(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 14 July 2011 (14.07.2011) WO 2011/083401 A2
(51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, A61K 36/61 (2006.01) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, PCT/IB20 11/000014 KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (22) International Filing Date: ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, 6 January 201 1 (06.01 .201 1) NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, (25) Filing Language: English TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (26) Publication Langi English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 2032 19 10 January 2010 (10.01 .2010) IL GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, (71) Applicant (for all designated States except US): TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, BCLEAN PROJECTS LTD. [IL/IL]; P.O. Box 591, 74 EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, Snir Street, Kfar Vradim 25 147 (IL). LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, (72) Inventors; and GW, ML, MR, NE, SN, TD, TG). (75) Inventors/Applicants (for US only): SIGLER, Simon [IL/IL]; P.O. Box 591, 74 Snir Street, Kfar Vradim 25 147 Published: (IL). LAYYOUS, Albir [IL/IL]; P.O. Box 385, 25140 — without international search report and to be republished Meiilya (IL). SUSSAN, Ihab [IL/IL]; P.O. Box 5376, upon receipt of that report (Rule 48.2(g)) 24952 Tarshiha (IL). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM,
(54) Title: A COMPOSITION AND DISPENSER FOR PERSONAL HYGIENE (57) Abstract: A liquid composition for personal hygiene use comprising an active ingredient of cyclopentasiloxane. Tea Tree oil or an active com ponent thereof, and combinations thereof. The composition could further include cyclopentasiloxane and dimethicone, and further include dime- thiconol. Another composition might include Tea Tree oil or an active component thereof; glycerin; and water. This composition might further in clude terpinen-4-ol or silicone oil. The composition can be used as a wet ting agent for a towelette or wet wipe. The invention includes a dispenser containing any of the compositions for dispensing and applying to rolled toilet tissue, thereby providing that sheets from the roll can be used as a wetted wipe for personal hygiene and health.
< o ∞ o A COMPOSITION AND DISPENSER FOR PERSONAL HYGIENE
Field of the Invention
This invention concerns maintenance of high standards of personal hygiene and comfort in both genders, of all ages and the more specific care needed when there are associated health problems. More specifically, the present invention relates to a composition for personal hygienic use, to a wetted wipe for personal hygiene incorporating the same and to a dispenser containing said composition in combination with a toilet roll holder.
Background of the Invention
Great importance is attached by most societies to personal hygiene, so it is surprising that the provision of effective dispensing means and lotions, lags behind increasing but commercially unsatisfied demands, even in the more developed world. This issue has been well described, as n US Patent No. 6,346,153. Why desirable standards have not been met - and here reference is to dynamic personal cleaning (wipes) as distinct from in situ means - may be partly cultural, e.g., taboos arising from the nature of this subject as compared to the subject of dental hygiene, or due to the absence of visual obviousness in this regard, as compared to the visual obviousness of acne or skin wrinkles. Whatever the causes of slow progress in this field, technical and manufacturing abilities have not yet enabled even the best marketing to overcome obstacles. Thus for example, the public resists dispensing means which are too expensive, complex, impractical or unaesthetic despite a plethora of ingenious product improvements and massive international commercial investment.
The prior art deals with one or more factors: body location, the moist compositions required and the dispensing process (dispenser and transfer from it by wipe or directly by foam or spray). However, the existing art does not adequately recognize the importance of differences in physiological tissues for the composition of lotions and gels, or the physical environment and social frameworks (and therefore behaviors) within which the products will be used and interplay between those parameters. A l these effect consumer decisions. Nevertheless, the prior art has long recognized (by example, US Patents No. 2,789,725; No. 3,796,185; No. 3,962,1 50; No. 4,657,691 ) and also more recently (by example, US Patents No. 5,558,873; No. 6,467,654: No. 6,520,942; No. 6,805,264; No. 6,818,204) that in many cases using a solid wipe alone
(paper, tissue, cloth) for personal cleansing with or without concurrent use of water, or water alone, does not achieve a high level of hygiene and that as dry wiping may be unpleasant and uncomfortable, or even painful in certain circumstances, physical or practical advantages can be gained from moistened wipes.
The earliest developments usually involved the moistening of ordinary toilet paper together with additives, but the -complexity, expense, unaesthetic nature or impracticality of the dispensing arrangements, drove manufacture of packaged, pre- moistened, disposable wipes. This received impetus from increasing knowledge of potential clinical implications of standards of personal hygiene in men and especially for women. However, these products tend to be expensive, even for periodic medicinal use and more so on a daily basis, whether normally for adults and children, or for infant and adult incontinence. Moreover, the strengthened web materials needed for
pre-moistened wipes tend to block sewers as they do not break up easily. Toilet paper does, 3 cheap and remain3 by far the most common personal hygienic wipe in
developed countries. In this context, improved personal hygiene may be achieved by
applying in a given form to a convenient source of dry toilet paper a moist material
composition of a given formula (regular, medicated), which is then manually directed to a body region. Thus, the choice whether to use dry wipe or one moistened with an
additive can be individual and instant. One or more of the elements in that process
have been addressed in one or more of many patents. Dispensing of toilet paper and
of a moist add-on have often been fixedly combined in a single device (by example, US Patents No. 2,789,725; No. 3,796,1 85; No.3,865,271 ; No. 4,667,846; No. 4,998,647; No. 5,435,465; No. 5,887,759; No. 6,314,971 ; No. 6,457,434), or have
been semi-combined by mounting a toilet roll on the container holding the composition (No. 4,436. 224; No. 6,91 8,513), or are basically separated (US Patents No. 4,087,022; No. 6,467,654; No. 6,520,942; No. 6,805,264; No. 6,81 8,204). All the latter art permits choice of applying the formulation or not, prior to wipe. Some have been relatively simple but unattractive or impractical, others more complex and expensive. By example, the device of the more recent US Patent No. 6,346,1 53 is operated by applying pressure to an upper surface which in turn lowers a support holding a roll of cellulose or other web into a lower reservoir of a wetting composition. The wetted tissue is then dispensed by pulling it from the roll under a roller, over a structural shoulder and out of the dispenser. The device has disadvantages: the web requires considerable tensile strength when wet to permit easy withdrawal through that route and out of the device. The need for strength is augmented by the total wetting of the required sheet. As the wetted web proceeds up the upper surface of the outlet side of the V-shaped roll-holding element, it will wet at least the next sheet on the roll and probably more. If a dry sheet is immediately desired for a drying purpose, it will not be available leading to frustration and waste of web in order to obtain a dry sheet. If a dry sheet is not wanted immediately, capillary action may cause additional partly damp sheets. Dampness persisting for a period may reduce web strength before next use. Total wetting of the web causes unnecessary waste of the composition. This is recognized by provision of metered fluid application to the web via adjustment of pressure on the lid roller assembly and the removal of excess liquid. Thus an attempt, successful or not, to deal with one drawback, creates another: presumably the excess liquid runs back down to the reservoir further wetting the roll. It is not clear whether use of ordinary toilot paper rolls is intended, or possible. A disposable version of the latter dispenser is also described. This has the same drawbacks, at a greater expense.
According to that US Patent, No. 6,346,1 53, because of the complexity and expense of devices dispensing a wet or dry product, the art has been stimulated in recent years to provide many pre-moistened products for a range of purposes, leaving a substantial need for a simple mechanism, manually powered and providing a dry or wetted tissue sheet on demand. Those needs and effectiveness and economy in price and use, were apparently not met by the art in that Patent. Also of interest is US Patent No. 6,467,654, because of its much greater simplicity and lower cost. However, the stopper spout it describes will provide drops of a formulation in a manner difficult to control in quantity and placed unevenly on a tissue sheet, with excess wetting in some spots. The latter can be overcome by a care often difficult to the elderly and by time and patience not always available, especially in children. Also, hanging the bottle on the toilet roll is unattractive. Today, increasing attention is being given to the esthetics of rooms designated for personal needs.
Accordingly, a major object of this invention is to provide practical, ergonometric, simple, esthetic and cost effective dispensing of lotions and in particular when this is desired for personal hygienic use in conjunction with common toilet roll tissue.
A further drawback of prior art is that dispensing a composition usually allowed use of only one composition and those few proposals that do provide for choice, suffer from at least one drawback amongst those of inconvenience, complexity, impracticality or expense. In the domestic context and an increasingly open society, a mass market of all ages and gender still awaits means whereby individual, personal, hygiene and treatment may be as commonptace, convenient and habitual, as has long been the maintenance of dental and oral health, comfort and esthetics and as individualized as is choice of toothpaste and toothbrush. Poor vision can be easily overcome by tactile indicators e.g. Braille.
Therefore it is also an object of this invention to provide a dispensing means that practically, conveniently and economically enables dispensing of different compositions from separate vessels that are easily identifiable for choice by individual users.
