WO2013072852A1 - Stretch mark preventer - Google Patents

Abstract

The present invention discloses a botanical composition that may be used for the care of the skin and lips, more specifically for preventing stretch marks; the methods comprising application/ administration of a composition that may include sweet or bitter almond in combination with avocado, lavender, chamomile, calendula and citrus; with turmeric, neem and/or their extracts. Also disclosed herein are methods of production of the composition and methods of using such composition that may include the prevention and inhibition of striae and scars among other skin diseases or conditions. It can also be used as a spray, roll-on, occlusive bandage, and wet wipes or in any other presentation, such as microsomes, liposomes and the like; preferably for topical use (I).

Description

STRETCH MARK PREVENTER Technical Field

[001]The information discosed in this patent relates to a botanical formulation that may be used on skin to prevent stretch marks and to revitalise and moisturise skin.

Background Art

Patent Number	Filing Date	Issue Date	Applicant	Original Assignee	Title
US5444091	24-05-1994	22-08-1995	Rappaport et al	Dermatology Home Products, Inc	Method of applying alpha hydroxy acids for treating striae distensae
US6809075	30-05-2000	26-10-2004	Mitte et al	ConnectiveTissue Imagineering LLC	Elastin peptide analogs and uses of same in combination with skin enhancing agents
US7429386	03-09-2004	30-09-2008	First	Allergan, Inc.	Stretch Mark treatment
US7176217	13-11-2002	13-11-2002	Hiruma et al	Shiseido Co. Ltd	Azabicyclo compound matrix metalloprotease inhibitor and skin preparations
US7887842	08-01-2004	15-02-2011	Koo et al	Teikoku Pharma USA, Inc; Teikoku Seiyaku Kabushiki Kaisha	Methods of administering a dermatological agent to a subject
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US6840910	01-08-2001	11-01-2005	Skover	Johnson & Johnson Consumer Care, Inc.	Method of distributing skin care products
US6495147	02-05-2000	17-12-2002	Dumas et al	LVMH Recherche	Uses of D-xylose, the esters thereof and oligosaccharides containing xylose for improving the functionality of cells
US6319942	06-06-2001	20-11-2001	Perricone		Topical scar treatments using alkanolamines
US6333356	08-05-2000	25-12-2001	Ptchelintsev et al	AVONProducts, Inc.	Compounds for treating skin conditions
US6299620	30-12-1999	09-10-2001	Shadduck et al	AQ Technologies, Inc.	Instruments and techniques for inducing neocollagenesis in skin treatment
US6221911	03-09-1998	24-04-2001	Lavin et al	Karo Bio AB (Huddinge, SE)	Uses for thyroid hormone compounds or thyroid hormone-like compounds
US4603146	26-07-1985	29-07-1986	Kligman		Methods for retarding the effects of aging of the skin
US7862564	31-10-2006	04-01-2011	Goble	Plasmogen Inc	Method of remodeling Stretch marks
US7981409	14-04-2009	19-07-2011	Vitkalova et al	United Technologies UT AG	Method of reducing Aging Skin
US20120142684	29-11-2011		Burk et al	Allergan Inc.	Compounds and methods for skin repair
US20110014251	02-01-2009		Ray	Lydac Neuroscience Limited	Microvesicles

OTHER PUBLICATIONS:

