UA145355U - METHOD OF TREATMENT OF PAIN AND INFLAMMATION - Google Patents

Abstract

A method of treating pain and inflammation comprises administering a pharmaceutical composition comprising an active pharmaceutical ingredient of formula (I) and at least one excipient and in the form of a solution for injection. (AND)

Description

The useful model belongs to the field of medicine, namely to methods of prevention and symptomatic treatment of pain and inflammation.

Technical level

Pain (physical) is an unpleasant feeling that occurs in a person. Pain is one of the most important and most alarming signs of a disorder in the body, which ultimately prompts the patient to seek professional medical help.

To date, several mechanisms of pain formation have been studied: nociceptive, neuropathic, psychogenic, and others. Nociceptive pain syndrome appears as a result of activation of nociceptors during trauma, inflammation, ischemia, tissue swelling. Impulses that arise at the same time enter the ascending nociceptive pathways and reach the higher parts of the nervous system, as a result of which a feeling of pain is formed.

With neuropathic pain syndrome, the mechanisms of generation and conduction of nociceptive signals in nerve fibers and processes of controlling the excitation of nociceptive neurons in the structures of the spinal cord and brain are disturbed. Nerve damage leads to structural and functional changes in nerve fibers, resulting in an inadequate response of the nervous system to irritation. For these reasons, the pain sensation is formed.

In clinical practice, a combination of various pain syndromes is most common.

For example, in rheumatoid arthritis, inflammatory (nociceptive) pain is combined with neuropathic pain.

Depending on the duration, the pain can be acute or chronic. Acute pain is associated with damage, the elimination of which leads to the disappearance of pain. Pain lasting more than 3 months, which lasts longer than the normal tissue healing period, is considered chronic.

Chronic pain, due to its prevalence among the population, is considered a separate disease in modern clinical practice.

According to the localization of acute pain, the following are distinguished: 1) superficial, which occurs in case of damage to the skin; 2) deep, which occurs with damage to the musculoskeletal system (for example, irritation of muscle receptors, tendons, ligaments, joints and bones);

From 3) visceral, which occurs when internal organs are damaged; 4) reflected pain, that is, the projection of pain in dermatomes that are innervated by the same segments as those involved in the pathological process.

Most often, the pain syndrome is not a separate disease, but a symptom of another disease, in particular, diseases accompanied by inflammatory processes, for example, arthritis. In general, inflammatory processes accompany a large number of human diseases, as they are the result of the body's protective reaction to the action of various harmful agents.

Arthritis is one of the leading causes of disability worldwide. Arthritis is a general designation of diseases (damages) of the joints of inflammatory etiology. Arthritis occurs in acute and chronic form with damage to one or more joints. At the same time, all types of arthritis are accompanied by pain, the nature of which depends on the type of arthritis. Arthritis is also characterized by reddening of the skin, limitation of joint mobility and a change in their shape.

The main class of pharmaceuticals used for the symptomatic treatment of pain and inflammation, particularly arthritis, are non-steroidal anti-inflammatory drugs. Opioid drugs are often recommended as an alternative to non-steroidal anti-inflammatory drugs, but they have obvious disadvantages, namely the possibility of drug addiction in the patient.

In the modern world, acute or chronic pain, which in particular are symptoms of diseases accompanied by inflammatory processes, e.g. arthritis is one of the most common causes of disability, disability and social maladjustment. Pathological conditions such as depression, sleep disorders, development and progression of the cardiovascular system are closely related to pain.

The need for long-term pharmacotherapy of pain becomes a heavy burden for the person suffering from pain, as well as for society. Moreover, chronic pain is considered as a serious factor that affects life prognosis.

A known method of symptomatic therapy for osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, as well as for pain and signs of inflammation associated with acute gouty arthritis, which includes the use of the pharmaceutical drug ARKOXIAF (see the web page at the address: /ПЕр:/ЛикисопигоЙ. sot.tsa/instructions/?(120551). The well-known pharmaceutical drug is produced in the form of film-coated tablets containing 30 mg, 60 mg, 90 mg or 120 mg of etoricoxib, as well as auxiliary substances - anhydrous calcium phosphate, microcrystalline cellulose , croscarmellose sodium and magnesium stearate.

