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Repeated Extractions at Exhaustive Organic Solvent Extraction Elevated Temp US00570517OA United States Patent (19) 11 Patent Number: 5,705,170 Kong et al. 45 Date of Patent: Jan. 6, 1998 54. HERBAL CELLULITE TREATMENTS "Controlling the Appearance of Cellulite: AHAs and Cellu lite Products" by Ronald M. DiSalvo, C & T Ingredient 75 Inventors: William C. Kong. Whitestone, N.Y.: Resource Series pp. 21 to 27. Raymond Yeung. Stamford, Conn. "Local Lipodystrophy and Districtual Microcirculation" by S.B. Curri et al., Cosmetics and Toiletries, vol. 109, pp. 51 73 Assignee: Plantech International, Inc., College to 53 (Sep. 1994). Point, N.Y. Primary Examiner-Jyothsan Venkat 21 Appl. No.: 547,417 Attorney, Agent, or Firm-Handal & Morofsky 22 Filed: Oct. 24, 1995 57 ABSTRACT (51) int. Cl. ................. A61k 7/48 The invention provides a herbal cellulite treatment (52) U.S. Cl. ........................ 424/401: 414/195.1: 514/860 employing, in preferred embodiments, topical treatments, 58) Field of Search ................................. 424/401, 195.1; both method and cosmetic composition, wherein a refined 514/860 lipophilic extract, and preferably also a refined aqueous extract of a Malvaceae plant, preferably whole Hibiscus 56 References Cited Abelmoschus, are applied to the skin overlying cellulite afflicted tissues. The treatments are intended to last at least U.S. PATENT DOCUMENTS four, and preferably eight or more weeks. Clinical tests show 5,165,935 11/1992 Andre et al. ............................ 424/450 suprisingly superior results to those obtainable with amino 5,194.259 3/1993 Soudant et al. ......................... 424/40 phylline compositions. Inventive treatments can reduce thigh diameters and fatty layer thickness, as well as skin OTHER PUBLICATIONS condition. In vitro tests show remarkable lipolytic Hortus Third, Liberty Hyde Bailey Hortorium, Macmillan properties, apparently attributable to B-receptor stimulation, Publishing Co., Inc. (New York, NY, U.S.), 1976, pp. 1.560, and valuable lipogenesis inhibition properties apparently 702. attributable to ot-blocking. Preferred extracts show low "Cellulite Treatments: Snake Oils or Skin Science" by toxicity. Walter P. Smith, Cosmetics & Toiletries magazine, vol. 110 pp. 61 to 70 (Jul 1995). 13 Claims, 5 Drawing Sheets PREPARATION OF MALWACEAE EXTRACT Hibiscus Plant (Malvaceae) Selected Whole Plant Pulverized with Dried and Pulverized waterfalcohol/glycols Repeated extractions at Exhaustive organic solvent extraction elevated temp. & press. at elevated temp. Supress. F iltration Filtration Crude lipophilic extract Crude aqueous extract Purification & differential extraction Column Chromato aph Aqueous Malvaceae extract Lipophilic Malvaceae extract U.S. Patent Jan. 6, 1998 Sheet 2 of 5 5,705,170 UI nesuo?oenxòpane3d3YI ºsseïdººduanpen?AÐIÐ U.S. Patent 5,705,170 £©ináH / U.S. Patent Jan. 6, 1998 Sheet 4 of 5 5,705,170 NON POLAR LIPIDS SQUALANE 2 WAX ESTERS TRIGLYCERIDES ----- CEREBROSIDE CERAMIDE - GLYCOLIPIDs Figure 4 U.S. Patent Jan. 6, 1998 Sheet 5 of 5 5,705,170 SCIIdII NVIOd. NON. SCIIdrooxior 5,705,170 1 2 HERBAL CELLULTE TREATMENTS volume 109, pages 51 to 53 (September 1994). Curri describes the symptomatic and anatomic pathology of cel TECHNICAL FIELD lulite in some detail. and urges that deterioration of the This invention relates to herbal cellulite treatments. Cel microvasculature leads to fatty accumulations, rather than lulite is a medical and cosmetic condition in which disorders vice versa. DiSalvo discloses methods and compositions for of the skin and underlying tissues and vasculature lead to treating cellulite which are described more fully hereinbe unsightly accumulations of adipose tissue. The treatments low. described herein employ non-toxic herbal extracts from a Afurther description of possible biochemical mechanisms common plant source to obtain, valuable and in some cases relevant to cellulite therapy, which is based upon the dis surprising, reductions of the cellulite condition, especially as O closures of Di Salvo and Curri, also appears below and determined by measurements of tissue thickness. More references FIG. 1 of the accompanying drawings. particularly, the invention relates to herbal methods of Known anticellulite active agents. Adrenergic agents are treating cellulite are suitable for unsupervised consumer use, substances that have an epinephrine- or norepinephrine-like and to novel topically applied consumer use, cosmetic adrenal stimulation function. The best known of these is compositions for cellulite treatment, which compositions 15 caffeine which is one member of a class of substances contain active herbal ingredients. known as xanthines. Caffeine and other xanthines, notably aminophylline and theophylline have been used in cellulite BACKGROUND treatments