1. Dobrev H: Modern Practical Skin Functional Dignostics Folia Medica 2002; 44(3):5-10.
2. Dobrev H. Changes in the water content of epidermis following single application of various humidifying agents. DermatolVenereol (Bulgaria) 1997, 36 (2): 11-13.
3. JP Gage, MTO Francis, JT Tiffit. Collagen and Dental Matrices, Wright Publishers, 1989; pages 1-24.
4. 'Aflatoxins in food'. European Food Safety Authority. 2010. http://www.efsa.europa.eu/en/topics/topic/aflatoxins.htm
5. 'The Food Safety Program & Almond Pasteurization'. Almond Board of California. copyrighted 2012. http://www.almondboard.com/Handlers/FoodQualitySafety/Pasteurization/Pages/Default.aspx
6. 'Almonds: Cholesterol lowering, heart-healthy snack' (Press release). Porter Novelli. September 2002..http://www.scienceblog.com/community/older/2002/D/20024677.html
7. Venkatachalam M and Sathe S (2006).'Chemical Composition of Selected Edible Nut Seeds'.J. Agric. Food Chem.54 (13): 4705-4714.http://pubs.acs.org/doi/abs/10.1021/jf0606959.
8. Toda S, Miyase T, Arich H, et al. Natural antioxidants. Antioxidative compounds isolated from rhizome of Curcuma longa L. ChemPharmacol Bull 1985;33:1725-1728.
9. Chandra D, Gupta S. Anti-inflammatory and anti-arthritic activity of volatile oil of Curcuma longa (Haldi).Indian J Med Res 1972;60:138-142.
10. Apisariyakul A, Vanittanakom N, Buddhasukh D. Antifungal activity of turmeric oil extracted from Curcuma longa (Zingiberaceae). J Ethnopharmacol1995; 49: 163-169
11. Rasmussen HB, Christensen SB, Kvist LP, Karazami A. A simple and efficient separation of the curcumins, the antiprotozoal constituents of Curcuma longa. Planta Med 2000; 66:396-398.
12. Kulkarni RR, Patki PS, Jog VP, et al. Treatment of osteoarthritis with a herbomineral formulation: a double-blind, placebo-controlled, cross-over study. J Ethnopharmacol1991; 33:91-95.
13. Dobrev H. How do cosmetics improve the skin mechanical properties? 18th Congress of the European Academy of Dermatology &Venereology(EADV), October 7-11, 2009, Berlin, Germany. J EurAcadDermatolVenerol2009 (Suppl.)
14. Dobrev H. Age related changes in the mechanical properties of human skin.DermatolVenereol (Bulgaria) 1999, 38 (2): 21-25
15. Dobrev H. Impact of three different emulsions on skin hydration and elasticity. II. Spring Symposium of the European Academy of Dermatology & Venereology (EADV), April 29 - May 1, 2004, Budapest, Hungary. J EurAcadDermatolVenerol 2004, 18, Suppl.1: 53.
16. Kanno et al, Journal of Investigative Dermatology 2008, 128; 2792-2797.
17. Dobrev H. In vivo noninvasive study of the mechanical properties of human skin after a single application of topical corticosteroids. Folia Med (Plovdiv) 1996, 38 (2): 11-17
18. Dobrev H. Photoaging and skin elasticity. Research Reports of the Union of Scientists in Bulgaria - Plovdiv. Annual, Series B. Natural Sciences and Humanities, Vol. 1. (Plovdiv) 2000: 117-120.
19. Morton, J. 1987. Avocado. p. 91-102. In: Fruits of warm climates. Julia F. Morton, Miami, FL. http://www.hort.purdue.edu/newcrop/morton/avocado_ars.htm
20. Shiina Y, Funabashi N, Lee K, Toyoda T, Sekine T, Honjo S, Hasegawa R, Kawata T, Wakatsuki Y, Hayashi S, Murakami S, Koike K, Daimon M, Komuro I.,'Relaxation effects of lavender aromatherapy improve coronary flow velocity reserve in healthy men evaluated by transthoracic Doppler echocardiography.' Int J Cardiol. 2008 Sep 26;129(2):193-7
21. Hwang JH.,'The effects of the inhalation method using essential oils on blood pressure and stress responses of clients with essential hypertension'Taehan Kanho Hakhoe Chi. 2006 Dec;36(7):1123-34
22. Woelk, H.; Schläfke, S. (2010). 'A multi-center, double-blind, randomised study of the Lavender oil preparation Silexan in comparison to Lorazepam for generalized anxiety disorder'. Phytomedicine17 (2): 94-99. doi:10.1016/j.phymed.2009.10.006. PMID19962288.
23. Cavanagh H, Wilkinson J. Lavender essential oil: a review. Australian Infection Council, March 2005, Vol 10 Issue 1. http://www.publish.csiro.au/?act=view_file&file_id=HI05035.pdf
24. Günther Ohloff, Wilhelm Pickenhagen, Philip Kraft: 'Scent and Chemistry - The Molecular World of Odors', Verlag Helvetica Chimica Acta, Zurich, 2011, ISBN 978-3-906390-66-6.
25. http://www.neemfoundation.org/neem-articles/using-neem/tips-on-using-neem.html
26. http://www.sabinsa.com/products/cosmeceuticals/neem-oil-limonoids/neem-oil-limonoids.pdf

Technical Problem

[002] Stretch marks, also called striae, may form from a laceration or tearing of collagen and elastin fibers of the skin. They may be commoner in women than men and may appear on almost any part of the body, except for the hands, feet and scrotum. The most vulnerable phases of life may be puberty and pregnancy. Rapid weight gain/loss and exercise may cause stretch marks. Long term use of tight trousers, corticosteroid containing creams, intake of anabolic steroids and the use of oral contraceptive pills may also be associated with stretch mark formation. Cushing's Syndrome, Marfan's and Ehlers-Danlos Syndromes, Diabetes mellitus, dryness of skin, dietary deficiencies, for example, of Vitamins C, E, Zinc, Silica, and acquired metabolic disturbances such as protein deficiency may also predispose a person to stretch marks.
[003] Human skin may be a multilayered structure made up of three major layers, the epidermis, dermis and subcutaneous tissue. A basement membrane may separate the 5-layered cellular epidermis from the cellular, fibrous and non-cellular, non-fibrous extracellular matrix. 70% of the dry weight of the dermis is thought to be made up of collagen, a fibrous protein, of which ten types are known. During pregnancy, collagen bundles may change their orientation and lie parallel to each other, and may be more vulnerable to tearing if a perpendicular force is applied to them. Fibronectin and laminin may be other fibrous proteins, which bind to sulfated sugars. Fibrillin and Elastin may also be present in the dermis. Elastin may constitute only 2% of the extracellular matrix, but may be special in that it may stretch to many times its original size and still come back to its original shape once the deforming force is removed. Stretch marks may not be completely understood but reduced amounts of elastin and Fibrillin (but not collagen) may have been found in stretch marks. It is thought that reduced elastin formation and failure to cross-link properly are the major events associated with the formation of stretch marks. This may be due to the fact that Glycosaminoglycans retain water, and may provide cell free spaces essential for cell migration. The non-cellular, non-fibrous components of the dermis may be Proteoglycans, which have a protein core associated with a Glycosaminoglycan. Chondroitin Sulfate, Dermatan Sulfate and Heparin Sulfate may be the Proteoglycans present in the dermis. Hyaluronic acid may be a Glycosaminoglycan, a unique sugar that may hold up to 10 times of water than its own volume. It may have a crucial role in maintaining the thickness, turgor, elasticity and viscoelasticity of the skin. The fibers may be mostly secreted by the fibroblast and degraded by a group of 20 enzymes called the matrix metalloproteinases (MMPs), which may not only degrade these fibers, but also may regulate menstruation etc. and may have been implicated in the spread of cancers, as they may be capable of dissolving the basement membrane at a particular point. Collagen may be degraded by MMPs- 1, 8 and 13. Elastin, laminin and type IV collagen may be degraded by MMPs- 2 and 9.
[004] With age, the elasticity and Distensibility of the skin may reduce, whereas the viscoelasticity of the skin may increase. In simple terms, the skin may not be able to return to its original shape after being deformed by an applied force. Reduced blood supply, local wear and tear accumulated over time, nutritional deficiencies and metabolic factors may add insult to injury. The result may be reduced density of connective tissue papillae, less collagen between the papillary and reticular layers of the connective tissue, thick and condensed collagen fiber, altered extra cellular non-collagenous matrix and reduced cell turnover. Solar Elastosis, a component of skin aging, may be seen under the microscope as clumps in the dermis, made up of over produced and poorly assembled elastic fibers at the dermo-epidermal junction and the papillary dermis. Vitamin B deficiency may be known to cause magenta tongue, and other vitamin deficiencies may cause beefy tongue. Deficiency of Niacin may cause Dermatitis (Dermatitis, diarrhea, dementia).
[005] Techniques to improve the mechanical properties of the skin thus may include: 1. Increasing hydration of the skin- that improves skin Distensibility, and improves viscoelasticity parameters. The current invention may primarily work on this premise. 2. Reducing intercorneal adhesion 3. New collagen and/or elastin 4. Inhibition of those Matrix Metallo Proteinases (MMPs) that degrade collagen or fibrillin, or elastin.

