TECHNICAL FIELD The present invention relates to a means for powder delivery to the nasal passages. In particular the present invention relates to a means for delivery of individual doses of powders such as ground tobacco (snuff) and other ground plant material, dried alcohol and powdered pharmaceutical compositions into the nasal passages. Any powder that is capable of being absorbed through the nasal passages can be used in the means described in the present invention.

BACKGROUND OF THE INVENTION

Popular smoking articles, in particular cigarettes, are well known in the art and are provided in the form of a substantially cylindrical rod-shaped structure comprising a charge, roll or column of smokable material, such as shredded tobacco, surrounded by a paper wrapper, thereby forming a so-called "smokable rod", "tobacco rod" or "cigarette rod." Normally, a cigarette is provided with a cylindrical filter element aligned in an end- to-end relationship with the tobacco rod. Preferably, the filter element comprises either a crepe paper or a plasticized cellulose acetate tow circumscribed by a paper material known as "plug wrap." Most preferably, the filter element is attached to one end of the tobacco rod using a circumscribing wrapping material known as "tipping paper." It also has become desirable to perforate the tipping material and plug wrap, in order to provide dilution of drawn mainstream smoke with ambient air. Examples of such perforations are shown in US 3,490,461 and US 4,256,122.

Descriptions of cigarettes and the various components thereof are provided in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999). A cigarette is employed by a smoker by lighting one end thereof and burning the tobacco rod. The smoker then receives mainstream smoke into his/her mouth by drawing on the opposite end (e.g., the filter end) of the cigarette. The direct application of tobacco to the nasal passages in the form of snuff is also popular. Snuff is a smokeless tobacco made from ground or pulverised tobacco leaves. It is insufflated (inhaled) or "snuffed" into the nasal cavity (into either nostril), delivering a swift dose of nicotine and a lasting flavoured scent (especially if flavouring has been blended with the tobacco). Traditionally snuff is sniffed or inhaled lightly after a pinch of snuff is placed onto the back surface of the hand, held pinched between thumb and index finger, or held by a specially made "snuffing" device. The nicotine in snuff is absorbed through the mucus membrane, so a pinch of snuff only needs to get into the nose. Snuff is prepared in a range of textures from very fine to very coarse, and from very dry to very moist. The use of tobacco-free snuffs, such as made from glucose powder or herbs is also known. All can be flavoured, for example with fruits, florals and spices such as apple, jasmine, cinnamon and menthol. Users of smokeless tobacco products, including snuff, face no known cancer risk to the lungs. Snuff has been proposed as a way of reducing harm from smoking tobacco. Russell et al in The British Medical Journal reported in 1981 that "unlike tobacco smoke, snuff is free of tar and harmful gases such as carbon monoxide and nitrogen oxides. Since it cannot be inhaled into the lungs, there is no risk of lung cancer, bronchitis, and emphysema. It is not known whether nicotine or carbon monoxide is the major culprit responsible for cigarette-induced coronary heart disease. If it is carbon monoxide a switch to snuff would reduce the risk substantially, but even if nicotine plays a part our results show that the intake from snuff is no greater than from smoking" (BMJ 1981 ; 283:814). Snuff is traditionally dosed by the user taking a pinch of snuff onto the back of the hand between thumb and forefinger and sniffing. Various devices are known for inhaling doses of powders such as snuff from powder line on a surface such as metal and glass tubes. Other re-useable devices for doses of snuff known as snuff bullets are also known in the art. A simple snuff bullet consists of a small bottle with a plug in the base, a rotatable "dosing chamber" and a hole on the top. More advanced snuff bullets have variable dosing settings. They can be made of plastic, glass or metal. A problem with these devices is that they can be used by multiple persons, and are unhygienic. There is a problem in traditional means for delivery of snuff in that the volume of snuff varies due to the amount of powder self-dosed by the snuff taker. Further, snuff taking has an old-fashioned image which is unattractive to users of other tobacco products such as cigarettes. There is accordingly a need for a suitable modern snuff inhaler which can be mass manufactured at low cost, which is hygienic and which delivers a known dosage of powder.