According to the known method, the pharmaceutical preparation is used orally, regardless of food intake. In the case of the need for rapid relief of symptoms, it is recommended to take the drug on an empty stomach. The recommended daily dose is from 30 mg to 120 mg of the active pharmaceutical ingredient per day, depending on the patient's condition.

The disadvantages of the known method are largely related to the dosage form of the pharmaceutical drug used in the method, i.e., the unpleasant smell and taste of the tablets, complications of taking tablets in case of impaired swallowing, complications of taking tablets in diseases of the liver and digestive tract, the influence of digestive enzymes and constituent parts of food on the disintegration of tablets and the absorption of active pharmaceutical ingredients, as well as the dependence of the absorption of the active pharmaceutical ingredient (API) on the filling of the digestive tract. In particular, the effectiveness of treatment according to the known method depends on the filling of the digestive tract, and the onset of action of the tablets of the known pharmaceutical drug occurs faster when taken on an empty stomach.

In addition, in pharmaceutical practice, the method of dividing tablets is widely used to select the necessary dose of the drug, and this may have a number of such disadvantages when using the known method, such as the inability to ensure the accuracy of the dosage of a known pharmaceutical drug, the difficulty of following the patient's treatment regimen, and reducing the willingness to follow the error therapy regimen during the procedure of dividing the tablets by the patient himself.

In addition, the degree of development of side effects, such as disorders of the cardiovascular system, from the use of the known method increases with an increase in the dose and duration of exposure, therefore it is recommended to conduct the shortest courses of treatment with the use of the smallest effective daily doses.

Another disadvantage of the known method is the impossibility of its use for the treatment of patients with active peptic ulcer or active gastrointestinal bleeding. In addition, even for healthy patients without gastrointestinal abnormalities, it is recommended to use a known method with the inclusion of additional pharmaceutical drugs that protect organs

Gastrointestinal tract from adverse effects from contact with etoricoxib. Thus, the cost of treatment increases due to the need to use several pharmaceutical drugs.

Another disadvantage of the well-known drug is the high cost of treatment. The daily dose of the well-known drug depends on the disease and ranges from 30 mg of etoricoxib once a day (for osteoarthritis) to 120 mg of etoricoxib per day (for acute gouty arthritis). Thus, large doses and the need to use the drug for at least several days lead to the need to purchase several packages of the pharmaceutical drug. At the same time, even one package of ARKOXIAF is relatively expensive, which contributes to a significant financial burden on patients, especially on elderly patients who are at risk for developing various types of arthritis.

In addition, if there is no response to the treatment of a number of diseases in a known way, it is recommended to use other methods of treatment. Thus, the effectiveness of the known pharmaceutical preparation is largely leveled by the disadvantages associated with the dosage form of the known pharmaceutical preparation.

Therefore, there is a need for new, highly effective methods of treating pain and inflammation that are successful and easy to follow in the treatment of pain and inflammation that are symptoms of a wide range of diseases, including arthritis.

The essence of the technical solution

The goal of a useful model is to create an effective and safe way to treat pain and inflammation, which is convenient to use and adhere to, and improves the quality and standard of living of patients.

The problem is solved by a method of treating pain and inflammation, which includes the administration of a pharmaceutical preparation containing an active pharmaceutical ingredient of the formula (I) and at least one auxiliary substance and made in the form of a solution for injections and

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In addition, according to one of the variants of the implementation of the technical solution, the pharmaceutical preparation contains the pharmaceutical ingredient of formula (I) in an amount from 30 mg/ml to 120 mg/ml.

In addition, according to one of the variants of the implementation of the technical solution, the pharmaceutical preparation contains the pharmaceutical ingredient of formula (I) in the amount of 90 mg/ml.

In addition, according to one of the variants of the implementation of the technical solution, the method includes the introduction of a pharmaceutical drug intramuscularly, intravenously or intra-articularly.

In addition, according to one of the variants of the implementation of the technical solution, the method includes the introduction of a pharmaceutical preparation at least once a day.

In addition, according to one of the variants of the implementation of the technical solution, the method includes the introduction of a pharmaceutical drug in courses lasting at least five days.

In addition, according to one of the variants of the implementation of the technical solution, the method is used for the treatment of inflammation, which is a symptom of rheumatoid arthritis, psoriatic arthritis, osteoarthritis, ankylosing spondylitis and gout.

A pharmaceutical preparation is a combination of substances (one or more APIs and excipients) that has properties and purpose for the treatment or prevention of diseases in humans. According to the technical decision, API is an active pharmaceutical ingredient of the formula ().

