WO1994013309A1

WO1994013309A1 - Topical composition containing garlic oil

Info

Publication number: WO1994013309A1
Application number: PCT/GB1993/002570
Authority: WO
Inventors: Peter David Dryden
Original assignee: GREEN CIRCLE ADMINISTRATION Co Ltd
Current assignee: GREEN CIRCLE ADMINISTRATION Co Ltd
Priority date: 1992-12-17
Filing date: 1993-12-16
Publication date: 1994-06-23
Anticipated expiration: 1995-06-17
Also published as: EP0674523A1; AU5705694A

Abstract

The invention provides a topical composition particularly for ungulate use comprising a pharmaceutically acceptable carrier and a healing agent particularly garlic oil. The invention also provides such a topical composition with a pharmaceutical acceptable thickener characterised in that the thickener and carrier confer on the composition in situ a viscosity in the range of NLGI 2 at the body heat of the intended animal recipient. The composition is particularly useful for treating skin conditions of agricultural animals.

Description

TOPICAL COMPOSITION CONTAINING GARLIC OIL

The present invention relates to medicinal and veterinary compositions and particularly to compositions for such use.

In a specific aspect of the invention there is provided a topically applied composition for the treatment of lesions such as sores on hairy and smooth skinned mammals and to a method of treating the same.

All mammals are susceptible to skin lesions or sores caused by genetic predisposition, injury, or living conditions etc. Particularly in the case of hairy mammals such as horses, dogs, sheep etc. these sores can be distressing to the animal because they can be positioned where the animal cannot see or reach the sore to treat the same by licking etc. For this reason animals tend to rub the area around the sore on branches, doorways etc. thereby making the same raw and removing fur. At appropriate times of the year, for example in early summer, insects then settle on the raw patches and further irritate, and sometimes lay their eggs in, the raw area. This much exacerbates the problem which can then require significant veterinary attention before healing. Such conditions are, for example, scab of the sheep, eczema of the dog, and sweet itch of the horse.

Although the specification subsequently deals extensively with sweet itch of the horse and scab in the sheep, it should be understood that the invention can be applied to all forms of similar complaints since the topically applied system of the present invention is applicable broadly.

Previous treatments, for example for sweet itch of the horse, involve applying thereto a systemic insecticide, such as benzyl benzoate, and Lindane, in a suitable

pharmaceutical carrier. However, these insecticides tend to reduce the immune responses of the horse or other mammal at the very time when it is under challenge. Accordingly, it is quite usual for the horse concerned to develop an allergy to such insecticide. Even when this does not occur the effectiveness of these topically applied insecticides is not particularly good. A further problem is that they can be difficult for an ordinary person to use safely.

In a further aspect the invention relates to a

pharmaceutical composition particularly to a veterinary composition for topical administration to reduce the numbers of, or even exterminate, ectoparasites significant from an animal health point of view.

It has particularly relevance to hairy mammals i.e. those with a woolly or furry coat in which mites or other

ectoparasites can breed, but is also used in human medicine for treatment of ectoparasites of the body such as head and body lice. Until recently it was compulsory, for example, to dip sheep on an annual basis to try to eliminate sheep scab, a decease caused by a mite, tsoroptes ovis which lives in the pelt of the sheep and causes lesions in the skin and a loss of fleece. The mite lays its eggs in the skin thereby causing further irritation to the animal and this results in a loss of condition of the animal and can, in extreme cases, result indirectly in the animal's death. Since such a disease is readily transmissible, entire flocks can be rendered uneconomic unless control measures are taken. The disease is particularly prevalent on sites which are regularly grazed by sheep. Similar problems also occur in the cow although other causative organisms tend to be a problem, e.g. warble fly.

Other ectoparasites of the horse or dog, for example the flea, can also be treated by compositions in accordance with the present invention. Further head and body lice of the human can be suitably treated.

The invention is therefore applicable for the treatment of all human and animal ectoparasites when the body has a hairy, furry or woolly coat in which the ectoparasite can breed unseen.

