TR201723199A2 - New pharmaceutical compositions. - Google Patents
New pharmaceutical compositions. Download PDFInfo
- Publication number
- TR201723199A2 TR201723199A2 TR2017/23199A TR201723199A TR201723199A2 TR 201723199 A2 TR201723199 A2 TR 201723199A2 TR 2017/23199 A TR2017/23199 A TR 2017/23199A TR 201723199 A TR201723199 A TR 201723199A TR 201723199 A2 TR201723199 A2 TR 201723199A2
- Authority
- TR
- Turkey
- Prior art keywords
- pharmaceutically acceptable
- pharmaceutical composition
- acceptable derivative
- composition according
- alginic acid
- Prior art date
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 58
- 239000004480 active ingredient Substances 0.000 claims abstract description 29
- 235000010443 alginic acid Nutrition 0.000 claims abstract description 29
- 229920000615 alginic acid Polymers 0.000 claims abstract description 29
- 239000000783 alginic acid Substances 0.000 claims abstract description 27
- 229960001126 alginic acid Drugs 0.000 claims abstract description 27
- 150000004781 alginic acids Chemical class 0.000 claims abstract description 25
- 238000010992 reflux Methods 0.000 claims abstract description 13
- 229940126409 proton pump inhibitor Drugs 0.000 claims abstract description 12
- 239000000612 proton pump inhibitor Substances 0.000 claims abstract description 12
- 208000002193 Pain Diseases 0.000 claims abstract description 9
- 230000036407 pain Effects 0.000 claims abstract description 9
- 208000008469 Peptic Ulcer Diseases 0.000 claims abstract description 7
- 208000021302 gastroesophageal reflux disease Diseases 0.000 claims abstract description 7
- 208000011906 peptic ulcer disease Diseases 0.000 claims abstract description 7
- 201000008629 Zollinger-Ellison syndrome Diseases 0.000 claims abstract description 6
- 210000000941 bile Anatomy 0.000 claims abstract description 6
- 201000006549 dyspepsia Diseases 0.000 claims abstract description 6
- 210000003238 esophagus Anatomy 0.000 claims abstract description 6
- 201000000052 gastrinoma Diseases 0.000 claims abstract description 6
- 208000024798 heartburn Diseases 0.000 claims abstract description 6
- 238000002636 symptomatic treatment Methods 0.000 claims abstract description 6
- 208000000718 duodenal ulcer Diseases 0.000 claims abstract description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 22
- 239000003826 tablet Substances 0.000 claims description 18
- 229960004157 rabeprazole Drugs 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 15
- 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 13
- 229960003174 lansoprazole Drugs 0.000 claims description 13
- 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 13
- 229960000381 omeprazole Drugs 0.000 claims description 13
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 12
- -1 anticholinergic Substances 0.000 claims description 11
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 9
- 239000000126 substance Substances 0.000 claims description 8
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 6
- 201000010099 disease Diseases 0.000 claims description 6
- RAXXELZNTBOGNW-UHFFFAOYSA-N imidazole Natural products C1=CNC=N1 RAXXELZNTBOGNW-UHFFFAOYSA-N 0.000 claims description 6
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims description 5
- 239000013543 active substance Substances 0.000 claims description 5
- 239000002775 capsule Substances 0.000 claims description 5
- 239000000796 flavoring agent Substances 0.000 claims description 5
- 208000000689 peptic esophagitis Diseases 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 5
- 230000001105 regulatory effect Effects 0.000 claims description 5
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 4
- 230000002378 acidificating effect Effects 0.000 claims description 4
- 230000003115 biocidal effect Effects 0.000 claims description 4
- 239000003085 diluting agent Substances 0.000 claims description 4
- 239000008187 granular material Substances 0.000 claims description 4
- 239000000314 lubricant Substances 0.000 claims description 4
- LXNHXLLTXMVWPM-UHFFFAOYSA-N pyridoxine Chemical compound CC1=NC=C(CO)C(CO)=C1O LXNHXLLTXMVWPM-UHFFFAOYSA-N 0.000 claims description 4
- 239000003381 stabilizer Substances 0.000 claims description 4
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 3
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims description 3
- 230000000567 anti-anemic effect Effects 0.000 claims description 3
- 230000001142 anti-diarrhea Effects 0.000 claims description 3
- 230000001567 anti-fibrinolytic effect Effects 0.000 claims description 3
- 239000002876 beta blocker Substances 0.000 claims description 3
- 229940097320 beta blocking agent Drugs 0.000 claims description 3
- 239000011230 binding agent Substances 0.000 claims description 3
- 239000002270 dispersing agent Substances 0.000 claims description 3
- 235000013355 food flavoring agent Nutrition 0.000 claims description 3
- 239000011777 magnesium Substances 0.000 claims description 3
- 229910052749 magnesium Inorganic materials 0.000 claims description 3
- 235000001055 magnesium Nutrition 0.000 claims description 3
- 239000004094 surface-active agent Substances 0.000 claims description 3
- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 claims description 2
- HBAQYPYDRFILMT-UHFFFAOYSA-N 8-[3-(1-cyclopropylpyrazol-4-yl)-1H-pyrazolo[4,3-d]pyrimidin-5-yl]-3-methyl-3,8-diazabicyclo[3.2.1]octan-2-one Chemical class C1(CC1)N1N=CC(=C1)C1=NNC2=C1N=C(N=C2)N1C2C(N(CC1CC2)C)=O HBAQYPYDRFILMT-UHFFFAOYSA-N 0.000 claims description 2
- 239000005541 ACE inhibitor Substances 0.000 claims description 2
- 229940077274 Alpha glucosidase inhibitor Drugs 0.000 claims description 2
- XNCOSPRUTUOJCJ-UHFFFAOYSA-N Biguanide Chemical compound NC(N)=NC(N)=N XNCOSPRUTUOJCJ-UHFFFAOYSA-N 0.000 claims description 2
- 229940123208 Biguanide Drugs 0.000 claims description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 claims description 2
- AUNGANRZJHBGPY-UHFFFAOYSA-N D-Lyxoflavin Natural products OCC(O)C(O)C(O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-UHFFFAOYSA-N 0.000 claims description 2
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims 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 claims description 2
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 claims description 2
- AUNGANRZJHBGPY-SCRDCRAPSA-N Riboflavin Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-SCRDCRAPSA-N 0.000 claims description 2
- BUGBHKTXTAQXES-UHFFFAOYSA-N Selenium Chemical compound [Se] BUGBHKTXTAQXES-UHFFFAOYSA-N 0.000 claims description 2
- FPIPGXGPPPQFEQ-BOOMUCAASA-N Vitamin A Natural products OC/C=C(/C)\C=C\C=C(\C)/C=C/C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-BOOMUCAASA-N 0.000 claims description 2
