Composition for treating multiple sclerosis (versions)

FIELD: medicine.

SUBSTANCE: invention refers to psychoneurology, particularly to an agent for treating multiple sclerosis. A composition (solid or liquid dosage form) contains triiodide 1,3-diethylbenzimidazolium as an agent, low-molecular surgical polyvinylpyrrolidone, presented as a solubiliser, and an agent stabiliser, and in addition in the liquid dosage form - ethanol as a solvent.

EFFECT: composition under the invention exhibits high therapeutic effectiveness in treating multiple sclerosis, and is characterised by relieving undesirable by-effects.

2 cl, 4 ex

 

The invention relates to the field of Psychoneurology, in particular to the means for the treatment of multiple sclerosis.

Well-known medication for the treatment of multiple sclerosis: Betaferon recombinant human interferon beta-1b (Mashkovsky PPM Medicines. M: New Wave, 2003, s-325). Currently Betaferon - only drug, the effectiveness of which is shown in long-term (5 years), placebo-controlled study (totolan N.A. Betaferon in the treatment of multiple sclerosis: the standard of proof efficiency // Journal of neurology and psychiatry. No. 7, 2005, s-71).

The disadvantage of this drug is the relatively low efficiency of its use - reduce the frequency of exacerbations of the disease and its severity only 30%, the presence of such side effects as increased depressive symptoms (V.S. Sokolov, totolan N.A., V.M. Klimenko Emotional changes during treatment with Betaferon patients with multiple sclerosis // "Stress and behavior" VII Multidisciplinary conference of biological psychiatry, Novosibirsk, 2003), as well as very high cost of pharmacotherapy with the use of Betaferon.

Also recently in the treatment of multiple sclerosis is very successfully used the drug Copaxone - glatiramer acetate (Zavalishin I.A., Schwartz GY Copaxone in the treatment of multiple sclerosis is (collection of articles). M: Miklos, 2007, pp.5-8). However, the clear disadvantage is the high cost of pharmacotherapy with the use of Copaxone.

The closest to the essential features of the composition of the same purpose is the technical solution according to the patent No. 2007112501 "Benzimidazole derivatives, compositions containing them, their preparation and use", by which the connection specified in the patent formula, their pharmaceutically acceptable salt, diastereomers, enantiomers or mixtures thereof are used in the manufacture of medicinal products for the treatment of multiple sclerosis. However, the connection of the specified General formula are not derived from the cation benzimidazole, which eliminates the possibility of formation of pharmacologically highly complex compounds with imidazole ring of these compounds.

The invention, which defines its purpose is to create new drugs with pronounced pharmacological activity for the treatment of multiple sclerosis with high therapeutic efficacy, reducing unwanted side effects, lower cost of treatment.

The technical result that can be achieved with the implementation of the invention is to provide a composition with high pharmacological activity for the treatment of multiple sclerosis C is through the use of its complex connections active iodine and Detelinara derived cation benzimidazole, namely triiodide 1,3-diethylbenzamide as the active agent.

The technical result is also achieved in that the composition for the treatment of multiple sclerosis (solid or liquid form) contains high pharmacological activity triode 1,3-diethylbenzamide as active principle, a low-molecular polyvinylpyrrolidone medical, which solubilizer and stabilizer for the active agent, and optionally in liquid form - solvent (ethyl alcohol), in the following ratio, wt.%:

liquid form

Triode 1,3-diethylbenzamide1,5-10,0
The low-molecular polyvinylpyrrolidone
medical6,0-30,0
Ethyl alcohol, 95%60,0-92,5

for solid form.

Triode 1,3-diethylbenzamide10,0-25,0
The low-molecular polyvinylpyrrolidone
medicalof 75.0 to 90.0

Justification of the selected limits of the concentrations of the components of the composition is the following. When the concentration of the active principle - triiodide 1,3-diethylbenzamide below 1.5% wt.% reduced therapeutic activity of the composition. When the concentration of the 1,3-diethylbenzamide of triiodide above to 25.0 wt.% occurs the probability of irreversible loss of solubility of the active principle, which also leads to reduced therapeutic activity of the composition. The concentration of polyvinylpyrrolidone below 6.0 wt.% does not provide the necessary solubility of triiodide 1,3-diethylbenzamide. Concentration of the solvent (ethyl alcohol) and its ratio in the composition depends on the need in each case the consistency of the composition (solid dosage form, the solution). In the case of production of the composition in the form of solid dosage forms such as the need to use solvents is absent, but the presence of polyvinylpyrrolidone is necessary to ensure the solubility of the active agent in the gastrointestinal tract. The excess solvent concentrations above 92,5,0 wt.% leads to decrease in the content of the composition mass fraction of active start - triiodide 1,3-diethylbenzamide, and consequently, reduce therapeutic activity of the composition.

