IE47172B1 - Improved styptic composition - Google Patents

Abstract

A styptic composition is in the form of a stable lotion or cream comprising from 2% to 12% by weight of a long chain fatty acid; from 0.4% to 3.5% by weight of a wax filler; from 1% to 10% by weight of polyethylene glycol stearate; from 1% to 5% by weight polyethylene glycol sorbitan beeswax; and from 0.5% to 25% by weight of an acidic metallic salt, the balance being water.

Description

This invention relates to a novel styptic composition which quickly and effectively stanches the flow of blood from a wound without causing irritation to the skin.

The use of styptic or astringent compositions is well g established in the art. As originally formulated, the compositions were comprised of highly acidic salts of such metals as iron, zinv or aluminum that were employed as a powder or shaped in the form of a stick or pencil. Typical styptic compositions in stick form are set forth in the U.S. Patent Nos. 459,738, 497,659 and 819,901.

In use, the acidic salts effectively curtailed the bleeding in the injured area by causing the adjacent blood vessels to constrict. Unfortunately, the acidic nature of the salts also caused a stinging sensation which often exceeded the pain caused by the original wound. The use of these styptic compositions was therefore restricted to very minor wounds, such as those received in shaving. If the composition were to be applied a major wound, the pain accompanying the application might send the injured person into shock. Of course, less 2o acidic compositions, which caused less pain, could be utilized. However, such compositions have a markedly reduced effectiveness in curtailing bleeding.

A second drawback of some of the highly acidic composition: is its deleterious effect on any clothing with which it may -247172 come into contact. According to the type of composition and fabric, the clothing could be indelibly stained or even deteriorated.

In an attempt to obviate these problems, liquid styptic compositions were formulated. It was hoped that by combining an acidic salt with a volatile solvent, the evaporation of the solvent would offset the stinging nature of the salt. See, for example, U.S. Patent Nos. 2,118,225 and 3,343,540. While the evaporation of the solvent took some of the pain out of the application of the styptic compound, it was found that the amount of styptic necessary to stop the flow of blood still caused a great deal of discomfort and hence precluded its use in major wounds.

Aerosols, emitting a liquid or a powder, were also attempted, as shown in U.S. Patent Nos. 3,624,201, 3,863,005, 3,928,556 and British Patent No. 1,254,534. Although the aerosol containers greatly simplified the application of the styptic composition and kept the composition sterile, the stinging problem associated with effective bleeding curtailment persisted.

It is also known in the art to prepare creams or lotions containing acidic metallic salts which are stable and hence do not separate into an oil phase and an aqueous phase. These creams or lotions, however, do not relate to styptic compositions. For example, U.S. Patent No. 2,492,085 discloses an astringent composition which is in the form of a stable cream or lotion.

The stated advantages of this composition are its non-irritating action upon the skin and non-deteriorating effect upon clothing. These advantages are explained as resulting from the use of aluminum chlorohydrate which has a low acidity in comparison with stronger aluminum salts, such as aluminum sulfate. The non-irritating action of the composition is restricted to its intended use as a deodorant. While it is almost inconceivable -347172 that a deodorant composition would be used as a styptic composition, if such a composition were applied to an open wound, a great amount of pain would result.

It is further known to prepare cosmetic gels which contain a variety of metallic salts in combination with a high molecular weight of polyvinyl alcohol and methyl cellulose. See, for example, U.S. Patent No. 3,856,941. While highly acid salts are employed, the patent does not disclose the formation of a cream or lotion, nor does it suggest that the gel can be applied to injured areas or curtail bleeding without irritation.

According to the present invention there is provided a non-sting styptic composition as a stable cream or lotion comprising from 2% to 12% by weight of a long chain fatty acid; from 0.4% to 3.5% by weight of a wax filler; from 1% to 10% by weight of polyethylene glycol stearate; from about 1% to about 5% by weight of polyethylene glycol sorbitan beeswax; and from 0.5% to 25% by weight of an acidic metallic salt; the balance being water.

The invention also comprehends a pressurized aerosol canister containing an improved styptic composition of the invention.

