MXPA00010494A - Solution containing nicotine - Google Patents

Abstract

A nicotine method and solution which utilizes an acidic solution containing nicotine. The solution is for use to treat various medical conditions, such as to reduce the need of a user of smoking tobacco to smoke tobacco, to reduce attention deficit disorder symptoms in a person who has attention deficit disorder, and/or to reduce Alzheimer's disease symptoms in a person who has Alzheimer's disease. The solution is palatable and may be introduced into the person by the person drinking it. Subsequent to drinking, the blood plasma levels are sufficient to reduce the need to smoke tobacco, to reduce attention deficit disorder symptoms, and/or to reduce Alzheimer's disease symptoms.

Description

SOLUTION CONTAINING NICOTINE Field of technique The present invention relates in general to a help to stop smoking, and more particularly to a solution containing nicotine, useful as an aid for a smoked tobacco user to quit smoking, said solution is acceptable for a user's appetite once it is ingested by it, and provides a sufficient amount of nicotine to the blood in order to reduce the user's need to smoke tobacco. The nicotine solution is also useful in the treatment of medical conditions other than the addiction of smoking tobacco products, conditions such as the treatment of the deficit condition in attention and in the treatment of Alzheimer's.

BACKGROUND OF THE INVENTION Related to more than one in six deaths, the habit of smoking cigarettes is the first Ref .: 124393 preventable cause of death in the United States. See, document U.S.D.H.H. S., "The Health Benefits of Smoking Cessation," A report of the Surgeon General, Rockville, MD: Public Health Service (1990). Unfortunately, about 50 million Americans continue to smoke. See the document "Cigarette Smoking Among Adults - United Stated," Centers for Disease Control and Prevention, (1992), and "Changes in Definition of Smoking," JAMA, Vol. 272, pages 14-16 (1994). With the currently available treatment, the long-term smoking cessation rates are generally less than 30%. See, Fiore, Smith, and Baker, "The Effectiveness of the Nicotine Patch in Smoking Cessation," JAMA, Vol. 271, pages 1940-1947 (1994).

With the increasing recognition of the health risks associated with the habit of smoking tobacco, particularly smoking cigarettes, an increasing attention has been focused on less harmful means to offer some of the satisfaction that is obtained when smoking. By temporarily giving the smoker an alternate source of nicotine, the symptoms of quitting can be remedied and abstinence is facilitated. Some of the alternative sources are replacing nicotine with nicotine-based chewing gum, nicotine-based skin patches, nicotine-based nasal spray or even nicotine vapor inhalers. See, Rose, J.E., "Nicotine Addiction and Treatment," Ann. Rev. Med., Vol 47, pages 493-507 (1996). In addition, oral administration of a nicotine tablet having an alkaline pH is shown in U.S. Patent No. 5,549,906 published on August 27, 1996 by Santus.

In addition to helping to quit smoking, alternative forms of nicotine administration may have applicability in long-term maintenance, to reduce, if not completely eliminate, the harm that results from smoking-related illnesses; such conditions have been pointed out by basic epidemiological and biological investigations as a result of the nicotine-free constituents found in tobacco smoke. Not only does the "tar" fraction contain numerous potent carcinogens including nitrosamines and polynuclear aromatic hydrocarbons, but also other toxic fractions of tobacco smoke including carbon monoxide, hydrogen cyanide as well as acreolein. See, Hoffman, D. and Hoffman, I., "The Changing Cigarrete", J. Toxicol. Environ, Health, Vol. 50, pages 307-364 (1997).

On the contrary, there is little evidence to implicate nicotine with the diseases related to smoking. Epidemiological evidence from studies of users of tobacco smokeless tobacco as well as cigar smokers, who obtain substantial levels of nicotine but do not inhale significant amounts of smoke, show little increase in morbidity and mortality, with the exception of cancer that probably results from the nicotine-free tobacco constituents. See, the document by Wald, N.J. and Watt, H.C., "Prospective Study of Effect of Switching from Cigarettes to Pipes or Cigars on Mortality from Three Smoking Related Diseases," Br. Med. J., Vol. 314, pages 1860-1863 (1997).

Apart from its application in smoking cessation treatment, there is growing evidence that nicotine may provide therapeutic benefits in the treatment of ulcerative colitis, and in neurodegenerative conditions such as Parkinson's disease and Alzheimer's disease. See, Westman, E.C., Levin, E.D., and Rose, J.E., "Nicotine as a Therapeutic Drug", N.C. Med. J., Vol. 56, pages 48-51 (1995), document showing the intravenous administration of nicotine for the treatment of ulcerative colitis. Most of the nicotine vis-a-vis studies that treat ulcerative colitis are reported in the paper by Zins, Sandborn, Mays, Lawson, McKinney, Tremainc, Mahoney, Zinsmeister, Hurt, Offord, and Lipsky, "Phar acokinetics of Nicotine Tartrate after Single-Dose Liquid Enema, Oral, and Intravenous Administration ", Vol. 37, pages 426-436 (May 1997), which shows a nicotine solution (see page 428) that is drunk by subjects for the effects of 45 μg of nicotine per kg of body weight, as well as a nicotine capsule that was ingested by the subjects.

However, the nicotine that is ingested is absorbed by the small intestine and must pass through the liver before it enters the general circulation. See, the document by Benowitz, N.L., Porchet, H., and Jacob, P.I., "Pharmacokinetics, Metabolism, and Pharmacodynamics .of Nicotine", Wonnacott, S., Russell, M.A.H, and Stolerman, I.P. (Eds), Nicotine Psychopharmacology (pages 112-157), Oxford: Oxford University Press (1990). Because the liver metabolizes much more nicotine during this first absorption step, it has generally been thought that nicotine ingested by drinking a solution might not be an effective way to administer nicotine as an aid to smokers in their attempts to stop smoking. Tobacco smoking, since they would have to take large doses of nicotine to deviate at the entrance of the portal vein of the liver, and as is well known, nicotine has a slightly disgusting taste. This limits the acceptability of drinking a liquid solution of nicotine. Smokers do not drink nicotine because they do not like the taste of nicotine in a large enough amount when they drink it in order to counteract the problem of the first step of absorption through the liver.