The active pharmaceutical ingredient of formula (I) - etoricoxib belongs to the group of coxibs and is a highly selective inhibitor of COX-2, which is formed exclusively in foci of inflammation.

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COX-2 cyclooxygenase is responsible for the formation of prostaglandins, is an isoform of the enzyme induced by a proinflammatory impulse and is considered to be the main factor responsible for the synthesis of prostanoid mediators of pain, inflammation and fever. Etoricoxib, due to the selective inhibition of COX-2, reduces the formation of prostaglandins from arachidonic acid, which effectively eliminates pain and inflammation, which are symptoms of many diseases. Since etoricoxib has less inhibitory activity to COX-1, its use is much less often accompanied by side effects from the gastrointestinal tract.

Etoricoxib binds to blood plasma proteins (at 92 95). Metabolized in the liver with the formation of inactive metabolites, excreted from the body, mainly with urine in the form of metabolites, part of etoricoxib is excreted with feces. The half-life of etoricoxib is 22 hours.

Additionally, the pharmaceutical preparation for use according to the method according to the technical solution may contain at least one pharmaceutically acceptable excipient.

The use of pharmaceutically acceptable excipients for the manufacture of pharmaceutical preparations allows obtaining pharmaceutical preparations in a liquid medicinal form, in particular in the form of a solution for injections, which is characterized by acceptable physico-chemical indicators and good indicators of storage terms.

According to the essence of the technical solution, the liquid dosage form of the pharmaceutical preparation for use according to the method according to the technical solution is a solution for injections, intended for injection into certain body tissues or organs, or a vascular bed. The solution for injection is in a pharmaceutically acceptable primary package and can contain 30 mg, 60 mg, 90 mg or 120 mg of etoricoxib in 1 ml of solution.

Pharmaceutically acceptable primary packaging of a pharmaceutical preparation for use according to the method according to the technical solution can be an ampoule, a bottle with a stopper, a syringe, etc., and can be made of materials acceptable in the field of pharmaceuticals, which are physically and chemically inert to the components of the pharmaceutical preparation, preserve it therapeutic activity, quality, purity in the process of manufacturing, storage, transportation, sale and use. Such acceptable materials can be glass and polymers.

The method according to the technical solution may include the introduction of a pharmaceutical drug intramuscularly, intravenously or intra-articularly.

Information confirming the possibility of implementing a technical solution

Example 1

Obtaining a pharmaceutical preparation in the form of a solution for injections for use according to the method according to the technical solution.

The production of a pharmaceutical preparation according to a technical solution is fully automated.

42.5 kg of water is loaded into a stainless steel reactor equipped with a stirrer. 6 kg of polyethylene glycol 3350 is loaded into the reactor with water. The reactor is heated to a temperature of 407C, and the contents of the reactor are stirred until the polyethylene glycol 3350 is completely dissolved. After the polyethylene glycol 3350 is completely dissolved, the reactor is allowed to cool to room temperature. 0.5 kg of polysorbate 80 is loaded into the reactor, and the contents of the reactor are stirred until the polysorbate 80 is completely dissolved. 5 kg of mannitol is loaded into the reactor and the contents of the reactor are stirred until the mannitol is completely dissolved. 50 mM of sodium phosphate is loaded into the reactor and the contents of the reactor are stirred until the sodium phosphate is completely dissolved. 0.9 kg of sodium chloride is loaded into the reactor and the contents of the reactor are stirred until the sodium chloride is completely dissolved.

The resulting solution is filtered through a filter with a cell size of 0.22 μm into a clean dry stainless steel reactor equipped with a stirrer. Three kg of etoricoxib are loaded into the reactor and the contents of the reactor are mixed to obtain a homogeneous suspension. The pH of the suspension is brought up to

From 7,050.1 sodium hydroxide. 42.5 kg of water is loaded into the reactor and the contents of the reactor are mixed until a homogeneous solution is obtained.

Ampoules with a nominal volume of 1 ml are filled with the obtained injection solution on a fully automated ampoule filling line. Filled ampoules are sealed on a fully automated ampoule sealing line.

Sealed ampoules are subjected to steam sterilization under pressure at a temperature of 121"7C and a pressure of 1.1 atm. for 2 hours.

