EFFERVESCENT GRANULES

Abstract: An effervescent granule for the release and efficient dispersion of a herbal preparation in water. Also provided is a method of making the herbal medication granule and a method of using the granule. The granule of the present invention is particularly efficient for the dispersion of a herbal preparation which includes an essential oil, although herbal preparations including an herbal extract can also be used.

Description: EFFERVESCENT GRANULES FIELD AND BACKGROUND OF THE INVENTION The present invention relates to effervescent granules containing an herbal preparation In particular, the present invention relates to effervescent granules which can conveniently and rapidly disperse beneficial herbal extracts, essential oils, or both, into bathing water for topical administration or into steam for inhalation. Herbal medicines in the form of extracts or essential oils are very beneficial in forms such as medicinal baths or πnses, or in a form which permits inhalation of medicinal vapors. Hereinafter, the term "herbal medication" refers to a medication deπved from botanical materials or a biologically active extract of these materials However, currently available formulations of these herbal medicines require elaborate preparation before use, which makes these formulations inconvenient to use and hampers patient compliance Also, from a technical perspective, one form of such medications, essential oil, which is hydrophobic, does not dissolve and disperse well in water There is thus a widely recognized need for, and it would be highly advantageous to have, a formulation which enhances the dispersion and dissolution of herbal medicines in water, which enables all forms of these herbal medicines to dissolve easily and efficiently in water, and which enables these medicines to be used in bathing water or to be inhaled in the form of steam SUMMARY OF THE INVENTION According to the present invention, there is provided an effervescent granule, including: (a) a pharmaceutically effective amount of a herbal medication as the active ingredient; (b) an acid; and (c) a base capable of releasing carbon dioxide upon reaction with the acid when contacted with water Preferably, the acid is selected from the group consisting of tartaπc acid and citπc acid. Alternatively and preferably, the acid is a mixture of tartaπc acid and citπc acid. More preferably, the tartaπc acid and the citπc acid are present in a ratio of about 2 1 by weight Also preferably, the base is selected from the group consisting of sodium bicarbonate, sodium carbonate and potassium bicarbonate More preferably, the base is sodium bicarbonate Most preferably, the acid is a mixture of citπc acid and tartan c acid, and the sodium bicai bonate, the citπc acid and the tartaπc acid aie present in a ratio of about 3 44 1 2 by weight According to another embodiment of the present invention, there is provided a method of releasing and evenly dispersing a herbal medication in water, including the steps of: (a) providing an effervescent granule, the granule including: (1) a pharmaceutically effective amount of a herbal medication as the active ingredient; (n) an acid; and (in) a base capable of releasing carbon dioxide upon reaction with the acid; and (b) placing the granule in water, such that the medication is released upon reaction of the acid and the base. In a preferred embodiment of the present invention the herbal medication does not include Oil of clove or eugenol In a preferred embodiment of the present invention the essential oil is selected from the group consisting of Cinnamon oil, Lavandula, Thyme oil, Eucalyptus oil and Peppermint oil. In a preferred embodiment of the present invention the effervescent granule compπses a predefined ratio of an amount of herbal medication to an amount of an effervescent earner such that a specific amount of herbal medication is released from the earner when the earner is contacted with water. According to another embodiment of the present invention there is provided a formulation of an effervescent granule, compnsing a pharmaceutically effective amount of a herbal medication as active ingredient, an acid, a base for releasing carbon dioxide upon reaction with the acid when contacted with water, and a soap for producing a foam when contacted with the water. According to another embodiment of the present invention