TR201410001A2

TR201410001A2 - Pharmaceutical compositions

Info

Publication number: TR201410001A2
Application number: TR2014/10001A
Authority: TR
Inventors: Karaağaç Bülent
Original assignee: Buelent Karaagac
Priority date: 2014-08-26
Filing date: 2014-08-26
Publication date: 2016-03-21

Abstract

Mevcut buluş; dispepsi, flatülans, gastrointestinal radyografi, ultrason görüntüleme, pankreas yetmezliği, biliyer kolik, sindirim enzimi eksikliği, ishal ve/veya kabızlık ile seyreden irritabl kolon sendromu, fonksiyonel sindirim bozuklukları ve sindirim kanalında aşırı gazın yarattığı ağrılı durumların profilaktik ve/veya semptomatik ve/veya terapötik tedavisinde antiflatulan ajan içeren bir etken madde ve/veya farmasötik olarak kabul edilebilir türevlerinin, enzim içeren gastrointestinal özellikteki bir etken madde ve/veya farmasötik olarak kabul edilebilir türevleri ve safra ekstresi içeren bir etken madde ve/veya farmasötik olarak kabul edilebilir türevleri ile kombine tedavisini içeren farmasötik bileşim/ler ile ilgilidir.The present invention includes; dyspepsia, flatulence, gastrointestinal radiography, ultrasound imaging, pancreatic insufficiency, biliary colic, lack of digestive enzyme, irritable colon syndrome with diarrhea and / or constipation, functional digestive disorders and painful conditions caused by excessive gas in the digestive tract and / or symptomatic and / or in combination with an active substance and / or pharmaceutically acceptable derivatives thereof containing an enzyme containing gastrointestinal properties and / or pharmaceutically acceptable derivatives and a bile extract and / or pharmaceutically acceptable derivatives thereof. and pharmaceutical composition (s) containing

Description

TARIFNAME FARMASÖTIK TERKIPLER BULUSUN ILGILI OLDUGU ALAN Mevcut bulus; dispepsi, flatülans, gastrointestinal radyografi, ultrason görüntüleme, pankreas yetmezligi, biliyer kolik, sindirim enzimi eksikligi, ishal ve/veya kabizlik ile seyreden irritabl kolon sendromu, fonksiyonel sindirim bozukluklari ve sindirim kanalinda asiri gazin yarattigi agrili durumlarin profilaktik ve/veya semptomatik ve/veya terapötik tedavisinde antiflatulan ajan içeren bir etkeii madde ve/veya farmasötik olarak kabul edilebilir türevlerinin, enzim içeren gastrointestinal özellikteki bir etken madde ve/veya farmasötik olarak kabul edilebilir türevleri ve safra ekstresi içeren bir etken madde ve/veya farmasötik olarak kabul edilebilir türevleri ile kombine tedavisini içeren farmasötik bilesim/ler ile ilgilidir. DESCRIPTION PHARMACEUTICAL COMPOSITIONS FIELD OF THE INVENTION The present invention; dyspepsia, flatulence, gastrointestinal radiography, ultrasound imaging, pancreas insufficiency, biliary colic, digestive enzyme deficiency, irritable with diarrhea and/or constipation colon syndrome, functional digestive disorders and excessive gas in the digestive tract Antiflatulent in the prophylactic and/or symptomatic and/or therapeutic treatment of painful conditions an active substance and/or pharmaceutically acceptable derivatives containing the a gastrointestinal active ingredient and/or pharmaceutically acceptable derivatives and an active ingredient containing bile extract and/or pharmaceutically acceptable relates to pharmaceutical composition(s) comprising combination therapy with its derivatives.

Mevcut bulus; antiflatulan ajanin simetikon, poli(dimetilsiloksan) (Formül I) ve/veya farmasötik olarak kabul edilebilir türevleri; gastrointestinal özellikteki pankreatin; proteaz, lipaz ve amilaz aktivitesine sahip enzimleri içeren memeli pankreas preperati ve/veya farmasötik olarak kabul edilebilir türevleri ve safra ekstresi içeren aktif madde, sigir safra ekstresi ve/veya farmasötik olarak kabul edilebilir türevlerinin oldugu ve uygun farmasötik formlarda etken maddeler olarak kombinasyon halinde kullanildigi farmasötik bilesimler ile Formül 1: Ayrica bulus, simetikon ve/Veya farmasötik olarak kabul edilebilir türevleri, pankreatin ve/veya farmasötik olarak kabul edilebilir türevleri ve sigir safra ekstresi ve/veya farmasötik olarak kabul edilebilir türevlerinin kombinasyon halinde kullanildigi farmasötik bilesimlerin oral uygulama için uygun olan formülasyonlarini ve profilaktik ve/veya semptomatik ve/veya terapötik kullanimlarini da kapsamaktadir. ÖNCEKI TEKNIK (TEKNIGIN BILINEN DURUMU) Irritabl barsak sendromu (IBS) bilinen bir organik sebebi olmayan, stres veya emosyonel gerilimin yüksek düzeyde oldugu dönemlerde ortaya çikan veya artan bir barsak hastaligidir. The present invention; simethicone, poly(dimethylsiloxane) (Formula I) and/or pharmaceutically acceptable derivatives; pancreatin of gastrointestinal nature; protease, mammalian pancreatic preparation containing enzymes with lipase and amylase activity and/or active ingredient containing pharmaceutically acceptable derivatives and bile extract, bovine bile extract and/or pharmaceutically acceptable derivatives and suitable pharmaceutical with pharmaceutical compositions where it is used in combination as active ingredients in forms Formula 1: In addition, the invention includes simethicone and/or pharmaceutically acceptable derivatives, pancreatin and/or pharmaceutically acceptable derivatives and bovine bile extract and/or pharmaceutical pharmaceutical compositions in which acceptable derivatives are used in combination formulations suitable for oral administration and prophylactic and/or symptomatic and/or It also includes therapeutic uses. PRIOR ART (KNOWN STATE OF THE ART) Irritable bowel syndrome (IBS) with no known organic cause, stress or emotional It is an intestinal disease that occurs or increases during periods of high tension.

Barsagin yapisinda bir bozukluk olmamasina ragmen, isleyisi aksamistir. Although there is no disorder in the structure of the intestine, its functioning is disrupted.

Kalin barsakta düzensiz, hareketler söz konusudur. Çok siddetli kasilmalarin yaninda bazen de barsak hareketlerinde yavaslama olabilir. Bütün bu degisiklikler diskilama düzeninin bozulmasina ve karin agrisina neden olur. IBS; barsak aliskanliklarindaki degisiklik, geçmeyen veya tekrarlayan ishal, kabizlik veya her ikisinin birden, birbirinin pesi sira gelmesi seklinde de olabilir. There are irregular movements in the large intestine. In addition to very severe contractions, sometimes There may also be slowing of bowel movements. All these changes are in the disk layout. causes deterioration and abdominal pain. IBS; change in bowel habits, successive or persistent diarrhea, constipation, or both It can also be in the form.

Irritabl barsak sendromu (IBS); karin agrisi, barsak islevinde degisiklikler (barsak frekansi ve/veya kabizlik), siskinlik, karin sisligi, eksik bosaltim hissi de dahil olinak üzere abdominal semptomlarin çesitli konsorsiyumu ile karakterize fonksiyonel barsak bozukluklari Dünya nüfusunun yaklasik %l2'sini etkileyen en yaygin gastroenteroloji uygulamalarinda multifaktöryel bir hastaliktir (Halvorson ve arkadaslari, 2006; Mertz, 2003). Son yillarda akut gastroenteritin, irritabl barsak sendromu gelisiminde kritik bir rol oynadigi kabul edilmistir Görülme sikligi kadinlarda erkeklere göre bir kat daha fazladir. 20 ile 50 yaslari arasinda sik rastlaninakla birlikte, çocuklarda da görülebilir. 50 yasin üzerinde ise oldukça nadir görülür. irritable bowel syndrome (IBS); abdominal pain, changes in bowel function (bowel frequency and/or constipation), bloating, abdominal distension, abdominal functional bowel disorders characterized by a diverse consortium of symptoms It is the most common gastroenterology practice affecting approximately 12% of the world's population. it is a multifactorial disease (Halvorson et al., 2006; Mertz, 2003). In recent years, acute gastroenteritis has been considered to play a critical role in the development of irritable bowel syndrome. Its incidence is one times higher in women than in men. Frequent between the ages of 20 and 50 Although it is common, it can also be seen in children. It is very rare if you are over 50 years old.

Cinsiyet, yas, duygusal sorunlar ve stres, besinlere karsi hassasiyet, bazi hastaliklar ve ilaçlar hastaligin sikligini etkiler. Gender, age, emotional problems and stress, food sensitivities, certain diseases and medications affect the frequency of the disease.

Yapilan çalismalar göstermistir ki, irritabl barsak sendromu olan hastalarin yaklasik üçte birinin semptomlari akut enterik enfeksiyon sonrasinda baslamis (Gwee ve arkadaslari, 1999; McKendrick ve Read, 1994; Neal ve arkadaslari, 2002) ve bu tür hastalarin yeni bir postinfeksiyöz irritabl barsak sendromunun alt tipi olarak kabul edilmistir (Gwee ve IBS sürekli veya yineleyici karin agrisi ya da karinda rahatsizlik hissi ile barsak aliskanligindaki degiskenlik, hastanin defekasyon ile rahatlamasi ve yakinmalari organik yönden açiklayacak fiziksel veya laboratuar bulgularinin olmayisi ile karakterizedir. Studies have shown that approximately one-third of patients with irritable bowel syndrome symptoms of one started after acute enteric infection (Gwee et al., 1999; McKendrick and Read, 1994; Neal et al., 2002) and a new study of such patients. It has been accepted as a subtype of postinfectious irritable bowel syndrome (Gwee et al. IBS with persistent or recurrent abdominal pain or discomfort in the bowel The variability in the habit, the relief of the patient with defecation, and the complaints are organic It is characterized by the absence of physical or laboratory findings to explain

Fonksiyonel barsak hastaliklarinin kaynagi bilinmemektedir. Henüz spesifik bir tedavi yoktur. The origin of functional bowel diseases is unknown. There is no specific treatment yet.