The importance of education and encouragement of children to good standards of
personal hygiene is well recognized but in practice this is generally limited to hands,
feet, and 'behind the ears'. It is particularly important to motivate the young to regular
and simple intimate cleanliness such as that embodied in the instant invention. This may be by well known figurative icons (e.g. Donald Duck, or Superman integrated with the pump head), or by short jingles played in certain conditions.
Therefore it is also an object of this invention to provide a method and product by which children can be educated to the long term importance of personal hygiene and
be motivated to its consistent daily practice. Although a major objective of this invention is to provide a more useful and acceptable moans of dispensing lotions for personal hygienic needs, the possibility of commercial satisfaction of a mass market for daily and other personal intimate hygiene requires the concomitant provision of suitable range of lotions for that purpose and for a public increasingly wary of personal application of synthetic chemicals. Herbal' Lot!ons and Phytochemicals.
Intimate hygiene and treatment products have in recent decades been increasingly influenced by a perception that compositions based on 'natural' materials from a herbal sources are safer and better. Such substances have become almost essential in the composition of cleansing and cosmetic products. Sometimes there are many different herbal substances in one product and certain herbs have been publicized to celebrity status for one reason or another. This is not necessarily beneficial. A declaration that "Natural products have several advantages over synthetic compounds in their slow and steady action with excellent safety profile [some of which] ... are applied topically to treat various skin conditions." (US Patent No. 6,248,343) is overoptimistic, as is the view that the chemistry and formulation of lotions for application by wipes used for hygiene and treatment is a well-matured and understood area of technology (US Patent No. 6,346,1 53). Those overlapping views deserve consideration .
The plant world did not develop the "fight or flight" defensive mechanism found in animals. Plants can only "fight". For this, phytochemicals active against bacteria, fungi, viruses and animal herbivores, have evolved in plants; grazers and other herbivores have co-evolved with them and survive the effects of most but not all of the phytochemicals. It is common knowledge that humans suffer from many skin sensitivities to plants, some very serious or worse and that consumption of phytochemicals may also cause allergies or other side effects, many of these barely studied. As with synthetic concoctions, when a composition Includes phytochemicals from more than one plant, or as is frequent from several, the potential increase in negative effects may be both additive and synergistic, yet this has barely disturbed much, sometimes blind public preference for 'natural' over synthetic chemistry. This is true also of potential complex interactions in humans of the many chemicals found in a single plant. Extensive, authoritative compendia on herbs and herbal constituents commonly used in herbal medicines and compositions of the prior art are: Duke J.A., "Handbook of Phytochemical Constituents of GRAS Herbs and Other Economic Plants", 654 pp., 2001 CRC Press; Duke JA., "Handbook of Medicinal Herbs" (2nd Edit), 896 pp. 2002 CRC Press: and "The Scientific Foundation for Herbal Medicinal Products (2nd Edit). 556 pp., 2003 The European Scientific Cooperative on Phytotherapy: Exeter, UK, with Georg Thieme Verlag, Stuttgart, Germany, and Th!eme, New York. There are also clear descriptions and discussion on herbs and their functions in US Patent No. 5,648,083 to Blieszner and Deckner. These sources are incorporated herein in their entirety by reference. Many patents (by example, US Patents No. 2,789,725; No. 3,364,259; No. 3,962,150; No. 4,657,691; No. 5,558,873); No. 6,346, 153; No. 6,520,942; No. 6,818,204) reveal herbal compositions for hygiene or treatment composed of a number of herbal substances each within specific concentration ranges.
Herbal substances may confer medical benefits: e.g. dibucaine, anesthetic, vitamin E, anti-oxidant or Aloe vera, anti-inflammatory; or may make the composition more pleasant or comfortable to use e.g. Jojoba, a natural wax, in lubrication and feel. Substances may also be humectant, emollient, skin protectant, preservative, surfactant, solvent, pH adjuster, fragrance or colorant. Some herbal substances may have more than one effect in humans e.g. quercetin, a flavanoid is both anti¬ inflammatory and antioxidant; some may be both ameliorative and technical in effect e.g. glycerine is a humectant, emollient and also a solvent and increases composition viscosity. Often the same function may be fulfilled in a composition by more than one of its constituents. A certain liquid 'botanical' soap, for example, included extracts from seven, named well known herbs. The impression is given that the larger the number of (consumer-recognized) different herbal sources incorporated, the greater the efficacy. Multiple herbal use may increase attractiveness, but be less than beneficial (and also costly).
Most phytochemicals can have an allergic or other side-effect in some individuals. The available information is that 1-5% of users are affected by herbal-instigated dermatological allergies or sensitivities (different reaction types which are often not distinguished). Data on systemic side effects i.e. adversity, are more limited as they may be much less obvious. Whether negative effects are recognizable or not, the greater the number of herbal sources used in a particular wipe, the number of individuals reacting will multiply and synergism is likely to increase that. When known, reactions are often warned against, but due to the wide variety and number of different substances used, there may be a high degree of 'hit or miss' in composition use and users are on the whole currently their own test models.
Of concern also are interactions between OTC herbal substances and drugs prescribed by health-carers without knowledge that herbals are in use, or if known, their full compositions are not. For example, interactions of herbals with oral health drugs and manifestations may be associated with adverse reactions affecting oral health and treatment and it is suggested that dental professionals should make themselves aware of the potential problems ('Abebe W. An overview of herbal supplement utilization with particular emphasis on possible interactions with dental drugs and oral manifestations.' J Dent Hyg. 2003 77: 37-46.'). Responsible manufacturers are now warning consumers of OTC herbal products, that they are intended to supplement, not replace clinical knowledge and judgment or that of pharmacists and other healthcare professionals. Such is the concern, that consumers may even be informed that the product cannot be assumed 'to be safe, appropriate or effective for the user and that a health care professional should be consulted prior to use'. It seems that a relatively safer, herbal composition for topical application, especially to mucous epithelium, would be from a single plant source. However, the wide variety of molecules present in a single plant could also be problematic.
It is not commonly known that each of the herbs used today can contain up to a hundred or more different molecules. For example, extracts from leaves of one variety of one commonly used Aloe species alone, contained 123 aroma chemicals: 42 alcohols, 23 terpenoids, 2 1 aldehydes, 9 esters, 8 ketones, 6 acids, 5 phenols, and 9 others compounds, the major ones 3-hexenol (29.9%), 3-hexenal (18.9%), hexenal (7.3%), 4-methyl-3-pentenol (5.7%) and butanoi (4.3%) ('Umano K et at., J Agric Food Chem. 1999 47: 3702-5'). The bark of a popular herb contained more than 160 chemicals in the volatile fraction of a distillation (Engel , Gutmann M , Hartisch C , Kolodziej H, Nah ted A study on the composition of the volatile fraction of Hamamelis virginiana. PMed. 1998, 64: 251-8.) Nevertheless, it seems that even when known, such facts may not bo of concern - indeed the opposite.
Thus in one view, overall benefit from a herb necessitates presence of all its constituents and that if some of those are harmful when alone, this will be prevented if all the others are present. The belief is, that if mankind has survived damage by a given combination of phytochemicals over hundreds of years or more, the combination is not only beneficial to the plant, but may also be presumed to be beneficial or at least not damaging to humans. Natural selection over tens of thousands of generations will have adapted animals to the toxicity of some vegetation consumed. However, because of reproduction at an early age and a longevity that formerly barely survived the reproductive years, it is most unlikely that even over hundreds or some thousands of years, traditional medicine has been as successful as natural selection in avoiding or negating long term toxic effects.
Whereas all the chemicals present in a plant cooperate for its natural metabolism and survival, some can be potentially toxic to humans. These are mainly metabolized by the liver, some filtered by the kidney and then expelled from the body. It is common medical knowledge that if detoxifying processes in those organs are overloaded, acute or chronic damage can be caused. In the past, when immediately acute, damage will have been relatively quickly recognized in traditional herbal usage, so avoidable: when only chronic, the effect of damage on life quality will have been unobservable, or if eventually diagnosed not easily ascribable to a particular cause. However, this was when life was uncertain for all ages. World-wide, traditional knowledge of herbal substances accumulated when average life-spans were little more than half those today. Ironically, drugs that today lead to increased longevity will increasingly reveal long term damage done by other drugs - and by 'traditional' treatments. This process is relatively recent in origin, but will eventually draw increased recognition of the possibility, especially for the young, of long term additive and synergistic negative effects from use of multiple herbal compositions. A belief that herbal hygiene or treatment is better when based on the whole plant (or selected part, e.g. root), rather than on knowledge of individual constituents, is no more tenable than an idea that, when an industrial synthesis produces a mixture of chemicals, there is no need to consider each individually, but rather the whole range should be administered. This is taught by commercial penicillin: partly natural, partly synthetic. Application of lotions or ointments including the whole of Penicillium chrysogenum would be suggested only by the eccentric today. However, home brews and ointments of that fungus were tried in the 1940's, but did not work. Today too, a burgeoning internet-driven cottage industry (OTN - Over The Net) offers advice to all, together with sale of 'proprietary' lotions for suffusion of home-made wipes for cosmetics, treatments and hygiene and not least, for infants. It is also ironic that so many substances found in herbs are now actually synthesized for products sold as 'herbal'. In view of the above, it is necessary to fully recognize and reduce as much as possible the multiple risks inherent in topical herbal treatments by preserving herbal benefits, while reducing the risk.
