TR201605993A1 - PHARMACEUTICAL FORMULATIONS USED IN THE TREATMENT OF GASTROINTESTINAL DISEASES - Google Patents

Abstract

The present invention includes; pain associated with functional bowel disorders, transitional disorders, stomach pain, irregular bowel diseases (constipation, diarrhea ..), correcting the normal contraction of the intestine and the relaxation of the intestinal muscles, reducing spasm, bloating, irritable bowel syndrome, also (gallbladder and bile duct) suitable for use in the therapeutic and / or prophylactic and / or symptomatic treatment of symptoms related to other intestinal disorders (also in the preparation of barium enema), in the relief of stomach or intestinal complaints caused by medical conditions in the intestine or bile duct, and / or pharmaceutical The present invention relates to pharmaceutical compositions (s) wherein acceptable derivatives are used alone or as combination therapy as monotherapy.

Description

DESCRIPTION USED IN THE TREATMENT OF GASTROINTESTINAL DISEASES PHARMACEUTICAL FORMULATIONS FIELD OF THE INVENTION The present invention; pain due to functional bowel disorders, transition disorders, stomach pain, irregular bowel diseases (constipation, diarrhoea..), impaired normal contraction of the bowel It helps to relax the intestinal muscles by correcting the process, reducing spasm, bloating, irritable bowel syndrome, as well as other bowel (including gallbladder and bile duct) in symptoms associated with disorders of the intestine (also in preparation of a barium enema), intestinal or stomach or intestinal complaints caused by medical conditions in the bile duct therapeutic and/or prophylactic and/or symptomatic treatment as a suitable active substance and/or pharmaceutical with antispasmodic properties to be used acceptable derivatives as monotherapy alone or in combination therapy relates to the pharmaceutical composition(s) for which it is used.

The present invention; The active ingredient with antispasmodic properties is Pinaverium, 4-(2-bromo-4,5- dimethoxybenzyl1)-4-(2-[2-(6,6-dimethylbicyclo[3.1 .1]heptan-2-iDethoxy]ethyl)morpholin-4-ium (Formula 1) and/or pharmaceutically acceptable derivatives as monotherapy alone relates to the pharmaceutical composition(s) for which it is used alone or in combination.

Formula 1: In addition, the invention includes the use of Pinaverium and/or its pharmaceutically acceptable derivatives. used alone as monotherapy or used as a combination therapy formulations of pharmaceutical compositions suitable for oral administration and prophylactic and/or symptomatic and/or therapeutic uses. PRIOR ART (KNOWN STATE OF THE ART) Irritable bowel syndrome (IBS) with no known organic cause, stress or emotional a bowel that occurs or increases during periods of high tension is the disease. irritable bowel syndrome (IBS); abdominal pain, changes in bowel function (bowel frequency and/or constipation), bloating, including feeling of incomplete evacuation functional bowel characterized by a diverse consortium of abdominal symptoms Irritable bowel syndrome is the most common, affecting approximately 12% of the world's population. It is a multifactorial disease in gastroenterology practices (Halvorson et al., 2006; Mertz, 2003). In the development of acute gastroenteritis and irritable bowel syndrome in recent years, (Neal et al., 1997, 'Party and Forgacs, 2005,' Rodriguez and Riii'gömez, 1999).

Studies have shown that approximately one-third of patients with irritable bowel syndrome symptoms of one started after acute enteric infection (Gwee et al., It has been accepted as a new subtype of 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

Strongly mild stimulation in patients with postinfectious irritable bowel syndrome Visceral hypersensitivity responding to abdominal pain is emphasized. Trimebutin and Some antispasmodics, such as pinaverium, are used to reduce muscle ion channels to relieve pain. inhibition of muscle mass contraction by modulation of irritable bowel syndrome is thought to be related.

Traditionally, therapies for abdominal pain; calcium channel blockers (eg. pinaverium), smooth muscle relaxants (eg mebeverine), and opioid receptor ligands (eg trimebutin), anticholinergic agents (eg Cimetropium bromide, dicycloine) Pinaverium is a quaternary ammonium derivative that acts selectively in the gastrointestinal tract. It is an antispasmodic and musculotropic drug, for functional gastrointestinal disorders used. It also shows a small antimuscarinic effect. Like a calcium channel blocker acts and helps to restore the normal contraction process of the intestine, helps him relax.

Prevention or treatment of intestinal disorders in patent document EP2641598 pharmaceutical in the form of coated tablets or capsules for oral administration used The composition and the auxiliary additives used are mentioned.

In the patent document no. EP2020234, the pinaverium broinide dimethicondaii or Synergistic combinations of simethicone are mentioned.

