NICOTINE DISPENSER WITH POLYMERIC RESERVOIR OF NICOTINE

Abstract: A nicotine dispenser comprising a polyolefin porous plug with reversibly retained nicotine therein. The dispenser is mounted in a tubular configuration to provide a cigarette-­ shaped product adapted to dispense nicotine vapor when air is drawn therethrough. The polymeric reservoir of nicotine comprises a polyolefin, preferably polyethylene or polyp­ ropylene, which reversibly absorbs nicotine.

Description: This invention relates to a non-combustible nicotine dispensing device designed to reduce or eliminate the disadvantages associated with conventional smoking habits. Nicotine is a toxic liquid alkaloid having the formula C₅H₄NC₄H₇CH₃. When nicotine is obtained from tobacco, as by chewing, sniffing or smoking the substance, the amount of nicotine absorbed into the body generally does not build up to a harmful dose, but produces certain pleasurable effects, frequently leading to habitual use. One of the most popular versions of nicotine use involves the smoking of cigarettes. When the tobacco in a conventional cigarette is ignited, the combustion of the processed tobacco leaves within the cigarette causes the release of vaporous nicotine, which is drawn through the cigarette and into the user's mouth and lungs when the user sucks or inhales air through the cigarette. The relative mildness of a cigarette, as compared to a pipe or cigar, permits a user to draw the smoke from the burning cigarette directly into the lungs. Nicotine vapors in the cigarette smoke are rapidly assimilated into the bloodstream of the user from the lungs, so that cigarette smoking provides a method by which a user may very quickly feel the effects of the nicotine. Although nicotine can be readily introduced into the body through cigarette smoking, the combustion of the tobacco, with the consequent elevated temperatures required in this process, unfortunately results in a number of undesirable consequences associated with smoking combustible cigarettes. Of primary concern are the serious health hazards thought by many to result from smoking combustible cigarettes. The nicotine content of a cigarette is not believed to cause any serious adverse long-term health effects on the human body. Other components, however, are present in tobacco smoke which are thought by many to be harmful. Some of these other components, for example, appear to be carcinogenic. Furthermore, the smoking of combustible cigarettes may pose a significant fire hazard. Many fires which have occurred both within buildings or in natural environments have been attributed to carelessly discarded burning cigarettes. In addition, substantial economic losses may be attributed to smoking, including, for example, significant damages to business and personal property resulting from burns in clothing, carpeting, furniture, etc. caused by stray ashes from cigarettes. Cigarette smoking has also become increasingly objectionable because of the discomfort it may cause to non-smokers who are exposed to the smoke and odor produced by practitioners of the smoking habit. Because of these undesirable side effects of conventional cigarette smoking, attempts have been made from time to time to provide acceptable substitutes. Such substitutes for combustible cigarette smoking eliminate or ameliorate some or all of the adverse consequences mentioned above. Tobacco concentrates, for example, have been processed into a tablet form which may be sucked or chewed, the nicotine being absorbed into the user's body through the lining of the mouth and digestive system. Such a tablet, of course, does not provide the user with the feel of a cigarette held between the lips. Furthermore, a tablet-type smoking substitute cannot provide the user with an opportunity to draw air and vapors into the mouth nor inhale the air and vapors into the lungs, these actions being a part of the conventional smoking habit. These actions or activities constitute an important aspect of the psychological and physiological affinities which a smoker acquires for the habit. Without an effective substitute for such smoking activities, a smoking substitute is less likely to satisfy the user and may thus result in a return to combustible cigarette smoking. An important step forward in the development of a smoking substitute is described in U.S. Patent 4,284,089. It discloses a simulated smoking device, adapted for non-burning or non-combustion uses comprising a container defining a passageway therethrough; a source of vaporizable nicotine in fluid communication; and means for preventing the evaporation of said nicotine during periods of non-use. In an illustrated embodiment, the above patent discloses a device having