- 229930003451 Vitamin B1 Natural products 0.000 claims description 2
- 229930003471 Vitamin B2 Natural products 0.000 claims description 2
- 229930003268 Vitamin C Natural products 0.000 claims description 2
- 229930003427 Vitamin E Natural products 0.000 claims description 2
- 229930003448 Vitamin K Natural products 0.000 claims description 2
- 239000003288 aldose reductase inhibitor Substances 0.000 claims description 2
- 229940090865 aldose reductase inhibitors used in diabetes Drugs 0.000 claims description 2
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 claims description 2
- 239000003888 alpha glucosidase inhibitor Substances 0.000 claims description 2
- 230000000202 analgesic effect Effects 0.000 claims description 2
- 229940044094 angiotensin-converting-enzyme inhibitor Drugs 0.000 claims description 2
- 229940069428 antacid Drugs 0.000 claims description 2
- 239000003159 antacid agent Substances 0.000 claims description 2
- 230000000507 anthelmentic effect Effects 0.000 claims description 2
- 230000001458 anti-acid effect Effects 0.000 claims description 2
- 230000003266 anti-allergic effect Effects 0.000 claims description 2
- 230000001078 anti-cholinergic effect Effects 0.000 claims description 2
- 230000003474 anti-emetic effect Effects 0.000 claims description 2
- 230000000843 anti-fungal effect Effects 0.000 claims description 2
- 230000003276 anti-hypertensive effect Effects 0.000 claims description 2
- 230000003110 anti-inflammatory effect Effects 0.000 claims description 2
- 230000003579 anti-obesity Effects 0.000 claims description 2
- 230000000648 anti-parkinson Effects 0.000 claims description 2
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- 230000000842 anti-protozoal effect Effects 0.000 claims description 2
- 230000001139 anti-pruritic effect Effects 0.000 claims description 2
- 230000002682 anti-psoriatic effect Effects 0.000 claims description 2
- 230000002421 anti-septic effect Effects 0.000 claims description 2
- 230000002921 anti-spasmodic effect Effects 0.000 claims description 2
- 230000002785 anti-thrombosis Effects 0.000 claims description 2
- 230000000840 anti-viral effect Effects 0.000 claims description 2
- 239000003146 anticoagulant agent Substances 0.000 claims description 2
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- 239000003904 antiprotozoal agent Substances 0.000 claims description 2
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- 239000011575 calcium Substances 0.000 claims description 2
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- 239000000480 calcium channel blocker Substances 0.000 claims description 2
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- 239000003086 colorant Substances 0.000 claims description 2
- 239000003246 corticosteroid Substances 0.000 claims description 2
- 239000007950 delayed release tablet Substances 0.000 claims description 2
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- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims description 2
- 210000004211 gastric acid Anatomy 0.000 claims description 2
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- 229960001438 immunostimulant agent Drugs 0.000 claims description 2
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- 229960003444 immunosuppressant agent Drugs 0.000 claims description 2
- 230000001861 immunosuppressant effect Effects 0.000 claims description 2
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- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 2
- 239000008141 laxative Substances 0.000 claims description 2
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- 239000003094 microcapsule Substances 0.000 claims description 2
- 239000011707 mineral Substances 0.000 claims description 2
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- 239000003158 myorelaxant agent Substances 0.000 claims description 2
- 239000008188 pellet Substances 0.000 claims description 2
- SHUZOJHMOBOZST-UHFFFAOYSA-N phylloquinone Natural products CC(C)CCCCC(C)CCC(C)CCCC(=CCC1=C(C)C(=O)c2ccccc2C1=O)C SHUZOJHMOBOZST-UHFFFAOYSA-N 0.000 claims description 2
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- RADKZDMFGJYCBB-UHFFFAOYSA-N pyridoxal hydrochloride Natural products CC1=NC=C(CO)C(C=O)=C1O RADKZDMFGJYCBB-UHFFFAOYSA-N 0.000 claims description 2
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- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 claims description 2
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- 239000011782 vitamin Substances 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000005550 wet granulation Methods 0.000 description 1
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/734—Alginic acid
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- 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
- A61K9/2009—Inorganic compounds
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Abstract
Mevcut buluş gastroözofegal reflü hastalığı (GERD), peptik ülser, duedonum ülseri, Zollinger-Ellison sendromu hastalıklarının tedavisi ile mide asidi ve safranın özfagusa doğru reflüsünden kaynaklanan ağrıların, mide yanmaları, reflü ozofajit, regritasyon ve retrosternal ağrılarının semptomatik tedavisinde kullanılacak proton pompası inhibitörlerinden seçilen bir etken madde ve aljinik asit içeren farmasötik bileşimlere ilişkindir.The present invention provides a treatment method for gastroesophageal reflux disease (GERD), peptic ulcer, duodenal ulcer, Zollinger-Ellison syndrome, and proton pump inhibitors to be used in the symptomatic treatment of pain caused by reflux of stomach acid and bile towards the esophagus, heartburn, reflux oophagitis, regression and retrosternal pain. relates to pharmaceutical compositions containing the active ingredient and alginic acid.
Description
TARIFNAME YENI FARMASÖTIK BILESIMLER Mevcut bulus, proton pompasi inhibitörleri ve aljinik asit kombinasyonlarina, bu kombinasyonlarin gastroözofegal reflü hastaligi (GERD), peptik ülser, duedonum ülseri, Zollinger-Ellison sendromu hastaliklarinin tedavisi ile mide asidi ve safranin özfagusa dogru reflüsünden kaynaklanan agrilarin, mide yanmalari, reflü ozofajit, regritasyon ve retrostemal agrilarin semptomatik tedavisinde kullanilmasina ve bunlari içeren farmasötik bilesimlerle iliskindir. DESCRIPTION NEW PHARMACEUTICAL COMPOUNDS The present invention relates to combinations of proton pump inhibitors and alginic acid. gastroesophegal reflux disease (GERD), peptic ulcer, duodenal ulcer, Zollinger-Ellison syndrome pain caused by stomach acid and reflux of bile into the esophagus with the treatment of diseases, symptomatic treatment of heartburn, reflux esophagitis, regression and retrostemal pain relates to the use and pharmaceutical compositions containing them.
