Patent Application
20090139533
1. Field
The present invention relates to a system and method for tobaccoless nicotine delivery.
2. Description of the Related Art
Current nicotine phase out systems utilize devices do not closely resemble the actual system and act of smoking. Completely eliminating the tactile and habitual sensations that are part of the cigarette experience may delay the adoption of the therapy by habitual smokers. For example, the nicotine patch completely removes the tactile sensation of the hand-to-mouth motion of smoking. Certain nicotine inhalation devices use a system that resembles a cigarette but are composed of materials that do not look or feel like cigarettes, such as plastic mouthpieces and metallic or plastic cartridges.
Thus, a need exists for a smoking cessation therapy comprising a nicotine replacement or phase out device that more closely resembles a cigarette and the experience of smoking a cigarette.
These and other systems, methods, objects, features, and advantages of the present invention will be apparent to those skilled in the art from the following detailed description of the preferred embodiment and the drawings.
A tobaccoless nicotine delivery device permits delivery of nicotine in a manner similar to a cigarette. The device may include an impermeable outer layer surrounding a micro-encapsulated nicotine layer that includes a measured amount of nicotine in a form that allows nicotine vapor to be released upon rupture of the micro-encapsulation. A permeable membrane may be disposed adjacent to the micro-encapsulated nicotine layer that allows pressure to be applied to the micro-encapsulated nicotine layer while permitting permeation of released nicotine into a central channel for inhalation by a user. A mouthpiece may be disposed at an open end of the central channel in order to provide air resistance to simulate the inhalation effect of a cigarette.
All documents mentioned herein are hereby incorporated in their entirety by reference. References to items in the singular should be understood to include items in the plural, and vice versa, unless explicitly stated otherwise or clear from the text. Grammatical conjunctions are intended to express any and all disjunctive and conjunctive combinations of conjoined clauses, sentences, words, and the like, unless otherwise stated or clear from the context.
The invention and the following detailed description of certain embodiments thereof may be understood by reference to the following figures:
Disclosed herein are systems and methods directed to tobaccoless nicotine delivery. The invention disclosed herein is a drug delivery device that delivers nicotine in a form factor similar to a cigarette but with no smoke, heat, or tobacco. This nicotine experience encourages the familiar and important social interactions that cigarettes generate including familiar tactile, oral, and visual interactions. However, the majority of the nicotine is delivered not to the lungs but to the oral and buccal cavity through which thereafter nicotine gets systemically distributed.
In an embodiment, a layer 104 of micro-encapsulated nicotine may be disposed adjacent to the impermeable outer layer 102. The nicotine 108 may comprise any form of nicotine, such as the nicotine free base, i.e., (S)-3-(1-Methyl-2-pyrrolidinyl)pyridine, a compound having the formula C10H14N2, “nicotine salt”, which refers to any mono- or bis-pharmaceutically acid addition acceptable salt or metal salt of nicotine, “pharmaceutically acceptable acid addition salt”, which refers to those salts which retain the biological effectiveness and properties of the free bases and which are not biologically or otherwise undesirable, formed with inorganic acids such as hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid and the like, and organic acids such as acetic acid, propionic acid, glycolic acid, pyruvic acid, oxalic acid, malic acid, malonic acid, succinic acid, maleic acid, fumaric acid, tartaric acid, citric acid, benzoic acid, cinnamic acid, mandelic acid, menthanesulfonic acid, ethanesulfonic acid, p-toluenesulfonic acid, salicylic acid and the like (For a description of pharmaceutically acceptable acid addition salts, see Bundgaard, H., ed., (1985) Design of Prodrugs, Elsevier Science Publishers, Amsterdam); and “pharmaceutically acceptable metal salt”, which refers to those salts which retain the biological effectiveness and properties of the free bases and which are not biologically or otherwise undesirable, formed with alkali metal ions such as sodium or potassium; alkaline earth metal ions such as calcium and magnesium; and other metal ions such as zinc.
