Title:  Solution containing nicotine

United States Patent:  6,211,194

Assignee:  Duke University (Durham, NC)

Filed:  April 30, 1998

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.

SUMMARY AND OBJECTS OF THE INVENTION

In accordance with the present invention, disclosed is a method for providing nicotine to a human person by administration to the upper gastro-intestinal tract of a selected amount of nicotine. The method comprises providing a palatably acceptable solution containing a selected amount of nicotine, having an acidic pH, and being adapted for introduction into the person's upper gastro-intestinal tract, administering the solution to the person's upper gastro-intestinal tract so as to introduce the nicotine to the metabolism of the person, and periodically repeating the administration of the solution so as to administer a selected amount of the nicotine to the person's metabolism after pass through the portal vein entry of the liver so that the nicotine achieves a selected blood level of nicotine in the person in order to reduce the symptoms of the person. Preferably, the solution reduces symptoms of a medical condition in a person who has the medical condition by the nicotine amount being a therapeutically effective amount to achieve a sufficient blood level of the nicotine to reduce the symptoms. More preferably, the medical condition is selected from the group consisting of addiction to smoking tobaccco, attention deficit disorder, Alzheimer's disease, Parkinson's disease, inability to regulate body weight at a level proper for body height, depression, ulcerative colitis, and combinations thereof.

In one embodiment, provided is a method for reducing tobacco smoking in a human user by administration to the upper gastrointestinal tract of a therapeutically effective amount of nicotine. The method comprises providing a palatably acceptable solution containing a therapeutically effective amount of nicotine, having an acidic pH, and being adapted for introduction into the human's upper gastrointestinal tract. The solution is administered to the human's upper gastrointestinal tract to introduce the nicotine to the human's metabolism, and periodically the administration is repeated, to administer a therapeutically effective amount of the nicotine to the human's metabolism after pass through the portal vein entry of the liver so that the nicotine achieves a sufficient blood level of nicotine in the human to reduce the human's need to smoke tobacco. In another embodiment, the method may be for administering a nicotine solution, as described in the paragraph above, to a human having attention deficit disorder or Alzheimer's disease to reduce the human's respective attention deficit disorder symptoms or Alzheimer's disease symptoms.

Thus, one object of the present invention is that although the general belief was that nicotine liquid would prove unacceptable for drinking due to the acrid, burning, bitter taste of nicotine in aqueous solution, nicotine indeed can be delivered effectively in an appropriate concentration in solution in a form that is palatable, and which produces significant systemic levels of nicotine as measured in venous blood, after pass through the liver.

An advantage of the present invention is to provide an acceptable level of nicotine-related sensory stimulation in the throat that may be important in reducing craving for cigarettes, such as the craving reported by Rose et al., "Subjective Response to Cigarette Smoking Following Airway Anesthetization", Addict. Behav., Vol. 9, pp. 211-215 (1984). A further advantage of the present invention is that by ensuring liquid intake along with nicotine, the local concentration of nicotine in the upper gastrointestinal tract can also be regulated to lessen the likelihood of cramping due to high local concentrations of nicotine, such as from swallowing a capsule.

Claim 1 of 26 Claims

What is claimed is:

1. A method for providing nicotine to a person by administration to the upper gastro-intestinal tract of a selected amount of nicotine, said method comprising:

(a) providing a palatably acceptable solution containing a therapeutically effective amount of nicotine, having an acidic pH, and being adapted for introduction into the person's upper gastrointestinal tract, and including a flavoring in the nicotine solution wherein the flavoring is selected from the group consisting of sugar, coffee, beer, wine, whiskey, fruit juice, milk, soda, and combinations thereof;

(b) administering the nicotine solution to the person's upper gastro-intestinal tract so as to introduce the nicotine to the metabolism of the person, wherein the administering is free of buccal administering and free of sublingual administering; and

(c) periodically repeating (b), so as to administer a selected amount of the nicotine to the person's metabolism after the first-pass absorption to the liver so that the nicotine achieves a selected blood level in the person.

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