The traditional way of treatment for such parasites is the application of an organic pesticide in a suitable carrier- This can cause adverse reactions. Sheep, for example, are traditionally treated for scab witli organo-phosphorous dips (OP's). These are effective in the treatment of sheep scab and other ectoparasitic diseases of the sheep, but over the years have given rise to the following drawbacks:-

1. In most flocks the number of sheep with scab is relatively low, but in order to alleviate the symptoms in the sheep with a significant infestation all must be dipped, and hence all the sheep must be gathered and treated at least once a year whether carrying the sheep scab mite or not.

2. OP's give rise to "sheep dippers' flu" which

debilitates the shepherd for up to three weeks. This condition is grossly under-reported; only 10% of shepherds reporting to their doctors, since the symptoms are well known, and the doctors can only prescribe rest. (N.F.U. and Women's Farmers Union). Lately more ominous side-effects have been reported such that the banning of OP's appears increasingly likely.

3. Since sheep-dogs can act as transmitters of the mite, many shepherds also "dip" the dog. This often causes the death or debilitation of the dog since the dog in common with other animals licks its fur as part of its grooming process and hence ingest OP's.

The invention therefore seeks to provide a topically

applied composition for healing lesions and/or killing ectoparasites without significant immunological challenge by use of a topical healing composition which may also be adapted to repel insects and/or to cause their demise by physical means. Most preferably the components of such a topical

composition should be food grade or should be based on materials which are non toxic to humans or which have already been approved and tried for topical administration for other purposes.

A further object of the invention is to seek to provide a topically applied composition which kills ectoparasites, their larvae and preferably their eggs in situ on the human or animal body and which is also safe for incidental contact with the human skin.

The invention lias as a further preferred object the

provision of a composition which can be sprayed onto the back of the animal and which spreads progressively over the animal body to effect healing of lesions on the human or animal body while killing the ectoparasites without

adversely affecting the animal.

The invention has as another object the provision of a treatment for sheep scab which alleviates the effects of tsoroptes ovis, does not require dipping of the sheep, is safe to use on the animal or animals concerned, is safe against incidental human contact, and which has a residual healing effect on the sheep while destroying at least some of the eggs of tsoroptes ovis.

According to a first aspect of the invention, therefore, there is provided a pharmaceutical composition for topical administration to a human or animal body for the treatment of lesions which comprises garlic oil as a healing agent and a pharmaceutically acceptable carrier or diluent therefor.

According to a second aspect of the invention there is provided a pharmaceutical composition for topical

administration to a human or animal body for the treatment of lesions which comprises :- a pharmaceutically acceptable carrier,

a healing agent, and

a pharmaceutically acceptable thickener;

characterised in that thickener and the carrier confer on the composition an in situ viscosity in the

range of NLG1 2 at the body heat of the intended animal recipient.

According to a third aspect of the invention there is provided a pharmaceutical composition for the topical admininstation to the human or animal body for the

treatment of ectoparasites on the skin of said human or animal which composition comprises a highly refined or synthetic paraffin. α hydrocarbon said composition being non-toxic to humans or animals and toxic to the active parasite. In a preferred form of the invention there is provided a two part topical composition comprising:-

A a pharmaceutically acceptable carrier;

a healing agent, and

a pharmaceutically acceptable thickener,

and

B a pharmaceutically acceptable carrier;

a healing agent,

a pharmaceutically acceptable thickener, and

a low friction additive.

Both composition A and B may include a conditioner if desired.

In a preferred form of this invention, the part B of the topical composition may be provided with a non-toxic, and preferably food grade, insect repellent. In use the composition A may be used for two to five days, depending upon the severity of the symptoms, by topically applying the composition A to the affected part. After that period, when healing is well established, control composition B should be utilised every two or three days to maintain the healing process and to act as a deterrent to further Infection from airborne infection. In a further aspect of the present invention there is provided a topical composition comprising:

a pharmaceutically acceptable carrier,

a healing agent,

a pharmaceutically acceptable thickener, and optionally a soothing agent and\or conditioner;

characterised in that the thickener and the carrier confer on the composition in situ a viscosity in the range NGLI 2 at the body heat of the intended recipient, and in that th composition further comprises a low friction additive. NLGI denotes the scale of viscosity values of the National

Grease and Lubr i cant I ns t i tute .