the general configuration of a cigarette. However, the exterior of the device defines a gas flow passageway with a flow restriction. The flow restriction is defined by an absorbent material carrying a nicotine solution on the material. In response to the fluid velocity developed at the restriction, nicotine is vaporized from the absorbent material and inhaled by the user. As a result, the user attains a nicotine induced sensation quite similar to that obtained by smoking conventional cigarettes. While it may be safely posited that the above patent represents a pioneering advance in the art, the inventors of the present invention have appreciated that it would be desirable to optimize the performance of a device of the general type disclosed in the above patent. In one aspect, for example, the present inventors have appreciated that it would be highly desirable to increase the amount of nicotine that is vaporized in response to a given puff on such a device. It is also very important in a nicotine dispenser of this kind to efficiently vaporize the nicotine. Liquid nicotine has an extremely bitter, almost caustic taste. Thus, it is important to dispense the nicotine in a fashion which encourages controlled vaporization while preventing inadvertent suction of unvaporized droplets, even those of a very small size. Finally, the present inventors have appreciated that the above described objectives are most advantageously achieved with a device having a "draw" similar to that of a conventional smoking device, such as a cigarette. It is believed that users may rapidly become dissatisfied with a smoking substitute that requires too little or, more particularly, too much inhalation effort for the sensation achieved. Similarly if the device dispenses too high a nicotine dosage with each puff, the user may receive more nicotine than desired and may be forced to change smoking habits. Either of these alternatives is undesirable in that the user will be less willing to substitute the smokeless substitute if the "familiar feeling" is compromised or if the substitute is somehow less pleasurable. In addition to U.S. 4,284,089 mentioned earlier herein, others have described nicotine dispensing devices. U.S. 4,393,884, for example, describes a demand inhaler holding a reservoir of pressurized nicotine and having a complicated mechanical system, all encased in a tube for oral nicotine input. U.S. 2,860,638 describes a tubular device for oral inhalation of substances such as nicotine. This device may contain filler material such as cotton or mineral matter in which substances such as nicotine may be absorbed. U.S. 3,280,823 describes a tobacco smoke filter comprising an ion-exchange resin containing nicotine for nicotine enrichment of gases inhaled therethrough. U.S. 3,584,630 describes a filter section comprising nicotine weakly absorbed on carbon black for nicotine enrichment of inhaled gases. U.S. 4,083,372 describes a cigarette-simulating inhaler with a fibrous wick of material such as cellulose acetate or cotton fibers and a puncturable capsule of flavorant for release into the wick prior to inhalation of air therethrough. It is the object of the present invention to provide a device adapted to simulate a cigarette and deliver satisfactorily an inhaled dose of nicotine, without any tars or other noxious products of tobacco combustion. Said object is achieved by a device for the non-pyrolytic inhalation of nicotine, comprising a tubular member adapted at one end to be held in the mouth for inhalation of air therethrough; said tubular member comprising a first polymer which is resistant to penetration by nicotine and a quantity of porous solid-form second polymer interposed in said member said second polymer containing absorptively retained nicotine characterized in that said second polymer is capable of releasing between about 2.5 and 12 µg of nicotine into a 35 cm³ puff of air drawn through said member. In the accompanying drawings, like reference numerals refer to like elements through all the figures. In the drawings: Figure 1 is a perspective view which illustrates one embodiment of a device constructed according to the present invention. Figure 2 is a cross-sectional view of one embodiment of the device of this invention taken along line 2-2 in Figure 1. The nicotine dispenser of the present invention, as generally designated by the numeral 10 in Figure 1 and Figure 2, includes a tubular member or housing 12 defining a passageway 14 for air drawn through the dispenser 10. The path of air drawn through the dispenser 10 may be in either direction. Interposed in the passageway 14 is a second polymer, preferably in the form of a porous plug 18. This particular nicotine dispenser 10 