A method of obtaining a composition for the treatment of disseminated is lerosa can be realized with the implementation of the specified destination as follows. As an active principle obtained compositions used triode 1,3-diethylbenzamide (Pharmacopeia 42-0609-6576-05), which causes its qualitative and quantitative composition. In the manufacture of liquid composition with ethanol 95% (Pharmacopeia 42-3072-00) dissolve the white powder of low molecular weight polyvinylpyrrolidone medical (Pharmacopeia 42-03-84-2668-02), used as a solubilizer and stabilizer of the active principle, in 95%ethyl alcohol. Then the resulting solution dissolve finely ground crystals dark brown triiodide 1,3-diethylbenzamide.

In the manufacture of solid dosage forms of the compositions of finely divided crystals of triiodide 1,3-diethylbenzamide mechanically mixed with white powder polyvinylpyrrolidone medical low molecular weight. The resulting mixture produce solid dosage forms (tablets, capsules).

A method of obtaining a composition for the treatment of multiple sclerosis is safe for individuals involved in the process.

The possibility of carrying out the invention is confirmed by the following:

Example 1

The low-molecular polyvinylpyrrolidone medical (Mm 12600 D) in an amount of 16.0 wt.% dissolved at 55±5°C in ethyl alcohol, taken inthe number 80,0 wt.%. The resulting solution dissolve the crystals of 1,3-diethylbenzamide of triiodide in the amount of 4.0 wt.%. Get composition (solution for oral administration) for the treatment of multiple sclerosis.

Example 2

The low-molecular polyvinylpyrrolidone medical (Mm 12600 D) in an amount of 6.0 wt.% dissolved at 55±5°C in ethyl alcohol, taken in an amount 92,0 wt.%. The resulting solution dissolve the crystals of 1,3-diethylbenzamide of triiodide in the amount of 2.0 wt.%. Get composition (solution for oral administration) for multiple sclerosis.

Example 3

The low-molecular polyvinylpyrrolidone medical (Mm 12600 D) in an amount of 75.0 wt.% mechanically mixed with finely ground crystals of 1,3-diethylbenzamide of triiodide in the amount of 25.0 wt.%. Metered dose resulting mixture is Packed in gelatin capsules. Get a solid dosage form is a capsule for oral administration for treatment of multiple sclerosis.

Example 4

The low-molecular polyvinylpyrrolidone medical (Mm 12600 D) in an amount of 90.0 wt.% mechanically mixed with finely ground crystals of 1,3-diethylbenzamide of triiodide in the amount of 10.0 wt.%. Metered dose resulting mixture is subjected to extrusion. Get a solid dosage form tablets for oral administration for treatment of multiple sclerosis.

The wedge is ical confirmed the efficiency of use of the claimed composition for the treatment of patients with multiple sclerosis. Described in the examples options composition was applied surveyed patients twice a day orally in number, containing the dose corresponding to 40 mg of the active principle.

Patient B., born in 1979

The signs of the disease since September 2003: weakness in legs, loss of sight in his right eye.

Neurological status: Krupnorazmernyj horizontal nystagmus, high knee reflexes, bilateral symptom Babinski. Reflexes along the pyramidal type, instability in the Romberg position.

MRI from 20.11.2003, Conclusion: MRI signs of multiple foci of demyelination, the acute phase, atrophic changes of the cerebral cortex.

Since 2003 pharmacotherapy composition obtained in example 1. 1.5 months condition began to improve after 3 months showed a significant improvement.

MRI from 13.01.2005, Conclusion: MRI signs of demyelinating diseases of the brain.

MRI from 23.07.2006, Conclusion: MRI signs of multiple sclerosis with elements of atrophy of the cerebral cortex. Compared with MRI from 13.01. 2005 in a stable condition.

Patient K., born in 1981

The signs of the disease since September 2003: weakness, numbness in the right limbs, double vision when looking to the side.

Neurological status: Horizontal and vertical nystagmus, paresis VI and VII FMN, dynamic and static taxi is, tendon reflexes are high, the uncertainty in the Romberg position, bilateral symptom Babinski.