On the other hand, although Jarvik, M.E., Glick, S.D., and Nakamura, R.K., "Inhibition of Cigarette Smoking by Orally Administered Nicotine", Clin. Pharmacol. Ther., Vol 11, pages 574-576 (1970), show that nicotine administered in capsules produced smoking effects that presumably result from some absorption of nicotine, and Benowitz, NL, Jacob, P., Denaro, C, and Jenkins, R., "Stable Isotope Studies of Nicotine Kinetics and Bioavailability", Clin. Pharmacol. Ther., Vol. 49, pages 270-277 (1991), reported systematic levels similar to those produced by chewing a nicotine gum after some subjects ingested nicotine-containing capsules, however it has been perceived that large doses of nicotine needed to overcome the metabolic effects of the liver in the first step, it could produce an intolerable gastric irritation. Actually, one of the subjects in the study by Benowitz et al. above, and entitled "Pharmacokinetics, Metabolism, and P armacodynamics of Nicotine," complained of nausea and cramping or abdominal cramping after he ingested a capsule containing nicotine.

Thus, since each of the current products to replace nicotine, as long as there is a role in the cessation of smoking, and perhaps also in long-term maintenance, these have significant disadvantages, there is a need to dispense convenient and well tolerated, nicotine-based formulations instead of smoking tobacco. For example, for many smokers, chewing gums containing nicotine not only have an unpleasant taste, which is a result of the high local concentration of nicotine in the mouth, but they are also difficult to chew. See, the document Rose, J.E., "Nicotine Addiction and Treatment," Ann.

Rev. Med., Vol. 47, pages 493-507 (1996). Nicotine patches, do not allow the rapid absorption of nicotine that some smokers prefer, can produce skin irritations of some individuals, and lacks the desired ritual and sensory aspects related to the behavior of oral tobacco consumption. See, Westman, E.C., Behm F.M., and Rose, J.E., "Airway Sensory Replacement as a Treatment for Smoking Cessation," Vol. 38, pages 257-262 (1996). Nicotine nasal spray is often observed as an irritant, initially producing adverse reactions of sneezing and tearing. See, Sutherland, G., Stapleton, JA, Russell, MAH, Jarvis, MJ, Hajek, P., Belcher, M., and Feyerabend, C, "Randomized Controlled Trial of Nasal Nicotine Spray in Smoking Cessation", Lancet, Vol. 340, pages 324-329 (1992). Finally, nicotine vapor inhaler can produce irritation in mouth and throat, provides low doses of nicotine often inadequate to satisfy most smokers, and some smokers see the action or behavior of puffs or blows, as too similar to smoking the tobacco they are trying to quit. See, from Schneider, et al., The document "Efficacy of a Nicotine Inhaler in Smoking Cessation: A Double-Blind, Placebo-Controlled Trial," Addiction, Vol. 91, pages 1293-1306 (1996). Thus, there is a continuing need to replace nicotine products, which are acceptable in terms of sensory aspects, and which provide a nicely regulated dose of nicotine, which has an acceptable taste and which can be self-administrable.

Brief Description and Objects of the Invention In accordance with the present invention, a method is described for providing nicotine to a human being, by administering to the upper intestinal tract, a selected amount of nicotine; the method comprises providing an acceptable solution for the appetite, containing a selected amount of nicotine, having an acidic pH, and which can be adapted for introduction into the upper gastrointestinal tract of a person, by administering the solution to the upper gastrointestinal tract of the person for the purpose of introducing nicotine to the metabolism of the person, and periodically repeat the administration of the solution to administer a selected amount of nicotine to the metabolism of the person, then deviating to the entrance of the portal vein of the liver, such luck that the nicotine reaches a selected level in the blood of the person in order to reduce the symptoms in it. Preferably, the solution reduces symptoms of a medical condition in a person having the medical condition by the amount of nicotine, which is a therapeutically effective amount to achieve a sufficient level in the blood of nicotine to reduce the symptoms. More preferably, the medical condition is selected from the group consisting of tobacco addiction, the disorders or disorders of attention deficit, Alzheimer's disease, Parkinson's disease, the inability to regulate body weight at an appropriate level at the height of the body, depression, ulcerative colitis, and combinations of the same conditions.

In one embodiment, a method is provided to reduce the consumption of tobacco smoked by a human user by administering a therapeutically effective amount of nicotine to the upper gastrointestinal tract. The method comprises providing an acceptable solution for the palate containing a therapeutically effective amount of nicotine, which has an acid pH, and is adapted for introduction into the upper gastrointestinal tract of the human. The solution is administered to the human upper gastrointestinal tract in order to introduce nicotine to human metabolism, repeating periodically the operation to administer a therapeutically effective amount of nicotine to the metabolism, then deviating to the entrance of the portal vein of the liver, in such a way that the nicotine reaches a sufficient level in the human blood to reduce its need to smoke tobacco. In another modality, the method can be applied to administer a nicotine solution, as described in the previous paragraph, to a human being who has problems or suffers from attention deficit or who suffers from Alzheimer's disease in order to reduce the symptoms of the respective problems of attention deficit or symptoms of Alzheimer's disease.

Thus, an object of the present invention is that, in spite of the general belief that liquid nicotine could present unacceptability to drink given the bitter, pungent and burning taste of nicotine in aqueous solution; in fact nicotine can be effectively delivered in an appropriate concentration in solution, in a form that is appetizing, and that produces significant systematic levels of nicotine as measured in the blood of the veins, then deviating to the liver.