is in a preferred shape, the elongated tube shape of a conventional cigarette. It should however be understood that other designs and form are equally viable. The cigarette format illustrated by Figure 1 is the most conventional configuration of the dispenser but not the only functionally effective form of the device. The housing 12 may be made of a variety of materials. It is preferable that the housing 12 material is chemically inert and non-absorptive with respect to nicotine which is to be reversibly retained by the porous plug 18. In the most preferred embodiment of this invention the housing 12 is manufactured with a diameter, length and weight which approximate that of a conventional cigarette. Furthermore, the housing 12 is preferably provided with the appropriate color to present the same appearance as a conventional cigarette. In addition, a tipping band 20 made of paper, cork or other suitable material may be applied around the mouthpiece end 22 of the device 10 to simulate the appearance of the filter tip on a conventional cigarette. The porous plug 18 comprises two materials: a second polymeric substance and nicotine. The second polymeric substance is able to absorptively and reversibly retain and release nicotine. The term absorptively retaining nicotine as used herein is to be distinguished as meaning a physical retention as yet incompletely defined. The physical retention apparently involves a reversible penetration of nicotine into the second polymeric substance, the nicotine intercalating between polymeric chains. A nicotine-bearing mixture or nicotine itself may be dispersed in and dispensed from the second polymeric substance. It has been found that a number of substances may be advantageously provided in the nicotine or nicotine mixture which is placed in the porous plug 18. Nicotine (d), nicotine (1), nicotine (d1) and possibly mixtures containing nicotine salts may all be used to advantage in the nicotine-bearing mixture to provide the nicotine vapors which are inhaled by the user. A product obtained commercially from Eastman Company, Stock No. 1242, having 98% nicotine (1), has been used in one embodiment of the device and found to perform with satisfactory results. When the term "nicotine" is used herein, it unless otherwise defined, indicates usage of Eastman Company nicotine or that from any numerous commercial sources. Commercial nicotine is preferably distilled under vacuum to provide high purity nicotine for the dispenser 10. Any number of nicotine-bearing mixtures are usable for emplacement in the porous plug 18. The specific nicotine-bearing mixture being used in a particular embodiment of the present invention is largely dependent upon the specific dispenser, its configuration and substances desired to be dispensed. In the most preferred embodiment of this invention, a number of other materials have been found to provide advantageous results when added to the nicotine bearing mixture. The commercial nicotine which is available in the marketplace is entirely a by-product of the tobacco industry. Extraction and purification procedures are generally well-known in the tobacco industry. In the nicotine-bearing mixture, nicotine enhancing materials, organic acids and volatile carriers may be added and mixed in accordance with normal manufacturing procedures. It should be noted in selecting additive materials, that they must be suitable for human exposure and/or consumption. In particular, most chemicals may be theoretically toxic if their level of concentration is increased enough. Therefore, it is essential to select the materials for use in the formulation of this invention such that they can be used within accepted toxicity guidelines. In addition to the above, a number of other materials such as menthol may for example be added to provide a desireable flavor when added to a nicotine-bearing mixture. Such flavorings may also be added in the form of synthetic ingredients. Menthol may also be added to the mixture for a variety of reasons including flavoring or as a carrier material or to suit the particular taste of the user. The menthol which has been used is USP Levorotatory, obtained from the Gentry Corporation and may be dissolved in solvents such as ethanol or liquid nicotine to form a liquid. Menthol vapors are absorbed by a polyolefin porous plug 18. Anti-oxidants such as butylated hydroxy toluene, butylated hydroxy anisole, propyl gallate or tertiary butyl hydroxy quinone may also be added to the nicotine before or after impregnation into the porous plug 18. Such anti-oxidants, for example may be used to stabilize nicotine for a dispenser 10 with a longer shelf life. Nicotine may be loaded into the porous plug by numerous means. For