Technical Solution

[006] Most available formulations use ingredients that may not be natural, and may fail to supply macro and micronutrients. The current formulation tries to overcome these problems. The current formulation may be entirely a botanical, intended for topical use. In case the ingredients used are organic, then the formulation may be organic. The present invention may describe a composition for preventing and/or reducing the signs of stretch marks or striae and/or to moisturise and revitalise the skin, the most preferred embodiment comprising application/ administration to the skin of a subject in need thereof a composition comprising almond, avocado, lavender, chamomile and citrus with turmeric, calendula and neem and/or extracts and/or their derivatives; preferably without a carrier or a preservative. The bitters in neem and almond may act as natural preservatives. The volunteer, whose photo is attached, used the bitter variety of almond oil. This formulation may packed in sterile, sealed containers. It may have preservative(s) if so required.
[007] The almond nut is not a true fruit. It is called a drupe, and may contain about 21.7% carbohydrates,12.2% fibre, 49.42 % fat and 21.22 % protein. Almond oil may consist primarily of unsaturated essential fatty acids, few saturated fatty acids, vitamins; and the bitter variety (derived from Prunus amygdalus var. amara, also known as Prunus dulcis var. amara or P. communis) has benzaldehyde and prussic acid that react in the presence of water to form cyanide. The sweet variety (Prunus dulcis var dulcis) may be preferred by some. Almond oil may be obtained by grinding and/or mashing and/or compressing almonds.
[008] The pulp of the ripe avocado fruit may be preferably used herein. Avocado oil may be obtained by crushing the dried ripened pulp of the avocado fruit. It may consist primarily of unsaturated fatty acid glycerides, vitamins A, B and E and minerals, and may have emollient properties. Avocado oil unsaponifiables may have anti inflammatory plant sterols, including beta sitosterol, campesterol and stigmasterol. Samples kept in a laboratory in Los Angeles at 40ºF showed only slight rancidity after 12 years.
[009] Fresh or dried Lavender flower(s) may also be used in some embodiments of this composition. Lavender oil may be an essential oil obtained by distillation from some varieties of lavender (for example, Lavendula latifolia) and may be flower oil or spike oil. The scent may have a calming effect which may aid in relaxation and the reduction of anxiety and stress. Lavender Capsules are sold in some regions as an anxiolytic.
[010] Citrus oils may be obtained from various Citrus species (family Rutaceae, subfamily Aurantioideae) that may include, but are not limited to, lemon, lime, sweet orange, bitter orange, grapefruit. Citrus oils may be located within the peel and the cuticles of the fruits. These oils may be removed mechanically by cold pressing and the watery emulsion thus obtained may then be centrifuged to separate the essential oil. This essential oil may be subject to age and when chilled may become murky. Citrus oils are a component of various best selling perfumes and a major soft drink. Preferably the peel, and optionally the leaves and/or flowers of citrus may also be used in some examples of this composition.
[011] Chamomile may be the name of a flower from a wide range of species, in the genus Matricaria. It may be included here for its soothing properties. The flowers may be dried thorughly and allowed to diffuse in oil ; or heated with oil ; or an essential oil may be obtained by distilling the flowers and a few drops added to the composition. Fresh or dried flower(s) of chamomile may als be used in some examples of this composition.
[012] The dried root of the turmeric plant (including, but not limited to Curcuma longa) may be mechanically mashed or a commercially available fine powder used in cooking may be used here. This turmeric may be antifungal, antiprotozoal, anti inflammatory and may promote healing. Any part of the turmeric plant may be used in this composition, the dried root is preferably used here.
[013] Calendula(family asteraceae) has been used since ancient times and may be antiinflammatory, antiviral, antigenotoxic, and is used in radiation induced dermatitis. It may be a part of many creams, tinctures and other preparations. The flowers may be obtained from any species referred to commonly as Calendula including, but not limited to, Calendula officinalis. The flowers are dried and allowed to diffuse into the oils; or are heated in the oil, or the essential oil commercially available may be used. Fresh calendula flowers may also be used in some embodiments of this composition.
[014] Any part of the neem tree(Azadirachta indica) may be used in this preparation including bark, leaves, flowers, seeds, leaves, fruits, mixture or even neem oil may be added to the other oils. Preferably the bark and leaves may be used in this preparation. The chemical compounds present in neem may have anti-inflammatory , antiarthritic ,antipyretic ,hypoglycaemic , Antifungal, spermicidal, antimalarial, antibacterial and Diuretic properties. Bark of neem may act as an antipyretic and may help to reduce fever.
[015] Derivatives of Almond oil, Avocado oil, citrus oils, Lavender oil, or Chamomile oil may include naturally and/or synthetically derived analogues that are, for example, extra virgin, virgin, acetylated, acylated, hydroxylated, methylated, amidated, phosphorylated, pegylated, fractionated, hydrogenated or glycosylated, that retain the biological activity of almond oil and/or avocado oil and/or citrus oils. These components may also be organic or pasteurized as required by regional laws. The species of plants given here in brackets are indicative. Any of the species of a plant having the common name used herein may be used in the preparation of this composition, provided they are not endangered or protected plant species.