An advantage of the present invention is to provide an acceptable level of sensory stimulation related to nicotine in the throat, stimulation that may be important in reducing appetite or craving for cigarettes, such as anxiety reported by Rose et al., in the document "Subjective Response to Cigarette Smoking Following Airway Anesthetization", Addict. Behav., Vol. 9, pages 211-215 (1984). A further advantage of the present invention is that by ensuring that the liquid is admitted together with the nicotine, ie the liquid is consumed together with the nicotine, the local concentration of nicotine in the upper gastrointestinal tract can also be regulated for the purpose of decreasing the probability of abdominal cramps due to high concentrations of nicotine, concentrations such as that which occurs when a capsule is swallowed.

Some of the objects and advantages of the invention have been set above, others will be obvious as the description proceeds, when considered in conjunction with the accompanying drawings and the Laboratory Examples as best described below.

Brief Description of the Drawings Figure 1 is a graph showing blood plasma levels, after 2 subjects drank several nicotine solutions according to the present invention. Figure 2 is a graph showing blood plasma levels, after 1 subject drank several nicotine solutions according to the present invention.

Detailed description of the invention The present invention offers a new and surprisingly effective method and product, used to deliver a nicotine-containing solution for the treatment of various medical conditions, such as relieving the craving or appetite of smoking tobacco (as is the case with cigarette smoking), to treat and alleviate the symptoms of problems or conditions of attention deficit, and / or to treat and alleviate the symptoms of Alzheimer's disease. More particularly, the nicotine is placed in a solution, for example in an aqueous solution. In addition to using water as the solvent for nicotine to be in solution, other solvents can be used, as long as these are acceptable for human consumption and can dissolve nicotine. For example, ethyl alcohol (ie, beer, wine, or whiskey) and / or milk can be used as a solvent. So far, a nicotine liquid is provided for administration to the upper gastrointestinal tract of a person, for example, for a smoked tobacco user to drink it. In addition to its administration to a person ingesting a drink orally, administration to the esophagus, stomach, and / or duodenum, such as through a feeding tube, is also contemplated. The administration of nicotine according to the present invention is specifically intended to exclude administration by ingestion of tablets and / or capsules buccally and sublingually.

The amount of nicotine, present in the total amount of the solution for a dose, should be at least about 0.5 mg of the nicotine per approximately 300 ml of the nicotine solution. Preferably, the amount of nicotine is in the range of from about 1, to about 42 mg of nicotine per 300 ml of the nicotine solution, more preferably in the range of from about 1, to about 36 mg of nicotine per 300 ml of nicotine. the nicotine solution, it is even more preferable that you are - * - - • - --- within the range of from about 2, to about 26 mg of nicotine per 300 ml of the nicotine solution, and even more preferred to be between about 4, and about 12 mg of nicotine per 300 ml of the nicotine solution.

The nicotine used may be nicotine, dextro nicotine, or a racemic mixture of both, nicotine and dextrose nicotine. As is well known, the (-) isomer is nicotine that occurs naturally, and which is a weak base with a pKa of 8.0 in aqueous solution at a temperature of 25 ° C. The tobacco plant has this (-) isomer. As is also well known, the combustion of tobacco in a product such as the cigarette converts some of the (-) nicotine into a racemic mixture of (±) nicotine isomers. Thus, a person who is smoking tobacco is also inhaling some of the (+) nicotine isomer, which does not occur naturally. As noted earlier, in the two articles by Benowitiz et al., The human body .x._ metabolizes isomers (-), (+), or mixtures (±) essentially in the same proportion.

As discussed in detail above, nicotine, when taken orally, has a bitter taste that produces aversion; to achieve that the nicotine solution of the present invention has a pleasant taste, ie a taste that is acceptable; particularly when the solution is a drink to be ingested orally, so that when the solution touches the taste buds in the mouth, the pH must be adjusted so that it (the solution) is acidic. More specifically, the pH of the solution must be adjusted to be approximately less than 6.9, and more preferably approximately less than 5.5, and most preferably to be within the range of from about 2.0 to about 4.0. Various acids can be used as well as pH controlling agents to obtain an adjustment in pH, such acids include, but are limited to, carbonic acid, citric acid, acetic acid, tartaric acid, maleic acid, ascorbic acid, adipic acid, as well as combinations thereof; Food acids are very suitable.

Because the control of the pH of the solution is acidic, the nicotine solution is made containing a relatively large amount of nicotine when compared to previous attempts at nicotine solutions to be orally drunk by a subject. The desired amount of nicotine in the inventive nicotine solution is noted above, but regardless of this, the amount is sufficient to counteract the problem of the first step of absorption to the liver, such that a therapeutically effective amount of the nicotine is administered. to the metabolism of the user, then deviating to the entrance of the portal vein of the liver, in such a way that the nicotine reaches a sufficient level in the blood of the user, in order to reduce the need that a smoker of tobacco has to smoke, to treating and alleviating the symptoms of attention deficit disorders in a person suffering from the disease, and / or treating and alleviating the symptoms of Alzheimer's disease in a person suffering from such disease.

The doses should be repeated with at least 1 dose, such as a drink, of the nicotine solution per day, and preferably 1 dose, such as a drink, every 1 or 2 hours during the hours that the person to be dosed with the nicotine solution is awake, this to maintain a sufficient level of nicotine in the blood in order to reduce the need for a person to smoke tobacco, reduce the symptoms of the person's attention deficit condition, and / or reduce the symptoms in a person suffering from Alzheimer's disease. Preferably, the incidence of the doses and the amount of nicotine in the nicotine solution is adjusted to an individual, such that the level of nicotine in the blood is not increased by exceeding about 35 ng of nicotine per 1 ml of nicotine. blood, but of course, this (the level) will vary depending on the intensity or accentuation of the smoking addiction that a particular person has, the symptoms of the attention deficit condition, and / or the symptoms of Alzheimer's disease .

