TR201723199A2 - New pharmaceutical compositions. - Google Patents

New pharmaceutical compositions. Download PDF

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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
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Turkey
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pharmaceutically acceptable
pharmaceutical composition
acceptable derivative
composition according
alginic acid
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TR2017/23199A
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Turkish (tr)
Inventor
Bi̇lgi̇ç Mahmut
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Neutec Ar Ge Sanayi Ve Ticaret Anonim Sirketi
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Priority to TR2017/23199A priority Critical patent/TR201723199A2/en
Priority to PCT/TR2018/000135 priority patent/WO2019216837A1/en
Publication of TR201723199A2 publication Critical patent/TR201723199A2/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/734Alginic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, 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.

Claims (1)

ISTEMLER Etken madde olarak aljinik asit ve proton pompasi inhibitörlerinden seçilen bir etken madde veya bunlarin farmasötik olarak kabul edilebilir türevlerini içeren bir farmasötik bilesimdir. Istem 1,e göre farmasötik bilesim olup, özelligi proton pompasi inhibitörlerinden seçilen etken maddenin rabeprazol veya onun farmasötik açidan kabul edilebilir türevi, omeprazol veya onun farmasötik açidan kabul edilebilir türevi, lansoprazol veya onun farmasötik açidan kabul edilebilir türevi olmasidir. Istem 1 veya 2,ye göre farmasötik bilesim olup, özelligi aljinik asit veya onun farmasötik olarak kabul edilebilir türevi ile kombinasyon halinde rabeprazol veya onun farmasötik olarak kabul edilebilir türevini içermesidir. Istem 3”e göre farmasötik bilesim olup, özelligi rabeprazol veya onun farmasötik olarak kabul edilebilir türevini 2-1 OOmg arasinda ve aljinik asit veya onun farmasötik olarak kabul edilebilir türevini 10-1500mg arasinda içermesidir. Istem 1 veya 2,ye göre farmasötik bilesim olup, özelligi aljinik asit veya onun farmasötik olarak kabul edilebilir türevi ile kombinasyon halinde omeprazol veya onun farmasötik olarak kabul edilebilir türevini içermesidir. Istem 5”e göre farmasötik bilesim olup, özelligi omeprazol veya onun farmasötik olarak kabul edilebilir türevini l-lOOmg arasinda ve aljinik asit veya onun farmasötik olarak kabul edilebilir türevini 10- l SOOmg arasinda içermesidir. Istem 1-2,ye göre farinasötik bilesim olup, özelligi aljinik asit veya onun farmasötik olarak kabul edilebilir türevi ile kombinasyon halinde lansoprazol veya onun farmasötik olarak kabul edilebilir türevini içermesidir. Istem 7,ye göre farmasötik bilesim olup, özelligi lansoprazol veya onun farmasötik olarak kabul edilebilir türevini 10-120mg arasinda ve aljinik asit veya onun farmasötik olarak kabul edilebilir türevini 10-1500mg arasinda içermesidir. Istem 1 veya 2”ye göre aljinik asit ile kombinasyon halinde rabeprazol, omeprazol veya lansoprazol içeren bir farmasötik bilesim olup, özelligi etken maddelerin farmasötik olarak kabul edilebilir tuzlari, hidratlari, solvatlari, esterleri, enantiomerleri, diastereomerleri formunda ve/veya amorf, kristal gibi polimorf'ik formlarin herhangi birinde veya bunlarin kombinasyonlari formunda olmasidir. Istem 1 veya 2,ye göre bir farmasötik bilesim olup, özelligi 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 veya bunlarin kombinasyonlari formunda bulunmasidir. Istem 10,a göre bir farmasötik bilesim olup, özelligi kapsül forumunda bulunmasidir. Istem 10,a göre bir farmasötik bilesim olup, özelligi tablet formunda bulunmasidir. Istem 1 veya 2,ye göre bir farmasötik bilesim olup, özelligi etken maddelerin yani sira farmasötik olarak kabul edilebilir en az bir yardimci madde içermesidir. Istem l3”e göre bir farmasötik bilesim olup özelligi etken maddelerin yani sira 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 içermesidir. Önceki istemlerin herhangi birine göre bir farmasötik bilesim olup özelligi içerdigi etken maddelere ek olarak istege bagli olarak; 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; inultivitamin 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, Ilorür, selenyum içerisinden seçilen en az bir üçüncü etken madde bulunmasidir. Önceki istemlerin herhangi birine göre bir farmasötik bilesim olup özelligi 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 kullanilmasidir.CLAIMS It is a pharmaceutical composition containing an active ingredient selected from alginic acid and proton pump inhibitors or their pharmaceutically acceptable derivatives. Pharmaceutical composition according to claim 1, characterized in that the active ingredient selected from the proton pump inhibitors is rabeprazole or its pharmaceutically acceptable derivative, omeprazole or its pharmaceutically acceptable derivative, lansoprazole or its pharmaceutically acceptable derivative. Pharmaceutical composition according to claim 1 or 2, characterized in that it contains rabeprazole or its pharmaceutically acceptable derivative in combination with alginic acid or its pharmaceutically acceptable derivative. It is a pharmaceutical composition according to claim 3, characterized in that it contains rabeprazole or