Sterilized ampoules are labeled and simultaneously packed in 5 pieces on an automatic device. Sterilized ampoules packed in polymer primary packaging are packed in a cardboard box with instructions.

Thus, the cardboard box contains a polymer package with five cells, in each of which there is a glass ampoule, which contains 1 ml of a pharmaceutical preparation according to the technical solution in the form of a solution for injections, and in 1 ml of a solution for injections contains 30 mg of etoricoxib

Example 2

Obtaining a pharmaceutical preparation in the form of a solution for injections for use according to the method according to the technical solution.

The production of a pharmaceutical preparation according to a technical solution is fully automated.

41 kg of water is loaded into a stainless steel reactor equipped with a stirrer. 6 kg of polyethylene glycol 3350 are loaded into the reactor with water. The reactor is heated to a temperature of 40"C and the contents of the reactor are stirred until the polyethylene glycol 3350 is completely dissolved. After the polyethylene glycol 3350 is completely dissolved, the reactor is allowed to cool to room temperature. 0.3 kg of polysorbate is loaded into the reactor 80 and the contents of the reactor are mixed until polysorbate 80 is completely dissolved. 5 kg of mannitol is loaded into the reactor and the contents of the reactor are mixed until the mannitol is completely dissolved. 50 mM sodium phosphate is loaded into the reactor and the contents of the reactor are mixed until sodium phosphate is completely dissolved. 0.9 kg is loaded into the reactor of sodium chloride and the contents of the reactor are stirred until the sodium chloride is completely dissolved.

The resulting solution is filtered through a filter with a cell size of 0.22 μm into a clean dry stainless steel reactor equipped with a stirrer. 6 kg of etoricoxib are loaded into the reactor and the contents of the reactor are stirred until a homogeneous suspension is obtained. The pH of the suspension is brought up to

7,020.1 sodium hydroxide. 41 kg of water are loaded into the reactor and the contents of the reactor are mixed until a homogeneous solution is obtained.

Ampoules with a nominal volume of 1 ml are filled with the obtained injection solution on a fully automated ampoule filling line. Filled ampoules are sealed on a fully automated ampoule sealing line.

Sealed ampoules are subjected to steam sterilization under pressure at a temperature of 1217C and a pressure of 1.1 atm. within 2 hours.

Sterilized ampoules are labeled and simultaneously packed in 5 pieces on an automatic device. Sterilized ampoules packed in polymer primary packaging are packed in a cardboard box with instructions.

Thus, the cardboard box contains a polymer package with five cells, in each of which there is a glass ampoule, which contains 1 ml of a pharmaceutical preparation according to the technical solution in the form of a solution for injections, and in 1 ml of a solution for injections contains 60 mg of etoricoxib.

Example C

Obtaining a pharmaceutical preparation in the form of a solution for injections for use according to the method according to the technical solution.

The production of a pharmaceutical preparation according to a technical solution is fully automated.

42.5 kg of water is loaded into a stainless steel reactor equipped with a stirrer. 5 kg of polyethylene glycol 3350 are loaded into the reactor with water. The reactor is heated to a temperature of 40"C and the contents of the reactor are stirred until the polyethylene glycol 3350 is completely dissolved. After the polyethylene glycol 3350 is completely dissolved, the reactor is allowed to cool to room temperature. 0.2 kg of polysorbate is loaded into the reactor 80 and the contents of the reactor are mixed until the complete dissolution of polysorbate 80. 50 mM sodium phosphate is loaded into the reactor and the contents of the reactor are mixed until the sodium phosphate is completely dissolved. 0.9 kg of sodium chloride is loaded into the reactor and the contents of the reactor are mixed until the sodium chloride is completely dissolved.

The resulting solution is filtered through a filter with a cell size of 0.22 μm into a clean dry stainless steel reactor equipped with a stirrer. 9 kg of etoricoxib are loaded into the reactor and

The contents of the reactor are mixed to obtain a homogeneous suspension. The pH of the suspension is adjusted to 7.020.1 with sodium hydroxide. 42.5 kg of water is loaded into the reactor and the contents of the reactor are mixed until a homogeneous solution is obtained.

Ampoules with a nominal volume of 1 ml are filled with the obtained injection solution on a fully automated ampoule filling line. Filled ampoules are sealed on a fully automated ampoule sealing line.

