Smoking articles, (e.g. cigarettes and cigars) are made from tobacco. The administration of nicotine from tobacco by smoking provides satisfaction. Smoking is however associated with health hazards which are not necessarily related to the administration of nicotine itself. Important risk factors are substances which are formed or released during the combustion of tobacco, such as carcinogenic nitrosamines, carbon monoxide and tar products.
As smoking of tobacco has health hazards it is desirable to formulate alternative means of administering nicotine in a pleasurable manner to facilitate reduction of or cessation from smoking. Nicotine is a strongly addictive substance and it is generally accepted that the difficulty to quit smoking results from the fact that smokers are dependent upon nicotine. It is therefore desirable to be able to provide nicotine with a low amount of other potential hazardous components. Prior art has suggested, as an alternative to smoking, a number of different nicotine administration forms such as gum, patch, nasal spray, lozenge and oral pouch.
When smoking a cigarette, nicotine is almost immediately absorbed into the smoker's blood and quickly reaches the brain. The quick uptake gives the smoker rapid satisfaction. Therefore, in the treatment with nicotine-containing products a rapid uptake of nicotine is desirable. It is therefore desirable to provide a nicotine product which rapidly delivers nicotine to the user and thereby provides the user with the desired effect.
It is also desirable to provide a nicotine product which gives an almost complete delivery of the nicotine to the user to avoid unnecessary waste.
Nicotine base is readily oxidized and formulations containing nicotine base may have problem with the volatility of nicotine. A number of different formulations where the nicotine base has formed a combination with other components have been developed to deal with the stability and volatility problems of nicotine base. Nicotine base has for example been bound to, adsorbed to, absorbed into, enclosed into or forming a complex or any other non-covalent bounding with other components, such as starch, alginate salts, beta-cyclodextrin and cellulose.
WO 2010/104464 A1 describes a matrix of alginate salt which entraps a biological active substance, such as nicotine within the matrix. The nicotine, which can be provided as a nicotine salt, is dissolved in an aqueous solution together with the alginate salt and other components, such as buffer components. When the solution is dried, the nicotine will, together with other dissolved components, be entrapped within the alginate matrix. The matrix will provide a protection for the nicotine and may also be used to regulate the nicotine delivery from the matrix.
US 2005/0053665 A1 describes nicotine which is absorbed into or adsorbed to cellulose of non-seed origin. This cellulose provides a high internal and external surface. In this way a high concentration of liquid free nicotine base, or other liquid, semisolid or solid form of nicotine are transferred to chemically stable, solid products. In the products, nicotine prevails in a readily bioavailable and unionized base form.
WO 92/01445 describes an osmotic device consisting of a compartment, such as a solid mass or a tablet, which is enclosed into a wall which is permeable to an aqueous fluid. The compartment contains nicotine salt and other components which initiate a chemical reaction between the nicotine salt and the aqueous fluid to produce nicotine base. The wall is not permeable for the nicotine base but the nicotine base is delivered from the compartment through a passageway in the wall. The release of nicotine base from the product can continue for several hours.
A rapid nicotine release rate has normally not been the major concern for nicotine combinations and in many cases the approach has resulted in a rather moderate release rate of nicotine. Further, a nicotine combination or an osmotic device requires a rather intricate manufacturing method. It is therefore desirable to provide a nicotine formulation with a satisfactory chemical stability and low volatility of the nicotine component without compromising the demands for a rapid nicotine delivery and a simple manufacturing method.
“Snus” or snuff is a tobacco mixture from which the consumer forms a portion and places it under the upper lip. Alternatively, the tobacco mixture is already preportioned into pouches which are placed under the upper lip. The use of “snus” normally results in nicotine blood levels with a rather high steady state nicotine blood concentration, but they do not provide the peak levels obtained from smoking. The reason for this is that nicotine is released too slowly from the “snus” product.
Further, “snus” normally deliver only a fraction of the available nicotine to the user. After 30 minutes use, for a number of “snus” products, the delivery of nicotine is often less than 50%, for some products less than 25% of the available amount of nicotine.
A nicotine product similar to tobacco “snus” pouches, but with a purer source of nicotine than tobacco, and a faster and more complete release of nicotine could be an important aid in smoke reduction or cessation.
To summarize, it is desirable to provide an improved product for reduction of or cessation from smoking. A product similar to tobacco “snus” pouches, but without the disadvantages associated with tobacco “snus” pouches, could be an attractive option. The product should give a rapid and almost complete delivery of nicotine, be free from other harmful components, deal with the stability and volatility problems of nicotine base and finally be cheap and simple to manufacture.
USPTO Backgrounds
USPTO Backgrounds