TR201720395A2 - NEW TABLET FORMULATIONS OF MONTELUKAST SODIUM AND RUPATADINE FUMARATE - Google Patents
NEW TABLET FORMULATIONS OF MONTELUKAST SODIUM AND RUPATADINE FUMARATE Download PDFInfo
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- TR201720395A2 TR201720395A2 TR2017/20395A TR201720395A TR201720395A2 TR 201720395 A2 TR201720395 A2 TR 201720395A2 TR 2017/20395 A TR2017/20395 A TR 2017/20395A TR 201720395 A TR201720395 A TR 201720395A TR 201720395 A2 TR201720395 A2 TR 201720395A2
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- tablet formulation
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- sodium
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- 239000007916 tablet composition Substances 0.000 title claims abstract description 27
- JYBLCDXVHQWMSU-WLHGVMLRSA-N (e)-but-2-enedioic acid;8-chloro-11-[1-[(5-methylpyridin-3-yl)methyl]piperidin-4-ylidene]-5,6-dihydrobenzo[1,2]cyclohepta[2,4-b]pyridine Chemical compound OC(=O)\C=C\C(O)=O.CC1=CN=CC(CN2CCC(CC2)=C2C3=NC=CC=C3CCC3=CC(Cl)=CC=C32)=C1 JYBLCDXVHQWMSU-WLHGVMLRSA-N 0.000 title claims abstract description 22
- 229960001951 montelukast sodium Drugs 0.000 title claims abstract description 18
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- HBNDBUATLJAUQM-UHFFFAOYSA-L magnesium;dodecyl sulfate Chemical compound [Mg+2].CCCCCCCCCCCCOS([O-])(=O)=O.CCCCCCCCCCCCOS([O-])(=O)=O HBNDBUATLJAUQM-UHFFFAOYSA-L 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
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- 235000010981 methylcellulose Nutrition 0.000 description 1
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- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 1
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- 229960000292 pectin Drugs 0.000 description 1
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 1
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- 229920000193 polymethacrylate Polymers 0.000 description 1
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- 235000017550 sodium carbonate Nutrition 0.000 description 1
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
Abstract
Mevcut buluş, rupatadin fumarat ile kombinasyon halinde montelukast sodyum içeren yeni bir tek katmanlı tablet formülasyonu ile ilgilidir.The present invention relates to a novel monolayer tablet formulation comprising montelukast sodium in combination with rupatadine fumarate.
Description
TARIFNAME MONTELUKAST SODYUM VE RUPATADIN FUMARATIN YENI TABLET FORMÜLASYONLARI Bulusun Alani Mevcut bulus, rupatadin fumarat ile kombinasyon halinde montelukast sodyum içeren yeni bir tek katmanli tablet formülasyonu ile ilgilidir. DESCRIPTION MONTELUKAST SODIUM AND RUPATADIN FUMARATIN NEW TABLET FORMULATIONS Field of Invention The present invention is a novel drug containing montelukast sodium in combination with rupatadine fumarate. relates to the single-layer tablet formulation.
Teknigin Bilinen Durumu Montelukast sodyum, asimetrik bir merkeze sahiptir ve R-izomeridir. Kristalin ve amorf formlari bilinmektedir. Montelukast sodyum, astimin profilaksisi ve kronik tedavisi için onaylanmis bir Iökotrien reseptör antagonistidir. Montelukast sodyumun kimyasal adi, [R- metil] siklopropan asetik asit mono sodyum tuzudur ve yapisi asagidaki formül I'de gösterilmektedir. Astim ve alerjik rinit belirtilerine neden olan vücuttaki bilesiklerin aktivitesini bloke ederek etki gösterir. Astim kaynakli hiriltili solunum, nefes alma güçlügü, gögüs sikismasi ve öksürügü önlemek için kullanilir. State of the Art Montelukast sodium has an asymmetric center and is the R-isomer. crystalline and amorphous forms are known. Montelukast sodium for the prophylaxis and chronic treatment of asthma It is an approved Iukotriene receptor antagonist. Chemical name of Montelukast sodium, [R- methyl]cyclopropane is acetic acid mono sodium salt and its structure is in formula I below is shown. The activity of compounds in the body that cause symptoms of asthma and allergic rhinitis. It acts by blocking. Asthma-induced wheezing, difficulty breathing, chest It is used to prevent burping and coughing.