example, the porous plug may be contracted with liquid nicotine, with nicotine vapor or with a solution of nicotine. A solution of nicotine in supercritical liquid carbon dioxide is also thought to represent an advantageous way of introducing nicotine to porous plugs 18. Porous plugs 18 may be impregnated with nicotine before or after their interposing placement in the passageway 14 of a dispenser 10. A variety of flavoring materials may be conveniently added to a formulation of nicotine to provide a desired effect. As has been previously mentioned, well-known flavorants which are approved for human consumption can be used in specified amounts. The use of such flavor materials is not intended to be a limiting factor in this application, but rather, it is intended to recite several of the possibilities for enhancing the final nicotine formulation. For the purpose of the present invention the second polymeric substance should be reversibly absorptive to nicotine so that nicotine is absorbable and releaseable. However, it is also important that the material be sufficiently absorbent of releasable nicotine to hold enough nicotine so that at least about 1 µg is dispensed in response to each puff of the user with a dispenser 10 having a nicotine-loaded porous plug 18. The second polymeric substance is typically a material generically described as an olefinic polymer. More specifically, the second polymeric substance is preferably polyethylene or polypropylene but may also be any polyolefin or polyolefindiene such as polybutadiene, poly-1-butene, polyisobutylene, polyisoprene, poly-4-methyl pentene, or combinations thereof, for example. Of particular preference in formulating the porous plug 18 is a high density polyethylene. Although amorphous rather than crystalline polyethylene appears to have a greater nicotine-absorptive capacity, porous plugs are more readily produced from high density polyethylene which has adequate capacity for reversible nicotine absorption. The porous plug may be produced mechanically as a molded unit and may also be a mass of filaments. Polymeric substances such as polystyrene and polycarbonate are dissolved by nicotine and are thus not usable in the practice of the present invention. Polymers containing halogens or nitrogen or sulfur, although they may be found to have the desired reversible nicotine absorptivity are not preferred because of their potential emission of noxious fumes upon accidental ignition. The housing 12 of the dispenser 10 is composed of a first polymeric substance. The first polymeric substance is resistant to penetration by nicotine and produces no noxious fumes upon accidental ignition. A preferred first polymeric substance is oriented polybutyleneterephthalate. The tipping paper comprising the hand 20 of the dispenser 10 is preferably non-nicotine absorbent. Ordinary cigarette tipping paper may be advantageously treated to decrease its absorbent capacity for nicotine. Such treatment may comprise: exposure to ammonium hydroxide, dimethyldichlorosilane or polyvinylpyrrolidone, for example. It is also preferred for preparation of packages containing the dispensers 10 to wrap sets of said dispensers 10 in a wrapping nonabsorptive for and substantially nonpermeable to nicotine. A wrapping of biaxially oriented polyethyleneterephthalate film has been found to suitably retain nicotine in nicotine loaded dispensers 10 wrapped therein. The following examples are presented to fully describe many features of the invention. EXAMPLE 1 Polyethylene Absorption from Liquid Nicotine A low density polyethylene tube (obtained from Blackwell Plastics, Houston, Texas) weighing 721.2 mg was immersed in liquid nicotine (98%, Eastman Kodak) for 17 h at 23,9°C (75°F). The tube was withdrawn from the nicotine, washed with water and dried. The dried tube weighed 743.5 mg. The net increase in weight was 22.3 mg, which indicated that low density polyethylene may absorb nicotine to form a composite with about 3% nicotine. Although it was noted that the dried tube was tactually dry, an odor of nicotine was emitted by the tube-nicotine composit. EXAMPLE 2 Attempted Extraction of Nicotine from a Nicotine Containing Polyethylene Tube A low density polyethylene tube (8 x 84 mm) weighing 743.5 mg and containing 22.3 mg of absorbed nicotine was immersed in 0.1 M hydrochloric acid at ambient temperature for periods of 1 min and 10 min. After washing, drying and weighing, the 1 min HCl immersion was found to have caused a weight loss of 0.4 mg and the 10 min immersion a weight loss of 1.4 mg. This experiment suggested that, should a nicotine containing polyethylene sample be ingested, that the internal emission of nicotine would be slow rather than immediate. It