With the recent moves towards restricting the sale of cigarettes and concerns over electronic cigarettes, there is seen to be a need for a means to deliver single and controlled doses of powders, such as but not restricted to snuff tobacco, to the nasal passages. With the familiarity of cigarettes such as described above to the general public, a means for delivering powder doses using a device in similar form to a cigarette rod would be an advantage.

SUMMARY OF THE INVENTION

Presently disclosed is a means in the form of a rod for the delivery of a powder, including but not restricted to powdered tobacco, to the nasal passages. There is further described a method for the construction of such delivery means. The delivery means comprises a hollow length of tube which contains a dose or unit amount of the powder. The hollow length of tube is abutted at either end by solid lengths of a paper or plasticized cellulose acetate. Preferably, as will be further described, one end of the hollow tube is separated from the adjoining solid length of acetate rod by a void. The lengths of hollow tube containing the powder and two solid rods, preferably if provided also the void, are then wrapped by a suitable wrapping material, such as plain or pre-printed plug wrap paper or any other type of wrap, to hold the various sections together in the form of a single rod, the plug wrap then being possibly wrapped with further artwork, and perforated to enable the hollow section to be accessed

In use, one of the solid rod sections is broken away from the assembled sections, along the perforation, revealing the open end of the hollow tube filled with powder. This is inserted into one of the nasal passages. The user then sniffs the powder into the nasal cavity from the hollow tube to provide a single measured dose of the powder, such as snuff. The used and empty rod assembly is then discarded. If possible, the component materials may be separately recycled. The powder contained within the device can be any powder designed for application to the nasal cavity, preferably powdered tobacco but further other powdered material such as but not restricted to powdered plant material, powdered foodstuffs, powdered confectionery, powdered herbs, powdered vitamins, powdered alcohol or powdered pharmaceuticals, optionally in combination with adjuvants, fillers and binders.

BRIEF DESCRIPTION OF DRAWINGS

The invention will be further described with reference to the accompanying drawings in which

Figure 1 shows the basic layout of a device according to the present invention in sectional view.

Figure 2 shows sections through the component parts of the device according to Figure 1.

Figure 3 shows an exploded view of the device according to Figure 1 in order to demonstrate in schematic view one of the methods of manufacture (Horizontal fill)

Figure 4 shows an alternative configuration of the device, in order to demonstrate one of the alternative methods of manufacture described below (Vertical fill)

Figure 5 shows a further exploded view of the device according to the present invention as shown in Figure 1 together with the surrounding wrapping paper.

Figure 6 shows the basic layout of the degree of perforation required to give the desired removal of the top section for the user to access the powder, as described below.

DEFINITIONS OF PREFERED MATERIALS: Acetate Rod: The raw material preferred for the manufacture of the acetate rod is cellulose (obtained from wood). The cellulose is acetylated (i.e. making it into a material called cellulose acetate or simply "acetate" for short), dissolved, and spun as continuous synthetic fibers arranged into a bundle called "tow". The cellulose is exemplified as a monoacetate or a substituted diacetate (having a 2.35 - 2.55 substitution range) cellulose. This tow is opened, plasticized, shaped, enclosed in an outer plug wrap, and cut to length into a longitudinally extending rod.

Paper Rod: The material preferred for the manufacture of the paper rod, is a high-quality semi-crepe paper compressed to the desired parameters. This is enclosed in an outer plug wrap and cut to length. Paper rods are highly preferable in that they degrade quicker than acetate rods. Paper rods typically have a lower pressure drop, and are more suited in the application to lift the powder by insufflation or sniffing into the nasal cavity as defined herein.

Tubular Rod: The raw material preferred for the manufacture of the tubular rod is cellulose (obtained from wood). The cellulose is acetylated (i.e. making it into a material called cellulose acetate or simply "acetate" for short), dissolved, and spun as continuous synthetic fibers arranged into a bundle called "tow". The cellulose is exemplified as a monoacetate or a substituted diacetate (having a 2.35 - 2.55 substitution range) cellulose. This tow is opened, plasticized, shaped on a mandrel and steamed to enable the plasticizer to take an accelerated set, to form a hollowed section, typically circular in nature, although other shapes can be used, and cut to length. The application of plug wrap is not usually required. Other materials can be used for the tube, such as but not restricted to moulded plastics material or card.