[016] As used herein, the term 'skin' encompasses the whole skin or any portion of the skin. In practicing the method for preventing and/or treating striae, the preferred areas are the abdomen, thighs, hips, buttocks, arms and knees. However, the invention is applicable to any area having intact, unbroken skin as well as to the lips. It is applicable to any mammal.
[017] As used herein, the term 'dermatologically acceptable carrier' refers to one or more liquid, semi-solid or solid diluents, which are compatible with almond, avocado, lavender, chamomile and citrus oils, and are suitable for administration to any portion of the skin without undue/ unacceptable effects. Examples of such carriers include, but are not limited to, distilled or de-ionized water, propylene glycol, glycerin, urea, glycerol, and oil.
[018]As used herein, the term "extract" encompasses any substance obtained by applying mechanical means to the fresh or dry botanical component; or by distillation of the botanical component; or by combining the botanical component with oil(s) for a variable period of time at room temperature or with application of sunlight or heat. This may be followed by refining, filtration or any other method of purification to obtain the "extract" as defined herein.
[019] The compositions may be administered between 1 and 7 days a week, for a period of time necessary to achieve the desired results, which may be several days to several months. The compositions can be administered once or several times a day depending on the desired effect. In certain embodiments, the compositions can be administered every 1, 2, 3, 4, 5, 6, or 7 days. In another embodiment, the compositions can be administered one or more times every 1, 2, 3, or 4 weeks. Further, the compositions can be administered for 1, 2, 3, 6, 9, or 12 months or more. In certain embodiments, the compositions can be administered on an ongoing basis to maintain a desired result.
[020] The disclosed formulation can be administered as part of a composition. As used herein, 'formulation' and 'composition' may be used interchangeably and refer to a combination of elements that is presented together for a given purpose. Such terms are well known to those of ordinary skill in the art. The composition described herein may be administered at least in the minimum dose necessary to achieve the desired therapeutic effect. The actual amount of the compound to be administered in any given case will be determined by taking into account the relevant circumstances, such as the age and weight of a patient, and patient's general physical condition. In some instances, dosing is evaluated on a case-by-case basis.
[021] Additionally, compositions may be designed to delay release of the compound over a given period of time, or to carefully control the amount of compound released at a given time during the course of treatment.
[022] Certain examples of this invention are described herein, including the best mode known to the inventors for carrying out the invention. Of course, variations on these described examples will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the invention to be practiced otherwise than specifically described herein.
[023] Accordingly, this invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the invention unless otherwise indicated herein or otherwise clearly contradicted by context.
[024] Any reference made to patents and publications throughout this specification is individually incorporated herein by reference in its entirety.
[025] It is to be understood that the embodiments of the invention disclosed herein are illustrative of the principles of the present invention. Other modifications that may be employed are within the scope of the invention. Thus, by way of example, but not of limitation, alternative configurations of the present invention may be utilized in accordance with the teachings herein. Accordingly, the present invention is not limited to that precisely as shown and described.
[026] As used herein, 'carrier,' 'inert carrier,' and 'acceptable carrier' may be used interchangeably and refer to a carrier which may be combined with the presently disclosed compounds in order to provide a desired composition. Those of ordinary skill in the art will recognize a number of carriers that are well known for making specific pharmaceutical and/or cosmetic compositions. Desirably, the carrier is suitable for application to keratinous surfaces or other areas of the body. Upon application, acceptable carriers are substantially free of adverse reactions with skin and other keratinous surfaces. For example, the carriers may take the form of fatty or non-fatty creams, milky suspensions or emulsion-in-oil or oil-in-water types, lotions, gels or jellies, colloidal or non-colloidal aqueous or oily solutions, pastes, aerosols, soluble tablets or sticks. In accordance with one embodiment, the composition includes a dermatologically compatible vehicle or carrier.
[027] The vehicle which may be employed for preparing compositions may comprise, for example, aqueous solutions such as e.g., physiological salines, oil solutions or ointments. The vehicle furthermore may contain dermatologically compatible preservatives such as e.g., benzalkonium chloride, surfactants like e.g., polysorbate 80, liposomes or polymers, for example, methyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone and hyaluronic acid; these may be used for increasing the viscosity.
[028] Examples of additional agents which may include, but are not limited to; are anti-itch, anti-cellulite, anti-scarring, and anti-inflammatory agents, anesthetics, anti-irritants, vasoconstrictors, vasodilators, as well as agents to prevent/stop bleeding, and improve/remove pigmentation, moisturizers, desquamating agents, tensioning agents, anti-acne agents.
[029] Anti-itch agents include but are not limited to, methyl sulphonyl methane, sodium bicarbonate, calamine, allantoin, kaolin, peppermint, tea tree oil and combinations thereof.
[030] Anti-cellulite agents include but are not limited to, forskolin, xanthine compounds such as, but not limited to, caffeine, theophylline, theobromine, and aminophylline, and combinations thereof.
[031] Anesthetic agents include but are not limited to, lidocaine, benzocaine, butamben, dibucaine, oxybuprocaine, pramoxine, proparacaine, proxymetacaine, tetracaine, and combinations thereof.
