CA2125190A1 - Skin therapeutic mixture containing cold-processed aloe vera extract, with yellow sap and aloin removed - Google Patents
Skin therapeutic mixture containing cold-processed aloe vera extract, with yellow sap and aloin removedInfo
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- CA2125190A1 CA2125190A1 CA002125190A CA2125190A CA2125190A1 CA 2125190 A1 CA2125190 A1 CA 2125190A1 CA 002125190 A CA002125190 A CA 002125190A CA 2125190 A CA2125190 A CA 2125190A CA 2125190 A1 CA2125190 A1 CA 2125190A1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
- A61K8/9783—Angiosperms [Magnoliophyta]
- A61K8/9789—Magnoliopsida [dicotyledons]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
- A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
- A61K8/9783—Angiosperms [Magnoliophyta]
- A61K8/9794—Liliopsida [monocotyledons]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
- A61Q19/10—Washing or bathing preparations
Abstract
According to present invention, a non-ionic skin therapeutic mixture useful for treatment of irradiated skin, open sores, wounds and abrasions is comprised of an extract of cold-processed aloe vera gel, with yellow sap and aloin removed to ensure the bradykininase activity has been preserved during the extracting process.
The mixture includes in combination allantoin and lavender essential oil to form a unique and synergistic product for enhanced healing with treatment of swelling. Additionally, an effective amount of an acceptable topical carrier or a cosmetically acceptable surfactant, and a cosmetically acceptable preservative is included.
The compositions of the invention may be in the form of a liquid, creme, ointment, paste, gel or powder.
The mixture includes in combination allantoin and lavender essential oil to form a unique and synergistic product for enhanced healing with treatment of swelling. Additionally, an effective amount of an acceptable topical carrier or a cosmetically acceptable surfactant, and a cosmetically acceptable preservative is included.
The compositions of the invention may be in the form of a liquid, creme, ointment, paste, gel or powder.
Description
2125190 ~`
WO 93/1~780 - PCI'/US92/08369 SKIN THERAPEUTIC MIXI~RE CONTAINING COLD-PROCESSED ALOE
VERA EXIRACI, WITH YELLOW SAP AND ALOIN REMOVED
Background of the Invention 1. Field of the Invention . ~ , ~ .
This invention relates to topical formulations for treatment of damaged sldn, such as irradiated sl~n in combination with wound treatment. In particular, the invention relates to topical formulations useful for the treatment of sldn damaged by the harmful effects of radiation and radioactive substances, such as used in thetreatment of cancer or e~posure to the sun, open sores, wounds and abrasions.
WO 93/1~780 - PCI'/US92/08369 SKIN THERAPEUTIC MIXI~RE CONTAINING COLD-PROCESSED ALOE
VERA EXIRACI, WITH YELLOW SAP AND ALOIN REMOVED
Background of the Invention 1. Field of the Invention . ~ , ~ .
This invention relates to topical formulations for treatment of damaged sldn, such as irradiated sl~n in combination with wound treatment. In particular, the invention relates to topical formulations useful for the treatment of sldn damaged by the harmful effects of radiation and radioactive substances, such as used in thetreatment of cancer or e~posure to the sun, open sores, wounds and abrasions.
2. Descnption of thePriorArt According to the American Cancer Society's Cancer Facts and Figures-1991, at the current rate, about 76 million Americans now living will eventually have cancer. It will strike three of four families. Ca~cer strikes at any age. It ldlls more children of age I to 14 ill the United States than any other disease and occurs more frequently with age. Based on current medical technology over half of these cancer patients will u~dergo some form of radiation tberapy.
In the 1930's, less than one in five was alive at least five years after treatment.
In the 1940's, it was one in four, and in the 1960's, it was one~ in three. Today about 440,000 America~ls, or 4 of 10 patients who get cancer, will be alive five years after diagnosis. The gain from 1 in 3 to 4 in 10 represents about 77,000 persons this year.
The primaly goal of tbe medical community has been to prolong the life of cancer patients. Until recently, and in relatio~ to the growing number of cancerpatients that call e~pect to survive five years or more? the quality of life of the cancer patie~t has received atten~ion.
The onset of radiode~matitis as a result of irradiation in cancer patients is well documensed. It is characterized by congestive or exudative redness of the skin WO 93/11780 PCI`/US92/08369 :
9Q 2 ~;
caused by hyperthermia. Therefore, there is a need for substances effective for treating irradiated skin damage or radiodermatitis.
The topical use of an~i-inflammatory agents to alleviate radiodeTmati~is is known. Such compositions contain combinations of one or more steroidal anti-S inflarnmatories, non-steroidal anti-inilammatories, as well as "natural" anti- ini larmnatories, such as an extract of aloe vera.
The "greying of America" is also well documented. People are living longer and have expectations for a quality life as well as a long life. People a~icted with ~ `
long term illness ruIl t~e risk of getting bed sores, pressure sores and a myriad of sldn ;`
10 irritations due to incontinence.
Looking at the treatment figures for pressure ulcers, just a small part of tbe entire market, one can quuckly see that tbere is a need to develop products that will effectively treat patients with long term illnesses.
'- As part of a study using AMA data on admissions to acute hospitals to derive 15 the number of patients at risk of pressure ulcers, the statistics and forecasts are as follows:
:,~
Pressure Ucleration in US Hospitals Table 1 PATIENTS (1000's) Therefore, there is a need for a substance which will reduce bed sores or ulceradon.
The brad~rldninase activity or ability to reduce swelling which is present in cold-processed aloe vera, with yellow sap and aloin removed, is clinically proven when used in high concentrations. See, K Fluita, R Teradair, and T. Nagatsu, Biochem. Pharm., VOla 25~ 205, 1976.
However, some extracts of aloe vera have been found to be toxic and the applicability of aloe vera for treatment of skin disorders is not generally accepted or ~;
understood. Winters et al. conducted a study to determine the toxicity of yellow sap WO 93J11780 212 ~19 0 PCltUS92/08369 ~:
and aloin on human sl~n cells (fibroblast) that were obtained from human foreskin.
The cells were grown in MEM supplemented with S percent human serum. The yellow sap was tested at 1, 10, 15, and 30 percent and compared to untreated control cells. There was a 100 percent cell kill recorded at all levels when yellow sap was 5 applied to fibroblast. L Danhof, Ph.D, M.D. and B. McAnalley, Ph.D., "Stabil~zed aloe vera EJ~ectonhumanslancells', D&CI,4-5,105-106,(Aug.1983).
Several prior art patents disclose cosmetic/therapeutic formulations including aloe vera. DeNava~e, "Non-irrita~ing Antiper~pirantn U.S. Patent. No. 4,302,443 discloses the use of aloe vera to prevent irritation. DeNavarre does not claim to use 10 fresh aloe vera that has been filleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially anthraquinone-free fillet that is ground, homogenized and processed into a stable aloe vera extract. There is also no combination in DeNavarre with allantoin and lavender essential oil, or any claim for ~-~ the treatment of irradiated sldn, open sores, wounds or abrasio~..
Mihalonts, "Comle~ic Facial Preparat~on Containing Aloe Vera" U.S. Patent.
No. 4,369,180 discloses the use of aloe vera in combination with cornstarch or cosmetic clay, albumin, aUantoin, vitamin A, vitamin D2, and vitamin E. Mihalonts also does not claim to use fresh aloe vera that has been filleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially anthraquinone-free fillet that is then ground, homogenized and processed into a stable aloe vera extract. Mihalovits teaches tbe use of allantoin, but only in formulations at 0.5 % by weight, which is significantly less than the present invention, and makes no claims for the use of lavender essential oil. Mihalovits further makes no cla~ms as a treatrnent for irradiated sldn, open sores, wounds or abrasions.
Millard, ~Shn Treahnent Preparation" U.S. Patent. No. 4,505,902 discloses a formulation which uses aloe vera juice i~ combination with mineral oil, apricot kernel oil, avocado oil, and cod liver oil. Milliard does not claim to use fresh aloe vera that has been filleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially anthraquinone-free fillet that is then groltnd, homogenized and processed into a stable aloe vera extract. There is no teaching to combine it with allantoin and lavender essential oil, and no claims as a treatment for i~radiated sldn, open sores, wounds or abrasions.
Trenzeluk, Hl~ Therapeutic M;XtUK Containing Aloe Vera Extract" U.S
Patent. No. 4,85?,328 discloses a formulation using the dried leaves of the aloe vera plant as the ~erapeutic agent for the treatment of acne, psoriasis, burns, pimples, blackheads, and open sores. Trenzeluk directs the use of dried leaves of the aloe vera plant and does not claim to use fresh aloe vera that has been iilleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially wo 93/11780 PCMlS92/08369 anthraquinone-free fillet that is then ground, homogenized and processed into a stable aloe vera extract. There is not teaching relating to the combination withallantoin and lavender essential oil.
Therefore, it iS an object of the present invention to provide a phase stable 5 topical formulation, which uses the extract from cold-processed aloe vera gel, with yellow sap and aloin removed, combined with allantoin and lavender essential oil, the use of which will provide treatment of radiodermatitis and the chronic effects of radiation exposure without interfering with the radiation therapy, treatment of open sores, wounds or abrasions.
It is also an object of the present invention to provide a pbase stable cleansing composition, wbich uses the extract from cold-processed aloe vera gel, with yellow sap and aloin removed, combined with allantoin and lavender essential oil, the use of which will provide a method for relieving the deleterious e~ects of radiation without interfering with the radiation therapy, treatment of open sores, wounds or abrasions.
Brief SummaIy of the Invention The present invention is a class of formulations containing a high level of cold-processed aloe vera extract, with yellow sap and aloin removed, combined with allantoin and lavender essential oil, and a topical carrier to create a unique therapy 20 for the management of open sores, wounds and abrasions. The anti-inflammatoryaction of aloe vera, used in combinadon with allantoin and lavender essendal oil, has a unique synergistdc effect that is effective in the treatment of open sores, wounds and abrasions. This healing effect of the mixture exceeds that which is known for allantoin alone to help heal wounds and skin ulcers and to stimulate the growth of ~5 healthy tissue.
The present inventdon also relates to formulations useful for treating the radiodermatdtis caused by irradiation on skin comprising the extract from cold-processed aloe vera gel, with yellow sap and aloin removed, combined with allantoin and lavender essential oil, and a safe and effective amount of a topical carrier.