Hollowed Rod: An acetate rod that has a defined cavity at one end, created either during the manufacturing process, whereby a reciprocating mandrel may be used to create a series of cavities in a continuous acetate rod, which when cut through the centre would produce two hollowed rods of relatively equal configuration, or through deforming a previously produced acetate rod, to create a cavity through the application of a combination of mechanical processing, for example involving direct heat, or the application of steam

Cap: In some embodiments a cap (12) preferably of a crepe paper or a plasticized cellulose acetate tow, or in some iterations a differing material (possibly moulded plastic or card or other material) may be utilised, either inserted inside or around the outside of the cavity, using possibly a friction fit, or being secured by a glue, sealant or wrap to ensure the contents are retained in the cavity. The cap may be removed prior to use. Plug wrap: The paper (10) used to overwrap the sections is preferably a plug wrap paper known in the field of cigarette manufacture. The weight range is in the region of 15 to 120 gsm. In a preferred embodiment, the plug wrap paper used is a heavier gauge paper of around 80 gsm, providing an opacity typically of 95% or greater. This ensures that in the case of the preferred device enclosing the void as described below, the powder will not leak through the porous paper, and will be firmly held in the device. The plug wrap paper may be foil lined. The foil lined plug wrap has a thickness of approximately 0.2 to 0.3 mm, most preferably approximately 0.25 mm. The heavier gauge paper, and the foil lined option also ensures light does not reach the powder, as this can degrade the powder. In addition, this maintains the powder in a substantially dry and moisture free condition for free flow of the powder by substantially preventing moisture from the air contacting the powder. The plug wrap may be white or any preferred colour, or a combination of colours, and may be pre-printed.

Tipping Paper: In conventional use, tipping paper connects the filter and tobacco column by overlapping the tobacco column and the filter. The tipping paper contains a coating of a silicone compound to prevent the tipping paper from sticking to the lips of the smoker. The tipping paper can be of various colors, such as white or, more generally, cork. In the case of our preferred device, pre-printed tipping paper may be wrapped to encase the device, or a section of the device, and will provide additional support to the void within the device. Application may be from a pre glued label type application, or glue applied at the point of use

Casing: Although plug wrap is the preferred embodiment, the casing may be made from other materials, particularly a soft plastic, and may be either wrapped, assembled around or moulded around the finished rod to protect the powder prior to use, with a perforation. Tear Tape: Also known as 'tearstrip' or 'tear-off ribbon' tear tape is typically a polymer- based narrow tape that is attached to the inner surface of film overwrap of common nondurable fast-moving consumer goods such as soft drinks, groceries or toiletries, as well as tobacco products such as cigarettes to aid the opening of the packaging. In the case of our preferred device the tear tape may be wrapped to encase the device, or a section of the device, and will provide additional support to the void within the device. Application is likely to be through self-adhesion., or application of adhesive.

Powder: In an example of the ground tobacco used in the device according to the present invention, the powder is provided is likely to have a bulk density of 0.2 to 0.5 g/cm ³ e.g. approximately 0.35 g/cm ³ . Flowability may be roughly 4 to 6 ffc (flow function coefficient). The powder is ground by known means to a particle size with a mean diameter greater than 10 μιη, preferably in the range of 100 to 1000 μιη. Horizontal Fill: A manufacturing process whereby powder fills the cavity / void either falling under its own weight (with the assistance of gravity), or is assisted using

mechanical, pneumatic or hydraulic assistance, similar to that used when filling capsules for pharmaceutical use. The cavity / void being filled from the side is as shown in Figure 3. Vertical Fill: A manufacturing process whereby powder fills the cavity / void either falling under its own weight (with the assistance of gravity), or is assisted using

mechanical, pneumatic or hydraulic assistance, similar to that used when filling capsules for pharmaceutical use. The cavity / void being filled from the top is as shown in Figure 4. DETAILED DESCRIPTION OF THE INVENTION

According to the invention there is provided a device for the nasal delivery of a powder to the nasal cavity as defined in the following claims. The device is constructed from one or more of a series of basic 'rods', four of which are defined above (acetate, paper, tubular, hollow). These different rods may be used to enable either a vertical or horizontal fill of a family of products that in the main are likely to hold a single fill of 'powder' . Specific products may use multi 'powder' fills, particularly with pharmaceuticals .

