(12) United States Patent (10) Patent No.: US 7.229,648 B2 Dreyer (45) Date of Patent: Jun

USOO7229648B2

(12) United States Patent (10) Patent No.: US 7.229,648 B2 Dreyer (45) Date of Patent: Jun. 12, 2007

(54) HOMEOPATHIC FORMULATIONS USEFUL http://www.archive.org. “Internet Archive Wayback Machine”. FOR TREATING PAN AND/OR Search for http://www.kingbio.com/onlinepharmacy.htm. on Jun. 8, NFLAMMATION 2005.* Interview with Dr. Frank J. King on Jun. 9, 2005.* http://www.homeopathy home.com/services/rshopfvshoppe? (76) Inventor: Lee R. Dreyer, P.O. Box 4880, topicals.shtml.* Whitefish, MT (US) 59937 http://web.archive.org/web/*/http://www.homeopathyhome.com/ Services/rshopfvshoppe? topicals.shtml. (*) Notice: Subject to any disclaimer, the term of this Product Label for Unscented Epicure Crystal Sports Cream, Natural patent is extended or adjusted under 35 Homeopathic Pain Reliever, 1996. U.S.C. 154(b) by 2 days. Product Label for Traumeel(R), Homeopathic Ointment, 1995. (21) Appl. No.: 10/797,009 * cited by examiner Primary Examiner Michele Flood (22) Filed: Mar. 11, 2004 (74) Attorney, Agent, or Firm—Sughrue Mion, PLLC (65) Prior Publication Data (57) ABSTRACT US 2004/O18O101 A1 Sep. 16, 2004 Homeopathic formulations (a) comprising tinctures and/or Related U.S. Application Data diluted extracts preferably subjected to potentization of at least 8 or 9 herbs selected from Bellis Perennis, Calendula (60) Provisional application No. 60/454,308, filed on Mar. Officinalis, Hamamelis Virginiana, Arnica Montana, 14, 2003. Hypericum Perforatum, Aconitum Napellus, Ledum Palus tre, Bryonia Alba and Ruta Graveolens; or (b) consisting of (51) Int. Cl. as active ingredients, tinctures and/or diluted extracts Sub AOIN 65/00 (2006.01) jected to potentization of 5, 6 or 7 herbs selected from Bellis A6 IK3I/74 (2006.01) Perennis, Calendula Officinalis, Hamamelis Virginiana, (52) U.S. Cl...... 424/725; 424/78.05; 424/730 Arnica Montana, Hypericum Perforatum, Aconitum Napel (58) Field of Classification Search ...... 424/725, lus, Ledum Palustre, Bryonia Alba and Ruta Graveolens. 424/730, 78.05, 764, 78.03: 514/886, 887, The potentized homeopathics are in a penetrating base, 514/944,994 preferably clear gel base. The homeopathic formulations are See application file for complete search history. highly effective in treating or relieving pain and inflamma (56) References Cited tion. Also, a method of treating or relieving pain and inflammation by administering any of the homeopathic U.S. PATENT DOCUMENTS formulations of the invention to a subject, preferably a subject in need of such treatment or relief. Further, a method 6,468,551 B1 * 10/2002 Diec et al. of making the homeopathic formulation by mixing the OTHER PUBLICATIONS homeopathically prepared herbal active ingredients with a http://www.lifesvigor.com. "King Bio Natural Medicines—911 base, preferably a clear gel base. Stress Control 2 oz. Liquid” (May 28, 2002) downloaded on Jun. 8, 2005, as evidenced by WayBackMachine at www.archive.org.* 12 Claims, No Drawings US 7,229,648 B2 1. 2 HOMEOPATHC FORMULATIONS USEFUL serially diluted) homeopathic products do not appear to have FOR TREATING PAN AND/OR strong or effective topical analgesic or anti-inflammatory NFLAMMATION properties. An examination of existing OTC topical pain products in This patent application claims the benefit of U.S. Provi most pharmacies reveals, that although there are many sional Patent Application No. 60/454.308, filed on Mar. 14, brands to choose from, they all basically use various com 2003 by the same inventor, Lee R. Dreyer. binations of the same active ingredients, namely: menthol, The present invention is related to novel homeopathic methyl salicylate, camphor, and trolamine salicylate which over-the-counter (OTC) pain-relieving and/or anti-inflam have the drawbacks mentioned above. There is a need of matory formulations containing (a) 8 or 9 different homeo 10 novel formulations having analgesic and/or anti-inflamma pathic herbal active ingredients described below, (b) 5, 6 or tory properties that can avoid the drawbacks of the prior art 7 homeopathic herbal active ingredients described below in analgesic products. The homeopathic formulations of the addition to Bryonia Alba, or (c) 5, 6 or 7 homeopathic herbal present invention fulfill such a need. The formulations of the active ingredients described below excluding Echinacea invention are not counterirritants and do not rely upon Augustifolia and Symphytum Officinale, that