GB2230439A - Nicotine lozenges - Google Patents

Abstract

A lozenge which is a substitute for smoking tobacco comprises a lozenge core which contains nicotine and/or a nicotine substitute, and a shell or coating around the lozenge core. The shell or coating may comprise an oral-acting, local analgesic, for example eugenol. Such lozenges are more palatable than known anti-smoking lozenges, and are more stable against humidity and loss of the nicotine or nicotine substitute.

Description

NICOTINE LOZENGES This invention concerns nicotine or nicotinesubstitute lozenges, and more particularly a nicotine or nicotine-substitute containing lozenge which can be dissolved in the mouth to satisfy a craving for tobacco, either as an aid in stopping the habit of smoking or as a substitute for cigarettes or other smokable tobacco products in areas where smoking is dangerous or prohibited.

According to the present invention there is provided a lozenge which contains nicotine or a nicotinesubstitute, the lozenge comprising a lozenge core which contains nicotine and/or a nicotine substitute, and a shell or coating around the lozenge core.

Conventional methods may be employed to provide a shell or coating, which may suitably be a sugar or sugar-substitute shell or coating, around the lozenge core. One suitable method is pan-coating whereby the lozenge cores are introduced into a rotating pan, and are sprayed with an initial, sealant layer, which may comprise, for example, shellac or glycerine, then removed and dried, then returned to the pan for coating with a syrup, prior to final drying and polishing. Another available method, known as dry coating by compression, involves the pressing together of pre-formed shell halves around the lozenge core.

The shell or coating may contain any desired flavouring agent.

The shell or coating may comprise an oral-acting, local analgesic. A herbal analgesic, for example eugenol (oil of cloves), is preferred.

Lozenges in accordance with the invention are more palatable than known anti-smoking lozenges because of the shell or coating, the flavouring thereof being untainted by the flavour of nicotine or a nicotinesubstitute. This effect is very marked initially and persists to a useful extent once the shell or coating has dissolved, due to the residual flavour in the mouth from the shell or coating. The sensation of burning in the mouth which may be experienced with conventional lozenges is substantially ameliorated with lozenges in accordance with the invention. Moreover, lozenges in accordance with the invention are more stable against humidity and escape of nicotine or nicotine-substitute than known lozenges, and will have a longer shelf-life.

The lozenge core may be of a conventional composition, as used for known, uncoated lozenges. A preferred composition is as claimed and described in U.K. Patent No. 2142822 and U.S. Patent No. 4806356, the contents of which are incorporated herein by reference.

In accordance with a second aspect of the present invention there is provided a process for the preparation of lozenges as described.

The invention will now be further described, by way of example, only, with reference to the following: A lozenge core is made up in accordance with the detailed description in U.S. Patent No. 4806356. Thus, a sweetened filler is made up; a binder is made up; and a solution of nicotine in alcohol is prepared, as a tobacco plant extraction. The three components are mixed to give, without the application of heat, a preparation which is then formed into tablets which will form the lozenge cores.

A large number of lozenge cores is conveyed to a coating pan which is rotated and agitated whilst a glycerine spray is applied. The lozenge cores are removed and dried, then returned to the coating pan, for application of a sugar syrup, containing, in this case, an orange colouring agent. The lozenges are dried and finally polished.

In another embodiment the sugar syrup incorporates eugenol, to act as an oral local analgesic.

The resultant lozenges dissolve slowly in the mouth releasing the nicotine contained in the lozenge cores gradually for absorbtion within the buccal cavity.

The reader's attention is directed to all papers and documents which are filed concurrently with this specification, and which are open to public inspection with this specification and the contents of all such papers and documents are incorporated herein by reference.

All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in the specification (including any accompanying claims, abstract and drawings), may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims (4)

1. A lozenge comprising a lozenge core which contains nicotine and/or a nicotine substitute, and a shell or coating around the lozenge core.

2. A lozenge as claimed in Claim 1, wherein the shell or coating comprises an oral-acting, local analgesic.

3. A lozenge as claimed in Claim 2, wherein the shell or coating comprises eugenol.

4. A lozenge substantially as hereinbefore described with reference to the Example.