Terapotik yaklasim; agriya yönelik (antispazmodik ilaçlar), antidepresanlar, konstipasyona yönelik (laksatifler), diyareye yönelik (anti-diyareik ilaçlar), gaz sikayeti-siskinlige yönelik (antispazmodik ilaçlar) tedavileri içine alir (Klein KB., 1988; Guthrie E, ve ark., 1991; Whorwell PJ, ve ark., 1984). therapeutic approach; for pain (antispasmodic drugs), antidepressants, constipation directed (laxatives), anti-diarrheal (anti-diarrheic drugs), flatulence-for bloating (antispasmodic drugs) treatments (Klein KB., 1988; Guthrie E, et al., 1991; Whorwell PJ, et al., 1984).

Pankreatin oral yoldan kullanilan gastrointestinal bir ilaçtir. Protein, nisasta ve yaglari sindirine yetenegine sahip lipaz, amilaz ve proteaz enzimlerini içerir. Pankreatin, pankreatik enzimlerin eksikliginde destek amaçli olarak veya kistik fibrozis, kronik pankreatit, pankreatektomi, gastrointestinal by-pass cerrahisi ya da neoplazma bagli kanal tikaninasi olgularinda görülen pankreas enzimlerinin eksikliginde kullanilir. Pancreatin is an orally administered gastrointestinal drug. Protein, starch and fats It contains lipase, amylase and protease enzymes with digestive ability. pancreatin, pancreatic for support purposes in the deficiency of enzymes or cystic fibrosis, chronic pancreatitis, duct obstruction due to pancreatectomy, gastrointestinal bypass surgery or neoplasm It is used in cases of pancreatic enzymes deficiency.

Pankreatin sindirim enziinlerinin bir kombinasyonudur. Bu enzimler normal olarak pankreas tarafindan üretilirler ve yaglarin, proteinlerin ve sekerlerin sindiriminde önemlidirler. It is a combination of pancreatin digestive enzymes. These enzymes are normally They are produced by bacteria and are important in the digestion of fats, proteins and sugars.

Pankreatin ekstra sindirim enzimi temin etmek suretiyle çalisir ki bu da sindirimi gelistirir. Pancreatin works by providing extra digestive enzymes, which improves digestion.

Simetikon ise gaz giderici etki gösterir. Simethicone has a carminative effect.

Pankreatin, pankreas kendi basina yeterli üretim yapmadigi zaman sindirim enzimlerinin yerine konmasi için kullanilir. Kistik fibröz, kronik pankreas iltihaplanmasi, pankreas kanseri veya pankreas ameliyati gibi belirli tibbi durumlar bu enzimlerin yokluguna yol açabilirler. Pancreatin is a function of digestive enzymes when the pancreas does not produce enough on its own. used for replacement. Cystic fibrosis, chronic pancreatic inflammation, pancreatic cancer or certain medical conditions, such as pancreatic surgery, can lead to the absence of these enzymes.

Simetikon, fizyolojik olarak inert bir maddedir. Oral yolla alindiktan sonra herhangi bir inetabolizasyona ugramadan diskiyla atilir. Simethicone is a physiologically inert substance. After oral administration, any It is excreted with the stool without undergoing inetabolization.

Simetikon, aktive edilmis dimetikon olup, güçlü gaz giderici özellige sahiptir. Gastrointestinal sistemdeki gaz kabarciklarinin yüzey gerilimlerini degistirerek, onlarin bir araya gelmesini ve ûzyoloj ik yollardan kolayca atilmalarini saglar. Simethicone is activated dimethicone and has strong carminative properties. gastrointestinal by changing the surface tension of the gas bubbles in the system, bringing them together and It allows them to be easily excreted through physiological pathways.

Simetikon, kimyasal olarak polidimetilsiloksan ve silikon dioksit karisimidir. Çok düsük yüzey gerilimi olan hidrofobik bir türevdir. Bütün sindirim kanali yolu boyunca mukoza üzerinde örtücü bir film tabakasi olusturur. Ayni zamanda köpük karsiti ve islanma karsiti etkileri ile gaz distansiyonunu azaltir. Simetikon gastrointestinal sistemden emilime ugramamaktadir, fiziksel özellikleriyle etki göstermektedir. Sivilarin yüzey gerilimini azaltarak, hava kabarcigi olusumunu ve köpügün içerisine gazin girmesini engelleinektedir. Simethicone is a chemical mixture of polydimethylsiloxane and silicon dioxide. Very low It is a hydrophobic derivative with surface tension. Mucosa throughout the entire gastrointestinal tract It forms a covering film on it. Also anti-foam and anti-wetting reduces gas distention. Simethicone is not absorbed from the gastrointestinal tract. It cannot be affected by its physical properties. Surface tension of liquids It prevents the formation of air bubbles and the entry of gas into the foam.

Ayni zamanda köpük içerisinden gazin kaçisini kolaylastirmaktadir (Brecevic L. ve ark, 1994). Mukus içerisine girmis gaz baloncuklarini birlestirip toplar ve böylece gazin fizyolojik yollardan (gegirrne, yellenme gibi) kolay atilmasini saglar (Oyar O. ve ark, 2000). Belli bir sürede daha fazla hacimde gaz uzaklastirilmis olur. Simetikon, gazlarin barsaktan geçis süresini hizlandirmaktadir. At the same time, it facilitates the escape of gas through the foam (Brecevic L. et al. 1994). It combines and collects the gas bubbles that have entered the mucus, and thus the physiological it allows easy removal from the roads (such as belching, winding) (Oyar O. et al, 2000). a certain More volume of gas is removed in time. Simethicone, the passage of gases from the intestine speeds up time.

Safra asitlerinin koleretik etkisi vardir ve oral yoldan verildiklerinde safra salgisini arttirirlar. Bile acids have a choleretic effect and increase bile secretion when administered orally.

Safra tuzlari koleretik etki göstennezler. Sigir safrasi ekstresinin ihtiva ettigi safra tuzlari, yaglari emülzifiye ederek, hidrolize olmalarini kolaylastirir. Gastrointestinal kanalda safra eksikligine bagli, yagda çözünür vitaminlerin absorbsiyonunun güçlestigi durumlarda absorbsiyona yardimci olarak kullanilirlar. olarak simetikonun kullanilabildigi bir bilesim uygulanarak karbonhidrat emiliminin arttirilmasi yoluyla irritabl barsak sendromunun tedavisine iliskin bir yöntemden bahsedilinektedir. simetikonun yer aldigi uygun polidimetilsiloksan örneklerinden bahsedilmistir. Bile salts do not show a choleretic effect. Bile salts contained in bovine bile extract, By emulsifying oils, it facilitates their hydrolysis. Bile in the gastrointestinal tract In cases where the absorption of fat-soluble vitamins becomes difficult due to a deficiency They are used to aid absorption. carbohydrate absorption by applying a composition in which simethicone can be used as from a method of treating irritable bowel syndrome by increasing is mentioned. Examples of suitable polydimethylsiloxane containing simethicone are mentioned.

BULUSUN AÇIKLAMASI Mevcut bulus; dispepsi, flatülans, gastrointestinal radyografi, ultrason görüntüleme, pankreas yetmezligi, biliyer kolik, sindirim enzimi eksikligi, ishal ve/veya kabizlik ile seyreden irritabl kolon sendromu, fonksiyonel sindirim bozukluklari ve sindirim kanalinda asiri gazin yarattigi agrili durumlarin profilaktik ve/veya semptomatik ve/veya terapötik tedavisinde antiflatulan ajan içeren bir etken inadde ve/veya farmasötik olarak kabul edilebilir türevlerinin, enzim içeren gastrointestinal özellikteki bir etken madde ve/veya farmasötik olarak kabul edilebilir türevleri ve safra ekstresi içeren bir etken madde ve/veya farmasötik olarak kabul edilebilir türevleri ile kombine tedavisini içeren farmasötik bilesim/ler ile ilgilidir. DESCRIPTION OF THE INVENTION The present invention; dyspepsia, flatulence, gastrointestinal radiography, ultrasound imaging, pancreas insufficiency, biliary colic, digestive enzyme deficiency, irritable with diarrhea and/or constipation colon syndrome, functional digestive disorders and excessive gas in the digestive tract Antiflatulent in the prophylactic and/or symptomatic and/or therapeutic treatment of painful conditions an active ingredient and/or pharmaceutically acceptable derivatives containing the agent, enzyme a gastrointestinal active ingredient and/or pharmaceutically acceptable derivatives and an active ingredient containing bile extract and/or pharmaceutically acceptable relates to pharmaceutical composition(s) comprising combination therapy with its derivatives.

