Aqueous extract of tobacco leaves and use thereof in treating dependence

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to pharmaceutical industry, particularly using an aqueous extract of tobacco leaves for preparing an agent for treating tobacco dependence. Using an aqueous solution of the aqueous extract of tobacco leaves or a lyophilizate of the aqueous extract of tobacco leaves in sterile water for preparing the agent in the form of injections for treating tobacco dependence wherein said solution have the certain content of a dry substance. A kit for treating tobacco dependence comprising a syringe, a sterile water bottle and the lyophilizate of the aqueous extract of tobacco leaves.

EFFECT: aqueous extract of tobacco leaves and kit are effective for treating tobacco dependence.

8 cl, 2 ex

 

The present invention relates to the use of extract of tobacco leaves for the preparation of a drug intended for the treatment of addiction. The invention also relates to a solution and set for injection of extracts of the leaves of tobacco.

The world health organization defines dependence or addiction as "a syndrome in which the consumption of the product becomes a necessity, dominating the needs of other behaviors, previously of great importance. In its most extreme form the state of dependence is characterized by an irresistible need in a product that pushes a person suffering from this addiction, the sudden search of this product.

In France, approximately 200,000 people are dependent on heroin, much less dependent on cocaine or derivatives of amphetamine. Meanwhile, the cause dependence and other products, which is manifested not so much: alcohol, tobacco, and coffee. This dependence also entails serious public health problems.

In particular, at present, to overcome tobacco dependence in addition to behavioral therapy or acupuncture there are three main types of treatment:

- substitutes for nicotine;

- zyban;

- homeopathy.

The principle of these techniques is based on allegations which, what in the mechanism of tobacco dependence participates nicotine. Molecules of nicotine can be attached to proteins present on the surface of nerve cells, nicotinic acetylcholine receptors. In the presence of nicotine these receptors, which are actually channels open. This starts a chain of events resulting in the release of the hormone dopamine. Nicotine triggers the "chain of remuneration", causing a feeling of pleasure.

When abstinence from Smoking body "requires" their dose of nicotine to satisfy the feelings of bliss: this condition addict without drugs.

Therefore, the aim of the use of substitutes for nicotine is the introduction to the smoker's brain the amount of nicotine sufficient to he experienced no suffering from a lack of nicotine.

Substitutes for nicotine may be introduced into the body in different ways: using percutaneous patches; orally in the form of chewing gum, tablets for sucking or sublingual tablets; by air, in the form of preparations for inhalers. Oral formulations can be used alone or in combination with dot placed patches. Patches emit nicotine, which is quickly absorbed by the skin, this helps to relieve the symptoms of physical withdrawal due to lack of nicotine.

The use of the Plaza is Ira recommended by the Ministry of health. Despite the fact that the main success factor is motivation, it is believed that the effectiveness of tobacco withdrawal is doubled when using the patch compared with placebo. In General, this means approximately 16 to 20% of smokers quit after a year.

Nicotine chewing gum (or "gum") ensure the intake of nicotine through the oral cavity, this form facilitates the symptoms of physical withdrawal. The number of chewing gum can be changed depending on the level of pharmacological dependence, which is estimated as for the patches, the answers to the test Fagerstrom. Usually the consumption of chewing gum lasts three months, it is recommended to stop using them after six months after Smoking cessation.

Numerous therapeutic studies have shown that the effectiveness of such chewing gum comparable to the effectiveness of the patches, the percentage of refuse area was 19% with experience of abstinence one year.

For optimal dosage and duration of treatment should be sufficient, subject to the application of (first gum needed to suck, and then very slowly to chew on for 30-40 minutes). Indeed, if too fast, chewing nicotine very quickly enters the body, when this is m danger of excessive salivation, and sometimes burning sensation in the stomach or hiccups. Besides chewing gum partially loses its effectiveness if ingested, so how much of it is destroyed by the liver. At the same time, some former smokers can hardly refrain from chewing gum.

Chewing gum can be used in addition to the patch to remove the strong desire to smoke, if the patch can't neutralize. Chewing gum is well suited for persons who smoked regularly, allowing former smokers to play an active role in Smoking cessation. They also ensure the safety of familiar gestures.

Nicotine can also be introduced into the body in the form of tablets that are placed under the tongue or intended for sucking.