DESCRIPTION OF THE INVENTION The present invention; pain due to functional bowel disorders, transition disorders, stomach pain, irregular bowel diseases (constipation, diarrhoea..), impaired normal contraction of the bowel It helps to relax the intestinal muscles by correcting the process, reducing spasm, bloating, irritable bowel syndrome, as well as other bowel (including gallbladder and bile duct) in symptoms associated with disorders of the intestine (also in preparation of a barium enema), intestinal or stomach or intestinal complaints caused by medical conditions in the bile duct therapeutic and/or prophylactic and/or symptomatic treatment as a suitable active substance and/or pharmaceutical with antispasinodic properties to be used acceptable derivatives as monotherapy alone or in combination therapy relates to the pharmaceutical composition(s) for which it is used.

Another aspect of the present invention is; suitable for oral use with antispasmodic properties of the active substance and/or its pharmaceutically acceptable derivatives as monotherapy by the preparation of pharmaceutical composition(s) where it is used alone or in combination The active substance used in the invention with antispasmodic properties, but not limited to together, oxyphencycline, kainilofin, mebeverine, trimebutin, rosivin, dicycloverine, dihexiverine, diphemerine, piperidolate, benzylone, glycopyrronyuni, oxyphenonyuni, penthienate, propantheline, otilonium, methantheline, tridihexethyl, isopropamide, hexocyclium, poldin, mepenzolate, bevonium, pipenzolate, diphemanil, thiemonium, pyrifiium, thymepidium, fenpiverinium, dimethylamiiopropionylphenothiazine, nicofetamide, thyropramide, papaverine, drotaverine, moxaverine, alosetron, tegaserod, silansetron, prucalopride, fenpiprane, diisopromine, chlorbenzoxamine, pinaverium, fenoverin, idanpramine, proxazole, alverin, trepibuton, isothepten, caroverin, phloroglucinol, trimethyldiphenylpropylamine, silicones and/or pharmaceutically acceptable derivatives, preferably pinaverium bromide is selected as.

In the invention, the term "pharmaceutically acceptable derivatives" is defined as pharmaceutically acceptable. Suitable salts, esters, solvates, hydrates, complexes, polymorts, enantiomers, prodrugs, acid addition salts, analogs, isomers, racemates, amides, enantiomer salts, basic salts, conjugates, tautomers, anhydrates, anhydrides, bases, one or more of acids, ethers, crystalline and amorphous forms or free forms is expressed.

The pharmaceutical composition for oral administration may be in solid or liquid dosage forms.

These dosage forms are; tablet (uncoated, chewable, mouth soluble, dispersible, water dispersible, film coated, single layer, double layer, intestinal release coated, mini tablet, controlled release, sustained release, immediate release, extended release, delayed release release, modified release, grocery), capsule (hard, soft, enteric-coated, film-coated, controlled release, sustained release, immediate release, extended release, delayed release, modified release), powder, granule, caplet, disc, oral film, bulk powder (multidose), pellet, sachet, water-dispersible powder, water-dispersible granule, effervescent tablet, effervescent granule, effervescent powder, microcapsule, dental tablets, pilula, syrup, solution, suspension, The elixir may be formulated in a dosage form such as drops, positions, emulsions or sprays.

In the present invention, tablet(s) prepared for oral use have one or more coatings. may contain.

coated tablets; The active ingredient is usually in the core, partially in the core and It is prepared in the form of formulas containing partially coating or only coating.

Coating materials must be physiologically harmless and incompatible with the active substance. should not be.

Coating types ; sugar coating, film coating and intestinal soluble (enteric) coating can be counted as

Sugar-coated tablets are compressed tablets having a coating consisting of sugar. are tablets. The coating may be colored and may have an offensive taste or coating of active substances with odor and sensitive to oxidation It is extremely useful in terms of protecting materials.

Film-coated tablets are a thin film applied using a water-soluble material. Compressed tablets coated with a layer or film. In line with this, the movie Maker A range of polymeric materials can be used with properties Film coatings, sugar Although it has the same general properties as the coatings, it is necessary for the coating process. It brings with it the important additional advantage of significantly reducing the time.

Purposes of Coating; o Protection of the active substance against light, oxygen and moisture o Masking off the offending odor and taste of the active ingredient o Correction of the aesthetic appearance of the tablet - Obtaining colored tablets with very little dyestuff o Increasing the easy swallowing of the tablet by the patient o Increased mechanical strength during production, packaging and transportation i Protection of the active substance against digestive secretions - Avoidance of side effects, eg stomach irritation o Facilitating the identification of the drug, thus ensuring safety in drug use. increase o Increasing the stability of the active ingredient - Editing of controlled release characteristics can be counted as

The pharmaceutical formulation of the invention may contain one or more layers. Sufficient therapeutic control the release of the drug in order to ensure the effect and minimize the side effects. alternating, controlled, extended, continuous, immediate or a delayed-release pharmaceutical formulated with one or more of the dosage forms can be done.