Sealed ampoules are subjected to steam sterilization under pressure at a temperature of 1217C and a pressure of 1.1 atm. within 2 hours.

Sterilized ampoules are labeled and simultaneously packed in 5 pieces on an automatic device. Sterilized ampoules packed in polymer primary packaging are packed in a cardboard box with instructions.

Thus, the cardboard box contains a polymer package with five cells, in each of which there is a glass ampoule, which contains 1 ml of a pharmaceutical preparation according to the technical solution in the form of a solution for injections, and in 1 ml of a solution for injections contains 90 mg of etoricoxib.

Example 4

Obtaining a pharmaceutical preparation in the form of a solution for injections for use according to the method according to the technical solution.

The production of a pharmaceutical preparation according to a technical solution is fully automated.

42 kg of water is loaded into a stainless steel reactor equipped with a stirrer. Three kg of polyethylene glycol 3350 are loaded into the reactor with water. The reactor is heated to a temperature of 40"C and the contents of the reactor are stirred until the polyethylene glycol 3350 is completely dissolved. After the polyethylene glycol 3350 is completely dissolved, the reactor is allowed to cool to room temperature. 0.1 kg of polysorbate is loaded into the reactor 80 and the contents of the reactor are mixed until the complete dissolution of polysorbate 80. 50 mM sodium phosphate is loaded into the reactor and the contents of the reactor are mixed until the sodium phosphate is completely dissolved. 0.9 kg of sodium chloride is loaded into the reactor and the contents of the reactor are mixed until the sodium chloride is completely dissolved.

The resulting solution is filtered through a filter with a cell size of 0.22 μm into a clean dry stainless steel reactor equipped with a stirrer. 12 kg of etoricoxib bo are loaded into the reactor and the contents of the reactor are mixed to obtain a homogeneous suspension. The pH of the suspension is brought up to

7,020.1 sodium hydroxide. 42 kg of water are loaded into the reactor and the contents of the reactor are mixed until a homogeneous solution is obtained.

Ampoules with a nominal volume of 1 ml are filled with the obtained injection solution on a fully automated ampoule filling line. Filled ampoules are sealed on a fully automated ampoule sealing line.

Sealed ampoules are subjected to steam sterilization under pressure at a temperature of 1217C and a pressure of 1.1 atm. within 2 hours.

Sterilized ampoules are labeled and simultaneously packed in 5 pieces on an automatic device. Sterilized ampoules packed in polymer primary packaging are packed in a cardboard box with instructions.

Thus, the cardboard box contains a polymer package with five cells, in each of which there is a glass ampoule, which contains 1 ml of a pharmaceutical preparation according to the technical solution in the form of a solution for injections, and in 1 ml of a solution for injections contains 120 mg of etoricoxib.

Example 5

A 12-week double-blind, randomized, placebo-controlled and active-controlled trial was conducted. 816 patients were involved in the study, in whom there was a worsening of the clinical picture of rheumatoid arthritis when non-steroidal anti-inflammatory drugs were stopped. Patients were randomized into three groups: placebo group - 323 people, etoricoxib group - 323 people and naproxen group - 170 people. The placebo group received placebo intramuscularly once daily, the etoricoxib group received etoricoxib 90 mg intramuscularly once daily, and the naproxen group received 500 mg naproxen twice daily.

The primary measure of treatment effectiveness was determined by patients and researchers using a global assessment of rheumatoid arthritis progression and a direct assessment of the number of painful and swollen joints. The secondary key effectiveness measure was determined using the patient's overall pain assessment, a questionnaire, and the percentage of patients who completed the 12-week course of treatment.

Out of 816 patients, 448 people completed the full 12-week course of treatment: placebo group - 122

Of the individuals, the etoricoxib group - 230 people and the naproxen group - 96 people. Compared with patients who received placebo, patients who received etoricoxib and naproxen showed significant improvements in all measures of effectiveness (p-<0.01). Compared with naproxen-treated patients, etoricoxib-treated patients showed significant improvements in all primary efficacy endpoints (p<0.05) and most secondary efficacy endpoints.

The percentage of patients who completed the 12-week treatment course was 21,905, 53,95, and 39,95 in the placebo, etoricoxib, and naproxen groups, respectively.

Thus, the results of the study show that the method according to the technical solution, which includes intramuscular injections of a pharmaceutical drug, is more effective than placebo or naproxen in the treatment of rheumatoid arthritis.