Were treated at the clinic at the Department of neurology, the Rostov state medical University with 17.02.06 on 27.02.06. Clinical diagnosis: multiple sclerosis, spinal form, acute stage, approaches pyramidal syndrome. Treatment: contrical, gemodez, piracetam, vitamins a, E, B6, solumedrol, carbamazepine.

At discharge: disabled.

MRI from 10.09.2004, Conclusion: MRI signs of demyelinating lesions of the brain.

MRI from 27.02.2006, Conclusion: MRI signs of demyelinating disease. Identified new stem and hemispheric lesions.

The composition obtained according to example 2 uses from March 2006 3 months marked reduction of symptoms was ready to get to work.

Patient K., born in 1971

The signs of the disease may 2002: dizziness and reduced vision. The recent escalation in the summer of 2005, when there was a numbness of the right hand, blurred vision.

Was hospitalized in the clinic of nervous diseases and neurosurgery Rostov state medical University in 28.11.2005, 08.12.2005, and in the neurological Department of the hospital No. 1, Rostov-on-don with 20.02.2007, 28.02.2007, and 26.12.2007, 10.01.2008 was diagnosed with multiple sclerosis, recurring-remitting course, the stage of exacerbation, pronounced MoH is eccolo-pyramidal syndrome, dysfunction of the pelvic organs, stenocardiceskie syndrome. Treatment: traditional, gets Copaxone since March 2006.

MRI from 24.11.2005, Conclusion: MRI signs of multiple sclerosis.

Started therapy composition obtained in example 3, against the backdrop of worsening during treatment with Copaxone since March 2008, After 2-3 months showed a significant improvement. Was ready to get to work. Aggravation against the background of pharmacotherapy composition is missing.

Patient S., born in 1957

Was on treatment in 2002, 2003 and 2005 in the neurological Department of the railway hospital and hospital № 6, Rostov-on-don diagnosed with multiple sclerosis, spinal shape, having a progressive course, tetraparesis in a stage of dynamic deterioration. Group II disability.

MRI from 14.05.2002 Conclusion: Signs of demyelinating lesions of the brain.

MRI from 13.05.2005, Conclusion: MRI signs of demyelinating disease. The number of lesions stable, progressive atrophic changes.

Therapy composition obtained in example 4, is held from 2005 For the observation time from the start of treatment composition stable neurological status, exacerbations are not checked.

Patient W., born in 1981

The signs of the disease since September 2005: severe headaches, sudden decreased vision in his right eye from 1.0 to 0.1.

<> Neurological status: adynamic-cephalgic syndrome. GNI - emotionally labile, estensione, disturbing. FMN is reduced vision in the right. 2-sided nystagmus, in the Romberg shakiness, coordinatorsee sample performs insecure with intention and promahivayas.

Was treated in the neurological Department of the hospital No. 6, Rostov-on-don 13.07.2006, 04.08.2006, treatment: Parenteral pentoxifylline, Mexidol, Riboxin, Actovegin, piracetam, Mildronate. Interline - atarax, Berlition, FT. Neurological status at discharge does not differ from that in the receipt.

Brain MRI from 20.10.2005, Conclusion: MRI signs of multifocal lesions of the white matter of the brain.

Brain MRI from 28.03.2006, Conclusion: there has been regression of the lesion in the right leg of the brain and the appearance of the lesion in the shaft of the corpus callosum.

In September 2006 initiated pharmacotherapy composition obtained in example 1. After 3 months marked reduction of symptoms, recovered sight in his right eye.

MRI from 31.05.2007,: reduction of process compared to MRI from 28.03.2006,

MRI from 15.05.2008,: signs of multiple sclerosis, the reduction process.

Currently, no complaints, functional.

The composition of the claimed composition can be obtained technological way. The composition is stated with the tava can be used as a drug for the treatment of multiple sclerosis in medicine.

1. Composition for treating multiple sclerosis, comprising triode 1,3-diethylbenzamide as active principle, a low-molecular polyvinylpyrrolidone health as a solubilizer and stabilizer for the active agent, and the solvent ethyl alcohol 95% in the following ratio, wt.%:

Triode 1,3-diethylbenzamide1,5-10,0
The low-molecular polyvinylpyrrolidone
medical6,0-30,0
Ethyl alcohol, 95%60,0-92,5

2. Composition for treating multiple sclerosis, comprising triode 1,3-diethylbenzamide as the active agent and a low molecular weight polyvinylpyrrolidone health as a solubilizer and stabilizer of the active principle in the following ratio, wt.%:

Triode 1,3-diethylbenzamide10,0-25,0
The low-molecular polyvinylpyrrolidone
medical of 75.0 to 90.0



 

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