GB2227659A

GB2227659A - Nicotine-containing lozenge

Info

Publication number: GB2227659A
Application number: GB8927618A
Authority: GB
Inventors: Alec Stanley Walter Shaw
Original assignee: STOPPERS Co Ltd
Current assignee: STOPPERS Co Ltd
Priority date: 1988-12-06
Filing date: 1989-12-06
Publication date: 1990-08-08
Anticipated expiration: 2009-12-06
Also published as: GB8828468D0; GB8927618D0; GB2227659B

Abstract

A lozenge is formed by compression of at least two mixed components, one component comprising a filler, and the other component comprising a fat or an essential oil with nicotine dissolved therein, the solution being dispersed on a carrier. <IMAGE>

Description

NICOTINE-CONTAINING LOZENGE This invention concerns a nicotine containing lozenge.

Such lozenges are used by smokers either as a substitute for cigarettes or the like in no-smoking areas or as an aid in giving up the smoking habit. They may also be used by those seeking the physiological effects of nicotine but who dislike or are unwilling to accept the risks of smoking.

One known such lozenge incorporating lactose to counteract the unpleasant symptoms following the ingestion of nicotine is described in my co-pending British Patent Application No. 8714665. Another known such lozenge is described in my granted British Patent No. 2142822. In both these lozenges the nicotine is introduced into the mixture from which the lozenges are formed as a solution in alcohol.

Although these lozenges have been found to have a satisfactory shelf-life particularly in the more temperate climates, there is a tendency for the nicotine to be lost through evaporation, particularly when the ambient temperature is above 150C, thus reducing shelf-life in hot climates to possibly unaceptable levels.

It is an object of the present invention to provide a lozenge containing nicotine which overcomes the problem aforesaid.

According to the present invention there is provided a lozenge formed by compression of at least two mixed components, one of said components comprising a filler and the other of said components comprising a fat or an essential oil having nicotine or a nicotine derivative dissolved therein dispersed in a carrier.

The carrier may be a silica preparation or a micro-cellulose material.

The nicotine may be dissolved in vanilla oil.

The invention will be further apparent from the following description which concerns, by way of example, only a number of nicotine containing lozenges embodying same.

The lozenges are produced by compression of a mixture of at least two components using conventional tablet forming machinery.

The first component is prepared from a mixture of lactose or lactose containing substance and a suitable binder.

A typical formulation for the first component might comprise : Acacia Powder 1000 gms and Lactose 2900 gms together with desired flavouring and colouring agents, for example: Liquorice 1000 gms Cocoa 500 gms Aniseed Flavouring 37 gms Peppermint Flavouring 20 gms If desired, up to 10 kgms of Icing Sugar may be incorporated in the formulation.

The lactose may be replaced by skimmed milk powder, a whey or other milk product.

Any of these formulations may include other additives such as sodium bicarbonate, sodium carbonate or potassium hydroxide or aluminium hydroxide for example.

Water is added to the formulation which is then wet granulated and dried in preparation for addition to the second component.

The second component comprises an inert carrier in which nicotine oil or a nicotine derivative which has been dissolved in a fat or essential oil is dispersed.

One suitable carrier comprises a synthetic silica fomulation marketed under the trade name Syloid by W R Grace Limited of North Dale House, North Circular Road, London. This has an average particle size in the range of from 1.5 - 14 microns and can absorb between 75 and 320% of its own weight of oil.

Another suitable carrier is Avicel microcellulose manufactured by FMC Corporation, USA or a similar gum material.

Suitable essential oils in which the nicotine may be dissolved include peppermint, aniseed, eucalyptus and vanilla, though the latter is greatly preferred as it counters the bitter taste of nicotine most effectively.

The carrier and oil containing the dissolved nicotine and any other desired additives such as other oils for flavour are gently mixed to cause the oil to be fully absorbed.

The two components are then gently mixed together with a lubricant such as magnesium stearate and compressed into small lozenges.

Each lozenge having a weight of 70 - 500 mg will typically contain between 0.1 and 8 mg of nicotine preferably in the range of 0.5 - 2 mg and the carrier will generally represent some one per cent by weight of the completed lozenge.

The fat or essential oils in which the nicotine is dissolved will generally constitute from 0.2% to 3% of the weight of the completed lozenge though greater amounts of vanilla oil - up to as much as 25% may be acceptable.

Generally, the acacia will constitute between 5% and 30% by weight and preferably in the region of 13% by weight of the total dry weight of the finished lozenge.

It will be appreciated that it is not intended to limit the invention to the above example only, many variations, such as might readily occur to one skilled in the art, being possible without departing from the scope thereof as defined by the appended claims.

For example, the wet granulation and drying steps in the preparation of the first component may be eliminated if pre-granulated lactose is used.

Claims

l. A lozenge formed by compression of at least two mixed components, one of said components comprising a filler and the other of said components comprising a fat or an essential oil having nicotine or a nicotine derivative dissolved therein dispersed in a carrier.
2. A lozenge according to claim 1, wherein the carrier comprises a silicon preparation.
3. A lozenge according to claim 1, wherein the carrier comprises a micro-cellulose material.
4. A lozenge according to any one of claims 1 to 3, wherein the nicotine or nicotine derivative is dissolved in vanilla oil.
5. A lozenge according to any preceding claim, wherein said first component comprises a mixture of lactose or lactose containing substances and a binder.
6. A lozenge according to claim 5, wherein said binder comprises Acacia powder.
7. A lozenge according to any preceding claim, having a weight of 70-500 mg and containing from 0.1-8 mg of nicotine.
8. A lozenge according to claim 7, wherein the carrier comprises about 1% by weight of the lozenge.
9. A lozenge according to claim 7 or claim 8, wherein the fat or essential oil in which the nicotine is dissolved comprises from 0.2-38 of the weight of the lozenge.