there is provided an effervescent granule compnsing a medication consisting essentially of a herbal medication, an acid, and a base for releasing carbon dioxide upon reaction with theacid when contacted with water. According to another embodiment of the present invention there is provided an effervescent granule consisting essentially of a pharmaceutically effective amount of a herbal medication, as medicinal agent, an acid, and a base for releasing carbon dioxide upon reaction with the acid when contacted with water. According to another embodiment of the present invention there is provided an effervescent granule compnsing a herbal medication, as the only active ingredient, an acid, and a base for releasing carbon dioxide upon reaction with the acid when contacted with water Hereinafter, the term "herbal medication" can include one or more herbal extracts, one or more essential oils, or a combination of both. Herbal extracts are extracts of plant matenals. Preferably, herbal extracts are a tincture of botanical matenals, which are prepared by contacting botanical matenal with a solvent [British Herbal Pharmacopeia, Peter R Bradley, ed., British Herbal Medicine Association, 1983; and British Herbal Compendium. Peter R. Bradley, ed., Bπtish Herbal Medicine Association, 1992]. The solvent can be aqueous or organic, or a combination thereof Acceptable organic solvents include, but are not limited to, glycenn, propylene glycol or alcohol, or a combination thereof. The most preferred solvents are hydroalcohohc solvents as defined in British Herbal Pharmacopeia and Compendium. The botanical matenal can include, but is not limited to, one or more of the following species: Plantago (Plantago major), Hypencum (Hypencaceae perforatus), Echinacea (Coneflower) (Echinaceae species such as Echinaceae angustifohae radix and Eclunaceae purpurea). Baptism, Calendula, Myrrh, Phytolaca, Salvia, Catechu black, Kramena. Tsuga, Rosmannus, Styrax, Crataegus, Glycerrhiza [Glycerrhiχa glabra), Angelica, Kramena, Matncana, Mallow, Sage, Witch Hazel (Hamamelis vitgimana), English Oak (Lobaria), Burdock (Arctium Lappa), Chickweed (Stellaria), Sanguinana Canadensis, Thuja Occidentals, Balm mint (Mentha pipereta), Devil's Claw {Harpagophytum Procumb), Comfrey (Symphytum), and Inula helenium. Propolis is the resinous substance found in beehives. Although stnctly speaking Propolis is not a botanical mateπal, extracts of this mateπal are prepared in a substantially similar manner as extracts of the plant matenals and are hereinafter included in the term "herbal extract". Although essential oils can also be descnbed as a "herbal extract", generally such oils are considered to be a separate entity from the tinctures descnbed above. As used herein, the term "herbal extract" refers to a tincture as descnbed previously. An essential oil is a volatile mixture of esters, aldehydes, alcohols, ketones and terpenes, which can be prepared from botanical matenals or plant cell biomass from cell culture. Examples of essential oils include, but are not limited to, oil of cinnamon, prepared from the dned bark of the roots of Cinnamomum zevlonaceae; cajeput oil, eucalyptus oil, prepared from the fresh leaves and branches of vanous species of Eucalyptus, such as E. globulus, fenne! oil, prepared from dned πpe fruit of Foeniculum vulgare. geranium oil, prepared from the aeπal parts of Pelargonium species, girofle oil, lavander oil, prepared from fresh floweπng tops of Lavandula species such as Lavandula offwinalis, lemon oil, obtained from the fresh peel of Citrus limon, spearmint oil, prepared from the overground parts of fresh flowenng Mentha species, such as M. spicata; peppermint oil (Mentha Pipereta), myrte oil, oregano oil, pme oil, rosemary oil, prepared from tops or leafy twigs of Rosmarinus officinahs; sarπette oil, thyme oil, prepared from the leaves and flowenng tops of Thymus vulgaris; tea-tree oil, obtained from the leaves of Melaleuca olternifoha, sweet marjoram oil (Margorana Hortensis), safflower oil, citronella oil (citronella boil, Androto Gon Nardus), garlic oil, and juniper oil (jumperus). DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is of effervescent granules for the release and efficient dispersion of herbal medicines into bathing water for topical administration, or into steam for inhalation These effervescent granules can introduce two liquids