Desirably, within about 30 to about 80 minutes, more preferably, within about 50 minutes, of the nicotine solution to be administered (such as in a beverage), the level of nicotine in the person's blood plasma should be at less about 1.5 ng of nicotine per approximately 1 ml of blood. As can be seen in Figure 1, blood plasma levels of about 2, up to about 7.5 ng per ml of blood, are typical for 1 dose of approximately 1 to 4 mg of nicotine per day; and approximately 2.5 to 30 ng for multiple daily doses with the purpose of obtaining a daily admission or assimilation of approximately 20 to 40 mg as can be seen in figure 2.

To further increase the appetite acceptability of the nicotine solution, for example, by the time the solution is to be ingested orally by drinking it, optionally there may be a flavor included in the nicotine solution. The amount of the optional flavor is not critical, and can typically be adjusted according to the personal preference of the person who drinks the solution containing the nicotine. Suitable flavors include, but are not limited to, sugar, coffee, beer, wine, whiskey or whiskey, fruit juices, milk, soda, and flavorings of that kind. Appropriate types of fruit juices are cranberry juice, grapefruit juice, lemon juice and orange juice. The appropriate types of milk are whole, 2%, 1%, and chocolate. Appropriate types of sodas are spring water, mineral water, tonic water, root beer, soft drinks, ginger ale, Sprite® and Dr. Pepper® In addition to the additional increase in taste acceptability of the nicotine solution, flavorings such as coffee, milk and / or fruit juices may also contribute to maintaining the pH of the nicotine solution in the acid range.

In addition to the nicotine solution discussed above, which can be conveniently presented on the market as a bottle and / or canned beverage, the invention contemplates, in another embodiment, a packet of nicotine powder, with an appropriate amount of the controlling agent. of the pH, in such a way that the user can open the package and pour the powder into the drink preferred by it, such as a glass with water. Laboratory example Example 1.

Part A. To test the efficacy of the present invention, the applicant conducted a controlled laboratory study, in which 2 non-smoking subjects drank several nicotine-based solutions. Each sample was prepared by adding the respective amount of levo nicotine (purchased from Kodak), as indicated in the graph in Figure 1, to one of aqueous cola drink (Diet Coke®) to make each sample a total of 300 ml from solution.

Each subject drank 1 drink per day, with each drink taken in a period of 10 minutes. Specifically, on day 1, each subject drank 1 drink containing 1 mg of nicotine; on day 2, each subject drank 1 drink containing 1.5 mg of nicotine; on day 3, each subject drank a beverage containing 2 mg of nicotine; on day 4, each subject drank 1 drink containing 3 mg of nicotine; and on day 5, each subject drank 1 drink containing 4 mg of nicotine.

All the nicotine solutions had a pH of 3.2 that was due to the carbonic acid already present in the cola drink. Regarding the nicotine content after each drink, the blood plasma levels of the 2 subjects were tested at the times indicated below in the graph of Figure 1, which were within the range from about 2 to about 7. ng of nicotine per ml of blood as plotted in the graph of Figure 1.

Part B. Additionally, as summarized in the following Table, each subject drank the following beverages (1 drink each day), each drink being 15 ml of a solution containing 10 mg of nicotine per 300 ml of the total solution. Table Indicated in the second column of the Table is the average of the percentages of the 2 subjects calculated from the throat scrape of each of them on a scale of 1 (without scraping) to 7 (extreme scraping). This data shows that the second best sensory effect in the throat is obtained from the nicotine solutions in milk (both 2% milk and chocolate milk), and the best sensory effect is obtained from nicotine in dietary root beer and in coffee.

Part C. To test the efficacy of the present invention, the applicant conducted another controlled laboratory study, in which a non-smoking individual drank several nicotine solutions for 5 consecutive days. Each sample was prepared by adding the 5 mg of levo nicotine (purchased from Kodak) to an aqueous cola drink (Diet Coke®) to make each sample a total of 300 ml of solution.

The subject drank several drinks per day, drank each drink for a period of time of 10 to 30 minutes, each drink at different times through the hours that the subject remained awake, to reach a total daily intake or assimilation of nicotine as indicates in the graph of figure 2. Specifically, on day 1, the subject drank 4 drinks to reach a total intake or assimilation for that day of 20 mg of nicotine; on day 2, the subject drank 6 drinks to reach an admission or total assimilation for that day of 30 mg of nicotine; on day 3, the subject drank 6 drinks to reach an admission or total assimilation for that day of 30 mg of nicotine; on day 4, the subject drank 7 drinks to reach an admission or total assimilation for that day of 35 mg of nicotine; on day 5, the subject drank 8 drinks to reach an admission or total assimilation for that day of 40 mg of nicotine.

All solutions had a pH of 3.2 due to the carbonic acid already present in the cola beverage. The subject's blood plasma levels were measured with respect to the nicotine content twice each day at 12:30 and at 6:00 pm, except that on day 5 such a measurement was made only once, and the levels were found within the range of approximately 30 ng of nicotine per ml of blood as shown in the graph of Figure 2.

Example 2 Repetition of Example 1 can be done, except that the present example is carried out with 2 smokers. Smoking is not allowed during the study, and subjects must arrive at the laboratory after 24 hours of abstaining from smoking (which is confirmed by the analysis of expired carbon monoxide).

Following the test, the subjects question each other to obtain percentages of their anxiety about cigarettes and other symptoms of smoking cessation experienced after drinking nicotine solutions. Both subjects must report their anxiety about cigarettes, as well as the symptoms of quitting, and these tend to decrease. In addition subsequent to each beverage, the blood plasma levels of the two subjects will be tested with respect to the nicotine content, and should be similar to those reported in Example 1.

