GB2134781A

GB2134781A - Composition for the treatment of stasis leg ulcers

Info

Publication number: GB2134781A
Application number: GB08304150A
Authority: GB
Inventors: Martin Whitefield; Hyman Yarrow
Original assignee: Diomed Developments Ltd
Current assignee: Diomed Developments Ltd
Priority date: 1983-02-15
Filing date: 1983-02-15
Publication date: 1984-08-22
Also published as: GB8304150D0; GB2134781B

Abstract

Stasis leg ulcers are advantageously treated by topical application, with pressure bandaging, of a composition comprising a film- forming material such as methyl- cellulose, an acid such as lactic acid, an anti-bacterial agent such as Brilliant Green, and water.

Description

SPECIFICATION Composition for the treatment of stasis leg ulcers This invention relates to compositions useful in the treatment of stasis leg ulcers.

The most common form of chronic leg ulcers are stasis ulcers also known as varicose, venous gravitational or post-thrombotic ulcers. Such ulcers are associated with damage to the valves of the veins in the leg which cause the normal venous blood flow from the leg to be impaired.

Tissue anoxia results, and minor injury can then produce an ulcer which, because of the poor nutrition and anoxia of the tissue, is very slow to heal and may increase in size. Such ulcers are commonest in old people, and are aggravated by obesity and immobility. The standard treatment for such ulcers involves tight bandaging of the affected leg in order to improve the venous blood flow, and also elevation of the leg for prolonged periods to produce the same effect.

While such treatment is usually effective by itself, there is a need for immediate local treatment of stasis ulcers in order to minimise the risk of infection and promote the natural healing process.

The present invention provides a composition for topical application to stasis ulcers which promotes their healing to a remarkable extent.

The composition of the present invention comprises a water soluble non-toxic film forming material, a non-toxic water-soluble acid, a water soluble anti-bacterial agent, and water. Preferably the composition may contain a minor proportion of a secondary solvent such as alcohol and/or a dye to provide an immediate visual indication of where the composition has been applied.

Desirably also the composition should include a thickener to facilitate the easy application of a relatively large amount of the composition to the affected area.

When such a composition is applied to a stasis ulcer and the water and other solvent (if present) allowed to evaporate, a solid water-absorbent and antiseptic film is formed on the surface of the ulcer. This acts as a support for the subsequently applied pressure bandaging and maintains antiseptic conditions in the vicinity of the ulcer during healing. The cellular debris which may accumulate during healing of the ulcer adheres to the film and is easily removed when the dressing is changed. However, it is an important advantage of the new compositions that frequent changing is not required and the solid dried film may remain in place for as long as a week before changing becomes desirable.

The water soluble non-toxic acid is preferably lactic acid, but may be any physiologically acceptable a-hydroxy carboxylic acid providing the requisite low pH, preferably from 2.5 to 4.5, and non-irritant to the tissues. The water-soluble film-forming material preferably also acts as a thickener for the composition. It is preferably a water-soluble film-forming cellulose derivative such as methyl cellulose. The molecular weight of the material should be chosen so that a film of adequate strength is obtained.

The anti-bacterial agent is conveniently also the dye stuff. Brilliant Green, in particular as specified in the British Pharmacopea, has an appropriate colour and anti-bacterial activity and is preferred.

It is generally desirable to include in the new compositions a small proportion of a non-toxic water-miscible solvent in order to promote the dissolution of the various ingredients. Ethyl alcohol is preferred for this purpose, but it will be understood that too high a proportion of ethyl alcohol is likely to cause irritation to the tissues.

Preferred compositions in accordance with the present invention thus comprise 1 to 5 parts by weight of methyl cellulose, 0.1 to 1 part by weight of lactic acid, 0.1 to 5 parts by weight of Brilliant Green, 1 to 10 parts by weight of ethyl alcohol with the balance to 100 parts by weight being formed of purified water. The ethyl alcohol is conveniently added in the form of industrial methylated spirit which contains a minor proportion of water.

The following Example illustrates the present invention.

Example parts by weight Brilliant Green 0.5 Lactic Acid 0.5 Methyl Cellulose 3.0 (MW=1 0,00) Ethyl alcohol (as Industrial Methylated Spirit) 5.0 Purified Water to 100.0 The Brilliant Green, lactic acid and methyl cellulose are dissolved in the water in the presence of the ethyl alcohol. A semi-solid viscous green gel is obtained.

This gel may be applied to a stasis ulcer and then allowed to dry when it forms a solid film which takes the shape of the lesion, which may then be covered with a dry sterile dressing or pad and then bandaged in the usual way. The solid film absorbs exudation from the ulcer and remains as a support for the pressure bandaging. It has anti-bacterial properties which reduce or eliminate the risk of infection. The film may be left in place for up to a week, and when removed, it assists in the removal of cellular debris and cleaning of the ulcerated area. The healing process is thus substantially accelerated.

Claims

1. A composition for topical application to stasis ulcers comprising a water-soluble, nontoxic, film-forming material, a non-toxic, watersoluble acid, a water-soluble anti-bacterial agent, and water.

