Pharmaceutical composition possessing soporofic effect

FIELD: medicine, pharmacology, pharmacy.

SUBSTANCE: invention relates to the medicinal preparation zolpidem. Pharmaceutical composition comprises zolpidem hemitartrate as active substance taken in the effective dose and ludipress, aerosil and stearate as special additives. Pharmaceutical composition is made preferably as a tablet covered by envelope. Invention solves the problem for the development of the nonprolonged soporofic medicinal agent based on zolpidem corresponding to all requirements of the State Pharmacopoeia of XI Edition. Proposed nonprolonged formulation of zolpidem is suitable for workers contingent suffering with insomnia, especially, in professions requiring attention and concentration.

EFFECT: improved and valuable medicinal properties of composition.

6 cl, 2 tbl, 3 ex

 

The invention relates to medicine, specifically to a tool that can be used for different types of insomnia.

The reduction of social welfare in some countries, the increasing pace of life, unemployment, crime and other adverse conditions of life has dramatically increased in recent years, the number of people suffering from different types of insomnia (chronic, abnormal, transient). Despite the availability of medical practice various sleeping pills, creation of new effective hypnotics necessary due to the fact that part of the used hypnotic drugs have side effects, to part from them is addictive and lost their original efficiency.

Zolpidem is hypnotic drug from the group of imidazopyridine is a specific agonist ω-receptors in CNS. Also has sedative, minor anxiolytic, anticonvulsant and Central muscle relaxant effect. Used in sleep disorders. For the first time zolpidem is referred to in European application ER, 1982, which describes derivatives of imidazo[1,2-a]pyridine-3-ndimethylacetamide, method of their production and use in therapy, in particular zolpidem (free base form). In the European patents EP 251859, 1988 and EP 1038875, 2000, describes how p is taking imidazopyridines, including zolpidem.

In the international application WO00/58310, 2000, describes the various salt of zolpidem, including those used in solid dosage forms for oral administration - tartrate and hemitartrate zolpidem.

In U.S. patent No. 5891891, 1999, describes the use of imidazo[1,2-a] pyridine-3-acetamide derivatives for therapeutic treatment of neuropsychiatric syndromes. Zolpidem is used to treat Parkinson's disease and parkinsonism syndromes. Sedative and hypnotic effects are observed at much lower doses than those required for other effects of zolpidem (anticonvulsant, anxiolytic and muscle relaxant). The composition in the form of a single dosage form preferably comprises from 5 to 20 mg of the active ingredient - zolpidem hemitartrate.

The main dosage forms of zolpidem described in the literature, are prolonged dosage forms, dosage forms with controlled release. So, in the international application WO 95/20947, 1995, describes the tablets containing two or more layers including one or more medicinal substances (a) and one or more gelling agent (B)contained in separate layers of the tablet. The weight of the gelling agent in the gelling layer is from 20 to 60%, the amount of gelling layer in the tablet which is from 50 to 80%. Gelling agent is a modified cellulose, sodium alginate, alginic acid, tragakant, polyacrylic acid and xanthan gum.

In example 10 the international application WO 95/20947, 1995, described Bologna tablet based zolpidem tartrate:

Part a, wt.%:
Zolpidem tartrate5,0
Lactose64,5
Microcrystalline cellulose25,0
Nitrocresols5,0
Magnesium stearate0,5
Part In, wt.%:
The hypromellose40,0
Acidic calcium phosphate19,2
Lactose29,0
Microcrystalline cellulose5,0
Povidone K 306,0
Colloidal silicon dioxide0,3
Magnesium stearate0,5

Bikinie tablets containing 5 mg of zolpidem hemitartrate weighing 325 mg and containing 125 mg of the composition of part a and 200 mg of the composition part In, get on a tablet press by a method of two-stage compression molding and covered with foil with p the physical alteration of the coating solution, contains hypromellose, polyethylene glycol and suitable dyes.

In the international application WO 00/33835, 2000, described dosage forms with controlled selection, comprising zolpidem or its salts. Zolpidem is released through a certain period of time in accordance with biphasic profile selection, in which the first phase is the immediate phase separation, and the second phase - the phase of prolonged selection. The first phase has a maximum duration ˜30 minutes, during which stands out from 40 to 70% of the total amount of zolpidem. The time that is released about 90% of the total amount of zolpidem is from 2 to 6 hours.

Prolonged form of zolpidem as a hypnotic drug is very convenient for disabled patients. For running, insomnia, prolonged form of the drug can be a barrier when performing their duties, particularly in occupations that require attention and concentration (for example, drivers of all types of transport, rescue services, law enforcement, and others).

Therefore, the development neprolongirovannymi form of zolpidem is very important.

The objective of the invention is neprolongirovannymi sleeping medicine on the basis of zolpidem, is responsible for all regulatory requirements Gosfarmakapei XI edition (see table 2).

The problem is solved by a pharmaceutical composition having soporific effect, which as the active substance contains a therapeutically effective amount of zolpidem hemitartrate and special additive in the amount of 7.2 to 8.8 mass parts per 1 mass part of existing substances (parts by weight to 1 parts by weight).