Formül l: Montelukast sodyum W09716173 numarali patentte, montelukast sodyumun tablet formülasyonu açiklanmistir. Formula 1: Montelukast sodium In the patent number W09716173, tablet formulation of montelukast sodium is disclosed.
Ayni zamanda ABD pazarinda SINGULAIR® markasi altinda tablet, çigneme tableti ve oral granül olarak bulunmaktadir. Also available in the US market are tablets, chewable tablets and oral tablets under the SINGULAIR® brand. available as granules.
Rupatadin, alerjilerin tedavisinde kullanilan ikinci nesil bir antihistamin ve PAF (Trombosit aktive edici faktör) antagonistidir ve pazarda Rupafin, Alergoliber, Rinialer, Pafinur, Rupax ve Ralif gibi birkaç marka tarafindan pazarlanmaktadir. Rupatadine is a second generation antihistamine and PAF (Platelet) used in the treatment of allergies. activating factor) antagonist and is commercially available in Rupafin, Alergoliber, Rinialer, Pafinur, Rupax and It is marketed by several brands such as Ralif.
Rupatadine fumarat, 12 yas üstü eriskinlerde ve çocuklarda alerjik rinit ve kronik ürtiker tedavisi için onaylanmistir. Tanimlanan günlük doz (DDD), oral yoldan 10mg'dir. Rupatadin 5H- benzo[5,6]siklohepta[1,2-b]piridin fumarattir ve asagidaki formül II'de gösterilen yapiya sahiptir. Rupatadine fumarate, allergic rhinitis and chronic urticaria in adults and children over 12 years of age approved for treatment. The defined daily dose (DDD) is 10mg orally. Rupatadine It is 5H-benzo[5,6]cyclohepta[1,2-b]pyridine fumarate and has the structure shown in formula II below. has.
Formül Il: Rupatadin fumarat Rupatadin ilk olarak U86803468 numarali patentte (Ranbaxy Laboratories Limited) açiklanmistir ve prosesini ve diger tuz formlarini açiklayan patent basvurulari bulunmaktadir. Önceki teknikte, tek basina veya kombinasyon halinde montelukast veya rupatadin içeren bazi kapsül formülasyonlari bulunabilir. Bununla birlikte, kapsül formülasyonu, tablet kombinasyonu kadar etkili degildir ve bu, geçimlilik ve stabilite problemlerine ve ayrica etkin maddede çözünme problemlerine yol açabilir. Formula II: Rupatadine fumarate Rupatadine was first published in patent U86803468 (Ranbaxy Laboratories Limited) has been disclosed and there are patent applications describing its process and other salt forms. In the prior art, it contains montelukast or rupatadine alone or in combination. some capsule formulations may be found. However, the capsule formulation combination and this causes compatibility and stability problems as well as effective may cause dissolution problems in the substance.
Ayrica rupatadin ve montelukast kombinasyonunun alerjik rinit belirtilerinin kontrolünde tek basina rupatadine göre daha etkin oldugu bulunmustur. In addition, the combination of rupatadine and montelukast alone is used to control the symptoms of allergic rhinitis. It was found to be more effective than rupatadine per head.
Ek olarak, bir dozaj formunda bir molekülden ziyade birden fazla molekülün kombine edilmesi, hastalarin yasam kalitesini ve hasta uyumunu arttirir. Tüm bunlar birlikte ele alindiginda, teknikte, tablet formülasyonu gibi uygun bir farmasötik dozaj formülasyonunda montelukast ve rupatadin kombinasyonlarina ihtiyaç bulunmaktadir. Bununla birlikte, bir tablette iki veya daha fazla molekül kombine edilirken çözünme ve stabilite problemleri gibi birçok zorluk ortaya çikmaktadir. Önceki teknikte, montelukast sodyum ve rupatadin fumarat içeren baska farmasötik dozaj formlari bulunmaktadir ancak önceki teknikte açiklanan proses karmasik, zaman alici ve yüksek maliyetlidir. In addition, it is a combination of more than one molecule rather than one molecule in a dosage form. It increases patients' quality of life and patient compliance. All this taken together in the art, in a suitable pharmaceutical dosage formulation, such as a tablet formulation. Montelukast and rupatadine combinations are needed. However, a such as dissolution and stability problems when combining two or more molecules in a tablet many difficulties arise. In the prior art, other pharmaceutical dosage forms containing montelukast sodium and rupatadine fumarate There are forms of it, but the process described in the prior art is complex, time consuming and is high cost.