Further the invention provides a bandage having a wound covering area comprising natural fibres and/or man-made fibres, said bandage including a styptic composition of the invention.

In the novel, non-styptic composition of the present invention which is in the form of a stable lotion or cream, the components other than the acidic metallic salt and the consistency of the lotion or cream exert a soothing and cooling sensation on the injured area which effectively -44-7172 overcanes the stinging sensation caused by the highly acidic metallic salt.

Tiie ability of the salt to curtail the bleeding of the wound, ncwever, is not affected by the balance of the canpcnents in the lotion or cream. Thus, the styptic composition not only stops the flow of blood, but it does so with an attended soothing sensation. Of course, if applied to major wounds, a slight stinging sensation will occur. The degree of pain, however, is far below that caused by known styptic compositions and can readily be tolerated without the fear of shock occurring.

A further surprising feature of the present invention is the stability of the lotion or cream. In most instances, when an acidic composition is added to an emulsion of an oleaginous material and an aqueous mixture, the emulsion rapidly breaks down into the two phases. In contradistinction to this normal occurrence, the styptic composition of the present invention exists as stable emulsion which can be stored on a shelf for months without phase separation occurring.

A preferred styptic composition has the following general formula; 1) from about 4% to 11% by weight of a long chain fatty acid; 2) from about 1% to 3% by weight of a wax filler; 3) from about 3% to 7% by weight of polyethylene glycol stearate; 4) from about 2% to 4% by weight of polyethylene glycol sorbitan beeswax; and, ) from about 5% to 20% by weight of an acidic metallic salt, 6) the balance being water. - 47172 The above formulae are unique in that they combine the attributes of an effective styptic composition with the desired non-sting, non-stain characteristics not found in the prior art. These advantages are believed to flow from the form of the styptic composition, namely a stable lotion or cream.

The long chain fatty acid, polyethylene glycol stearate and polyethylene glycol sorbitan beeswax are employed as emulsifiers or dispersing agents which promote the formation of the stable lotion or cream.

Polyethylene glycol stearate, for example, is a nonionic emulsifier and dispersing agent which consists of a water soluble polyoxyethylene’ derivative of stearic acid. This compound can be purchased under the trade name Myrj-52 (Myrj is a Trade Mark) manufactured by Atlas Powder Company. Polyethylene glycol sorbitan beeswax is an analogous compound which can be purchased under the trade name Atlas G-1726 (Atlas is a Registered Trade Mark) which is also manufactured by Atlas Powder Company. While -64 7172 the exact mechanism is not completely understood, the polyethylene glycol stearate and polyethylene glycol sorbitan beeswax are also believed to be primarily responsible for the soothing nature of the lotion or cream.

The term long chain fatty acid as used herein includes those' unsaturated or saturated fatty acids having from nine to twenty-three carbon atoms in the molecule. The saturated fatty acids are preferred for purposes of the present invention. The unsaturated fatty acids, e.g. oleic acid, exhibit a tendency to oxidize and-thus are typically employed in conjunction with a conventional anti-oxidant. Exemplary of such anti-oxidants are butylated hydroxyanisole, butylated hydroxytoluene and propyl gallate. While the specific amount of anti-oxidant which is added to the composition containing an unsaturated fatty acid will depend on the'particular anti-oxidant utilized, about .02% based on the weight of the long chain unsaturated fatty acid has generally been found to yield acceptable results. Exemplary of saturated fatty acids are lauric, palmitic and, preferably, stearic acid. As may be seen from the above general formula, 20 the amount of fatty acid incorporated into the composition may vary from 2% to 12% of the total weight of the composition. When a fatty acid having a longer carbon chain is employed, a lesser amount is required which approaches the lower limit of the range as the length of the carbon chain approaches twenty-three carbon atoms. Conversely, if a fatty acid having a shorter carbon chain is employed, a greater amount is required. The precise amount of a specific fatty acid in the composition can readily be determined by routine experimentation by those of ordinary skill in the art. - 7 47173 The term wax filler defines various wax products which increase the viscosity or consistency of the lotion or cream.

