Tobacco – Antismoking product or device – i.e. – deterent – No smoke to user
Reexamination Certificate
2002-05-15
2004-10-05
Walls, Dionne A. (Department: 1731)
Tobacco
Antismoking product or device, i.e., deterent
No smoke to user
C131S270000, C131S328000, C128S200140, C128S200120
Reexamination Certificate
active
06799576
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to a method for treating conditions responsive to nicotine therapy. More specifically, the invention relates to pulmonary administration of nicotine to effect smoking cessation.
BACKGROUND OF THE INVENTION
Diseases related to cigarette smoking, such as lung disease, heart disease and cancer, claim an estimated 400,000 lives each year. The combustion of tobacco produces poisons and carcinogens that present a significant health hazard for smokers and non-smokers alike. Nicotine is a principal component of tobacco, and the most pharmacologically active. It is physically addictive, making it extremely difficult for a smoker to quit.
Smoking a cigarette delivers nicotine vapors to the lungs, where nicotine is rapidly absorbed through the arteries and delivered to the brain. Nicotine interacts with nicotinic cholinergic receptors in the brain to induce the release of neurotransmitters and produce an immediate reward—the “rush” that smokers experience—that is associated with a rapid rise in blood level. A persistent stimulus is also produced, and is associated with a high blood level of nicotine. As such, the dopaminergic reward system is activated which eventually results in nicotine dependency. Complex behavioral and social aspects of smoking, e.g., the hand-to-mouth ritual, etc., are also habit-forming.
A therapeutic approach to aid in smoking cessation is to provide the smoker with nicotine from sources other than cigarettes. Nicotine can be administered orally. However, after oral administration it is absorbed from the gut into the portal blood and degraded promptly by the liver. Nicotine can also be administered parenterally, e.g., intravenously, transcutaneously, muscosally, etc. Although preparations of nicotine appropriate for intravenous administration have been available for some time, intravenous cannulation as a means for gaining access to the circulation for the administration of nicotine on demand is not a socially acceptable alternative to cigarette smoking. There are also a number of commercially available nicotine replacement therapies that deliver nicotine to the systemic circulation via absorption through mucosal membranes or the skin. These include nicotine-containing chewing gum, sachets, transdermal patches, capsules, tablets, lozenges, nasal sprays and oral inhalation devices.
In particular, nicotine delivery via inhalation offers the benefit of addressing the psychological component of cigarette smoking in addition to the physiological dependence on nicotine. Nicotine inhalation systems release nicotine as a vapor (see U.S. Pat. Nos. 5,167,242; 5,400,808; 5,501,236; 4,800,903; 4,284,089; 4,917,120; 4,793,366), aerosol (see U.S. Pat. Nos. 5,894,841; 5,834,011) or dry powder (see U.S. Pat. No. 5,746,227) when air is inhaled through the inhaler. A droplet ejection device (U.S. Pat. No. 5,894,841) has also been described that delivers a controlled dose of nicotine via inhalation. These systems deliver low doses of nicotine to the mouth and throat, where nicotine is absorbed through the mucosal membranes into the circulation. Some inhalation therapies feature devices that simulate or approximate the look, feel and taste of cigarettes.
Currently available nicotine replacement therapies, such as transdermal and buccal systems where absorption occurs slowly, provide a low, steady-state blood level of nicotine to the patient without the early nicotine concentration spike that occurs due to immediate, arterial delivery of nicotine to the brain. Thus, the goal of these therapies is to eliminate the immediate, pleasurable effects associated with smoking while still alleviating the nicotine withdrawal effects until complete cessation of nicotine is physically and psychologically possible for the patient. The perceived advantage of these therapies is that the likelihood of abusing the nicotine delivery device (e.g., transdermal patch, nicotine chewing gum, nicotine inhalers, etc.) is very low. However, it is believed by some that it is because of this complete lack of “rush” experienced by the patient, that the success rates of these conventional therapies are not higher than they are.
Thus, the need remains for a smoking cessation therapy that delivers a precise dose of nicotine directly to the lungs and, therefore, directly into the arterial circulation in a profile that mimics the blood levels achieved by cigarette smoking—providing an initial sharp rise in blood level followed by a slow release of nicotine—making it possible for the user to be weaned off of nicotine and to quit smoking.
SUMMARY OF THE INVENTION
A system for aiding a patient in quitting smoking is disclosed. The system is comprised of a means for the delivery of aerosolized nicotine which makes it possible to gradually decrease the amount of nicotine that the patient receives. The system comprises a means for aerosolizing a formulation comprised of nicotine and a means for decreasing the amount of nicotine formulation which is aerosolized and/or the amount which actually reaches the patient's circulatory system. The amount of nicotine aerosolized or effectively delivered to the patient can be changed in several different ways using either the device aerosolization mechanism, the formulation or formulation containers loaded into the device.
A preferred system of the invention aerosolizes the liquid formulation by applying force to a container of nicotine formulation and causing the nicotine formulation to be moved through a porous membrane which results in creating particles of nicotine formulation which are inhaled by the patient. This system modifies the amount of nicotine aerosolized by providing a plurality of different containers or different groups of containers wherein the different containers or groups of containers contain different concentrations of nicotine. A patient using the system can utilize packets of nicotine formulation containing a high concentration initially and then gradually switch towards lower and lower concentrations so that the patient receives essentially the same amount of aerosolized formulation but receives gradually reduced amounts of nicotine due to the reduced concentration of the nicotine in the formulation.
The same procedure described above can also be carried with a dry powder inhaler (DPI). Using the dry powder inhaler technology the packets of dry powder nicotine formulation loaded into the device can initially contain a relatively high concentration of nicotine. Thereafter, the concentration of nicotine in the dry powder formulation added into the device is gradually decreased. Thus, using this system the same amount of dry powder is aerosolized, but the amount of nicotine is gradually decreased by decreasing the concentration or simply the total amount of nicotine in the dry powder package loaded into the device.
Additionally, the same procedure can be utilized with a conventional metered dose inhaler (MDD device. It is somewhat more difficult to utilize the invention with an MDI device. However, small pressurized canisters conventionally used with MDIs can contain different concentrations of nicotine along with the propellant. By using a first container which includes the highest concentration of nicotine and gradually changing to lower and lower concentrations of nicotine in the pressurized canister the desired result of reducing the amount of nicotine delivered to the patient can be obtained. The same results could be obtained by gradually decreasing the amount of formulation released when the value of a container is opened.
When using a dry powder inhaler or a system which aerosolizes a liquid formulation by moving the formulation through a porous membrane, it is possible to decrease the amount of nicotine gradually by making changes in the device, or more specifically the operation of the device. For example, a dry powder inhaler often utilizes a burst of air in order to aerosolize the dry powder. The burst of air could be decreased so that not all of the powder is fully aerosolized or so that th
Aradigm Corporation
Bozicevic Karl
Bozicevic Field & Francis LLP
Walls Dionne A.
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