Prolonged interferon solution

FIELD: pharmaceutical industry, in particular drug containing human recombinant alpha-2 interferon.

SUBSTANCE: claimed prolonged solution contains human recombinant alpha-2 interferon, citric acid, boric acid, sodium tetraborate, unithiol, human serum albumin, sodium chloride, sodium carboxymethylcellulose and purified water. Preparation of present invention has wide spectrum of therapeutic application.

EFFECT: drug of high specific antiviral and antimicrobial activity without side effects.

1 tbl, 3 ex

 

The invention relates to medicine and the pharmaceutical industry and relates to dosage forms containing human recombinant interferon alpha 2.

Human recombinant interferon alpha 2 has antiviral, immunomodulatory and antiproliferative properties. In addition, interferon possesses antimicrobial activity due to stimulation of phagocytes. Due to its unique properties interferon preparations are widely used in clinical practice.

Currently in Russia are produced in several dosage forms of human recombinant interferon alpha-2, approved for use in the practice of public health. This injectable form containing 500000 ME, ME 1000000, 3000000 ME and 5000000 ME in the ampoule, trade names, respectively, IFN, IFN EU and Interal. Available dosage form for oral administration, containing 500000 ME in a bottle, trade name which IFN - Lient (see the case of pharmaceuticals "encyclopedia of drugs," No. 10, 2003).

Also available dosage forms for external use, ointments containing 10000 ME, ME 20000 and 40000 ME in 1 g of ointment, produced respectively under the trade names Infiel, Intergen and Viferon. Available dosage form for intranasal use, the content is Asa ME 10000 in 1 ml, manufactured under the brand name of Grapperon. At the moment, have found wide application in medical practice candles with interferon containing 150000 ME 500000 ME, 1000000 ME and 3000000 ME in one suppositories produced under the trademark Viferon (reg. No. 96/432, the register of medicines "encyclopedia of drugs," No. 10, 2003).

Originally dosage form of interferon was a plain products containing only interferon and excipients. Were further developed complex preparations, which included components that increased the effectiveness of interferon and, in addition, reduced side effects. For example, interferon, produced under the trademark Viferon (suppositories and ointment), contain in addition to recombinant human interferon alpha 2 antioxidants tocopherol acetate (vitamin E) and ascorbic acid (vitamin C), which significantly increase the activity of interferon.

However, all the above drugs do not possess antibacterial and fungistatic properties, so they are not active in the treatment of mixed viral-bacterial infections.

Closest to the proposed drug for its principle of operation is the drug Grapperon, which contains in addition to interferon-polymer with habilitator antiviral activity polyvinylpyrrolidone or polyethylene oxide and antioxidant Trilon B (see register of medicines "encyclopedia of drugs," No. 10, 2003).

However, this drug, as well as the above drugs, does not possess antibacterial and fungistatic activity, which is essential in the treatment of mixed viral-bacterial infections.

Proposed same drug has both antiviral and immunomodulatory activity, due to member interferon, and antibacterial and fungistatic activity that will significantly improve the efficiency interferonoterapii in the case of mixed viral-bacterial infection.

Thus, the basis for the development of the proposed drug product is based on the following main tasks (technical result):

- to expand the range of therapeutic applications due to the presence of complex substances with different actions when those entities where the application of similar monotherapy interferon little or ineffective;

- to increase the level of specific antiviral activity of the drug due to the introduction of the antioxidants;

- to avoid possible side effects interferon due to the presence of antioxidants.

The task is solved by the fact that prolonged proposed solution interferon (in view of the clear viscous solution), containing human recombinant interferon Alfa-2, a complex of antioxidants and substances with antimicrobial properties, the following composition, per 10 ml solution:

Human recombinant interferon alpha-21-50·104ME
Citric acid0.01-0.03 g
Boric acid0.08 to 0.11 g
Sodium tetraborate0,05-0,1 g
Unithiol0,01-0,05 g
Albumin human serum0,01-0,05 g
Sodium chloride0.01-0.03 g
Sodium carboxymethylcellulose
or hydroxyethylcelluloseof 0.05-0.5 g
Purified waterrest

Usually in pharmaceutical practice for drugs of this class in the quality of the purified water is deionized water with a resistance of 15-20 MW (purified water FS 42-2619-97).