its pharmaceutically acceptable derivative between 2-1 OOmg and alginic acid or its pharmaceutically acceptable derivative between 10-1500mg. Pharmaceutical composition according to claim 1 or 2, characterized in that it contains omeprazole or its pharmaceutically acceptable derivative in combination with alginic acid or its pharmaceutically acceptable derivative. Pharmaceutical composition according to claim 5, characterized in that it contains omeprazole or its pharmaceutically acceptable derivative between 1-100mg and alginic acid or its pharmaceutically acceptable derivative between 10-100mg. Pharmaceutical composition according to claims 1-2, characterized in that it contains lansoprazole or its pharmaceutically acceptable derivative in combination with alginic acid or its pharmaceutically acceptable derivative. Pharmaceutical composition according to claim 7, characterized in that it contains between 10-120mg of lansoprazole or its pharmaceutically acceptable derivative and 10-1500mg of alginic acid or its pharmaceutically-acceptable derivative. It is a pharmaceutical composition containing rabeprazole, omeprazole or lansoprazole in combination with alginic acid according to claim 1 or 2, characterized in that it is in the form of pharmaceutically acceptable salts, hydrates, solvates, esters, enantiomers, diastereomers and/or amorphous, crystalline polymorphs of the active ingredients. It is in any of the two forms or combinations thereof. A pharmaceutical composition according to claim 1 or 2, characterized by tablet, effervescent tablet, effervescent granule, effervescent dry powder, film-coated tablet, enteric-coated tablet, double-coated tablet, homogeneous mixture tablet, dry powder, granule, capsule, microcapsule It is available in the form of pellets, extended-release tablets, modified-release tablets, delayed-release tablets, orodispersible tablets, chewable tablets, or combinations thereof. It is a pharmaceutical composition according to claim 10, characterized in that it is in the capsule forum. It is a pharmaceutical composition according to claim 10, characterized in that it is in tablet form. A pharmaceutical composition according to claim 1 or 2, characterized in that it contains active ingredients as well as at least one pharmaceutically acceptable excipient. It is a pharmaceutical composition according to claim 13 and its feature is active substances as well as dispersant, diluent, lubricant, lubricant, binder, effervescent couple consisting of at least one acidic agent and at least one basic agent, coloring agent, pH regulatory agent, surfactant, stabilizer, sweetening and/or taste regulating agent, flavoring agent, at least one excipient selected from the group. It is a pharmaceutical composition according to any of the previous claims and optionally, in addition to the active ingredients it contains; antacid, anticholinergic, antispasmodic, antiemetic, antibiotic, antipropulsive, antiallergic, antidiarrheal, antiobesity, antithrombotic, antifibrinolytic, antianemic, antihypertensive, antifungal, antipruritic, antipsoriatic, antibiotic, antiseptic, antiacneantibacterial, antidiarrheal, antiviral, antifibrinolytic, antianemic, antipsychotic, anti-parkinsonian, antiprotozoal, anthelmintic, anti-inflammatory, diuretic, laxative, sulfonamide, imidazole, corticosteroid, thiazolidinedione, biguanide, immunostimulant, immunosuppressant, muscle relaxant, analgesic, psycholeptic, psychoanaleptic beta-blocker, beta-blocker, lipid-modifier, calcium-blocker, lipid-modifier, peripheral channel, ; alpha-glucosidase inhibitors, aldose reductase inhibitors, ACE inhibitors; At least one third factor selected from inultivitamin and minerals, vitamin A, vitamin D and its analogs, vitamin B1, vitamin C, vitamin E, vitamin B6, vitamin B2, vitamin K, calcium, potassium, sodium, zinc, magnesium, Iloride, selenium substance is found. A pharmaceutical composition according to any of the preceding claims, characterized in the treatment of gastroesophegal reflux disease (GERD), peptic ulcer, duodenal ulcer, Zollinger-Ellison syndrome, and pain caused by the reflux of gastric acid and bile into the esophagus, heartburns, reflux esophagitis, regression and retrostemal used in symptomatic treatment.
TR2017/23199A 2017-12-30 2017-12-30 New pharmaceutical compositions. TR201723199A2 (en)

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TR2017/23199A TR201723199A2 (en) 2017-12-30 2017-12-30 New pharmaceutical compositions.
PCT/TR2018/000135 WO2019216837A1 (en) 2017-12-30 2018-12-28 Novel pharmaceutical compositions

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Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9600071D0 (en) * 1996-01-08 1996-01-08 Astra Ab New oral formulation of two active ingredients I
AR056062A1 (en) * 2006-06-05 2007-09-19 Bago Sa Labor ANTI-AGED PHARMACEUTICAL COMPOSITION IN DUST FORM, PHARMACEUTICAL PREPARATION THAT UNDERSTANDS IT AND PROCESS FOR PREPARATION
WO2010038241A2 (en) * 2008-09-30 2010-04-08 Panacea Biotec Limited Pharmaceutical compositions comprising of proton pump inhibitor, prokinetic agent and alginic acid
WO2013141827A1 (en) * 2012-03-21 2013-09-26 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Enteric coated solid pharmaceutical compositions for proton pump inhibitors

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