In delayed release systems, the release of the active substance from the system is in a certain region. is happening. It is generally used for enteric coated tablets.

To increase the stability of the enteric coating formulation, to prevent acid-induced degradation. It is expressed as the substance or substance mixture used for These enteric coatings before it starts to decompose, it resists stomach acid and at the same time, it It provides a slow drug release in the upper part of the small intestine or in the upper part of the small intestine.

Direct compression, wet or dry granulation in the preparation of tablet(s) of the invention applicable.

Direct compression of the powdered material without disturbing the physical structure of the material. It is obtained by compression. Widely used as a direct compaction tool The excipient studied in this way is microcrystalline cellulose (Avicel, FMC).

Many techniques are used in the preparation of dosage forms. one of them granulation method. Granulation; as the growth of fine dust particles is defined. Granulation for pharmaceutical purposes; a preparation for tableting This is the stage of filling hard gelatin capsules or granules as a final product. It is also applied for the purpose of being placed in a package.

The purpose of the granulation is to give the unit drug % of the particles of the powder substance participating in the mixture. is to create a unit of weight that will be equivalent to the quantities. Pharmaceutical powder mixes (active substance or auxiliary substances) in a unit by preventing their separation. It is necessary to ensure that they remain in a homogeneous form, this is achieved by granulation. possible.

The methods to be chosen in granulation can be classified in 3 main categories: wet granulation, dry granulation and other granulation methods.

Age Granulation: In the wet granulation method, high speed fluidized bed granulation, spray drying and extrusion pelleting methods are used. Mourning In granulation, the active ingredient and the binder (solution) are mixed for a certain period of time. sieved and dried in a fluidized bed dryer. This dried mixture is the other filling. It is mixed with the ingredients until it reaches a certain homogeneity. My wife's last 3-5 slider is added in minutes. Samples are taken from the final mixture obtained and sent to the laboratory. sent. According to the laboratory result, for tablet compression or for the desired pharmaceutical form stages can be passed.

Age granulation methods: 1. Age granulation method (Classical method) 2. Granulation by fluidized bed method 3. Granulation by Spray-Drying method 4. Microgranulation method . Extrusion-Spheronization method 6. Method of preparing granules with high-level mixers The wet granulation process is as follows: - Grinding the active ingredient (if necessary), - Mixing with powder substances, - Ensuring the aggregation of the particles of the powder mixture with the addition of Baglayioi, (This The process is called granulation.) ° Screening of agglomerated particles as wet, - Drying of the sifted powder mixture is common in the drying process using bed dryers, - Dry grinding after drying, - Homogenizing in double conical or V type mixers The mixture is called the Inal product.) - It is the transition to tablet pressing or the stages for the desired pharmaceutical form.

Dry Granulation: In the dry granulation method, pre-compression and inter-roll compression methods are used. In dry granulation, it is usually 1/3 of the lubricant is mixed with other powder mixtures. This is because dust gets into the cylinders. prevents it from sticking. The rest of the lubricant is added to the mix after sand granulation. and stirred for 3-5 minutes. Samples are taken from the final mixture formed after the mixture and It is sent to the laboratory for various tests. According to the laboratory results, tablet compression or The steps can be passed for the desired pharmaceutical form.

Pharmaceutical Iilm coated tablet formulation prepared for oral use in the present invention; at least one filler, as well as suitable pharmaceutically acceptable active ingredients agent/diluent, at least one dispersant, at least one glidant, at least one lubricant, at least one one or more selected from the group consisting of film coating agent and granulation fluid describes a composition that may contain more excipients.

As a filler/diluent in the invention; talc, lactose, sucrose, dextrin, mannitol, lactilol, lactitol, xylitol, sorbitol, isomalt, microcrystalline cellulose, powdered cellulose, dextrose, dextrate, pregelatinized starch, modified starch, corn starch, lactose anhydrous, lactose monohydrate, dibasic calcium phosphate, silicic acid, kaolin, hydroxy propyl methylcellulose, tribasic calcium phosphate, polyhydric alcohols or cellulose ethers, calcium hydrogen phosphate dihydrate, calciuin sulfate trihydrate, cellulose calcium sulfate, calcium sulfate dihydrate, maltodextrin, calcium carbonate, kaolin, sodium hydroxide or their mixtures can be used. in the find preferably lactose monohydrate and/or microcrystalline cellulose are used. the amount of filler/diluent used is 1-80%, preferably 8-60% by weight.