with moderate efficacy. Cellulite afflictions are a stubborn problem causing emo These materials bind either directly or indirectly to the tional and psychological distress to many women. Cellulite B-receptor, thereby stimulating it. The stimulated receptor primarily afflicts the thighs and buttocks but may also be triggers a complex series of events involving multiple present on the stomach and upper arms. Frequently, cellulite enzyme systems which results in an accumulation of cyclic presents an unsightly, lumpy orange-peel appearance. AMP within the cell and decreased ATP. These conditions Clinically, cellulite manifests a range of symptoms including activate lipases which break down triglyceride fats in the thinning of the epidermis, reduction and breakdown of the 25 adipocytes into free fatty acids, which can be used by the cell microvasculature leading to subdermal accumulations of for growth and metabolism, or may be discharged extracel fluids, and subdermal agglomerations of fatty tissue. lularly. Current scientific thinking postulates that fat particles The o-receptor is regulated by other materials which stored within the cells in women's hips and thighs are more 30 usually do not themselves influence the B-receptor. The difficult to reduce because of an abundance of external B-receptors exert a regulatory control over the Breceptors so cellular receptors whose activation inhibits lipolysis, the that stimulation of the B-receptors can only be partially breaking down of fat. effective, unless the O2-receptor is simultaneously inhibited. Many treatments for cellulite have been devised and are Di Salvo reports, page 21, right-hand column, line 9 from directed at reducing the agglomerations of fatty tissue. 35 the bottom, that topical application of a B-adrenergic stimu While some treatments rely upon sweating to reduce fluid lator and an O-adrenergic inhibitor produces a blocking of accumulations, and perhaps stimulate circulation, more lipolysis inhibition so that fatty acids are released more effective treatments are more directly targeted to reducing readily. Di Salvo points out that for this approach to be the volume of the fatty deposits by, for example, massage successful, the active agent or agents must be delivered with mechanical implements, or by application of topical (through the dermis) into the vicinity of the fatty deposits treatments containing an active agent. Such topical treat that are to be broken down. ments are usually accompanied by more or less massage. W. Di Salvo discloses various adrenergic stimulators and P. Smith in "Cellulite Treatments: Snake Oils or Skin adrenergic inhibitors. As listed by Di Salvo, the former are Science” Cosmetics & Toiletries (trademark) magazine primarily the known B-receptor adrenergic stimulators listed pages 61 to 70 (July 1995), "Smith C & T" herein, describes 45 above, namely pharmaceutical substances that include the various stages of cellulite disorder in detail and reviews the hormone epinephrine, also known as adrenaline and analogs efficacy of a number of cellulite treatments by reference to of epinephrine including xanthines, such as aminophylline, their ability to improve microcirculation, skin firmness and and caffeine. Although some compounds such as theophyl skin thickness, and to reduce thigh diameter. line are derived from herbal sources such as cacao beans, Mechanism of action of anti-cellulite agents. Two recep 50 kola nuts and tea leaves, they are all chemical isolates, or tors on the outer membranes surface of adipocytes (fatty substances. cells) are believed to control the fat volume of the cell. These The o-adrenergic inhibitors listed by DiSalvo are exotic receptors are a B receptor activation of which stimulates plant alkaloids, also chemical isolates, fully identified as lipolysis and an or receptor, activation of which stimulates individual chemical substances, which have hypertensive or lipogenesis and inhibits lipolysis. 55 vasoconstrictive action. Exemplary compounds are yohim Lipolysis is a breaking-down of the fatty deposits and is bine and dihydroergotamine. Unfortunately, these com therefore a very desirable mechanism to stimulate in any pounds are sourced from families of plant or fungal alka cellulite treatment while lipogenesis refers to a cell's ability loids which include some extremely poisonous members. to manufacture fatty materials. Clearly, lipogenesis is to be They are rare and exotic, expensive and potentially danger inhibited. Thus, according to these models, the B receptor ous. They are not suitable for unsupervised consumer use, should be stimulated, B-adrenergic stimulation, and the ol nor are they suitable for formulating in topical cosmetic receptor should be inhibited, oadrenergic inhibition. These compositions. Di Salvo also reported
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