Daha özel olarak bulus, aljinik asit ile kombinasyon halinde, rabeprazol veya omeprazol veya lansoprazol ve/veya bunlarin farmasötik olarak kabul edilebilir türevlerinden seçilen en az bir proton pompa inhibitörü içeren farmasötik bilesim ile ilgilidir. More particularly, the invention, in combination with alginic acid, rabeprazole or omeprazole or at least one proton selected from lansoprazole and/or pharmaceutically acceptable derivatives thereof relates to a pharmaceutical composition containing a pump inhibitor.
Rabeprazol, gastrik asit salgisini inhibe eden sübstitüe benzimidazol yapili bir proton pompasi inhibitörüdür. Rabeprazolün kimyasal adi 2-[[[4-(3-metoksipropoksi)-3-meti1-2-pridinil]- meti1]sülfinil]-1H-benzimidazol olup ilk defa EP0268956 numarali basvuru ile açiklanmistir. Söz konusu dokümanda rabeprazolün mide ülseri tedavisinde kullaniminda etkili oldugu açiklanmistir. Rabeprazole is a proton pump inhibitor with a substituted benzimidazole structure that inhibits gastric acid secretion. is an inhibitor. Chemical name of rabeprazole 2-[[[4-(3-methoxypropoxy)-3-methyl1-2-pyridinyl]- methyl]sulfinyl]-1H-benzimidazole and was first disclosed in application EP0268956. Promise In the document in question, it is explained that rabeprazole is effective in the treatment of gastric ulcer.
Sekil 1. Rabeprazol Rabeprazol piyasada 50mg711k kapsül, lOmg ve 20mgllik enterik tablet formlarinda bulunmaktadir. Figure 1. Rabeprazole Rabeprazole is available in the market in the form of 50mg711k capsules, 10mg and 20mg enteric tablets.
Omeprazol gastrik asit salgisini azaltan bir proton pompasi inhibitörüdür. Omeprazolün kimyasal adi 5- numarali basvuru ile açiklanmistir. SÖZ konusu dokümanda omeprazolün peptik ülser tedavisinde kullanilmasi açiklanmistir. Omeprazole is a proton pump inhibitor that reduces gastric acid secretion. Chemical name of omeprazole 5- Explained with reference no. In the mentioned document, omeprazole in the treatment of peptic ulcer use is explained.
Sekil 2. Omeprazol Lansoprazol gastrik asit salgilanmasini, gastrik pariyetal hücrelerin enzim sistemini inhibe ederek baskilayan bir proton pompasi inhibitörüdür. Lansoprazolün kimyasal adi 2-({3-Metil-4-(2,2,2- açiklanmistir. Söz konusu dökümanda lansoprazolün ülser tedavisinde kullaniminda etkili oldugu açiklanmistir. Figure 2. Omeprazole Lansoprazole inhibits gastric acid secretion by inhibiting the enzyme system of gastric parietal cells. It is a proton pump inhibitor. Chemical name of lansoprazole 2-({3-Methyl-4-(2,2,2- has been explained. The document in question states that lansoprazole is effective in the treatment of ulcers. has been explained.
Sekil 3. Lansoprazol Aljinik asidin kimyasal adi Poly[beta-D-mannopiranozilüronik asit- (1- >4), alfa-L-gulopiranozilüronik asit- (1- >4) olup ilk defa US2128551 numarali basvuru ile açiklanmistir. Söz konusu dokümanda aljinik asidin mide asidi ve reflüden kaynakli agrilarin tedavisinde kullaniminda etkili oldugu açiklanmistir. Figure 3. Lansoprazole Chemical name of alginic acid Poly[beta-D-mannopyranosiluronic acid- (1->4), alpha-L-gulopyranosyluronic acid- (1- >4) and was first disclosed in the application numbered US2128551. In the document in question, alginic It has been explained that acid is effective in the treatment of stomach acid and pain caused by reflux.
Sekil 4. Aljinik asit Aljinik asit piyasada karbonatli bilesikler ile kombine halde 200mg aljinat içeren oral süspansiyon, çigneme tableti ve magnezyuin aljinat ile kombine halde 225mg'lik oral solüsyon için toz formlarinda bulunmaktadir. Figure 4. Alginic acid Alginic acid is an oral suspension containing 200mg alginate in combination with carbonated compounds on the market. In powder forms for chewing tablet and oral solution of 225mg in combination with magnesium alginate are available.
Sasirtici bir sekilde tespit edilmistir ki, gastroözofegal reflü hastaligi (GERD), peptik ülser, duedonum ülseri, Zollinger-Ellison sendromu hastaliklarinin tedavisi ile mide asidi ve safranin özfagusa dogru reflüsünden kaynaklanan agrilarin, mide yanmalari, reflü ozofajit, regritasyon ve retrostemal agrilarin semptomatik tedavisinde beklenmedik bir terapötik fayda, özellikle sinerjistik terapötik bir fayda proton pompasi inhibitörlerinden seçilen bir etken madde ve aljinik asidin kullanildigi kombinasyon terapisi ile elde edilebilir. Söz konusu terapötik faydanin; o Yalnizca proton pompasi inhibitörleri ya da aljinik asit ile tedavide kullanildiginda gerek duyulanlara kiyasla bu kombinasyonun kullanilmasi durumunda; gerekli olan terapötik etkinin elde edilmesi için gereken dozajlari azaltilmasi seklinde ve/veya o Istenmeyen yan etkilerin azaltilmasi seklinde ve/veya o Terapötik etkinin daha kisa sürede gözlenmesi seklinde ve/veya o Terapötik etkinin daha uzun süre boyunca gözlenmesi seklinde ve/veya 0 Daha etkin bir tedavinin saglanmasi seklinde 0 Hasta uyuncunun arttirilmasi seklinde olmasi mümkündür. Surprisingly, it has been determined that gastroesophegal reflux disease (GERD), peptic ulcer, duodenum ulcer, with the treatment of Zollinger-Ellison syndrome diseases, stomach acid and bile flow into the esophagus pain caused by reflux, heartburn, reflux esophagitis, regression and retrostemal pain An unexpected therapeutic benefit in symptomatic treatment, especially a synergistic therapeutic benefit proton Combination therapy using an active ingredient selected from pump inhibitors and alginic acid obtainable. The therapeutic benefit in question; o Only when used in treatment with proton pump inhibitors or alginic acid in the case of using this combination compared to those heard; necessary therapeutic effect. by reducing the dosages required to achieve and/or o Reducing undesirable side effects and/or o If the therapeutic effect is observed in a shorter time and/or o If the therapeutic effect is observed over a longer period of time and/or 0 In the form of providing a more effective treatment 0 In the form of increasing patient compliance it is possible to be.