was also indicated that nicotine had deeply penetrated the polyethylene rather than being adsorbed or superficially absorbed. EXAMPLE 3 Polyethylene Absorption of Vaporous Menthol A low density polyethylene tube (8 x 84 mm) weighing 824.3 mg was sealed in a test tube with menthol crystals. The test tube was then placed in an oven at 51,7°C (125°F) for 2 h. The tube was removed from the test tube, washed with ethanol, dried and weighed. The tube then weighed 865.4 mg, showing a weight increase of 41.1 mg ascribable to absorbed menthol. This experiment indicates that menthol, as well as nicotine may be absorbed by polyethylene. EXAMPLE 4 Polyethylene Film Absorption from Liquid Nicotine Two types of polyethylene film (0,0254 mm (1 mil) thickness) from Phillips Petroleum, Bartlesville, OK were obtained: NO. TR140, a blown film of high crystallinity; and No. 0X611, a cast film of low crystallinity. Samples of both film types were weighed and immersed in nicotine (98% Eastman Kodak, Rochester, N.Y.) at 25°C for 5 h. After withdrawal from the nicotine, the film samples were carefully wiped until completely free of liquid, and weighed. The results of this immersion are shown in Table 1. Nicotine Absorption by Polyethylene Film Sample Preliminary Weight Postimmersion Weight Nicotine Absorbed % Nicotine (of original wt.) TR140 84.9 mg 86.8 mg 1.9 mg 2.2% OX611 128.9 mg 133.7 mg 4.8 mg 3.7% As the data in Table 1 indicates both types of polyethylene film absorb nicotine, the low crystallinity polyethylene absorbing nicotine more efficiently. EXAMPLE 5 Absorption of Nicotine Vapor by Various Polymers Valox (polybutyleneterephthalate) in various forms was obtained from General Electric (Polymer Products Department). Tedlar (polyvinylfluoride film) was obtained from DuPont de Nemours & Company. Gafphite 1600A (polybutyleneterephthalate) was obtained from General Aniline Fiber. PPH (Polypropylene homopolymer) was obtained from Tee] Plastics, Baraboo, Wisconsin. Various preweighed samples (from 40 mg to about 800 mg in weight) of these polymers were incubated in sealed containers with a nicotine saturated air for different times and at different temperatures and again weighed. The results of these manipulations are shown in Table 2. Percent Weight Gain For Various Polymers Subjected to Nicotine Vapors Sample Temperature Time (Days) Weight Gain (wt. %) Valox (10% glass filled) ambient 12 1.46 Valox (10% glass filled) 51,7°C (125°F) 12 0.67 Valox (40% glass filled) ambient 12 0.09 Valox (40% glass filled) 51,7°C (125°F) 12 0.02 Valox 310-083 ambient 7 0.08 Valox 310-083 51,7°C (125°F) 7 0.29 Valox 310-095 ambient 7 0.10 Valox 310-095 51,7°C (125°F) 7 0.98 Gafphite 1600A ambient 7 0.072 Gafphite 1600A 51,7°C (125°F) 7 0.35 Tedlar ambient 7 0.055 Tedlar 51,7°C (125°F) 7 1.00 PPH 60°C 1 1.2 PPH 60°C 3 3.7 PPH 60°C 5 5.7 PPH 60°C 10 6.0 PPH 60°C 20 6.8 PPH 50°C 1 0.4 PPH 50°C 3 0.8 PPH 50°C 5 1.9 PPH 50°C 10 2.7 PPH 50°C 20 4.1 PPH 25°C 1 0.05 PPH 25°C 3 0.15 PPH 25°C 5 0.20 PPH 25°C 10 0.25 PPH 25°C 20 0.5 PPH 5°C 1 0.05 PPH 5°C 3 0.08 PPH 5°C 5 0.10 PPH 5°C 10 0.10 PPH 5°C 20 0.15 As the data in Table 2 indicates, under comparable conditions, (polypropylene at 50°C for 10 days and polybutylene terephthalate or polyvinylfluoride at 51,7°C (125°F) for 7 days), that the polyolefin polypropylene is much more effective as a nicotine absorbent (2.7 wt. % gain) than is the polybutylene terephthalate (less than 1%) or polyvinyl fluoride (about 1%). Also, these results suggest the usability of such relatively nonabsorptive polymers for portions of the presently described nicotine dispenser 10 where nicotine non-absorption is desirable such as the housing 14 or wrapping (not shown). EXAMPLE 6 Absorption and Desorption of Nicotine Vapors By Low Density Polyethylene Tubes Preweighed low density polyethylene tubes (Blackwell Plastics, Houston, Texas) were subjected to nicotine vapors from a predetermined amount of nicotine in a sealed tube at a temperature of about 51,7°C (125°F) for 24 h. The weight gain of the tubes were determined and the results are shown in Table 3. Polyethylene Sample Absorption Of Nicotine Vapors Polyethylene or Nicotine Weight Sample 1 Sample 2 Sample wt. before exposure 1.0159 g 1.0177 g Nicotine available 22.0 mg 25.6 mg Sample wt. after exposure for 24 h. 1.0350 g 1.0387 g Nicotine absorbed 19.1 mg 21.0 mg Sample 1 and Sample 2 were then exposed to ambient air for various periods of time and periodically weighed to determine loss of absorbed nicotine. The measurements of nicotine desorption are shown in Table 4. Polyethylene Desorption of Absorbed Nicotine Time Decrease in Sample Weight (Nicotine Loss) Sample 1 Sample 2 1 h 0.9 mg 0.4 mg 2 h 1.6 mg 1.3 mg 4 h 3.3 mg 