Mevcut bulusun bir diger yönü oral kullanilmak üzere antitlatulan ajan içeren bir etken madde ve/veya farmasötik olarak kabul edilebilir türevleri ile enzim içeren gastrointestinal özellikteki bir etken madde ve/veya farmasötik olarak kabul edilebilir türevleri ve safra ekstresi içeren bir etken madde ve/veya farinasötik olarak kabul edilebilir türevlerini ve faimasötik olarak uygun yardimci maddeleri içeren farmasötik bilesim/lerin hazirlanmasi ile Bulusta antiflatulan ajan içeren uygun etken madde; Simetikon (Poli(dimetilsil0ksan)), balmumu, kandelila mumu, karbauba mumu, selak, parafinler, mineral yagi, vazelin, mikrokristalin mumu, sakiz benzoik, kristalin mumu, pirinç kepegi mumu ve/veya farmasötik olarak kabul edilebilir türevleri arasindan tercihen Simetikon olarak seçilir. Another aspect of the present invention is an active ingredient containing an antitylated agent for oral use. and/or pharmaceutically acceptable derivatives and enzymes containing gastrointestinal an active substance and/or its pharmaceutically acceptable derivatives and bile an active ingredient containing the extract and/or pharmaceutically acceptable derivatives and by the preparation of pharmaceutical composition(s) containing pharmaceutically acceptable excipients. In the invention, a suitable active ingredient containing an antiflatulent agent is; Simethicone (Poly(dimethylsiloxane)), beeswax, candelila wax, carbauba wax, selak, paraffins, mineral oil, petroleum jelly, microcrystalline wax, gum benzoic, crystalline wax, rice bran wax and/or pharmaceutical preferably selected as Simethicone among its acceptable derivatives.

Bulusta enzim içeren gastrointestinal özellikteki uygun etkeii madde; diastaz, pankreatin, pankrelipaz, pepsin ve/Veya farmasötik olarak kabul edilebilir türevleri arasindan terciheii Pankreatin olarak seçilir. In the invention, suitable active substance with gastrointestinal properties containing enzymes; diastase, pancreatin, Preferred among pancrelipase, pepsin and/or pharmaceutically acceptable derivatives It is selected as pancreatin.

Bulusta safra ekstresi içeren uygun etken madde; safra asidi (kenodeoksikolik asit, kolik asit, ursodeoksikolik asit), sigir safra ekstresi (ox-bile), obetikolik asit, nikotinil metilamit, piprozolin, himekromon, siklobütirol ve/veya farmasötik olarak kabul edilebilir türevleri arasindan tercihen Sigir Safra Ekstresi (ox-bile) olarak seçilir. In the invention, suitable active ingredient containing bile extract; bile acid (chenodeoxycholic acid, cholic acid, ursodeoxycholic acid), bovine bile extract (ox-bile), obeticholic acid, nicotinyl methylamide, piprozoline, hymecromon, cyclobutyrol and/or pharmaceutically acceptable derivatives It is preferably chosen as Bovine Bile Extract (ox- even).

Bulusta “farmasötik olarak kabul edilebilir türevleri” terimi ile farmasötik olarak kabul edilebilir uygun tuzlar, esterler, solvatlar, hidratlar, kompleksler, polimorflar, enantiyomerler, Önilaçlar, asit adisyon tuzlari, analoglar, izomerler, rasematlar, amidler, enantiyomer tuzlari, bazik tuzlar, konjugeler, tautoinerler, anhidratlar, anhidritler, bazlar, asitler, eterler, kristal ve amorf formlar veya serbest formlarindan bir veya daha fazlasi ifade edilmektedir. In the invention, the term "pharmaceutically acceptable derivatives" is defined as pharmaceutically acceptable. Suitable salts, esters, solvates, hydrates, complexes, polymorphs, enantiomers, Prodrugs, acid addition salts, analogs, isomers, racemates, amides, enantiomer salts, basic salts, conjugates, tautoiners, anhydrates, anhydrides, bases, acids, ethers, crystal and amorphous forms or one or more of their free forms are meant.

Oral uygulama için hazirlanan fanriasötik bilesim/ler kati ya da sivi dozaj formlarinda olabilir. Bu dozaj formlari; tablet (çignenebilir tablet, agizda çözünen tablet, dagilabilen tablet, suda dagilabilen tablet, film kapli tablet, barsakta açilan kaplamali (enterik) tablet, mini tablet, kontrollü salimli tablet (sürekli salimli tablet, hemen salimli tablet, uzatilmis salimli tablet, degistirilmis salimli tablet Vb.), kapsül (sert, yumusak, enterik kapli, film kapli), kontrollü salimli kapsül (sürekli salimli kapsül, hemen salimli kapsül, uzatilmis salimli kapsül, geciktirilmis salimli kapsül), toz, granül, kaplet, disk, agizda çözünen film, yigin toz (çok dozlu), pellet, sase, suda dagilabilen toz, suda dagilabilen granül, efervesan tablet, efervesan granül, efervesan toz, jelül, pilül, surup, solüsyon, süspansiyon, eliksir, damla, posyon, emülsiyon veya sprey gibi bir dozaj sekli halinde formüle edilebilir. Pharmaceutical composition(s) prepared for oral administration in solid or liquid dosage forms it could be. These dosage forms are; tablet (chewable tablet, mouth soluble tablet, dispersible tablet, dispersible tablet, film-coated tablet, coated (enteric) tablet that opens in the intestine, mini tablet, controlled-release tablet (sustained-release tablet, immediate-release tablet, extended-release tablet tablet, modified-release tablet Etc.), capsule (hard, soft, enteric-coated, film-coated), controlled-release capsule (sustained-release capsule, immediate-release capsule, extended-release capsule capsule, delayed-release capsule), powder, granule, caplet, disc, oral film, bulk powder (multi-dose), pellet, sachet, water-dispersible powder, water-dispersible granule, effervescent tablet, effervescent granule, effervescent powder, gel, pill, syrup, solution, suspension, elixir, drops, may be formulated in a dosage form, such as a post, emulsion, or spray.

Bulusta kullanilan oral farmasötik bilesim, uygun etken madde/ler yaninda en az bir seyreltici madde, en az bir glidant, en az bir dagitici madde, en az bir baglayici madde, en az bir granülasyon sivisi, en az bir lubrikant, en az bir ara kaplama ajani, en az bir enterik kaplama ajani, en az bir film kaplama ajani, çözücünün ve gerekli görüldügü durumlarda nisasta hidrolize eden enzimin de dahil oldugu gruptan seçilen bir veya daha fazla yardimci madde içerebilen bir bilesimi tanimlar. The oral pharmaceutical composition used in the invention must contain at least one diluent in addition to the appropriate active ingredient(s). substance, at least one glidant, at least one dispersant, at least one binder, at least one granulation fluid, at least one lubricant, at least one intermediate coating agent, at least one enteric coating agent, at least one film coating agent, solvent and, if necessary, starch one or more excipients selected from the group consisting of hydrolyzing enzyme Defines a composition that can contain

Bulusta “seyreltici madde” terimi; tablet ya da kapsüllerin üretim için pratik, hasta kullanimina uygun büyüklükte olmasi için kullanilan madde veya madde karisimlari olarak ifade edilmektedir. Seyreltici madde olarak; laktoz, sukroz, dekstrin, maiiiiitol, laktilol, sakkaroz, ksilitol, sorbitol, izomalt, inikrokristalin selüloz, dekstroz, dekstrat, prejelatinize nisasta, modifiye nisasta, misir nisastasi, laktoz anhidröz, laktoz monohidrat, dibazik kalsiyum fosfat, hidroksi propil metilselüloz, tribazik kalsiyum fosfat, polihidrik alkoller veya selüloz eterleri, kalsiyum hidrojen fosfat anhidröz, kalsiyum sülfat trihidrat, kalsiyum sülfat dihidrat, kalsiyum karboiiat, kaolin, sodyum hidroksit, modifiye silikon dioksit veya bunlarin karisimlari kullanilabilir. Bulusta tercihen laktoz monohidrat, mikrokristalin selüloz ve modifiye modifiye silikon dioksit kullanilmaktadir. Bulusta kullanilan seyreltici madde miktari %0.01-60 tercihen %0. 1-50 agirlik oranindadir. The term "diluent" in the invention; practical, patient for the production of tablets or capsules as a substance or a mixture of substances used to be in a suitable size for its use is expressed. As a diluent; lactose, sucrose, dextrin, maiiiiitol, lactilol, sucrose, xylitol, sorbitol, isomalt, incrocrystalline cellulose, dextrose, dextrate, pregelatinized starch, modified starch, corn starch, lactose anhydrous, lactose monohydrate, dibasic calcium phosphate, hydroxy propyl methylcellulose, tribasic calcium phosphate, polyhydric alcohols or cellulose ethers, calcium hydrogen phosphate anhydrous, calcium sulfate trihydrate, calcium sulfate dihydrate, calcium carbonate, kaolin, sodium hydroxide, modified silicon dioxide or their mixes can be used. Preferably, lactose monohydrate, microcrystalline cellulose and modified modified silicon dioxide is used. The diluent used in the invention the amount is 0.01-60%, preferably 0%. It is in the weight ratio of 1-50.

Bulusta “glidant” terimi; tablet basimi aninda matris bosluguna materyalin akisini kolaylastiran ekstra küçük partiküllü, dansitesi düsük madde olarak ifade edilmektedir. The term "glidant" in the invention; Tablet pressing immediately allows the flow of material into the matrix space. It is expressed as a substance with extra small particles and low density that facilitates it.