can relieve 15 massage, heat, stimulation or counterirritation to allay pain. external pain and/or inflammation and that is amenable to The formulations also do not require a trained classical self diagnosis and treatment. homeopath to do casework diagnostics (costing significant time) to attempt to discover the similimum (remedy most BACKGROUND OF THE INVENTION resembling the patient’s symptoms) and then attempt to prescribe correct potency, dosage and duration of action. Currently known OTC analgesic products for topical uses When any of the formulations of the invention is used, no have many problems. There is a need for an OTC topical drug individualization using only one drug ingredient per pain relieving product that relieves most external acute or dose for each person as practiced in classical homeopathy is chronic pain within a few minutes, providing relief that lasts required. up to several hours (for uninterrupted sleep and work), and 25 without unpleasant physical and social side effects such as SUMMARY OF THE INVENTION strong odors, counterirritation, redness, itching, stinging, cooling, sensitization, staining, burning, perfumes, anesthe One of the aspects of the invention provides homeopathic sia, etc. Ideally such product would also quickly relieve formulations having analgesic and/or anti-inflammatory inflammation, edema, redness, and Swelling along with pain, 30 uses. The homeopathic formulation of the invention com thereby increasing pain free range of motion, even in diffi prises cult to treat pain cases, without the patient needing strong (a) the tinctures and/or homeopathic preparations of at topical and oral OTC or prescription drugs with powerful least 8 or 9 herbs selected from Bellis Perennis, Calendula undesirable and unpleasant side effects. Currently, most Officinalis, Hamamelis Virginiana, Arnica Montana, OTC topical pain relief counterirritant products may not be 35 Hypericum Perforatum, Aconitum Napellus, Ledum Palus used as frequently as needed because of six problems listed tre, Bryonia Alba and Ruta Graveolens, below. (b) the tincture and/or homeopathic preparation of Bryo 1. The currently available OTC topical analgesics have nia Alba and the tinctures and/or homeopathic preparations limited effectiveness and duration in treating pain. of at least 5, 6 or 7 herbs selected from Bellis Perennis, 2. The currently available OTC topical analgesics may 40 Calendula Officinalis, Hamamelis Virginiana, Arnica Mon have socially embarrassing odors after application because tana, Hypericum Perforatum, Aconitum Napellus, Ledum of the strong scent of menthol, wintergreen (methyl salicy Palustre, and Ruta Graveolens, late), camphor, or strongly aromatic essential oils, etc. (c) the tinctures and/or homeopathic preparations of at 3. The currently available OTC topical analgesics may 45 least 5, 6 or 7 herbs selected from Bellis Perennis, Calendula contain staining or allergenic artificial dyes (e.g. blue or Officinalis, Hamamelis Virginiana, Arnica Montana, green) or synthetic perfumes. Hypericum Perforatum, Aconitum Napellus, Ledum Palus 4. The oil or fat contents (creams, salves and lotions, etc.) tre, Bryonia Alba and Ruta Graveolens, with the proviso that of the currently available OTC topical analgesics, or plant the formulation does not contain the tincture(s) and/or pigments or dyes in the currently available OTC topical 50 homeopathic preparation(s) of Echinacea Augustifolia and analgesics may visibly stain clothing or leave greasy spots, Symphytum Officinale; or or be allergenic and/or sensitizing to certain individuals. (d) active ingredients and one or more inactive ingredi 5. The currently available OTC topical analgesics may ents, wherein the active ingredients consist of the tinctures contain Substances that are irritating, allergenic, sensitizing, and/or homeopathic preparations of 5, 6 or 7 herbs selected or toxic in excess or high concentrations that should not be 55 from Bellis Perennis, Calendula Officinalis, Hamamelis applied more than 3 or 4 times daily, or are dangerous if Virginiana, Arnica Montana, Hypericum Perforatum, Aconi ingested. Such products may contain ingredients that pro tum Napellus, Ledum Palustre, Bryonia Alba and Ruta duce unpleasant or distracting physical sensations (counter Graveolens. irritants) Such as stinging or burning from capsaicin (which In one of the embodiments of the homeopathic formula may occur for several days), hot or cold sensations from 60 tions of