As the target additives used ludipress, Aerosil and salt of stearic acid in the following ratio of components, parts by weight to 1 parts by weight of active ingredient:

Ludipress7,100-8,680
Aerosil0,018-0,022
Salt of stearic acidof 0.081-0,099

As a salt of stearic acid pharmaceutical composition having widespread effects, contains magnesium and/or calcium salts.

A new pharmaceutical composition is made in the form of a solid dosage form, preferably in the form of coated tablets.

As the shell proposed the following composition at a ratio of components, parts by weight to 1 parts by weight of active ingredient:

Oksipropilmetiltselljuloza0,128-of) 0.157
Propylene glycolbeing 0.036-0,045
is ALK 0,112 was 0.138
Titanium dioxide0,126-0,158
Dye0,001-0,002

As the dye can be used Indigo Carmine and/or acid red, and/or tropeolin and other

The proposed ratio of the active substance and the target additives found experimentally and is optimal, providing the drug zolpidem compliance with all requirements of Gosfarmakapei XI ed. (see table 2).

The following examples illustrate the invention.

Example 1. (Trust supplements to 8.0 parts by weight to 1 parts by weight of active substance; see table 1). Mix the powders zolpidem hemitartrate in the amount of 40.0 g, ludipress in the number 315,0 g of Aerosil in a quantity of 0.8 g of magnesium stearate in the amount of 3.6 g, mix thoroughly and tabletirujut on a tablet machine. Get 3833 tablets with a total weight of 345 g Tablet-kernel zolpidem cover film-forming composition prepared in a known manner from powders 5,46 g oksipropilmetiltselljulozy (OPMC), 1.54 g of propylene glycol, of 5.40 g of titanium dioxide, 4,78 g of talc, 0,0498 g of Indigo Carmine and 143 ml of water. The film is applied in a known manner on the pill-kernel zolpidem to obtain a uniform coating. Weight gain pills averages 5%. The obtained tablets zolpidem meet all the requirements of Gosfarmakapei I ed (see table 2).

Example 2. (Trust supplements to 7.2 parts by weight to 1 parts by weight of active substance; see table 1). Obtaining tablets zolpidem carried out as in example 1 based on 40 g of zolpidem hemitartrate, 284 g of ludipress, 0,72 g of Aerosil or 3.24 g of calcium stearate, get 3540 tablets with a total weight of 311,52 g, which is covered with a membrane of example 1. The obtained tablets zolpidem meet all the requirements of Gosfarmakapei XI ed. (see table 2).

Example 3. (Trust supplements to 8.8 parts by weight to 1 parts by weight of the active substance (see table 1). Obtaining tablets zolpidem is conducted according to example 1 based on 40 g of zolpidem hemitartrate, 347 g of ludipress, 0.87 g of Aerosil and 3.95 g of magnesium stearate. Get 4087 tablets with a total weight of 380 g that cover the film, as in example 1. The obtained tablets meet all regulatory requirements (see table 2).

A comparative Toxicological study of the claimed pharmaceutical compositions zolpidem and standard sample, which used the drug ivadal company LABORATOIRES SYNTHELABO, France.

The study was conducted with the use of modern physiological, biochemical, hematological and histological methods in accordance with the requirements of FC RF Ministry of health.

Studied subacute toxicity in two weeks on randombred rats-males with an average weight 214&x000B1; 4, the Drugs were injected intragastrically at doses of 2 (therapeutic) and 20 mg/kg once a day for 2 weeks.

Compare the drugs had no significant effect on the integral performance (weight gain, feed consumption, water).

The test preparations hypnotic action exerted a dampening effect on the behavior of animals. The severity of the effect, the nature and duration of its holding had a dose dependence. At a dose of 2 mg/kg of depression was observed within 2-3 hours, at a dose of 20 mg/kg lasted for 6-8 hours.

According to the results of the experiment revealed no irritant effect on the mucous membrane of the gastrointestinal tract in laboratory animals when exposed to both drugs.

Experimental data show no significant differences from peripheral blood, glucose and total lipids in blood serum, the functional state of the cardiovascular and renal systems. A two-week exposure to drugs at a dose of 20 mg/kg caused similar changes in the nervous system, manifested in the reduction of motor and emotional components of animal behavior. The drugs tested doses did not cause structural abnormalities in organs and tissues.

Thus, the studies confirm bi is the equivalence of the actions proposed pharmaceutical compositions and standard drug.

Were conducted clinical trials offer neprolongirovannymi hypnotic medicines on the basis of zolpidem to study its efficacy and tolerability in patients with insomnia inorganic nature. The study was conducted in accordance with the requirements of FC RF Ministry of health.

In total, the study included 40 patients (14 men and 26 women aged 24 to 64 years (mean age of 43.4 years). The average disease duration from 1 month to 5 years.

Before treatment, the patients complained of difficulty falling asleep, short, shallow sleep with frequent awakenings, dreams of a different nature. Patients reported that sleep does not bring feelings of relaxation, felt sluggish, broken, worried about reduced performance, increased fatigue when performing normal load at home and at work.