Glidant olarak; talk, magnezyum stearat, hidrojene nebati yag, kalsiyum stearat, stearik asit, kolloidal silikon dioksit, silika, silikon dioksit, kolloidal anhidrus silika, polietilenglikol, selüloz türevleri, nisasta, modifiye silikon dioksit veya bunlarin karisimlari kullanilabilir. As a glidant; talc, magnesium stearate, hydrogenated vegetable oil, calcium stearate, stearic acid, colloidal silicon dioxide, silica, silicon dioxide, colloidal anhydrous silica, polyethyleneglycol, cellulose derivatives, starch, modified silicon dioxide or their mixtures can be used.

Bulusta tercihen modifiye silikon dioksit ve silikon dioksit (enterik kaplama içerisinde) kullanilmaktadir. Bulusta kullanilan glidant miktari %0.01-10 agirlik oranindadir. In the invention preferably modified silicon dioxide and silicon dioxide (in enteric coating) is used. The amount of glidant used in the invention is 0.01-10% by weight.

Bulusta “dagitici madde” terimi, parçaciklarin ayrilmasini kolaylastiran ve topaklaninasini engelleyen bir madde olarak ifade edilmektedir. Dagitici madde olarak; agar agar, kalsiyum karbonat, sodyum karbonat, aljinik asit, nisasta, mikrokristalin selüloz, prejelatinize nisasta çapraz-bagli polivinil pirolidon, misir nisastasi, sodyum aljinat, hidroksipropil selüloz, kroskarmelloz sodyum, kil, iyon degistirici reçine, krospovidon, kolloidal silikon dioksit, sodyum nisasta glikolat veya bunlarin karisimlari kullanilabilir. Bulusta tercihen kroskarmelloz sodyum ve misir nisastasi kullanilmaktadir. Bulusta kullanilan dagitici madde miktari %0. l-20 agirlik oranindadir. In the invention, the term "dispersant" means that which facilitates the separation of particles and does not clump together. referred to as an inhibitor. As a dispersant; agar agar, calcium baking soda, sodium carbonate, alginic acid, starch, microcrystalline cellulose, pregelatinized starch cross-linked polyvinyl pyrrolidone, corn starch, sodium alginate, hydroxypropyl cellulose, croscarmellose sodium, clay, ion exchange resin, crospovidone, colloidal silicon dioxide, sodium starch glycolate or their mixtures can be used. preferably in the invention croscarmellose sodium and corn starch are used. The dispersant used in the invention amount of 0%. It is in the weight ratio of l-20.

Bulusta “baglayici madde” terimi, tablet içerigindeki maddeleri bir arada tutmak, tablet ve granüllerin gerekli olan mekanik güçte formüle edilmesini saglamak ve düsük aktif dozaj tabletlerine hacim vermek için kullanilan madde veya madde karisimlari olarak ifade edilmektedir. Baglayici madde olarak; prejelatinize nisasta, sodyum nisasta glikolat, kroskannelloz sodyum, hidroksi propil selüloz, hidroksi propil metil selüloz, metilselüloz, etilselüloz, mikrokristalin selüloz, sodyum karboksi metilselüloz, dekstrin, polivinilpirolidon, al jinik asit, aljinat, jelatin, glukoz, zamklar, nisasta, povidon, krospovidon, guar gum, sukroz veya bunlarin karisimlari kullanilabilir. Bulusta tercihen povidon kullanilmaktadir. Bulusta kullanilan baglayici madde miktari %0.1-15 tercihen %1-10 agirlik oranindadir. In the invention, the term "binding agent" is used to keep the ingredients in the tablet together, to keep the tablet and ensuring that the granules are formulated with the required mechanical strength and low active dosage. expressed as substances or mixtures of substances used to give bulk to tablets is being done. As a binding agent; pregelatinized starch, sodium starch glycolate, croscannellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose, methylcellulose, ethylcellulose, microcrystalline cellulose, sodium carboxy methylcellulose, dextrin, polyvinylpyrrolidone, alginic acid, alginate, gelatin, glucose, gums, starch, povidone, crospovidone, guar gum, sucrose or mixtures of these can be used. Povidone is preferably used in the invention. in the find The amount of binder used is 0.1-15%, preferably 1-10% by weight.

Bulusta, granülasyon sivisi olarak saflastirilmis su, etil alkol, metil alkol, isopropil alkol, butil alkol gibi alkoller, metilen klorür veya bunlarin karisimlari kullanilabilir. Bulusta tercihen satlastirilmis su kullanilmaktadir. In the invention, purified water, ethyl alcohol, methyl alcohol, isopropyl alcohol, butyl as granulation liquid Alcohols such as alcohol, methylene chloride or mixtures thereof may be used. preferably in the invention purified water is used.

Bulusta “lubrikant” sürtünmeyi azaltan veya engelleyen bir toz karisiminin akis özelliklerini iyilestiren ajan veya ajan karisimlarini belirtmektedir. Lubrikant olarak; talk, kalsiyum stearat, magnezyum stearat, kati polietilen glikol, tristearin, sodyum lauril sülfat, koloidal silikon dioksit, stearik asit, sodyum stearil fumarat, oleik asit, tripalmitil, potasyum oleat, kaprilik asit, gliseril palmitostearat, sodyum benzoat, çinko stearat, çinko oleat, çinko palmitat veya bunlarin karisimlari kullanilabilir. Bulusta tercihen magnezyum stearat kullanilmaktadir. In the invention, the "lubricant" reduces or inhibits the flow properties of a powder mixture. denotes ameliorating agent or agent mixtures. As a lubricant; talc, calcium stearate, magnesium stearate, solid polyethylene glycol, tristearin, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, sodium stearyl fumarate, oleic acid, tripalmityl, potassium oleate, caprylic acid, glyceryl palmitostearate, sodium benzoate, zinc stearate, zinc oleate, zinc palmitate or mixtures of these can be used. Preferably, magnesium stearate is used in the invention.

Bulusta kullanilan lubrikant miktari %0.01-IO tercihen %0.l-5 agirlik oranindadir. The amount of lubricant used in the invention is 0.01%-IO preferably 0.1-5% by weight.

Bulusta “ara/seal kaplama” terimi etken maddelerin bozuninasini önlemek, çekirdek kisim ile ana kaplama arasindaki etkilesimleri ve geçimsizlikleri ortadan kaldirinak için kullanilan madde veya madde karisimlari olarak ifade edilir. Bulusta kullanilan ara/sea] kaplama agirligi 1-30 mg olup toplam tablet agirliginin %0.1-10 oranindadir. In the invention, the term "intermediate/seal coating" is to prevent the degradation of the active ingredients, used to eliminate interactions and incompatibilities between the main coating expressed as substances or mixtures of substances. Intermediate/sea] coating weight used in the invention It is 1-30 mg and is 0.1-10% of the total tablet weight.

Bulusta kullanilan ara/seal kaplama; en az bir film Olusturucu ajan, en az bir plastifiyan, en az bir yapisma önleyici ajan ve en az bir kaplama çözücüsü de dahil oldugu gruptan seçilen bir veya daha fazla yardimci madde içerebilen bir bilesimi tanimlar. Intermediate/seal coating used in the invention; at least one film-forming agent, at least one plasticizer, at least an anti-adhesive agent and at least one coating solvent. describes a composition that may contain one or more excipients.

Bulusta “enterik kaplama” terimi fonnülasyonun stabilitesini arttirmak, asit kaynakli bozunmalari önlemek için kullanilan madde veya madde karisimlari olarak ifade edilir. Bu enterik kaplamalar ayrismaya baslamadan önce mide asidine direnç göstermekte ve ayni zamanda midenin alt kisminda veya ince bagirsagm üst kisminda yavas bir ilaç salinimini saglamaktadir. Bulusta kullanilan enterik kaplama agirligi l-150 mg olup toplam tablet agirliginin %1-20,si ve tercihen %1-15,i oranindadir. In the invention, the term "enteric coating" is used to increase the stability of the formulation, It is expressed as the substance or mixture of substances used to prevent decomposition. This enteric coatings resist stomach acid before they begin to decompose and It also causes a slow drug release in the lower part of the stomach or the upper part of the small intestine. it provides. The enteric coating weight used in the invention is 1-150 mg and the total tablet weight is 1-20%, preferably 1-15%, by weight.

Bulusta kullanilan enterik kaplama; en az bir film olusturucu ajan, en az bir plastifiyan, en az bir opaklastirici madde, en az bir yapisma önleyici ajan, en az bir glidant ve en az bir kaplama çözücünün de dahil oldugu gruptan seçilen bir veya daha fazla yardimci madde içerebilen bir bilesimi tanimlar. Enteric coating used in the invention; at least one film-forming agent, at least one plasticizer, at least an opacifying agent, at least one anti-adhesive agent, at least one glidant, and at least one coating which may contain one or more excipients selected from the group consisting of the solvent. defines the composition.

Bulusta “film kaplama ajani” terimi tablet içerigini havadaki nem tarafindan bozunmaya karsi korumak ve tadi hos olmayan tabletleri yutma kolayligi saglamak için kullanilan madde veya madde karisimlari olarak ifade edilir. Bulusta kullanilan film kaplama ajani agirligi 1-50mg olup toplam tablet agirliginin %0. l -107u oranindadir. In the invention, the term "film coating agent" protects the tablet content against degradation by moisture in the air. substance or substance used to preserve unpleasant taste and facilitate swallowing expressed as substance mixtures. The weight of the film coating agent used in the invention is 1-50mg and 0% of the total tablet weight. l is in the ratio of -107u.