**WARNING** end of DESC field may overlap start of CLMS **.

Claims

**WARNING** start of CLMS field may overlap end of DESC **. SPECIFICATION Composition for the treatment of stasis leg ulcers This invention relates to compositions useful in the treatment of stasis leg ulcers. The most common form of chronic leg ulcers are stasis ulcers also known as varicose, venous gravitational or post-thrombotic ulcers. Such ulcers are associated with damage to the valves of the veins in the leg which cause the normal venous blood flow from the leg to be impaired. Tissue anoxia results, and minor injury can then produce an ulcer which, because of the poor nutrition and anoxia of the tissue, is very slow to heal and may increase in size. Such ulcers are commonest in old people, and are aggravated by obesity and immobility. The standard treatment for such ulcers involves tight bandaging of the affected leg in order to improve the venous blood flow, and also elevation of the leg for prolonged periods to produce the same effect. While such treatment is usually effective by itself, there is a need for immediate local treatment of stasis ulcers in order to minimise the risk of infection and promote the natural healing process. The present invention provides a composition for topical application to stasis ulcers which promotes their healing to a remarkable extent. The composition of the present invention comprises a water soluble non-toxic film forming material, a non-toxic water-soluble acid, a water soluble anti-bacterial agent, and water. Preferably the composition may contain a minor proportion of a secondary solvent such as alcohol and/or a dye to provide an immediate visual indication of where the composition has been applied. Desirably also the composition should include a thickener to facilitate the easy application of a relatively large amount of the composition to the affected area. When such a composition is applied to a stasis ulcer and the water and other solvent (if present) allowed to evaporate, a solid water-absorbent and antiseptic film is formed on the surface of the ulcer. This acts as a support for the subsequently applied pressure bandaging and maintains antiseptic conditions in the vicinity of the ulcer during healing. The cellular debris which may accumulate during healing of the ulcer adheres to the film and is easily removed when the dressing is changed. However, it is an important advantage of the new compositions that frequent changing is not required and the solid dried film may remain in place for as long as a week before changing becomes desirable. The water soluble non-toxic acid is preferably lactic acid, but may be any physiologically acceptable a-hydroxy carboxylic acid providing the requisite low pH, preferably from 2.5 to 4.5, and non-irritant to the tissues. The water-soluble film-forming material preferably also acts as a thickener for the composition. It is preferably a water-soluble film-forming cellulose derivative such as methyl cellulose. The molecular weight of the material should be chosen so that a film of adequate strength is obtained. The anti-bacterial agent is conveniently also the dye stuff. Brilliant Green, in particular as specified in the British Pharmacopea, has an appropriate colour and anti-bacterial activity and is preferred. It is generally desirable to include in the new compositions a small proportion of a non-toxic water-miscible solvent in order to promote the dissolution of the various ingredients. Ethyl alcohol is preferred for this purpose, but it will be understood that too high a proportion of ethyl alcohol is likely to cause irritation to the tissues. Preferred compositions in accordance with the present invention thus comprise 1 to 5 parts by weight of methyl cellulose, 0.1 to 1 part by weight of lactic acid, 0.1 to 5 parts by weight of Brilliant Green, 1 to 10 parts by weight of ethyl alcohol with the balance to 100 parts by weight being formed of purified water. The ethyl alcohol is conveniently added in the form of industrial methylated spirit which contains a minor proportion of water. The following Example illustrates the present invention. Example parts by weight Brilliant Green 0.5 Lactic Acid 0.5 Methyl Cellulose 3.0 (MW=1 0,00) Ethyl alcohol (as Industrial Methylated Spirit) 5.0 Purified Water to 100.0 The Brilliant Green, lactic acid and methyl cellulose are dissolved in the water in the presence of the ethyl alcohol. A semi-solid viscous green gel is obtained. This gel may be applied to a stasis ulcer and then allowed to dry when it forms a solid film which takes the shape of the lesion, which may then be covered with a dry sterile dressing or pad and then bandaged in the usual way. The solid film absorbs exudation from the ulcer and remains as a support for the pressure bandaging. It has anti-bacterial properties which reduce or eliminate the risk of infection. The film may be left in place for up to a week, and when removed, it assists in the removal of cellular debris and cleaning of the ulcerated area. The healing process is thus substantially accelerated. Claims

2. A composition according to claim 1 in which the said acid is an a-hydroxy-carboxylic acid and the composition contains sufficient of the said acid to provide a pH of 2.5 to 4.5.

3. A composition according to claim 2 in which the said acid is lactic acid.

4. A composition according to any one of claims 1 to 3 in which the film-forming material is a cellulose derivative.

5. A composition according to claim 4 in which the film-forming material is methyl-cellulose.

6. A composition according to any one of claims 1 to 5 in which the anti-bacterial agent is also a dyestuff.

7. A composition according to claim 6 in which the anti-bacterial agent is Brilliant Green.

8. A composition according to any one of claims 1 to 7 which also contains alcohol as a secondary solvent.

9. A composition according to claim 1 comprising 1 to 5 parts by weight of methylcellulose, 0.1 to 1 part by weight of lactic acid, 0.1 to 5 parts by weight of Brilliant Green, 1 to 10 parts by weight of ethyl alcohol, and the balance to 100 parts by weight of purified water.

10. A composition according to claim 1 substantially as described in the Example.

11. A composition as claimed in any one of claims 1 to 10 for use in therapy in the treatment of stasis ulcers.