It is therefore a major object of the invention to provide compositions for personal intimate hygiene that balance benefit with risk, by limiting the number of herbal (and other) constituents to the minimum.
Skin and Intimate Mucous Epithelia.
The prior art has not clearly recognized the important difference between the compositional needs of regular, daily intimate hygiene and of intermittent treatment of a semi-chronic condition. Such differentiation is especially important for intimate care of mucous epithelium lining body cavities e.g. rectum, vagina and mouth. It is well known that such tissue has a much greater absorption capacity than skin, both because of Its persistent molstness and a surface structure different to skin. These matters concern women in particular, and those with a rectal condition. This has become even more important due to newer delivery systems e.g. colloidal drug carriers, drug coupling to carrier particles such as microspheres and nanoparticles and encapsulation in liposomes. Mucoadhesive carriers developed for local and systemic activity and directed to the mucous epithelial layer of rectal, vaginal, buccal, nasal and ocular sites, instigate use of high-capacity transport pathways for cytoadhesion and cytoinvasion, as has been demonstrated for example in the intra-cellular, lysosomal accumulation of wheat germ agglutinin and even of DNA repair enzymes (US Patent No. 5 190762). These methods will be increasingly used in topical herbal applications and may have unwanted systemic consequences.
Adverse systemic effects due to absorption through external epithelia, particularly in body cavities, are further magnified in that substances passed through external epithelium will not (as does the portal blood flow carrying absorption from the intestine) undergo a first pass through hepatic detoxifying processes. Undesired affects at the mucous membrane are relatively easily observed. Longer term systemic effects are more difficult to monitor and the already growing regulatory concern in respect of OTC herbal skin treatments, will be intensified, especially in respect of mucous sites, whether for daily hygiene or treatment courses.
It is therefore also an object of this invention to take into account the needs of the two main types of external epithelia and of the different sub-populalions concerned.
Risk nd Regulation
It is increasingly clear to academic researchers, regulatory authorities and some herbal practitioners that safety is becoming as serious an issue for "herbals* as it is for 'synthetics'. In a semi-systematic review of herbal dermatological remedies, it was reported that virtually all, including the popular Aloe vera, eucalyptus, camphor, henna and kava can cause allergic reactions, with several causing photosensitization or systemic adverse effects. It was concluded that adverse effects of herbal medicines are an important but neglected subject in dermatology deserving systematic investigation (Ernst E. Dept. of Complementary Medicine, Univ. of Exeter, UK. Adverse effects of herbal drugs in dermatology. Br J Dermatol. 2000; 143: 923-9.). Aloe provides an example.
Aloe species contain a significant number and proportion of anthraquinone derivatives of anthracene, a known carcinogen. At least some of the derivatives are unstable under visible (390-500 nm) light in aerobic conditions and photo-toxic in vitro when examined by a photo-hemolysis test under oxygen but also without it, possibly also by stable photo-products ('Vargas F, Fraile G, Velasquez M, Correia H, Fonseca G, Marin M, arcano E, Sanchez Y. Studies on the photostability and phototoxicity of aloe-emodin, emodin and rhein. Pharmazie. 2002 576:399-404.'). Reports that polysaccharides found in Aloe species can limit or prevent cancer are widely publicized. However, after a thorough review of all the available research, the National Toxicology Program of the US Federal Department of Health and Human Services, concluded finally in 2005 that there is clear evidence in male and female B6C3F1 mice and in female F344/N rats of the carcinogenicity of anthraquinone. There are no available human studies of effects from exposure to specific levels, but breathing it and skin contact seem to be associated with cancer.
Of particular recent interest is the phytoestrogen, resveratrol (found in various plants, grape skins - and red wine). Advanced as an estrogenic supplement for treatment of skin or maintaining its health, the molecular structure of the supplement is different but akin to that of a synthetic estrogenic molecule, di-ethyl-stilbestrol (DES). Additional epithelial and non-epithelial benefits of resveratrol are also reported including anti- carcinogenicity. However, evidence is exjntradictory and confusing in that respect. DES, a human carcinogen absorbed through the skin, caused a large-scale long term genetic tragedy (thought to affect males as well as females), persisting even into the third generation. Yet, although it was also shown to stimulate the human estrogen dependent breast cancer cell lines MCF-7 and T47D at low levels and to cause ovarian hypertrophy and disrupted estrus cycles ('Gehm BD, McAndrews JM, Chien P- Y, Jameson JL. Resveratrol, a polyphenolic compound found in grapes and wine is an agonist for the estrogen receptor. Proc Nat Acad Sci 1997, 94: 14138-14143'), at much higher levels, it inhibits growth of those cell lines. Thus the effects of resveratrol on cancer differ according to type, concentration and location of estrogen receptors, i.e. it is apparently a mixed agonist/antagonist of the tamoxifen type. It too, is currently under test and review by the National Toxicology Program. Treatment of cancer patients with tamoxifen is limited to five years because of a tendency to eventual resistance to and even reversal of its anti-cancer effect. The effect of resveratrol concurrent with tamoxifen treatment is not known. Phytoestrogens arc ubiquitous in nature and found in many popular topical herbal applications. Though concern for endocrine disruption should not be exaggerated as they are also present in many common foods, caution is required particularly as so many women are already commonly and regularly experiencing various types and levels of pharmaceutical intervention in endogenous steroid chemistry, whether for clinical or other reasons. For this reason too and especially for women and pre- or pubertal children, limitation of the number and range of different plant sources in a given topical application is a desirable aim.
Though in the US regulatory interest in herbals is relatively limited and inconsistent, it is gathering momentum. Even though herbal dietary supplements are regulated by the Dietary Supplement Health and Education Act (DSHEA), which limits their regulation by the U.S Food and Drug Administration (FDA), under the U.S. Food, Drug, and Cosmetic Act, manufacturers are not allowed to claim that a dietary supplement can "diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases". Thus herbal products for consumption, are already regulated by the FDA to some extent. This is much less so for topical use - even though, many herbal substances such as resveratrol and anthaquinon© are manufactured by the same p oc s as are some prescription drugs. Though the law currently limits FDA authority on non¬ prescription drugs it was, for example, entitled to issue in 2002 a rule stating that the stimulant laxative ingredients from aloe (including aloe extract and aloe flower extract) and some cascara products in OTC drug products are not generally recognized as safe and effective or are misbranded. This was part of an ongoing FDA review of OTC drug products. It is likely that regulation will be much tightened on phytochemicals for topical use including for personal intimate hygiene, at least to a degree similar to that now applied to their use as dietary supplements.
In addition to the research institutions assisting the National Center for Complementary and Alternative Medicine of the Federal Department of Health & Human Services and to the many State health and safety bodies working towards that future, independent NGO's are also trying to introduce more logic, safety, order and consistency. For example, the Natural Standard Research Collaboration is an independent organization publishing what are stated to be scientific reviews of complementary and alternative medicine. Similarly, The International Aloe Science Council (IASC) has declared that each Aloe vera product must contain a consistent amount of Aloe vera activity per liter.
Regulations in Europe have for many years limited use of colorants and fragrances to substances identified by the well-known E numbers. The Directorate-General for Health and Consumer Protection of the European Union Commission now operates advisory bodies including a standing Scientific Committee on Consumer Products (SCCP). This issues Opinions intended to be applied under EU law, on various aspects of herbal usage, including on specific substances. Though not perhaps always consistent or objective as disparate interests are involved, increasing regulatory interest will come from all directions. From this (justified) aspect too, it is necessary to reduce the multiplicity of potential individual and synergistic problems that can arise from the use of a multiplicity of natural (and other) substances in topical personal applications, especially those for intimate personal hygiene and treatment. For this purpose, it is necessary to choose a herbal substance with a maximum number of positive characteristics (relative also to any negative ones).
Summary and Description of the Invention
According to the present invention there is now provided a composition for personal hygiene use comprising an active ingredient selected from the group consisting of cyclopentasiloxane, Tea Tree oil or an active component thereof, and combinations thereof.
In preferred embodiments of the present invention, said composition comprises cyclopentasiloxane and dimethicone.
Preferably, said composition comprises cyclopentasiloxane, dimethicone and dimcthiconol.