In the invention, the term "dispersant" means that the dosage form can be easily and quickly dissolved in water. It is expressed as substances that allow it to disperse. As a dispersant; agar agar, calcium carbonate, sodium carbonate, alginic acid, potato starch, corn starch, wheat Starches such as starch, pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, cross-linked polyvinyl pyrrolidone, sodium alginate, hydroxypropyl cellulose, cross bound hydroxypropyl cellulose, croscarmellose sodium, clay, ion exchange resin, crospovidone, xylitol, D-sorbitol, D-mannitol, lactose, sucrose, urea, high molecular weight polymers, povidone, alginic acid, xanthan gum, colloidal silicon dioxide or their mixes can be used. Pregelatinized starch is preferably used in the invention. in the find the amount of dispersant used is 0%. 1-30 preferably 3-15% by weight.

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.

As a glidant; talc, magnesium stearate, hydrogenated vegetable oil, calcium stearate, stearic acid, colloidal silicon dioxide, sodium stearylfumate, polyoxyethyleneglycol, leucine, sodium benzoate, sodium chloride, sodium acetate, sodium fumarate, silica, colloidal anhydrous silica, polyethyleneglycol, cellulose derivatives, starch or their mixtures can be used. in the find preferably colloidal anhydrous silica is used. Amount of glidant used in the invention "Lubricant" in the Invention Flow of a powder mixture that reduces or inhibits friction It is expressed as agent or agent mixtures that improve its properties. lubricant aspect; talc, calcium stearate, magnesium stearate, aluminum stearate, polyethylene glycol, tristearin, stearic acid, sodium lauryl sulfate, magnesium lauryl sulfate, colloidal silicon dioxide, stearic acid, sodium stearyl fumarate, polyoxyethylene glycol, oleic acid, tripalmityl, potassium oleate, hydrogenated vegetable oils, leucine, alanine, glycine, caprylic acid, glyceryl behenate, glyceryl palmitostearate, sodium benzoate, sodium acetate, fumaric acid, zinc stearate, zinc oleate, zinc palmitate, paraffins, fatty alcohols or their mixtures can be used.

Preferably, magnesium stearate is used in the invention. The amount of lubricant used in the invention In the invention, purified water, water for injection, ethyl alcohol, methyl alcohol, Isopropyl alcohol or mixtures thereof can be used. In the invention preferably purified water is used.

In the invention, the term "film coating agent" causes the tablet content to degrade by moisture in the air. It is used to protect against unpleasant taste and to provide ease of swallowing tablets. expressed as substances or mixtures of substances. Film coating weight used in the invention The film coating agent used in the invention; at least one film-forming agent, at least one plasticizer, at least one at least one wetting agent, at least one opacifying/dyeing agent, at least one anti-adhesive agent and from the group consisting of at least one coloring agent and at least one coating solvent describes a composition that may contain one or more selected excipients.

As a film-forming agent; polyvinyl alcohol, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, methacrylic acid copolymer, basic butylated methyl methacrylate copolymer, polyethylene glycol, polyethylene oxide, gelatin or selected from among their mixtures. In the invention, it is preferably basic as a film-forming agent. butylated methyl methacrylate copolymer and/or hydroxypropyl methyl cellulose is used. The amount of film-forming agent used in the invention is 0.0l-8% by weight. is in the ratio.

In the invention, the term "plasticizer" is used to increase the flexibility of the coating, reduce the risk of film breakage. It is expressed as substances used to reduce the film and increase the adhesion of the film to the core. They must be compatible with the polymer and not be volatile.

As a plasticizer; polyethylene glycols (Macrogol), glycerin, propylene glycol, acetyl citrate, aniyl oleate, myristyl acetate, butyl oleate, butyl stearate, triacetin, diethylphthalate, acetylated monoglycerides or mixtures thereof may be used. Preferably as plasticizer in the invention polyethylene glycol is used. The amount of plasticizer used in the invention is 0.01-6% by weight. is in the ratio.

In the invention, the term "wetting agent" is readily available in the dispersion medium of hydrophobic drugs. It is expressed as substances used to help dispersal. slacker as an agent; sodium lauryl sulfate, sodium docusate, polysorbates, sorbitan monolaurate, octoxynol-9, nonoxynol-10, poloxamers, sodium carboxymethyl cellulose, bentonite, benzalkonium chloride, tetradecyltrimethyl ammonium bromide, cetylpyridinium chloride, glyceryl monostearate, macrogol cetostearyl ether, sorbitan tristearate, aluminum magnesium silicate or mixtures of these can be used. Preferably sodium lauryl sulfate in the invention is used. The amount of wetting agent used in the invention is 0.01-4% by weight.