or a liquid and a solid into a solid dosase form. Therefore, effervescent granules enable both herbal extracts and essential oils to be evenly and efficiently dispersed in water. This is particularly beneficial for essential oils which, as their name suggests, are hydrophobic oils and therefore do not disperse well in water alone Additionally, the use of effervescent granules provides convenient packaging and dispersal of accurate doses of the herbal medicines. This is important since essential oils and herbal extracts produce a medicinal effect when present in a well defined concentration range, preferably from about 1 percent to about 30 percent, more preferably from about 2 percent to about 25 percent and most preferably from about 10 percent to about 25 percent of the total formulation weight per weight. The herbal medication preferably contains a mixture of essential oil to herbal extract in a ratio of from about 1 to about 38 weight per weight, more preferably of from about 1 to about 10 weight per weight and most preferably of from about 1 to about 4 weight per weight. Furthermore, the granules of the present invention are specifically designed to be used with herbal medications. Effervescent salts have classically been used to disperse medicines in water for oral administration Effervescent salts are granules or coarse powders containing a medicinal agent in a dry mixture, usually composed of sodium bicarbonate, citπc acid and tartanc acid When the salts are added to water, the acids and the base react to liberate carbon dioxide gas, thereby causing "effervescence" By using granules or coarse particles, rather than fine powder, the contact aiea of the substances is decreased, and the rate of the reaction is reduced to a controlled rate and rapid uncontrollable effervescence is eliminated The properties of these salts are also useful for introduction and dispersion of herbal preparations in water for bathing Hereinafter, the term "bathing" includes topically contacting at least a portion of the body with an aqueous solution. The solution could be water alone, or water with one or more additives. For the present invention, generally the skin will be contacted with water containing a herbal preparation. The herbal preparation could include one or more herbal extracts, one or more essential oils, or both. The effervescent salts of the present invention are particularly effective for the dispersion of essential oils in water, thereby overcoming the hydrophobicity of these oils. Thus, the salts enable herbal preparations containing one or more essential oils to be easily administered as a topical formulation in bathing water. Formulation of Effervescent Granules The choice of ingredients for effervescent granules depends both upon the requirements of the manufactunng process and the necessity of making a preparation which dissolves readily in water. The two required ingredients are at least one acid and at least one base. The base must release carbon dioxide upon reaction with the acid. Examples of such acids include, but are not limited to, tartaπc acid and citπc acid. Preferably, the acid is a combination of both tartaπc acid and citπc acid. Examples of bases include, but are not limited to, sodium carbonate, potassium bicarbonate and sodium bicarbonate. Preferably, the base is sodium bicarbonate. Effervescent granules are usually prepared from a combination of citπc and tartaπc acid rather then from a single acid because the use of either acid alone causes difficulties. When tartaπc acid is the sole acid, the resulting granules readily crumble Citπc acid alone results in a sticky mixture which is difficult to granulate duπng the manufactunng process, as descnbed below. Effervescent salts preferably include the following ingredients, which actually produce the effervescence sodium bicarbonate, citπc acid and tartaπc acid. When added to water the acids and base react to liberate carbon dioxide, resulting in effervescence. It should be noted that any acid-base combination which results in the liberation of carbon dioxide could be used in place of the combination of sodium bicarbonate and citπc and tartaπc acids, as long as the ingredients were suitable for pharmaceutical use It should be noted that it is requires 3 molecules of sodium bicarbonate to neutralize 1 molecule of citπc acid and 2 molecules of sodium bicarbonate to neutralize 1 molecule of tartaπc acid. The proportion of acids may be vaπed, so long as the total acidity is maintained and the bicarbonate completely neutralized. Usually it is desired that ratio of citπc acid to tartaπc acid equal 1 to about 2, so that the desired ratio of ingredients can be calculated as follows : Citπc Acid : Tartanc Acid : Sodium Bicarbonate = 1 . 