A structure 109 (which is shown in even greater detail in
In an embodiment, the nicotine 108 may be encapsulated in a gaseous soluble form, such as vaporized free base nicotine. The encapsulation may also be in the form of micro-spheres. The structure 109 surrounding the nicotine 108 may rupture with an applied pressure (as indicated by an arrow 110), which may include a finger pressure applied by someone holding the device 100, or flow-induced or suction pressure created by inhalation on the device 100, thus allowing the nicotine 108 to escape and enter a central channel 112 (see
An inner layer 120 may be positioned adjacent to the layer 104 of micro-encapsulated nicotine. The inner layer 120 may be substantially cylindrical and coaxial with the outer layer 102, and may provide a permeable and structural inner layer that provides a solid base against which to apply exterior force to the device 100 in order to release nicotine 108 from the layer 104 of micro-encapsulated nicotine. As a result, the nicotine 108 may permeate the inner layer 120 and enter the central channel 112 for inhalation. The inner layer 120 may include any gas-permeable material, such as paper, perforated plastic, polymers, and the like, as well as various combinations of these. In general, the outer layer 102 may yield upon application of a predetermined amount of pressure and the inner layer 120 may not yield (e.g., remains rigid) upon application of the predetermined amount of pressure to the outer layer, so that the structure 109 of the intermediate layer 104 ruptures and releases the nicotine 108.
In an embodiment, the inner layer 120 may be permeable to ambient air. For example, when a user wishes to use the device, they may remove a cover that permits the exposure of the central channel 112 to air, either through an open end 105 of the device 100, or through a porous region 107 of the outer layer 102 (which may be covered by a cap when the device 100 is not in use). In an embodiment, the central channel 112 may be capped on an inhaling end by a filter element 114 or other porous element. The filter element 114 may provide air resistance to simulate the inhalation effect of a cigarette but may be permeable to nicotine 108 released within the central channel 112. The filter element 114 may also provide a medium for inclusion of flavorants to flavor the nicotine 108 as it passes through the filter element 114. For example, the flavorant may be menthol, tobacco, or any other flavor. In an embodiment, the filter element 114 may be a detachable element. When a user wishes to use the nicotine delivery device 100, they may attach a filter element 114 corresponding to the flavorant of their choosing. The filter element 114 may be changed during use to allow a user to try different flavorings. In an embodiment, the filter element 114 may be attached to any nicotine inhalation device, cigarette, cigar, and the like to provide flavoring.
In an embodiment, the central channel 112 may be capped by a one way valve 118 or other flow restrictor to restrict the intake of nicotine upon inhalation. The one way valve 118 may provide a user with a sensation of inhaling a cigarette by restricting air flow in a manner similar to a cigarette filter. In an embodiment, the one way valve 118 may take the place of the filter element 114 or work with the filter element 114 in capping the end of the nicotine delivery device. In any event, a mouthpiece 122 may be placed on the end of the filter element 114 or one way valve 118. The user may rupture the structure 109 surrounding the nicotine 108 in the layer 104 of micro-encapsulated nicotine as generally described above, and then during or after this rupturing, inhale using the mouthpiece. In operation, inhalation may draw air (e.g., through the porous region 107 of the outer layer 102, or through an open end 105 of the central channel 112), and with it, nicotine 108 from the layer 104 of micro-encapsulated nicotine, into the mouth of the user from where it may be systemically distributed.
Referring to
Thus it will be appreciated that there is generally described herein a tobaccoless nicotine delivery device and a method for using same to orally deliver nicotine to a user in a manner similar to smoking a cigarette. It will be appreciated that the various steps identified and described above may be varied, and that the order of steps may be adapted to particular applications of the techniques disclosed herein. All such variations and modifications are intended to fall within the scope of this disclosure. As such, the depiction and/or description of an order for various steps should not be understood to require a particular order of execution for those steps, unless required by a particular application, or explicitly stated or otherwise clear from the context.
While the invention has been disclosed in connection with the preferred embodiments shown and described in detail, various modifications and improvements thereon will become readily apparent to those skilled in the art. Accordingly, the spirit and scope of the present invention is not to be limited by the foregoing examples, but is to be understood in the broadest sense allowable by law.
All documents referenced herein are hereby incorporated by reference.
This application claims the benefit of U.S. Prov. Appl. No. 60/992,217, filed Dec. 4, 2007, the entire content of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60992217 | Dec 2007 | US |