Mevcut bulusta, yukarida belirtilen bu problemleri asmak için, basit ve uygun maliyetli standart teknikler kullanilarak montelukast ve rupatadinin tek katmanli bir tablet formülasyonu gelistirilmistir. In the present invention, to overcome these above mentioned problems, simple and cost-effective A single-layer tablet of montelukast and rupatadine using standard techniques. formulation has been developed.
Bulusun Açiklamasi Mevcut bulusun esas amaci, istenen çözünme ve stabilite profiline sahip olan stabil ve geçimli bir montelukast sodyum ve rupatadin fumarat kombinasyonu içeren tek katmanli bir tablet formülasyonu elde edilmesidir. Description of the Invention The main object of the present invention is to obtain stable and A monolayer containing a compatible combination of montelukast sodium and rupatadine fumarate. tablet formulation.
Bu uygulamaya göre, mevcut bulusta, astim tedavisinde kullanilmak üzere sinerjik etkiye sahip stabil bir kombinasyon formülasyonu elde edilmesi amaçlanmaktadir. According to this application, the present invention has a synergistic effect for use in the treatment of asthma. It is aimed to obtain a stable combination formulation with
Mevcut bulusun bir diger amaci, montelukast sodyum ve rupatadin fumarat kombinasyonun kolaylikla çözünen ve dolayisiyla yüksek emilim ve biyoyararlanim sergileyen, daha gelismis bir tek katmanli tablet formülasyonunun hazirlanmasi için basit, uygun maliyetli ve zaman kazandirici bir proses sunulmasidir. Another object of the present invention is the combination of montelukast sodium and rupatadine fumarate. more advanced, readily soluble and therefore exhibiting high absorption and bioavailability. simple, cost-effective and time-consuming to prepare a monolayer tablet formulation presenting a rewarding process.
Mevcut bulusun farmasötik kompozisyonu, direkt baski, yas ve kuru granülasyon gibi teknikte iyi bilinen standart teknikler ve üretim prosesleri kullanilarak hazirlanabilir. The pharmaceutical composition of the present invention can be used in art such as direct printing, wet and dry granulation. can be prepared using well-known standard techniques and manufacturing processes.
Direkt baski, bir zamanlar oldukça yaygin olan ve basitligi ve uygun maliyeti sayesinde yine popüler hale gelen, oral dozaj üretiminin en basit formu ve düsük maliyetli bir yöntemdir. Ek fayda olarak direkt baski, yas granülasyona kiyasla tabletlerin fiziksel ve kimyasal stabilitesini iyilestirebilir. Direct printing is what was once very common and is now again due to its simplicity and affordability. It is the simplest form of oral dosage manufacture and a low-cost method that has become popular. Additional As a benefit, direct compression improves the physical and chemical stability of tablets compared to wet granulation. can improve.
Direkt baski kullanildiginda, etkin madde miktari üretim prosesi sirasinda zamanla azalabilir çünkü etkin madde, kabin duvarina yapisabilir. Genellikle bu teknik, daha az miktarda etkin madde kullanildiginda (örnegin etkin madde %01 ile %20 arasinda oldugunda) kullanilmaz. When using direct pressure, the amount of active ingredient may decrease over time during the manufacturing process. because the active substance can stick to the cabinet wall. Usually this technique is less effective. it is not used when the substance is used (for example, when the active substance is between 01 and 20%).
Bu problemin üstesinden gelmek için etkin madde miktari arttirilir, dolayisiyla daha etkili bir tablet formülasyonu elde edilir. Sonuç olarak, istenen içerik tekdüzeligi ve çözünme oranlari elde edilmis olur. rupatadin fumarat içerebilir. To overcome this problem, the amount of active substance is increased, therefore a more effective tablet formulation is obtained. As a result, the desired content uniformity and dissolution rates are it is obtained. May contain rupatadine fumarate.
Bu uygulamaya göre tercihen tablet formülasyonu, agirlikça %210 ila %250, %260 ila Bu uygulamaya göre tablet formülasyonu, agirlikça %21.00 ila %99.00 montelukast sodyum montelukast sodyum içermektedir. Preferably, the tablet formulation according to this application is 210 to 250%, 260% to 260% by weight. The tablet formulation according to this embodiment is from 21.00% to 99.00% by weight montelukast sodium. Montelukast contains sodium.