[032] Anti-scarring agents include but are not limited to, Interferons, fluorouracil, poly(lactic-co-glycolic acid), methylated polyethylene glycol, polylactic acid, polyethylene glycol and combinations thereof.
[033] Anti-inflammatory agents include but are not limited to, dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, mesalamine and derivatives and combinations thereof.
[034] Additionally, active agents such as epinephrine, thymidine, cytidine, uridine, antiypyrin, aminocaproic acid, tranexamic acid, eucalyptol, allantoin, glycerin, and sodium selenite, can be included.
[035] Formulations can further comprise degradation inhibitors for the skin. Degradation inhibitors include, but are not limited to, glycosaminoglycans (e.g., heparin, heparin sulfate, dermatan sulfate, chrondroitin sulfate, o-sulfated HA, Inamarin, and amygdalin), antioxidants (e.g. ascorbic acid, melatonin, vitamin C, vitamin E), proteins (e.g., serum hyaluronidase inhibitor), and fatty acids (e.g. saturated C10 to C22 fatty acids). In certain embodiments, additional active agent is an antioxidant. In certain embodiments, the antioxidant comprises a vitamin C and/or a vitamin E such as d-alpha-tocopheryl polyethylene glycol 1000 succinate (TPGS).
[036] Conventional pharmaceutical or cosmetic forms for this purpose include ointments, liniments, creams, shampoos, lotions, pastes, jellies, sprays, aerosols, and the like, and may further be applied directly or in patches or impregnated dressings depending on blemish and skin region to be treated. The term 'ointment' embraces formulations (including creams) having oleaginous, water-soluble and emulsion-type bases, e.g., petrolatum, lanolin, polyethylene glycols, as well as mixtures of these.
[037] In accordance with the disclosure, a pharmaceutical or cosmetic composition can optionally include one or more agents such as, without limitation, emulsifying agents, wetting agents, sweetening or flavoring agents, tonicity adjusters, preservatives, buffers antioxidants and flavonoids.
[038] Tonicity adjustors useful in a pharmaceutical composition of the present disclosure include, but are not limited to, salts such as sodium acetate, sodium chloride, potassium chloride, mannitol or glycerin and other pharmaceutically acceptable tonicity adjusters.
[039] Preservatives useful in the pharmaceutical compositions described herein include, without limitation, benzalkonium chloride, chlorobutanol, thimerosal, phenyl mercuric acetate, and phenyl mercuric nitrate.
[040] Various buffers and means for adjusting pH can be used to prepare a pharmaceutical composition, including but not limited to, acetate buffers, citrate buffers, phosphate buffers and borate buffers.
[041] Similarly, antioxidants useful in pharmaceutical compositions are well known in the art and include for example, sodium metabisulfite, sodium thiosulfate, acetylcysteine, butylatedhydroxyanisole and butylatedhydroxytoluene. Flavonoids are compounds found in plants that are well known to have diverse beneficial biochemical and antioxidant effects. Subcategories of flavonoids include: flavones, flavonols, flavanonse and flavanonols. Examples of flavonoids include: luteolin, apigenin, tangeritin, quercetin, kaempferol, myricetin, fisetin, isorhamnetin, pachypodol, rhamnazin, hesperetin, naringenin, eriodictyol, homoeriodictyol, taxifolin, dihydroquercetin, dihydrokaempferol, tannic acid, tannis, condensed tannis, and hydrolysable tannis. It is understood that these and other substances known in the art can be included in a pharmaceutical or cosmetic composition disclosed herein.
[042] The composition of the present invention can comprise optional ingredients. Such optional ingredients may include, but are not limited to, depigmentation agents; reflectants; humectants; antimicrobial (e.g. antibacterial) agents; UV absorbers; anti-acne agents; anti-inflammatories; analgesics; anti-wrinkling agents; antiseptics; DHAE; enzymes and/or their cofactors; enzyme inhibitors; hormones; Hyaluronic acid and its derivatives; local anesthetics; wound healing promoters; deodorants and anti-perspirants; skin emollients and skin moisturizers; tanning agents; skin lightening agents; antifungals; depilating agents; external analgesics; counter irritants; anti-diaper rash agents; make-up preparations; vitamins and nutrients such as thiamin, riboflavin, niacin, pantothenates, pyridoxine, folic acid, cobalamin, biotin, choline, inositol, ascorbic acid, lipoic acid, carnitine etc.; amino acids and their derivatives such as alanine, arginine, asparagine, aspartic acid, carnitine, citrulline, cysteine, dimethylglycine, gamma amino butyric acid, glutamic acid, glutamine, glutathione, glycine, histidine, isoleucine, leucine, lysine, methionine, ornithine, phenylalanine, praline, serine, taurine, threonine, tryptophan, tyrosine, valine; minerals such as boron, calcium, chromium, cobalt, copper, fluoride, germanium, iodine, iron, lithium, magnesium, manganese, molybdenum, phosphorous, potassium, selenium, silicon, sodium, sulfur, vanadium, zinc; herbal extracts; retinoids; bioflavonoids; anti-oxidants, preservatives; skin conditioners; hair lighteners; chelating agents; cell turnover enhancers; coloring agents; sunscreens and the like; alpha and beta hydroxy acids; agents for chemical peeling; botulinum/tetanus toxins, esapeptide and agents for muscle relaxation; and mixtures thereof.
[043] Examples of suitable reflectants include, but are not limited to, mica, alumina, silica, calcium silicate, glycol dioleate, glycol distearate, sodium magnesium fluorosilicate, and mixtures thereof.
[044] Examples of suitable UV absorbers include, but are not limited to, benzophenone, bromelone, cinnamido propyl trimethyl ammonium chloride, disodium distyrylbiphenyldisulfonate, paba, potassium methoxycinnamate, and mixtures thereof.
[045] Examples of suitable humectants include, but are not limited to water soluble liquid polyols selected from the group comprising glycerine, propylene glycol, hexylene glycol, butylenes glycol, pentylene glycol, dipropylene glycol, and mixtures thereof.