The use of tablets is more discreet and easier way relieve symptoms than chewing gum.

Like other nicotine substitutes, these pills can cause headaches at the beginning of treatment.

Nicotine can enter the body by inhalation. The inhaler is a tip with a cartridge-shaped mouthpiece, with the help of nicotine delivered by inhalation through the mouth. When you experience the desire to smoke a former smoker takes a breath in the form of torque, while receiving about 5 mg of nicotine.

The inhaler is not only the about can ease painful symptoms related to the lack of nicotine, but also gestural support, simulating the process of Smoking. As chewing gum, sublingual tablet or tablets for sucking, it can be used as a Supplement to the patch.

A certain concentration of nicotine in the blood is slower than when Smoking cigarettes, so a smoker must wait until his desire to smoke will pass.

Another method of withdrawal from tobacco is taking bupropion - drug, marketed under the name of zyban, which is produced by laboratories GlaxoSmithKline (GSK) and has an effect on certain brain neurotransmitters, such as catecholamines, norepinephrine and dopamine. Zyban is a selective inhibitor of reuptake of catecholamine neurons, which gives it the properties of the antidepressant. This drug, which due to its antidepressant properties since 1989 was also issued in the USA, can ease some of the symptoms associated with giving up Smoking, in particular the desire to smoke, and difficulty concentrating.

The effectiveness of sibuna comparable to the effectiveness of nicotine patches (percent refused 20%). In clinical studies, zyban demonstrated high efficacy in the treatment of chronic bronchitis is in, patients, who often are heavy smokers and have problems with tobacco withdrawal.

Zyban acts on the mental component of tobacco dependence and facilitates the elimination of tobacco by a mechanism other than nicotine substitutes.

Zyban requires medical purposes, its use may be accompanied by a sensation of dry mouth, insomnia and dizziness. Treatment with this drug should be under the control of the French Agency for supervision of sanitary security of health products, as in the UK were recorded deaths after application. However, the serious consequences of drug treatment, apparently, there are rarely, if zyban was spelled correctly, taking into account contraindications.

The third method of treatment for tobacco withdrawal is homeopathy, which is based on the use of very small doses obtained by serial dilutions of a substance that relieves painful symptoms that were. In this context, the refusal of tobacco is often used extract "tabacum". In particular, in Irish patent application IE 960511 described the use of homeopathic dilutions of extract of tobacco for the manufacture of the drug, designed to restore the functions of neurons.

Egoista in the treatment of symptoms of tobacco withdrawal has not been proven. As with other unconventional ways relieve symptoms of failure, its effectiveness is insufficient for heavy smokers. Specialists from the Ministry of health consider the application of the extract "tabacum", i.e. aqueous extracts of tobacco leaves in very small doses (less than 0,00001 g/ml), justified only for the treatment of allergic reactions to tobacco, which is very rare. In these cases, the extract is introduced by mesotherapy in accordance with strictly prescribed procedure.

The mechanisms of dependency or propensity is complex and not yet fully understood. However, recent studies have found that the relationship involves three neuromodulators: dopamine, norepinephrine and serotonin (Jean-Paul Tassin and Jacques Glowinski. Proceedings of the American Academy of Sciences, 24 April 2006 (Jean-Paul Tassin et Jacques Glowinski dans Comptes rendus de l Academie des sciences americaines, 24 avril 2006). Numerous kinetics of production of these neuromodulators shows the formation of dependencies.

In classic view, nicotine is only one component of cigarettes that is addictive, and therefore the main method for weaning from tobacco is the intake of nicotine. Now this approach is questioned, because in the light of recent works mentioned above, nicotine is not the main factor determining the dependency.

A surprising and unexpected way, the authors of the present invention have found that an aqueous solution of an aqueous extract of tobacco leaves can reduce the dependence. More specifically, the authors were able to show that a single injection of an extract of tobacco according to the invention is usually enough to reduce or even remove tobacco smokers. This property is a major advantage for the patient, taking into account that the drugs currently available on the market, suggest long-term treatment with multiple courses. The method of treatment according to the invention on the contrary is a shock therapy, i.e. the treatment, consisting preferably of a single injection of the extract of tobacco, after which in a few days or weeks is optional, at least one re-injection if the patient feels it necessary.

