TR201310782A2 - Compositions used in pain treatment - Google Patents

Abstract

The present invention includes; pain (mild), pain (moderate), actinic keratosis, allergic conjunctivitis, ankylosing spondylitis, arthralgia, headache, dysmenorrhea, photophobia, heterotopic ossification, bone pain, keratoconjunctivitis, corneal ulcer, migraine, myalgia, myosis inhibition, ocular pain, relates to pharmaceutical compositions comprising a suitable non-steroidal anti-inflammatory (NSAID) active agent and / or pharmaceutically acceptable derivatives thereof for use in the prophylactic, symptomatic or therapeutic treatment of postoperative ocular inflammation, rheumatoid arthritis.

Description

DESCRIPTION COMPOSITIONS USED IN THE TREATMENT OF PAIN FIELD OF THE INVENTION The present invention; pain (mild), pain (moderate), actinic keratosis, allergic conjunctivitis, ankylosing spondylitis, arthralgia, headache, dysmenorrhea, photophobia, heterotopic ossification, bone pain, keratoconjunctivitis, corneal ulcer, migraine, myalgia, miosis inhibition, ocular pain, osteoarthritis, postoperative ocular inflammation, prophylactic, symptomatic of rheumatoid arthritis a non-steroidal anti-inflammatory drug for use in the treatment or therapeutic Accept the appropriate active substance with inflammatory (NSAID) properties and/or pharmaceutical It relates to pharmaceutical compositions containing soluble derivatives.

The present invention; non-steroidal anti-inflammatory (NSAID) agent Diclofenac, 2[(2,6-dichlorophenyl)amino]benzeneacetic acid (Formula 1) and/or have pharmaceutically acceptable derivatives and are active in suitable pharmaceutical forms. relates to pharmaceutical compositions in which it is used as a substance.

Formula 1: In addition, the invention includes Diclofenac and/or its pharmaceutically acceptable derivatives. of pharmaceutical compositions suitable for oral, parenteral, rectal, ophthalmic, topical administration formulations and their prophylactic, symptomatic or therapeutic use. covers. PRIOR ART (KNOWN STATE OF THE ART) Non-steroidal anti-inflammatory drugs (N SAIDs) are widely used in modern medicine. is used. NSAIDs that convert aracidonic acid to prostaglandin H2 they alleviate inflammation. They can be classified as follows according to their chemical groups. o Salicylic acids o Propionic acids o Fenamates o Oxicams he understands Pyrazole Diclofenac, an acetic acid NSAID derivative used in the treatment of inflammation and pain It has analgesic and antipyretic properties as well as anti-inflammatory activity. Other It has higher anti-inflammatory, antipyretic and analgesic efficacy than NSAIDs.

Non-effervescent containing Diclofenac Sodium in patent application EP1312355 from the preparation of water-soluble solid pharmaceutical form, to mask bad taste The use of excipients is mentioned.

Modified-release drug formulations, although they may be more expensive, short half-life, peak, in which adherence to treatment is important for treatment success For drugs that reach concentration rapidly, with varying pharmacokinetics, they are convenient and reduce the cost of treatment (Immediate Release and Extended Release in Treatment Differences of Formulations, Yagiz Uresinl, Elif Baranz, Bulletin of Clinical Psychopharmacology, Volume: 21, Supplementary Issue: 1, 2011) DESCRIPTION OF THE INVENTION The present invention; pain (mild), pain (moderate), actinic keratosis, allergic conjunctivitis, ankylosing spondylitis, arthralgia, headache, dysmenorrhea, photophobia, heterotopic ossification, bone pain, keratoconjunctivitis, corneal ulcer, migraine, myalgia, miosis inhibition, ocular pain, osteoarthritis, postoperative ocular inflammation, prophylactic, symptomatic of rheumatoid arthritis a non-steroidal anti-inflammatory drug for use in the treatment or therapeutic Accept the appropriate active substance with inflammatory (NSAID) properties and/or pharmaceutical It relates to pharmaceutical compositions containing soluble derivatives.

Another aspect of the present invention is; anti-steroidal anti-steroid for oral use Accept the appropriate active substance with inflammatory (NSAID) properties and/or pharmaceutical It relates to pharmaceutical compositions containing soluble derivatives.