Bir baska açidan proton pompasi inhibitörlerinden seçilen bir etken madde ve aljinik asidin birlikte veya simultane olarak kullanildigi farmasötik bilesim bu iki etken maddenin ayri ayri kullanildigi bilesimlere kiyasla daha yüksek terapötik fayda göstermektedir. On the other hand, an active ingredient selected from proton pump inhibitors and alginic acid together or The pharmaceutical composition in which these two active substances are used simultaneously is compared to the compositions in which these two active substances are used separately. shows higher therapeutic benefit compared to
Buna göre mevcut bulus, etken madde olarak aljinik asit ve proton pompasi inhibitörlerinden seçilen bir etken madde veya bunlarin farmasötik olarak kabul edilebilir türevlerini içeren bir farmasötik bilesimdir. Accordingly, the present invention is a drug selected from alginic acid and proton pump inhibitors as the active ingredient. is a pharmaceutical composition containing the active ingredient or pharmaceutically acceptable derivatives thereof.
Bir baska açidan proton pompasi inhibitörlerinden seçilen bir etken madde ve aljinik asidin kombine kullanimi terapötik etkinin kisa sürede görülmesini ve etkinin bu iki etken maddenin tek basina kullanilmasina kiyasla daha güçlü olmasini saglar. Bu sekilde hastalara daha etkin bir tedavinin saglanmasi inümkün olur. Sasirtici bir sekilde tüm bu olumlu etkiler her iki etken maddenin dizinsel olarak verildigi kombinasyonlarda görüldügü gibi, her iki etken maddenin bir dozaj formu içerisinde ayni anda veya birbirinden bagimsiz dozaj formlari içerisinde simultane olarak verildiginde de sergilenir. Yüksek terapötik fayda daha uzun etki seklinde de gözlemlenebilir. In another respect, a combination of an active ingredient selected from proton pump inhibitors and alginic acid Its use ensures that the therapeutic effect is seen in a short time and that the effect is not achieved by these two active substances alone. It makes it more powerful compared to using it. In this way, more effective treatment can be given to patients. provision is possible. Surprisingly, all these positive effects are indexed by both active ingredients. As seen in combinations given as It can also be given simultaneously or simultaneously in independent dosage forms. is displayed. High therapeutic benefit can also be observed in the form of longer action.
Buna göre mevcut bulus ayri dozaj formlari içerisinde dizinsel kullanim için, ayri dozaj formlari içerisinde simultane olarak veya ayni dozaj formunda ayni anda verilmek üzere proton pompasi inhibitörlerinden seçilen rabeprazol, omeprazol veya lansoprazol ile aljinik asidi birlikte ihtiva eden farmasötik bilesimlere iliskindir. Accordingly, the present invention provides separate dosage forms for sequential use within separate dosage forms. proton pump to be administered simultaneously or in the same dosage form containing alginic acid together with rabeprazole, omeprazole or lansoprazole selected from the inhibitors relates to pharmaceutical compositions.
Diger bir deyisle bulus, etken madde olarak asagidakileri içeren bir farmasötik bilesim ile ilgilidir; a) Aljinik asit veya farmasötik olarak kabul edilebilir türevi ve b) Rabeprazol veya farmasötik olarak kabul edilebilir türevi. In other words, the invention relates to a pharmaceutical composition comprising as active ingredient: a) Alginic acid or its pharmaceutically acceptable derivative; and b) Rabeprazole or its pharmaceutically acceptable derivative.
Diger bir deyisle bulus, etken madde olarak asagidakileri içeren bir farmasötik bilesim ile ilgilidir; a) Aljinik asit veya farmasötik olarak kabul edilebilir türevi ve b) Omeprazol veya farmasötik olarak kabul edilebilir türevi. In other words, the invention relates to a pharmaceutical composition comprising as active ingredient: a) Alginic acid or its pharmaceutically acceptable derivative; and b) Omeprazole or its pharmaceutically acceptable derivative.
Diger bir deyisle bulus, etken madde olarak asagidakileri içeren bir farmasötik bilesim ile ilgilidir; a) Aljinik asit veya farmasötik olarak kabul edilebilir türevi ve b) Lansoprazol veya farmasötik olarak kabul edilebilir türevi. In other words, the invention relates to a pharmaceutical composition comprising as active ingredient: a) Alginic acid or its pharmaceutically acceptable derivative; and b) Lansoprazole or its pharmaceutically acceptable derivative.
Bir açidan mevcut bulus proton pompasi inhibitörlerinden seçilen bir etken madde ve aljinik asidin farmasötik olarak etkin miktarini ve en az bir farmasötik olarak kabul edilebilir maddeyi içeren farmasötik bilesimlere iliskindir. In one aspect, an active ingredient selected from the present invention proton pump inhibitors and alginic acid containing a pharmaceutically active amount and at least one pharmaceutically acceptable substance relates to pharmaceutical compositions.
Söz konusu farmasötik bilesimler içerisinde etken maddeler en az bir farmasötik olarak kabul edilebilir yardimci madde ile birlikte tek bir bilesimde bir arada olabilecegi gibi, etken maddeler birbirinden ayri olarak en az bir farmasötik olarak kabul edilebilir yardimci madde ile birlikte de formüle edilebilir. Elde edilen farkli bilesimler tek bir dozaj formu içerisinde birlestirilebilir veya ayri ayri dozaj formlarinda olacak sekilde hazirlanabilir. Bilesimlerin ayri dozaj formlarinda bulunmasi durumunda söz konusu dozaj formlari birbiri ile ayni veya birbirinden farkli olabilir. In said pharmaceutical compositions, the active ingredients can be considered as at least one pharmaceutical. It can be together with the excipient in a single composition, or the active ingredients can be separated from each other. It may also be formulated together with at least one pharmaceutically acceptable excipient. in hand The different compounds obtained may be combined in a single dosage form or used in separate dosage forms. can be prepared as Where the compounds are available in separate dosage forms, dosage forms may be the same or different from each other.