3.1 mg After a 4 h exposure to ambient air, over a 10% loss in absorbed nicotine was noted. This indicates the reversible nature of nicotine absorption in this particular polyolefin, similar to that qualitatively noted with other polyolefins. EXAMPLE 7 Polyethylene and Teflon Absorption from Liquid Nicotine and Desorption of Nicotine Vapors from the Polyethylene A low density polyethylene tube weighing 753.3 mg and a Teflon cylinder weighing 14.4983 g were immersed in liquid nicotine for 3 h at 48,9°C (120°F). After withdrawal and removal of superficial nicotine, the polyethylene sample showed an increase in weight of 48.1 mg and the Teflon sample showed a decrease in weight of 0.8 mg. The polyethylene sample was then exposed to ambient air for three days and exhibited a weight loss of 27.0 mg (about 56% loss of absorbed nicotine). The suitability of polyethylene as a nicotine reservoir for a nicotine dispenser in further demonstrated by the above data, as well as the nicotine non-absorptivity of Teflon. EXAMPLE 8 Polypropylene Absorption from Liquid Nicotine and Desorption Under Vacuum Four polypropylene samples obtained from Teel, Baraboo, Wisconsin, were washed, dried, weighed and immersed in liquid nicotine for 21 h at 48,9°C (120°F). The samples were withdrawn, washed with water, dried and weighed again to determine the extent of nicotine absorption in the nicotine-loaded samples. These nicotine-loaded polypropylene samples were then placed in a vacuum dessicator, subjected to a vacuum of about 75 mm of pressure for 10 min and reweighed to determine loss of absorbed nicotine. The results of these manipulations are shown in Table 5. Polypropylene Absorption from Liquid Nicotine and Desorption Under Vacuum 1 2 3 4 Sample weight (mg) 428.5 429.3 511.0 623.4 Sample weight after immersion 443.8 455.6 540.5 640.7 Nicotine absorbed (mg) 15.3 31.7 29.5 17.3 % nicotine of sample weight 3.6 7.5 5.8 2.8 Sample weight after 10 min under vacuum 443.4 454.5 539.9 640.6 Mg nicotine desorbed under vacuum 0.4 1.1 0.6 0.1 As the above data indicate, polypropylene is an effective nicotine absorbent and absorbed nicotine does not flash evaporate when subjected to a vacuum which would quickly evaporate free nicotine liquid. This again indicates more than adsorption or superficial absorption, such as in surface crevices. EXAMPLE 9 High Density Porous Polyethylene Absorption of Nicotine Vapors Four samples (cylinders with about a 0,64 cm (1/4 inch) diameter and 3,81 cm (1-1/2 inch) length) of porous high density polyethylene were obtained from Porex Technologies (Fairburn, GA). These samples were weighed and then each incubated at ambient temperature in a sealed tube and in the presence of 40-50 mg nicotine. The weight of the samples were periodically determined and the resultant data shown in Table 6. The data in Table 6 demonstrates the absorptive ability of high density porous polyethylene for nicotine vapors. EXAMPLE 10 Vaporization of Nicotine from a Nicotine-Loaded Porous Polyethylene Plug A 360 mg piece of Porex high density porous polyethylene was interposed in the passageway of an aluminum tube. The aluminum tube was 84 mm long, had an outer diameter of 0,79 cm (5/16 inch) and a wall thickness of 0,13 mm (5/1000 inch). The porous plug was contacted with about 18 mg of liquid nicotine which was promptly absorbed to form a porous plug containing about 5% by weight nicotine. Puffs of air (35 cm³/puff) were drawn through the tube and nicotine-loaded porous plug at about 1050 cm³ per min (2 s/puff). The nicotine content of the air puffs was monitored by gas chromatography (Model 5880A, Hewlett Packard). Table 7 contains the data concerning nicotine in the air puffs. Nicotine Vaporized From A Porous Nicotine-Loaded Polyethylene Plug Time Number Puffs µg Nicotine Per Puff 10:31 1 8.2 10:33 74 8.1 10:36 147 6.7 10:40 220 5.6 10:43 292 5.2 10:46 365 4.7 10:49 438 4.2 10:52 511 3.8 10:55 584 3.2 10:58 657 2.9 The total nicotine in the puffs was 3423 µg or about 19% of the nicotine originally loaded into the porous plug. The temperature was about 25°C for these manipulations. EXAMPLE 11 Attempted Extraction with Ethanol of Nicotine from a Porous Polyethylene Plug An aluminum tube with an interposed porous high density polyethylene plug (Porex Technologies) was constructed as described in Example 10 except that the plug was loaded with 20 mg of liquid nicotine. A 35 cm³ volume of 95% ethanol was drawn through the loaded plug in a 3 s period and then analyzed for nicotine content. The volume of 95% ethanol, an excellent nicotine solvent under normal conditions, contained 1.4 mg of nicotine, this being about 7% of the absorbed nicotine. These data illustrate that rapid extraction of