Pharmaceutical composition for treating eye diseases related to eye tissue metabolic disease and inflammatory eye tissue injury

FIELD: medicine.

SUBSTANCE: pharmaceutical composition can additionally contain ethylenediaminotetraacetic acid, polyvinyl pyrrolidone, polyvinyl alcohol, a preserving agent specified in a group: Nipagin, Nipasol, benzoic acid, sodium benzoate, sorbic acid, benzalkonium chloride. As a body-forming base, the composition can contain distilled water, polyethylene oxide 400, polyethylene oxide 4000, polyethylene glycol, propylene glycol, a phosphate buffer, a borate buffer, an acetate-borate buffer depending on a dosage form.

EFFECT: high therapeutic effectiveness, prolonged corneal contact of the preparation which reduces the number of instillations, avoids a risk of side effects and provides good tolerance.

5 cl, 5 ex

 

The invention relates to medicine, namely to ophthalmology, and can be used for the treatment of various eye diseases associated with impaired metabolism in ocular tissues and inflammatory lesions of the eye tissues. The drug can be used in the treatment of peptic ulcer, traumatic, infectious-allergic and degenerative diseases of the cornea in the treatment of uveitis, chronic optic neuropathy, degenerative lesions of the eye (glaucoma, macular degeneration, optic nerve atrophy, severe myopia, in the treatment of dry eye disease, age, diabetes and radiation cataract).

Known biogenic connection - taurine, contained high concentrations in the tissues of the retina and lens and one of the end products of the metabolism of sulfur-containing acids (cysteine, methionine, glutathione, cysteine), which is directly involved in the conduction of nerve impulses and in the regulation of metabolic processes and energy, protein and carbohydrate metabolism, osmoregulation. A characteristic feature of taurine is the ability to stimulate reparative processes in dystrophic lesions of the eye tissues. The most widely recognized drops based on taurine, known as eye drops "Taufon".

Apply taufon adults with distrotion the fir (associated with malnutrition tissue) lesions of the retina, including hereditary retinal degeneration, corneal dystrophy, old age, diabetes, and traumatic cataract ray, and also as a means of stabilizing the electrolyte composition of the cytoplasm, to stimulate recovery for injuries of the cornea (the transparent membrane of the eye). There is evidence of the effectiveness taufona as a means of reducing intraocular pressure in patients with glaucoma due to inhibition of synaptic transmission (elevated intraocular pressure). This drug can be used for a long time, and in the treatment of open-angle glaucoma eye drops combination taufona with timelimited leads to the possibility of reducing the concentration of timolol maleate, i.e. eliminate or reduce negative effects on the cardiovascular, respiratory, Central nervous system.

(The certificate on "Taufon" ICN "Leksredstva", , Kursk; Michuk Û.F. "New drugs in the treatment of bacterial keratitis and chlamydial conjunctivitis". Russian journal of medicine, M., 1998; Michuk Û.F., Larina L.A. "the Use of Vita-iadarola method of installation and magnetophoresis in the treatment of metabolic diseases of the eye". Clinical ophthalmology, volume 4, No. 3, 2003)

The disadvantage taufona, as in many other plain products eye drops is that they eno is but a short therapeutic effect, what leads to the necessity of putting the drops 4-6 times a day. However, frequent instillation of 4% solution of taurine may cause eye irritation.

It is known that in the treatment of taufona initial uncomplicated senile cataracts, damage to the cornea additional instillation in the eye vitamin drops leads to increased therapeutic effect. Vitamin eye drops based cyanocobalamin (vitamin B12) as monotherapy apply at least 4 times a day in case of damage to the cornea, the treatment of ulcerations of the cornea, retro-bulbar neuritis nerve, degeneration of the retina, at the early stages of cataracts.

However, for patients difficult to follow precisely a prescription for instillation of the eye different drugs several times a day. In addition, frequent exposure eye preparations the mucous membrane of the eye, which in various diseases, and so is irritable.