2 . 3.44 (by weight). Of course, this ratio could be vaned within a fairly wide range of values as defined in the pnor art and still provide a reasonably efficient release of carbon dioxide. For example, ratios of from about 1 to about 0 to about 3 or from about 0 to about 1 to about 2 would also be effective The selection of a specific ratio of ingredients could easily be determined by one of ordinary skill in the art, according to the desired properties of the final formulation. Methods of Prepanng Effervescent Granules The method of preparation of the granules of the present invention is as follows. There are three basic methods wet and dry granulation, and fusion The fusion method is the preferred method of preparation for effervescent granules, although the other two methods can also be used. Indeed, the fusion method is used for the preparation of most commercial effervescent powders. It should be noted that although these methods are intended for the preparation of granules, the formulations of effervescent salts of the present invention could also be prepared as tablets, according to well known pnor art technology for tablet preparation Such a tablet could also be used for dissolution in bathing water or in boiling water for steam inhalation Wet Granulation This is the oldest method of granule preparation, although it suffers from problems of reproducibility The individual steps in the wet granulation process of tablet preparation include milling and sieving of the ingredients; dry powder mixing, wet massing; granulation; and final gnnding Wet massing is the most important step in the wet granulation piocess In this step, the granulation agent is added to the powder mixture At the end of wet massing, the damp powder will pack to the consistency of a dry snowball, and crumble into fragments, not powder, under fingei pressure The granulation agent may be water added to a solvent, such as alcohol, which is employed as the moistening agent In the granulation step, the granules themselves are formed by forcing the moistened powder through a screen in an oscillation granulator or in a hammer mill. The resulting granulated matenal is dned on trays in a hot air circulation oven or preferably in a fluid bed dner. Particles may agglomerate and lump dunng drying, particularly in an oven. Therefore a sizing or dry screening operation is usually required after drying. An oscillation granulator is often used for this sizing step. The screen used for sizing should have slightly larger openings then that used to prepare the oπginal granules if excessive powder is not to be formed and granulation lost duπng sizing. If, for example, 20-mesh screen is used for granulation, a 16-mesh screen would be a good selection for sizing. Dry Granulation Typically, the process involves compressing a powder mixture into a rough tablet or "slug" on a heavy-duty rotary tablet press The slugs are then broken up into granular particles by a gnnding operation, usually by passage through an oscillation granulator. The individual steps include mixing of the powders, compressing (slugging); and gnnding (slug reduction or granulation) No wet binder or moisture is involved in any of the steps. Fusion method The most preferred method for prepanng the granules of the present invention is the fusion method. In this method, the compressing (slugging) step of the dry granulation process is eliminated. Instead, the powders are heated in an oven or other suitable source of heat. The particular advantage of this process is that it uses the water molecule complexed with each molecule of citnc acid as the granulation, or binding agent Just before mixing the powders, the citnc acid crystals are powdered and then mixed with the other powders (previously passed through a number 60 sieve) to ensure uniformity of the mixture. The sieves and the mixing equipment should be made of stainless steel or other mateπal resistant to the effects of the acids. The mixing of the powders is performed as rapidly as is