Bulusta kullanilan film kaplama ajani; en az bir film olusturucu ajan, en az bir plastifiyan, en az bir tatlandirici madde, en az bir opaklastirici madde, en az bir yapisma önleyici ajan ve en az bir kaplama çözücünün de dahil oldugu gruptan seçilen bir veya daha fazla yardimci madde içerebilen bir bilesimi tanimlar. The film coating agent used in the invention; at least one film-forming agent, at least one plasticizer, at least one at least one sweetening agent, at least one opacifying agent, at least one anti-adhesive agent and at least one one or more auxiliary agents selected from the group consisting of at least one coating solvent defines a composition that can contain a substance.

Bulusta “film olusturucu ajan” terimi, bir baglayicinin bir film, örnegin ince tabaka veya örtü olusturmak için gerekli komponentler olarak ifade edilmektedir. Film olusturucu ajan olarak; polivinil alkol, metil selüloz, etil selüloz, hidroksipropil selüloz, hidroksietil selüloz, hidroksipropil metil selüloz, metakrilik asit kopolimeri, polietilen glikol, polietilen oksit, jelatin veya bunlarin karisimlari kullanilabilir. Bulusta tercihen hidroksipropil metil selüloz (film kaplama ve ara/sea] kaplama içerisinde) ve metakrilik asit kopolimeri (enterik kaplama içerisinde) kullanilmaktadir. Bulusta kullanilan film olusturucu ajan miktari %0.l-10 agirlik oranindadir. In the invention, the term "film-forming agent" refers to the use of a binder as a film, eg film or film. It is expressed as the necessary components to create it. As a film forming agent; polyvinyl alcohol, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, methacrylic acid copolymer, polyethylene glycol, polyethylene oxide, gelatin or mixtures of these can be used. In the invention preferably hydroxypropyl methyl cellulose (in film coating and intermediate/sea] coating) and methacrylic acid copolymer (enteric coating in) are used. The amount of film forming agent used in the invention is 0.1-10% by weight. is in the ratio.

Bulusta plastifiyan olarak; polietilen glikol, gliserin, propilen glikol, asetil sitrat, amil oleat, miristil asetat, butil oleat, butil stearat, triasetin, dietilftalat, dibutilftalat, asetillenmis monogliseridler, trietil sitrat veya bunlarin karisimlari kullanilabilir. Bulusta tercihen polietilen glikol (film kaplama ve ara/sea] kaplama içerisinde) ve trietil sitrat (enterik kaplama içerisinde) kullanilmaktadir. Bulusta kullanilan plastifiyan miktari %0.01-5 agirlik oranindadir. As a plasticizer in the invention; polyethylene glycol, glycerin, propylene glycol, acetyl citrate, amyl oleate, myristyl acetate, butyl oleate, butyl stearate, triacetin, diethylphthalate, dibutylphthalate, acetylated monoglycerides, triethyl citrate or mixtures thereof can be used. preferably in the invention polyethylene glycol (in film coating and intermediate/sea] coating) and triethyl citrate (in enteric coating) in) are used. The amount of plasticizer used in the invention is 0.01-5% by weight. is in the ratio.

Bulusta “yapisma önleyici ajan” terimi; kaplama sirasinda pelletlerin birbirine yapismasini, topaklanmasini ya da proses ekipmanlarina tutunmasini önlemek için kullanilan madde veya madde karisimlari olarak ifade edilir. Yapisma önleyici ajan olarak; talk, kolloidal silikon dioksit, magnezyum silikat veya bunlarin karisimlari kullanilabilir. Bulusta tercihen yapisma önleyici ajan olarak talk kullanilmaktadir. Bulusta kullanilan yapisma önleyici ajan miktari Bulusta opaklastirici madde olarak; titanyum dioksit, kalsiyum karbonat, çinko asetat, alüminyum stearat, çinko stearat veya bunlarin karisimlari kullanilabilir. Bulusta tercihen titanyum dioksit kullanilmaktadir. Bulusta kullanilan opaklastirici madde miktari %0.01-3 agirlik oranindadir. The term "anti-adhesive agent" in the invention; sticking of pellets to each other during coating, substance used to prevent it from clumping or clinging to process equipment, or expressed as substance mixtures. As an anti-adhesive agent; talc, colloidal silicon dioxide, magnesium silicate or mixtures thereof can be used. Preferably adhesion in the invention Talc is used as a preventative agent. The amount of anti-adhesive agent used in the invention As an opacifying agent in the invention; titanium dioxide, calcium carbonate, zinc acetate, aluminum stearate, zinc stearate or mixtures thereof can be used. preferably in the invention titanium dioxide is used. The amount of opacifying agent used in the invention is 0.01-3% is in the weight ratio.

Bulusta “tatlandirici madde” terimi etken maddenin kötü tadini ortadan kaldirmak amaciyla kullanilan dogal ve yapay maddeler olarak ifade edilmektedir. Tatlandirici madde olarak; seker, gliserin, misir pekmezi, fruktoz, sukraloz, potasyum asesülfam, sodyum sakkarin, sodyum sakkarin dihidrat, mannitol, aspartam, sodyum siklamat, sorbitol veya bunlarin karisiinlari kullanilabilir. Bulusta tercihen aspartam kullanilmaktadir. Bulusta kullanilan tatlandirici madde miktari %0.01-10 agirlik oranindadir. In the invention, the term "flavoring agent" is used to eliminate the bad taste of the active ingredient. It is expressed as natural and artificial substances used. As a flavoring agent; sugar, glycerin, molasses, fructose, sucralose, potassium acesulfame, sodium saccharin, sodium saccharine dihydrate, mannitol, aspartame, sodium cyclamate, sorbitol or their mixtures can be used. Aspartame is preferably used in the invention. used in the invention the amount of sweetener is 0.01-10% by weight.

Kaplama çözücüsü olarak saflastirilmis su, etil alkol, polioller (gliserol, propilen glikol, sivi- polietilen glikol vb.), izopropil alkol veya bunlarin karisimlari kullanilabilir. Bulusta tercihen saflastirilmis su kullanilmaktadir. Purified water, ethyl alcohol, polyols (glycerol, propylene glycol, liquid- polyethylene glycol etc.), isopropyl alcohol or their mixtures can be used. preferably in the invention purified water is used.

Bulusta, nisasta hidrolize eden enzim oi-amilaz, ß- amilaz, G-ainilaz, glukoamilaz gibi amilaz türevleri, pululanaz, hidralaz arasindan tercihen hidralaz olarak seçilir. Bulusta kullanilan nisasta hidrolize eden enzim miktari %0.1-25 agirlik oranindadir. In the invention, starch hydrolyzing enzyme amylase such as oi-amylase, ß-amylase, G-ainylase, glucoamylase derivatives are preferably selected as hydralase from pululanase, hydralase. used in the invention The amount of starch hydrolyzing enzyme is 0.1-25% by weight.

Mevcut bulustaki etken maddelerin kombinasyon halinde kullanildigi farmasötik bilesiinleri için uygun olan formülasyonlarina ait doz araligi; Simetikon ve/veya farmasötik olarak kabul 69.19mg, 80mg, 300mg; Pankreatin ve/veya farmasötik olarak kabul edilebilir türevleri için 300mg, 400mg; Sigir Safra Ekstresi (cx-bile) ve/veya farmasötik olarak kabul edilebilir bireysel ihtiyaçlarina ve uzmanin degerlendirmesine göre ayarlanmaktadir. Pharmaceutical compositions in which the active ingredients of the present invention are used in combination dosage range of formulations suitable for Simethicone and/or pharmaceutically acceptable 69.19mg, 80mg, 300mg; For pancreatin and/or pharmaceutically acceptable derivatives 300mg, 400mg; Sigir Bile Extract (cx-even) and/or pharmaceutically acceptable adjusted to individual needs and expert judgment.