In this regard, there was a trend of combining different substances with the aim of eliminating the side effects for the expansion of therapeutic effect and prolongation of therapeutic effects. It is now widely known work aimed at combining different drugs. But despite this, kombinirovannaya all over the world there are not more than 30% of the whole range of medicinal ophthalmic drugs.

Such preparations are different composite compositions with taurine (taufona): eye drops for treatment of degenerative diseases and injuries of the eye (EN 2414218, 2009); eye drops "Citrin" reparative and antiglaucoma action (EN 2295331, 2007); eye drops containing taurine, carnosine and glutathione (EN 2404768, 2010) and others.

Closest to the claimed invention, we offer essence and the achieved result is a combined preparation "Citrin"containing taurine, cyanocobalamin, dextran, benzalkonium chloride and water as consistentarea basis (EN 2295331, 2007).

However, these compositions do not provide sufficient efficiency. In addition, the use of these eye drops cause side effects in the form of irritation of the eye tissue and heavy tolerability of patients.

The task of the invention is the creation of more effective domestic remedies than known compositions, in the form of combined drug with antioxidant, reparative and regenerative therapeutic effect in inflammatory, traumatic, degenerative lesions of the eye tissues, which increases contact of the drug with the cornea to reduce the number of instillations, as well as eliminating the risk of their side effects and is especial good tolerance by patients.

The technical result of the invention is to increase therapeutic efficacy funds due to their antioxidant, reparative and regenerative therapeutic action, providing a prolonged therapeutic effect on the cornea of the eye, providing a reduction in treatment and reduce complications compared with the prototype.

To achieve the technical result of the pharmaceutical composition for the treatment of eye diseases associated with impaired metabolism in ocular tissues and inflammatory lesions of the tissues of the eye containing taurine and consistantness basis, according to the invention, it further comprises etilmetilgidroksipiridina succinate, boric acid and hypromellose in the following ratio of components in g per 1 ml of a mixture of:

taurinewithin 0.00001 to 0.5
etilmetilgidroksipiridina succinatewithin 0.00001 to 0.5
boric acidwithin 0.00001 to 0.5
the hypromellosewithin 0.00001 to 0.5
consistentread baserest

In addition, the pharmaceutical composition may contain ethylenediaminetetraacetic acid number within 0.00001-0.5 g in 1 ml of the mixture.

In addition, the pharmaceutical composition may contain polyvinylpyrrolidone in an amount within 0.00001-0.5 g in 1 ml of the mixture.

In addition, the pharmaceutical composition may contain polyvinyl alcohol in an amount within 0.00001-0.5 g in 1 ml of the mixture.

In addition, the pharmaceutical composition may contain a preservative selected from the group: nipagin, nipazol, benzoic acid, sodium benzoate, sorbic acid, benzalkonium chloride in a quantity within 0.00001-0.5 g in 1 ml of the mixture.

As consistentarea basis of the claimed pharmaceutical composition may contain, depending on the dosage form following ingredients: distilled water, polyethylene oxide 400, 4000 polyethylene oxide, polyethylene glycol, propylene glycol, phosphate buffer, borate buffer, acetate-borate buffer mixture.

Spent an analysis of the prior art, including searching by the patent and scientific and technical information sources, and identify sources that contain information about the equivalents of the claimed pharmaceutical compositions, has allowed to establish that the petitioners have not found a similar, characterized by signs, identical to all the essential features of the claimed f the pharmaceutical composition.

The definition from the list of identified unique prototype allowed us to identify a set of essential in relation to perceived technical result of the distinctive features in the claimed pharmaceutical compositions set forth in the claims.

Therefore, the claimed claimed pharmaceutical composition meets the criterion of "novelty."

For verification of the compliance of the pharmaceutical compositions of the prior art, the applicants conducted an additional search of the known solutions to identify signs that match the distinctive features of the prototype of the characteristics of the claimed invention.

The search results showed that the claimed invention not apparent to the expert in the obvious way from the prior art, certain applicants have identified no impact envisaged the essential features of the claimed pharmaceutical compositions of transformations to achieve a technical result.

Therefore, the claimed invention meets the criterion of "inventive step".