The drug is prepared as follows. In a pre-prepared sterile concentrate the polymer solution sequentially injected sterile solutions of the active ingredients, mix and pour in aseptic conditions in sterile vials, sealed the rubber stoppers and aluminum caps. The resulting product is a homogeneous transparent viscous solution with a pH of 6.2 to 7.2, density (1008±5) kg/m3. With the introduction of the drug is evenly distributed over the surface of the mucous membrane, forming a thin film, which has an additional protective effect and after 1.5-2 hours is removed. When you re applying because of the structure of the polymer residues do not interfere with the absorption of active substances.

The effectiveness of the proposed substances can be proven on the basis of the following facts.

First, the proposed drug has the effect of "extension".

The extension is to increase the viscosity of the solution to increase the contact time of the drug with mucous areas of the body of the patient and the implementation thereby reducing the multiplicity of the application of an average single dose of medication. This effect has long been applied in the pharmaceutical industry and described in the book Kondratieva FORCE "Technology of medicinal forms" M, 1991

According to the literature for increasing the viscosity of the pharmaceutical forms commonly used are the following polymers:

- cellulose derivatives (carboxymethylcellulose, methoxypropylacetate and others). Derivatives of cellulose are widely used in the pharmaceutical industry as prolongator of action of medicinal substances is STV, as well as the hydrophilic base for ointments and gels;

- polyvinyl alcohol;

- polyglucin or polyacrylamide;

- polyethylene glycol.

In the case of the claimed invention proposed dosage form contains a polymer of carboxymethylcellulose, which increases the viscosity of the solution and allows the interferon prolonged contact with mucous membrane of the nasopharynx or the uterus and the cornea of the eye, covering it with a thin film. While the single concentration reduced (40000 ME, at final concentrations in finished dosage form 40000 IU/ml), decreased frequency of administration 3 times a day (in the treatment of ophthalmic herpes and adenovirus conjunctivitis interferon enter up to 8 times per day).

As mentioned above, the basis of the proposed drug based on a combination of interferon, a complex of antioxidants and substances that have antimicrobial activity. Antioxidants stabilize the cell membrane and prevent them from damage due to exposure to pathogens (viruses and microorganisms, and toxins) and ionizing radiation through the process of lipid peroxidation of membranes. In the composition of the solution are antioxidants citric acid and unithiol, allowing to hinder the development process peroxidation at different stages. So, for example, citric acid binds metal ions to change the Oh valence, and unithiol neutralizes hydroxyl radicals, which are the initiators of the process of lipid peroxidation. In laboratory experiments showed a synergistic effect of the complex of antioxidants and interferon to enhance specific antiviral activity of interferon in multiple times.

In addition to antioxidants, the formula contains a complex of substances with antimicrobial properties, boric acid and sodium tetraborate. These substances prevent microbial contamination of drug use and, in addition, have a local antibacterial and fungistatic action. According to the register of medicines "encyclopedia of drugs" - M.: 2004, boric acid has fungistatic, antibacterial, antiparasitic action, absorbed through mucous membranes and damaged skin. A solution of boric acid, and 0.5-4% retards the growth and development of bacteria, has anti-fungal (mould) action. As proposed in the application pharmaceutical form the content of boric acid, about 0.8%, therefore, sufficient for the manifestation of therapeutic effect. Sodium tetraborate according to the above "Encyclopedia of drugs" refers antiseptics and disinfectant drugs, effective against fungi of the genus Candida, because it removes the mycelium is C crypt epithelium and interferes with the attachment of the fungus to slimy. As a means of local therapy using 0.5-4% aqueous solution and a 20% solution in glycerol. In medicinal form, the content of sodium tetraborate about 0.5%, therefore, it is also sufficient for the manifestation of therapeutic effect. Thus, the joint presence of interferon, antioxidants, antibacterial and fungistatic substances allows to obtain the above technical result.

To illustrate the essence of the proposed invention the following are the results of a clinical study, the prolonged solution.

In special analyses were selected quantities of active ingredients, which allowed to achieve the best therapeutic effect. The effectiveness of the claimed prolonged solution was investigated in 40 patients with various diseases: 10 patients with conjunctivitis, 12 patients with endometritis, 10 patients with acute respiratory infections of viral etiology and 7 patients with sinusitis.

In the case of conjunctivitis solution was injected into the eyes 4-5 times a day for 5 days. Patients in the control group was performed by standard therapy.

In the case of SARS, the solution was administered intranasally in each nasal passage 3 drops 3-4 times a day. The control group consisted of patients who had therapy drug Grapperon in fact the same pattern.

In the case of endometritis solution was injected into the uterine cavity using a probe in the amount of 3-5 ml 2 times daily for 5 days. In the control group was systemic therapy of diseases antimicrobial agents.