30 ~ The present invention also relates to formulations useful in treating open sores, wounds or abrasions on skin comprising the extract from cold-processed aloe vera gel, with yeDow sap and aloin removed, combined with allantoin and lavenderessential oil, and a safe and effective amount of a topical carrier.
More specifically the inventi~n is a mixture for treatment of irradiated skin~
35 open sores, wounds and abrasions. The mixture comprises a substantially anthraquinone-free cold processed fresh aloe vera extract. The aloe vera extractcomprises from about 1 percent by weight per uI~it volume up to about 98 percent per WO93/~1780 ~l25~l9n Pcr~US92/08369 unit volume. Allantoin comprises from about 0.10 percent by weight per unit volume up to about 8 percent by weight per unit volume. As a result, a combination is provided which synergistically increases the healing eflect of each the mixture over that provided separately by its constituents.
S The mi~ure further comprises a topical carrier. The mîxture still further comprises a nondegradable extract of lavender essential oil from about 0.01 percent by weight per unit volume up to about 2 percent by weight per unit volume.
The mixture may include a cosmetic surfactant and a cosmetic preservative.
In one embodilhent the a~oe vera extract comprises from about 40 percent by weight per unit volume to about 95 percent by weight per unit volume. The allantoin ;;
comprises from about 1 percent by weight per unit volume to about 2 percent by weight per unit volume.
The fresh aloe vera has been processed from an aloe vera plant havi,ng an ~~ outer rind, sap and containing aloin. Tbe outer rind, yellow sap and alo~n are -removed by a conventional cold process to produce the substantially anthraquunone-free aloe vera extract. The anthraquinone-free aloe vera extract is ground, homogeDized and processed into a stable aloe vera extract.
ln anotber embodiment the lavender essential oil comprises from about Q03 percent by weight per unit volume up to about 0.09 percent by weight per unit volume.
Other ratios of the active ingredients are also contemplated in the invention.
For example, the aloe vera extract may comprise about 77.7 percent by weight perunit volume and tbe allantoin comprises about 2 percent by weight per unit volume.
Alternatively, the aloe vera extract comprises about 93.8 percent by weight per unit volume and tbe allantoin comprises about 2.0 percent by weight per unit volume. In yet another embodiment the aloe vera extract comprises about 45.2 percent by weight per unit volume and the allantoin comprises about 2.0 percent by weight per unitvolume.
More generally the invention is a mixture for damaged sldn comprising an element for reducing inflammation of the skin, and an element for simultaneouslyhealing the skin. The element for reducing in~ammation coacts w~th the element for healing the skin to accelerate the action of the element for heallng. The mixture further comprises an dement for calming nervous activity while simultaneously ~-~
prov~ding the element for reducing inflammation and element for healing to -35 holistically coact with eacb other to heal.
The invention can better be understood by turning to the examples in the following detailed description.
WO 93/11780 PCI'/US92/08369 ?.~'~ ' .`
DETAILED DESCRIPI ION OF THE INVENTION
In accordance with the present imvention, there is provided herein folmulations useful for topical application comprising the extract from cold-processed aloe vera gel, with yellow sap and aloin removed, combined with allantoin and S lavender essential oil, and a safe and effective amount of a topical carrier.
According to present invention, a non-ionic skin therapeutic mixture useful for treatment of irradiated skin, open sores, wounds and abrasions is comprised of an extract of cold-processed aloe vera gel, with yellow sap and aloin removed to ensure the bradykininase activity has been preserved during the extracting process. ThemLxture includes in combination allantoin and lavender essential oil to form a unique and synergistic product for enhanced healing with treatment of swelling. Additionally, an effective amount of an acceptable topical carrier or a cosmetically acceptable surfactant, and a cosmetically acceptable preservative is included. The compos'itions of the invention may be in the form of a liquid, creme, ointment, paste, gel or powder.
E~ract of Aloe Vera Gel Aloe is a tropical or subtropical plant that is a member of the lily family.
There are about 325 species of Aloe known, and most are indigenous to Africa. Aloe barbadensis is a native of northern Africa, and was introduced into the island of Barbados in about 1630. Aloe barbadensis Miller has a short, woody stem, and lancelolate embracing leaves, of glaucous green color, with hard, pale spines. It is now grown commercially in the Rio Grande region of Texas.
The mucilaginous jelly from the parenchymal cells of the plant is referred to asaloe vera gel. There are generally no anthraquinones to decompose and cause discoloration of the gel unless the gel is contaminated by an improper processing technique. Aloe vera gel is about 985% water by weight. More than 60% of the total solid is made up of polysaccharides of carbohydrate origin. Organic acids and inorganic compounds, especially calcium oxalate, account for the remainder of the solid.
Whole leaves, exudates and fresb gels of aloe plants have been u;sed for a variety of human alelictions. Evidence of tbeir use as medicinal remedies can betraced to tbe Egyptians of 400 BC. Aloe vera has enjoyed a long history of lay acceptance as possessing "curative" or '~ealing" qualities. Over tbe last few years, numerous books and articles meeting scientific stalldards have been written on aloe vera Aloe vera has been featured extensively in the field of dermatology, especially for treating radiation-caused skin conditions. See, ~ackee, X-Rays and Radium in 212Slgo WO 93/1 1 780 PCI'/US92~08369 `
the Treatment of Diseases of the Skin, 3rd Ed., Lea and Febiger, Philadelphia, 319-320 (1938); Rovalti et al., Industrial Medicine and Surgery, 28: 364-368 (1959).Presently, there has been controversy over the identity of the active substancesin aloe vera. It is therefore important to clearly distinguish between the components S of the present invention and those found in the exudates found in aloe vera that employs the use of the whole leaf without the aloin and yellow sap being removed.
The harvesting and extracting of aloe vera has been hindered by tbe lack of ~-knowledge about the aloe plant and its characteristics. Methods currently employed for the processing of the plant and its components result in end products which do not 10 consistently achieve desired results because of the presence of yellow sap, wbich is known to be cytotoxic to skin. For example, Cobble, U.S. Patent 3,892,853 and Coats, U.S. Patent 4,178,372 both teach a process for producing a~ alleged stabilized (i.e.
bacteriologically stable) aloe juice by extracting the mucilage from the aloe lçaves ~fand adding a mild oxidant (H202). No reference is made to removing yellow sap.15These processes for example, typically involve crushing (pressure rollers), gnnding (e.g., use of Thompson aloe leaf slitter), or pressing (TCX pressure ex~ruder) the entire leaf of the a~oe plant to produce an aloe vera juice, which is f;ltered and used in cosmetics and topical ointments. It can be appreciated that crushing the `
whole leaf of aloe vera and/or chemically altering the substance, without removing 20 the yellow sap, instead of separating the constituents prior to processing, and insuring the removal of all yellow sap, alters the chemical composition of the aloe vera extract.
Winters' conclusion that "The cytotoxic effects of commercially prepared aloe vera gel fractions on normal human and tumor cells in culturen, suggests that these commercial preparations contain substances introduced during commercial 25 processing which can alter the levels of lectin-like activities and can markedly disrupt the in vit70 attachment and growth of human cells". Wmters et al. reported to the instant applicant that he used material received from Coates as a commercial stabilized aloe preparation.
Recent studies indicate that tbe yellow sap found just under the ou~er green 30 waxy surface of the aloe vera plant is toxic to human sldn cells. I.E. Danhof et al., "Stabilized Aloe Vera~ Effect on Human Shn Cells' D & CI, 52-54, 105-106 (August, 1983). He reported the use of products with yellow sap should be minimized in topical products where it can come in contact witb broken or damaged sldn.
Idiosyncratic hypersensitivity bas been demonstrated in processed aloe vera gel tbat 35 consists of a variable mixture of yellow sap. D.M. Morrow, M.D., et al, "~per~e~dM~ ~oAloe', ARCH. DERMATOL, 116, 1064-165 (Sept. 1980).
McAna ey, U.S. Patents 4,966,892, 4,917,890 and 4,73S,935 teach a process for producing an alleged stabilized aloe mucilaginous that is a "substantially"
WO 93/1 1780 PCI`/US92/08369 . .
anthraguinone ~ee extract. No reference is made to color stabili~ or to the removal of aloin to < Sppm. In fact, litera~ure des~ibing the aloe extract obtained using the McAnalley process addresses the inability of the extract to maintain color stability.
While the McAnalley process is an improvement over the Cobble and Coates S methods, it still falls short of reasonable stability expectations and allows for challenge to the overall chemical stability of the product produced-using the McAnalley process.
The invention is directed to use aloe vera that has been extracted in a manner that is chemically stable as well as color stable, that renders the chemical substance 10 substantially non-degradable and can be administered in a prescribed amount. It has been cold-processed to retain all natural en~natic activities and to preserve heat sensitive constituents. It is prepared from mature leaves, ha~vested at peak conditions. Aloin is removed by non-chemical means (<5ppm in 1:1 aloe vera) to ~ obviate leeching of natural ingredients. The aloe vera gel is treated with a unique 15 double control system that guarantees microbiological stab~ity. It is subjected to rigorous quality control procedures that assure enviable batch-to-batch consistency for a bota~ically derived product.
Allantoin Allantoin has not suf~ered from the challenge to its ef~ectiveness that al~e vera extract has had to endure. Allantoin is chemically a diureide of glyoxylic acid and thus is an urea derivative. Its use as a therapeutic agent in dermatology was based formerly on its ability to facilitate the removal of necrotic tissue and to stimulate wound healing by promoting cell proliferation. E. Young, '~llantoin in Treatment of Psoriasis', Dermatologica, 147: 338-341 (1973). It can be prepared synthetically by the oxidation of uric acid or by headng uric acid with dichloroacetic acid. Uric acid is prepared from urea and is present in the unne of all carnivorous animals.
Allantoin is an important ingredient which stimulates healing of wounds, and burns and which increases hydration and elasticity of sldn. M. Sznitowska and S
Janicki, 'The, Effect of Vehicle on Allantoin Penetration into Human S~an from an Ointment for Improving Scar Elasticity', Department of Pharmaceutical Technology, Medical Academy, Gdanks, Poland (Oct. 1987).