Tablets zolpidem was administered after a "washout"of not less than 7 days, except in cases where it is not used other sleeping pills. The drug in monotherapy was used in a dose of 10 mg (one tablet for 20-30 minutes before bedtime). Patients older than 60 years, treatment was started with half tablets (5 mg) during the first 7 days. The maximum dose was 10 mg Duration of therapy zolpidem was 14 days. the status of patients was assessed before the start of therapy (background screening), on the third, seventh days of therapy and at the end of treatment (day 14 of therapy). Drugs with psychotropic activity were excluded.

All 40 patients included in the study, completed the course of therapy.

As a result of clinical trials, it was found that the claimed drug zolpidem shortened sleep time, reduces the number of nighttime awakenings, increases the duration of sleep and improves its quality. It extends the phase II sleep, deep sleep phase (III and IV), does not affect the duration of the phase of REM sleep.

Zolpidem is rapidly absorbed, with a peak concentration of drug in plasma is reached after 1.5-2 hours, and the threshold hypnotic action in the blood plasma is registered within 20-30 minutes after ingestion. The half of the body is 1.5-4 hours. The product has no active metabolites. These features allow you to define the claimed hypnotic drug on the basis of zolpidem as a hypnotic drug with a quick, short steps.

Important qualities of this drug is fast hypnotic actions, lack of significant side effects and the lack of any negative impact on the level of alertness and performance both in the morning and continued all day.

During the study period (14 day is) used a dose of 10 mg at night was sufficient and did not require correction. Moreover, there was a trend consistent consolidate and improve the overall effect of therapy that allows to speak about the restoration of sleep for the majority of patients. In this study, all patients were able-bodied and had full employment. In the research process, reduce disability is not marked. Almost all patients reported improvement in their ability to cope with mental and physical stress.

Thus, preclinical and clinical trials claimed neprolongirovannymi hypnotic medicines on the basis of zolpidem has shown:

its high efficacy in patients with insomnia inorganic nature;

- the speed of falling asleep, quality of sleep, no, or minor severity postsomnic phenomena;

therapeutic security, lack of significant and persistent and unwanted side effects;

the use of this drug prevents daily activity and does not adversely impact on the intellectual and physical performance;

- the drug does not cause changes to the vital functions.

Thus, the claimed drug zolpidem is a highly effective drug for the treatment of patients with insomnia inorganic nature, has good portability is recommended for use in medical practice with sleep disorders inorganic nature as hypnotics.

Table 1
Ingredient nameThe ratio of components, parts by weight to 1 parts by weight of active substance
Example 1Example 2Example 3
Additives target
Ludipress7,9007,1008,680
Aerosil0,0200,0180,022
Salt of stearic acid0,090of 0.0810,099
The shell
Oksipropilmetiltselljuloza0,1430,128of) 0.157
Propylene glycol0,040being 0.0360,044
Talc0,1250,1120,137
Titanium dioxide0,1410,1260,158
Dye0,00150,00100,0020

Table 2
Name quality scoreStandards of quality requirementsThe actual software is a simple
Example 1Example 2Example 3
Average weight, g0,0945±7,5%, i.e. from 0,087 up is 0.1020,0940,0920,098
The deviation in the weight of individual tablets from the average mass %± 10% (allowed for two

tablets ±20%)
-1,1+1,4-1,9+1,1-1,2+1,1
Raspadaemost, minNot more than 157610
Dissolution, %Not less than 75 per 45 min100,097,098,0
The content of zolpidem in table 1., g0,01±7,5%, i.e. from 0,0092 to 0,01080,01000,01020,0097
The content of talc, Aerosil and titanium dioxideNot more than 4,0%1,701,852,30
ImpuritiesThe amount of impurities

not more than 0,5%


0,03


0,02


0,05
any not more than 0.20,010,010,03

1. Pharmaceutical composition having widespread effects, comprising as active ingredient zolpidem and target doba is key, characterized in that it contains a therapeutically effective amount of zolpidem hemitartrate, as well as special additives it contains ludipress, Aerosil and salt of stearic acid in the following ratio of these additives parts by weight to 1 parts by weight of active ingredient:

Ludipress7,100-8,680
Aerosil0,018-0,022
Salt of stearic acidof 0.081-0,099

2. The pharmaceutical composition according to claim 1, characterized in that salts of stearic acid it contains magnesium and/or calcium salts.

3. The pharmaceutical composition according to claim 1 or 2, characterized in that it is made in the form of solid dosage forms.

4. The pharmaceutical composition according to claim 3, characterized in that it is made mostly in the form of coated tablets.

5. The pharmaceutical composition according to claim 4, characterized in that the shell contains oksipropilmetiltselljuloza, propylene glycol, talc, titanium dioxide and dye in the following ratio of ingredients, parts by weight to 1 parts by weight of active ingredient:

Oksipropilmetiltselljuloza0,128-of) 0.157
Propylene glycolbeing 0.036-0,045
is ALK 0,112 was 0.138
Titanium dioxide0,126-0,158
Dye0,001-0,002

6. The pharmaceutical composition according to claim 5, characterized in that as a dye it contains mainly Indigo Carmine, and/or acid red, and/or tropeolin.



 

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