In the basic 'horizontal fill' configuration, a longitudinally extending cylindrical 'paper rod' or 'acetate rod' similar to that used in standard cigarette filters is manufactured and is as shown in Figure 2A. According to Figure 2A, this rod (3) is typically provided in a length of 120 to 180 mm, preferably approximately 130 mm. This rod is then cut by machine into two equal lengths. The two equal lengths are then further cut, each into two further lengths (1,2) of proportional lengths one-third to two thirds, or approximately 20 - 30 mm and 40 - 60 mm as shown in Figure 1. The most preferred lengths of these longitudinally extending cylindrical rods are approximately 26 mm (1) and 39 mm (2). The rod has an external circumference of 10 to 30 mm, preferably 20 to 25 mm, most preferably 24.3 mm. These sizes will enable construction of a device when assembled with other components to be similar in size to a standard cigarette.

A second 'tubular rod', or 'hollow rod' is also provided as shown in Figure 2B. This longitudinally extending cylindrical rod would typically have an internal diameter of from 2 mm to 6 mm, preferably 4 to 5 mm in which the powder is to be stored and inhaled. According to Figure 2B, this rod (4) is provided in a length of 60 to 120 mm, preferably approximately 72 mm. This rod is then cut by machine into a plurality of equal lengths (5), approximately 10 to 14 mm in length, most preferably 12mm. The tubular or hollow rod is of the same external circumference as the solid rod shown in Figure 2A.

The sections of the longitudinally extending cylindrical 'acetate rods' or 'paper rods' (1, 2) and the longitudinally extending 'hollowed rod' or 'tubular rod' (5) are then assembled in the filling machine, wherein a powder dose such as powdered dry snuff is filled into the tubular rod (5) before rods (1, 2) are positioned onto each end of the tube, thus enclosing the powder. The sections are then wrapped with a suitable paper known in the art of cigarette manufacture, preferably a plug wrap, which holds the three parts together in a longitudinally extending cylindrical assembly. MANUFACTURING METHODS

The devices according to the present invention can be manufactured in accordance with known techniques used in the cigarette manufacturing industry. The various longitudinal rod elements described above are dropped onto the assembly line in the correct order of solid rods and hollowed rods, part wrapped together in a long string, filled, finally wrapped and then cut to individual dispensing powder filled rods. The techniques would be well known to those skilled in the art of cigarette manufacture. Automation and computer control can enable the production of many thousands of units per minute.

In a preferred embodiment, horizontal fill, as shown in Figures 1, 3 and 5, a void (6) is left between one end of the tube and the proximate rod (2) during manufacture. The void may have a length of 2 to 6 mm, preferably 4mm. The hollow within the tube may of varying length to accommodate various volumes and densities of powders. Preferred is a dose of from 0.01 to 2g of powder. The preferred dose for nasal ingestion of snuff can vary typically from 0.05g to 0.2g, with a target weight of 0.115g. During manufacture, as shown in Figure 3, the powder is fed down through a delivery line or shute (7) and is drawn into the tubular rod (5) through the void (6) by a suction device (8). At the point of filling, the paper (10) is then wrapped around the two solid rods (1, 2) and powder filled tube (5), and also around the void (6). Powder can be recirculated back to delivery line (7) from the suction device (8).

As shown in Figure 5, the various rod sections are laid onto a plug wrap during the manufacturing process, before the fill, the plug wrap being part glued to the rods before it is then wrapped around the three rods and the void after the fill, and glued together. During the process, the plug wrap (10) is moved up around the rods in a horseshoe shape.

In order to further protect the void, a further layer of paper (16) can be circumferentially affixed around the assembled plug wrapped rods in the form of a band. This further layer is preferably tipping paper as described above. The further wrapping of a length of paper, especially tipping paper, around the assembled rod serves two functions. Firstly, a reinforcing layer is provided around the void when present, in order that the rod does not bend around the filled void. Secondly, the additional wrapping section can be optionally coloured and optionally printed, for example with details of the product, the brand name, and so on. The additional wrapping paper can be pre-glued over its length, which may be the whole length of the assembled rod or a shorter length, e.g. 20 - 40 mm.

