NICOTINE CONTAINING LOZENGE

Abstract: There is disclosed a lozenge formed by compression of at least two mixed components, one of said components including lactose or a lactose containing substance and the other of said components comprising a carrier having nicotine or a nicotine derivative absorbed therein such that there is no direct contact between the nictone and the lactose whilst together in the lozenge.

Description: 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. One problem with such lozenges is the nausea and discomfort that can follow the ingestion of nicotine or nicotine containing substances. It is well known that lactose is an effective antidote to nicotine poisoning and the unpleasant symptoms aforesaid. EP-A-0 135 264 describes the preparation of a nicotine containing lozenge prepared by a method which comprises the steps of thoroughly mixing together an inert filler, a binder and either pure nicotine or a nicotine-containing substance and forming measured doses of the mixture into tablets by a process not involving the application of heat. Hitherto it has not, however, been possible to incorporate lactose or a lactose containing substance into a nicotine containing lozenge since contact between the nicotine and the lactose has caused a reaction destroying the effect of the nicotine. It is an object of the present invention to provide a lozenge containing both nicotine and lactose and 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 including lactose or a lactose containing substance and the other of said components comprising a carrier having nicotine or a nicotine derivative absorbed therein such that there is no direct contact between the nicotine and the lactose whilst together in the lozenge. The component including lactose or a lactose containing substance may be granulated and dried. 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 g and Lactose 2900 g together with desired flavouring and colouring agents, for example:- Liquorice 1000 g Cocoa 500 g Aniseed Flavouring 37 g Peppermint Flavouring 20 g If desired, up to 10 kg of Icing Sugar may be incorporated in the formulation. The lactose may be replaced by skimmed milk powder, a whey or other milk product. The acacia powder may be replaced by Avicel (Registered Trade Mark) micro-cellulose manufactured by FMC Corporation, USA or a similar gum material. 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 might conveniently be dissolved in alcohol is absorbed. One suitable carrier comprises a synthetic silica fomulation marketed under the trade name Syloid (Registered Trade Mark) 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 µm and can absorb between 75 and 320% of its own weight of oil. The carrier and nicotine oil 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. Generally, the acacia or Avicel 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. The wet granulation and drying steps in the preparation of the first component may be eliminated if pre-granulated lactose is used.

Claims: A lozenge formed by compression of at least two mixed components, one of said components including lactose or a lactose containing substance and the other of said components comprising a carrier having nicotine or a nicotine derivative absorbed therein such that there is no direct contact between the nicotine and the lactose whilst together in the lozenge. A lozenge according to claim l wherein said first component comprises lactose or a lactose containing substance and a binder. A lozenge according to claim 2 having between 5% and 30% by weight of said binder therein. A lozenge according to claim 2 wherein said binder comprises acacia powder. A lozenge according to any preceding claim wherein said first component includes one or more of the following ingredients: cocoa, liquorice, aniseed, peppermint, icing sugar. A lozenge according to any preceding claim wherein the first component is wet granulated and dried. A lozenge according to any preceding claim wherein the carrier of said second component comprises a synthetic silica formulation. A lozenge according to any preceding claim having between 0.1 and 8 mg of nicotine therein, each lozenge having a weight of 70-500 mg. A lozenge according to any preceding claim wherein a lubricant is added to the two components before compression thereof. A lozenge according to claim 9 wherein said lubricant comprises magnesium stearate.

Inventors: SHAW, ALEC STANLEY WALTER
Applicants: CHARWELL CONSUMER PRODUCTS LIMITED
Application year: 1987
Main classification: A23G3
IPC codes: A61K36, A23G3, A61K31, A61K9