Example 3 You can repeat the example 1, except that it is 2 people with attention deficit problems. Smoking is not allowed during the study, and if the subjects are smokers, they must reach the laboratory after 24 hours of abstaining from smoking (which is confirmed by the analysis of expired carbon monoxide), to ensure that the effects of nicotine they are due to nicotine in solutions and not to nicotine in smoked tobacco products.

Following the test, the subjects must be questioned to obtain percentages of the symptoms of the attention deficit problem experienced after drinking the nicotine solutions. Both subjects must report that the symptoms tend to decrease.

Also subsequent to each drink, the blood plasma levels of the 2 subjects are tested in relation to the nicotine content, and should be similar to those reported in Example 1.

Example .

Example 1 can be repeated, except that it concerns 2 people with Alzheimer's problems. No smoking was allowed during the study, and if the subjects are smokers, they should arrive at the laboratory after 24 hours of smoking abstinence (which is confirmed by the expired carbon monoxide analysis), to ensure that the effects of nicotine they were due to nicotine in solutions, and not to nicotine in smoked tobacco products.

Following the test, the subjects are questioned to obtain percentages of the symptoms of Alzheimer's disease experienced after drinking the nicotine solutions. Both subjects must report that the symptoms tend to decrease.

Also subsequent to each beverage, the blood plasma levels of the 2 subjects are tested in relation to the nicotine content, and these levels should be similar to those reported in Example 1.

These results support the applicant's belief that the nicotine solutions described herein can be useful in alleviating the cravings for smoking thereby facilitating the cessation of such a habit.

It should be understood that various details of the invention may change without departing from the scope of the invention. In addition, the foregoing description is for the purpose of being illustrative, but not limiting, the invention is defined by the claims.

It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention. Having described the invention as above, property is claimed as contained in the following:

Claims (96)

1. A method for providing nicotine to a human being by administering to the upper gastrointestinal tract a selected amount of nicotine, said method is characterized in that it comprises: (a) providing an acceptable solution for the appetite, the latter containing a therapeutically effective amount of nicotine, with a Acidic pH, and that also adapts for its introduction to the upper gastrointestinal tract of a person; (b) administer the nicotine solution to the upper gastrointestinal tract of the person, in order to introduce nicotine to the metabolism of the person; and (c) periodically repeating step (b), for the purpose of administering a selected amount of nicotine to the metabolism of the person, then deviating to the entrance of the portal vein of the liver, in such a way that nicotine reaches a selected level of nicotine. nicotine in the blood of the person. ~ J

2. The method according to claim 1, characterized in that the nicotine solution is made to be acceptable by the person's appetite, adjusting the pH to be less than about 6.9.

3. The method according to claim 2, characterized in that the nicotine solution has a pH lower than about 5.5.

4. The method according to claim 3, characterized in that the nicotine solution has a pH from about 2.0 to about 4.0.

5. The method according to claim 2, characterized in that the amount of the nicotine contained in the nicotine solution is at least about 0.5 milligrams of the nicotine per 300 milliliters of the nicotine solution.

6. The method according to claim 5, characterized in that the nicotine solution contains from about 1 milligram to about 42 milligrams of the nicotine per about 300 milliliters of the nicotine solution.

7. The method according to claim 1, characterized in that the level of nicotine in the blood is at least about 1.5 nanograms of nicotine per 1 milliliter of blood.

8. The method according to claim 7, characterized in that the level of nicotine in the blood is from about 2 nanograms to about 35 nanograms of the nicotine per about 1 milliliter of blood.

9. The method according to claim 1, characterized in that the nicotine is selected from the group consisting of the levo nicotine, dextro nicotine and racemic mixtures thereof.

10. The method according to claim 1, characterized in that in addition a flavoring in the nicotine solution.

11. The method according to claim 10, characterized in that the flavor is selected from the group consisting of sugar, coffee, beer, wine, whiskey, fruit juices, soda as well as combinations thereof.

12. The method according to claim 1, characterized in that administration to the upper gastrointestinal tract is performed in the manner of a portion of the upper gastrointestinal tract selected from the group consisting of a mouth, esophagus, stomach, duodenum, and combinations thereof organs.

13. The method according to claim 1, characterized in that providing the nicotine solution reduces the symptoms of a medical condition in a person having a medical condition, by the amount of nicotine the which is a therapeutically effective amount to reach a sufficient level of nicotine in the blood in order to reduce the symptoms.

14. The method according to claim 13, characterized in that the medical condition is selected from the group consisting of tobacco smoking addiction, attention deficit problems, Alzheimer's disease, Parkinson's disease, inability to regulate body weight at a level appropriate to body height, depression, ulcerative colitis and combinations of the same conditions.

15. A method for providing nicotine to a human by ingesting a selected amount of nicotine, said method comprising: (a) providing an aqueous solution, acceptable by appetite, containing from about 0.5 to about 42 milligrams of nicotine per 300 milliliters of the nicotine solution, with a pH of less than about 6.9; (b) drink the nicotine solution in order to introduce nicotine to the metabolism of the person; and (c) periodically repeating step (b), at least once a day, for the purpose of diverting towards the entrance of the portal vein of the liver and reaching a level in the blood of at least 1.5 nanograms of nicotine by about 1 milliliter of blood in the person within about 30 to about 80 minutes of each repetition of step (b).

16. An appetizing solution for providing the nicotine solution to a human being, said solution is characterized in that it comprises an acid solution containing a selected amount of nicotine reaching a selected level of nicotine in a person's blood.

17. The nicotine solution according to claim 16, characterized in that the nicotine solution has a pH of less than about 6.9.