In an especially preferred embodiment, said composition comprises cyclopentasiloxane, dimethicone, dimethiconol and Tea Tree oil. Preferred compositions comprise 70 - 97.9 % w/v of cyclopentasiloxane, 1 - 25 % w/v dimethicone, 1 - 25 % w/v of dimethiconol and 0.1- 5 % w/v of Tea Tree Oil.
While these are the preferred percentages of the active ingredients, further ingredients such as Vitamin E, Parafin Oil, Almond Oil and fragrances can be added to said combination of active ingredients.
According to the present invention, there is now also provided a composition for
personal hygiene use comprising: Tea Tree oil or an active component thereof; glycerin; and water.
In preferred embodiments of the present invention, said composition comprises
terpinen-4-ol; glycerin and water, wherein said water is preferably sterile water.
In preferred compositions, the content of said Tea Tree oil is about 0.01 5 - 15% w/w;
the glycerin content is about 10 - 80%, and the remainder o the composition is sterile water.
In especially preferred embodiments of the present invention the content of said Tea
Tree oil is about 0.03 - 0.75% w/w; the glycerin content is about 15 - 35%, and the
remainder of the composition is sterile water.
In some preferred embodiments of the present invention said composition is used as a wetting agent for a towelette.
In other preferred embodiments of the present invention said composition is used as a wetting agent for a wet wipe.
In some preferred embodiments of the present invention said composition further comprises a silicone oil selected from the group consisting of dimethicone, stearyldlmethlcone, cyclomethlcone, and dimethiconol or any other commercially
available silicone oil suitable for use in the composition in the present invention Especially preferred is dimethicone.
In preferred embodiments of the present invention the content of silicone oil is about
0.5 - 3.0% w/w, which amount is added to the amounts of Tea Tree oil and glycerin and subtracted from the amount of sterile water set forth above.
In especially preferred embodiments of the present invention the content of silicone oil is about 1 - 2% w/w, which amount is added to the amounts of Tea Tree oil and glycerin and subtracted from the amount of sterile water set forth above.
In preferred embodiments of the present invention said composition further comprises an agent for pH-adjustment to about 4.0 - 6.5.
In a further preferred embodiment of the present invention, there is provided a wetted wipe for personal hygiene and health comprising an active ingredient selected from the group consisting of cyclopentasiloxane, Tea Tree oil or an active component thereof, and combinations thereof.
In another aspect of the present invention, there provided a method of moist treatment of a body surface comprising applying thereto a wetted wipe for personal hygiene and health comprising an active ingredient selected from the group consisting of cyclopentasiloxane, Tea Tree oil or an active component thereof, and combinations thereof.
In especially preferred embodiments of the present invention, there is provided a method of moist treatment of anal and vaginal surfaces comprising applying thereto a wetted wipe for personal hygiene and health comprising an active ingredient selected from the group consisting of cyclopentasiloxane, Tea Tree oil or an active component thereof, and combinations thereof.
In US 2008/01 93387, there are described essential oil compositions for killing or repelling ectoparasites and pests which inter alia may contain Tea Tree oil. Similarly, in W O
01/1 9 190 there is described and claimed a method and composition for the control of arthropods which inter alia can contain Tea Tree oil. However, neither of these publications teaches or suggests compositions for personal hygiene containing this component and especially these publications do not teach wetted wipes for personal hygiene and health or methods for moist treatment of a body surface utilizing the same.
Unique to and long-used in Australia and world-wide, Tea Tree oil (TTO) is an aromatic steam distilled extract (main constituent: terpinen-4-ol) from the plant Melaleuca alternifolia.. Much of the commercial and similar information such as that now found on the internet, may be of limited value as the multitude of proponents of TTO (and a few critics), may be not too objective concerning the many different health and hygiene benefits ascribed to it. However, there are now many non-anecdotal, peer-reviewed research reports and reviews originating in Europe as well as in Australia.
Tea Tree oil contains over 100 components, mostly monoterpenes, sesquiterpenes and their alcohols. Terpinen-4-ol is dominant and responsible for most of the antimicrobial activity. The oil has been through a public process of standardization. An International Standard (ISO 4730, 996; ISO/FDIS 4730, 2004) for the Oil (Terpinen-4- ol type) requires a minimum 30% and maximum 48% of Terpinen-4-ol and this is supported by an Australian Standard that defines min/ max content of 14 main constituents in TTO. Such standardization for herbal extracts is unusual.
Most herbal products may be relatively efficacious in one respect, few in more than one and spurious, doubtful or exaggerated claims are rife, without adequate supervision (comment by Kessler DA. MD., Editorial, New England J Med, June 2000, on the USA Dietary Supplement Health and Education Act, 1994). In contrast, Tea Tree oil has a wider, more proven range of benefits than other herbal extracts in similar use. It provides a wide spectrum of defined anti-bacterial, anti-fungal and anti¬ viral activity, is strongly anti-inflammatory through a substantiated immuno-mechanism and has efficacious, mild astringent and anesthetic effects (Carson CF, Hammer KA, Riley TV. Melaleuca alternifolia (Tea Tree) oil: a review of antimicrobial and other medicinal properties. Clin Microbiol Rev. 2006 19:50-62.). TTO is also a humectant, solvent, emollient, lubricant and has a barrier quality protecting against the effecte of natural waste evacuations sitting on delicate skin between wiping events. The wide range of effects enable it to better fulfill two main objects of the invention: a minimal number of ingredients in the compositions of the invention to reduce overall risk of allergies, sensitivities and side effects; second, to support in particular the regular and periodic hygiene of vaginal and rectal mucous epithelium and to treat some common health problems at those sites.
Bacteria are natural inhabitants on skin and multiply rapidly in the presence of natural evacuations and in other undesirable, but often unavoidable conditions. The action of Tea Tree oil is rapid against both Gram negative (e.g. E. coli, a faecal bacterium easily transferred into the wider domestic environment, by children, the very old and the careless) and Gram positive bacteria (e.g. Staph aureus, now increasingly resistant to some antibiotics) by compromising bacterial membrane integrity and respiration (Cox, S.D.; Mann, CM.; Markham, Bell, H.C.; Gustafson, J.E.; Warmington, J. .; Wyllie, S.G. The mode of antimicrobial action of the essential oil of Melaleuca alternifolia (Tea Tree oil). J Appl Microbiol 2000, 88: 170-1 75.) Minimal inhibitory Tea Tree oil concentrations against a range of oral bacteria were between 0.029% and 1.25% and minimum bactericidal levels between 0.052% and 2.5%. (Kulik E, Lenkeit K, Meyer J. Antimicrobial effects of Tea Tree oil (Melaleuca alternifolia) on oral microorganisms, [in German] Schweiz Monatsschr Zahnmed. 2000: 110: 125-1 30.) In efforts to eradicate methoxycillin resistant Staphylococcus aureus (MRSA) in a difficult hospital environment, the microbe was cleared from superficial skin sites and lesions more successfully by a short Tea Tree oil treatment (10% cream + 5% body wash) than by a standard chlorhexidine or silver sulfadiazine regime. The Tea Tree oil preparations were well tolerated. (Dryden MS, Dailly S, Crouch M. A randomized, controlled trial of Tea Treetopical preparations versus a standard topical regimen for the clearance of MRSA colonization. J Hosp Infect. 2004. 56: 283-6.).
Similar effectiveness of TT oil is found in the prevention and treatment of fungal infections, particularly of Candida species, as for bacteria. Candida albicans is a common vaginal inhabitant, . glabrata much less so; both are potential serious pathogens. Activity in-vitro of Tea Tree oil against 8 1 C. albicans isolates and 33 non- albicans Candida isolates was examined. Minimum concentration of oil inhibiting 90% of all isolates was 0.25% (v/v) and for killing 90% was 0.25% for C. albicans and 0.5% for non-albicans Candida species (Hammer KA. Carson CF. Riley TV. In-vitro activity of essential oils, in particular Melaleuca alternifolia (tea tree) oil and Tea Tree oil products, against Candida spp. J Antimicrob Chemother. 1998, 42,:591 -5.) These results have been confirmed in vivo in the rat.
Regardless of susceptibility or resistance of Candida strains to fluconazole and itraconazole, candidastatic and fungicidal concentrations of terpinen-4-ol were equivalent in vitro and in the rat vaginal Candida model (treated during only 3 days after infectious inoculation, 1% v/v terpinen-4-ol was as active as 5% TTO in accelerating clearance (monitored for 2 1 days) from the vagina of all Candida strains examined. Remarkably, 1% v/v TTO was by 2 1 days as effective as the latter two treatments (Mondello F, De Bernardis F, Girolamo A, Cassone A , Salvatore G. In vivo activity of terpinen-4-ol, the main bioactive component of Melaleuca alternifolia Cheel (tea tree) oil against azole-susceptible and -resistant human pathogenic Candida species. 2006, 6: 158.). No negative reactions to the short treatment period were observed. TTO is also appropriate for intimate personal hygiene in respect of some very prevalent pathogenic viruses.