In a still further aspect of the present invention there is provided a topical composition comprising;

a pharmaceutically acceptable carrier,

a healing agent,

a pharmaceutically acceptable thickener, and optionally a soothing agent and/or conditioner,

characterised in that the thickener and the carrier confer on the composition in situ a viscosity in the range NGLI 2 at the body heat, of the intended recipient,

and in that the composition comprises an additional carrier vaporizable above ambient temperature and below 40° C, said additional carrier being adapted to flash off on contact with the living animal body. It will be appreciated that by utilisation of such a vaporizable carrier which may, for example, be lsobar-Il (Isobar-Il is a Registered Trade Mark), the viscosity of the composition as applied will be

artificially reduced and hence the composition will tend to run down the hairs onto the flesh of the animal under treatment whereupon the vaporizable carrier flashes off to leave the composition in situ. This assists in applying the composition satisfactorily where hair growth is heavy.

Although the precise function of the low friction additive usually disposed in control composition B of the topical composition is not fully understood, it is believed that the addition of the low friction additive allows the composition, at body heat, to enter the proboscis of biting insects. As the biting insects withdraw from the animal, the temperature within the proboscis falls rapidly,

whereupon the low friction qualities of the composition are insufficient to allow the insect to clear its proboscis thereby leaving it blocked and causing its demise. This is particularly so since insects are, of course, cold blooded.

It is also the case that the addition of a low friction additive, such as polytetrafluoroethylene (PTFE), causes a significant degree of reflection from the composition thereby protecting any raw patch on the animal from sunburn in summer. In a specific embodiment of the present invention there is provided a topical composition comprising by weight:

75-90% of a pharmaceutically acceptable carrier,

3-8%, and preferably 4-5%, of a healing agent,

5-15%, and preferably 7-11% of a pharmaceutical ly

acceptable thickener, and optionally

0.1-1-0% conditioner: the components to add to 100%, and being so arranged as to have a viscosity at body heat of the intended recipient in the range of NGLI 2.

Preferably in such an arrangement, said topical composition may be divided into two base portions A and B, said control portion B being additionally provided with a low friction additive.

In a particularly preferred form of the invention the pharmaceutically acceptable carrier is white oil med

(liquid paraffin); the healing agent is zinc oxide, the thickening agent is microfined reciprocated silica, and the conditioner where used is selected from citronella,

lavender or myrrh, which last is also a soothing agent.

As stated above the invention embraces a topically

applicable pharmaceutical composition particularly for the treatment of sheep scab but also for the treatment of ectoparasites in general on the human or animal body. The composition utilises a defined paraffinic hydrocarbon. Preferably the paraffinic hydrocarbon is in its

isoparaffinic form.

The composition may also act as a carrier or solvent for a healing composition for the treatment of lesions of the skin of the animal concerned. The healing composition should also be safe if internally ingested by an animal in small amounts. The healing composition for treatment of the lesions of the skin may be a herbally based composition . In a particularly preferred form of the invention the synthetic isoparaffinic hydrocarbon is produced by

synthesis from petroleum gases to provide a mixture of liquid hydrocarbons having a boiling point of 93-26ºC. In a further aspect of the. invention there is provided a method for the treatment of an ectoparasite on the human or animal body which comprises applying to the body a

composition comprising a highly refined or synthetic paraffinic hydrocarbon, allowing said hydrocarbon to spread naturally over the skin of the body, said composition being non-toxic, non-irritant and non-dermally sensitizing to the skin, and leaving said composition in situ on the animal to destroy ectoparasites, their larvae and eggs until removed or neutralized by natural processes.