Bulusta, Simetikon ve/veya farmasötik olarak kabul edilebilir türevlerinin pankreatin ve sigir safra ekstresi (ox-bile) ile kombinasyonunu içeren farmasötik bilesimlerin oral uygulamasina yönelik enterik kapli tablet formülasyonu asagidakileri içermektedir; -yaklasik %0. 1-10 agirlik oraninda Simetikon -yaklasik %1-50 agirlik oraninda pankreatin -yaklasik %0.1-10 agirlik oraninda sigir safra ekstresi (ox-bile) -yaklasik %0.01-60 agirlik oraninda bir veya daha fazla seyreltici madde -yaklasik %0.01-10 agirlik oraninda bir veya daha fazla glidant -yaklasik %0.1-20 agirlik oraninda bir veya daha fazla dagitici madde -yaklasik %0.1-15 agirlik oraninda bir veya daha fazla baglayici madde -yaklasik %0.01-10 agirlik oraninda bir veya daha fazla lubrikant -kafi miktarlarda bir veya daha fazla granülasyon sivisi -yaklasik %0.1-10 agirlik oraninda bir veya daha fazla ara/seal kaplama ajani (bu ara/seal kaplama, yaklasik %0. I -1 0 agirlik oraninda bir veya daha fazla film Olusturucu ajan, yaklasik bir veya daha fazla yapisma önleyici ajan ve kafi miktarda bir veya daha fazla kaplama çözücüsü içermektedir.) -yaklasik %1-20 agirlik oraninda bir veya daha fazla enterik kaplama ajani (bu enterik kaplama, yaklasik %0. 1-10 agirlik oraninda bir veya daha fazla film Olusturucu ajan, yaklasik bir veya daha fazla opaklastirici madde, yaklasik %0.01-7 agirlik oraninda bir veya daha fazla yapisma önleyici ajan, yaklasik %0.01-10 agirlik oraninda bir veya daha fazla glidant ve kafi miktarda bir veya daha fazla kaplama çözücüsü içermektedir.) -yaklasik %0.l-10 agirlik oraninda bir veya daha fazla film kaplama ajani (bu film kaplama, yaklasik %0.1-10 agirlik oraninda bir veya daha fazla film Olusturucu ajan, yaklasik %0.01-5 agirlik oraninda bir veya daha fazla plastifiyan, yaklasik %0.01-10 agirlik oraninda bir veya daha fazla tatlandirici madde, yaklasik %0.01-3 agirlik oraninda bir veya daha fazla opaklastirici madde, yaklasik %0.01-7 agirlik oraninda bir veya daha fazla yapisma önleyici ajan ve kafi miktarda bir veya daha fazla kaplama çözücüsü içermektedir.) -gerekli görüldügü durumlarda yaklasik %O.1-25 agirlik oraninda bir veya daha fazla nisasta hidrolize eden enzim. In the invention, simethicone and/or pharmaceutically acceptable derivatives of pancreatin and bovine Oral administration of pharmaceutical compositions containing bile extract (ox-bile) in combination with The enteric coated tablet formulation for -about 0%. 1-10 weight ratio of Simethicone -approximately 1-50% by weight of pancreatin -approximately 0.1-10% by weight bovine bile extract (ox-bile) - about 0.01-60% by weight of one or more diluents - about 0.01-10% by weight of one or more glidants -one or more dispersants at a rate of about 0.1-20% by weight -one or more binders at a rate of about 0.1-15% by weight -one or more lubricants at a rate of approximately 0.01-10% by weight -sufficient amounts of one or more granulation fluids - one or more intermediate/seal coating agents (approximately 0.1-10% by weight) coating, about 0%. I -1 0 by weight one or more film-forming agents, approx. one or more anti-adhesive agents and a sufficient amount of one or more coatings includes solvent.) - about 1-20% by weight of one or more enteric coating agents (this enteric coating, about 0%. One or more film-forming agents at a weight ratio of 1-10, approx. one or more opacifying agents, approximately 0.01-7% by weight of one or more excess anti-adhesive agent, approximately 0.01-10% by weight of one or more glidants and a sufficient amount of one or more coating solvents.) -approximately 0.1-10% by weight of one or more film coating agents (this is film coating, about 0.1-10% by weight of one or more film-forming agents, about 0.01-5% by weight one or more plasticizers by weight, approximately 0.01-10% by weight of one or more more sweetening agent, approximately 0.01-3% by weight of one or more opacifying agent, approximately 0.01-7% by weight of one or more anti-adhesive agent and a sufficient amount of one or more coating solvents.) -one or more starches at a rate of 0.1-25% by weight when deemed necessary hydrolyzing enzyme.

Bulus esas olarak oral kullanilmak üzere antiflatulan ajan içeren bir etken madde ve/Veya farmasötik olarak kabul edilebilir türevleri ile enzim içeren gastrointestinal özellikteki bir etken madde ve/veya farmasötik olarak kabul edilebilir türevleri ve safra ekstresi içeren bir etken madde ve/veya farmasötik olarak kabul edilebilir türevlerini ve farmasötik olarak uygun yardiinci maddeleri içeren farmasötik bilesim/lerin hazirlanmasi ile ilgilidir. Bulusun farmasötik bilesimlerinin enterik kapli tablet formunda olmasi temeldir. Böylece elde edilen fonnülasyonlarin sasirtici bir sekilde fiziksel ve kimyasal kararlilik açisindan oldukça stabil bir davranis sergiledikleri gözlenmistir. The invention mainly consists of an active substance containing an antiflatulent agent for oral use and/or A gastrointestinal tract containing enzymes with pharmaceutically acceptable derivatives containing the active ingredient and/or its pharmaceutically acceptable derivatives and bile extract. active ingredient and/or pharmaceutically acceptable derivatives and pharmaceutically acceptable It concerns the preparation of pharmaceutical composition(s) containing excipients. find it It is essential that the pharmaceutical compositions are in enteric coated tablet form. Thus obtained The formulations are surprisingly quite stable in terms of physical and chemical stability. It has been observed that they exhibit a behavior.

Bulusun özellikleri asagidakilerle sinirli kalmamak üzere örnekler asagida verilmistir: Simetikon ve/veya farinasötik olarak kabul edilebilir türevlerinin pankreatin ve sigir safra ekstresi (ox-bile) ile kombinasyonunu içeren farmasötik bilesimlerin oral uygulamasina yönelik enterik kapli tablet formülasyonu asagidakileri içermektedir; -yaklasik %0.1-10 agirlik oraninda simetikon -yaklasik %1-50 agirlik oraninda pankreatin -yaklasik %0.1-10 agirlik oraninda sigir safra ekstresi (ox-bile) -yaklasik %0.01-60 agirlik oraninda laktoz monohidrat, mikrokristalin selüloz ve modifiye silikon dioksit -yaklasik %0.01-10 agirlik oraninda modifiye silikon dioksit -yaklasik %0.1-20 agirlik oraninda kroskarmelloz sodyum ve misir nisastasi -yaklasik %0.1-15 agirlik oraninda povidon -yaklasik %0.01-10 agirlik oraninda magnezyum stearat -kafi miktarlarda saflastirilmis su -yaklasik %0.1-10 agirlik oraninda bir veya daha fazla ara/seal kaplama ajani (bu ara/seal kaplama, yaklasik %0.1-10 agirlik oraninda hidroksipropil metil selüloz, yaklasik %0.01-5 agirlik oraninda polietilen glikol, yaklasik %0.01-7 agirlik oraninda talk ve kafi miktarda saflastirilmis su içermektedir.) -yaklasik %1-20 agirlik oraninda bir veya daha fazla enteiik kaplama ajani (bu enterik kaplama, yaklasik %0.1-10 agirlik oraninda metakrilik asit kopolimeri, yaklasik %0.01-5 agirlik oraninda trietil sitrat, yaklasik %0.01-3 agirlik oraninda titanyum dioksit, yaklasik miktarda saflastirilmis su içermektedir.) -yaklasik %0.1-10 agirlik oraninda bir veya daha fazla film kaplama ajani (bu film kaplama, yaklasik %0.1-10 agirlik oraninda hidroksipropil metil selüloz, yaklasik %0.01-5 agirlik oraninda polietilen glikol, yaklasik %0.01-10 agirlik oraninda aspartam, yaklasik %0.01-3 agirlik oraninda titanyum dioksit, yaklasik %0.01-7 agirlik oraninda talk ve kafi miktarda saflastirilmis su içermektedir.) -gerekli görüldügü durumlarda yaklasik %0.1-25 agirlik oraninda hidralaz Simetikon ve/veya farmasötik olarak kabul edilebilir türevlerinin pankreatin ve sigir safra ekstresi (ox-bile) ile kombinasyonunu içeren farmasötik bilesimlerin oral uygulamasina yönelik enterik kapli tablet fonnülasyOnu asagidakileri içennektedir; -yaklasik 5-800mg simetikoii -yaklasik l-lOOOmg paiikreatiii -yaklasik l-300mg sigir safra ekstresi (ox-bile) -yaklasik l-500mg laktoz monohidrat, mikrokristalin selüloz ve modifiye silikon dioksit -yaklasik 0.1-60mg modifiye silikon dioksit -yaklasik 1-250mg kroskarrnelloz sodyum ve misir nisastasi -yaklasik l-60mg povidon -yaklasik 0.1-20mg magnezyum stearat -kafi miktarlarda saIlastirilmis su -yaklasik 1-30mg ara/seal kaplama ajani (bu ara/seal kaplama, l-20mg hidroksipropi] irietil selüloz, yaklasik 0.1-5nig polietilen glikol, yaklasik 0.01-3mg talk ve kafi miktarda saflastirilmis su içermektedir.) -yaklasik 1-150mg enterik kaplama ajani (bu enterik kaplama, yaklasik l-80mg inetakrilik asit kopolimeri, yaklasik l-20mg trietil sitrat, yaklasik 1-25mg titanyum dioksit, yaklasik 1- 30mg talk, yaklasik 0.1-51ng silikon dioksit ve kafi miktarda saIlastirilmis su içermektedir.) -yaklasik 1-50mg film kaplama ajani (bu film kaplama, yaklasik 1-25mg hidroksipropi] metil selüloz, yaklasik 0.1-4mg polietilen glikol, yaklasik 0.1-6mg aspartam, yaklasik 0.1-8mg titanyum dioksit, yaklasik 0.1-5mg talk ve kafi miktarda saflastirilmis su içermektedir.) -gerekli görüldügü durumlarda 5-300mg hidralaz Üretim prosesi Mikrokristalin selüloz ve modifiye silikon dioksit elek araciligiyla elenir ve belirli bir süre Simetikon ile granülasyon yapilir [ön karisim] Laktoz monohidrat, misir nisastasi ve uygun elek araligindan elenmis kroskamieloz sodyum eklenir. Berrak bir solüsyon elde edilene kadar Polivinil pirolidon satlastirilmis su içinde çözülür. Yüksek kesmeli bir granülatör kullanilarak hazirlanan baglayici solüsyon ile granülasyon yapilir. Belirli bir sicaklikta akiskan yatakli kurutma makinesi kullanarak istenilen nem miktari saglanana kadar kurutulur. Kurutulan granüller uygun boyuttaki elekten geçirilir. [plasebo granülasyonu] Pankreatin ve sigir safra ekstresi ve gerekli görüldügü takdirde hidralaz uygun boyuttaki elekten elenir. Elde edilen karisim yukarida granülasyonu yapilan karisimlar ile yüksek kesmeli bir granülatörde karistirilir ve sonra belirli miktarda saflastirilmis su eklenir. Elde edilen karisim uygun boyuttaki elekten elenir. Uygun boyuttaki elekten kroskarmeloz sodyum ve modifiye silikon dioksit elenir ve belirli bir süre uygun karistiricida karistirilir. Elde edilen karisim uygun boyuttaki elekten elenmis Magnezyum stearat ile uygun karistirici kullanilarak yaglama yapilir. Yaglanmis karisim uygun bir zimba kullanilarak tabletler halinde sikistirilir. Examples of the features of the invention are given below, but not limited to the following: Pancreatin and bovine bile of simethicone and/or pharmaceutically acceptable derivatives For oral administration of pharmaceutical compositions containing its extract (ox-bile) in combination with The enteric coated tablet formulation for -approximately 0.1-10% by weight simethicone -approximately 1-50% by weight of pancreatin -approximately 0.1-10% by weight bovine bile extract (ox-bile) -approximately 0.01-60% by weight of lactose monohydrate, microcrystalline cellulose and modified silicon dioxide -approximately 0.01-10% by weight of modified silicon dioxide -approximately 0.1-20% by weight of croscarmellose sodium and corn starch -approximately 0.1-15% by weight povidone -approximately 0.01-10% by weight magnesium stearate -sufficient amounts of purified water - one or more intermediate/seal coating agents (approximately 0.1-10% by weight) coating, approx. 0.1-10 wt% hydroxypropyl methyl cellulose, approx. 0.01-5% by weight polyethylene glycol, approximately 0.01-7% by weight talc and sufficient amount Contains purified water.) - about 1-20% by weight of one or more enteric coating agents (this enteric coating, approx. 0.1-10 wt% methacrylic acid copolymer, approx. 0.01-5% by weight triethyl citrate, approx. 0.01-3% by weight titanium dioxide, approx. amount of purified water.) -approximately 0.1-10% by weight of one or more film coating agents (this is film coating, approx. 0.1-10 wt% hydroxypropyl methyl cellulose, approx. 0.01-5% wt. polyethylene glycol, approximately 0.01-10% by weight, aspartame, approximately 0.01-3% by weight titanium dioxide, approximately 0.01-7% by weight talc and a sufficient amount Contains purified water.) -hydralase at a rate of approximately 0.1-25% by weight, when deemed necessary Pancreatin and bovine bile of simethicone and/or pharmaceutically acceptable derivatives For oral administration of pharmaceutical compositions containing its extract (ox-bile) in combination with The enteric-coated tablet formulation for -approximately 5-800mg simethicoii -about 1-100mg paiikcreatiii -approximately l-300mg bovine bile extract (ox-bile) -about l-500mg of lactose monohydrate, microcrystalline cellulose and modified silicon dioxide - about 0.1-60mg of modified silicon dioxide -approximately 1-250mg croscarnellose sodium and corn starch -about l-60mg povidone -approximately 0.1-20mg magnesium stearate -Adequate amounts of distilled water - about 1-30mg of break/seal coating agent (this is break/seal coating, 1-20mg of hydroxypropyl] iriethyl cellulose, approx. 0.1-5nig polyethylene glycol, approx. 0.01-3mg talc and sufficient amount Contains purified water.) -about 1-150mg of enteric coating agent (this enteric coating is approximately 1-80mg of inetacrylic acid copolymer, approx. 1-20mg triethyl citrate, approx. 1-25mg titanium dioxide, approx. 1- It contains 30mg of talc, about 0.1-51ng of silicon dioxide and a sufficient amount of distilled water.) -approximately 1-50mg film coating agent (this film coater, approx 1-25mg hydroxypropyl] methyl cellulose, approx. 0.1-4mg polyethylene glycol, approx. 0.1-6mg aspartame, approx. 0.1-8mg titanium dioxide, about 0.1-5mg of talc and a sufficient amount of purified water.) - if necessary 5-300mg hydralase production process Microcrystalline cellulose and modified silicon dioxide are sieved through a sieve and Granulation with simethicone [premix] Lactose monohydrate, corn starch and croscamielose sodium sieved through appropriate sieves is added. Polyvinyl pyrrolidone in saline solution until a clear solution is obtained. is resolved. With a binder solution prepared using a high shear granulator granulation is done. Using a fluidized bed dryer at a certain temperature dried until the desired moisture content is achieved. The dried granules are passed through a suitable size sieve. is passed. [placebo granulation] Pancreatin and bovine bile extract and, if necessary, hydralase in appropriate size sieved from the sieve. The obtained mixture is higher than the granulated mixtures above. It is mixed in a shear granulator and then a certain amount of purified water is added. in hand The resulting mixture is sieved through a sieve of appropriate size. Croscarmellose sodium through a properly sized sieve and modified silicon dioxide are sieved and mixed in a suitable mixer for a certain period of time. Obtained The mixture is sieved through a sieve of appropriate size with Magnesium stearate using the appropriate mixer. lubrication is done. The oiled mixture is compressed into tablets using a suitable punch.