Data from the US Centers for Disease Control and Prevention (CDC) show that human papillomavirus (HPV) is America's most common sexually transmitted infection. It generally clears within two years, and most infected people don't realize they have the virus. However, some strains of HPV can cause cervical cancer and genital and anal warts - men may also suffer from HPV. Between 2003 to 2004, 27% of U.S. women (25 million) aged 14-59 had HPV infection, according to the CDC. Of these, 3 million had any of the four HPV strains capable of causing cervical cancer and genital warts. From a national study (2003 - 2004) on ,921 women who submitted vaginal swabs (reported in The Journal of the American Medical Association^, it is estimated that among women aged 14-24 nearly 7.5 million had HPV infection. - far more than previous estimates.
Infection by Herpes simplex (HSV) is also very common, causes permanent infection of ganglia in the spinal cord of all and as a result of that, chronic eruptions in some. Herpes simplex - type 1 (HSV1 , Herpes labialis) causes small and painful blister eruptions for 7-1 0 days on the skin of the lips, mouth, gums, or around the mouth ('cold sores') in a high proportion of the US population and in increasing numbers of genital cases. Herpes simplex - type 2 (HSV2) is sexually transmitted and infects the genital tract. Using a culture of monkey kidney cells and a plaque reduction assay, the 50% inhibitory concentration (IC50) of Tea Tree oil (TTO) against herpes simplex virus type 1 (HSV-1 ) and herpes simplex virus type 2 (HSV-2) was 0.0009% and 0.0008%, respectively. TTO also exhibited high levels of virucidal activity against HSV-1 and HSV-2 in viral suspension tests. At concentrations of TTO noncytotoxic for the cell culture, plaque formation was reduced by 98.2% and 93.0% for HSV-1 and HSV-2, respectively. Further tests demonstrated that TTO affect the virus before or during adsorption, but not after penetration into the host cell, i.e. TTO exerts a direct antiviral effect on HSV and at very low concentrations (Schnitzler P, Schon K, Reichling J. Antiviral activity of Australian Tea Tree oil and eucalyptus oil against herpes simplex virus in cell culture. Pharmazie.2001 , 56: 343-7.). Eucalyptus Oil was also examined, but showed 5 - 10 times less activity than TTO. Not surprisingly, a low concentrate
was enough for treatment. (Carson, CF. Ashton L. Dry L Smith DW Riley TV. Melaleuca altemifolia (tea tree) oil gel (6%) for the treatment of recurrent Herpes labialis (letter). J Antimicrob Chemother 2001 , 48: 450-451 ). It is not yet proven that TTO effects on Herpes are pertinent to HPV however th)3 is likely, as though only anecdotal, the evidence is extensive on elimination by Tea Tree oil of genital warts caused by HPV.
Because of the nature of the epithelial tissues and of dress (from tight jeans to diapers) associated with personal intimacy, microbial effects are frequently associated with inflammation (particularly pruritis ani and vulvae, and vaginitis and vaginosis). Tea Tree oil is anti-inflammatory in these cases. That TTO has this beneficial action is shown by evidence that its water soluble components at concentrations equivalent to 0.1 25% significantly suppressed LPS (lipopolysaccharide)-induced production of known inflammatory mediators: TNFalpha, IL-1 beta and IL-1 0 (by 50%) and PGE2 (by 30%) after 40 h (Hart PH, Brand C, Carson CF, Riley TV, Prager RH, Finlay-Jones JJ . Terpinen-4-ol, the main component (30 - 45%) of the essential oil of Melaleuca altemifolia (Tea Tree oil), suppresses inflammatory mediator production by activated human monocytes. Inflammation Research 2000, 49: 6 19-626). This evidence is probably the basis for the finding that though minor irritation and skin sensitivity may be noticed in a few users of TTO, this is usually only when concentration is over 15%. Thus the probably most important constituent of TTO is not only anti-microbial, anti¬ viral and anti-inflammatory as confirmed by mechanisms that have been specifically identified, it is substantially neither allergenic or a skin irritant. It is especially remarkable that when a burning sensation on skin was experienced by patients due to 25% benzyl benzoate, this was ameliorated when the benzoate was combined with 5% TTO. (Walton SF, McKinnon M, Pizzutto S, Dougall A , Williams E, Currie BJ. Acaricidal activity of Melaleuca alternifolia (tea tree) oil: in vitro sensitivity of Sarcoptes scabiei var hominis to terpinen-4-ol. Arch Dermatol. 2004, 140: 563-6). This suggests a mild anesthetic effect additional to the anti-inflammatory action, both together counteracting tendency to irritation when used on especially sensitive skins.
The consequent widespread and increasing use of TTO is now under close attention, including in Australia where government supervision and producer bodies support voluntary agreed standards for content and quality control. However, more than in the USA, concern for safety of herbal products is currently centered i Europe. There, an advisory body to the EU Commission, The Scientific Committee on Consumer Products published an 'Opinion on Tea Tree oil' (December 2004), after reviewing the available non-anecdotal (scientific) reports.
The Opinion reports an LD 50 of 2.6 g (oral) TTO per kg body weight in rats. Though not necessarily indicative for humans, this is better than the highest European Union classification of harmful substance levels. The Opinion also mentions that Tea Tree oil showed a lower level of in vitro cyto-toxicity in cultured human epithelial and fibroblast cells in the neutral red bioassay, than did three resin acid analogues. Though cyto¬ toxicity of up to 50% and more in cell cultures has been found due to materials released over time from certain dental adhesives and canal sealant, this seems to have been of limited concern. Serious toxic events in humans due to Tea Tree oil have been, relative to historical and now very widespread use, as accidental and rare as those from most materials in common use in industry, services and medicine; if you drink it (or many domestic cleaning materials or methanol) neat - you will suffer grievous harm. According to the Opinion, no data were available on repeated dose toxicity, subchronic and chronic toxicity, carcinogenicity, reproductive toxicity and percutaneous absorption, so no conclusions could be drawn on them. However, sensitive tests for liver and renal function are now in common use. if after decades of use of Tea Tree oil by many millions there are no negative clinical reports available, relative safety from acute or potential harm may be reasonably affirmed, though with the alert caution mandatory for chemically intensive modern living and its environment. The Commission did comment on a number of reports on skin allergy and sensitivity related to TTO.
In semi-occlusive patch tests according to OEC Directive 404, in rabbits 1 .5 % and 25 % Tea Tree oil was not irritating, 50% was minimally so and 75 % slightly irritating. However, neat Tea Tree oil sensitized 3 out of 150 humans in a study including nine treatments. Of 12 16 patients patch tested for allergic contact dermatitis in a Swiss dermatological clinic, only 0.6% reacted positive to Tea Tree oil. In a multi-center study of 1 dermatological departments in Austria and Germany, 36 out of 3375 patients ( 1. 1 %) reacted positive to a 5 % solution of Tea Tree oil. In a study by the North American Contact Dermatitis Group, 0.5 % of patients reacted in patch testing of oxidized Tea Tree oil (5 % in petrolatum). By their nature, dermatological clinics are attended by those more prone to skin problems than the population as a whole. This, together with the estimated overall average sensitivity (0.8%) of the clinical data above, suggests that skin sensitivity to topical Tea Tree oil preparations in the population as a whole must be very low to negligible, except for the neat oil, use of which needs caution and supervision. This overall view is reinforced by the report by the Opinion that in an occlusive patch test of Tea Tree oil on 25 humans for 2 1 days in eight concentrations between 0 % and 28.1 % in soft white paraffin, compared with 8 preparations (from 1.5 % to 28.8 %) containing similar concentrations of 1,8-cineole (a constituent of Tea Tree oil that has been said by some to be an irritant), none of the groups showed skin irritation. Nevertheless, users of Tea Tree oil as a whole are aware and producers caution when appropriate.
Europe has a huge pharmaceutical industry (particularly in certain countries) facing increasing competition from OTC 'herbal' products. The European Cosmetic Toiletry and Perfumery Association (COUPA) represents that industry, including 23 major international companies. It recommended (2001 ) that not more than 1% Tea Tree oil be included in compositions for cosmetic use. In view of the evidence reported by the Scientific Committees' Opinion itself, it is not clear why the Opinion generalized that only products having a concentration of 2 % or more seem to cause skin reactions, without presentation of a factual basis. That 2% level does not meet the scientific criteria laid down at the outset by the Committee itself, does not equate with the bulk of the evidence it itself brought on skin reaction to TTO and contradicts research reported from around Europe. Moreover the Committee did not actually recommend 98% dilution as a condition for dermal use of Tea Tree oil.
The only firm concern by the Scientific Committee was about the use of neat (100%) Tea Tree oil - a warning appropriate to a large number of regulatory-supervised substances in both OTC and prescription use. From the evidence, in specific tests on rabbits and humans and clinical, skin reactions will be very minor in the population as a whole, when using TTO at concentrations under 25-30%. Compositions of this invention use concentrations a fraction of those, being formulated for specific intimate purposes and tissues.