PreferabJy the animal if an agricul turally signi ficant ungulate or domestic pet. In a particularly preferred form of the invention the hydrocarbon is synthetic isoparaffinic hydrocarbon having a BP if 93-23ºC, a U.V. absorbence of; 260-319 mu- 1.5 max, 320-329 mu-0.08 max, 330-350 mu-0.05 max and a non-volatile residuum of 0.002 gm 100 ml max. The invention will now be described by way of illustration only with reference to the following example:-

Example 1

Two topical compositions were made up as follows:-

Healer Composition A:

White oil med 86.5% by weight

Garlic oil 0.043%

Zinc oxide 1.1 kilos 4.32%

Aerosil (reciprocated silica)

(Registered Trade Mark)

8.06%

Myrrh 0.25%

Calamine 0.25%

Control Composition B;

White oil med 83.47% by weight

Garlic oil 0.05%

Zinc oxide 4.21%

Aerosil (reciprocated silica) 9.86%

Citronella 0.246%

Lavender 0.246%

Polytetraf luoroethylene (PTFE) 1.90% To use the two topical, compositions A and B, the healer composition A is applied daily for two or three days fully covering the raw areas. Subsequently the control

composition B is applied when the healing properties of the composition A are fully established and should be continued either every other day or every third day for as long as necessary. The control composition B should also be applied to similar areas likely to be attacked by a biking insect, such as a collodion midge.

The following tests were conducted under veterinary

supervision.

The two topical, compositions A and B as described in

Example 1 above were applied below as follows:

Example 2

Clinical trial using Sweet Itch Healer (A) and Sweet Itch Control (B)

Subjects: 1) 9 year old Suffolk Gelding "Charlie"

2) 14 year old Shire mare "Domino" - (Paired control)

First examination: 29th April 1992

Both these horses have had a long history of sweet itch over several, years; they have adjacent stabling, or are left in an open barn, and are grazed in the same fields. 1) Charlie had extensive crusty lesions along the whole mane and tail base extending over both quarters. Intense irritation had caused loss of hairs in mane and tail, with many damaged and broken hairs present. Inflammation and exudative lesions present, especially over tail head and quarters, some sore areas on abdomen and under chest.

Treatment with the Healer composition A was commenced as recommended.

2) Domino was not badly affected at this examination, with only slight crusty lesions in mane and tail head, without much irritation, and therefore only slight hair damage. There was evidence of previous damage to abdomen. No treatment was given.

Second examination 1st May 1992

1) Charlie - all exudative lesions were less inflamed and had begun to heal. Less irritation reported, no new areas developed, Healer A and Control B now used.

2) Domino - about the same as on 29th April.

Third examinatio n 7thMay 1992

1) Charlie - lesions still improving, also this horse had improved in temperament and was easier to handle and examine. 2) Domino - lesions on mane and tail head worsened, and were more irritation. Also the abdominal lesions had flared up, with slight oxidation. Fourth examination 14th May 1992

1) Charlie - two new smalI inflamed patches appeared, one on tail head and one on left quarter (half inch diameter). Otherwise generally improved still further, especially under abdomen and under chest - in fact ventral lesions had all cleared up except for two small half inch lesions on sheath only. Temperament had markedly improved - farrier reported that horse was much easier to work on than

previously, when severe lesions present. The impression was of a slight regrowth of downy hair on quarters. Healer composition A treatment continued to remaining lesions and Control B to other parts of mane, tail head and quarters. 2) Domino - now developing open sores on tail head,

slightly in mane and mid-line abdominal areas up to the udder - beginning to resent examination. Treatment started with Dermisol cream on the open lesions and Benzyl Benzoate to rest of mane and tail head.

Fifth examination 21th May 1992

1) Charlie - marked improvement in mane and tail areas - skin now visible with crustiness gone, lateral splits in skin or crest healed, definite regrowth of hair over quarters, chest and abdomen have three or four small half inch areas still bare, but healed over. Continued use of Control B composition.

2) Domino - raw areas on chest had healed by use of

Dermisol, but areas affected had spread laterally. Still very irritant with mane and tail head very crusty with many broken and loose hairs coining away on handling. Continued treatment witli Dermisol and Benzyl Benzoate. Sixth examination 28th May 1992

1) Charlie - still further improvement with good regrowth of hair, apart from several small chronic patches which may never regrow due to severe hair follicle damage from previous years. Temperament still very good. Control continued.