Bu uygulamaya göre tablet formülasyonu, agirlikça %21.00 ila %99.00 rupatadin fumarat rupatadin fumarat içermektedir. The tablet formulation according to this embodiment is 21.00% to 99.00% by weight of rupatadine fumarate. Contains rupatadine fumarate.
Mevcut bulusun bir uygulamasina göre, farmasötik kombinasyon, basilmis tabletler, kapli veya kapli olmayan tabletler, çok katmanli tabletler, mini tabletler, çift katmanli tablet, tablet içinde pellet, bukkal tabletler, dil alti tabletleri, efervesan tabletler, çabuk salim saglayan tabletler, tablet içinde çekirdek, modifiye salim saglayan tabletler, tablet içinde tablet, film kapli tabletler, agizda dagilan tabletler, midede dagilan tabletler, çigneme tableti, dagilabilir tablet, veya pastiller gibi tablet seklinde formüle edilmektedir. According to one embodiment of the present invention, the pharmaceutical combination, pressed tablets, coated or uncoated tablets, multi-layer tablets, mini-tablets, double-layer tablet, tablet in pellets, buccal tablets, sublingual tablets, effervescent tablets, immediate release tablets, core-in-tablet, modified-release tablets, tablet-in-tablet, film coated tablets, mouth dispersible tablets, stomach dispersible tablets, chewable tablet, dispersible It is formulated in tablet form, such as tablets, or lozenges.
Mevcut bulusta farmasötik kombinasyon, film kapli tablet dozaj formundadir. Tabletler ayri bölmeler veya katmanlar içerebilir. In the present invention, the pharmaceutical combination is in film-coated tablet dosage form. Tablets separate may contain partitions or layers.
Mevcut bulusta farmasötik kombinasyon, tablet formundadir. Tablet, mini tablet, pelletler, granüller, toz gibi en az bir tip partikül içerebilir. In the present invention, the pharmaceutical combination is in tablet form. Tablets, mini tablets, pellets, The granules may contain at least one type of particle, such as powder.
Mevcut bulusun bir baska amaci, daha az yan etki görülmesidir. Montelukast sodyum ile rupatadin fumaratin tek katmanli tablet formunun standart tekniklerle hazirlanma prosesi sirasinda, montelukast sodyum ile rupatadin fumaratin önceki teknikteki diger farmasötik dozaj formuna göre daha az eksipiyan kullanildigi bulunmustur. Daha az eksipiyan kullanilmasi, tek katmanli tablete, agirligin ve hacmin daha az olmasi ve eksipiyan kaynakli yan etkilerin daha az olmasi gibi avantajlar vermektedir. Another object of the present invention is to experience fewer side effects. Montelukast with sodium Preparation process of rupatadine fumarate monolayer tablet form with standard techniques Montelukast sodium and rupatadine fumarate were used as other prior art pharmaceuticals during It was found that less excipient was used compared to the dosage form. Fewer excipients use, single-layer tablet, less weight and volume, and excipient-induced It offers advantages such as fewer side effects.
Bu uygulamaya göre tablet formülasyonu ayrica en az bir eksipiyan içermektedir. According to this embodiment, the tablet formulation further comprises at least one excipient.
Bu uygulamaya göre eksipiyan, dagiticilar, baglayicilar, dolgu maddeleri, lubrikanlar veya bunlarin karisimlarini içeren gruptan seçilmektedir. According to this application, excipients, dispersants, binders, fillers, lubricants or selected from the group containing mixtures of these.
Bu uygulamaya göre dagiticilar, kroskarmelloz sodyum, prejelatinize nisasta, krospovidon, sodyum nisasta glikolat, düsük ikameli hidroksipropil selüloz, polivinilpirrolidon, hidroksipropil metil selüloz, karboksi metil selüloz kalsiyum, sodyum karboksi metil selüloz, magnezyum alüminyum silika, sodyum dodesil sülfat, kalsiyum silikat veya bunlarin karisimlarini içeren gruptan seçilmektedir. According to this application, the dispersants are croscarmellose sodium, pregelatinized starch, crospovidone, sodium starch glycolate, low substituted hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl methyl cellulose, carboxy methyl cellulose calcium, sodium carboxy methyl cellulose, magnesium containing aluminum silica, sodium dodecyl sulfate, calcium silicate or mixtures thereof selected from the group.