The FDA-OTC Topical Analgesic Review Panel recently classified allantoin in Category I (~afe and Effective) as an active skin "protectant." The FDA monograph on sldn protectant published in the Federal Register (Vol.43 No. 151) on August 4, 1978, stated that, based on the wide use and clinical acceptance of allantoin, as well WO93J11780 212519~ PCr/US92/08369 as on published reports in the literature, the Panel approved the following statements for products containing allantoiD:
'Temporarily relieves, protects, soothes, gives comfort to minor skin i~Titations, such as chapping, peeling, scaling, minor burns, sunburn, windburn, scrapes, abrasions or cracked lips."
While the attributes of allantoin bave been clinically proven and the FDA has :
classiiied it in Category I (Safe and Effective~, there remain di~culties in themanufactunng process as related to allantoin with a mesh size of 200 or less.
Allantoin is water soluble to 0.50%, according to A. Fisher,M.D., '~Allantoin: ANon-sensiti~ng Topical Medicament: Therapeutic Effects of the Addition of S.aO%
A~lantoin to Vaseline' CulTnet Contact News, vol. 27, 23~231, 23~235, (Marchl981). ~ -The industry standard 200 mesh particle size, when used in higher by-weight percentages (over 0.50~o), tends to crystalize and fall-out. Fall-out reduces the ;
~~ effectiveness of the mixture and crystallization alters the texture.
In order to overcome fall-out and crystallization the present invention is directed to use 400 mesh allantoin or finer. A unique process micronizes the allantoin in a manner that allows for the reduction of particle size by 50%. Four hundred mesh allanto~n provides for improved product shelf-life, reduced crystallization, and greater absorption of the ingredient into the rni~ture.
;
Ei~trac~ of Lavender Lavender is a shrubby plant indigenous to the mountainous regions of the countries bordering the westerll half of the Mediterranean, and cultivated ex~ensively for its aromatic flowers in various parts of France, Italy and England. There are four major varieties of lavender. One is spike lavender (Lavandula Latifolia). This is a strong growing shrub that grows naturally at lower altitudes around the northernMediterranean shore, particularly Spain and Italy. A second is true lavender (Lavandula angustifolia). This is a dwarf shrub that is distinguished from all others by being camphor free. Its natural habitat is restricted to a small area above 1000 meters altitude in the southern French Alps. A third is lava~din (Hybrid: L Latifolia X L angustifolia). This is grown as a natural hybrid at medilml altitudes in the south of France. It has a high camphor content.
Finally, there is Lavendula offlcinalis. This is the true lavender which grows wild at altitudes of 700 1100 meters in southern France. The preferred embodiment of the i~vention directs the use of extracts derived from the flowers and leave from the Lavendula offianalis.
WO 93~1 1780 PC~/US92/08369 ?~?J The Greeks called lavender by the name Nardus, from Naarda, a city of Syria near the Euph~ates. St. Mark mentions it as Spikenard, a thing of great value...In Pliny's time, blossoms of the nardus, called asarum by the RomaIls, sold for a hundred Roman denarii. The Romans use of lavender is well documented. Lavender is also S cited as one of the ingredients of the 'Four Thieves' vinegar famous in the Middle Ages.
The use of lavender in the present invention employs the belief that a patient must be treated holistically. Bach et al., stated 'the second du~ of the physician will be to administer such remedies as will help the physical body to gain strength and assist the mind to become calm'.
Essences work organically and can replace the use of tranquilizers. There use dates back to antiquity when such physicians as Galen aIld Celsus used aromatic herbs as remedies against hysterical convulsions, and reported that they sometimes stopped attacks immediately Unlike the modem sleeping pill, essences are not mere sedatives. Most of them are very pleasant to smell providing the uplifting effect, a more positive attribute than for that of a sedative. R. l~sserand, '~e Art of Aromatkera~y', Destiny Books, 95-101, (1977).
Mme Maury et al. stated, 'but of the greatest interest is the effect of the fragrance on the psychic and mental state of the individual. Powers of perception become clearer and more acute, and there is a feeling of having to a certain e%tent, outstripped events. They are seen more objectively and therefore in ~ruer perspective. It might even be said the emotional trouble which in general obscures our perception is practically suppressed'.
Professor Rovesti has studied tbe effects of essences on the human psyche and 25 states:
"According to sociologists and neurologists the salient characteristics of our age are those of anxiety and depression, and material proof of this is available in the even higher figures shown for the consumption of tranqllili7ers and stimulants. It is well known that disturbance and toxicosis can be caused by these products if taken regularly. "
"Both neuroses often causes aversion to any t~pe of pleasure, by producing a sense of weariness which many people are unable to overcome. "
'The possibility of applying new therapies to these widespread psycho-neuroses is therefore of considerable importance. "
"For such purposes, therefore, interest attaches to the use of essential oils as aids, or even as sole remedies in psychotherapy. "
WO93/11780 21~Slgo P~/US92/0~369 ~
' The matter is of still further interest, since ~he essential nils that are employed in aromatherapy, in the appropriate doses, are harmless to the organism and do not cause troubles like those produced by the ordinary psychological drugs. VeIy conclusive e~eriments in this direction have been carried out in various clinics for nervous diseases, on patients af~ected by hysteria or pSy~:hiG depression."
Lavender is listed as aIl ef~ctive means to improve the physical condition of patients in two areas. It is mentioned i~ the treatment of anxiety alld nelvous te~sion, and for depression and melancholy. R ISsserand, 'The art of aromatherap~', Destiny Books, 95-101, (1977).
The trust of lavender is still widely held in Europe. Some of this trust is founded upon the use of lavender dumlg World War I to swab the wounds of so~diers.
~' The French Academy of Medicine is giViDg attention to the oil of lavender for this and other antiseptic surgical purposes. The oil is successfully used in the,treatment of sores, varicose ulcers, bu~ns and scalds. Peter Smith, et al,; and GrieYe, A Modern Herbal, vol. 2, 467~73 ~1981).
French chemist Rene-Maurice Gattefosse found early in t~is centuly, a~
essential-oil house that produced oil for use in cosmetics and fragrances. It is alleged one day Gattefosse burne~ his hand in his laboratoIy. Remembe~ g that lavender was supposed to heal burns and reduce inflammation, he immediately immersed his hand in a container of pure lavender on his workbench. The burn quickly lsst itsredness, and began to heal.
French lavender is rich in foLklore. It has been endowed with many rich qualities. Used externally, it is believed to be antiseptic and disinfectant. It is believed to be helpful in healing wounds, sore and sldn ulcers.
The halvesting of lavender takes great care. The stalks of laYender are spread out in the operl, on trays or sieves, in a co~l, shady place, out of the sun, so that they may dry slowly. The trays are raised a few feet from the ground, to ensure a walm current of air, and the stems are not allowcd to touch, or the fl~wers will be spoiled by the moist heat engendered. Lavender is taken indoors before there is any risk of getting damp either by dew or showers. ~en dry, it is stored in a dry place and the flowers stripped from the staL~s and dried by a moderate heat.
The curre~t invention is directed to use lave~der that has been e~tracted in a manner that renders the chemical substance substantially non-degradable and can be a~stered in a prescribed amount. It has been cold-processed to retain all natural activities and to preserve heat sensitive constituents. It is prepared from flowers and leaves of mature pla~its, harvested at peak conditions. The lavender is subjected to WO 93/~1,178~ PCI/U~92/08369 ~,~'l,5~9~ 12 rigorous quality control procedures that assure enviable batch-to-batch consi~tency ~or a botan~cally derived produ~.
Topical Compositions In addition to the active agents of extract of cold-processed aloe vera, with yellow sap and aloin removed, combined with allantoin and lavender esse~tial oil, ~he compositions of the present inventis:~n contains a safe and eflective amount of an acceptable topical carrier. The term "acceptable topical carrier" encompassss both pharmaceutically-acceptable carners and cosmetically-acceptable carriers, and encompasses substantially non-ilTitating compatible components ~either taken alone or in mixtures) which are suitable for delivering the active components to the sldn.
The term "compatible", as used herein, means that the components of the ca~rier ~-~must be capable of being commingled with cold-processed aloe vera extract, with yellow sap and alo~n removed, combined with allanto~n and lavender essential oil, in a manner such that there is no interaction which would substalltially reduce theefficacy of the composition during use for protecting the sldn from the eff~cts of radiation and in the treatment of open sores, wounds or abrasions. These carriers must, of course, be of sufficiently high purity alld sufficiently low to~acity to render them suitable for chronic topical a~inistration to the sl~ of humans or lower animals. The term "safe and effective amount" of carrier means an amount suf~icient to deliver the aloe vera extract to the skin but not so much as to cause any side effects or skin reactions.
The topical compositions of the present invention contain generally from about 1% to 98% by weight preferably from about 40~o to 95% by weight cold-processed aloe vera extract, with yellow sap and aloin removed, combined with 0.10~o to 8% by weight preferably from 1% to 2~o by weight allantoin, and combined withfrom 0.01% to 2~o by weight preferably from 0.03 to 0.09% by wei8ht lavender essential oil.
Variations in formulation of these camers will result in a wide variety of products w~ich fall within the scope of the present invention. These product ~pes can be divided into hvo classes: pharmaceutical/cosmetic compositions and cleaning compositions. ;
, Pharmaceutical/Cosme~ic Composihons The invention relates to mixtures contai~ing cold-processed ialoe vera extract with yellow sap iand aloin removed in combination with allantom iand lavender essential oil. The phalmaceuticial/cosmetic compositions, of the present invention 212Slgo :,`
WO 93/11780 PCr/US92/08369 may be made into a wide varie~y of product ~pes. ~hese include, for example, lotions, creams, gels, sprays, ointments, rinses, ~oothpaste and powders.
It has been said, "We know more about traveling into space than how the body repairs itsel~'. At birth, a baby's body knows more about the healing process than the S combined knowledge of man. An injury to the soft tissues of the body starts a complicated chain of events that have ouh~ard manifestations including, redness,hea~ swelling, p~in and tissue death due to the loss of o~ygen to the area. These events take place within minutes of an injury. One of the body's fundamental reactions to injury is acute inflammation. It is the body's way to protect, localize and -10 rid the body of injurious agents in preparation for healing and repair. Inflammation is a natural way in which pain is used to cause a change in the behavior of the animal to avoid reinjury of the affect site until healing is completed.
It is import~ant to note the two distinct bodily activities. First, the,body ~~ responds with inflammation as a way to protect itself and rid itself of injurious agents.