Typical of such wax products are microcrystalline wax, paraffin wax and, preferably, beeswax. g The term acidic metallic salt as used herein includes those metal salts which exhibit a degree of acidity sufficient to stanch the flow of blood yet may be formulated into a stable lotion or cream. Typical of such acidic salts are the· chloride, sulfate, phenolsulfonate and chlorohydrate salts of aluminum, zinc and iron, either as a simple salt or as a dibasic salt as in the case of aluminum potassium sulfate. The preferred salts are those having aluminum contained therein, particularly aluminum ammonium sulfate, aluminum potassium sulfate and, as the most preferred acidic metallic salt, aluminum sulfate.

Combinations of salts may also be employed, it will be apparent to those of ordinary skill in the art upon a perusal of the list of possible acidic metallic salts that they do not all exhibit the same degree of acidity. Accordingly, a greater amount of a less acidic metallic salt will be required 2o in the composition than in the case of a more acidic metallic salt. The precise amount of acidic metallic salt must be • selected such that the composition is effective in curtailing bleeding without causing an inordinate amount of pain when applied. These criteria create a variation in the time needed to completely stop the bleeding, the most preferred acidic metallic salt, namely aluminum sulfate, being the most effective in curtailing bleeding without causing pain. In all instances, however, the amount of acidic metallic salt required in the composition will fall within the limits established by the above formula. - 8 47172 The following Examples are given as specific illustrations of the invention. Xt should be understood, however, that the invention is not limited to the specific details set forth therein. In the following Examples, all percentages are by weight of the total composition.

EXAMPLE I 1) Stearic Acid............. 7.5% 2) Beeswax................ 1.7% 3) Polyethylene glycol stearate . . . . . 5.3% 1q 4) Polyethylene glycol sorbitan beeswax . 3.5% ) Aluminum sulfate ...........13% 6) Water ...............69% EXAMPLE II 1) Palmitic acid ............9% 2) Microcrystalline Wax...... . . . 2.5% 3} Polyethylene glycol stearate ..... 3.8% 4) Polyethylene glycol sorbitan beeswax 2.3% ) Aluminum Potassium Sulfate......10% 6) Water ......... 72.4% EXAMPLE III 1} Lauric acid ........... . .11% 2) Paraffin Wax .............3.0% 3) Polyethylene glycol stearate ..... 6.2% 4) Polyethylene glycol sorbitan beeswax 4% ) Zinc Sulfate.............18% 6) Water .............57.8 % - 9 47172 1 A humectant may optionally be present in an amount ranging from about 1% to about 4% by weight. Although the humectant does not affect the ability of the styptic lotion or cream to stanch the flow of blood, it is generally incorporated into the composition to prevent the lotion or cream from drying out. Typical of the humectants which may be snployed are the polyhydric aliphatic conpounds. Glycerin is the preferred hunectant. Glycerin may be present in an amount ranging fran about 1% to about 7% by weight.

Any conventional antiseptic may also be incorporated into the composition. Such antiseptics include the quaternary ammonium compounds and the alcohol compounds including phenol compounds. One preferred antiseptic composition is hexylresorcinol. The amount of antiseptic utilized in the composition will depend on the particular compound employed. Since most known antiseptic compounds cause some degree of stinging, the amount of antiseptic utilized should be maintained at the minimum amount necessary to effectively prevent the growth of microorganisms. In the case of hexylresorcinol this amount is in the order of about 2% by weight.

The above mentioned ingredients may be combined in the following manner: the long chain fatty acid, the wax filler, polyethylene glycol stearate, polyethylene sorbitan beeswax and optionally, glycerin are mixed together and heated to a temperature of about 70°C. After the mixture has reached this temperature, a warm (70°C) aqueous solution of the highly acidic metallic salt is blended in. The mixture is then cooled while being agitated.

