)-n-methyl-n-(2-methylpropyl)aniline Chemical compound CC(C)CN(C)C1=CC=CC=C1CS(=O)C1=NC2=CC=CC=C2N1 PSIREIZGKQBEEO-UHFFFAOYSA-N 0.000 claims description 4
NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 4
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TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 description 1
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IUVKMZGDUIUOCP-BTNSXGMBSA-N quinbolone Chemical compound O([C@H]1CC[C@H]2[C@H]3[C@@H]([C@]4(C=CC(=O)C=C4CC3)C)CC[C@@]21C)C1=CCCC1 IUVKMZGDUIUOCP-BTNSXGMBSA-N 0.000 description 1
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ILJOYZVVZZFIKA-UHFFFAOYSA-M sodium;1,1-dioxo-1,2-benzothiazol-3-olate;hydrate Chemical compound O.[Na+].C1=CC=C2C(=O)[N-]S(=O)(=O)C2=C1 ILJOYZVVZZFIKA-UHFFFAOYSA-M 0.000 description 1
UUYQXLQNUVEFGD-UHFFFAOYSA-M sodium;hydrogen carbonate;6-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]-1h-benzimidazole Chemical compound [Na+].OC([O-])=O.N1C2=CC(OC)=CC=C2N=C1S(=O)CC1=NC=C(C)C(OC)=C1C UUYQXLQNUVEFGD-UHFFFAOYSA-M 0.000 description 1
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NFMWFGXCDDYTEG-UHFFFAOYSA-N trimagnesium;diborate Chemical compound [Mg+2].[Mg+2].[Mg+2].[O-]B([O-])[O-].[O-]B([O-])[O-] NFMWFGXCDDYTEG-UHFFFAOYSA-N 0.000 description 1
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