the invention, the formulation comprises the tinc menthol or wintergreen, or the possibility of allergic reaction tures and/or homeopathic preparations of Bellis Perennis, to Salicylate containing aspirin-like products (trolamine sali Calendula Officinalis, Hamamelis Virginiana, Arnica Mon cylate, methyl salicylate). tana, Hypericum Perforatum, Aconitum Napellus, Ledum 6. Some currently available homeopathic products are Palustre, Bryonia Alba and Ruta Graveolens. In another reported to have limited therapeutic indications (e.g. arnica 65 embodiment of the homeopathic formulations of the inven tincture and 1x potency may produce toxic symptoms with tion, the formulation comprises the tinctures and/or homeo open cuts or ingestion); and some higher potency (i.e. more pathic preparations of Bellis Perennis, Calendula Officinalis, US 7,229,648 B2 3 4 Hamamelis Virginiana, Arnica Montana, Hypericum Perfo fied, preferably sterile, water. The homeopathic formulations ratum, Aconitum Napellus, Ledum Palustre, and Ruta Gra of the invention preferably are made in a clear gel base. veolens. Preferably, the clear gel base comprises water, glycerine Alternatively, the invention provides a homeopathic for (preferably, vegetable glycerine USP), a polyacrylic acid mulation comprising the tinctures and/or homeopathic resin thickener (preferably, CARBOPOL 940), triethanola preparations of Bellis Perennis, Hamamelis Virginiana, mine and methylparaben. Arnica Montana, Hypericum Perforatum, Aconitum Napel The homeopathic formulations of the invention solve the lus, Ledum Palustre, and Ruta Graveolens, but excluding the problems described above related to currently available tincture(s) and/or homeopathic preparation(s) of Echinacea OTC topical analgesics by effecting very fast pain and/or Augustifolia and Symphytum Officinale. The invention also 10 provides a homeopathic formulation comprising the tinc inflammation relief, as well as long duration of relief even tures and/or homeopathic preparations of Bellis Perennis, after discontinuance of usage. Typically only a small Arnica Montana, Hypericum Perforatum, Aconitum Napel amount, such as about 5–20 mg of the formulation per lus, Ledum Palustre, and Ruta Graveolens, with the proviso square inch of area to be treated (e.g. 10 mg/square inch), of that the formulation does not contain the tincture(s) and/or 15 the formulation is able to effectively treat a painful area, homeopathic preparation(s) of Echinacea Augustifolia and unlike currently available OTC topical analgesics which Symphytum Officinale. Within the scope of the invention is require far greater quantities. For most acute and chronic a homeopathic formulation comprising the tinctures and/or cases, analgesic relief is obtained within approximately 30 homeopathic preparations of Bellis Perennis, Arnica Mon seconds to 2 /2minutes after the first topical application, tana, Hypericum Perforatum, Aconitum Napellus, and Ruta without massage, of a homeopathic formulation of the Graveolens, but excluding the tinctures and/or homeopathic invention with an average pain-free duration of 8 hours (or preparations of Echinacea Augustifolia and Symphytum longer duration, e.g. days to months, with one to multiple Officinale. applications). The formulations of the invention can also Yet another embodiment of the homeopathic formulations offer pain relief after discontinuance even in chronic pain of the invention consists of the tinctures and/or homeopathic 25 cases. The formulations of the invention can also treat even preparations of Bellis Perennis, Hamamelis Virginiana, difficult pain problems (e.g., Lyme disease pain, migraine Arnica Montana, Hypericum Perforatum, Aconitum Napel headaches, etc.) not normally considered topically treatable lus, Ledum Palustre, and Ruta Graveolens, mixed with one and also resolve many cases on a long term to permanent or more inactive ingredients. Still another embodiment of basis without socially embarrassing odors, redness, stains, the homeopathic formulations of the invention consists of 30 greasiness; or unpleasant physical sensations such as sting as active ingredients, the tinctures and/or homeopathic ing, itching, burning, cooling sensations, irritations, drying preparations of Bellis Perennis, Arnica Montana, Hyperi of skin, or numbness, found in many, if not most, currently cum Perforatum, Aconitum Napellus, Ledum Palustre, and known OTC topical analgesics or anti-inflammatory agents. Ruta Graveolens, mixed with one