18. The nicotine solution according to claim 17, characterized in that the pH is less than about 5.5.

19. The nicotine solution according to claim 18, characterized in that the pH is from about 2.0 to about 4.0.

20. The nicotine solution according to claim 16, characterized in that the amount of nicotine contained in the nicotine solution is at least 0.5 milliliters of nicotine per approximately 300 milliliters of the nicotine solution.

21. The nicotine solution according to claim 20, characterized in that the nicotine contained is within about 1 and about 42 milligrams of the nicotine by about 300 milliliters of the nicotine solution.

22. The nicotine solution according to claim 16, characterized in that the nicotine is selected from levo nicotine, dextro nicotine and racemic mixtures thereof.

23. The nicotine solution according to claim 16, characterized in that it also includes a flavor in the nicotine solution.

24. The nicotine solution according to claim 23, characterized in that the flavor is selected from the group consisting of sugar, coffee, beer, wine, whiskey or whiskey, fruit juices, milk, soda, and combinations thereof.

25. A powder composition comprising nicotine and a pH controlling agent, which is soluble in water to form a nicotine solution which is aqueous, which has an acidic pH, such that the powder dissolves in an aqueous solution, providing an acceptable aqueous solution for the appetite, which when administered to the upper gastrointestinal tract of a person, will administer a selected amount of nicotine to the metabolism of the person, then deviating to the entrance of the portal vein of the liver, in such a way that the Nicotine reaches a selected level in the person's blood.

26. The composition of claim 25, characterized in that the nicotine solution, when administered, will reduce the symptoms of a medical condition in a person having the medical condition, by the amount of nicotine, which is a therapeutically effective amount to reach a sufficient level of nicotine in the blood, this in order to reduce these symptoms.

27. The composition of claim 26, characterized in that the medical condition is selected from the group consisting of tobacco addiction, attention deficit problems, Alzheimer's disease, Parkinson's disease, inability to regulate body weight at a level appropriate to the body height, depression, ulcerative colitis, and combinations of the same conditions.

28. A method for reducing the incidence of tobacco smoking in a human user, by administering to the upper gastrointestinal tract a therapeutically effective amount of nicotine, said method comprising: (a) providing an acceptable solution for the appetite, containing this one therapeutically effective amount of nicotine, with an acidic pH, and which is further adapted for introduction to the upper gastrointestinal tract of a user; (b) administering the nicotine solution to the user's upper gastrointestinal tract, in order to introduce nicotine to the user's metabolism; and (c) periodically repeating step (b), for the purpose of administering a selected amount of nicotine to the user's metabolism, then deviating to the entrance of the portal vein of the liver, such that nicotine reaches a selected level of nicotine in the user's blood, with the ._to -_._. purpose of reducing the user's need to smoke tobacco.

29. The method according to claim 28, characterized in that the nicotine solution is made to be palatable to the user, adjusting the lower pH to about 6.9.

30. The method according to claim 29, characterized in that the nicotine solution has a pH of less than about 5.5.

31. The method according to claim 30, characterized in that the nicotine solution has a pH from about 2.0 to about 4.0.

32. The method according to claim 29, characterized in that the therapeutically effective amount of nicotine contained in the nicotine solution is at least about 0.5 milligrams of the nicotine per approximately 300 milliliters of the nicotine solution.

33. The method according to claim 32, characterized in that the nicotine solution contains from about 1 milligram to about 42 milligrams of the nicotine per about 300 milliliters of the nicotine solution.

34. The method according to claim 28, characterized in that the level of nicotine in the blood is at least 1.5 nanograms of nicotine per 1 milliliter of blood.

35. The method according to claim 34, characterized in that the level of nicotine in the blood is from about 2 nanograms to about 35 nanograms of the nicotine per about 1 milliliter of blood.

36. The method according to claim 28, characterized in that the nicotine is xfer _a- * A.te is selected from the group consisting of levo nicotine, dextro nicotine and racemic mixtures thereof.

37. The method according to claim 28, characterized in that it also includes a flavor in the nicotine solution.

38. The method according to claim 37, characterized in that the flavor is selected from the group consisting of sugar, coffee, beer, wine, whiskey, fruit juices, soda as well as combinations thereof.

39. The method according to claim 28, characterized in that administration to the upper gastrointestinal tract is performed in the manner of a portion of the upper gastrointestinal tract selected from the group consisting of a mouth, esophagus, stomach, duodenum, and combinations of these organs.

40. A method to reduce the incidence of smoking tobacco in a human user by ingesting a The therapeutically effective amount of nicotine, said method is characterized in that it comprises: (a) providing an aqueous solution, acceptable by appetite, containing it from about 0.5 to about 42 milligrams of nicotine per 300 milliliters of the nicotine solution , with a pH lower than approximately 6.9; (b) drinking the nicotine solution in order to introduce nicotine to the user's metabolism; and (c) periodically repeating step (b), at least once a day, in order to divert it towards the entrance of the portal vein of the liver and reach a level in the blood of at least 1.5 nanograms of nicotine by about 1 milliliter of blood in the user, within about 30 to about 80 minutes of each repetition of step (b).

41. An appetizing solution for reducing the incidence of tobacco smoking in a human user, said solution is characterized in that it comprises an acid solution containing an amount , _____ Therapeutically effective to achieve a sufficient level of nicotine in the blood to reduce a user's need to smoke tobacco.

42. The nicotine solution according to claim 41, characterized in that the nicotine solution has a pH of less than about 6.9.

43. The nicotine solution according to claim 42, characterized in that the pH is less than about 5.5.

44. The nicotine solution according to claim 43, characterized in that the pH is from about 2.0 to about 4.0.

45. The nicotine solution according to claim 41, characterized in that the therapeutically effective amount of the nicotine contained in the nicotine solution is at least about 0.5 milligrams of the nicotine per approximately 300 milliliters of the nicotine solution.