The criteria of the invention "industrial applicability" is confirmed by the fact that the claimed pharmaceutical composition having anti-inflammatory, reparative and renegeration the action of inflammatory, traumatic and degenerative lesions of tissues chap is as long fixation on the cornea of the eye, contributing to prolonged action and can be successfully used for the treatment of various eye diseases associated with impaired metabolism in ocular tissues and inflammatory tissue damage in the eye.

The present invention is illustrated with specific examples of implementation, which, however, are not only possible, but clearly demonstrate the possibility of achieving the desired technical result.

Example 1. The preparation of the claimed pharmaceutical compositions provide a standard method of preparation of eye drops, by mixing all of their components to obtain a homogeneous mass, soluble in distilled water, used as consistentarea basis. Received eye drops conform to the requirements of the pharmaceutical agent.

The composition of the funds administered taurine, etilmetilgidroksipiridina succinate, boric acid and hypromellose in the following ratio of components in g per 1 ml of a mixture of:

taurine
Options
1234
0,000010,020,040,5
etilmetilgidroksipiridina succinate0,000010,0150,030,5
boric acid0,50,030,050,00001
the hypromellose0,50,050,050,00001
consistentread basethe rest is up to 1 ml of a mixture

Example 2. For the preparation of the claimed pharmaceutical compositions in the form of a gel is carried out analogously to example 1 except that the composition additionally impose ethylenediaminetetraacetic acid number within 0.00001 to 0.5 g per 1 ml of the mixture.

Example 3. Carried out analogously to example 1 except that the composition further added polyvinylpyrrolidone in an amount within 0.00001 to 0.5 g per 1 ml of the mixture.

Example 4. Carry out a similar example is 1 except that the composition further added polyvinyl alcohol in an amount within 0.00001 to 0.5 g per 1 ml of the mixture.

Example 5. Carried out analogously to example 1 except that the composition further added preservatives selected from the group: nipagin, nipazol, benzoic acid, sodium benzoate, benzalkonium chloride, sorbic acid number within 0.00001 to 0.5 g per 1 ml of the mixture.

The obtained pharmaceutical composition overlook transparent mixture solution or gel.

The resulting compositions were controlled by a number of characteristics that reflect the purity and effectiveness. This pH, transparency, optical refraction, moisturizing effect, surface tension, dynamic viscosity, no irritating to the cornea, and the duration of retention on the cornea.

The pH values of the developed formulations were subjected to minor changes and were lying in the range of 6.8 to 7.6.

The analyzed mixture of the claimed pharmaceutical compositions on a black background and scattered light was not different from water transparency.

Measurement of the known methods of surface tension of the compositions of the claimed pharmaceutical composition showed that all the compounds have surface activity and, therefore, well spread across the cornea.

The refractive index of the developed formulations Savino the pharmaceutical composition is small, does not cause a hazy look, and close to tears (1,334).

The retention time of the claimed pharmaceutical compositions on the cornea was determined in rabbits. The results showed a 2-3 times greater prolonging the ability of the claimed compositions of the claimed pharmaceutical compositions due to the increased penetration in the tissue of the eye, increased their enveloping action, high viscosity and high selectivity relative to the surface of the eye compared to the prototype.

Irritating and toxic effects of the compounds of the claimed pharmaceutical compositions investigated in rabbits when introducing them into the conjunctival SAC 5-8 times a day 1-2 drops for 2 weeks. The study found no redness, swelling or other changes of the conjunctiva. No reported deaths of animals or acute poisoning.

In the lung model, non-infectious inflammation of the conjunctiva of the eye was reduced during the treatment of inflammatory lesions of the conjunctiva of the eye during application of the claimed pharmaceutical compositions.

The effectiveness of the claimed pharmaceutical compositions made according to the present examples was studied in 4 groups of patients, 5 people in each suffering from dry eye disease (AAH) - dry Kera is conjunctivitis.

The first group of patients (control), with diagnosis of AAH with phenomena keratopathy after herpetic stromal keratitis in one eye, treated the prototype. After 20 days there was an improvement in the health of patients. Eyes completely calmed down. Restore the corneal surface and reducing the degree of opacity of the cornea in both eyes came a month after the start of treatment.