Hidroksipropil metilselüloz (H PMC) saflastirilmis su içinde çözülür ve berrak bir çözelti elde edilene kadar polietilen glikol eklenir ve talk eklenerek uniforin bir çözelti elde edilene kadar karistirilir. Elde edilen dispersiyon karisimi, uygun kaplama pani kullanilarak istenilen agirliktaki tabletler elde edilene kadar ara kaplama için kullanilir. [Ara kaplaina] Enterik kaplama maddesi saflastirilmis su içinde disperse edilir. Üniform bir dispersiyon elde edilene kadar belirli bir süre karistirilir. Ara kaplama yapilmis tabletler istenilen agirliktaki tabletler elde edilene kadar enterik kaplama yapilir. [Enterik kaplama] HPMC saflastirilmis su içinde çözülür ve berrak bir çözelti elde edilene kadar karistirilir. Hydroxypropyl methylcellulose (H PMC) is dissolved in purified water and a clear solution is obtained. polyethylene glycol is added until a uniform solution is obtained by adding talc. is mixed. The dispersion mixture obtained is prepared by using the appropriate coating pan. It is used for intermediate coating until tablets in weight are obtained. [To the intermediate tiger] The enteric coating agent is dispersed in purified water. obtain a uniform dispersion. It is mixed for a certain time until it is mixed. Intermediate coated tablets of the desired weight Enteric coating is applied until tablets are obtained. [Enteric coating] HPMC is dissolved in purified water and stirred until a clear solution is obtained.

Kaplama dispersiyonu için; polietilen glikol eklenir ve talk, titanyum dioksit ve aspartam eklenerek uniform bir çözelti elde edilene kadar belirli bir süre karistirilir. Istenilen agirliktaki tabletler elde edilene kadar, hazirlanan kaplama dispersiyonu karisimi ile enterik kapli tabletlere kaplanir. Elde edilen kaplanmis tabletler belirli bir süre kurutulur. For coating dispersion; polyethylene glycol is added and talc, titanium dioxide, and aspartame It is mixed for a certain time until a uniform solution is obtained. in desired weight Enteric coated with the prepared coating dispersion mixture until tablets are obtained. coated in tablets. The resulting coated tablets are dried for a certain period of time.