46. The nicotine solution according to claim 45, characterized in that the nicotine contained is within about 1 and about 42 milligrams of the nicotine by about 300 milliliters of the nicotine solution.

47. The nicotine solution according to claim 41, characterized in that the nicotine is selected from levo nicotine, dextro nicotine and racemic mixtures thereof.

48. The nicotine solution according to claim 41, characterized in that it also includes a flavor in the nicotine solution.

49. The nicotine solution according to claim 48, characterized in that the flavor is selected from the group consisting of sugar, coffee, beer, wine, whiskey or whiskey, fruit juices, milk, soda, and combinations thereof.

50. A powder composition comprising nicotine and a pH controlling agent, which is soluble in water to form a nicotine solution which is aqueous, which has an acidic pH, such that the powder dissolves in an aqueous solution, providing an acceptable aqueous solution for the appetite, which when consumed by a tobacco user administers a therapeutically acceptable amount of nicotine to the metabolism of the person, then deviates to the entrance of the portal vein of the liver, in such a way that the nicotine reaches a level selected in the blood of the person, to reduce the need for smoking by the user.

51. A method for reducing the symptoms of attention deficit problems in a person having attention deficit disorders by administering to the upper gastrointestinal tract a therapeutically effective amount of nicotine, said method comprising: (a) providing an acceptable solution for the appetite, containing a therapeutically effective amount of nicotine, with an acidic pH, and which is also adapted for introduction to the upper gastrointestinal tract of the person; (b) administer the nicotine solution to the upper gastrointestinal tract of the person, in order to introduce nicotine to the metabolism of the person; and (c) periodically repeating step (b), for the purpose of administering a selected amount of nicotine to the metabolism of the person, then deviating to the entrance of the portal vein of the liver, such that the nicotine reaches a selected level of nicotine in the blood of the user, in order to reduce the symptoms of problems or conditions of attention deficit of the person.

52. The method according to claim 51, characterized in that the nicotine solution is made to be palatable to the user, adjusting the lower pH to approximately 6.9.

53. The method according to claim 52, characterized in that the nicotine solution has a pH of less than about 5.5.

54. The method according to claim 53, characterized in that the nicotine solution has a pH from about 2.0 to about 4.0.

55. The method according to claim 52, characterized in that the therapeutically effective amount of nicotine contained in the nicotine solution is at least about 0.5 milligrams of the nicotine per approximately 300 milliliters of the nicotine solution.

56. The method according to claim 55, characterized in that the nicotine solution contains from about 1 milligram to about 42 milligrams of the nicotine per about 300 milliliters of the nicotine solution.

57. The method according to claim 51, characterized in that the level of nicotine in the blood is at least about 1.5 nanograms of nicotine per 1 milliliter of blood.

58. The method according to claim 57, characterized in that the level of nicotine in the blood is from about 2 nanograms to about 35 nanograms of nicotine per about 1 milliliter of blood.

59. The method according to claim 51, characterized in that the nicotine is selected from the group consisting of the levo nicotine, dextro nicotine and racemic mixtures thereof.

60. The method according to claim 51, characterized in that it also includes a flavor in the nicotine solution.

61. The method according to claim 60, characterized in that the flavor is selected from the group consisting of sugar, coffee, beer, wine, whiskey, fruit juices, soda as well as combinations thereof.

62. The method according to claim 51, characterized in that administration to the upper gastrointestinal tract is performed in the manner of a portion of the upper gastrointestinal tract selected from the group consisting of a mouth, esophagus, stomach, duodenum, and combinations thereof organs.

63. A method for reducing the incidence of attention deficit disorders a human person suffering from attention deficit disorders, by ingesting a therapeutically effective amount of nicotine, said method is characterized in that it comprises: (a) providing an aqueous solution, acceptable by the appetite, containing from about 0.5 to about 42 milligrams of nicotine per 300 milliliters of the nicotine solution, with a pH less than about 6.9; (b) drink the nicotine solution in order to introduce nicotine to the metabolism of the person; and (c) periodically repeating step (b), at least once a day, in order to divert the solution afterwards to the entrance of the portal vein of the liver, and reach a blood level of at least 1.5. nanograms of nicotine for about 1 milliliter of blood in the person, within about 30 to about 80 minutes of each repetition of step (b).

64. An appetizing solution to reduce the incidence of the symptoms of problems or disorders of attention deficit, in a person suffering from attention deficit disorders, said solution is characterized because it comprises a solution containing a therapeutically effective amount to reach a sufficient level of nicotine in the blood, to reduce the symptoms of disorders or problems of attention deficit of the person.

65. The nicotine solution according to claim 64, characterized in that the nicotine solution has a pH of less than about 6.9.

66. The nicotine solution according to claim 65, characterized in that the pH is less than about 5.5.

67. The nicotine solution according to claim 66, characterized in that the pH is from about 2.0 to about 4.0.

68. The nicotine solution according to claim 64, characterized in that the therapeutically effective amount of the nicotine contained in the nicotine solution is at least about 0.5 milligrams of the nicotine per approximately 300 milliliters of the nicotine solution.

69. The nicotine solution according to claim 68, characterized in that the nicotine contained is within about 1 and about 42 milligrams of the nicotine by about 300 milliliters of the nicotine solution.

70. The nicotine solution according to claim 64, characterized in that nicotine is selected from levo nicotine, dextro nicotine and racemic mixtures thereof.

71. The nicotine solution according to claim 64, characterized in that it also includes a flavor in the nicotine solution.

72. The nicotine solution according to claim 71, characterized in that the flavor is selected from the group consisting of sugar, coffee, beer, wine, whiskey or whiskey, fruit juices, milk, soda, and combinations thereof.