2) Domino - a marked deterioration in spite of treatment with Dermisol and Benzyl Benzoate for two weeks. Mane and tail not too bad, but new areas developed on the left side of face and along the orbital ridge inside left hind leg, inside both thighs and the mammary glands and along ventral chest. All these areas showed extreme irritation. Also temperament was deteriorating. On humane grounds Dermisol and Benzyl Benzoate treatment discontinued, and Domino treated with Healer composition A. Seventh examination 3rd June 1992

1) Charlie - fairly static situation, no new lesions developed. 2) Domino - improvement seen to lesions on face, and to those on the ventrum, including the mammary glands. The lesions on the tail head, mane and those on the inside of the hind leg were not much changed. Eighth examination 10th June 1992

1) Charlie - same as previous week except a slight

irritation on lower chest - Healer composition A applied to this area.

2) Domino - a very marked improvement. Tail head, face, ventral lesions all cleared up - many lesions virtually invisible. Temperament greatly improved - back to normal.

Example 3

6th May 1992

Two horses examined pre-trial were kept at the same stables which had paddocks closely adjacent to heavily wooded downland.

Subjects:

1) 7 yr bay old part Cleveland Bay gelding Peregrine

Affected along whole of crest with palpable nodules and inflamed areas but no exudative lesions. Intense tail head irritation with raw area partially concealed by matted hair. Considerable damage to stable door frame from rubbing.

2) 11 yr skewbald part shire gelding Theo Affected mainly on tail head with some lesions on crest. Lesions on belly reported but had cleared by the time the trial started. Both horses had hogged manes and were treated with "Hilton Cooler" (herbal sweet itch mixture) in feed twice daily from February to end of April 1992. Both deteriorated whe medication stopped. Theo was put back on it after two weeks and was still receiving it. Peregrine had none since end of April. Both horses stabled 23 hours daily.

20th May 1992: Trial commenced with application of Healer composition A to Peregrine's neck and tail head. Seemed to need more gel than expected to get adequate cover.

21st May 1992: Second application of Healer composition A by owner. Much less gel required. Owner commented that it had made reins extremely slippery!

22nd May 1992: Third application of Healer composition A. Crest improved but tail head still very itchy with strong 'nibbling' response to manual scratching.

23rd - 25th May 1992: Initial applications of Control composition B. Both horses out at night from 24th May onwards.

26th May 1992: Fourth application of Control composition B. Crest greatly improved with virtual disappearance of nodular areas. Difficulty in getting proper penetration of gel through matter hair of tail head solved by clipping short. Can now see healing of previously exudative lesions. Less marked response to manual scratching.

29th May 1992: Peregrine now on Control composition B every third day and much improved following clipping of the tail head. Crest now virtually free of lesions and no "nibble" reflex on stimulation of tail head. Theo worse, with considerable pruritis of tail head and hypersensitive nodular lesions just behind the poll.

3rd June 1992: Peregrine had started scratching tail head again so Control composition B applications were increased to alternate days. No sign of new lesions but some areas of sloughing, possibly associated with hair regrowth after clipping. Crest still free of lesions. Theo much the same but has been kept in 24 hours a day due to lameness.

19th June 1992: Peregrine is looking very good and the owner was sufficiently impressed to ask if she could now start using compositions A and B on Theo as well.

Examples 2 and 3 show that in controlled trials the topical compositions in accordance with the present invention cure heal and control sweet itch if correctly used.

Example 4 Clinical Trial on the dog

A Pekinese bitch which suffered from an apparent drug- resistant alopecia was treated with Healer A over a number of days. A reduction in the alopecia was noted and new hair started to grow. Similar results were found when Healer composition A was applied to sheep suffering from scab.

Example 5

A synthetic isoparaff inic hydrocarbon (SIll) having the following compostion was utilized as the active component in a topical composition for the treatment of sheep scab.