15 Secondly, the body starts the healing and repair phase.
A key event that takes place in the "first stage" of soft tissue trauma is a chemical response called bradykinin which results in the creation of pain. This is the release of a peptide tbradykin), which is a fragment of a large protein molecule that circulates in the blood stream. When tissue is damaged in any way, tiny capillaries 20 break rele~sing bradykin into the affected area. The release of bradykin also triggers a chemical reaction know to be r~sponsible for sending the pain message to the brain.
During the brady~nin response cellular death occurs, due to the loss of oxygen to the cells, caused in part by inflammation. If cell loss is to be minirnized, it is important to as quickly as possible reverse the bradykinin response, the very response 25 tbe body has engineered to protect itself.
Cold-processed aloe vera extract, with yellow sap and aloin removed, is clinically proven to have a bradykininase effect on humall tissue (fibroblast).
Bradyldninase activity simply means to slow or stop the release of bradyl~n. This `
important "first step' the application of properly processed aloe vera extract, helps 30 calm the affected area and allows for an orderly commencement of the healing process. K. F~jita, R Teradaira, and T. Nagatsu, '~rad~ininase Ac~ of Aloe Extract', Biochem. Pbarm., 205, (August 1975~.
Tissue repair or regeneration takes place during the healing process. There are tbree ways in which the dssue can heal: (1) normal restoration; (2) formation of -;
granuladon dssue (if restoration is delayed); and (3) regeneradon, the replacement of ~ ~
dssue by the same tissue. Van der Meulen et al., commented, ~-WO 93/11780 PCr/US92/083C9 9~ 14 "In man--unlike the salamander, which can regrow an amputated limb--the capaci~ for regeneration is limited to a few cells, which comprise the endothelial cells, the fibroblasts and the epithelial cells."
S The ability for cells to rege~erate deteriorates with age. As people live longer it is importaIIt to fiIld ways to assist in ~he healing and regeneration process.
Allantoin, a derivative of uric acid, is clinically proven to be a cell proliferator. In other words, cells multiply more quickly in the presence of allantoin than without. M.
Szniroqak, and A. Janicki, Pharmazie, 45, 218, (1988).
Just as the body demonstrates a coordinated in~ammation-healing process, the present invention produces a synergy by combining the appropriate aloe vera extract with allantoin to initiate a process to reduce ~ammation-promote healing. The aloe vera reduoes in~ammacion to keep oxygen levels in the cell environment from ~eing reduced. This has the synergi~c e~ect that the aloe vera then allows the allantoin to work more effectively with the surviving cells in a more oxygen rich environment.
The present invention is ho~stic in its approach to healing with the addition o~lavender essential oil, which has been proven to reverse the effects of an~nety and nervous tension characteristically found in patients undergoing trea~ment. Lavender is additive to the aloe vera extract and allantoin, in that it brings peace of mind, aromatherapy, into play while the body works to heal itself. R. Igsserand, ~7~e Art of Aromathera~y, Destiny Books, 95-101, (1977).
Cleanin~ Composi~ons .
The skin/hair cleaning compositions of the present invention comprise, i~
addition to aloe vera extract, allantoin and lavender essential oil, a cosmetically-acceptable surfactant. The term "cosmetically-acceptable surfactant" refers to asurfactant which is not only an effective sldn/hair cleanser, but also can be used without undue toxicity, ir~itation, allergic response, and the like. Furthermore, the surfactant must be capable of being commingled with cold-processed aloe vera extract, with yell~w sap and aloin removed, combined with allantoin and lavenderessential oil, in a manner such that there is no interaction which would substantially reduce the efficacy of the composition for protecting the sldn/hair.
~he sldn/hair cleansing compositions of the present invention contain ~om about 1% to 98~o by weight, preferably 40% to 95% by weight cold-processed aloe vera extract, with yellow sap and aloin removed, combined with 0.10% to 8% by weight preferably 1% to 2% by weight al~antoin, and combined with 0.01 to 2% by weight preferably from 0.03~o to 0.09~ by weight lavender essential oil.
212~190 WO 93/11780 PCI`/US92/08369 The cleaniIlg compositions of the present invention may be made into a wide variety of product types. These include, for example, body lathers, facial lathers, shampoos, and toilet bars.
S EXAA/fPLE I
A therapeutic skin lotion is prepared by combining the following components utilizing conventional mixing techniques.
Therapeutic Skin Lotion Table 2 INGREDIENT I PERCENTAGEBYWEIGHT :~:
~ .~ . _ -Aloe Vera Extract 77.70%
Allantoin 2.00%
Walnut Oil 2.00 Tocopherol Acetate (Vitamin) 2.00~
Stearic Acid 2.00~o 1~Hexadecanol 2.00%
Polysorbate~60 2.00%
Apricot Kernel Oil 2.00%
Jojoba Oil 2.00%
Glyceryl Stearate 2.00%
PEG-100 Stearate 1.00%
Dimethicone 1.00%
Whole Wheat Protein 1.00~o Triethanolamine 0.60~o Carbomer-940 0.20%
Methylparaben 0.20%
Quanternium 15 0.15~o Propylparaben 0.10~
Lavender Essential Oil 0.05~o ."
WO 93/1178~ PCr/US92/08369 EXAMPLE Il A therapeutic skin gel is prepared by combining the ~ollowing components utili~nng conventional mixing techniques.
S Therapeutic Skin Gel Table 3 r~ _ ~ -INGREI)IENTS PERCENTAGE BY WEIGHT
Aloe vera ex~act 93.80%
Allantoin 2.00~o ,~ ,Tocopherol Acetate (vitamin) 2.00~o Triethanom~ne 85% 1.00%
Carbomer-940 .50%
Panthenol .20%
Sodium PCA .20%o Potassium Sorbate .10~o ` Sodium Citrate .10%
Tocopherol .05%
Lavender Essential Oil .05~o W(~ 93/117~0 2 1 2 5 1 9 ~ PCI/IJS9~/08369 EXAMPLE II~
A therapeutic body cleaIlsing lather is prepared by combining the following compo~ents utilizing conventional mixing techniques.
Therapeutic Body Cleansirlg Lather Table 4 __ . . ~
INGREDIENTS PEROENTAGE BY WEIGHT
.~
Aloe Vera Extract 45.20%
Sodium C-14-16 Olefin Sulfona~e 20.00%
~-~ Lecithin 10.00%
Sodium Laureth Sulfate 10.00%
Lauramide DEA 5.00%
CocamidQpropyl Betaine 3.QO~o Allantoill 2.00~
Chamomile Extract 1.00%
Comf~y Extract 1.00~o Calendula 1.00%
Tocopberol Acetate ~Vitamin) 1.00%
Panatbol 0.20%
Sodium PCA 0.20%
Tocopherol 0.15%
Potassium Sorbate 0.10~o Sodium Citrate 0.10%
Lavender Essential Oil 0.05%
... -- ~ . . . ~ ~
Many jalterations may be made by those having ordinaly skill in the art without departing f~om the spirit and scope of the invention. Therefore, it must be 30 understood that the invention described above has been set forth in various examples as an illustration of the irlvention and should be talcen as limiting the invention as de~ed L~l the following claims. The following claims must be construed to include not o~ly what is literally claîmed but all means for performing substantially the same function in substantially the same way to obtain substantially the same result.
In the 1930's, less than one in five was alive at least five years after treatment.
In the 1940's, it was one in four, and in the 1960's, it was one~ in three. Today about 440,000 America~ls, or 4 of 10 patients who get cancer, will be alive five years after diagnosis. The gain from 1 in 3 to 4 in 10 represents about 77,000 persons this year.
The primaly goal of tbe medical community has been to prolong the life of cancer patients. Until recently, and in relatio~ to the growing number of cancerpatients that call e~pect to survive five years or more? the quality of life of the cancer patie~t has received atten~ion.
The onset of radiode~matitis as a result of irradiation in cancer patients is well documensed. It is characterized by congestive or exudative redness of the skin WO 93/11780 PCI`/US92/08369 :
9Q 2 ~;
caused by hyperthermia. Therefore, there is a need for substances effective for treating irradiated skin damage or radiodermatitis.
The topical use of an~i-inflammatory agents to alleviate radiodeTmati~is is known. Such compositions contain combinations of one or more steroidal anti-S inflarnmatories, non-steroidal anti-inilammatories, as well as "natural" anti- ini larmnatories, such as an extract of aloe vera.
The "greying of America" is also well documented. People are living longer and have expectations for a quality life as well as a long life. People a~icted with ~ `
long term illness ruIl t~e risk of getting bed sores, pressure sores and a myriad of sldn ;`
10 irritations due to incontinence.
Looking at the treatment figures for pressure ulcers, just a small part of tbe entire market, one can quuckly see that tbere is a need to develop products that will effectively treat patients with long term illnesses.
'- As part of a study using AMA data on admissions to acute hospitals to derive 15 the number of patients at risk of pressure ulcers, the statistics and forecasts are as follows:
:,~
Pressure Ucleration in US Hospitals Table 1 PATIENTS (1000's) Therefore, there is a need for a substance which will reduce bed sores or ulceradon.
The brad~rldninase activity or ability to reduce swelling which is present in cold-processed aloe vera, with yellow sap and aloin removed, is clinically proven when used in high concentrations. See, K Fluita, R Teradair, and T. Nagatsu, Biochem. Pharm., VOla 25~ 205, 1976.
However, some extracts of aloe vera have been found to be toxic and the applicability of aloe vera for treatment of skin disorders is not generally accepted or ~;
understood. Winters et al. conducted a study to determine the toxicity of yellow sap WO 93J11780 212 ~19 0 PCltUS92/08369 ~:
and aloin on human sl~n cells (fibroblast) that were obtained from human foreskin.
The cells were grown in MEM supplemented with S percent human serum. The yellow sap was tested at 1, 10, 15, and 30 percent and compared to untreated control cells. There was a 100 percent cell kill recorded at all levels when yellow sap was 5 applied to fibroblast. L Danhof, Ph.D, M.D. and B. McAnalley, Ph.D., "Stabil~zed aloe vera EJ~ectonhumanslancells', D&CI,4-5,105-106,(Aug.1983).