Bu uygulamaya göre kompozisyondaki toplam dagitici miktari, agirlikça %5.0'ten, tercihen Bu uygulamaya göre dagiticilar, kroskarmelloz sodyum ve prejelatinize nisastadir. According to this application, the total amount of dispersant in the composition should be greater than 5.0% by weight, preferably According to this application, the dispersants are croscarmellose sodium and pregelatinized starch.
Bu uygulamaya göre kompozisyondaki toplam kroskarmelloz sodyum miktari, agirlikça Bu uygulamaya göre kompozisyondaki toplam prejelatinize nisasta miktari, agirlikça %3.0'ten Bu uygulamaya göre kroskarmelloz sodyumun prejelatinize nisastaya agirlik orani, 0.01- .0, tercihen 0.05-5.0'tir. According to this application, the total amount of croscarmellose sodium in the composition, by weight According to this application, the total amount of pregelatinized starch in the composition is more than 3.0% by weight. According to this application, the weight ratio of croscarmellose sodium to pregelatinized starch is 0.01- .0, preferably 0.05-5.0.
Uygun baglayicilar, hidroksipropil selüloz, hidroksipropil metil selüloz, metil selüloz, karboksimetil selüloz, polietilen glikol, polivinil alkol, polivinil asetat, polivinilpirrolidon, sekelerler, glikoz suruplari, dogal zamklar, guar zamki, kitre zamki, prejelatinize nisasta, jelatinler, pullulan, agar, aljinat, sodyum aljinatlar, gliserizin, polimetakrilatlar, kollajen, hiyalüronik asit, pektin, karrageenan, karbomer, poloksamer, poliakrilamid, alüminyum hidroksit, bentonit, laponit, setostearil alkol, polioksietilen-alkil eterler, akasya müsilaji, polidekstroz, polietilen oksit, ksilitol, sukroz stearat veya bunlarin karisimlarini içeren gruptan seçilmektedir. Tercihen baglayici, hidroksipropil selülozdur. Suitable binders are hydroxypropyl cellulose, hydroxypropyl methyl cellulose, methyl cellulose, carboxymethyl cellulose, polyethylene glycol, polyvinyl alcohol, polyvinyl acetate, polyvinylpyrrolidone, sugar syrups, glucose syrups, natural gums, guar gum, gum tragacanth, pregelatinized starch, gelatins, pullulan, agar, alginate, sodium alginates, glycerizine, polymethacrylates, collagen, hyaluronic acid, pectin, carrageenan, carbomer, poloxamer, polyacrylamide, aluminum hydroxide, bentonite, laponite, cetostearyl alcohol, polyoxyethylene-alkyl ethers, acacia mucilage, from the group consisting of polydextrose, polyethylene oxide, xylitol, sucrose stearate or mixtures thereof. is selected. Preferably the binder is hydroxypropyl cellulose.
Uygun dolgu maddeleri Iaktoz monohidrat, mikrokristalin selüloz, nisasta, mannitol, dibazik kalsiyum fosfat, tribazik kalsiyum fosfat, trehaloz, izomalt, sodyum karbonat, sodyum bikarbonat, kalsiyum karbonat veya bunlarin karisimlarini içeren gruptan seçilmektedir. Suitable fillers Ilactose monohydrate, microcrystalline cellulose, starch, mannitol, dibasic calcium phosphate, tribasic calcium phosphate, trehalose, isomalt, sodium carbonate, sodium bicarbonate, calcium carbonate or mixtures thereof.
Tercihen dolgu maddeleri, Iaktoz monohidrat ve mikrokristalin selülozdur. Preferably the fillers are Iactose monohydrate and microcrystalline cellulose.
Uygun Iubrikanlar, magnezyum stearat, sodyum stearil fumarat, polietilen glikol, sodyum lauril sülfat, magnezyum Iauril sülfat, fumarik asit, gliseril palmitostearat, hidrojene dogal yaglar, çinko stearat, kalsiyum stearat, silika, talk, stearik asit, polietilen glikol, parafin veya bunlarin karisimlarini içeren bir gruptan seçilmektedir. Tercihen Iubrikan, magnezyum stearattir. Suitable lubricans, magnesium stearate, sodium stearyl fumarate, polyethylene glycol, sodium lauryl sulfate, magnesium lauryl sulfate, fumaric acid, glyceryl palmitostearate, hydrogenated natural oils, zinc stearate, calcium stearate, silica, talc, stearic acid, polyethylene glycol, paraffin or selected from a group containing mixtures of these. Preferably Iubrican, magnesium is stearate.