[046] Examples of suitable Amino Acids include, but are not limited to, amino acids derived from the hydrolysis of various proteins as well as the salts, esters, and acyl derivatives thereof. Examples of such amino acid agents nonexclusively include amphoteric amino acids such as alkyl amidoalkylamines, i.e. stearyl acetyl glutamate, capryloyl silk amino acid, capryloyl collagen amino acids, capryloyl keratin amino acids, capryloyl pea amino acids, cocodimoniumhydroxypropyl silk amino acids, corn gluten amino acids, cysteine, glutamic acid, glycine, keratin amino acids, hair amino acids such as aspartic acid, threonine, serine, glutamic acid, glycine, alanine, half-cysteine, valine, methionine, isoleucine, leucine, tyrosine, phenylalanine, cysteic acid, lysine, histidine, arginine, cysteine, tryptophan, citrulline; lysine; silk amino acids; germinated or otherwise wheat/oat /maize/lentil derivatives, and mixtures thereof.
[047] Examples of suitable enzyme inhibitors include, but are not limited to, Matrix Metalloproteinase inhibitors such as Aspirin E 5510, Retinoids, Glucocorticoids, Vitamin D3, GII 2947, Tissue Inhibitor of MetalloProteinases(TIMP), hydroxyamates, hydroxyurea derivatives, a tetracycline, a genistein, green tea extract, N-acetyl cysteine.
[048] Examples of suitable proteins include, but are not limited to, collagen, deoxyribonuclease, ribonuclease, iodized corn protein; keratin; milk protein; protease; serum protein (from any animal); silk; wheat protein, germinated wheat protein, alpha and beta helix of keratin proteins; hair proteins, such as intermediate filament proteins, high sulphur proteins, ultra high sulphur proteins, intermediate filament-associated proteins, high-tyrosine proteins, high glycine-tyrosine proteins, tricohyalin, arginine-rich peptides such as oligoarginines and mixtures thereof.
[049] Examples of suitable anti perspirants and deodorants include, but are not limited to, aluminiumchlorohydrates, aluminium zirconium chlorohydrates, and mixtures thereof.
[050] Examples of suitable sunscreens include, but are not limited to, titanium dioxide and zinc oxide.
[051] Examples of suitable counterirritants include, but are not limited to, camphor, capsiacin, menthol, methyl salicylate, peppermint, cinnamon and clove oils, ichthammol, and combinations thereof.
[052] Examples of suitable anti-aging agents include, but are not limited to, inorganic sunscreens such as zinc oxide, organic sunscreens such as octyl methyl cinnamates and derivatives thereof; retinoids; vitamins such as vitamin A, B, C, D, E, K, folic acid and derivatives thereof; antioxidants including acid such as glycolic acid, oxa acids, citric acid, lactic acid, malic acid, mandelic acid, ascorbic acid, alpha hydroxy butyric acid, alpha hydroxyisobutyric acid, alpha hydroxyisocaproic acid, alpha hydroxyisovaleric acid, ethyl pyruvate, galacturonic acid, glucopheptono 1,4 lactone, gluconic acid, glucono lactone, glucuronic acid, glucurronolactone, isopropyl pyruvate, methyl pyruvate, mucic acid, pyruvic acid, saccharic acid, saccaric acid 1,4-lactone, tartaric acid and tartronic acid, succinic acid or salts thereof; acids such as beta hydroxy butyric acid, beta phenyl lactic acid, beta phenyl pyruvic acid; botanicals and/or their extracts such as green tea, soy, milk thistle, algae, aloe, angelica, orange, coffee, gold, silver, grapefruit, hoellen, honeysuckle, Job's tears, lithospermum, strawberry, mulberry, blueberry, papaya and other fruits; peony, puerarua, safflower, and other flowers; flax, canola, olive, peanut, sesame, shea nut, maize, cottonseed, grape, mustard, beech, pecan, brazil, pistachio, hickory, filbert, macadamia, cashew, neem, chia, kuikui, hemp, pumpkin, soy, walnut, wheat germ, evening primrose, sunflower, truffle; yeasts; animal derived fats and/or collagens and/or elastins and their products, and mixtures thereof.
[053] Examples of suitable anti-inflammatory agents include, but are not limited to, plant extracts such as those from Lentopodium alpinum, Echinacea purpurea, Malva sylvestris, Thymus vulgaris, Peucedanum ostruthium, Marrubium vulgare.
[054] Examples of suitable depigmentation agents include, but are not limited to, hydroquinone and its derivatives; vitamins such as niacin, Vitamin C and its derivatives; extracts such as green tea, and mixtures thereof.
[055] Examples of suitable hormonal agents include, but are not limited to, those that affect the water, collagen and/or elastin content of the skin, for example, thyroid hormones, estrogens, and their mimics.
[056] As well known to a person skilled in the art, other additives to dermatological compositions include, but are not limited to, ointment bases, solvents, buffering agents, pH adjusting agents, preservatives, humectants, chelating agents, antioxidants, stabilizers, emulsifying agents, suspending agents, gel-forming agents, perfumes and skin protective agents.
[057] The compositions of the present invention can be formulated in a variety of forms including, but are not limited to, lotions, gels, creams, sprays, solutions, tissue wipes soaked with the invention, oil in water emulsions, water in oil emulsions, oil in oil emulsions, stick forms, transdermal patches, silicone sheets, microspheres, liposomes, nanosomes, cyclodextrins; sustained release preparations including micro particle suspensions.
[058] These may be used in combination with lasers, alpha and beta hydroxyl acids, heating, ultrasound, electric treatments and tissue freezing with vacuum pressure plus photo-heating. The present invention may also be used in combination with oral, topical or injectable agents that enhance skin appearance and/or function.
[059] In practicing the methods of using the present invention, an effective amount of the composition of the invention is applied/administered to the skin of a subject in need thereof, may be rubbed in or massaged, and is left on the skin (for at least 15 minutes, more preferably for at least about 30 minutes, even more preferably for at least an hour, most preferably for at least several hours, e.g. up to about 24 hours). This method can be repeated from one to five, preferably from one to three times per day, starting preferably from before and/or the start of pregnancy/ exercise/weight loss and/or gain as is applicable to a subject in need of the treatment. Typically, the effective amount of the composition to be applied at one time is from about 1 gram to about 100 grams, more preferably from about 1 gram to about 20 grams. Advantageous Effects