The resulting stable cream or lotion is an effective styptic composition which has a wide range of applications. In use, the cream or lotion is spread on the wound and is quickly absorbed by the skin. Therefore, if suturing is required or desired, 4 7172 it may be performed without having to clean the wound of the Styptic composition. Due to its non-sting characteristic, the styptic composition of the present invention may be spread on minor cuts, abrasions and even major wounds without causing pain to the injured entity. The term entity is utilized to reflect the fact that the styptic composition of the present invention is effective on animals as well as humans. The composition can also be employed in the dental field if a flavoring agent is added and can be incorporated into first-aid kits for civilian and military use.

A second advantageous feature of the styptic composition of this invention is that it does not stain or deteriorate fabrics with which it comes in contact. This feature enables the composition to be applied to a small cut or abrasion on an area of skin which is normally covered by clothing without the need for a restrictive bandage or covering.

The cream or lotion which comprises the styptic composition of this invention can be packaged in any convenient container including jars, bottles, tubes, pump applicators and preferably, in pressurized aerosol canisters. The aerosol canisters which may be employed to distribute the lotion or cream are well known in the art so that a further exposition of the details of the canisters need not be set forth here (see for example, U.S. Patents 2,631,814, 2,645,387 and 2,662,668.

In an aerosol canister, the composition may be maintained in a sterile condition irrespective of the surrounding environment and may be directly applied where needed with a minimum of effort.

The styptic composition of the present invention may also be utilized to impregnate prepackaged bandages. The wound covering area of the bandages may be fabricated out of natural fibers, such as cotton, man-made fibers, such as polyester or rayon or mixtures thereof. According to the type of fabric employed, the bandage density and thickness and the type of wound intended to be covered, it is necessary to vary the amounts of the several components which comprise the styptic compositions. However, such variation will fall within the ranges established above. In this form, the combination of the styptic composition and the bandage may be maintained in a sterile package. When required, it maybe quickly opened and applied to the wound thereby stanching the flow of blood, easing the pain of the wound and initiating the healing process without delay. Such advantages make the impregnated bandage particularly suitable for first aid kits, emergency units, physician's bags and a variety of other locations.

Although the invention has been described with reference to preferred embodiments, it is to be understood that variations and modifications may be employed without departing from the scope of the invention as defined in the following claims. 47173

Claims (14)

1. CLAIMS:1. A non-sting styptic composition as a stable cream or lotion comprising: from

2. % to 12% by weight of a long chain fatty acid; from 0.4% to 3.5% by weight of a wax filler; from 1% to 10% by weight of polyethylene glycol stearate; from 1% to 5% by weight of polyethylene glycol sorbitan beeswax; and from 0.5% to 25% by weight of an acidic metallic salt, the balance being water. 10 2. A styptic composition according to Claim 1, wherein the acidic metallic salt is aluminum sulfate, or aluminum potassium sulfate, or aluminum ammonium sulfate.

3. A styptic composition according to Claim 1 or Claim 2, wherein the wax filler is beeswax, or microcrystalline wax, 15 or paraffin wax.

4. A styptic composition according to any one of Claims 1 to 3, wherein a humectant is present in an amount ranging from 1% to 4% by weight.

5. A styptic composition according to Claim 4, wherein 20 the humectant is glycerin.

6. A styptic composition according to any one of Claims 1 to 5, wherein glycerin is present in an amount ranging from 1% to 7% by weight.

7. A styptic composition according to any one of -1347172 Claims 1 to 6, including an antiseptic.

8. A styptic composition according to any one of Claims 1 to 7, wherein the long chain fatty acid is stearic acid. 5

9. A pressurized aerosol canister containing a styptic composition as claimed in any one of Claims 1 to 8.

10. A bandage having a wound covering area comprising natural fibers and/or man-made fibers, said bandage 10 including a styptic composition as claimed in any one of Claims 1 to 8.

11. A non-sting styptic composition substantially as herein desoribed.

12. A non-sting styptic composition as described 15 in any one of Examples I to III.

13. A pressurized aerosol canister containing a styptic composition according to Claim 11 or Claim 12.

14. A bandage having a wound covering area including a styptic composition according to Claim 11 or Claim 12. F.R. KELLY & CO., AGENTS FOR THE APPLICANTS.