Bulusun bir uygulamasina göre tablet formülasyonu, %21.00 ile %99.00 montelukast stearat içermektedir. According to one embodiment of the invention, the tablet formulation consists of 21.00% to 99.00% montelukast. Contains stearate.
Bu proses sadece harmanlama ve sikistirma islemlerini içerir. Böylece, özellikle hizli üretim açisindan avantaj saglamaktadir. Çünkü daha az birim islem, daha az makine, daha az sayida personel ve çok daha az islem süresi gerektirmesinin yaninda daha fazla ürün stabilitesi sunar. This process includes only blending and compacting. Thus, especially rapid production advantage in terms of Because fewer units of operations, fewer machines, less more staff and much less processing time, as well as more products offers stability.
Mevcut bulusun bir baska uygulamasina göre farmasötik tablet formülasyonu, yas veya kuru granülasyon veya sprey granülasyonu kullanilarak hazirlanabilir. According to another embodiment of the present invention, the pharmaceutical tablet formulation may be wet or dry. It can be prepared using granulation or spray granulation.
Tablet hazirlama prosesi asagidaki adimlardan olusmaktadir; a) montelukast sodyum, rupatadine fumarat, hidroksipropil selüloz (Klucel LF), kroskarmelloz sodyum, prejelatinize nisasta, mikrokristalin selüloz pH 101, Iaktoz monohidrat ekleme ve karistirma b) bu karisima magnezyum stearat ekleme ve 5 dakika daha karistirma c) karisimi tablet olarak basma Ajanlar Agirlikça (%) Montelukast sodyum 21.00 - 99,0 Hidroksipropil selüloz (Klucel LF) 1.00 - 5,00 Kroskarmelloz sodyum 1.00 - 3,00 Prejelatinize nisasta 0.05 - 10.00 Magnezyum stearat 0.01 - 3,00 Örnek 1 için proses Örnek 1'deki tablet formülasyonunu hazirlama prosesi, asagidaki adimlardan olusmaktadir; a. montelukast sodyum, rupatadine fumarat, hidroksipropil selüloz (Klucel kroskarmelloz sodyum, prejelatinize nisasta, mikrokristalin selüloz pH 101, Iaktoz monohidrat ekleme ve karistirma b. bu karisima magnezyum stearat ekleme ve 5 dakika daha karistirma c. karisimi tablet olarak basma The tablet preparation process consists of the following steps; a) montelukast sodium, rupatadine fumarate, hydroxypropyl cellulose (Klucel LF), croscarmellose sodium, pregelatinized starch, microcrystalline cellulose pH 101, Iactose adding and mixing monohydrate b) adding magnesium stearate to this mixture and mixing for another 5 minutes c) pressing the mixture as tablets Agents by Weight (%) Montelukast sodium 21.00 - 99.0 Hydroxypropyl cellulose (Klucel LF) 1.00 - 5.00 Croscarmellose sodium 1.00 - 3.00 Pregelatinized starch 0.05 - 10.00 Magnesium stearate 0.01 - 3.00 Process for Example 1 The process of preparing the tablet formulation in Example 1 consists of the following steps; a. montelukast sodium, rupatadine fumarate, hydroxypropyl cellulose (Klucel croscarmellose sodium, pregelatinized starch, microcrystalline cellulose pH 101, Iactose adding and mixing monohydrate b. adding magnesium stearate to this mixture and mixing for another 5 minutes c. pressing the mix as a tablet
Claims (11)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TR201618525 | 2016-12-14 |
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| Publication Number | Publication Date |
|---|---|
| TR201720395A2 true TR201720395A2 (en) | 2018-06-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TR2017/20395A TR201720395A2 (en) | 2016-12-14 | 2017-12-14 | NEW TABLET FORMULATIONS OF MONTELUKAST SODIUM AND RUPATADINE FUMARATE |
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| TR (1) | TR201720395A2 (en) |
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2017
- 2017-12-14 TR TR2017/20395A patent/TR201720395A2/en unknown
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