practical, preferably in an environment of low humidity to avoid the absorption of moisture from the air by the chemicals and a premature chemical reaction After mixing the powder is placed on a plate or glass or a suitable dish in an oven previously heated to between 93° and 104°C Dunng the heating process the powder must be turned over S The heat causes the release of the water of crystallization from the citπc acid. The released water then dissolves a portion of the powder mixture and causes the chemical reaction to start, with the consequent release of some carbon dioxide. This causes the softened mass of powder to become somewhat spongy, and when of the proper consistency, similar to bread dough, the mass is removed from the oven and rubbed through an acid resistant sieve to produce granules of the desired size. A No 4 sieve may be used to produce large granules, while a No. 8. sieve can be used to prepare small granules. When all of the mass has passed through the sieve, the granules are immediately dned at a temperature not exceeding 54°C and immediately transferred to containers which are then tightly sealed. Specific Examples A number of examples of formulations of effervescent granules according to the present invention are given below for purposes of illustration only and are not intended to be limiting Ingredients are given as a percentage, weight per weight, of the final product EXAMPLE 1 In this example, as in all further examples given below, the acid and base combination is citnc acid, tartanc acid and sodium bicarbonate. The leaves and flowers of Rosmarmi and Eucalypti plants, and the fruits of Jumperi plants were used to prepare the dry herbal extracts. Oleum pini, or pine oil, and Thyme oil are the essential oils. Ingredients % w/w (weight per weight) Citπc Acid 12.0 Tartaπc Acid 24.0 Sodium Bicarbonate 39.0 Rosmanni 4.0 Eucalypti 8.0 Junipeπ 8.0 Oleum pini 2 5 Thyme oil 2 5 EXAMPLE 2 In this example, extracts prepared from Phxtolacca decand.. Calendula offic, Echinacea purpurea and Propolis extract are the dry herbal extracts. Tea Tree oil and Thyme oil are the essential oils. Ingredients % w/w Citnc Acid 14.0 Tartanc Acid 28.1 Sodium Bicarbonate 47.9 Phytolacca decand. 4.0 Calendula offic 2.0 Ectinacea purpurea 1.0 Propolis extract 1.0 Thyme oil 1.0 EXAMPLE 3 In this example, extracts prepared from Harpagophytum, Hammamelis and Aπnca plants are the dry herbal extracts. Lavendula oil and Rosmannus oil aie the essential oils. Ingredients % w/w Citnc Acid 14.0 Tartanc Acid 28.1 Sodium Bicarbonate 47.9 Harpagophytum 4.0 Hammamelis 2.0 Arnica 2.0 Lavendula oil 1 0 Rosmannus oil 1 0 EXAMPLE 4 In this example, extracts prepared from Calendula, Stelloria and Hammamelis plants are the dry herbal extracts Chamomile oil and Juniperus oil are the essential oils Ingredients % w/w Citnc Acid 13.0 Tartanc Acid 26.0 Sodium Bicarbonate 48 0 Calendula 3 0 Stelloπa 3 0 Hammamelis 3 0 Chamomile oil 2 0 Juniperus oil 2.0 EXAMPLE 5 In this example, extracts piepaied from Willow (Sain Albe) bark, Hammamelis virgin, Calendula ef ic and Harpegophvtum procume are the dry herbal extracts Menthol, Lavender oil and Geranium oil are the essential oils Ingredients % w/w Citnc Acid 12.0 Tartanc Acid 24.0 Sodium Bicarbonate 41.1 Willow (Sain Albe) bark 6 0 Hammamelis virgin 5 0 Calendula effic 5 0 Harpegophytum procume 3 9 Menthol 1 0 Lavendei oil 1 0 Geranium oil 1 0 EXAMPLE 6 In this example, extracts prepared from Arcticum Lappa, Stellaria media, Calendula offic, Hamamelis and Symphytum offic plants are the dry herbal extracts. Thyme oil and Ornanum marjorana oil are the essential oils. Ingredients % w/w Citπc Acid 14.0 Tartanc Acid 28.1 Sodium Bicarbonate 47.9 Arcticum Lappa 2.0 Stellana media 1.0 Calendula offic 1.0 Hamamelis 1.0 Symphytum offic 1.0 Thyme oil 2.0 Ornanum marjorana oil 2.0 EXAMPLE 7 In this example, there are no dry herbal extracts. Instead, a mixture of essential oils is used. Lavandula, Rosmannus. Eucalyptus, Pine, Thymus, Citrus Limonum and Menthol This represents a potentially difficult combination for dissolution into water, since such a large proportion of the ingredients are oils. However, effervescent granules of the present invention are able to overcome this difficulty and promote even and efficient dispersion of such oils, thereby illustrating one advantage of these granules. Ingredients % w/w Citric Acid 