The second group of patients. Diagnosis: AAH events keratopathy after herpetic stromal keratitis in one eye. Treatment eye drops declared, made according to example 1, 2 drops 6 times a day for two weeks. As a result of treatment in patients on day 2 marked signs of improvement: decreased lacrimation and photophobia. After a week, the eye became more calm, infiltrates in the corneal stroma decreased. Eyes completely calmed down, the corneal surface is recovered. To 16 days after the start of treatment showed a significant restoration of transparency of the cornea.

The third group of patients. The diagnosis of adenoviral keratoconjunctivitis: sharp hyperemia and edema of the mucosa of both eyes. Corneal subepithelial point infiltrates and microerosion of the cornea. Along with the conventional treatment of interferon treatment claimed eye drops is izgotovlenie according to example 2, 2 drops 3-4 times a day for two weeks. On the fourth day there was a positive effect: decreased hyperemia, disappeared discomfort. Two weeks eyes calmed down, came a significant resorption of turbidity and complete epithelialization. In the study of patients after 6 months of recurrent erosion of the cornea is not marked.

The fourth group of patients. The diagnosis of adenoviral keratoconjunctivitis with rough subepithelial opacities, micro - and macroeconomy cornea, follicular and papillary reaction of the conjunctiva, marked swelling. Assigned instillation of levomycetin and claimed eye drops according to example 3. On day 5 there has been a marked improvement: reducing photophobia, decrease swelling of the conjunctiva, the epithelization of the cornea, resorption part of subepithelial infiltrates. On day 14 after the start of treatment eyes completely calmed down; conjuctiva became calm. The cornea was completely transparent.

The analysis of the results in the claimed pharmaceutical compositions showed a positive therapeutic result in 2, 3 and 4 groups of patients, manifested in the lack of side effects and allergic reactions on the background of the application of the claimed pharmaceutical compositions.

The choice of the components of the claimed pharmaceutical compositions and their quantitative values given the opportunity, the floor is given a new technical result - the manifestation of a good anti-inflammatory effect, prevention of pathological changes in the epithelial cells of the conjunctiva and cornea, which can cause damage to the corneal stroma and the occurrence of erosions, ulcers and perforations.

Thus, the claimed pharmaceutical composition has a high therapeutic efficacy in the treatment of a wide range of inflammatory eye diseases, in the treatment of peptic ulcer, traumatic, infectious-allergic and degenerative diseases of the cornea in the treatment of uveitis, chronic optic neuropathy, degenerative lesions of the eye (glaucoma, macular degeneration, optic nerve atrophy, severe myopia, in the treatment of dry eye disease, age, diabetes and radiation cataract.

1. Pharmaceutical composition for the treatment of eye diseases associated with impaired metabolism in ocular tissues and inflammatory lesions of the tissues of the eye containing taurine and consistantness base, characterized in that it further comprises etilmetilgidroksipiridina succinate, boric acid and hypromellose, in the following ratio of components in g per 1 ml of a mixture of:

taurinewithin 0.00001 to 0.5
etilmetilgidroksipiridina succinatewithin 0.00001 to 0.5
boric acidwithin 0.00001 to 0.5
the hypromellosewithin 0.00001 to 0.5
consistentread baserest

2. The pharmaceutical composition according to claim 1, characterized in that it can contain ethylenediaminetetraacetic acid number within 0.00001-0.5 g in 1 ml of the mixture.

3. The pharmaceutical composition according to claim 1, distinguish fact that it can contain polyvinylpyrrolidone in an amount within 0.00001-0.5 g in 1 ml of the mixture.

4. The pharmaceutical composition according to claim 1, characterized in that it may contain polyvinyl alcohol in an amount within 0.00001-0.5 g in 1 ml of the mixture.

5. The pharmaceutical composition according to claim 1, characterized in that it may contain a preservative selected from the group: nipagin, nipazol, benzoic acid, sodium benzoate, sorbic acid, benzalkonium chloride in a quantity within 0.00001-0.5 g in 1 ml of the mixture.



 

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