[060] Appealing features of this composition may include its all natural composition, novel formula, convenience of use, effectiveness, universal acceptability, versatility, light weight, compact size, portability and safety. The composition may be organic. The composition may be useful to people having dry skin, rashes, eczema; or to those who wash their hands frequently. The composition may provide nutrients to the skin. It may be reasonably priced. For those allergic to any of the essential oils, other essential oils may be substituted to create a similar composition. Used frequently, preferably before the onset of itching, many times a day if so required, the composition may keep the skin looking soft and young.

Industrial Applicability

[061] Sweet or bitter almond oil in combination with avocado oil, lavender oil, chamomile oil and citrus oils; with turmeric, calendula, neem, and/or their extracts may be applied on intact unbroken skin once or many times a day as required, preferably after a bath by anybody. The invention may help prevent the formation of stretch marks. In its most preferred embodiment, the present invention may be beneficial to the expectant mother preferably from the first trimester onwards, in order to prevent the formation of stretch marks on the skin. It may be used in any condition that predisposes to stretch marks; before, during and after weight gain, strenuous exercise, dieting and/or rapid weight loss, as well as cachectic states like tuberculosis and/or typhoid fever etc., by people using corticosteroid based creams, taking cortisone and/or hormone based drugs such as anabolic substances and/or hormonal creams and/or hormonal contraceptives. People who occupationally and/or habitually wear tight clothes may also benefit from the present invention. People who have dry skin, psoriasis, xerosis etc. or those who wash frequently may also benefit from the present invention.
[062] The composition may be an oil based emollient having organic ingredients useful for the entire body. It may also be available as a herbal paste or cream; or an emulsion. Depending on how dry the skin tends to be, a suitable embodiment may be chosen. The composition may include edible ingredients and may contain natural essential oils that may contribute to fragrance. The composition may be used to keep the skin soft and moist. The composition may be packaged in a bottle or jar and may be offered in a variety of sizes and odors, and may be used daily or many times a day. It may be sealed in plastic sachets. It may be enclosed in soft capsule that are cut with scissors or opened up to apply the oil. These encapsulated forms may be packaged in blister packs to enable convenience while travelling.

Sequence List Text

Description of Drawings

[063] The invention has been clinically tested on a lady having her first child from the first trimester onwards, once to twice daily on the abdomen, immediately after a bath, till the end of the pregnancy. The subject is prone to stretch marks. At the end of the pregnancy and thereafter, there have been no stretch marks on the area of the application. The photograph shows the abdominal area after the birth of the child.