Example 6

The method of treating pain in osteoarthritis according to a technical solution includes the following stages. 1. Establishing a diagnosis; 2. Prescribing the treatment regimen; 3. Removing the diagnosis.

Establishing a diagnosis includes determining the symptoms of osteoarthritis (pain in the area of the affected joint, increased pain when standing or with load, increasing pain at the end of the day, morning stiffness of less than 30 minutes), conducting a general blood test, an analysis of

C-reactive protein, rheumatoid factor analysis and X-rays of the affected joints.

The diagnosis of osteoarthritis is established if the general blood test is within normal limits, the C-reactive protein test is negative, the rheumatoid factor test is negative, and uneven narrowing of the joint space, osteosclerosis, and osteophytes are observed on the X-ray.

The treatment regimen includes intravenous use of a pharmaceutical drug according to

Example 2, C or 4 once or twice a day in courses of 5 days with breaks. The dosage of the pharmaceutical preparation depends on the severity of osteoarthritis and is prescribed individually for each patient. An additional measure is compliance with the diet according to Table Mo 15. Treatment is carried out on an outpatient basis.

The diagnosis is removed after the evaluation of treatment effectiveness indicators, which include the absence of damage to new joints, reduction or disappearance of pain syndrome 60 and signs of inflammation, and improvement in quality of life.

Technical result, which is achieved when applying the method according to the technical solution

- Efficiency.

The speed of action, because the pharmaceutical preparation used in the method according to the technical solution is administered intramuscularly, intravenously or intra-articularly, and not orally.

In this regard - practicality, speed and efficiency for the rapid termination of acute pain or for the short-term treatment of perioperative and/or post-traumatic pain of patients in the hospital.

Greater efficiency due to more complete bioavailability, since etoricoxib in the composition of the solution for injections bypasses such protective barriers of the body as the gastrointestinal tract and the liver.

- Safety.

Reduction of the manifestation of side effects from the use of the method according to the technical solution, which includes the introduction of etoricoxib, for example, from the gastrointestinal tract, since etoricoxib is not used orally.

Also, the method according to the technical solution can be used to treat patients with diseases of the gastrointestinal tract.

The accuracy of the dosage of the pharmaceutical preparation in the form of a solution for injections, which reduces the risks of overdose.

- Convenience of using the method according to the technical solution, since there is no need to take additional actions to obtain an effective therapeutic amount of etoricoxib, for example, drink the tablet with water, eat or not eat before taking the medicine, divide the tablet in half, etc.

Also, when using the method according to the technical solution, there is no need to take additional drugs to protect the gastrointestinal tract.

The possibility of applying the method to patients with limited functional capacity, in particular, with a violation of the act of swallowing.

Absence of unpleasant sensations associated with the unpleasant smell and/or taste of the pharmaceutical preparation.

- Improving the quality and standard of living of patients.

Faster onset of action and high efficiency of the method according to the technical solution allow to achieve effective therapy of pain and symptoms of inflammation, and improve the patient's condition and quality of life.

Claims (7)

USEFUL MODEL FORMULA 1. A method of treating pain and inflammation, which is characterized by the fact that it includes the introduction of a pharmaceutical preparation containing an active pharmaceutical ingredient of the formula (I) and Zo at least one auxiliary substance and is made in the form of a solution for injections M ne SI eh rya M | M is not Xa Z (I). 2. The method according to claim 1, which is characterized by the fact that the pharmaceutical preparation contains the pharmaceutical ingredient of formula (I) in an amount from 30 mg/ml to 120 mg/ml. 3. The method according to any of claims 1-2, which is characterized by the fact that the pharmaceutical preparation contains the pharmaceutical ingredient of formula (I) in the amount of 90 mg/ml. 4. The method according to any one of claims 1-3, which is characterized by the fact that it includes the introduction of a pharmaceutical preparation intramuscularly, intravenously or intra-articularly. 5. The method according to any one of claims 1-4, which is characterized by the fact that it includes the introduction of a pharmaceutical preparation at least once a day. b. The method according to any one of claims 1-5, which is characterized by the fact that it includes the introduction of the pharmaceutical preparation in courses lasting at least five days. 7. The method according to any one of claims 1-6, which is used to treat inflammation which is a symptom of rheumatoid arthritis, psoriatic arthritis, osteoarthritis, ankylosing spondylitis and gout.