On the stability of Tea Tree oil in cosmetic formulations, the Committee referred to degradation under influence of room temperature, light and oxidation processes leading to the formation of peroxides, endoperoxides and epoxides. The relative contributions or the interactions of those conditions were not mentioned and quantification was negligible. Thus, though it was noted that an investigation of Tea Tree oil stored for 9 months under sunlight reported that an endoperoxide was formed, essential details about the oil container (open/ closed, opaque/ transparent, thickness), the kind of exposure (indirect/ direct light), the average total daily photon flux on the sample and the average daily ambient and container temperatures was not given. Some constituents of Tea Tree oil are sensitive to part of the light spectrum (as are many natural and synthetic substances used in hygiene and health applications). So to ensure minimal efficacy of the compositions of the invention for a reasonable period of time after production, it is desirable to use substantially opaque materials for packaging (as suggested by the Scientific Committee. In such conditions, photo- stability will be maintained many timee longer than that under nine months of sunlight.
As mentioned above, only 0.5 % of patients reacted to oxidized Tea Tree oil during patch testing of 5 % TTO in petrolatum. As for properly corked, bottled wine, stability of TTO is also maintained longer by isolation of TTO constituents from ambient oxygen - in this case by appropriate self pressure packaging. Limitation of degradation by light or oxygen, together with an intrinsic wide anti-bacterial and anti-fungal spectrum, accords to Tea Tree oil products durability ranging from one to five years. This range of periods is adequate (comparable to that of most pharmaceuticals), for normal distribution and consumer use, depending on Tea Tree oil concentration, the specific, overall composition and quality of production.
t is seen above that Tea Tree oil and its main constituent terpinen -4-ol, present a uniquely wide range of proven hygienic and therapeutic actions together with useful physico-chemical attributes. These enable the formulation of herbal compositions for personal hygiene use limited to one herbal source only and eliminate need Tor multiple risks, production complications and costs intrinsic to the baskets of herbs now being offered in the market for 'natural' products. Furthermore, the research on TTO has shown that it can be applied at very low yet effective concentrations for intimate hygiene and health.
It is therefore a main object of this invention to incorporate the steam distillate of Tea Tree oil or its chief constituent, terpinen -4-ol as the single constituent of purely herbal origin in compositions for personal hygiene and health.
Much confusion is caused to consumers and even to health carers by the description of some constituents in products for health, hygiene or cosmetics, as 'active', implying that all the others (frequently unnamed on the label) are inert, when the intention is active in a different sense i.e. performing a particular function. Whether the substances said to be not 'active' are fillers, surfactants, thickeners, preservatives, stabilizers, emulsifiers, gellants, fragrances or colorants, the great majority cannot be 'inert' - If they are to perform their functions. Moreover, some commonly used substances, inert when alone prior to inclusion in a composition, may react with others prior to use e.g. it is well known that potentially carcinogenic nitrosoamines may be formed in personal treatment products when certain substances react together (e.g. an amine with a nitrous group). It is confusing too if a substance has more than one function e.g. 'active' as an emollient, but "inactive' when it transforms the composition as a whole by acting as a thickener. For this reason too. minimizing the number of ingredients benefits the consumer; by aiding awareness and understanding in respect of product content Cwhat you get, is what you see'). As for Tea Tree oil, the many facets of glycerin (glycerol, glycerine) make it exceptionally useful in this respect.
Glycerin is commonly regarded as a sweet, viscous and pleasant liquid, traditionally useful for easing sore throats, soothing the skin, or as a thickener in different kinds of concoctions. However, like many small, apparently simple and rather innocuous physiological molecules (e.g. nitric oxide, NO) it is not so simple. Glycerin has additional valuable properties. It is an alcohol and as a solvent has much of the ability of ethanol to dissolve oils. According to the FDA, cosmetics (in the wider sense, compositions intended Tor topical application) must not be contaminated with pathogenic microorganisms, density of non-pathogenic microorganisms must be low and this must be maintained during consumer use. Moreover, when 3ome alcohols are present at about 10% or over (glycerin was among those specified by the FDA), the compositions are usually self-preserving and are not likely to become contaminated with microorganisms (FDA Cosmetic Handbook. Cosmetic Product-Related Regulatory Requirements and Health Hazard Issues, 992). This characteristic integrates with the wide anti-microbial spectrum of Tea Tree oil and use of self-pressure containers to maintain sterility. This challenges the use of a range of substances e.g. anti-microbial preservatives (to name but a few: the parabens, more potentially harmful when absorbed through the skin than in the enteric tract; DDMM, degrades to release formaldehyde, a probable human carcinogen (FDA); triclosan, forms dioxins in sunlight). These are commonly used in personal hygiene products, even though they are being increasingly questioned because of the serious risks they pose to the individual and the environment. Long known to hasten skin healing, glycerin may also be of developmental value. In the epidermis, keratinocytes continuously proliferate and differentiate. In a continuous cycle, the youngest cells emerge from the deepest epidermal layer, cease replicating and become mature surface cells that release lipids before they die. This process forms a barrier that is protective mechanically and also reduces loss of water due to skin permeability. The cell enzyme phospholipase D hydrolyzes phospholipids to generate phosphatidic acid and was found also to catalyzes production of phosphatidylglycerol in the presence of glycerin, so glycerin may be part of the signalling processes involved in skin cell differentiation (Zheng X, Bollinger Bollag W. Aquaporin 3 colocates with phospholipase d2 in caveolin-rich membrane microdomains and is down-regulated upon keratinocyte differentiation. J Invest Dermatol 2003 12 1: 1487-95). In addition to the above functions, glycerin is a humectant, emollient and mild astringent suited to both skin and mucous membrane and to the needs of children. Overall and in particular, glycerin is appropriate for non- aggressive treatment of mucous tissue, including hemorrhoids and its many benefits are without physiological harm. Thus Tea Tree oil and glycerin remarkably complement and reinforce one another.
Therefore, it is a further object of this invention to combine the steam distillate of Tea Tree oil, or terpinen -4-ol, with glycerin in innovative compositions for personal hygiene and health.
Compositions of the kind described herein are more particularly illustrated by the following Examples.
While the invention will now be described in connection with certain preferred embodiments in the following examples so that aspects thereof may be more fully understood and appreciated, it is not intended to limit the invention to these particular embodiments. On the contrary, it is intended to cover all alternatives, modifications and equivalents as may be included within the scope of the invention as defined by the appended claims. Thus, the following examples which include preferred embodiments will serve to illustrate the practice of this invention, it being understood that the particulars shown are by way of example and for purposes of illustrative discussion of preferred embodiments of the present invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of formulation procedures as well as of the principles and conceptual aspects of the invention.
Examplel
% w/v
Cyclopentasiloxane 85 Dimethicone 15
Example 1 is prepared by mixing the Dimethicone with the Cyclopentasiloxane for 1 minutes at a temperature of 25-30 °C. The resultant composition is suitable for anal and vaginal contact during regular hygiene, in both adults and children.
Example2
% w/v
Cyclopentasiloxane 89 Dimethicone 8 Dimethiconol 3
Example 2 is prepared by mixing the Dimethicone and Dimethiconol with the Cyclopentasiloxane for 1 minutes at a temperature of 25-30 °C. The resultant composition is suitable for anal and vaginal contact during regular hygiene, in both adults and children. Example3
% w/v
Cyclopentasiloxane 85 Dimethicone 8 Dimethiconol 6 Tea Tree Oil (extract of Maleleuca alternifolia) 1
Example 3 is prepared by mixing the Dimethicone and Dimethiconol with the Cyclopentasiloxane for 1 minutes at a temperature of 25-30 °C. The Tea tree oil is then added and stirred for a further 2 minutes also at a temperature of 25-30 °C. The resultant composition is suitable for anal and vaginal contact during regular hygiene, in both adults and children.
Example 4
% w/v
Tea Tree Oil (extract of Maleleuca alternifolia; ISO/FDIS 4730, 2004; 0.05 Glycerin 15.00 Water (sterile) 84.95
Example 4 is prepared by mixing the glycerin with the water for 4 minutes at a temperature of 25-30 °C. The Tea tree oil is then added and stirred for a further 4 minutes also at a temperature of 25-30 °C). The resultant composition is suitable for anal and vaginal contact during regular hygiene, in both adults and children. Example 5
% w/v
Tea Tree Oil (extract of Maleleuca alternifolia; ISO/FDIS 4730. 2004J 0.05 Glycerin 15.00 Silicone oil (dimethicone) 1.00 Water (sterile) 83.95
Example 5 is prepared as ia Example 4, but with an additional final step during which the silicone oil is added and the total composition stirred at 25-30 °C for 5 minutes. The composition of Example 5 is suitable for intimate anal and vaginal contact during regular hygiene, in both adults and children and is particularly appropriate in regular care for infant and adult incontinence.