nicotine from a state of polyethylene absorption is not easily accomplished and that the nicotine had penetrated the polyethylene. EXAMPLE 12 Absorption of Nicotine Vapors by Several Materials at Different Temperatures Preweighed samples of various materials were sealed in tubes with excess nicotine vapors. After various periods of time at different temperatures the samples were removed and reweighed. Increases in sample weight were calculated as weight percent (wt %) increases based upon the original sample weights. Tip paper number MR-320 was obtained from the Schweitzer Paper Company, Division of Kimberly Clark, Neenah, Wisconsin. Kimdura, a polypropylene trilaminate, was also obtained from Kimberly Clark. A polypropylene tube (PPT) was obtained from Teel Plastics, Baraboo, Wisconsin and polypropylene fiber (PPF) Type 701 from Hercules Plastics, Wilmington, Delaware. The absorption of nicotine by these samples, as shown in wt% increases is presented in Table 8. Absorption of Nicotine Vapor Sample Temp (°C) wt % nicotine 1 day 3 day 5 day 10 day 20 day Tip Paper 5 1.8 2.5 1.9 3.6 2.7 25 0.78 1.3 1.9 3.0 4.1 20 4.0 7.4 7.5 6.4 13.0 60 5.1 14.0 7.1 12.0 18.0 Kimdura 5 1.3 0.08 0.08 0.31 0.28 25 0.11 0.16 0.33 0.30 0.58 50 0.82 1.1 1.3 1.6 2.5 60 1.3 3.0 3.5 4.2 6.2 PPT 5 0.03 0.07 0.08 0.11 0.14 25 0.06 0.18 0.18 0.27 0.52 50 0.40 0.74 1.9 2.7 4.1 60 1.2 3.7 5.7 6.0 6.0 PPF 5 0.06 0.05 0.002 0.11 0.22 25 0.07 0.12 0.24 0.15 0.64 50 0.75 1.5 1.7 1.2 3.6 60 1.6 3.2 5.1 2.9 8.7 As shown by the data in Table 8 tip paper, trilaminate polypropylene, polypropylene tube and polypropylene fiber all absorb nicotine vapors and that this absorption is proportional to time and temperature. These observations further are applicable to a choice of materials for a nicotine dispenser, for example, tip paper will absorb nicotine and thus preferably, if used at all, should be treated so it does not effectively absorb nicotine in a fashion so it is not readily deliverable by a nicotine dispenser. Additionally, a nicotine dispenser with a polypropylene tube housing of the type studied above, may likewise result in the nicotine being absorbed by the housing in a fashion not readily deliverable to the user. EXAMPLE 13 Desorption of Nicotine Vapors from a Porous Polyethylene Plug A 360 mg porous polyethylene plug was interposed in a tubular aluminum housing as described in Example 10. The porous plug was loaded by contact with different amounts of nicotine to form an interposed porous plug containing a particular weight percent (wt%) nicotine. Air puffs were drawn through the tube and nicotine emitted and monitored as described in Example 10. The puffs were continued at ambient temperature until the nicotine emission per puff first reached a level below 3 µg of nicotine. The puffing was then terminated and total emitted nicotine calculated. The data resulting from this test is shown in Table 9. wt % nicotine total mg nicotine loaded maximum nicotine per 35 cm³ puff (µg) no. of puffs before content is below 3µg per puff total mg nicotine emitted 2 7.2 8.9 365 2.3 3 10.8 7.5 730 3.8 4 14.4 8.3 511 2.7 5 18.0 8.2 657 3.4 6 21.6 9.9 948 5.4 7 25.2 9.7 1895 11.1 8 28.8 11.3 2187 16.5 The data in Table 9 shows, a nicotine dispenser configuration of this type, preferably delivering at least 500 puffs containing from 3 to 10 µg of nicotine per puff, should contain a porous polyethylene plug of at least about 3% nicotine or about 10.8 mg nicotine. The dosage of nicotine per puff from a nicotine dispenser is most preferably less than 10 µg but more than 5 µg, although a dosage between 2.5 µg and 12 µg is acceptable. Preferred typical temperatures and flow rates for usage of a nicotine dispenser 10 of the present invention preferably range from 0°C to 40°C and flow rates from 100 cm³/min to 2000 cm³/min. EXAMPLE 14 Absorption of Nicotine Vapors by a Selection of Papers and Treated Papers A variety of paper samples potentially usable as tipping papers for a tubular nicotine dispenser were tested for nicotine absorption. Samples were washed either with water or with 5% aqueous ammonium hydroxide, dried and weighed. The paper samples were then subjected to nicotine vapors in a sealed tube at 50°C for 6-1/2 days and reweighed. Paper samples were obtained from Schweitzer Paper Company, a Division of Kimberly Clark. The results of these tests are shown in Table 10. Paper Absorption of Nicotine Vapors Paper Sample wt % nicotine water washed 5% NH₄OH washed WTA-33 gsm 2.2 2.4 Abrol 10#500 2.1 1.1 GSR156-HO-34 gsm 2.4 4.1 MR320 Maretip 2.2 2.7 GSR-236-M2-36HD 2.4 1.7 GSR-236-M1-36HD 1.9 2.0 MR320 Maretip (Printed version) 4.2 3.7 The above data indicates that, for at least some papers, treatment with 5% aqueous