Mevcut bulus ayni zamanda gastroözofegal reflü hastaligi (GERD), peptik ülser, duedonum ülseri, Zollinger-Ellison sendromu hastaliklarinin tedavisi ile mide asidi ve safranin özfagusa dogru reflüsünden kaynaklanan agrilarin, mide yanmalari, reflü ozofajit, regritasyon ve retrostemal agrilarinin semptomatik tedavisinde siinültane, dizinsel ya da ayri ayri verilme yolu ile kombinasyon terapisinde kullanilacak bir ilacin hazirlanmasi için bulusa uygun etken maddelerin kullanilmasina iliskindir. The present invention also includes gastroesophegal reflux disease (GERD), peptic ulcer, duodenal ulcer, Gastric acid and bile flow into the esophagus with the treatment of Zollinger-Ellison syndrome diseases. reflux, heartburn, reflux esophagitis, regression and retrostemal pains in combination therapy with simultaneous, sequential or separate administration in symptomatic treatment It is about the use of active substances according to the invention for the preparation of a drug to be used.
Bulus konusuna uygun farmasötik bilesimlerde “türevi” ifadesi ile kastedilen, bulus konusu etken maddelerin farmasötik olarak kabul edilebilir tuzlari, hidratlari, solvatlari, esterleri, enantiomerleri, diastereomerleri, rasematlari ve/veya amorf, kristal gibi polimorfik formlarin herhangi biri veya bunlarin kombinasyonlaridir. In the pharmaceutical compositions suitable for the subject of the invention, the term "derivative" refers to the subject of the invention. pharmaceutically acceptable salts, hydrates, solvates, esters, enantiomers, diastereomers, racemates and/or polymorphic forms such as amorphous, crystalline, or any of these are combinations.
Bulusa uygun farmasötik bilesimler tablet, efervesan tablet, efervesan granül, efervesan kuru toz, film kapli tablet, enterik kapli tablet, çift kapli tablet, homojen karisim tablet, kuru toz, granül, kapsül, mikro kapsül, pelet, uzatilmis salinimli tablet, modifiye salinimli tablet, geciktirilmis salinimli tablet, orodispersible tablet, çigneme tableti gibi dozaj forrnlarindan herhangi biri formunda hazirlanabilir. Pharmaceutical compositions according to the invention tablet, effervescent tablet, effervescent granule, effervescent dry powder, film coated tablet, enteric coated tablet, double coated tablet, homogeneous mixture tablet, dry powder, granule, capsule, micro capsule, pellet, extended-release tablet, modified-release tablet, delayed-release tablet, It can be prepared in any of the dosage forms such as orodispersible tablet, chewing tablet.
Bulusa uygun farmasötik bilesimler bir arada bu dozaj formlarindan herhangi biri formunda bulunabilecegi gibi, etken maddelerin birbirinden ayri dozaj formlarinda depolanmasi halinde söz konusu bilesimler bu dozaj formlarindan herhangi biri formunda bulunabilir. Pharmaceutical compositions according to the invention together in the form of any of these dosage forms. can be found, if the active ingredients are stored in separate dosage forms, The subject compositions may be present in any of these dosage forms.
Bir baska deyisle, bulusa uygun kombinasyonu içeren bilesimler yukarida bahsedilen dozaj formlarinin herhangi biri formunda veya bu dozaj formlarinin kombinasyonlari formunda veya bu kombinasyondan olusan bir tedavi paketi formunda bulunabilir. In other words, compositions comprising the combination according to the invention are equivalent to the above-mentioned dosage forms. in the form of any or combinations of these dosage forms, or from this combination It can be found in the form of a treatment pack.
Bulusa uygun farmasötik bilesimler tercihen kapsül veya tablet formlarindadir. The pharmaceutical compositions according to the invention are preferably in the form of capsules or tablets.
Bulusa uygun farmasötik bilesimler etken maddelere ek olarak çesitli yardimci maddeler içerebilir. Pharmaceutical compositions according to the invention may contain various excipients in addition to the active ingredients.
Bulusa farmasötik bilesimler etken maddelere ek olarak dagitici, seyreltici, kayganlastirici, yaglayici, baglayici, en az bir asidik ajan ve en az bir bazik ajandan olusan efervesan çifti, renklendirici ajan, pH düzenleyici ajan, sürfaktan, stabilizan, tatlandirici ve/veya tat düzenleyici ajan, aroma ajanini içeren gruptan seçilen en az bir yardimci madde içerir. In addition to the active ingredients, the pharmaceutical compositions of the invention are dispersant, diluent, lubricating, lubricating, effervescent couple consisting of binder, at least one acidic agent and at least one basic agent, coloring agent, pH containing regulating agent, surfactant, stabilizer, sweetening and/or taste regulating agent, flavoring agent contains at least one excipient selected from the group.
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan dagitici bunlarla sinirli olmamak üzere; karboksimetil selüloz, karboksimetil selüloz kalsiyum, karboksimetil selüloz sodyum, kroskarmeloz sodyum, krospovidon, hidroksipropil selüloz, mikrokristalin selüloz, metil selüloz, çitosan, nisasta, sodyum nisasta glikolat içeren bir grubun içerisinden seçilebilir. The dispersant which may be used in pharmaceutical compositions according to the invention is not limited to to; carboxymethyl cellulose, carboxymethyl cellulose calcium, carboxymethyl cellulose sodium, croscarmellose sodium, crospovidone, hydroxypropyl cellulose, microcrystalline cellulose, methyl cellulose, chitosan, starch, sodium starch glycolate.
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan seyreltici bunlarla sinirli olmamak üzere; kalsiyum karbonat, dibazik kalsiyum fosfat, tribazik kalsiyum fosfat, kalsiyum sülfat, mikrokristalin selüloz, dekstroz, fruktoz, laktitol, laktoz, magnezyum karbonat, magnezyum oksit, maltitol, maltodekstrin, maltoz, mannitol, simetikon, sorbitol, nisasta, sodyum klorür, sükroz, talk, ksilitol içeren bir grubun içerisinden seçilebilir. The diluent which may be used in pharmaceutical compositions according to the invention is not limited to to; calcium carbonate, dibasic calcium phosphate, tribasic calcium phosphate, calcium sulfate, microcrystalline cellulose, dextrose, fructose, lactitol, lactose, magnesium carbonate, magnesium oxide, maltitol, maltodextrin, maltose, mannitol, simethicone, sorbitol, starch, sodium chloride, sucrose, talc, may be selected from a group containing xylitol.