14.0 Tartanc Acid 28.1 Sodium Bicaibonate 47.9 Lavandula 1 0 Rosmannus 1 0 Eucalyptus 2 0 Pinus 2.0 Thymus 2.0 Citrus Limonum 1.0 Menthol 1.0 EXAMPLE 8 In this example, extracts prepared from Rotunculus, Symphytum and Calendula plants are the dry herbal extracts Cupressus oil is the essential oil. Ingredients % w/w Citnc Acid 14.0 Tartanc Acid 28.1 Sodium Bicarbonate 47.9 Rotunculus 4.0 Symphytum 2.0 Calendula 2.0 Cupressus oil 2.0 EXAMPLE 9 In this example, the dry herbal extracts are prepared from Echinacea and Inula helenium. The essential oils are prepared from Thymus Serpiliwn, Saturea montana and Origanum vulgar e. Ingredients % w/w Citnc Acid 14.0 Tartaπc Acid 28.1 Sodium Bicarbonate 47.9 Echinacea 2 5 Inula helenium 2.5 Thymus Serpi um 1.5 Saturea montana 2.0 Onganum vulgare 1.5 EXAMPLE 10 In this example, extracts prepared from Phytolacca, Calendula and Hamamelis plants are the dry herbal extracts. Thyme oil, Lavender oil and Tea Tree oil are the essential oils Ingredients % w/w Citπc Acid 12.0 Tartaπc Acid 24.0 Sodium Bicarbonate 54.0 Phytolacca 2.0 Calendula 1.0 Hamamelis 1.0 Thyme oil 2.0 Lavender oil 2.0 EXAMPLE In this example, extracts prepared from Phytolacca. Calendula. Hamamelis and Arnica plants, as well as Propolis extract, are the dry herbal extracts. Thyme oil, Lavendula oil and Geranium oil are the essential oils. Ingredients % w/w Citπc Acid 12.0 Tartanc Acid 24.0 Sodium Bicarbonate 39.0 Phytolacca 4 0 Calendula 3 0 Hamamelis 3.0 Arnica 4 5 Propolis 4 5 Thyme oil 2.0 Lavendula oil 2.0 Geranium oil 2.0 EXAMPLE 12 In this example, there are no dry herbal extracts. Instead, a mixture of essential oils is used: Lavender oil, Eucalypti oil. Pine oil, Thyme oil and Myrtus coinmunis oil are the essential oils. Ingredients 9r w/w Citric Acid 15.0 Tartanc Acid 30.0 Sodium Bicarbonate 51.0 Lavender oil 0.67 Eucalypti oil 1.32 Thyme oil 0.67 Myrtus communis oil 0.67 EXAMPLE 13 In this example, extracts prepared from ConefJower and Inula helenium are the dry herbal extracts. Oregano oi l, Thyme vulgaris oil and Cinnamon oil are the essential oils. Ingredients % w/w Citπc Acid 12.23 Tartanc Acid 24.47 Sodium Bicarbonate 41.64 Conel lower 9.25 Inula helenium 7.41 Oregano oil 2.00 Thyme vulgaπs oil 2.00 Cinnamon oil 1.00 EXAMPLE 14 In addition to these thirteen previous Examples, two formulations of effervescent salts according to the present invention were both prepared and tested according to a protocol descnbed in detail below. Bnefly. the effervescent salts were prepared and were then placed in water to dissolve. Both formulations descnbed below dissolved rapidly and completely. Thus, effervescent salts formulated according to the present invention are effective as vehicles for herbal preparations Examples of herbal preparations using these formulations are described below. The particular advantage of these two formulations is that they contain a soap (sodium lauryl sulfate) so that they produce foam when contacted with water. Like the previous formulations, these two formulations are also effervescent. Thus, effervescent salts prepared according to these two formulations can act as bath foam with an effervescent effect when added to bathing water, for example. In addition, the soap helps dispersion of herbal mixtures, where dispersion was found to be problematic. In this Example, the formulation tested was for a vehicle only with dry powdered ingredients as listed below. Ingredients % w/w Citπc Acid 12.0 Tartanc Acid 24.0 Sodium Bicarbonate 39.0 Sodium Lauryl sulfate 10.0 Lactose 15.0 The dried powdered ingredients listed above were mixed Next, a moistening agent was added to the mixtuie The moistening agent was 90% cthanol and 10% water As an example of a suitable ratio between the moistening agent and the dry ingredients, if the powdered ingredients weighed 250 grams total, then 23 ml of moistening agent was used, although of course other proportions would be possible. After the moistening agent was added, then the moistened powder mixture was pressed through a screen of mesh size 600. Finally, the resultant granules were dned in an oven at about 55-58 °C for three hours, to form the effervescent salt vehicle of the present invention. The granules of the effervescent salt vehicle were placed in water, where they dissolved completely and rapidly. Furthermore, a large amount of foam was formed. indicating the