Non-steroidal anti-inflammatory agent (NSAID) used in the invention dexketoprofen, ibuprofen, alminoprofen, benoxaprofen, carprofen, dexibuprofen, fenbufen, fenoprofen, flunoxaprofen, flurbiprofen, ibuproxam, indoprofen, ketoprofen, loxoprofen, miroprofen, naproxen, oxaprozin, pirprofen, suprofen, tarenflurbil, tiaprofenic acid, diclofenac, aceclofenac, acemetacin, alclofenac, broinfenac, etodolac, ketorolac, sulindac, lanozolac, oxamethasine, proglumethacin, tolmetin, zomepirac, bumadizoii, fentiazac, diphenpramide, bufexamak and/or pharmaceuticals acceptable Among its derivatives, it is preferably chosen as Diclofenac sodium.

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, 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 (chewable, mouth-soluble, dispersible, water-dispersible, film coated, bilayer, multilayer, enteric coated, mini, controlled release, sustained release, immediate release, extended release, delayed release, modified release, modified release), capsule (hard, soft, enteric-coated, film-coated, controlled-release, sustained-release, immediate release, extended release, delayed release, modified release, modified release), powder, granule, caplet, disc, oral film, bulk powder (multidose), pellet, sachet, aqueous dispersible powder, water dispersible granule, effervescent tablet, effervescent granule, effervescent powder form, gel, pill, syrup, solution, suspension, elixir, drop, position, emulsion or may be formulated in a dosage form such as a spray.

In order to provide adequate therapeutic effect and to minimize side effects, the drug should be formulations to control its release; modified, extended, continuous, one or more of immediate, delayed, modified release pharmaceutical dosage forms can be formulated with

The oral pharmaceutical modified-release tablet formulation used in the invention is an appropriate agent. substance(s) as well as at least one binder, at least one glidant, at least one lubricant, at least a release controlling agent, at least one diluent, at least one coating agent, granulation solvent and at least one film coating solvent describes a composition that may contain one or more selected excipients.

The term "binding agent" in the invention; keeping the ingredients together, tablets, pellets or ensuring that the granules are formulated with the required mechanical strength and low active dosage. It is expressed as the substance or mixture of substances used to give volume to the units.

As the aforementioned binding substance; pregelatinized corn starch, pregelatinized starch, gelatin, microcrystalline cellulose, cellulose, gums, polyvinyl pyrrolidone, polymethacrylates, sodium carboxy methyl cellulose, starch, paraffins, stearic acid, methyl cellulose, ethyl cellulose, polyethyleneglycol, carboxy methylcellulose, hydroxy propylcellulose, hydroxy ethylcellulose, crospovidone, povidone, copovidone, hypromellose or their mixtures can be used.

Povidone is preferably used in the invention. The amount of binder used in the invention 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, lethal, sodium benzoate, sodium chloride, sodium acetate, sodium fumarate, silica, colloidal anhydrous silica, polyethyleneglycol, cellulose derivatives, starch, synthetic amorphous silica or their mixes can be used. Talc and colloidal silicon dioxide are preferably used in the invention.

The amount of glidant used in the invention is 0.001-10% by weight.

In the invention, the term "lubricant" refers to the 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, uimaric 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 As "release controlling agent" in the invention; polyvinyl acetate phthalate, polyethylene glycol-polyvinyl alcohol copolymer, polyacrylic acid derivatives, polysaccharide derivatives, methacrylate polymer, polymethacrylate, ethyl methacrylate copolymer, methacrylic acid-methylmethacrylate copolymer, methacrylic acid-ethyl acrylate copolymer, polylactic acid, polylactic acid copolymer, polyvinylpyrrolidone, polyvinylalcohol, glyceride, polyethylene oxide, glyceryl behenate, methacrylic acid copolymer, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose acetate, dioxy methyl cellulose succinate, carboxy methyl ethyl cellulose, sodium carboxy methyl cellulose, ethyl cellulose, methyl acrylate, ethylacrylate, methylmethacrylate, ethylmethacrylate, acrylic and methacrylic acid esters, sodium alginate, hypromellose phthalate, hypromellose acetate succinate, cellulose butyrate phthalate, cellulose hydrogen phthalate, cellulose propyanate phthalate, cellulose acetate phthalate, cellulose acetate trimellitate, gelatin, celak, xanthan gum, cetyl alcohol or mixtures thereof can be used. Hydroxypropyl methyl cellulose and cetyl alcohol are preferably used in the invention.