Several prior art patents disclose cosmetic/therapeutic formulations including aloe vera. DeNava~e, "Non-irrita~ing Antiper~pirantn U.S. Patent. No. 4,302,443 discloses the use of aloe vera to prevent irritation. DeNavarre does not claim to use 10 fresh aloe vera that has been filleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially anthraquinone-free fillet that is ground, homogenized and processed into a stable aloe vera extract. There is also no combination in DeNavarre with allantoin and lavender essential oil, or any claim for ~-~ the treatment of irradiated sldn, open sores, wounds or abrasio~..
Mihalonts, "Comle~ic Facial Preparat~on Containing Aloe Vera" U.S. Patent.
No. 4,369,180 discloses the use of aloe vera in combination with cornstarch or cosmetic clay, albumin, aUantoin, vitamin A, vitamin D2, and vitamin E. Mihalonts also does not claim to use fresh aloe vera that has been filleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially anthraquinone-free fillet that is then ground, homogenized and processed into a stable aloe vera extract. Mihalovits teaches tbe use of allantoin, but only in formulations at 0.5 % by weight, which is significantly less than the present invention, and makes no claims for the use of lavender essential oil. Mihalovits further makes no cla~ms as a treatrnent for irradiated sldn, open sores, wounds or abrasions.
Millard, ~Shn Treahnent Preparation" U.S. Patent. No. 4,505,902 discloses a formulation which uses aloe vera juice i~ combination with mineral oil, apricot kernel oil, avocado oil, and cod liver oil. Milliard does not claim to use fresh aloe vera that has been filleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially anthraquinone-free fillet that is then groltnd, homogenized and processed into a stable aloe vera extract. There is no teaching to combine it with allantoin and lavender essential oil, and no claims as a treatment for i~radiated sldn, open sores, wounds or abrasions.
Trenzeluk, Hl~ Therapeutic M;XtUK Containing Aloe Vera Extract" U.S
Patent. No. 4,85?,328 discloses a formulation using the dried leaves of the aloe vera plant as the ~erapeutic agent for the treatment of acne, psoriasis, burns, pimples, blackheads, and open sores. Trenzeluk directs the use of dried leaves of the aloe vera plant and does not claim to use fresh aloe vera that has been iilleted with the outer rind, yellow sap and aloin removed by a cold-process to produce a substantially wo 93/11780 PCMlS92/08369 anthraquinone-free fillet that is then ground, homogenized and processed into a stable aloe vera extract. There is not teaching relating to the combination withallantoin and lavender essential oil.
Therefore, it iS an object of the present invention to provide a phase stable 5 topical formulation, which uses the extract from cold-processed aloe vera gel, with yellow sap and aloin removed, combined with allantoin and lavender essential oil, the use of which will provide treatment of radiodermatitis and the chronic effects of radiation exposure without interfering with the radiation therapy, treatment of open sores, wounds or abrasions.
It is also an object of the present invention to provide a pbase stable cleansing composition, wbich uses the extract from cold-processed aloe vera gel, with yellow sap and aloin removed, combined with allantoin and lavender essential oil, the use of which will provide a method for relieving the deleterious e~ects of radiation without interfering with the radiation therapy, treatment of open sores, wounds or abrasions.
Brief SummaIy of the Invention The present invention is a class of formulations containing a high level of cold-processed aloe vera extract, with yellow sap and aloin removed, combined with allantoin and lavender essential oil, and a topical carrier to create a unique therapy 20 for the management of open sores, wounds and abrasions. The anti-inflammatoryaction of aloe vera, used in combinadon with allantoin and lavender essendal oil, has a unique synergistdc effect that is effective in the treatment of open sores, wounds and abrasions. This healing effect of the mixture exceeds that which is known for allantoin alone to help heal wounds and skin ulcers and to stimulate the growth of ~5 healthy tissue.
The present inventdon also relates to formulations useful for treating the radiodermatdtis caused by irradiation on skin comprising the extract from cold-processed aloe vera gel, with yellow sap and aloin removed, combined with allantoin and lavender essential oil, and a safe and effective amount of a topical carrier.
30 ~ The present invention also relates to formulations useful in treating open sores, wounds or abrasions on skin comprising the extract from cold-processed aloe vera gel, with yeDow sap and aloin removed, combined with allantoin and lavenderessential oil, and a safe and effective amount of a topical carrier.
More specifically the inventi~n is a mixture for treatment of irradiated skin~
35 open sores, wounds and abrasions. The mixture comprises a substantially anthraquinone-free cold processed fresh aloe vera extract. The aloe vera extractcomprises from about 1 percent by weight per uI~it volume up to about 98 percent per WO93/~1780 ~l25~l9n Pcr~US92/08369 unit volume. Allantoin comprises from about 0.10 percent by weight per unit volume up to about 8 percent by weight per unit volume. As a result, a combination is provided which synergistically increases the healing eflect of each the mixture over that provided separately by its constituents.
S The mi~ure further comprises a topical carrier. The mîxture still further comprises a nondegradable extract of lavender essential oil from about 0.01 percent by weight per unit volume up to about 2 percent by weight per unit volume.
The mixture may include a cosmetic surfactant and a cosmetic preservative.
In one embodilhent the a~oe vera extract comprises from about 40 percent by weight per unit volume to about 95 percent by weight per unit volume. The allantoin ;;
comprises from about 1 percent by weight per unit volume to about 2 percent by weight per unit volume.
The fresh aloe vera has been processed from an aloe vera plant havi,ng an ~~ outer rind, sap and containing aloin. Tbe outer rind, yellow sap and alo~n are -removed by a conventional cold process to produce the substantially anthraquunone-free aloe vera extract. The anthraquinone-free aloe vera extract is ground, homogeDized and processed into a stable aloe vera extract.
ln anotber embodiment the lavender essential oil comprises from about Q03 percent by weight per unit volume up to about 0.09 percent by weight per unit volume.
Other ratios of the active ingredients are also contemplated in the invention.
For example, the aloe vera extract may comprise about 77.7 percent by weight perunit volume and tbe allantoin comprises about 2 percent by weight per unit volume.
Alternatively, the aloe vera extract comprises about 93.8 percent by weight per unit volume and tbe allantoin comprises about 2.0 percent by weight per unit volume. In yet another embodiment the aloe vera extract comprises about 45.2 percent by weight per unit volume and the allantoin comprises about 2.0 percent by weight per unitvolume.
More generally the invention is a mixture for damaged sldn comprising an element for reducing inflammation of the skin, and an element for simultaneouslyhealing the skin. The element for reducing in~ammation coacts w~th the element for healing the skin to accelerate the action of the element for heallng. The mixture further comprises an dement for calming nervous activity while simultaneously ~-~
prov~ding the element for reducing inflammation and element for healing to -35 holistically coact with eacb other to heal.
The invention can better be understood by turning to the examples in the following detailed description.
WO 93/11780 PCI'/US92/08369 ?.~'~ ' .`
DETAILED DESCRIPI ION OF THE INVENTION
In accordance with the present imvention, there is provided herein folmulations useful for topical application comprising the extract from cold-processed aloe vera gel, with yellow sap and aloin removed, combined with allantoin and S lavender essential oil, and a safe and effective amount of a topical carrier.
According to present invention, a non-ionic skin therapeutic mixture useful for treatment of irradiated skin, open sores, wounds and abrasions is comprised of an extract of cold-processed aloe vera gel, with yellow sap and aloin removed to ensure the bradykininase activity has been preserved during the extracting process. ThemLxture includes in combination allantoin and lavender essential oil to form a unique and synergistic product for enhanced healing with treatment of swelling. Additionally, an effective amount of an acceptable topical carrier or a cosmetically acceptable surfactant, and a cosmetically acceptable preservative is included. The compos'itions of the invention may be in the form of a liquid, creme, ointment, paste, gel or powder.
E~ract of Aloe Vera Gel Aloe is a tropical or subtropical plant that is a member of the lily family.
There are about 325 species of Aloe known, and most are indigenous to Africa. Aloe barbadensis is a native of northern Africa, and was introduced into the island of Barbados in about 1630. Aloe barbadensis Miller has a short, woody stem, and lancelolate embracing leaves, of glaucous green color, with hard, pale spines. It is now grown commercially in the Rio Grande region of Texas.
The mucilaginous jelly from the parenchymal cells of the plant is referred to asaloe vera gel. There are generally no anthraquinones to decompose and cause discoloration of the gel unless the gel is contaminated by an improper processing technique. Aloe vera gel is about 985% water by weight. More than 60% of the total solid is made up of polysaccharides of carbohydrate origin. Organic acids and inorganic compounds, especially calcium oxalate, account for the remainder of the solid.
Whole leaves, exudates and fresb gels of aloe plants have been u;sed for a variety of human alelictions. Evidence of tbeir use as medicinal remedies can betraced to tbe Egyptians of 400 BC. Aloe vera has enjoyed a long history of lay acceptance as possessing "curative" or '~ealing" qualities. Over tbe last few years, numerous books and articles meeting scientific stalldards have been written on aloe vera Aloe vera has been featured extensively in the field of dermatology, especially for treating radiation-caused skin conditions. See, ~ackee, X-Rays and Radium in 212Slgo WO 93/1 1 780 PCI'/US92~08369 `
the Treatment of Diseases of the Skin, 3rd Ed., Lea and Febiger, Philadelphia, 319-320 (1938); Rovalti et al., Industrial Medicine and Surgery, 28: 364-368 (1959).Presently, there has been controversy over the identity of the active substancesin aloe vera. It is therefore important to clearly distinguish between the components S of the present invention and those found in the exudates found in aloe vera that employs the use of the whole leaf without the aloin and yellow sap being removed.
The harvesting and extracting of aloe vera has been hindered by tbe lack of ~-knowledge about the aloe plant and its characteristics. Methods currently employed for the processing of the plant and its components result in end products which do not 10 consistently achieve desired results because of the presence of yellow sap, wbich is known to be cytotoxic to skin. For example, Cobble, U.S. Patent 3,892,853 and Coats, U.S. Patent 4,178,372 both teach a process for producing a~ alleged stabilized (i.e.
bacteriologically stable) aloe juice by extracting the mucilage from the aloe lçaves ~fand adding a mild oxidant (H202). No reference is made to removing yellow sap.15These processes for example, typically involve crushing (pressure rollers), gnnding (e.g., use of Thompson aloe leaf slitter), or pressing (TCX pressure ex~ruder) the entire leaf of the a~oe plant to produce an aloe vera juice, which is f;ltered and used in cosmetics and topical ointments. It can be appreciated that crushing the `
whole leaf of aloe vera and/or chemically altering the substance, without removing 20 the yellow sap, instead of separating the constituents prior to processing, and insuring the removal of all yellow sap, alters the chemical composition of the aloe vera extract.