Thus, the object of the invention is the use of an aqueous extract of tobacco leaves for the preparation of a drug for treatment of tobacco dependence.

More specifically, an object of the invention is the use of an aqueous extract of tobacco leaves for the preparation of the drug in the form of a solution in sterile water for injection, preferably subcutaneous injection for the treatment of dependencies.

An aqueous extract of tobacco leaves soda which provides a lot of connections and only a small amount of nicotine he could almost not contain nicotine.

Without being bound to theory, the authors suggest that substances present in water extracts of tobacco, counteract pathological dissociation of the three major neuromodulators, namely dopamine, norepinephrine and serotonin.

The preferred method of implementing the present invention relates to the use of an aqueous extract of tobacco leaves for the preparation of a drug for treatment of tobacco dependence.

Preferably you should use lyophilizate aqueous extracts of tobacco leaves. Indeed, the use of aqueous extracts of tobacco leaf allows you to have water extracts of the leaves of tobacco in any time of the year, despite the fact that their presence is not associated with the season of harvesting tobacco.

The preferred method of performing this drug is a form for injection for a single injection, preferably subcutaneous injection.

Introduction extracts of leaves of tobacco leads to decrease over a longer period (3-5 weeks), largely or even completely, the needs of the body, thereby suppressing the desire to take the toxic substance to which the patient has a dependence, in particular, the desire to smoke a cigarette, and reduce the associated stress. Thus, as p is Avila, one injection is enough to ease or relieve the symptoms of tobacco dependence. It is obvious that you may need at least one more subsequent injection in accordance with the state of treatment of the patient, in particular, according to the level of tobacco dependence. For each patient in accordance with his state specialist should choose the period of time between the first and second injection and, consequently, the number of additional injection.

Without being bound to theory, the authors believe that this method of administration allows the active substances present in the extract of tobacco leaves, very quickly in the bloodstream and contribute to the massive release of neuromodulators involved in the mechanisms of addiction. In this case we can speak about the mechanism with a threshold effect, which occurs when the residual saturation and neutralization sites, which are inducers of stress. Of course, that for this purpose any suitable route of administration, providing a threshold effect of the same order. Consequently, it is possible to provide for intramuscular or intravenous route of administration.

It is thereby possible and start the process of detoxification. It will continue throughout the period of residual effect caused by the treatment is receiving.

Tolerability is excellent, the danger of addiction is excluded.

Depending on the specific mode of carrying out the invention relates to the use of an aqueous extract of tobacco leaves with dry matter content, expressed in mg/ml, 0.05 to 150 mg of dry matter per 1 ml of sterile water, preferably from 0.5 to 100 mg per 1 ml of sterile water, most preferably from 1 to 20 mg per 1 ml of sterile water for preparation of solution for injection for the treatment of dependencies.

Even at high concentration aqueous solutions of tobacco leaves are not toxic, more specifically when they are subcutaneous. However, when applying the solution with a concentration above 150 mg/ml treatment efficiency is not increased. In contrast, with decreasing concentrations below 0.5 mg/ml, the treatment efficiency was lower.

For the patient in accordance with the degree of his dependence and the ability to control the associated stresses may be sufficient to only one injection.

Thus, the object of the invention is the use of an aqueous extract of tobacco leaves for the preparation of a single injection of the drug for the treatment of dependencies.

Indeed, in the case of tobacco dependence one injection of an aqueous extract of tobacco leaves was sufficient to release the patient from the areas of addiction, in particular sleep disturbances, increased excitability, nervousness, hyperactivity and increased tone. After the first injection, the patient feels a characteristic indicating the success of detoxification: deep sleep, fatigue from the first days, progressive and rapid recovery of smell, taste, sensitivity throat.

In other cases a single injection is not sufficient, and therefore it is necessary to make at least the second injection.

Thus, the object of the invention is the use of an aqueous extract of tobacco leaves for the preparation of at least two injections of the drug that is injected with an interval of 4 to 30, preferably from 5 to 15, most preferably from 6 to 13 days.

The need for a second injection, and possibly other additional injections will be determined for each patient depending on the results obtained after the first injection and/or previous injection.

When tobacco dependence the number of injections should not be more than 5, preferably not less than 4 and most preferably not be more than 2.