The amount of release controlling agent used in the invention is 1 to 60% by weight.

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; talc, lactose, sucrose, dextrin, mannitol, lactilol, lactitol, xylitol, sorbitol, isomalt, microcrystalline cellulose, powdered cellulose, dextrose, dextrate, pregelatinized starch, modified starch, 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, calcium sulfate trihydrate, cellulose calcium sulfate, calcium sulfate dihydrate, maltodextrin, calcium carbonate, kaolin, sodium hydroxide or mixtures thereof can be used. Sucrose is preferably used in the invention. The diluent used in the invention the amount is 3-70%, preferably 10-40% by weight.

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 It is 1-40 mg, 0% of the total tablet weight. 1-15°i and preferably 1%-S.

The film coating agent used in the invention; at least one film-forming agent, at least one opacifier Ingredient, at least one plasticizer, at least one glidant, at least one film coating solvent, and optionally one or more selected from the group consisting of at least one coloring agent, depending on the describes a composition that may contain more excipients.

As a Film Maker agent; polyvinyl alcohol, hydroxypropyl methyl cellulose, methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, methacrylic acid copolymer, polyethylene glycol, polyethylene oxide, gelatin or mixtures thereof. preferably in the invention Hydroxypropyl methyl cellulose is used as film forming agent. in the find The amount of film forming agent used is 0.1-10% by weight.

In the invention, the term "opacifying agent" refers to the addition of the desired system to make it opaque. referred to as items. As an opacifying agent; titanium dioxide, calcium carbonate, zinc acetate, aluminum stearate, zinc stearate or mixtures thereof can be used. Titanium dioxide is preferably used in the invention. used in the invention The amount of opacifying agent is 0.1-5% by weight.

In the invention, the term "plasticizer" is used to increase the flexibility of the composition, reduce the risk of breakage. and as a substance or mixtures of substances used to increase adhesion to the core Expressed. Desired mechanical properties such as flexibility and hardness of the coating layers Plasticizers are used to provide Thus, the coated pharmaceutical compound It is ensured that the acid resistance does not decrease. As the aforementioned plasticizer; polyethylene glycol, glycerin, propylene glycol, cetyl alcohol, polysorbate, acetyl citrate, triethylcitrate, acetyl triethyl citrate, dibutyl sebecate, dibutyl tartrate, dibutyl maleate, dibutyl succinate, diethyl succinate, arnyl oleate, myristyl acetate, butyl oleate, butyl stearate, triacetin, diethylphthalate, dibutylphthalate, acetylated monoglycerides or mixtures thereof may be used. In the invention preferably polyethylene glycol is used. The amount of plasticizer used in the invention is 0.01-5% by weight.

In the invention, the term "coloring agent" is a pleasant-looking and intermediate between the two formulations. They are expressed as substances that provide optical discrimination. Colorant as substances, but not limited to, yellow iron oxide, red iron oxide iron oxide pigments such as ß-carotene, red beet powder, chloroûl, tartrazine, yellow orange, quinoline yellow, erythrosine, titanium dioxide pigments, caramel, tartrazine aluminum lacquer, synthetic yellow azo aluminum lacquer or their mixtures can be used.

In the invention, preferably yellow iron oxide, tartrazine aluminum lacquer and synthetic yellow azo aluminum lacquer is used. The amount of coloring matter used in the invention is 0.0001-0.1% by weight. is in the ratio.

In the invention, purified water, ethyl alcohol, isopropyl alcohol or any of these are used as the granulation solvent. mixes can be used. Isopropyl alcohol is preferably used in the invention.

In the invention, purified water, ethyl alcohol, methyl alcohol, isopropyl alcohol, butyl are used as film coating solvents. alcohols such as 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.

Pure water is preferably used in the invention.