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan kayganlastirici bunlarla sinirli olmamak üzere; kalsiyum stearat, magnesyum stearat, polietilen glikol, sodyum benzoat, potasyum benzoat, sodyum lauril sülfat, talk, stearik asit, çinko stearat içeren bir grubun içerisinden seçilebilir. Lubricants that can be used in pharmaceutical compositions according to the invention are limited to not to be; calcium stearate, magnesium stearate, polyethylene glycol, sodium benzoate, potassium benzoate, sodium lauryl sulfate, talc, stearic acid, zinc stearate.
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan yaglayici bunlarla sinirli olmamak üzere; tribazik kalsiyum fosfat, koloidal silikon dioksit, magnezyum silikat, magnezyum trisilikat, talk içeren bir grubun içerisinden seçilebilir. Lubricant which may be used in pharmaceutical compositions according to the invention, including but not limited to to; tribasic calcium phosphate, colloidal silicon dioxide, magnesium silicate, magnesium trisilicate, talc can be selected from a group containing
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan baglayici bunlarla sinirli olmamak üzere; karboksimetil selüloz sodyum, etil selüloz, jelatin, hidroksietil selüloz, hidroksimetil selüloz, hidroksipropil selüloz, hipromelloz, magnezyum alüminyum silikat, maltodekstrin, metil selüloz, povidon, nisasta içeren bir grubun içerisinden seçilebilir. The binder which may be used in pharmaceutical compositions according to the invention is not limited to to; carboxymethyl cellulose sodium, ethyl cellulose, gelatin, hydroxyethyl cellulose, hydroxymethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium aluminum silicate, maltodextrin, methyl cellulose, povidone can be selected from a starch containing group.
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan en az bir asidik ajan ve en az bir bazik ajandan olusan efervesan çiftini olusturan asidik ajan bunlarla sinirli olmamak üzere; malik asit, sitrik asit, tartarik asit, fumarik asit gibi organik asitlerden olusan bir grubun içerisinden, bazik ajan; sodyum karbonat, potasyum karbonat, sodyum hidrojen karbonat, potasyum hidrojen karbonat gibi ajanlari içeren bir grubun içerisinden seçilebilir. At least one acidic agent and at least one ingredient that can be used in pharmaceutical compositions according to the invention. The acidic agent forming the effervescent couple consisting of the basic agent, but not limited to these; malic acid, basic agent from a group of organic acids such as citric acid, tartaric acid, fumaric acid; such as sodium carbonate, potassium carbonate, sodium hydrogen carbonate, potassium hydrogen carbonate may be selected from a group containing agents.
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan pH düzenleyici ajan bunlarla sinirli olmamak üzere; sitrat, fosfat, karbonat, tartarat, fumarat, asetat ve amino asit tuzlarinin içerisinden seçilebilir. The pH regulating agent which may be used in the pharmaceutical compositions according to the invention is limited thereto. not to be; citrate, phosphate, carbonate, tartrate, fumarate, acetate and amino acid salts can be selected.
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan sürfaktan bunlarla sinirli olmamak üzere; sodyum lauril sülfat, polisorbat, polioksietilen, polioksipropilen glikol ve benzeri ajanlarin içerisinden seçilebilir. Surfactant which may be used in pharmaceutical compositions according to the invention is not limited to to; sodium lauryl sulfate, polysorbate, polyoxyethylene, polyoxypropylene glycol and similar agents can be selected from.
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan stabilizan bunlarla sinirli olmamak üzere; tokoferol, tetrasodyum edetat, nikotinamid, siklodekstrin içeren bir grubun içerisinden seçilebilir. The stabilizer which may be used in pharmaceutical compositions according to the invention is not limited to to; tocopherol, tetrasodium edetate, nicotinamide, cyclodextrin.
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan tatlandirici ve/veya tat düzenleyici ajan bunlarla sinirli olmamak üzere; asesülfam, aspartam, dekstroz, fruktoz, maltitol, maltoz, mannitol, sakkarin, sakarin sodyum, sodyum siklamat, sorbitol, sükraloz, sükroz, ksilitol, sodyum klorür içeren bir grubun içerisinden seçilebilir. Sweetener and/or flavor stabilizer which may be used in pharmaceutical compositions according to the invention the agent is not limited thereto; acesulfame, aspartame, dextrose, fructose, maltitol, maltose, mannitol, containing saccharin, saccharin sodium, sodium cyclamate, sorbitol, sucralose, sucrose, xylitol, sodium chloride can be selected from a group.
Bulusa uygun farmasötik bilesimler içerisinde kullanilabilecek olan aroma ajani bunlarla sinirli olmamak üzere; mentol, limon, portakal, vanilya, çilek, ahududu, karamel ve benzeri aromalar içerisinden seçilebilir. The flavoring agent which may be used in the pharmaceutical compositions according to the invention is limited thereto. not to be; menthol, lemon, orange, vanilla, strawberry, raspberry, caramel and similar flavors can be selected from.
Bulusa uygun farmasötik bilesimler içerisinde agirlikça % 0,1 ile 99 oraninda, tercihen %1 ile 98 oraninda, özellikle tercihen % 5 ile 95 oraninda rabeprazol veya farmasötik olarak kabul edilebilir türevi bulunabilir. 0.1 to 99% by weight, preferably 1 to 98%, in pharmaceutical compositions according to the invention. rabeprazole or a pharmaceutically acceptable derivative thereof, particularly preferably 5 to 95% can be found.
Bulusa uygun farmasötik bilesimler içerisinde agirlikça % 0,1 ile 99 oraninda, tercihen %1 ile 98 oraninda, özellikle tercihen % 5 ile 95 oraninda omeprazol veya farmasötik olarak kabul edilebilir türevi bulunabilir. 0.1 to 99% by weight, preferably 1 to 98%, in pharmaceutical compositions according to the invention. of omeprazole or its pharmaceutically acceptable derivative, particularly preferably from 5 to 95%. can be found.