SIH typical values

Distillation range

IBP (initial boiling point) oC 85 to 273 ASTM D86/ASTM D1078

50% (initial boiling point) oC 88 to 289 ASTM D86/ASTM D1078

DP/FBP OC 95 to 310 ASTM D86/ASIM D1078

(dry point/final Boiling point)

Flash point oC <0 to 137 ASTM D93/ASIM D56

Evapoiation late (n-BuAc— 100) 840 to < 1 Exxon Chemical

Density at 15 oC kg/dm ³ p.693 to 0.8191 ASIM D4052

KB value- 29 to 23 ASIM D1133

Aniline point oC71 to 96 ASTM D611

Aromatic content ppm 10 to 700 UV

Bromine index ing/100g I0 to 400 ASTM 1)2710

Viscosity at 25 oC mPa.s. 0.39 to 11.9 ASTM D445

Surface tension mN/n 19.3 to 76.5 du Nouy ring

Colour (saybolt) 130 ASTM D156

Refractive index at 20 oC 1.389 to 1.451 ASTM D1218

Solubility parameter(cal) 0.5/(CM)1.57.2 to 7.4 Calculated

Vapour pressure at 38 oC kPa 19 to <0.1 Calculated

Auto-ignition temperature oC 230 to 350 Din 51794 Pur ity

Acids ppm none AS T M D 16 1 3

Chlor ides ppm 1 to 7 Exxon Chemicals

Nitrogen ppm 1 Exxon Chemicals

Peroxides ppm < 1 Exxon Chemicals

Sulphur ppm 3 to 1 AS T M D 3 120

Inter facial tension with water mN/M 35.5 to 5 1 du Nouy r ing

Freezing point oC < -40 to 4 AS T M D2386

Such SIH fluids are not dei mal sensitizers and do not requir e classi fication as flammable or labelling for toxicity or in itancy .

Example 6

An SIH fluid as previously described was poured or sprayed onto the back of each of a flock of sheep in an amount of about half a litre per sheep. The spraying or pouring was carefully effected such that each portion of the sheep received an appropriate percentage of the active

ingredient, which in practice meant paying particular attention to the foreguarters and hindquarters;

particularly about the tail.

The act of pouring the SIH onto the back of the animal allows the liquid to flow harmlessly over the skin of the animal and at half a litre per sheep it was found that after a short period, drips of Sill were found dripping from the underside of the sheep indicating that the composition had flowed from a line at the centre of the back through the fleece, and over the underside of the sheep in an excess. It was found that the mite tsoroptes ovis, when coming into contact with SIH, dies within 24 hours. The sheep were found to be in good condition after treatment, were not distressed, and ate normally.

In severe cases of scab it was necessary to repeat the treatment. This is because tsoroptes ovis causes lesions in the skin by laying eggs in the skin. This causes increased irritation in the skin of the animal as well as causing the fleece to detach. Eggs laid in the skin with a minimal lesion may escape destruction by SIH in some climatic conditions, for example heavy rain, often experienced in upper pastures. It is for this reason that after a

predetermined period the treatment should be repeated in cases of severe infestation.

Example 7

The following formulations were formed for the treatment of sheep scab in the sheep and ectoparasitic infestations of the dog, for example by the dog flea.

No. 1 SH/S/Fluid

a. SIH fluid 62g

b. IFC liquid gel 400g Selective Services Product

c. Calendula 30g

d. Chamomile 30g No. 2 SH/CFluid

a. SIH Fluid 135g

b. Oil of Garlic 12g

c. Oil of Calendula 6g

d. Oil of Chamomile 5g

No. 3 SH/S/Fluid

a. SIH fluid 400g

b. Oil of Garlic 20g

c. Oil of Calendula 60g

d. Oil of Chamomile 40g

NO. 4SH/S/Gel*

a. White oil med 86.5% wt

b. Garlic oil 0.043% wt

c. Zinc oxide 1.1 kg 4.32% d. Aerosol reciprocated silica) 8.06% wt

e. Myrrh 0.25% wt

f) Calamine 0.25% wt

* Sold under trade name Sweet Itch Healer in a 200g pump action container.