73. A powder composition comprising nicotine and a pH controlling agent, which is soluble in water to form a nicotine solution which is aqueous, characterized in that it has an acidic pH, such that the powder dissolves in an aqueous solution, providing an acceptable aqueous solution for the appetite, which when consumed by a tobacco user, delivers a therapeutically acceptable amount of nicotine to the metabolism of the person, then deviating to the entrance of the portal vein of the liver, such that the Nicotine reaches a selected level in the person's blood to reduce the symptoms of the person's attention deficit condition.

74. A method for reducing the symptoms of Alzheimer's disease in a human being by administering an amount to the upper gastrointestinal tract i -therapeutically effective nicotine, said method is characterized in that it comprises: (a) providing an acceptable solution for the appetite, containing this a therapeutically effective amount of nicotine, with an acidic pH, and which is also adapted for introduction to the gastrointestinal tract superior of the person; (b) administer the nicotine solution to the upper gastrointestinal tract of the person, in order to introduce nicotine to the metabolism of the person; and (c) periodically repeating step (b), for the purpose of administering a therapeutically effective amount of nicotine to the metabolism of the person, then deviating to the entrance of the portal vein of the liver, such that nicotine reaches a selected level of nicotine in the blood of the user, in order to reduce the symptoms of disorders or problems of attention deficit of the person.

75. The method of. according to claim 74, characterized in that the nicotine solution is made to be palatable to the user, adjusting the lower pH to about 6.9.

76. The method according to claim 75, characterized in that the nicotine solution has a pH of less than about 5.5.

77. The method according to claim 76, characterized in that the nicotine solution has a pH from about 2.0 to about 4.0.

78. The method according to claim 75, characterized in that the therapeutically effective amount of nicotine contained in the nicotine solution is at least about 0.5 milligrams of the nicotine per approximately 300 milliliters of the nicotine solution.

79. The method according to claim 78, characterized in that the nicotine solution contains from about 1 milligram to about 42 milligrams of nicotine per about 300 milliliters of the nicotine solution.

80. The method according to claim 74, characterized in that the level of nicotine in the blood is at least about 1.5 nanograms of nicotine per 1 milliliter of blood.

81. The method according to claim 80, characterized in that the level of nicotine in the blood is from about 2 nanograms to about 35 nanograms of nicotine per about 1 milliliter of blood.

82. The method according to claim 74, characterized in that the nicotine is selected from the group consisting of the levo nicotine, dextro nicotine and racemic mixtures thereof.

83. The method according to claim 74, characterized in that it also includes a flavor in the nicotine solution.

84. The method according to claim 83, characterized in that the flavor is selected from the group consisting of sugar, coffee, beer, wine, whiskey, fruit juices, soda as well as combinations thereof.

85. The method according to claim 74, characterized in that the administration to the upper gastrointestinal tract is carried out in the manner of a portion of the upper gastrointestinal tract, selected from the group consisting of a mouth, an esophagus, a stomach, a duodenum, and combinations of these organs.

86. A method for reducing the incidence of Alzheimer's disease symptoms in a human suffering from this disease by ingesting a therapeutically effective amount of nicotine, said method comprising: (a) providing an aqueous solution acceptable to the patient; appetite, the latter containing from about 0.5 to about 42 milligrams of nicotine per 300 milliliters of the nicotine solution, with a pH of less than about 6.9; (b) drink the nicotine solution in order to introduce nicotine to the metabolism of the person; and (c) periodically repeating step (b), at least once a day, in order to divert the nicotine solution towards the entrance of the portal vein of the liver, and reach a level in the blood of at least 1.5 nanograms of nicotine, for approximately 1 milliliter of blood in the person, within about 30 to about 80 minutes of each repetition of step (b).

87. An appetizing solution for reducing the incidence of the symptoms of Alzheimer's disease in a person suffering from this disease, said solution is characterized in that it comprises an acid solution containing a therapeutically effective amount, in order to reach a sufficient level of nicotine in the blood to reduce the symptoms of Alzheimer's disease suffered by the person.

88. The nicotine solution according to claim 87, characterized in that the nicotine solution has a pH of less than about 6.9.

89. The nicotine solution according to claim 88, characterized in that the pH is less than about 5.5.

90. The nicotine solution according to claim 89, characterized in that the pH is from about 2.0 to about 4.0.

91. The nicotine solution according to claim 87, characterized in that the therapeutically effective amount of the nicotine contained in the nicotine solution is at least about 0.5 milligrams of the nicotine per approximately 300 milliliters of the nicotine solution.

92. The nicotine solution according to claim 91, characterized in that the nicotine contained is within about 1 and about 42 milligrams of the nicotine by about 300 milliliters of the nicotine solution.

93. The nicotine solution according to claim 87, characterized in that the nicotine is selected from levo nicotine, dextro nicotine and racemic mixtures thereof.

94. The nicotine solution according to claim 87, characterized in that it also includes a flavor in the nicotine solution.

95. The nicotine solution according to claim 94, characterized in that the flavor is selected from the group consisting of sugar, coffee, beer, wine, whiskey or whiskey, fruit juices, milk, soda, and combinations thereof.

96. A powder composition comprising nicotine and a pH controlling agent, which is soluble in water to form a nicotine solution which is aqueous, characterized in that it has an acidic pH, in such a way that the powder is dissolved in an aqueous solution, providing an acceptable aqueous solution for the appetite, which when administered to the upper gastrointestinal tract of a person with Alzheimer's disease will administer a therapeutically effective amount of nicotine to the metabolism of the person, then deviating to the entrance of the portal vein of the liver, in such a way that the nicotine reaches a sufficient level in the blood of the person, in order to reduce the symptoms of Alzheimer's disease that the person suffers.