Winters' conclusion that "The cytotoxic effects of commercially prepared aloe vera gel fractions on normal human and tumor cells in culturen, suggests that these commercial preparations contain substances introduced during commercial 25 processing which can alter the levels of lectin-like activities and can markedly disrupt the in vit70 attachment and growth of human cells". Wmters et al. reported to the instant applicant that he used material received from Coates as a commercial stabilized aloe preparation.
Recent studies indicate that tbe yellow sap found just under the ou~er green 30 waxy surface of the aloe vera plant is toxic to human sldn cells. I.E. Danhof et al., "Stabilized Aloe Vera~ Effect on Human Shn Cells' D & CI, 52-54, 105-106 (August, 1983). He reported the use of products with yellow sap should be minimized in topical products where it can come in contact witb broken or damaged sldn.
Idiosyncratic hypersensitivity bas been demonstrated in processed aloe vera gel tbat 35 consists of a variable mixture of yellow sap. D.M. Morrow, M.D., et al, "~per~e~dM~ ~oAloe', ARCH. DERMATOL, 116, 1064-165 (Sept. 1980).
McAna ey, U.S. Patents 4,966,892, 4,917,890 and 4,73S,935 teach a process for producing an alleged stabilized aloe mucilaginous that is a "substantially"
WO 93/1 1780 PCI`/US92/08369 . .
anthraguinone ~ee extract. No reference is made to color stabili~ or to the removal of aloin to < Sppm. In fact, litera~ure des~ibing the aloe extract obtained using the McAnalley process addresses the inability of the extract to maintain color stability.
While the McAnalley process is an improvement over the Cobble and Coates S methods, it still falls short of reasonable stability expectations and allows for challenge to the overall chemical stability of the product produced-using the McAnalley process.
The invention is directed to use aloe vera that has been extracted in a manner that is chemically stable as well as color stable, that renders the chemical substance 10 substantially non-degradable and can be administered in a prescribed amount. It has been cold-processed to retain all natural en~natic activities and to preserve heat sensitive constituents. It is prepared from mature leaves, ha~vested at peak conditions. Aloin is removed by non-chemical means (<5ppm in 1:1 aloe vera) to ~ obviate leeching of natural ingredients. The aloe vera gel is treated with a unique 15 double control system that guarantees microbiological stab~ity. It is subjected to rigorous quality control procedures that assure enviable batch-to-batch consistency for a bota~ically derived product.
Allantoin Allantoin has not suf~ered from the challenge to its ef~ectiveness that al~e vera extract has had to endure. Allantoin is chemically a diureide of glyoxylic acid and thus is an urea derivative. Its use as a therapeutic agent in dermatology was based formerly on its ability to facilitate the removal of necrotic tissue and to stimulate wound healing by promoting cell proliferation. E. Young, '~llantoin in Treatment of Psoriasis', Dermatologica, 147: 338-341 (1973). It can be prepared synthetically by the oxidation of uric acid or by headng uric acid with dichloroacetic acid. Uric acid is prepared from urea and is present in the unne of all carnivorous animals.
Allantoin is an important ingredient which stimulates healing of wounds, and burns and which increases hydration and elasticity of sldn. M. Sznitowska and S
Janicki, 'The, Effect of Vehicle on Allantoin Penetration into Human S~an from an Ointment for Improving Scar Elasticity', Department of Pharmaceutical Technology, Medical Academy, Gdanks, Poland (Oct. 1987).
The FDA-OTC Topical Analgesic Review Panel recently classified allantoin in Category I (~afe and Effective) as an active skin "protectant." The FDA monograph on sldn protectant published in the Federal Register (Vol.43 No. 151) on August 4, 1978, stated that, based on the wide use and clinical acceptance of allantoin, as well WO93J11780 212519~ PCr/US92/08369 as on published reports in the literature, the Panel approved the following statements for products containing allantoiD:
'Temporarily relieves, protects, soothes, gives comfort to minor skin i~Titations, such as chapping, peeling, scaling, minor burns, sunburn, windburn, scrapes, abrasions or cracked lips."
While the attributes of allantoin bave been clinically proven and the FDA has :
classiiied it in Category I (Safe and Effective~, there remain di~culties in themanufactunng process as related to allantoin with a mesh size of 200 or less.
Allantoin is water soluble to 0.50%, according to A. Fisher,M.D., '~Allantoin: ANon-sensiti~ng Topical Medicament: Therapeutic Effects of the Addition of S.aO%
A~lantoin to Vaseline' CulTnet Contact News, vol. 27, 23~231, 23~235, (Marchl981). ~ -The industry standard 200 mesh particle size, when used in higher by-weight percentages (over 0.50~o), tends to crystalize and fall-out. Fall-out reduces the ;
~~ effectiveness of the mixture and crystallization alters the texture.
In order to overcome fall-out and crystallization the present invention is directed to use 400 mesh allantoin or finer. A unique process micronizes the allantoin in a manner that allows for the reduction of particle size by 50%. Four hundred mesh allanto~n provides for improved product shelf-life, reduced crystallization, and greater absorption of the ingredient into the rni~ture.
;
Ei~trac~ of Lavender Lavender is a shrubby plant indigenous to the mountainous regions of the countries bordering the westerll half of the Mediterranean, and cultivated ex~ensively for its aromatic flowers in various parts of France, Italy and England. There are four major varieties of lavender. One is spike lavender (Lavandula Latifolia). This is a strong growing shrub that grows naturally at lower altitudes around the northernMediterranean shore, particularly Spain and Italy. A second is true lavender (Lavandula angustifolia). This is a dwarf shrub that is distinguished from all others by being camphor free. Its natural habitat is restricted to a small area above 1000 meters altitude in the southern French Alps. A third is lava~din (Hybrid: L Latifolia X L angustifolia). This is grown as a natural hybrid at medilml altitudes in the south of France. It has a high camphor content.
Finally, there is Lavendula offlcinalis. This is the true lavender which grows wild at altitudes of 700 1100 meters in southern France. The preferred embodiment of the i~vention directs the use of extracts derived from the flowers and leave from the Lavendula offianalis.
WO 93~1 1780 PC~/US92/08369 ?~?J The Greeks called lavender by the name Nardus, from Naarda, a city of Syria near the Euph~ates. St. Mark mentions it as Spikenard, a thing of great value...In Pliny's time, blossoms of the nardus, called asarum by the RomaIls, sold for a hundred Roman denarii. The Romans use of lavender is well documented. Lavender is also S cited as one of the ingredients of the 'Four Thieves' vinegar famous in the Middle Ages.
The use of lavender in the present invention employs the belief that a patient must be treated holistically. Bach et al., stated 'the second du~ of the physician will be to administer such remedies as will help the physical body to gain strength and assist the mind to become calm'.
Essences work organically and can replace the use of tranquilizers. There use dates back to antiquity when such physicians as Galen aIld Celsus used aromatic herbs as remedies against hysterical convulsions, and reported that they sometimes stopped attacks immediately Unlike the modem sleeping pill, essences are not mere sedatives. Most of them are very pleasant to smell providing the uplifting effect, a more positive attribute than for that of a sedative. R. l~sserand, '~e Art of Aromatkera~y', Destiny Books, 95-101, (1977).
Mme Maury et al. stated, 'but of the greatest interest is the effect of the fragrance on the psychic and mental state of the individual. Powers of perception become clearer and more acute, and there is a feeling of having to a certain e%tent, outstripped events. They are seen more objectively and therefore in ~ruer perspective. It might even be said the emotional trouble which in general obscures our perception is practically suppressed'.
Professor Rovesti has studied tbe effects of essences on the human psyche and 25 states:
"According to sociologists and neurologists the salient characteristics of our age are those of anxiety and depression, and material proof of this is available in the even higher figures shown for the consumption of tranqllili7ers and stimulants. It is well known that disturbance and toxicosis can be caused by these products if taken regularly. "
"Both neuroses often causes aversion to any t~pe of pleasure, by producing a sense of weariness which many people are unable to overcome. "
'The possibility of applying new therapies to these widespread psycho-neuroses is therefore of considerable importance. "
"For such purposes, therefore, interest attaches to the use of essential oils as aids, or even as sole remedies in psychotherapy. "
WO93/11780 21~Slgo P~/US92/0~369 ~
' The matter is of still further interest, since ~he essential nils that are employed in aromatherapy, in the appropriate doses, are harmless to the organism and do not cause troubles like those produced by the ordinary psychological drugs. VeIy conclusive e~eriments in this direction have been carried out in various clinics for nervous diseases, on patients af~ected by hysteria or pSy~:hiG depression."
Lavender is listed as aIl ef~ctive means to improve the physical condition of patients in two areas. It is mentioned i~ the treatment of anxiety alld nelvous te~sion, and for depression and melancholy. R ISsserand, 'The art of aromatherap~', Destiny Books, 95-101, (1977).
The trust of lavender is still widely held in Europe. Some of this trust is founded upon the use of lavender dumlg World War I to swab the wounds of so~diers.
~' The French Academy of Medicine is giViDg attention to the oil of lavender for this and other antiseptic surgical purposes. The oil is successfully used in the,treatment of sores, varicose ulcers, bu~ns and scalds. Peter Smith, et al,; and GrieYe, A Modern Herbal, vol. 2, 467~73 ~1981).
French chemist Rene-Maurice Gattefosse found early in t~is centuly, a~
essential-oil house that produced oil for use in cosmetics and fragrances. It is alleged one day Gattefosse burne~ his hand in his laboratoIy. Remembe~ g that lavender was supposed to heal burns and reduce inflammation, he immediately immersed his hand in a container of pure lavender on his workbench. The burn quickly lsst itsredness, and began to heal.
French lavender is rich in foLklore. It has been endowed with many rich qualities. Used externally, it is believed to be antiseptic and disinfectant. It is believed to be helpful in healing wounds, sore and sldn ulcers.