Each of the formulations 1,2,3 and 4 were applied to the backs of the sheep. The incorporation of herbal oils of calendula and chamomile and garlic in the amounts suggested assist with the penetration of the lesions colonised by the mite and garlic oil particularly heals the affected areas of the skin while acting as repellents to control many other types of ectoparasites found on the sheep.

From the foregoing Fxamples it can be seen that the

compositions in accordance with the present invention treat ectoparasites, and particularly sheep scab, effectively. SIH is classed as a composition which is safe for

incidental contact by the human hand, is non-toxic and does not cause dermatitis to the sheep, human or other animal such as the dog and neither does it irritate the skin.

Claims

1. A pharmaceutical composition for topical administration to the human or animal body for the treatment of lesions which comprises garlic oil as a wound healing agent, and

pharmaceutically acceptable carrier of diluent therefor.

2. A composition according to Claim 1 wherein the

composition further comprises a pharmaceutically acceptable thickener which together with the pharmaceutically

acceptable carrier forms a system which is adapted to confer on the composition in situ on the body under

treatment a viscosity in the range of NGLI 2 at the body heat of the intended recipient and wherein the carrier comprises at least one carrier component vaporisable above ambient temperature and below 40°C, said carrier component being adapted to flash off on contact with the body under treatment.

3. A pharmaceutical composition for topical administration to the human or animal body for the treatment of lesions which comprises a pharmaceutically acceptable carrier, a healing agent and a pharmaceutically acceptable thickener; characterised in that the thickener and the carrier confer on the composition and in situ viscosity in the range of NGLI 2 at the body heat of the intended recipient.

4. A pharmaceutical composition according to Claim 3 comprising an additional carrier vaporisable above ambient temperature and below 40°C, said additional carrier being adapted to flash off on contact with the body of a

recipient.

5. A pharmaceutical composition according to any preceding claim comprising a low friction additive.

6. A pharmaceutical composition according to any preceding claim wherein the totality of the components of the composition are non-toxic or food-grade.

7. A pharmaceutical composition according to any of Claims 2 to 6 comprising by weight:

75-90% of a pharmaceutically acceptable carrier,

3-8% of a healing agent, and

5-15% of a pharmaceutically acceptable thickener.

8. A pharmaceutical composition according to Claim 7 divided into two base portions A and B, a control portion B being additionally provided with a low friction additive.

9. A pharmaceutical, composition according to either of Claims 7 or 8 wherein the pharmaceutically acceptable carrier is white oil med (liquid paraffin); the healing agent is zinc oxide, and the thickening agent is microfined reciprocated silica.

10. A pharmaceutical composition for topical administration to the human or animal body for the treatment of

ectoparasites on the skin of said human or animal, which composition comprises a highly refined synthetic paraffinic hydrocarbon, said composition being non-toxic to humans or animals and toxic to the ectoparasite.

11. A pharmaceutical composition according to Claim 10 wherein the paraffinic hydrocarbon is an isoparaffinic hydrocarbon.

12. A pharmaceutical composition according to either of Claims 11 or 12 wherein the composition also acts as a carrier for a healing composition for the treatment of lesions of the skin.

13. A pharmaceutical composition according to either of Claims 11 or 12 wherein the synthetic isoparaffinic

hydrocarbon is the product of synthesis of petroleum gases to provide a mixture of liquid hydrocarbons with a boiling point of 93-26ºC.

14. A method of the treatment of an ectoparasite on the human or animal body which comprises applying to said ectoparasite a composition comprising a highly refined or synthetic paraffinic hydrocarbon, allowing said hydrocarbon to spread naturally over the skin of said animal, said composition being non-toxic, non-irritant and non-dermally sensitizing to said animal, and leaving said composition in situ on the animal until removed or neutralized by natural processes.

15. A process according to Claim 7 wherein the animal is an agriculturally significant ungulate; or a domestic pet.