efficient release of large amounts of carbon dioxide Thus, the effervescent salt vehicle of this Example was an effective formulation. EXAMPLE 15 A second formulation was tested, as descπbe in this Example. Again, the formulation tested was for a vehicle only with dry powdered ingredients as listed below. Ingredients % w/w Citπc Acid 12.0 Tartaπc Acid 24.0 Sodium Bicarbonate 39.0 Sodium Lauryl sulfate 20.0 Lactose 5.0 The formulation was prepared as for Example 14, including the same relative amount of the same moistening agent. Again, the resultant granules were placed in water, where they dissolved completely, although less rapidly than those of the formulation of Example 14. Although foam was formed as a result, the amount of foam was less than that formed previously, indicating the release of less carbon dioxide. However, these tests indicate that the effervescent salt vehicle of this Example was still an effective vehicle formulation. EXAMPLE 16 In this example, there are no diy herbal extracts. Instead, a mixtuie of essential oils is used. Eucalyptis oil. Lavender oil. Citrus lemon oil, Pmi oil. Juniper oil and Thyme oil Ingredients % w/w Citπc Acid 13.75 Tartanc Acid 27 50 Sodium Bicarbonate 46.75 Lauryl sulfate sodium salt 10.00 Eucalyptus oil 0.56 Lavender oil 0.28 Citrus lemon oil 0.30 Juniper oil 0.28 Thyme oil 0.28 EXAMPLE 17 In this example, extracts prepared from Burdock, Calendula offic, Chickweed. Hamanelis Virginia and aie the dry herbal extracts. Lavender oil. Thyme oil and Sweet marjoram oil are the essential oils Ingredients % w/w Citπc Acid 12.50 Tartaπc Acid 25.00 Sodium Bicarbonate 42.50 Sodium lauryl sulfate 9.76 Burdock 3.34 Calendula offic. 1.68 Chickweed 1.66 Hamanelis virginiana 1.66 Comfrey 1.66 Lavender oil 0.08 Thyme oil 0.08 Sweet marjoram oil 0.08 EXAMPLE 18 In this example, extracts prepared from Poke root, Calendula, Coneflower and Propolis are the dry herbal extracts. Tea Tree oil. Lavender oil, Thyme oil and Geranium oil are the essential oils. Ingredients % w/w Citπc Acid 13.0 Tartaπc Acid 26.0 Sodium Bicarbonate 43.2 Sodium lauryl sulfate 10.0 Poke root 1 J Calendula 1.7 Coneflower 1.7 Propolis 1.7 Lavender oil 0.5 Thyme oil 0.5 Geranium oil 0.5 EXAMPLE 19 In this example, extracts prepared from Harpagophytum Procwnb and Hammamelis virgin are the dry herbal extracts. Mynstica oil, Lavandula oil and Rosmannus oil are the essential oils. Ingredients % w/w Citric Acid 12.73 Tartaπc Acid 25.47 Sodium Bicarbonate 43.27 Sodium Lauryl sulfate 10.00 Harpagophytum Procumb 5.55 Hammamelis virgin 2.78 Mynstica 0.80 Lavandula 0.40 Rosmannus 0.80 It will be appreciated that the above descriptions are intended only to serve as examples, and that many other embodiments are possible withm the spirit and the scope of the present invention.

Claims: WHAT IS CLAIMED IS 1 An effervescent granule, compnsing: (a) a pharmaceutically effective amount of a herbal medication as active ingredient, (b) an acid, and (c) a base capable of releasing carbon dioxide upon reaction with said acid when contacted with water 2. The effervescent granule of claim 1 , wherein said acid is selected from the group consisting of tartanc acid and citnc acid. 3 The et fervescent granule of claim 1 , wherein said acid is a mixture of tartanc acid and citric acid 4 The effervescent granule of claim 3, wherein said tartaπc acid and said citπc acid are piesent in a ratio of about 2 1 by weight 5 The effervescent granule of claim 1 , wherein said base is selected from the group consisting of sodium bicarbonate, sodium carbonate and potassium bicarbonate 6 The ef fervescent granule of claim 5, wherein said base is sodium bicarbonate 7 The effervescent granule of claim 6, wherein said acid is a mixture of citnc acid and tartanc acid, and said sodium bicarbonate, said citnc acid and said tartaπc acid are present in a ratio of about 3.44 1 2 by weight 8 The eftei vescent granule of claim 1 , wherein said herbal medication is at least one herbal extiact oi a mixture of herbal extracts 9 The effervescent granule of claim 8, wherein said herbal extract includes Plantago (Plantaι>o majυi ), Hypericum (Hvpencaceae perforatus), Echinacea (Coneflowei ) (Echinaceae species such as Ldunaceae radix and Echinaceae purpurea) Baptism. Calendula, Myrrh, Phytolaca, Salvia, Catechu black, Kramena, Tsuga, Rosmannus. Styrax, Crataegus, Glycerrhiza (Glvcerrhiza glabra). Angelica, Kramena, Matncaπa, Mallow, Sage, Witch Hazel (Hamamelis vitgimana), English Oak (Lobana), Burdock (Arctium Lappa), Chickweed (Stellaπa), Sanguinaπa Canadensis, Thuja Occidentals, Balm mint (Mentha pipereta), Devil's Claw (Harpagophytum Procumb), Comfrey (Symphytum), Propolis and Inula helenium. 