Claims

REQUESTS . An active substance containing an antiflatulent agent for oral use and/or an active substance containing pharmaceutically acceptable derivatives and enzymes with gastrointestinal properties and/or an active substance containing pharmaceutically acceptable derivatives and bile extract and/or pharmaceutically acceptable derivatives and pharmaceuticals Preparation of pharmaceutical composition(s) containing suitable excipients. . It is a pharmaceutical composition/s as in Claim 1 and its feature is; suitable active substance containing antiflatulent agent; Simethicone (P0Ii(dimethylsil0xane)), beeswax, candelila wax, carbauba wax, celak, paraffins, mineral oil, petroleum jelly, microcrystalline wax, gum benzoic, crystalline wax, rice bran wax and/or pharmaceutically acceptable derivatives. . It is a pharmaceutical composition/s as in Claim 1 and its feature is; suitable active substance with gastrointestinal properties containing enzymes; diastase, pancreatin, pancrelipase, pepsin and/or pharmaceutically acceptable derivatives. . It is a pharmaceutical composition/s as in claim 1 and its feature is; suitable active ingredient containing bile extract; bile acid (chenodeoxycholic acid, cholic acid, ursodeoxycholic acid), bovine bile extract (ox-bile), obeticholic acid, nicotinyl methylamide, piprozoline, hymecromone, cyclobutyrol and/or pharmaceutically acceptable derivatives. . It is a pharmaceutical composition/s as in the request, and its feature is; Enteric-coated tablet formulation for oral administration of pharmaceutical compositions containing simethicone and/or its pharmaceutically acceptable derivatives in combination with pancreatin and bovine bile extract (OX-bile) contains the following; -approximately 0.1-10% by weight of simethicone -approximately 1-50%wt. pancreatin -approximately 0.1-10%wt. bovine bile extract (CX- even] -approximately 0.01-60%wt. of one or more diluents - about 0.01-10% by weight of one or more glidants -about 0.1-20% by weight of one or more dispersants -about 0.1-15% by weight of one or more binders -about 0.01-10% by weight of one or more more lubricant -sufficient amounts of one or more granulation fluids -about 0.1-10% by weight of one or more intermediate/seal coating agents (this intermediate/sea) coating, approximately 0.1-10% by weight of one or more film formers The agent contains approximately 0.01-5% by weight of one or more plasticizers, approximately 0.01-7% by weight of one or more anti-adhesive agents, and an adequate amount of one or more coating solvents.) -about 1-20% by weight of a coating solvent or more entries plum coating agent (this enteric coating is about 0.1-10% by weight of one or more film-forming agents, about 0.01-5% by weight of one or more plasticizers, about 0.01-3% by weight of one or more opacifying agents, It contains about 0.01-7% by weight of one or more anti-adhesive agents, about 0.01-10% by weight of one or more glidants, and an adequate amount of one or more coating solvents.) - about 0.1-10% by weight of one or more excess film coating agent (this is film coating, about 0.1-10% by weight, one or more film-forming agents, about 0.01-5% by weight, one or more plasticizers, about 0.01-10% by weight, one or more sweeteners) ) contains about 0.01-3% by weight of one or more opacifying agents, about 0.01-7% by weight of one or more anti-adhesive agents, and a sufficient amount of one or more coating solvents.) -ge Enzyme that hydrolyzes one or more starches at an approximate rate of 0.1-25% by weight, when seen in color. It is a pharmaceutical composition/s as in the request, and its feature is; Enteric-coated tablet formulation for oral administration of pharmaceutical compositions containing simethicone and/or pharmaceutically acceptable derivatives in combination with pancreatin and bovine bile extract (OX-bile), comprising: -approximately 0.1-10% by weight of simethicone -approximately 1-50%wt. pancreatin10 -approximately 0.1-10%wt. bovine bile extract (OX-bile) -approximately 0.01-60%wt. lactose monohydrate, microcrystalline cellulose and modified silicon dioxide -about 0.01-10% by weight of modified silicon dioxide -about 0.1-20% by weight of croscarmellose sodium and cornstarch -about 0.1-15% by weight of povidone -about 0.01-10% by weight of magnesium stearate -purified water in sufficient quantities - approximately 0.1-10% by weight of one or more intermediate/sea] coating agents (this intermediate/sea] coating, approximately 0.1-10% by weight hydroxypropyl methyl cellulose, approximately 0.01-5% by weight polyethylene glycol, approximately 0.01%- It contains 7 parts by weight of talc and a sufficient amount of saline water.) -one or more enteric coating agents at approximately 1-20% by weight (this enteric coating is a methacrylic acid copolymer, approximately 0.1-10% by weight, approx. It contains acid dioxide, approximately 0.01-7% by weight of talc, approximately 0.01-10% by weight of silicon dioxide and a sufficient amount of purified water.) -one or more film coating agents at approximately 0.1-10% by weight (this film coating is approximately It contains 0.1-10% by weight of hydroxypropyl methyl cellulose, about aspartame, about 0.01-3% by weight of titanium dioxide, about 0.01-7% by weight of talc and sufficient amount of diluted water.) - at a rate of about 0.1-25% by weight when necessary hydralase 7. Pharmaceutical composition/s according to any one of the above claims and its feature is; The diluent; lactose, sucrose, dextrin, mannitol, lactilol, sucrose, xylitol, sorbitol, isomalt, microcrystalline cellulose, dextrose, dextrate, pregelatinized starch, modified starch, corn starch, lactose anhydrous, lactose propagated calcium monophosphate, dibasic calcium monophosphate, dibasic calcium monophosphate phosphate, polyhydric alcohols or cellulose ethers, calcium hydrogen phosphate anhydrous, calcium sulfate trihydrate, calcium sulfate dihydrate, calcium carbonate, kaolin, sodium hydroxide, modified silicon dioxide or mixtures thereof. It is a pharmaceutical composition/s according to any of the above claims and its feature is; preferably the diluent is lactose monohydrate, microcrystalline cellulose and modified silicon dioxide. It is a pharmaceutical composition/s according to any of the above claims and its feature is; glidantin; talc, magnesium stearate, hydrogenated vegetable oil, calcium stearate, stearic acid, colloidal silicon dioxide, silica, silicon dioxide, colloidal anhydrous silica, polyethyleneglycol, cellulose derivatives, starch, modified silicon dioxide or their mixtures. It is a pharmaceutical composition/s according to any of the above claims and its feature is; The glidantin is preferably modified silicon dioxide and silicon dioxide (in an enteric coating). It is a pharmaceutical composition/s according to any of the above claims and its feature is; dispersant; agar agar, calcium carbonate, sodium carbonate, alginic acid, starch, microcrystalline cellulose, pregelatinized starch cross-linked polyvinyl pyrrolidone, corn starch, sodium alginate, hydroxypropyl cellulose, croscaimellose sodium, clay, ion exchange resin, crospovidone, sodium colloidal starch glycolate or their mixtures. It is a pharmaceutical composition/s according to any of the above claims and its feature is; The dispersant is preferably croscarmellose sodium and corn starch. It is a pharmaceutical composition/s according to any of the above requirements and its feature is; The binding substance; pregelatinized starch, sodium starch glycolate, croscarmellose sodium, hydroxy propyl cellulose, hydroxy propyl methyl cellulose, methylcellulose, ethylcellulose, microcrystalline cellulose, sodium carboxy methylcellulose, dextrin, polyvinylpyrrolidone, alginic acid, alginate, gelatin, donnisa, glycospostases, , guar gum, sucrose or their mixtures. It is a pharmaceutical composition/s according to any of the above claims and its feature is; The binding agent is preferably povidone. It is a pharmaceutical composition/s according to any of the above claims and its feature is; granulation fluid; Purified water, ethyl alcohol, methyl alcohol, isopropyl alcohol, butyl alcohol such as alcohol, methylene chloride or their mixtures are selected. It is a pharmaceutical composition/s according to any of the above claims and its feature is; the granulation liquid is preferably purified water. It is a pharmaceutical composition/s according to any of the above claims and its feature is; lubricant; talc, calcium stearate, magnesium stearate, solid polyethylene glycol, tristearin, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, sodium stearyl fumarate, oleic acid, tripalmityl, potassium oleate, caprylic acid, glyceryl palmitostearate, sodium benzoate, zinc stearate, zinc oleate, zinc palmitate or mixtures thereof. It is a pharmaceutical composition/s according to any of the above claims and its feature is; The lubricant is preferably magnesium Stearate. It is a pharmaceutical composition/s according to any of the above claims and its feature is; Your Film Builder agent; polyvinyl alcohol, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, methacrylic acid copolymer, polyethylene glycol, polyethylene oxide, gelatin or their mixtures. It is a pharmaceutical composition/s according to any of the above claims and its feature is; The film-forming agent is preferably hydroxypropyl methyl cellulose (in the film coating and intermediate/seal coating) and methacrylic acid copolymer (in the enteric coating). It is a pharmaceutical composition/s according to any of the above claims and its feature is; plastiyanine; polyethylene glycol, glycerine, propylene glycol, acetyl citrate, arnyl oleate, myristyl acetate, butyl oleate, butyl stearate, triacetin, diethylphthalate, dibutylphthalate, acetylated monoglycerides, triethyl citrate or mixtures thereof. It is a pharmaceutical composition/s according to any of the above claims and its feature is; the plasticizer is preferably polyethylene glycol (in the film coating and intermediate/seal coating) and triethyl citrate (in the enteric coating). It is pharmaceutical composition/s according to any of the above claims and its feature is; Anti-adhesive agent; talc, colloidal silicon dioxide, magnesium silicate or mixtures thereof. It is a pharmaceutical composition/s according to any of the above claims and its feature is; The anti-adhesive agent is preferably talc. It is a pharmaceutical composition/s according to any of the above claims and its feature is; opacifying agent; titanium dioxide, calcium carbonate, zinc acetate, aluminum stearate, zinc stearate or mixtures thereof can be used. It is a pharmaceutical composition/s according to any of the above claims and its feature is; preferably the opacifying agent is titanium dioxide. It is a pharmaceutical composition/s according to any of the above claims and its feature is; Sweetener; sugar, glycerin, molasses, fructose, sucralose, potassium acesulfame, sodium saccharine, sodium saccharine dihydrate, mannitol, aspartame, sodium Cyclamate, sorbitoi or their mixtures. It is a pharmaceutical composition/s according to any of the above claims and its feature is; The sweetener is preferably aspartame. It is a pharmaceutical composition/s according to any of the above claims and its feature is; Coating solvent; Purified water, ethyl alcohol, polyols (glycerol, propylene glycol, liquid-polyethylene glycol, etc.), isopropyl alcohol or their mixtures. It is a pharmaceutical composition/s according to any of the above claims and its feature is; The coating solvent is preferably purified water. It is a pharmaceutical composition/s according to any of the above claims and its feature is; starch hydrolyzing enzyme; (It is selected from among amylase derivatives such as x-amylase, ß-amylase, o-amylase, glucoamylase, pululanase, hydralase or their mixtures. It is a pharmaceutical composition/s according to any of the above claims and its feature is that the starch hydrolyzing enzyme is preferably hydralase. is the pharmaceutical composition/s according to one of the following;

1-1000mg, 1-300mg for Bovine Bile Extract (ox-bile) and/or pharmaceutically acceptable derivatives. 34. It is a pharmaceutical composition/s according to any of the above claims and its feature is; It is indicated for the symptomatic, prophylactic and chronic treatment of dyspepsia, flatulence, gastrointestinal radiography, ultrasound imaging, pancreatic insufficiency, biliary colic, digestive enzyme deficiency, irritable colon syndrome with diarrhea and/or constipation, functional digestive disorders and painful conditions caused by excessive gas in the digestive tract. .