Best Mode

[064] The following examples are presented to demonstrate the invention. The examples are illustrative only and are not intended to limit the scope of the invention in any way.
Example 1 : This example demonstrates the most preferred composition of the invention.

Ingredient	Content, in wt%
Almond oil	99 gm
Avocado oil	0.7 gm
Citrus oils	3 drops
Lavender oil	3 drops
Chamomile oil	3 drops
Neem leaves and bark (dried)	7 grams
Calendula oil	3 drops
Turmeric chunks or powder	0.03 gm (a pinch)

[065] The solution preparation: Turmeric, calendula and neem in the form of roughly pounded herb or fresh/ dried leaves may be packed in a muslin bag, sealed and left in the oils at room temperature so that actives seep into the oils with time. Alternatively, first the avocado oil may be heated and the turmeric, dessicated calendula flowers and neem muslin bag inserted in the hot oil for diffusion to occur. Once the oil cools, the muslin bag with turmeric and neem is removed from the oil and thoroughly squeezed. After thoroughly cooling the avocado oil, the rest of the ingredients are mixed in the conventional fashion. Sweet Almond oil may also be heated as above, but it may be preferable to heat avocado oil as avocado oil has a higher smoke point than sweet almond oil. Simply put, avocado oil may withstand higher temperatures without degradation. It may or may not be dispensed in dark colored glass containers to protect it from the sun. The composition may be kept away from the reach of children, and may not be ingested. This preparation may be meant for external use only, on unbroken skin, or broken skin with a healing scab that acts as a semi permeable membrane. This composition may be applied on the skin all over the body, and may be left on afterwards, for example, after a bath. It may also be re applied after a few hours as required. If especially formulated for scars or in cases of allergies and sensitive skin, the invention may preferably contain refined oils rather than the cold pressed extra virgin oils that are recommended herein.

Other Modes for Invention:

[066] Example 2: This example illustrates another embodiment of the composition:

Ingredient	Content in weight %
Almond oil	50%
Dried Avocado pulp	15%
Dried Citrus peels	15%
Dried Lavender flowers	3%
Dried Chamomile flowers	3%
Dried Neem leaves and bark	6%
Dried Calendula flowers	3%
Dried Turmeric roots	5%

[067] All the dried herbs may be finely ground to a powder along with Almond oil, taking care not to overheat the mixture during preparartion so as to not lose any nutrients. The colloid or suspension thus obtained may not need a preservative. Fresh herbs may also be used, but their use may require the need for additional preservatives such as, but not limited to Vitamin C. This example may be suitable for people who do not wish to use the most preferred embodiment of this invention due to oiliness.
[068] Example 3: This example demonstrates yet another embodiment of the composition:

Ingredient	Content, in weight %
Almond nut (drupe)	70%
Avocado pulp	10%
Citrus peels	5%
Lavender flowers	3%
Chamomile flowers	3%
Neem leaves and bark	3%
Calendula flowers	3%
Turmeric roots	3%

[069] The fresh herbs may be all ground to make a thick paste taking care not to overheat the ingredients while grinding them so as to preserve all nutrients. Almonds may be used with their skin intact. The skin of the avocado fruit may be preferably excluded from this composition. This composition may also need a preservative such as, but not limited to Vitamin C.
[070] The examples described herein may be prepared in any desired manner and the ingredients added in any sequence as will be evident to those skilled in the art for ease and speed of production. The information disclosed herein is provided merely to illustrate principles and should not be construed as limiting the scope of the subject matter in terms of its claims. The written specification and figures are, accordingly, to be regarded in an illustrative rather than a restrictive sense. The principles disclosed herein may be used to achieve other objectives as well.

Claims (16)

1. A skincare composition comprising sweet and/or bitter almond oil, avocado oil, citrus oil, lavender oil, chamomile oil, turmeric, calendula and neem.

The skincare composition of claim 1, wherein the components are organic

The skincare composition of claim 1, wherein the almonds are pasteurised

The skincare composition of claims 1 to 3, wherein the fresh or dried herbs are added to the oils at room temperature for a varied period of time.

The skincare composition of claims from 1 to 4, wherein almond oil and/or avocado oil is heated in order to extract substances from the fresh or dried herbs and/or lentils.

The skincare composition of any of the claims from 1 to 5 that contains refined oils.

The skincare composition of any of the claims from 1 to 6 that contains cold pressed or extra virgin or virgin oils.

The skincare composition of any of the claims from 1 to 7 containing a preservative and/or additive and/or substitute.

The skincare composition of any of the claims from 1 to 8 that prevents or reduces stretch marks when applied on the skin or its appendage directly by application or massage; or by spray, roll-on, occlusive bandages or wet wipes.

A skincare composition comprising almond oil, avocado, lavender, chamomile, calendula, citrus, neem and turmeric.

The skincare composition of claim 10 that contains a substitute and/or additive and/or preservative

The skincare composition of claims 10 and 11 wherein the almond oil is organic and/or extra virgin and/or virgin and/or refined

The skincare composition of claims 10-12 wherein the herbs are fresh and/or dried

The skincare composition of claims 10-13 that contains an additive and/or preservative and/or substitute

A skincare composition comprising almonds, avocado, lavender, chamomile, calendula, citrus, neem and turmeric

The skincare composition of claim 15 that contains a substitute and/or additive and/or preservative.