In an alternative embodiment, vertical fill, as shown in Figure 4, the cavity in a 'hollowed' rod (11) is filled, and a closing 'cap' (12) placed over to seal the cavity, secured either through friction surround, a sealant or a casing, e.g. a plug wrap paper (10).

Following the manufacture of the filled rod, in both these and similar embodiments, the paper (10) is preferably weakened, preferably perforated, at the point (9) where it contacts the abutment point between the hollow tube and the shorter rod (1). This can be seen in Figure 5. The line of weakness, e.g. perforation enables the solid rod part (1) to be easily snapped off when the user wishes to sniff up the powder in the tube (5). In a further preferred option, the weakness e.g. perforation lies slightly over the hollowed tube (5), e.g. by about 1.0 mm, rather than exactly at the join of the rod (1) and the tube (5). This will ensure that in use the user will not be irritated by a torn paper edge in the nostril.

The perforation may be applied by either mechanical blades, or in a preferred embodiment the use of a laser. The laser may be of single or split beam, multiplex or pulsed, with either the rod held stationary, or in a preferred embodiment rotated a single revolution. The width of cut may be varied.

The laser is preferably set to cut at a depth greater than the thickness of the 80gsm paper as described above (0.2 to 0.3 mm) to penetrate the paper, deeper, if it needs to cut through both plug wrap and tipping paper, and will likely remove 25 - 75% of the paper circumference (ideally around 50%) to allow the finished product to be both presented to the user with the powdered protected, and providing ease of removal of the upper section to access the powder. Hole diameters as shown in Figure 6 can range from 40 microns to 100 microns and can be controlled by varying the pulse duration, e.g. from 20

microseconds to 75 microseconds High-frequency excited, fast modulating C0 ₂ lasers are especially suited for perforating paper or plastic foils. Laser drilling of cigarette paper is well known in the art.

After snapping off the rod (1), the open end of the hollow tube (5) is applied into the nostril of the user of the device. The user then sniffs the powder into the nasal cavity. Air can pass through the 'paper rod' or 'acetate rod' (2), enabling the user to draw air into the void (6) and the hollow of the tube (5) and thus allow substantially all of the pre-filled powder to pass into the nasal cavity from the void (6) and the hollow of the tube (5).

The device according to the present invention is a single use device. This is highly preferred since the device cannot be emptied and re-filled and used e.g. for the delivery of illegal substances.

The devices can be filled into packets or cartons for commercial sale, e.g. in quantities of from 1 to 8, 10, 12, 14 and so on. Bulk packaging in boxes of up to 50 or 100 units is envisaged as required. The packaging may be specifically designed for ease of use, with devices separated by dividers in clearly defined compartments, to enable ease of removal, without breaking the perforation (9). The compartments further provide a responsible place to store used devices for considerate disposal, and eventually recycling. The devices can also be packaged singularly.

In the packs, the devices are preferably stored with the void in the downwards orientation, i.e. with the rod section (2) at the floor of the packet. The void assists to ensure that the powder does not become so dense during storage that it cannot be drawn up by the user into the nasal cavity. A looser fill is achieved by the preferred provision of the void.

The specific materials used in the composition of the device, are generally hygroscopic. Hygroscopy is the ability of a substance to attract and hold water molecules from their surroundings. In addition the product packaging, helps prevent the powder from absorbing additional moisture that might make it 'clumpy' and difficult to lift from the device during inhalation.

The preferred powder for use in the devices of the present invention is ground tobacco, or snuff. However, other powders can be envisaged for use in the device according to the present invention, including powdered tobacco in combination with other carrier materials such as dextrose, stimulants such as taurine and caffeine, powdered herbs such as rosemary, and air dried or lyophilised powdered alcohol. It is also envisaged that the device could be used for the delivery of pharmaceutical agents, with the powders being provided in a form such that they can pass through the nasal cavity into the lungs, e.g. pharmaceuticals for inhalation to improve lung function or the treatment of bronchospasm, such as salbutamol. FURTHER EMBODIMENTS

Those of skill in the art will appreciate that embodiments not expressly illustrated herein may be practiced within the scope of the invention, including that features described herein for different embodiments may be combined with each other and/or with currently-known or future-developed technologies. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting. Furthermore, the advantages described above are not necessarily the only advantages of the invention, and it is not necessarily expected that all of the described advantages will be achieved with every embodiment.