Bulusa uygun farmasötik bilesimler içerisinde agirlikça % 0,1 ile 99 oraninda, tercihen %1 ile 98 oraninda, özellikle tercihen % 5 ile 95 oraninda lansoprazol veya farmasötik olarak kabul edilebilir türevi bulunabilir. 0.1 to 99% by weight, preferably 1 to 98%, in pharmaceutical compositions according to the invention. lansoprazole, particularly preferably 5 to 95%, or pharmaceutically acceptable derivative can be found.
Bulusa uygun farmasötik bilesimler içerisinde yer alan aljinik asit veya farmasötik olarak kabul edilebilir türevi agirlikça % 0,1 ile 99 oraninda, tercihen %1 ile 98 oraninda, özellikle tercihen % 5 ile 95 oranindadir. Alginic acid contained in pharmaceutical compositions according to the invention or pharmaceutically acceptable 0.1 to 99%, preferably 1 to 98%, particularly preferably 5%, by weight of the derivative It is 95 percent.
Bulusa uygun farmasötik bilesimler içerisinde yer alabilecek rabeprazol veya farmasötik olarak kabul edilebilir türevi 2 mg ile 100 mg araliginda, tercihen 2 mg ile 90mg araliginda özellikle tercihen 2mg ile 80mg araligindadir. Rabeprazole, which may be included in the pharmaceutical compositions according to the invention, or pharmaceutically acceptable 2mg to 100mg, preferably 2mg to 90mg, especially preferably 2mg It is in the range of 80mg.
Bulusa uygun farmasötik bilesimler içerisinde yer alabilecek omeprazol veya farmasötik olarak kabul edilebilir türevi 1 mg ile 100 mg araliginda, tercihen 2 mg ile 90mg araliginda özellikle tercihen 2mg ile 80mg araligindadir. Omeprazole, which may be included in the pharmaceutical compositions according to the invention, or pharmaceutically acceptable in the range of 1 mg to 100 mg, preferably 2 mg to 90mg, particularly preferably 2mg It is in the range of 80mg.
Bulusa uygun farmasötik bilesimler içerisinde yer alabilecek lansoprazol veya farmasötik olarak kabul mg ile 80 mg araligindadir. Lansoprazole, which may be included in the pharmaceutical compositions according to the invention, or pharmaceutically acceptable It is in the range of mg to 80 mg.
Bulusa uygun farmasötik bilesimler içerisinde yer alan aljinik asit 10mg ile 1500 mg araliginda, tercihen mg ile 1200 mg araligindadir. Alginic acid, which is included in the pharmaceutical compositions according to the invention, is in the range of 10 mg to 1500 mg, preferably It is in the range of mg to 1200 mg.
Bulusa uygun farmasötik bilesimler içerisinde istege bagli olarak üçüncü bir etken madde bulunabilir. Üçüncü ekten madde; antiasit, antikolinerjik, antispazmodik, antiemetik, antibiyotik, antipropulsif, antialerjik, antidiarreal, antiobezite, antitrombotik, antifibrinolitik, antianemik, antihipertansif, antifungal, antipruritik, antipsoriatik, antibiyotik, antiseptik, antiakneantibakteriyel, antimikotik, antiviral, antineoplastik, antiaritmik, antiadrenerjik, antiepileptik, anti-parkinson, antiprotozoal, anthelmintik, antienflamatuar, diüretik, laksatif, sulfonamid, imidazol, kortikosteroid, tiozolidindion, biguanid, immunostimulant, immunusupresant, kas gevsetici, analjezik, psikoleptik, psikoanaleptik periferal vazodilatör, beta bloker, kalsiyum kanal bloker ve lipid modifiye edici ajanlar; alfa-glukosidaz inhibitörleri, aldoz redüktaz inhibitörleri, ACE inhibitörleri; multivitamin ve mineraller, A vitamini, D vitamini ve analoglari, B1 vitamini, C vitamini, E vitamini, B6 vitamini, B2 vitamini, K vitamini, kalsiyum, potasyum, sodyum, çinko, magnezyum, florür, selenyum içerisinden seçilebilir. A third active ingredient may optionally be present in the pharmaceutical compositions according to the invention. Article in the third appendix; antacid, anticholinergic, antispasmodic, antiemetic, antibiotic, antipropulsive, antiallergic, antidiarrheal, antiobesity, antithrombotic, antifibrinolytic, antianemic, antihypertensive, antifungal, antipruritic, antipsoriatic, antibiotic, antiseptic, antiacne, antibacterial, antimycotic, antiviral, antineoplastic, antiarrhythmic, antiadrenergic, antiepileptic, antiparkinsonian, antiprotozoal, anthelmintic, anti-inflammatory, diuretic, laxative, sulfonamide, imidazole, corticosteroid, thiozolidindione, biguanide, immunostimulant, immunosuppressant, muscle relaxant, analgesic, psycholeptic, psychoanaleptic peripheral vasodilator, beta blocker, calcium channel blocker and lipid modifying agents; alpha-glucosidase inhibitors, aldose reductase inhibitors, ACE inhibitors; multivitamin and minerals, vitamin A, D vitamin and its analogues, vitamin B1, vitamin C, vitamin E, vitamin B6, vitamin B2, vitamin K, may be selected from calcium, potassium, sodium, zinc, magnesium, fluoride, selenium.
Bulusa uygun farmasötik bilesim; o Etken maddelerin homojen bir sekilde karistirilmasi ve gerekli oldugu takdirde yukarida belirtilen yardimci maddelerin en az bir tanesinin eklenmesi ile veya o Etken maddelerin yardimci maddelerin en az bir tanesini içeren bir granülasyon solüsyonu ile granüle edilmesi ve sonrasinda diger yardimci maddeler ile homojen bir sekilde karistirilmasi o Etken maddelerin yukarida belirtilen yardimci maddelerin en az bir tanesini içeren bir karisimin, bir granülasyonu solüsyonu ile granüle edilmesi ve sonrasinda diger yardimci maddeler ile homojen bir sekilde karistirilmasi veya o Etken maddelerin yukarida belirtilen yardimci maddelerin en az bir tanesi ile karistirilmasi ve en az bir yardimci madde içeren granülasyon solüsyonu ile granüle edilmesi veya o Etken maddelerin iki ayri bilesim içerisinde hazirlanmasi durumunda yukarida sözü geçen metotlarin herhangi birinin etken madde bilesimleri için ayri ayri kullanilmasi ve elde edilen bilesimlerin bir araya getirilmesinden veya farkli dozaj formlarinda depolanmasindan olusan bir yöntem ile elde edilebilir. Pharmaceutical composition according to the invention; o Mixing the active ingredients homogeneously and, if necessary, with the addition of at least one of the specified excipients or o With a granulation solution containing at least one of the active ingredients and excipients granulating and then mixing homogeneously with other excipients o A product containing at least one of the above-mentioned excipients of the active ingredients granulation of the mixture with a granulation solution and then other auxiliary mixing it homogeneously with the substances or o Mixing the active ingredients with at least one of the excipients mentioned above and granulation with a granulation solution containing at least one excipient, or o In case the active ingredients are prepared in two different compositions, the above-mentioned using any of the methods separately for the active ingredient compositions and consisting of combining compounds or storing them in different dosage forms. can be obtained by one method.