Diclofenac Sodium and/or pharmaceutically acceptable in the present invention dose range of suitable formulations of pharmaceutical compositions containing derivatives; The invention contains Diclofenac and/or its pharmaceutically acceptable derivatives. pharmaceutical modified release tablet for oral administration of pharmaceutical compositions Its formulation includes the following; - approximately 10-60% by weight Diclofenac Sodium - about 0%. l One or more binders in a weight ratio of -10 - about 0.001-10% by weight of one or more glidants - one or more lubricants at a weight ratio of approximately 0.01 -6 % - about 1% to 60% by weight of one or more release controlling agents - about 3 -70% by weight of one or more diluents -sufficient amount of granulation solvent - one or more film coating agents in a ratio of about 0.1-15% by weight (this coating, At least one film-forming agent at a rate of approximately 0.1-10% by weight, approximately 0.1-5% by weight at least one opacifying agent, approximately 0.01-5% by weight plasticizer, approximately 0.001-3% by weight of at least one glidant and optionally It contains at least one coloring matter at a weight ratio of approximately 0.0001% -0.1%.) -And a sufficient amount of one or more film coating solvents.

The invention is mainly used as a non-steroidal anti-inflammatory drug for oral use. (NSAID) and/or pharmaceutically acceptable pharmaceutical derivatives and pharmaceutically acceptable excipients relates to the composition/s. Modified-release tablet of the pharmaceutical compositions of the invention Being in shape is essential. The pharmaceutical forms thus obtained are surprisingly showed a very stable behavior in terms of physical and chemical stability. Moreover an astonishing approach to ensure adequate therapeutic effect and minimize side effects. It has been determined that they are effective in this way.

Examples of the features of the invention are given below, but not limited to the following: Pharmaceuticals containing diclofenac and/or its pharmaceutically acceptable derivatives pharmaceutical modified release tablet for oral administration of compositions Its formulation includes the following; - approximately 10-60% by weight Diclofenac Sodium - approximately 0.1-10% by weight povidone - approximately 0.001-10% by weight of talc and colloidal silicone - approx. 001 to 6% by weight magnesium stearate - approximately 1-60% by weight of hydroxypropyl methyl cellulose and cetyl alcohol - approx. 3 -70% by weight sucrose -sufficient amount of isopropyl alcohol - one or more film coating agents in a ratio of about 0.1-15% by weight (this coating, approximately 0.1-10% by weight hydroxypropyl methyl cellulose, approximately 0.1-5% by weight part titanium dioxide, approximately 0.01-5% by weight polyethylene glycol, approximately yellow iron oxide, tartrazine aluminum lacquer and synthetic yellow azo aluminum lacquer includes.) -And enough pure water.

Pharmaceuticals containing diclofenac and/or its pharmaceutically acceptable derivatives pharmaceutical modified release tablet for oral administration of compositions Its formulation includes the following; - about 12.5 -225mg Diclofenac Sodium - about l-30mg of povidone - about 0.01-20mg of talc and colloidal silicon - about 0.1-8mg magnesium stearate - about 10-250mg of hydroxypropyl methyl cellulose and cetyl alcohol - about 25-250mg sucrose -sufficient amount of isopropyl alcohol - approximately 1-40mg of one or more film coating agents (this coating is approximately 1-30mg hydroxypropyl methyl cellulose, approx. 1-8mg titanium dioxide, approx. 0.1-4mg polyethylene glycol, approximately 0.01-3mg talc and optionally approximately 0.001-lmg yellow iron oxide, tartrazine aluminum lacquer and synthetic yellow azo aluminum lac.) -And enough pure water. Production process: All raw materials are weighed and then sieved through the appropriate sieve. Diclofenac Sodium, sucrose, cetyl alcohol and hydroxypropyl methyl cellulose (HPMC) are mixed in the granulator. The resulting mix It is mixed with povidone solution prepared with isopropyl alcohol. Wet granules are dried and sieved through the appropriate sieve. The obtained granules are pre-screened talc, HPMC and colloidal mixed with silicon dioxide. The resulting mixture was mixed with pre-sifted magnesium stearate. is mixed. The mixture is compressed into tablets using suitable punches. The resulting tablets coated with the appropriate coating solution.