After injection or injection, the patient feels a strong incentive incentive to ensure himself in the full success of detoxification.

Of course, for maximum effectiveness, these injections must be accompanied by a compliance classically the recommendations for behavior during withdrawal from tobacco, it is strongly recommended to systematically abandon the use of alcohol, spices, coffee, since it is recognized that the desire to smoke a cigarette often associated with these taste sensations and entails the manifestation of Pavlov's conditioned reflex.

The invention also relates to a sterile aqueous solution aqueous extracts of tobacco leaves with a dry matter content of from 0.05 to 150 mg per 1 ml, preferably from 0.5 to 100 mg per 1 ml, most preferably from 1 to 20 mg per 1 ml of sterile water.

Preferably, these water extracts must be dried.

In a particular implementation method the invention relates also to a sterile aqueous solution of an aqueous extract of tobacco leaves with a dry matter content of from 0.05 to 50 mg per 1 ml of sterile water, preferably from 0.5 to 20 mg per 1 ml of sterile water, most preferably from 1 to 15 mg per 1 ml of sterile water, while the above extract should preferably be dried.

The invention also relates to a kit, ready for use, including a syringe, a bottle of sterile water, and lyophilized aqueous extract of the leaves of tobacco. These aqueous solutions and this kit are intended for use in the treatment of addiction, more specifically, tobacco dependence.

In more detail, the image is giving will be described in the following examples, which are included solely to illustrate the invention and are not limiting.

Information confirming the possibility of carrying out the invention

Example 1. Preparation of solutions for injection

Solutions for injection were prepared by dissolving 20 mg of lyophilized leaf tobacco IP 100, manufactured in the sale of the Company Stillorgan (Société Stallergènes)in 2 ml of sterile water.

Example 2

150 patients suffering from tobacco addiction, fill out a questionnaire with questions about allergies, risk of cardiovascular complications, diabetes, known sensitivity to alcohol, toxic chemical substances or drugs. Then each of these 150 patients was made by subcutaneous injection in the upper arm or buttock) solution described above.

After 10-12 days, 15 patients survived the desire to smoke, was made the second injection.

The number of patients who never touched cigarettes in 1 month, 3 months, 6 months and 12 months below as the percentage of success:

The percentage of success:

1 month - 74%, of which 69% was made one injection and 5% two injections.

3 months - 61%

6 months 57%

12 months 53%

The number of patients resume Smoking within a month after the last injection below as percentage breakdown:

Percentage breakdown:

month - 26%, 25% of which was made by one injection, and 1% two injections.

Theoretically percentage breakdown 26% could be reduced to 10%, systematically introducing the second injection. The results after 3, 6 and 12 months would have been higher.

Thus, the results obtained are much greater than those when using the drugs available on the market currently:

16-20% success rate when applying patches or chewing gum after a year of treatment,

20% - the percentage of success in the application of sibuna.

A short course of treatment and is much cheaper compared to existing treatments, designed for many months.

1. The use of an aqueous solution of an aqueous extract of tobacco leaf or freeze-dried aqueous extract of the leaves of tobacco in sterile water for the production of drugs in injectable form for the treatment of tobacco dependence, where this solution has a dry matter content of from 0.05 to 150 mg per 1 ml of sterile water.

2. The use according to claim 1, where this solution has a dry matter content of from 0.5 to 100 mg per 1 ml of sterile water.

3. The use according to claim 1, where this solution has a dry matter content of from 1 to 20 mg per 1 ml of sterile water.

4. The use according to claim 1, where the treatment includes one injection, the specified solution.

5. The use according to claim 1, where the treatment is dependent on the STI includes at least two injections of the indicated solution, are conducted at intervals of from 4 to 30 days.

6. The use according to claim 5, where at least two injections are performed with an interval of 5 to 15 days.

7. The use according to claim 9, where at least two injections are performed with an interval of 6 to 13 days.

8. Set for treatment of tobacco dependence, including a syringe, a vial with sterile water and lyophilized aqueous extract of tobacco leaves, where injectable form for the treatment of tobacco dependence is an aqueous solution freeze-dried aqueous extract of the leaves of tobacco in sterile water, and this solution has a dry matter content of from 0.05 to 150 mg per 1 ml of sterile water.



 

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