Elde edilen farmasötik bilesim veya bilesimler yukarida belirtilen dozaj forinlarindan herhangi biri formuna getirilebilir. Tablet formunda olmasi durumunda elde edilen tabletlere film kaplama ajanlari ile örnegin seker bazli kaplama ajanlari, suda çözünebilir film kaplama ajanlari, enterik kaplama aj anlari, geciktirilmis salinim kaplama ajanlari veya bunlarin herhangi bir kombinasyonunu içeren kaplama kompozisyonlari ile muamele edilebilir. The resulting pharmaceutical composition or compositions can be any of the above-mentioned dosage forms. can be brought into the form. Film coating agents to the tablets obtained in the case of tablet form with eg sugar-based coating agents, water-soluble film coating agents, enteric coating agents, coating containing delayed release coating agents or any combination thereof can be treated with the compositions.
Seker bazli kaplama ajani olarak sakaroz tek basina veya istege bagli olarak talk, kalsiyum karbonat, kalsiyum fosfat, kalsiyum sülfat, jelatin, gum arabik, polivinilpirolidon ve pullulan gibi ajanlarin herhangi biri veya bunlarin herhangi bir kombinasyonu ile birlikte kullanilabilir. As a sugar-based coating agent, sucrose alone or optionally talc, calcium carbonate, agents such as calcium phosphate, calcium sulfate, gelatin, gum arabic, polyvinylpyrrolidone and pullulan may be used with any or any combination thereof.
Suda çözünebilir film kaplama ajani hidroksipropil selüloz, hidroksipropil metil selüloz, hidroksietil selüloz, metil hidroksietil selüloz ve sodyum karboksimetil selüloz gibi selüloz türevleri, polivinil asetal dietil aminoasetat, aminoalkil metakrilat kopolimerleri ve polivinilpirolidon gibi sentetik polimerler ve pullulan gibi polisakkaritler veya bunlarin kombinasyonlari içerisinden seçilebilir. Water soluble film coating agent hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose derivatives such as cellulose, methyl hydroxyethyl cellulose and sodium carboxymethyl cellulose, polyvinyl acetal synthetic polymers such as diethyl aminoacetate, aminoalkyl methacrylate copolymers and polyvinylpyrrolidone, and polysaccharides such as pullulan or combinations thereof.
Enterik kaplama ajanlari hidroksipropil metil selüloz fitalat, hidroksipropil metil selüloz asetat süksinat, karboksimetil etil selüloz, selüloz asetat fitalat gibi selüloz türevleri, metakrilik asit kopolimer L, metakrilik asit kopolimer LD ve metakrilik asit kopolimer S gibi akrilik asit türevleri ve sellak gibi dogal maddeler veya bunlarin kombinasyonlari içerisinden seçilebilir. Enteric coating agents hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose acetate succinate, cellulose derivatives such as carboxymethyl ethyl cellulose, cellulose acetate phthalate, methacrylic acid copolymer L, acrylic acid derivatives such as methacrylic acid copolymer LD and methacrylic acid copolymer S and natural products such as sellak substances or combinations thereof.
Geçiktirilmis salinim kaplama ajanlari etil selüloz gibi selüloz türevleri, aminoalkil metakrilat kopolimer RS, etil akrilat-metil metakrilat kopolimer emülsiyonu gibi akrilik asit türevleri veya bunlarin kombinasyonlari içerisinden seçilebilir. Delayed release coating agents cellulose derivatives such as ethyl cellulose, aminoalkyl methacrylate acrylic acid derivatives such as copolymer RS, ethyl acrylate-methyl methacrylate copolymer emulsion or their can be selected from combinations.
Bulusa uygun farmasötik bilesim gastroözofegal reflü hastaligi (GERD), peptik ülser, duedonum ülseri, Zollinger-Ellison sendromu hastaliklarinin tedavisi ile mide asidi ve safranin Özfagusa dogru reflüsünden kaynaklanan agrilarin, mide yanmalari, reflü özofajit, regritasyon ve retrostemal agrilarinin önlenmesinde ve semptomatik tedavisinde kullanilabilir. The pharmaceutical composition according to the invention is suitable for gastroesophegal reflux disease (GERD), peptic ulcer, duodenal ulcer, With the treatment of Zollinger-Ellison syndrome diseases, stomach acid and bile flow into the esophagus. reflux, heartburn, reflux esophagitis, regression and retrostemal pains It can be used for prevention and symptomatic treatment.
Asagidaki örnek bulus konusu kombinasyonlarin açiklanmasi için verilmis olup bulus konusu bu örnekle sinirlandirilamaz. ÖRNEK : Rabeprazol ve Aljinik Asit içeren Tablet Formülasyonu Rabeprazol sodyum ve sodyum aljinat etken maddeleri, mannitol ve seyreltici ile islak granülasyon yöntemi ile granüle edilir ve diger yardimci maddeler ile karistirilir. Elde edilen formülasyonlar tablet formunda basilir ve kaplama ajanlari ile kaplanir. The following example is given for the explanation of the combinations which are the subject of the invention. cannot be limited to examples. EXAMPLE: Tablet Formulation with Rabeprazole and Alginic Acid Wet granulation with rabeprazole sodium and sodium alginate active ingredients, mannitol and diluent It is granulated by the method and mixed with other auxiliary materials. The resulting formulations are tablets. It is printed in the form and coated with coating agents.
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