The halvesting of lavender takes great care. The stalks of laYender are spread out in the operl, on trays or sieves, in a co~l, shady place, out of the sun, so that they may dry slowly. The trays are raised a few feet from the ground, to ensure a walm current of air, and the stems are not allowcd to touch, or the fl~wers will be spoiled by the moist heat engendered. Lavender is taken indoors before there is any risk of getting damp either by dew or showers. ~en dry, it is stored in a dry place and the flowers stripped from the staL~s and dried by a moderate heat.
The curre~t invention is directed to use lave~der that has been e~tracted in a manner that renders the chemical substance substantially non-degradable and can be a~stered in a prescribed amount. It has been cold-processed to retain all natural activities and to preserve heat sensitive constituents. It is prepared from flowers and leaves of mature pla~its, harvested at peak conditions. The lavender is subjected to WO 93/~1,178~ PCI/U~92/08369 ~,~'l,5~9~ 12 rigorous quality control procedures that assure enviable batch-to-batch consi~tency ~or a botan~cally derived produ~.
Topical Compositions In addition to the active agents of extract of cold-processed aloe vera, with yellow sap and aloin removed, combined with allantoin and lavender esse~tial oil, ~he compositions of the present inventis:~n contains a safe and eflective amount of an acceptable topical carrier. The term "acceptable topical carrier" encompassss both pharmaceutically-acceptable carners and cosmetically-acceptable carriers, and encompasses substantially non-ilTitating compatible components ~either taken alone or in mixtures) which are suitable for delivering the active components to the sldn.
The term "compatible", as used herein, means that the components of the ca~rier ~-~must be capable of being commingled with cold-processed aloe vera extract, with yellow sap and alo~n removed, combined with allanto~n and lavender essential oil, in a manner such that there is no interaction which would substalltially reduce theefficacy of the composition during use for protecting the sldn from the eff~cts of radiation and in the treatment of open sores, wounds or abrasions. These carriers must, of course, be of sufficiently high purity alld sufficiently low to~acity to render them suitable for chronic topical a~inistration to the sl~ of humans or lower animals. The term "safe and effective amount" of carrier means an amount suf~icient to deliver the aloe vera extract to the skin but not so much as to cause any side effects or skin reactions.
The topical compositions of the present invention contain generally from about 1% to 98% by weight preferably from about 40~o to 95% by weight cold-processed aloe vera extract, with yellow sap and aloin removed, combined with 0.10~o to 8% by weight preferably from 1% to 2~o by weight allantoin, and combined withfrom 0.01% to 2~o by weight preferably from 0.03 to 0.09% by wei8ht lavender essential oil.
Variations in formulation of these camers will result in a wide variety of products w~ich fall within the scope of the present invention. These product ~pes can be divided into hvo classes: pharmaceutical/cosmetic compositions and cleaning compositions. ;
, Pharmaceutical/Cosme~ic Composihons The invention relates to mixtures contai~ing cold-processed ialoe vera extract with yellow sap iand aloin removed in combination with allantom iand lavender essential oil. The phalmaceuticial/cosmetic compositions, of the present invention 212Slgo :,`
WO 93/11780 PCr/US92/08369 may be made into a wide varie~y of product ~pes. ~hese include, for example, lotions, creams, gels, sprays, ointments, rinses, ~oothpaste and powders.
It has been said, "We know more about traveling into space than how the body repairs itsel~'. At birth, a baby's body knows more about the healing process than the S combined knowledge of man. An injury to the soft tissues of the body starts a complicated chain of events that have ouh~ard manifestations including, redness,hea~ swelling, p~in and tissue death due to the loss of o~ygen to the area. These events take place within minutes of an injury. One of the body's fundamental reactions to injury is acute inflammation. It is the body's way to protect, localize and -10 rid the body of injurious agents in preparation for healing and repair. Inflammation is a natural way in which pain is used to cause a change in the behavior of the animal to avoid reinjury of the affect site until healing is completed.
It is import~ant to note the two distinct bodily activities. First, the,body ~~ responds with inflammation as a way to protect itself and rid itself of injurious agents.
15 Secondly, the body starts the healing and repair phase.
A key event that takes place in the "first stage" of soft tissue trauma is a chemical response called bradykinin which results in the creation of pain. This is the release of a peptide tbradykin), which is a fragment of a large protein molecule that circulates in the blood stream. When tissue is damaged in any way, tiny capillaries 20 break rele~sing bradykin into the affected area. The release of bradykin also triggers a chemical reaction know to be r~sponsible for sending the pain message to the brain.
During the brady~nin response cellular death occurs, due to the loss of oxygen to the cells, caused in part by inflammation. If cell loss is to be minirnized, it is important to as quickly as possible reverse the bradykinin response, the very response 25 tbe body has engineered to protect itself.
Cold-processed aloe vera extract, with yellow sap and aloin removed, is clinically proven to have a bradykininase effect on humall tissue (fibroblast).
Bradyldninase activity simply means to slow or stop the release of bradyl~n. This `
important "first step' the application of properly processed aloe vera extract, helps 30 calm the affected area and allows for an orderly commencement of the healing process. K. F~jita, R Teradaira, and T. Nagatsu, '~rad~ininase Ac~ of Aloe Extract', Biochem. Pbarm., 205, (August 1975~.
Tissue repair or regeneration takes place during the healing process. There are tbree ways in which the dssue can heal: (1) normal restoration; (2) formation of -;
granuladon dssue (if restoration is delayed); and (3) regeneradon, the replacement of ~ ~
dssue by the same tissue. Van der Meulen et al., commented, ~-WO 93/11780 PCr/US92/083C9 9~ 14 "In man--unlike the salamander, which can regrow an amputated limb--the capaci~ for regeneration is limited to a few cells, which comprise the endothelial cells, the fibroblasts and the epithelial cells."
S The ability for cells to rege~erate deteriorates with age. As people live longer it is importaIIt to fiIld ways to assist in ~he healing and regeneration process.
Allantoin, a derivative of uric acid, is clinically proven to be a cell proliferator. In other words, cells multiply more quickly in the presence of allantoin than without. M.
Szniroqak, and A. Janicki, Pharmazie, 45, 218, (1988).
Just as the body demonstrates a coordinated in~ammation-healing process, the present invention produces a synergy by combining the appropriate aloe vera extract with allantoin to initiate a process to reduce ~ammation-promote healing. The aloe vera reduoes in~ammacion to keep oxygen levels in the cell environment from ~eing reduced. This has the synergi~c e~ect that the aloe vera then allows the allantoin to work more effectively with the surviving cells in a more oxygen rich environment.
The present invention is ho~stic in its approach to healing with the addition o~lavender essential oil, which has been proven to reverse the effects of an~nety and nervous tension characteristically found in patients undergoing trea~ment. Lavender is additive to the aloe vera extract and allantoin, in that it brings peace of mind, aromatherapy, into play while the body works to heal itself. R. Igsserand, ~7~e Art of Aromathera~y, Destiny Books, 95-101, (1977).
Cleanin~ Composi~ons .
The skin/hair cleaning compositions of the present invention comprise, i~
addition to aloe vera extract, allantoin and lavender essential oil, a cosmetically-acceptable surfactant. The term "cosmetically-acceptable surfactant" refers to asurfactant which is not only an effective sldn/hair cleanser, but also can be used without undue toxicity, ir~itation, allergic response, and the like. Furthermore, the surfactant must be capable of being commingled with cold-processed aloe vera extract, with yell~w sap and aloin removed, combined with allantoin and lavenderessential oil, in a manner such that there is no interaction which would substantially reduce the efficacy of the composition for protecting the sldn/hair.
~he sldn/hair cleansing compositions of the present invention contain ~om about 1% to 98~o by weight, preferably 40% to 95% by weight cold-processed aloe vera extract, with yellow sap and aloin removed, combined with 0.10% to 8% by weight preferably 1% to 2% by weight al~antoin, and combined with 0.01 to 2% by weight preferably from 0.03~o to 0.09~ by weight lavender essential oil.
212~190 WO 93/11780 PCI`/US92/08369 The cleaniIlg compositions of the present invention may be made into a wide variety of product types. These include, for example, body lathers, facial lathers, shampoos, and toilet bars.
S EXAA/fPLE I
A therapeutic skin lotion is prepared by combining the following components utilizing conventional mixing techniques.
Therapeutic Skin Lotion Table 2 INGREDIENT I PERCENTAGEBYWEIGHT :~:
~ .~ . _ -Aloe Vera Extract 77.70%
Allantoin 2.00%
Walnut Oil 2.00 Tocopherol Acetate (Vitamin) 2.00~
Stearic Acid 2.00~o 1~Hexadecanol 2.00%
Polysorbate~60 2.00%
Apricot Kernel Oil 2.00%
Jojoba Oil 2.00%
Glyceryl Stearate 2.00%
PEG-100 Stearate 1.00%
Dimethicone 1.00%
Whole Wheat Protein 1.00~o Triethanolamine 0.60~o Carbomer-940 0.20%
Methylparaben 0.20%
Quanternium 15 0.15~o Propylparaben 0.10~
Lavender Essential Oil 0.05~o ."
WO 93/1178~ PCr/US92/08369 EXAMPLE Il A therapeutic skin gel is prepared by combining the ~ollowing components utili~nng conventional mixing techniques.
S Therapeutic Skin Gel Table 3 r~ _ ~ -INGREI)IENTS PERCENTAGE BY WEIGHT
Aloe vera ex~act 93.80%
Allantoin 2.00~o ,~ ,Tocopherol Acetate (vitamin) 2.00~o Triethanom~ne 85% 1.00%
Carbomer-940 .50%
Panthenol .20%
Sodium PCA .20%o Potassium Sorbate .10~o ` Sodium Citrate .10%
Tocopherol .05%
Lavender Essential Oil .05~o W(~ 93/117~0 2 1 2 5 1 9 ~ PCI/IJS9~/08369 EXAMPLE II~
A therapeutic body cleaIlsing lather is prepared by combining the following compo~ents utilizing conventional mixing techniques.