In the invention, the term "opacifying/dying agent" is used as an additive to make the desired system opaque. referred to as items. As an opacifier / dyestuff; titanium dioxide, calcium carbonate, zinc acetate, aluminum stearate, zinc stearate, yellow iron oxide, Iron oxide pigments such as red iron oxide or their mixtures can be used.

Titanium dioxide is preferably used in the invention. The opacifier/dyer used in the invention the amount of substance is 0.01-5% by weight.

As an anti-adhesive agent in the invention; talc, colloidal silicon dioxide (Aerosil, Syloid, Cab- O-Sil), magnesium stearate, corn starch, magnesium trisilicate or mixtures thereof can be used. Talc is preferably used in the invention. The anti-adhesive used in the invention the amount of agent is 0.01-7% by weight.

In the invention, the term "coloring agent" is a pleasant-looking and intermediate between the two formulations. It is expressed as substances that provide optical discrimination. Colorant as substances, but not limited to, yellow iron oxide, red iron oxide such as iron oxide pigments, ß-carotene, red beet powder, chlorophyll, tartrazine, yellow orange, quinoline yellow, erythrosine, titanium dioxide pigments, caramel, sunset yellow or mixtures of these can be used. Yellow iron oxide is preferably used in the invention.

The amount of coloring matter used in the invention is 001-3% by weight.

In the invention, purified water, ethyl alcohol, methyl alcohol, isopropyl alcohol, alcohols such as butyl alcohol, acetone, diacetone, polyols, polyethers, alkyl ketones, methylene chloride, methyl acetate, ethyl acetate, isopropyl acetate, ethylene glycol monoethyl ether, diethylene glycol monobutyl ether, diethylene glycol monoethyl ether or mixtures thereof may be used.

Purified water and/or ethyl alcohol are preferably used in the invention.

Suitable active ingredient(s) and/or pharmaceutically acceptable in the present invention dosage range of formulations suitable for derivatives; Pinaverium and/or pharmaceutical 10-1200mg for acceptable derivatives; preferably 50mg and 100mg. adjusted to individual needs and expert judgment.

The invention contains Pinaverium and/or its pharmaceutically acceptable derivatives. film-coated tablet formulation for oral administration of pharmaceutical compositions It includes the following; - approximately 1-60% by weight of Pinaverium Bromide - about 1-80% by weight of one or more fillers/diluents - about 0%. One or more dispersants in a weight ratio of 1-30 - about 0.01-20% by weight of one or more glidants - one or more sliders of approximately 0.1-15% by weight -sufficient amount of granulation fluid - about 0.01-10% by weight of one or more film coating agents (this coating, about 0.01-8% by weight of one or more film-forming agents, about 0.01-6% one or more plasticizers by weight, approximately 0.01-4% by weight of one or more plasticizers more wetting agent, about 0.01-5% by weight of one or more opacifying/dying agent, one or more adhesions of approximately 0.01-7% by weight inhibitory agent and one or more coloring agents at a rate of about 0.01-3% by weight and a sufficient amount of one or more coating solvents.) The invention is mainly used for oral use with antispasmodic Pinaverium and/or where pharmaceutically acceptable derivatives are used alone as monotherapy or to the pharmaceutical composition(s) for which it is used as a combination therapy. find it It is essential that the pharmaceutical composition(s) be in the form of film-coated tablets. Thus obtained pharmaceutical formulation/s surprisingly in terms of physical and chemical stability exhibited a very stable behavior. In addition, to provide adequate therapeutic effect and side effects They have been found to be surprisingly effective in minimizing the effects.