Example 6
% w/v
Tea Tree Oil (extract of Maleleuca alternifolia; ISO/FDIS 4730, 2004j 1.00 Glycerin 15.00 Silicone oil (dimethicone) 1.50 Water (sterile) 82.50
Example 6 is prepared in the same manner as Example 5. The composition of Example 6 is suitable for vaginal contact during periodic or chronic use for inflammatory and/or infective conditions in both adults and children, and for regular care for more troublesome cases of adult incontinence.
Example 7 ___
Tea Tree Oil (extract of Maleleuca alternifolia; ISO/FDIS 4730, 2004; 2.00 Glycerin 15.00
Silicone oil
(dimethicone) 3.00
Water (sterile) 8 1.00
Prepared in same manner as Example 5, the composition of Example 7 is suitable for intimate anal contact during periodic or chronic treatment of hemorrhoids or for severe pruritis ani from any cause, especially when associated with an infection. Use of the concentration of Tea Tree oil of this example provides an additional a3tringency beneficial to hemorrhoids: the anal environs involves more skin than mucous epithelial areas, so overall it is less sensitive and absorptive than vaginal mucous epithelium.
The increased concentration of silicone oil for the purpose of this Example provides extra lubrication, prior to defecation when this is desired, during cleaning and also afterwards if during body movement or at rest pain is caused by pressure of epithelium against epithelium. In addition, the silicone oil leaves a more substantial barrier between cleanings against attachment of solid, dry fecal excreta to epithelia and also accords increased stability to toilet paper against a deleterious mechanical effect of possibly over repetitious or energetic anal rubbing, compared to that during vaginal application.
If in Examples such as the above and others, terpinen-4-ol is substituted for Tea Tree oil, the concentration of that alcohol will usually but not necessarily be between 10% and 40% of that of the Tea Tree oil substituted, depending on the specific purpose of the composition.
In summary, in conjunction with the innovative simple, practical, esthetic, and economic dispenser and dispenser system provided by the invention, Tea Tree oil (or terpinen-4-ol) and glycerin together in a water based composition or compositions from examples 1, 2 and 3, are able to satisfactorily fulfill the further purpose of this invention, i.e., to provide a liquid composition with a single or multiple herbal ingredient which, as an additive to ordinary toilet paper, or a wet wipe, can (also when optionally combined with a silicone oil) efficaciously provide diverse needs for personal intimate hygiene and health in a manner which is relatively safe compared to that available from the prior art. More particularly, the composition provides for the special needs of vaginal and rectal mucous epithelia, both in regular hygiene and for common health issues requiring extra care. Furthermore, the invention is intended to encourage the bringing of regular care of the critical vaginal and rectal regions to a high standard, concomitant with that common for oral and dental care. This is achieved in a cost- effective manner suitable to the public as a whole, while showing special concern for problems affecting a high proportion of women and a smaller (but painful) proportion of men; and concern also for the education of children at an early age to the importance of hygiene, no less in body areas which are masked, than in those open to vision.
Essentially the invention comprises an innovative, safe, practical, aesthetic and modestly priced system which provides dispensing by self-pressure from a closed vessel on to ordinary toilet roll, one of the water-based compositions according to the invention comprising Tea Tree oil (or terpinen-4-ol) together with glycerin and water (optionally combined with a silicone oil or other Silicone based liquids) in concentrations suited to tissue, gender, age, or special need.
In another aspect of the present invention there is provided a dispenser containing a liquid composition as defined above for dispensing and applying the same to rolled toilet tissue so that sheets from the roll can be used as a wetted wipe for personal hygiene and health, said dispenser comprising: a substantially opaque vessel, a major part of which is of spherical body shape, having about 5-1 5cms at the maximum cross- sectional diameter of the round part of the container; a round externally threaded neck portion open at both ends and extending away from the body of said vessel, the inner volume of said body and neck portion being contiguous; said vessel being provided with a flattened portion at a location essentially opposite to said neck portion; a standard manually operated dispensing aerosol pump with spring-loaded valve, integral with an internally-threaded collar, said pump being inserted into said vessel and secured to the threaded neck portion of the vessel by said threaded collar ring for airtight coupling; a dip tube attached to said pump at its point of input and of a length maximizing removal of said composition from the vessel prior to replacement, or refilling.
In some preferred embodiments of the present invention said dispenser is provided in combination with an independent shelf stand comprising: a vertical lip for attachment to a wall, a flat thin portion extending horizontally away from said wall and bounding a round aperture of such diameter and rim profile that said rim can effectively receive and support said dispenser vessel when in contact with a spherical portion of surface of said vessel and allow easy, manual multidirectional rotation and angling of said dispenser; said shelf stand being further provided on both of its sides with depressions located and profiled to effectively guide, hold and support a toilet roll holder.
Said shelf stand can further comprise an optional horizontal portion extending away from said shelf stand to a length enabling it to be inserted through the center of a toilet roll and project slightly from it; at the end of the extension distal to said shelf stand comprising a bent stop element contiguous with and upwardly inclined to said extension so as to retain a roll during use, while not preventing its convenient replacement when desired; and further comprising, at the end of the horizontal extension proximal to the shelf stand, a short portion of said extension bent over and reversed through 180 degrees to enable clipping of said proximal end of said horizontal roll holder on to the said shelf stand with utilization of the said depressions on both surface of the shelf stand. Said shelf stand further comprises a toilet roll holder comprising a horizontal portion extending 5-10 cms away from said shelf stand and a vertical portion 10-20cms long attached to said horizontal portion.
Brief Description Of The Drawings
This aspect of the invention will now be described in connection with certain preferred embodiments with reference to the following illustrative figures so that it may be more fully understood.
With specific reference now to the figures In detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the preeent invention only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.
Figure 1a is a perspective view of a preferred dispenser according to the present invention; Figure 1b is a perspective view of a further preferred dispenser according to the present invention; Figure c is a perspective view of an aerosol spray for use with the dispenser bottle of Figure 1a. Figure 1d is a perspective view of a dispenser according to the present invention in combination with a shelf designed for use therewith; Figure 2a is a perspective view of a shelf unit; Figure 2b is a perspective view of a toilet roll holder which attaches to said shelf unit; Figure 2c is a perspective view of the toilet roll holder of Figure 2b attached to the shelf stand of Figure 2a; Figure 2d is a perspective bottom view of the shelf stand of Figure 2a; Figure 2e is a perspective view of a different arrangement of a shelf unit and a toilet roll holder; Figure 2f is a perspective view of the shelf unit and toilet roll holder of Figure 2e with a toilet roll held thereby; and Figure 3 is a perspective view of a water closet with a double dispenser shelf unit and toilet roll combination attached to a wall thereof.
Detailed Description Of The Illustrated Embodiments
Referring now to Figures 1a through 1d and Figure 2a, it can be seen that the dispenser consists of a substantially opaque vessel I (Fig 1a) or 2 (Fig 1b) for containing a lotion to be dispensed and a standard, manually-pressured suction pump 3 (Fig 1c) incorporating a standard spring-operated valve, to dispense the lotion. The vessel 1 is for the most part spherical and may be ball-like 4 or pear-like 5 (Fig 1c) or any other shape that forms a spherical surface of an area enabling vessels land 2 to be rotated or to lean from vertical (Fig. 1d) when sitting (Fig. 2a) on the shelf 20 in the aperture 2 1. A typical vessel will be from 5-1 5cms at the maximum cross-sectional diameter of the round part of the container and a preferred diameter is between 8 to 10cms (about 4-500 cc in volume)
Each vessel is of a color, or indicates by a color which is specific to the composition within and each such vessel will bear an indentation or other such physical sign tactilely recognizable in poor light or vision. The extension of the neck 6 of pear- shaped vessel 5 will be from 1-10cms in length additional to the maximum diameter of the ball-like part of the vessel, depending on practical and/or esthetic considerations. A portion 7 of the otherwise circular surface of each of the vessels 1 and 2 is substantially flat and at one preferred position opposite the single mouth 8 of vessels 1 and 2 but this is not an essential orientation. The area of flat portion 7 is always sufficient to ensure positional stability of vessels 1 and 2 when standing on a standard horizontal shelf, i.e. not the shelf 20 of the invention.
The pump 3 is secured by internally threaded collar 9 to the external thread 10 on mouth 8 thus closing vessels 1 and 2. The standard dip tube 11 fixed to and extending away from pump 3 is of a length such that its distal end can reach a point at which the flat portion 7 abuts the spherical surface 4 of vessels 1 and 2. The pump-head 3 has an orifice 14 shaped to dispense a lotion of the invention efficiently onto a toilet roll, internal width of said orifice between 5 and 5 mm (preferably between 7and 9mm) and internal height 2 - 3mms. From at or close to the open rim of collar 9 and at an angle which is substantially 90 degrees to the said collar radiates a thin, substantially and preferentially flat ring 15 which is between 1 to 2cms wide and in any event not less or more than will enable adequate leverage for operating the pump head conveniently (Fig. 1c).