ammonium hydroxide decreases nicotine absorption capacity. EXAMPLE 15 Polypropylene Absorption from Liquid Nicotine Time and Temperature Dependency Polypropylene homopolymer tubes (Teel Plastics) were weighed and immersed in liquid nicotine. After withdrawal, the tubes were washed, dried and weighed. Increases in weight were utilized to calculate wt% absorption. Table 11 shows data obtained from these manipulations. Polypropylene Nicotine Absorption Time (h) wt% absorption, at 5°C 25°C 50°C 60°C 1 0.007 0.014 0.37 0.87 25 0.016 0.085 5.4 6.9 88 0.008 0.47 5.9 6.4 192 0.028 0.87 6.0 6.5 The data in Table 11 shows that polypropylene effectively absorbs liquid nicotine in a manner dependent on time and temperature. EXAMPLE 16 Packaging Materials Test Samples 7,62 cm² (3 in²) of Van Leer microporous polypropylene film were each weighed and loaded with 40 mg of nicotine. The nicotine-loaded samples were heat-sealed in pouches formed from 30,5 cm² (12 in²) packing film. Packaging films included PET (polyethyleneterephthalate); PP (polypropylene); and aluminum metalized PET. After incubating the sealed pouches of nicotine for 2 weeks at 51,7°C (125°F), the microporous polypropylene film samples were removed and weighed. Table 12 shows the data resulting from the above manipulations in terms of the percentage of nicotine lost during the 2 week period. Nicotine Permeability of Packaging Materials Packaging Film % Nicotine Lost I.C.I. Melinex 470 (PET) 31 I.C.I. Melinex 475 (PET) 42 Bemis Esterphane (PET) 5 Bemis Propa Film (Polypropylene) 99 I.C.I. Melinex Metalized 850 (PET/Aluminum) 40 I.C.I. Melinex 850 (PET) 31 Kimberly Clark KimDura (Polypropylene) 99 Bemis Metalized Esterphane (PET/Alum) 5 As indicated by the above data, polypropylene film would be unsatisfactory for packaging nicotine dispensers while certain biaxially oriented polyethyleneterephthalate film or metalized polyethyleneterephthalate film appears to effectively retard nicotine evaporation.

Claims: A device for the non-pyrolytic inhalation of nicotine, comprising a tubular member (12) adapted at one end (22) to be held in the mouth for inhalation of air therethrough; said tubular member comprising a first polymer which is resistant to penetration by nicotine; and a quantity of porous solid-form second polymer interposed in said member said second polymer containing absorptively retained nicotine characterized in that said second polymer is capable of releasing between about 2.5 and 12 µg of nicotine into a 35 cm³ puff of air drawn through said member. The device of claim 1 characterized in that said second polymer comprises a polyolefin. The device of claim 1 or 2 characterized in that said second polymer comprises polyethylene, polypropylene, polybutadiene, poly-1-butene, polyisobutylene, polyisoprene, poly-4-methyl-1-pentene or combinations thereof. The device of any of claims 1 to 3 characterized in that said second polymer is high density polyethylene. The device of any of claims 1 to 4 characterized in that said first polymer is polybutyleneterephthalate. The device of any of claims 1 to 5 characterized in that the second polymer is in the form of a porous plug (18). The device of claim 6 characterized in that the porous plug (18) comprises a molded unit. The device of claim 6 characterized in that the porous plug (18) comprises a shaped mass of filaments. The device of claim 6 characterized in that a second porous plug being resistant to the absorption of nicotine is interposed in the passageway. The device of claim 9 characterized in that at least one porous plug (18) comprises a vaporizable flavorant such as menthol or tobacco extract releaseable into air drawn through the member. The device of claim 1 characterized in that the nicotine further contains an anti-oxidant. The device of claim 11 characterized in that the anti-oxidant is butylated hydroxyanisole propyl gallate, tertiary butylhydroxy-quinone butylated hydroxytoluene or mixtures thereof. The device of claim 1 characterized in that the end (22) of the tubular member adapted to be held in the mouth has a band of generally cork-colored paper. The device of claim 13 characterized in that the cork-colored paper has been subjected to a treatment to reduce nicotine absorbtivity. The device of claim 14 characterized in that the treatment comprises exposure to ammonium hydroxide, dimethyldichlorosilane or polyvinylpyrrolidone. The device of claim 6 characterized in that the porous plug (18) comprises between 1 and 25 mg of nicotine.

Inventors: ELLIS, MICHAEL P., HILL, IRA D., OLDHAM, RONALD G., RAY, JON PHILIP, TURNER, JAMES E.
Applicants: KABI PHARMACIA AB
Application year: 1986
Main classification: A61M15
IPC codes: A24F13, A24F47, A61M15, A24D1