When sinusitis solution was injected into the maxillary sinus after removal of mucus in the amount of 3 ml in each cavity on the background of traditional antimicrobial therapy. In the control group, additional therapy with local resources was not conducted.

Safety and reactogenicity of the drug was determined by the variance in the General condition of the patients (blood, urine, fever, General health) and local changes of the mucous membranes, as well as changes in the results of ultrasound examination. therapeutic effect was evaluated by shortening or reducing the clinical manifestations of the disease. The results of the study are presented in the table.

Data from clinical trials of the drug prolonged solution
Name the pathologyThe time duration of the disease when therapy prolonged solution daysThe time duration of the disease in the control group, days
Conjunctivitis10-1212-14
ARI 5-77-10
Endometritis5-710-12
Sinusitis8-1012-14

From the table it follows that the claimed solution has higher activity than the same drug Grapperon in the case of treatment of SARS. In addition, declared the drug has a broader spectrum of activity compared with the dosage forms of interferon for local use.

For example, it is proposed to use the product for local use in pathologies where previously interferon is not used (endometritis and sinusitis).

The invention is illustrated by the following examples.

Example 1. Patient T., 28, endometritis.

Was appointed to the solution of the following composition:

or hydroxyethylcellulose
Human recombinant interferon alpha-232-104ME
Citric acid0.02 g
Boric acid0.1 g
Sodium tetraborate0.07 g
Unithiol0.02 g
Albumin human serum0.02 g
Sodium chloride0.03 g
Sodium carboxymethylcellulose
0.05 g
Purified waterto 10 ml

The drug was injected into the uterine cavity. On the 5th day by ultrasound examination of the uterine size was reduced to normal, the structure of the endometrium is close to homogeneous. No side effects the drug did not cause.

Example 2. Patient K., aged 14. ARVI. He was appointed a solution of the same composition as in example 1.

The drug was administered in the nose 2-3 drops 3-4 times a day, after the introduction of lightly massaged with the fingers of the wings of the nose to the uniform distribution. After 5 days the symptoms disappeared. No side effects the drug did not cause.

Example 3. Patient, 26 years. The sinusitis. He was appointed antimicrobial therapy, after removal of mucus was scheduled introduction in the maxillary sinus of the drug prolonged the solution of the same composition as in example 1.

The drug was injected through the catheter into the maxillary sinus after removal of mucus. After 8 days the symptoms disappeared. No side effects the drug did not cause.

Thus, on the basis of clinical studies it was concluded that the drug is safe, well tolerated, highly effective compared to conventional therapy drugs. Compared with drug Grapperon prolonged solution of interferon and eat higher efficiency and a wider range of actions, because it contains antioxidants enhance antiviral and antimicrobial activity of interferon.

In the preparation includes the components have antibacterial and fungistatic properties, significantly enhancing antimicrobial activity of the interferon.

In addition, declared the drug has a broader spectrum of activity compared with the dosage forms of interferon for local use. For example, the authors conducted the research proposed to use the product for local use in pathologies where previously interferon is not used (endometritis and sinusitis).

Studies suggest the claimed solution for wide use in medical practice. The special properties of the drug can be used in areas where previously the interferon products (dosage forms for local use) were little or ineffective, for example, in gynecology and otolaryngology.

Received the drug can be used as eye drops, intranasal use, intrawaginalno intraurethral, to enter into the maxillary sinus, to irrigate mucous membrane of the respiratory tract.

High therapeutic effect of the drug allows you to avoid long-term rate is in antibacterial therapy or to reduce the duration of the course in the treatment of common diseases such as endometritis in women and sinusitis in children and adults.

Prolonged solution of interferon containing human recombinant interferon alpha-2, the polymer and the antioxidant, characterized in that it further comprises an antimicrobial substance is boric acid, sodium tetraborate, and albumin human serum, sodium chloride, water, and antioxidant citric acid, unithiol, polymer is the sodium carboxymethyl cellulose or hydroxyethyl cellulose in the following ratio of components, g / 10 ml solution:

Human recombinant interferon alpha-21-50·104ME
Citric acid0.01-0.03 g
Boric acid0.08 to 0.11 g
Sodium tetraborate0,05-0,1 g
Unithiol0,01-0,05 g
Albumin human serum0,01-0,05 g
Sodium chloride0.01-0.03 g
Sodium carboxymethylcellulose or
hydroxyethylcelluloseof 0.05-0.5 g
Purified waterRest



 

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1 ex

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