Examples of the features of the invention are given below, but not limited to the following: Pharmaceuticals containing pinaverium and/or its pharmaceutically acceptable derivatives Film-coated tablet formulation for oral administration of the compounds includes; - approximately 1-60% by weight of Pinaverium Bromide - about 1 -80% by weight of lactose inonohydrate and/or microcrystalline cellulose - approx. 0.1-30% by weight pregelatinized starch - approximately 0.01-20% by weight colloidal anhydrous silica - about 0%. 1-15 parts by weight magnesium stearate - approximately 0.01-10% by weight of film coating agent (this coating is approximately 0.01-8% by weight) by weight basic butylated methyl methacrylate copolymer and/or hydroxypropyl methyl cellulose, ca. 0.01-6% wt. polyethylene glycol, ca. 0.01-4% wt. sodium lauryl sulfate, approx. 0.01-5% by weight titanium dioxide, approx. amounts of purified water and/or ethyl alcohol.) Pharmaceuticals containing pinaverium and/or its pharmaceutically acceptable derivatives Film-coated tablet formulation for oral administration of the compounds includes; - about 10-1200mg Pinaverium Bromide - about 5-600mg lactose monohydrate and/or microcrystalline cellulose - about l-75mg of pregelatinized starch - about 0.1-15mg colloidal anhydrous silica - about 0.1-25mg magnesium stearate - solid amount of salified water butylated methyl methacrylate copolyiner and/or hydroxypropyl methyl cellulose, ca. 0.0] - 10mg polyethylene glycol, approx. 0.01-8mg sodium lauryl sulfate, approx. 0.01-6mg% titanium dioxide, about 0.01-7mg of talc and about 0.01-3mg of yellow iron oxide and enough amounts of purified water and/or ethyl alcohol.) Production process: Pinaverium Bromide, pregelatinized starch, microcrystalline cellulose, lactose monohydrate suitable It is sieved from the sieve in the range and transferred to the appropriate granulator and mixed dry, Granulation Purified water is used as the liquid. Wet granulation is done. mourning ganulation The mixture is properly dried until it reaches the desired drying loss. dried The granules are sieved through a suitable sieve and the drying loss is controlled. microcrystalline cellulose and colloidal anhydrous silica are sieved through a suitable sieve. Dry granules sieved It is mixed with microcrystalline cellulose and colloidal anhydrous silica for a certain period of time. mix By adding magnesium stearate, the mixture is lubricated by mixing for a certain period of time. in hand The resulting mixture is compressed, suitable punches and tablets with appropriate physical parameters. is printed. The core tablets are coated with the film coating solution until the desired weight is obtained. is covered.

Claims (34)

