Nicotine therapy method and oral carrier for assuaging...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C424S434000, C424S435000, C424S464000, C424S465000, C424S474000, C424S479000, C514S772000, C514S772400, C514S777000, C514S784000, C514S810000, C514S813000, C514S960000, C514S974000

Reexamination Certificate

active

06583160

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to tobacco-addiction therapies, and more particularly to methods and devices for assuaging nicotine cravings in users.
2. Description of Related Art
Tobacco-addiction is a serious health problem through out the world. The hundreds of compounds carried along with the nicotine cause most of the trouble, but the nicotine is responsible for the chemical addiction. Tobacco users find it too difficult to quit because both the nicotine cravings and ritual behaviors are too severe and ingrained. The prior art has therefore developed a multitude of therapies, devices, and methods for helping people quit tobacco. Many of them follow similar ritual patterns of putting things in the mouth.
Given the large number of users who continue using tobacco, it can be assumed that no prior art attempt has been completely successful.
Many smokers have decided to continue smoking, no matter what. But recent changes in social behavior and even the Law have put many places out-of-bounds for smokers, e.g., commercial airflights, restaurants, school, work, home, etc. So in these situations, such smokers need a temporary relief from the pains of abstinence. Others wanting to quit altogether also need effective relief from cravings.
One line of therapy for tobacco-addiction is aversion therapy. An attempt is preferably made to associate some ill-effect whenever the user engages in the addiction. For example, ANTABUSE is a brand of tetraethylthiuram disulfide that will induce nausea, vomiting, and headache if the user drinks alcohol. A chemical reaction in the bloodstream generates acetaldehyde, and it's this compound that produces the aversive symptoms. A similar, less severe aversion therapy is known as TEMPOSIL, e.g., citrated calcium carbamide.
Conventional behavioral aversion therapies also include hypnosis and electroshock. In hypnosis, a suggestion is preferably made to quit tobacco outright, or associate it with a bad taste or smell. In electroshock therapy, a harmless shock is sent, for example, to punish the user each time a cigarette is smoked. An interesting observation is made by W. L. Jenkins, combinations of warm heat and shock are interpreted as hot. (
Journal of Experimental Psychology,
1938, v22:564-572.) So a more effective, but harmless electroshock therapy would include the application of warm heat, perhaps even constant warm heat punctuated by the shocks.
Theodore Stanley, et al., observed in U.S. Pat. No. 5,824,334, issued Oct. 20, 1998, that heavy smokers seem to adjust their levels of nicotine in their blood to stay within narrow limits. They also state that “a smoker's craving for tobacco is not mitigated by a relatively low, constant level of nicotine.” When nicotine is received through smoking, the rapid absorption of the nicotine through the lungs results in an initial peak of nicotine which then trails off. The blood-level concentration peak produced by cigarettes is higher and sharper than steadier levels obtained from patches or gums. Such initial peak is said to be 30-40 nanograms per milliliter of blood, and is reached within ten minutes. So Stanley, et al., concluded that quick-rise effects are probably necessary for more complete relief from craving in the early stages of withdrawal.
One of the present inventors, Paul Wilhelmsen, was issued U.S. Pat. No. 6,248,760, on Jun. 19, 2001. It describes a tablet giving rapid release of nicotine for transmucousal administration. He says quick-rise effects are necessary for relief from craving. A nicotine layer in an oral tablet is designed to be rapidly absorbed through the tissues inside the user's mouth.
SUMMARY OF THE INVENTION
Briefly, a method and oral tablet embodiment of the present invention comprise a flash dissolve nicotine payload disposed in a delivery carrier that is then placed in the mouth of a user. For example, a pill, tablet, or capsule is a suitable oral delivery form. The nicotine payload liberates from its fixing with the delivery carrier all at once sometime after being wetted inside the mouth. The result is a short, intense nicotine dose pulse that enters the bloodstream and circulates to the brain before being filtered out by the liver. Such rapid spiking of nicotine mimics that received from a single puff of a cigarette. Multiple bursts are received by multiple takings.
In alternative embodiments of the present invention, a plurality of flash dissolve nicotine payloads are carried in time-release envelopes that burst sequentially over time. The number of bursts and interval time between them are similar to those obtained from the ordinary smoking of one whole cigarette.
An advantage of the present invention is a method and oral tablet are provided for relief of cravings in a tobacco-addicted user.
Another advantage of the present invention is that a method and oral tablet are provided for more satisfying delivery of nicotine to the brain of an addicted user.
A still further advantage of the present invention is that a method and oral tablet are provided for cigarette smokers wishing to quit.
Another advantage of the present invention is that a method and oral tablet are provided for cigarette smokers wishing to bridge over periods when they cannot smoke a cigarette.
An advantage of the present invention is a method and oral tablet are provided for pulsing nicotine into the bloodflow to the brain of a user.
The above and still further objects, features, and advantages of the present invention will become apparent upon consideration of the following detailed description of specific embodiments thereof, especially when taken in conjunction with the accompanying drawings.


REFERENCES:
patent: 4953572 (1990-09-01), Rose et al.
patent: 5824334 (1998-10-01), Stanley et al.
patent: 6248760 (2001-06-01), Wilhelmsen
patent: 0 526 524 (1995-12-01), None

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