The outer edge 22 of shelf stand 20 (Fig. 2a) may be of any convenient and esthetic shape. The inner aperture 2 of the shelf stand is round and of a diameter sufficient in relation to size of said vessel to allow the secure seating on it of vessels 1or 2, profile of inner edge 23 of said aperture allowing facile rotation and angling of said vessel for the efficient and convenient use of the dispenser. The total area and thickness of shelf stand 20 extraneous to aperture 22 is any that affords mechanical strength and an esthetic value appropriate lo the function of said dispenser. Al least two holes 24 in a vertically downward lip 25 extending from the outer edge 22 of shelf stand 20 allow horizontal attachment of said shelf stand to a wall.
Not less than three pairs of depressions 26 in the upper surface 27 of shelf stand 20 with at least one said pair aligned parallel with and to each side of the downward vertical lip 25, are of a cross-sectional size and profile enabling said depressions to electively accept, position and hold effectively a toilet roll holder 40 (Figs. 2b and 2c). Each pair of depressions is reflected in a similar pair 28 of similar profile on the undersurface 29 of shelf stand 20. At each point where a depression 26 abuts inner rim 23, a notch 30 inwards into said depression (Fig. 2 d) permits embedding of the reversed ends 4 1 of roll holder 40 so that easy rotary motion of vessels 2 and 3 on a shelf stand 20 is not prevented, while the position of the roll holder is locked by slight protrusions 3 1 into each notch, from the corners formed by the inner rim with a depression. Roll holder 40 may be electively linked to shelf stand 20 by positioning the two essentially parallel branches 42 on a pair of parallel depressions 26 with the two open ends 43 of said roll holder beyond aperture edge 23, so that when said roll holder is pulled in a direction away from aperture 2 1 the tips 44 of the two open end3 43 pass under the said shelf stand and slide into the appropriate depressions on its underside (Fig 2c) until they are prevented from going further by reverse turns 4 1 on roll holder branches 42. In one version of the axis on which rolls rotate, the said roll holder extends horizontally away from shelf stand 20 to a length enabling the roll holder to be inserted through the full length (Fig. 2f) of the center of a standard toilet roll (or of other paper rolls appropriate to any other use of the dispensing means of the invention) and extends just beyond a roll to a point where a bend 45 in said extension forms a stop element 46 angled upwards between 10 and 90 degrees (in one preferred version, 30 degrees) and away from parallel branches 42 to a height ensuring that the roll will not slip off during normal use. In another version (Fig. 2e) of the axis of the roll holder, a horizontal portion extends about 5-1 0 cms away from said shelf stand and a vertical portion 47 attached to said horizontal portion is about 10-20 cms long and not shorter than necessary to hold the toilet (or other paper) roll (Fig. 2f) securely.
The maximum distance between the two outer edges of the parallel branches of roll holder 40 is not usually more than 42mms and n t more or less than what will enable a toilet (or other paper) roll to rotate on it easily.
The ergonometric nature of the invention provides a range of choices and therefore is particularly useful in family bathrooms and toilets. One or more dispensers sitting on one or more of shelf holder 20 (to which roll holders 40 are electively not attached) may be arranged (Fig. 3) around a dispenser to which a roll holder 40 is attached (or around an existing standard toilet roll holder). Of course, one dispenser or more (without holders) can be located on a standard shelf. With or without attachment of paper roll holder 40, the flexibility, simplicity and convenience will make it obvious to those skilled in the art, that the said dispensers with the compositions of the invention together embody an innovative system for the needs of personal intimate hygiene and treatment. The system will also be beneficial to nursery hygiene and for cosmetic or cleaning activity in the domestic and public setting generally not only, for example, for such as hair and skin, but also for surfaces of inanimate objects and when also using compositions other than those of the invention.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative examples and that the present invention may be embodied in other specific forms without departing from the essential attributes thereof, and it is therefore desired that the present embodiments and examples be considered in all respects as illustrative and not restrictive, reference being made to the appended claims, rather than to the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. WHAT IS CLAIMED IS:
1. A liquid composition for personal hygiene use comprising an active ingredient selected from the group consisting of cyclopentasiloxanc, Tea Tree oil or an active component thereof, and combinations thereof.
2. A composition for personal hygiene use according to claim 1 comprising cyclopentasiloxane and dimethicone.
3. A composition for personal hygiene use according to claim 1 comprising cyclopentasiloxane, dimethicone and dimethiconol.
4 . A composition for personal hygiene use according to claim 1 comprising cyclopentasiloxane, dimethicone, dimethiconol and Tea Tree oil.
5. A composition for personal hygiene use according to claim 1 comprising: Tea Tree oil or an active component thereof; glycerin; and water.
6. A composition according to claim 5 comprising: terpinen-4-ol; glycerin and water.
7. The composition according to claim 5 for personal hygiene use wherein the content of said Tea Tree oil is about 0.01 5 - 15% w w; the glycerin content is about 10 - 80%, and the remainder of the composition is sterile water.
8. The composition according to claim 5 for personal hygiene use wherein the contents of said Tea Tree oil is about 0.01 5 - 15% w/w; the glycerin content is about 15 - 35%, and the remainder of the composition is sterile water.
9. The composition of claim 5, for daily personal hygiene use as a wetting agent for a towelette. 0. The composition of claim 1, for daily personal hygiene use as a wetting agent for a wet wipe.
1 . The composition of claim 5 further comprising a silicone oil selected from the group consisting of dimethicone, stearyldimethicone, cyclomethicone, and dimethiconol.
12. The composition according to claim 11 wherein the content of silicone oil is about 0.5 - 3.0% w/w.
13. The composition according to claim 11 wherein the content of silicone oil is about 1 - 2% w/w.
14. The composition according to claim 5 further comprising an agent for pH adjustment to about 4.0 - 6.5.
15. A dispenser containing a composition according to claim 1 for dispensing and applying the same to rolled toilet tissue so that sheets from the roll can be used as a wetted wipe for personal hygiene and health, said dispenser comprising: a substantially opaque vessel, a major part of which is of spherical body shape, having about 5- 5cms at the maximum cross-sectional diameter of the round part of the container; a round externally threaded neck portion open at both ends and extending away from the body of said vessel, the inner volume of said body and neck portion being contiguous; said vessel being provided with a flattened portion at a location essentially opposite to said neck portion; a standard manually operated dispensing aerosol pump with spring-loaded valve, integral with an internally-threaded collar, said pump being inserted into said vessel and secured to the threaded neck portion of the vessel by said threaded collar ring for airtight coupling; a dip tube attached to said pump at its point of input and of a length maximizing removal of said composition from the vessel prior to replacement, or refilling. 16. The dispenser of claim 15 in combination with an independent shelf stand comprising: a vertical lip for attachment to a wall, a flat thin portion extending horizontally away from said wall and bounding a round aperture of such diameter and rim profile that said rim can effectively receive and support said dispenser vessel when in contact with a spherical portion of surface of said vessel and allow easy, manual multidirectional rotation and angling of said dispenser; said shelf stand being further provided on both of its sides with depressions located and profiled to effectively guide, hold and support a toilet roll holder.
7. The shelf stand as in Claim 6, comprising: a horizontal portion extending away from said shelf stand to a length enabling it to be inserted through the center of a toilet roll and project slightly from it; at the end of the extension distal to said shelf stand comprising a bent stop element contiguous with and upwardly inclined to said extension so as to retain a roll during use, while not preventing its convenient replacement when desired; and further comprising, at the end of the horizontal extension proximal to the shelf stand, a short portion of said extension bent over and reversed through 180 degrees to enable clipping of said proximal end of said horizontal roll holder on to the said shelf stand with utilization of the said depressions on both surface of the shelf stand.
18. The shelf stand as in Claim 17, further comprising a toilet roll holder comprising a horizontal portion extending 5-1 0 cms away from said shelf stand and a vertical portion 10-20cms long attached to said horizontal portion.
19. A wetted wipe for personal hygiene and health comprising an active ingredient selected from the group consisting of cyclopentasiloxane, Tea Tree oil or an active component thereof, and combinations thereof.
20. A method of moist treatment of a body surface comprising applying thereto a wetted wipe for personal hygiene and health comprising an active ingredient selected from the group consisting of cyclopentasiloxane, Tea Tree oil or an active component thereof, and combinations thereof. A method of moist treatment of anal and vaginal surfaces comprising applying thereto a wetted wipe for personal hygiene and health comprising an active ingredient selected from the group consisting of cyclopentasiloxane, Tea Tree oil or an active component thereof, and combinations thereof.