REQUESTS . Preparation of pharmaceutical composition(s) in which the appropriate active ingredient and/or pharmaceutically acceptable derivatives with antispasmodic properties are used alone or in combination as monotherapy for oral use. . It is a pharmaceutical composition/s as in Claim P and its feature is; The appropriate active ingredient with antispasmodic properties is oxyphencycline, kamilofin, mebeverine, triinebutin, rosiverin, dicycloloverine, dihexiverine, diphemerin, piperidolate, benzylone, glycopyrronium, oxyphenonium, pentienate, propantheline, otinebutin, rosivinium, methantheline, dihexiverine, diphemerin, metanthelium, glycopyrronium, oxyphenonium, penthienate, propantheline, otyllium, otyllium, ethylenzoloncyclonium, metanthelium, cyclopyramidium, benzoethylencyclonium, metanthelium, cyclopyramidium, benzoethylencyclonixopyl, metanthelium, isthylencyclopropyldinium, metanthelin, , diphemanil, thiemonium, pyrifinium, thimepidium, phenpiverinium, dimethylaminopropionylphenothiazine, nicofetamide, thyropramide, papaverine, drotaverine, moxaverine, alosetron, tegaserod, silansetron, prucalopride, fenpiprane, chlorbenzodanipiprazole, phenpiprane, chlorobenzo, pyramidine, pyramidine, is selected from among caroverin, phloroglucinol, trimethyldiphenylpropylamine, silicones and/or pharmaceutically acceptable derivatives. . It is a pharmaceutical composition/s as in claim, and its feature is; The appropriate active ingredient with antispasmodic properties is preferably pinaverium bromide. . It is a pharmaceutical composition/s as in claim 1 and its feature is; tablet (chewable tablet, orally soluble tablet, dispersible tablet, water-dispersible tablet, film-coated tablet, enteric tablet, mini-tablet, controlled-release tablet (sustained-release tablet, immediate-release tablet, extended-release tablet, delayed-release tablet) etc.), capsule (hard, soft, enteric-coated, film-coated), controlled-release capsule (sustained-release capsule, immediate-release capsule, extended-release capsule, delayed-release capsule), powder, granule, caplet, disc, oral soluble film, bulk One or more pharmaceutical dosages selected from powder (multi-dose), pellet, sachet, water-dispersible powder, water-dispersible granule, effervescent tablet, effervescent granule, effervescent powder, gel, battery, liquid solution, ampoule, vial, infusion, or lyophilized powder contains the form. . It is a pharmaceutical composition/s as in Claim 4 and its feature is; preferably the pharmaceutical dosage form is a film-coated tablet. . It is a pharmaceutical composition/s as in claim 1 and its feature is; It is the use of direct compression and/or wet and/or dry granulation methods/s in the preparation of tablet/s. . The formulation of film-coated tablets for oral administration of pharmaceutical compositions containing pinaverium and/or its pharmaceutically acceptable derivatives includes; - approximately 1 - 60% by weight Pinaverium Bromide - approximately 1 -80% by weight of one or more fillers/diluent - approximately 0%. 1-30 wt.% of one or more dispersants - about 0.01-20% by weight of one or more glidants - about 0% one or more film-coating agents by weight (this coating consists of one or more film-forming agents at approximately 0.01-8% by weight, one or more plasticizers at approximately 0.01-6% by weight, one or more of approximately 0.01-4% by weight of one or more film-forming agents more wetting agents, about 0.01-5% by weight of one or more opacifying/dyestuffs, about 0.01-7% by weight of one or more anti-adhesive agents, and about 0.01-3% by weight of one or more coloring agents, and contains a sufficient amount of one or more coating solvents.) . The formulation of film-coated tablets for oral administration of pharmaceutical compositions containing pinaverium and/or its pharmaceutically acceptable derivatives contains the following; - approximately 1 - 60% by weight Pinaverium Bromide - approximately 1 -80% by weight lactose monohydrate and/or microcrystalline cellulose - approximately 0%. 1-30 wt% pregelatinized starch - ca. 0.01-20 wt% colloidal anhydrous Silica - ca. 0%. 1-15 wt% magnesium stearate - ca. 0.01-10 wt% film coating agent (this coating consists of ca. 0.01-8% wt. of basic butylated methyl inethacrylate copolymer and/or hydroxypropyl methyl cellulose, ca. , about 0.01-4% by weight of sodium lauryl sulfate, about 0.01-5% by weight of titanium dioxide, about 0.01-7% by weight of talc and about 0.01-3% by weight of yellow iron oxide and a sufficient amount of purified water and / or ethyl alcohol.) 9. It is a pharmaceutical composition/s as in Claim 77 and its feature is; of filler/diluent talc, lactose, sucrose, dextrin, mannitol, lactilol, lactitol, xylitol, sorbitol, isomalt, microcrystalline cellulose, powdered cellulose, dextrose, dextrate, pregelatinized starch, modified starch, corn starch anhydride, lactose anhydrous, lactose calcium phosphate, silicic acid, kaolin, hydroxy propyl methylcellulose, tribasic calcium phosphate, polyhydric alcohols or cellulose ethers, calcium hydrogen phosphate dihydrate, calcium sulfate trihydrate, cellulose calcium sulfate, calcium sulfate dihydrate, maltodextrin, calcium carbonate, kaolin, sodium hydroxide or their is chosen from among the mixtures. 10. It is a pharmaceutical composition/s as in Claim 9 and its feature is; the filler/diluent is preferably lactose monohydrate and/or microcrystalline cellulose. 11. It is a pharmaceutical composition/s as in Claim 7 and its feature is; dispersant agar agar, calcium carbonate, sodium carbonate, alginic acid, potato starch, corn starch, wheat starch, pregelatinized starch, starches such as sodium starch glycolate, microcrystalline cellulose, cross-linked polyvinyl pyrrolidone, cross-linked polyvinyl pyrrolidone, sodium alginate, hydroxypropyl hydroxyl cellulose cellulose, croscarinellose sodium, clay, ion exchange resin, crospovidone, xylitol, D-sorbitol, D-inannitol, lactose, sucrose, urea, high molecular weight polymers, povidone, alginic acid, xanthan gum, colloidal silicon dioxide, or a mixture of these . 