Claims (3)

REQUESTS 1. Preparation of pharmaceutical composition/s containing an appropriate non-steroidal anti-inflammatory (NSAID) active ingredient and/or pharmaceutically acceptable derivatives and suitable pharmaceutically acceptable excipients for oral use. 2. It is the pharmaceutical composition/s specified in Claim 1 and its feature is; non-steroidal anti-inflammatory (NSAID) suitable active ingredient dexketoproferi, ibuprofen, almiioprofen, benoxaprofen, carprofen, dexibuprofen, fenbufen, fenoprofen, flunoxaprofen, flurbiprofen, ibuproxam, indoprofen, ketoprofen, ibuproprofen, indoprofen, ketoprofen, ibuproprofen, indoprofen, ketoprofen, mixoprofen, oxaprofen, 10 acceptable as suprofen, tarenflurbil, tiaprofenic acid, diclofenac, aceclofenac, acemetacin, alclofenac, bromfenac, etodolac, ketorolac, sulindac, lanozolac, oxamethacin, proglumethacin, tolmetin, zomepirac, bumadizone, phenthiazac, phenthiazac, or arachnid are acceptable. . 15 3. Pharmaceutical modified release tablet formulation for oral administration of pharmaceutical compositions containing diclofenac and/or its pharmaceutically acceptable derivatives comprising; - approximately 10-60% by weight Diclofenac Sodium - approximately 0.1-'10% by weight one or more binders 20 - approximately 0.001-`10% by weight one or more glidants - approximately 0.01-6% by weight one or more more lubricant - approximately 1 - 60% by weight of one or more sales-controlling agents - approximately 3 -70% by weight of one or more diluents - a cuff amount of granulation solution 25 - approximately 0.1-15% by weight of a or more film coating agents (this coating includes at least one film-forming agent at approximately 0.1-10% by weight, at least one plasticizer at approximately 0.001-3% by weight of at least one glidant, and optionally approximately 0.0001% by weight- It contains at least one colorant 30 substance at a weight ratio of 0.1) - and one or more film coating solvents in a solid amount. . The pharmaceutical modified release tablet formulation for oral administration of pharmaceutical compositions containing diclofenac and/or its pharmaceutically acceptable derivatives contains the following; - approximately 10-60% by weight Diclofenac Sodium - approximately 0%. l -10 wt% povidone - ca. 0.001-10 wt.% talc and colloidal silicone - ca. 0.01-6% wt. magnesium stearate - approx. 1-60 wt.% hydroxypropyl methyl cellulose and cetyl alcohol - approx. 3-70 wt.% sucrose - sufficient amount of isopropyl alcohol - approximately 0.1-15% by weight one or more film coating agents (this coating is approximately 0.1-10% by weight hydroxypropyl methyl cellulose, approximately glycol, approximately 0.001-3% by weight) It contains talc and optionally about azo aluminum lacquer.) -And enough distilled water. . It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; binder pregelatinized corn starch, pregelatinized starch, gelatin, microcrystalline cellulose, cellulose, gums, polyvinyl pyrrolidone, polymethacrylates, sodium carboxy methyl cellulose, starch, paraffins, stearic acid, methyl cellulose, methyl cellulose, ethyl cellulose, polyethyleneglycol, carboxyoxymethylcellulose ethylcellulose, crospovidone, povidone, copovidone, hypromellose or mixtures thereof. . It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; The binding agent is preferably povidone. . It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; glidantin; talc, magnesium stearate, hydrogenated vegetable oil, calcium stearate, stearic acid, colloidal silicon dioxide, sodium stearylfumate, polyoxyethyleneglycol, leucine, lethal, sodium benzoate, sodium chloride, sodium acetate, sodium fumarate, silica, colloidal anhydrous silica, polyethyleneglycol, cellulose derivatives , starch, synthetic amorphous silica or mixtures thereof. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; the glidant is preferably talc and colloidal silicon dioxide. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; lubricant talc, calcium stearate, magnesium stearate, aluminum stearate, polyethylene glycol, tristearin, stearic acid, sodium lauryl sulfate, magnesium laurii 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, paratins, fatty alcohols or mixtures thereof. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; the lubricant is preferably magnesium stearate. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; polyvinyl acetate phthalate, polyethylene glycol-polyvinyl alcohol copolymer, polyacrylic acid derivatives, polysaccharide derivatives, methacrylate polymer, polymethacrylate, ethyl methacrylate copolymer, methacrylic acid-methylmethacrylate copolymer, methacrylic acid-ethyl acrylate copolymer, polylactic acid-ethyl acrylate copolymer, polyvinyl acetate phthalate, release controlling agent , polyvinylpyrrolidone, polyvinylalcohol, glyceride, polyethylene oxide, glyceryl behenate, methacrylic acid copolymer, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose acetate, dioxy methyl cellulose succinate, carboxy methyl ethyl cellulose, sodium carboxyethyl ethyl cellulose, sodium, methyl ethyl methyl cellulose, ethylacrylate, methylmethacrylate, ethylmethacrylate, acrylic and methacrylic acid esters, sodium alginate, hypromellose phthalate, hypromellose acetate succinate, cellulose butyrate phthalate, cellulose hydrogen phthalate, cellulose propyanate phthalate, cellulose acetate phthalate, cellulose acetate trimellitacel, cellulose acetate trimellitacel, cellulose gelathane cetaminophen, alcohol or their is to be chosen among the pictures. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; preferably the release controlling agent is hydroxypropyl methyl cellulose and cetyl alcohol. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; of diluent talc, lactose, sucrose, dextrin, mannitol, lactilol, lactitol, xylitol, sorbitol, isomalt, microcrystalline cellulose, powdered cellulose, dextrose, dextrate, pregelatinized starch, modified starch, starch, lactitol monohydrate, corn starch anhydrous, cellulose 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. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; preferably the diluent is sucrose. It is a pharmaceutical composition/s according to any of the above-mentioned claims 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, polyethylene glycol, polyethylene oxide, gelatin or their mixtures. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; The film forming agent is preferably hydroxypropyl methyl cellulose. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; The opacifying agent is selected from titanium dioxide, calcium carbonate, zinc acetate, aluminum stearate, zinc stearate or mixtures thereof. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; preferably the opacifying agent is titanium dioxide. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; plastifiyanin polyethylene glycol, glycerine, propylene glycol, cetyl alcohol, polysorbate, acetyl citrate, triethylcitrate, acetyl triethyl citrate, dibutyl sebecate, dibutyl tartrate, dibutyl maleate, dibutyl succinate, diethyl succinate, ami] oleate, myrisolerate, butyl stearate, butyl acetate, triacetin is selected from diethylphthalate, dibutylphthalate, acetylated monoglycerides or mixtures thereof. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; preferably the plasticizer is polyethylene glycol. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; iron oxide pigments such as yellow iron oxide, red iron oxide, ß-carotene, beet powder, chlorophyll, tartrazine, yellow orange, quinoline yellow, erythrosine, titanium dioxide pigments, caramel, tartrazine aluminum lacquer, synthetic yellow azo aluminum lacquer or is to choose from among their mixtures. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; the coloring matter is preferably yellow iron oxide, tartrazine aluminum lacquer and synthetic yellow azo aluminum lacquer. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; The granulation solvent is selected from pure water, ethyl alcohol, isopropyl alcohol or mixtures of these. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; preferably the granulation solvent is isopropyl alcohol. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; of the film coating solvent purified water, 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. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; the film coating solvent is preferably pure water. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; The dose range of suitable formulations of pharmaceutical compositions containing diclofenac and/or its pharmaceutically acceptable derivatives is 12.5-225 mg. It is a pharmaceutical composition/s according to any of the above-mentioned claims and its feature is; pain (mild), pain (moderate), actinic keratosis, allergic conjunctivitis, ankylosing spondylitis, arthralgia, headache, dysmenorrhea, photophobia, heterotopic ossification, bone pain, keratoconjunctivitis, corneal ulcer, migraine, myalgia, myosis inhibition, o It is indicated for the prophylactic, symptomatic or therapeutic treatment of osteoarthritis, postoperative ocular inflammation, rheumatoid arthritis.