Therapeutic Body Cleansirlg Lather Table 4 __ . . ~
INGREDIENTS PEROENTAGE BY WEIGHT
.~
Aloe Vera Extract 45.20%
Sodium C-14-16 Olefin Sulfona~e 20.00%
~-~ Lecithin 10.00%
Sodium Laureth Sulfate 10.00%
Lauramide DEA 5.00%
CocamidQpropyl Betaine 3.QO~o Allantoill 2.00~
Chamomile Extract 1.00%
Comf~y Extract 1.00~o Calendula 1.00%
Tocopberol Acetate ~Vitamin) 1.00%
Panatbol 0.20%
Sodium PCA 0.20%
Tocopherol 0.15%
Potassium Sorbate 0.10~o Sodium Citrate 0.10%
Lavender Essential Oil 0.05%
... -- ~ . . . ~ ~
Many jalterations may be made by those having ordinaly skill in the art without departing f~om the spirit and scope of the invention. Therefore, it must be 30 understood that the invention described above has been set forth in various examples as an illustration of the irlvention and should be talcen as limiting the invention as de~ed L~l the following claims. The following claims must be construed to include not o~ly what is literally claîmed but all means for performing substantially the same function in substantially the same way to obtain substantially the same result.
Claims (20)
1. A mixture for treatment of irradiated skin, open sores, wounds and abrasions, said mixture comprising:
a substantially anthraquinone-free filet of fresh aloe vera extract which is ground, homogenized and cold processed to form a stable extract, said aloe vera extract comprising from about 1 percent by weight per unit volume up to about 98 percent per unit volume; and allantoin comprising from about 0.10 percent by weight per unit volume up to about 8 percent by weight per unit volume, whereby a combination is provided which synergistically increases the healing effect of each said mixture over that provided separately by its constituents.
a substantially anthraquinone-free filet of fresh aloe vera extract which is ground, homogenized and cold processed to form a stable extract, said aloe vera extract comprising from about 1 percent by weight per unit volume up to about 98 percent per unit volume; and allantoin comprising from about 0.10 percent by weight per unit volume up to about 8 percent by weight per unit volume, whereby a combination is provided which synergistically increases the healing effect of each said mixture over that provided separately by its constituents.
2. The mixture of Claim 1 further comprising a topical carrier.
3. The mixture of Claim 1 further comprising a nondegradable extract of lavender essential oil from about 0.01 percent by weight per unit volume up to 2 percent by weight per unit volume.
4. The mixture of Claim 1 further comprising a cosmetic surfactant.
5. The mixture of Claim 1 further comprising a cosmetic preservative.
6. The mixture of Claim 1 wherein said aloe vera extract comprises from about 40 percent by weight per unit volume to 95 percent by weight per unit volume.
7. The mixture of Claim 1 wherein said allantoin comprises from about 1 percent by weight per unit volume to 2 percent by weight per unit volume.
8. The mixture of Claim 6 wherein said allantoin comprises from about 1 percent by weight per unit volume to 2 percent by weight per unit volume.
9. The mixture of Claim 1 wherein said fresh aloe vera has been processed from an aloe vera plant having an outer rind, sap and containing aloin, said outer rind, yellow sap and aloin being removed by a cold process to produce saidsubstantially anthraquinone-free aloe vera extract.
10. The mixture of Claim 9 wherein said anthraquinone-free aloe vera extract is ground, homogenized and processed into a stable aloe vera extract.
11. The mixture of Claim 3 wherein said lavender essential oil comprises from about 0.03 percent by weight per unit volume up to about 0.09 percent by weight per unit volume.
12. The mixture of Claim 1 wherein said aloe vera extract comprises about 77.7 percent by weight per unit volume and said allantoin comprises about 2 percent by weight per unit volume.
13. The mixture of Claim 1 wherein said aloe vera extract comprises about 93.8 percent by weight per unit volume and said allantoin comprises about 2.0 percent by weight per unit volume.
14. The mixture of Claim 1 wherein said aloe vera extract comprises about 45.2 percent by weight per unit volume and said allantoin comprises about 2.0 percent by weight per unit volume.
15. A mixture for damaged skin comprising:
a substance for reducing inflammation of said skin; and a substance for simultaneously healing said skin, said substance for reducing inflammation coacting with said substance for healing said skin to accelerate action of said substance for healing.
a substance for reducing inflammation of said skin; and a substance for simultaneously healing said skin, said substance for reducing inflammation coacting with said substance for healing said skin to accelerate action of said substance for healing.
16. The mixture of Claim 15 further comprising a substance for calming nervous activity while simultaneously providing said substance for reducing inflammation and said substance for healing to holistically coact with each other to heal.
17. The mixture of Claim 15 wherein said substance for reducing inflammation is cold processed anthraquinone-free aloe vera comprising not less than about 1 percent by weight per unit volume.
18. The mixture of Claim 15 wherein said substance for healing comprises allantoin of not less than about 1 percent by weight per unit volume.
19. The mixture of Claim 16 wherein said substance for calming comprises lavender essential oil of not less than about 0.01 percent by weight per unit volume.
20. A mixture for damaged skin comprising:
means for reducing inflammation of said skin; and means for simultaneously healing said skin, said means for reducing inflammation coacting with said means for healing said skin to accelerate said means for healing.
means for reducing inflammation of said skin; and means for simultaneously healing said skin, said means for reducing inflammation coacting with said means for healing said skin to accelerate said means for healing.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/803,508 US5266318A (en) | 1991-12-09 | 1991-12-09 | Skin therapeutic mixture containing cold-processsed aloe vera extract, with yellow sap and aloin removed |
| US07/803,508 | 1991-12-09 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2125190A1 true CA2125190A1 (en) | 1993-06-24 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002125190A Abandoned CA2125190A1 (en) | 1991-12-09 | 1992-09-30 | Skin therapeutic mixture containing cold-processed aloe vera extract, with yellow sap and aloin removed |
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|---|---|
| US (1) | US5266318A (en) |
| EP (1) | EP0621787A4 (en) |
| JP (1) | JPH07505133A (en) |
| CA (1) | CA2125190A1 (en) |
| WO (1) | WO1993011780A1 (en) |
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| US6649194B2 (en) * | 2001-04-03 | 2003-11-18 | Roger S. Salmonson | Topical analgesics and methods of use |
| EP1416948A1 (en) | 2001-08-13 | 2004-05-12 | Riley, Michael Hargreaves | Compositions for removal of toxins |
| FR2829928B1 (en) * | 2001-09-24 | 2003-11-21 | Clarins Lab | COSMETIC COMPOSITION FOR THE CARE OF HUMAN SKIN AND HAIR |
| US7157106B2 (en) * | 2002-04-01 | 2007-01-02 | Salmonson Roger S | Topical analgesic and methods of use |
| US7205012B1 (en) * | 2005-02-25 | 2007-04-17 | Hill Wendy L | Scar reducing and massage emollient |
| US20070003632A1 (en) * | 2005-06-30 | 2007-01-04 | Lapointe Jennifer H | Burn treatment formulation and method of treating burns |
| US20070014881A1 (en) * | 2005-07-13 | 2007-01-18 | Ingrid Harder-Tolar | Cosmetic formulations and skin treatment |
| US20070098670A1 (en) * | 2005-11-01 | 2007-05-03 | Melissa Jochim | Compositions and methods for using juice organic, juice based skin care products |
| US8057830B2 (en) * | 2006-03-21 | 2011-11-15 | Access Business Group International Llc | Cleansing compositions and methods of reducing skin irritation |
| ITPD20080084A1 (en) * | 2008-03-14 | 2009-09-15 | Stefano Sala | COMPOSITION INCLUDING ALOE PURE AND ITS USE AS A COSMETIC BASE |
| US8591960B2 (en) * | 2008-04-22 | 2013-11-26 | Boris Gorinshteyn | Composition and method for treating bedsores, cuts and burns |
| US8173183B2 (en) * | 2008-07-02 | 2012-05-08 | Carmell Hergert | Mucosal membrane healant and moisturizer |
| US20110165276A1 (en) * | 2009-08-19 | 2011-07-07 | Rufus Coley | Composition for burn treatment |
| CA2684258A1 (en) | 2009-11-03 | 2011-05-03 | Guy Chamberland | Compositions comprising plant extracts and methods of treating wounds, burns and skin injuries therewith |
| KR101702056B1 (en) * | 2009-11-16 | 2017-02-03 | 주식회사 유니베라 | Baby Aloe vera concentrate or extract having excellent effects of promotion of skin cell proliferation, antioxidant and anti-allergy |
| WO2011123619A2 (en) * | 2010-03-31 | 2011-10-06 | Penguin Ip Holdings Inc. | Permeable mixtures, methods and compositions for the skin |
| US8466335B2 (en) | 2010-04-26 | 2013-06-18 | The Procter & Gamble Company | Personal care product |
| US8685309B2 (en) | 2010-04-26 | 2014-04-01 | The Procter & Gamble Company | Method for making a personal care product |
| WO2013033365A2 (en) * | 2011-08-30 | 2013-03-07 | Biorestorative Therapies, Inc. | Stem cell compositions and methods |
| WO2013103944A1 (en) * | 2012-01-07 | 2013-07-11 | Aloe Baby, Llc | Compositions and methods for treating skin conditions |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS55104205A (en) * | 1979-02-01 | 1980-08-09 | Lion Corp | Cosmetics for skin |
| US4369180A (en) * | 1981-09-10 | 1983-01-18 | Randolph C. Karrh | Cosmetic facial preparation containing aloe vera |
| US4627934A (en) * | 1985-01-25 | 1986-12-09 | International Flavors & Fragrances Inc. | Single phase clear liquid after-shave treatment product containing aloe vera |
| US5122418A (en) * | 1985-12-09 | 1992-06-16 | Shiseido Company Ltd. | Composite powder and production process |
| US5002760A (en) * | 1989-10-02 | 1991-03-26 | Katzev Phillip K | Retinol skin care composition |
-
1991
- 1991-12-09 US US07/803,508 patent/US5266318A/en not_active Expired - Lifetime
-
1992
- 1992-09-30 JP JP5510877A patent/JPH07505133A/en active Pending
- 1992-09-30 EP EP92921973A patent/EP0621787A4/en not_active Withdrawn
- 1992-09-30 CA CA002125190A patent/CA2125190A1/en not_active Abandoned
- 1992-09-30 WO PCT/US1992/008369 patent/WO1993011780A1/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| EP0621787A4 (en) | 1995-01-18 |
| EP0621787A1 (en) | 1994-11-02 |
| WO1993011780A1 (en) | 1993-06-24 |
| US5266318A (en) | 1993-11-30 |
| JPH07505133A (en) | 1995-06-08 |
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