12. It is a pharmaceutical composition/s as in Claim 11 and its feature is; the dispersant is preferably pregelatinized starch, 13. It is a pharmaceutical composition/s as in Claim 7 and its feature is; glidantine talc, magnesium stearate, hydrogenated vegetable oil, calcium stearate, stearic acid, colloidal silicon dioxide, sodium stearylfumarate, polyoxyethyleneglycol, leucine, sodium benzoate, sodium chloride, sodium acetate, sodium fumarate, silica, colloidal anhydrous silica, polyethyleneglycol, cellulose derivatives, starch or their mixtures. 14. It is a pharmaceutical composition/s as in Claim 13 and its feature is; the glidantine is preferably colloidal anhydrous silica. 15. It is a pharmaceutical composition/s as in Claim 7 and its feature is; lubricant talc, calcium stearate, magnesium stearate, aluminum stearate, polyethylene glycol, tristearin, stearic acid, sodium lauryl sulfate, magnesium lauryl sulfate, colloidal silicon dioxide, stearic acid, sodium stearyl fumarate, polyoxyethylene glycol, oleic acid, tripalinityl, potassium oleate, hydrogenated vegetable oils, leucine, alanine, glycine, caprylic acid, glyceryl behenate, glyceryl palmitostearate, sodium benzoate, sodium acetate, fumaric acid, zinc stearate, zinc oleate, zinc palmitate, paraffins, fatty alcohols or mixtures thereof. 16. It is a pharmaceutical composition/s as in Claim 15 and its feature is; preferably the lubricant is magnesium stearate. 17. It is a pharmaceutical composition/s as in claim 7 and its feature is; granulation liquid is selected from purified water, water for injection, ethyl alcohol, methyl alcohol, isopropyl alcohol or mixtures of these. 18. It is a pharmaceutical composition/s as in Claim 17 and its feature is; the granulation liquid is preferably purified water. 19. It is a pharmaceutical composition/s as in claim 7 and its feature is; Purified water of coating solvent, alcohols such as ethyl alcohol, methyl alcohol, isopropyl alcohol, butyl alcohol, acetone, diacetone, polyols, polyethers, alkyl ketones, methylene chloride, methyl acetate, ethyl acetate, isopropyl acetate, ethylene glycol monoethyl ether, diethylene glycol monobutyl ether, diethylene glycol monoethyl ether or mixtures thereof. 20. It is a pharmaceutical composition/s as in claim 19. Its feature is; the coating solvent is preferably purified water and/or ethyl alcohol. 21. It is a pharmaceutical composition/s as in Claim 7 and its feature is; The film forming agent is selected from among polyvinyl alcohol, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, methacrylic acid copolymer, basic butylated methyl methacrylate copolymer, polyethylene glycol, polyethylene oxide, gelatin or mixtures thereof. 22. It is a pharmaceutical composition/`s as in claim 2l and its feature is; preferably basic butylated methyl methacrylate copolymer and/or hydroxypropyl methyl cellulose. 2.3. The request is pharmaceutical composition/s as in 7° and its feature is; plasticizer polyethylene glycols (Macrogol), glycerine, propylene glycol, acetyl citrate, arnyl oleate, myristyl acetate, butyl oleate, butyl stearate, triacetin, diethylphthalate, acetylated monoglycerides or mixtures thereof. 24. It is a pharmaceutical composition/s as in Claim 23 and its feature is; preferably the plasticizer is polyethylene glycol as the plasticizer. 25. It is a pharmaceutical composition/s as in Claim 7 and its feature is; wetting agent sodium lauryl sulfate, sodium docusate, polysorbates, sorbitan monolaurate, octoxynol-9, nonoxynol-10, poloxamers, sodium carboxymethyl cellulose, bentonite, benzalkonium chloride, tetradecyltrimethyl ammonium bromide, cetylpyridinium chloride, glyceryl cetosterate, trigolocteraterate, trigolocteraterate, esterostarate aluminum magnesium silicate or their mixtures. 26. It is a pharmaceutical composition/s as in Claim 257 and its feature is; preferably the wetting agent is sodium lauryl sulfate. 27. It is a pharmaceutical composition/s as in Claim 7 and its feature is; The opacifier/dyer is selected from among iron oxide pigments such as titanium dioxide, calcium carbonate, zinc acetate, aluminum stearate, zinc stearate, yellow iron oxide, red iron oxide or their mixtures. 28. It is a pharmaceutical composition/s as in Claim 27. Its feature is; The opacifier/dyer is preferably titanium dioxide. 29. It is a pharmaceutical composition/s as in Claim T, and its feature is; The anti-adhesive agent is selected from talc, colloidal silicon dioxide (Aerosil, Syloid, Cab-O-Sil), magnesium stearate, corn starch, magnesium trisilicate or mixtures thereof. 30. It is a pharmaceutical composition/s as in claim 29 and its feature is; preferably the anti-adhesive agent is talc. 31. It is a pharmaceutical composition/s as in claim, and its feature is; the coloring matter is not limited to, but is not limited to, iron oxide pigments such as yellow iron oxide, red iron oxide, ß-carotene, red beet powder, chlorophyll, tartrazine, yellow orange, quinoline yellow, erythrosine, titanium dioxide pigments, caramel, sunset yellow or their is chosen from among the mixtures. 32. It is a pharmaceutical composition/s as in Claim 31 and its feature is; the coloring matter is preferably yellow iron oxide. 33. It is a pharmaceutical composition/s according to any of the above claims and its feature is; Dose range of formulations suitable for Pinaverium and/or its pharmaceutically acceptable derivatives; It is 10-1ZOOmg. 34. It is a pharmaceutical composition/s according to any of the above claims and its feature is; Pain due to functional intestinal disorders, transition disorders, stomach ache, irregular bowel diseases (constipation, diarrhea..), restoring the normal contraction of the intestine, relaxation of the intestinal muscles, reducing spasm, bloating, irritable bowel syndrome, bile duct and bile duct It is indicated for the therapeutic and/or prophylactic and/or symptomatic treatment of symptoms associated with other intestinal disorders (including in the preparation of barium enemas), the relief of stomach or intestinal complaints caused by medical conditions in the intestine or bile duct.