10. The effervescent granule of claim 1, wherein said herbal medication is at least one essential oil or a mixture of essential oils. 1 1 The effervescent granule of claim 10, wherein said essential oil is selected from the group conssisting of Cinnamon oil, Lavandula, Thyme oil, Eucalyptus oil and Peppermint oil. 12. The effervescent granule of claim 10, wherein said essential oil includes cinnamon oil, cajeput oil, eucalyptus oil, fennel oil, geranium oil, girofle oil, lavender oil, lemon oil, spearmint oil, peppermint oil (Mentha Pipereta), myrte oil, pine oil, rosemary oil, sarπette oil, thyme oil, tea-tree oil, sweet marjoram oil (Margorana Hortensis), safflower oil, citronella oil, garlic oil, juniper oil (juniperus) and oregano oil. 13 The effervescent granule of claim 12, with the proviso that the essential oil is not Oil of clove or eugenol. 14. The effervescent granule of claim 1 , wherein said herbal medication is a mixture of at least one essential oil and at least one herbal extract. 15 The effervescent granule of claim 14, wherein said mixture of said at least one essential oil and said at least one herbal extract is present in an amount of from about one percent to about thirty percent weight pei weight 16 The effervescent granule of claim 14, wherein the ratio of said at least one essential oil to said at least one herbal extract is from about 1 5 to 1 to about 1 to 10 17 An effervescent granule compnsing a predefined ratio of an amount of herbal medication to an amount of an effervescent earner such that a specific amount of herbal medication is released from said earner when said earner is contacted with water. 18. The effervescent granule of claim 1, wherein the proportion of herbal medication to carrier is from about 1 percent to about 30 percent weight per weight. 19. The effervescent granule of claim 18, wherein the proportion of herbal medication to earner is preferably from about 2 percent to about 25 percent weight per weight. 20. The effervescent granule of claim 18, wherein the proportion of herbal medication to earner is more preferably from about 10 percent to about 25 percent weight per weight 21. A formulation of an effervescent granule, compnsing: (a) a pharmaceutically effective amount of a herbal medication as active ingredient; (b) an acid; (c) a base for releasing carbon dioxide upon reaction with said acid when contacted with water; and (d) a soap for producing a foam when contacted with said water 22. The formulation of claim 21, wherein said soap is sodium lauryl sulfate. 23 An effervescent granule compnsing: (a) a medication consisting essentially of a herbal medication; (b) an acid; and (c) a base for releasing carbon dioxide upon reaction with said acid when contacted with water 24 An effervescent granule consisting essentially of: (a) a pharmaceutically effective amount of a herbal medication, as medicinal agent; (b) an acid; and (c) a base for releasing carbon dioxide upon reaction with said acid when contacted with water. 25. An effervescent granule compnsing: (a) a herbal medication, as the only active ingredient; (b) an acid; and (c) a base for releasing carbon dioxide upon reaction with said acid when contacted with water 26 A method of releasing and evenly dispersing a medication in water, compnsing the steps of: (a) providing an effervescent granule, said granule containing; (l) a pharmaceutically effective amount of a herbal medication as the active ingredient; (n) an acid; and (in) a base for releasing carbon dioxide upon reaction with said acid, and (b) placing said granule in water, such that the medication is released upon reaction of said acid and said base.

Inventors: FORMAN YOCHANAN, FRIEDMAN DORON, FRIEDMAN MICHAEL, LEVIN ORNA, FORMAN, YOCHANAN, FRIEDMAN, DORON, FRIEDMAN, MICHAEL, LEVIN, ORNA
Applicants: FARMO NAT LTD, FORMAN YOCHANAN, FRIEDMAN DORON, FRIEDMAN MARK M, FRIEDMAN MICHAEL, LEVIN ORNA, FARMO-NAT LTD., FORMAN, YOCHANAN, FRIEDMAN, DORON, FRIEDMAN, MARK, M., FRIEDMAN, MICHAEL, LEVIN, ORNA
Application year: 1998
Main classification: A61K9
IPC codes: A61K9