or more inactive ingredi The formulations of the invention preferably are made in a ents. The invention also provides a homeopathic formulation 35 gel base. consisting of as active ingredients, the tinctures and/or homeopathic preparations of Bellis Perennis, Arnica Mon The homeopathic formulations of the invention are not tana, Hypericum Perforatum, Aconitum Napellus, and Ruta counterirritants and thus do not rely upon the principal of Graveolens, mixed with one or more inactive ingredients. producing a less severe pain to counteract a more intense 40 pain; and consequently these formulations are not required The homeopathic formulations are useful in treating pain to incorporate menthol, camphor, methyl salicylate, or tro and/or inflammation. Another object of the invention is a lamine salicylate. The formulations of the invention can be method of treating pain in a Subject, preferably a subject in novel homeopathic topical pain relief products preferably in need of Such treatment, which method comprises the step of a nearly clear gel base. Each of the formulations of the administering a pain treating effective amount of a homeo 45 invention can be legally sold as a homeopathic OTC drug pathic formulation of the invention to the subject, wherein per the requirements of the Food and Drug Administration, the Subject is an animal. Preferably, the Subject is a mammal. or as a homeopathic prescription drug where lower potencies More preferably, the subject is a human. In the method, the of certain ingredients such as Aconitum as specified in homeopathic formulation is administered, preferably, topi cally. HPUS can only be sold on a prescription basis. 50 Each of the formulations of the invention can be applied Another object of the invention is a method of treating as a small dab (e.g. about 100 mg) to the fingertip and lightly inflammation in a Subject, preferably a Subject in need of the spread across approximately 10 square inches of skin Sur treatment, which method comprises administering an anti face over a painful area or inflammatory region. Massage or inflammatory amount of a homeopathic formulation of the pressure is unnecessary for the therapy. The formulations of invention to the Subject, wherein the Subject is an animal. 55 the invention are dry to touch in a few minutes leaving the Preferably, the subject is a mammal. More preferably, the skin smooth, moist and soft. A few chronic or difficult to Subject is a human. In the method, the homeopathic formu treat conditions may require a second or third application of lation is administered, preferably, topically. any of the formulations of the invention a few hours apart. There does not appear to be another OTC topical product in DETAILED DESCRIPTION OF THE 60 any category that can stop pain so quickly, and with Such INVENTION long lasting duration; that upon application is virtually “socially invisible', and feels pleasant and soothing during In addition to the herbal active ingredients described application. Furthermore, those unable to get relief from above, the homeopathic formulations of the invention topical pain relievers often resort to oral aspirin and non optionally further contain one or more physiologically 65 steroidal anti-inflammatory drugs which dramatically acceptable carriers and/or excipients. An example of the increase the risk of peptic ulceration and renal failure when physiologically acceptable carriers and/or excipients is puri used chronically—and increase the risk of drug interaction. US 7,229,648 B2 5 6 Thus, because of unique topical effectiveness, the formula nalis, Hamamelis Virginiana, Arnica Montana, Hypericum tions of the invention may prevent many adverse internal Perforatum, Aconitum Napellus, Ledum Palustre, Bryonia reactions from unnecessary overuse of non-steroidal anti Alba and Ruta Graveolens. In yet some of the homeopathic inflammatory drugs. formulations, the active drugs can be 5, 6 or 7 herbs selected In each of the formulations of the invention, there is a from the list: Bellis Perennis, Calendula Officinalis, Hama polypharmaceutical combination of individual herbal active melis Virginiana, Arnica Montana, Hypericum Perforatum, ingredients that are botanically derived. Preferably, the Aconitum Napellus, Ledum Palustre, Bryonia Alba and Ruta herbal active ingredients of the formulations of the invention Graveolens, with the proviso that the formulations do not are prepared according to the Homeopathic Pharmacopoeia contain the tincture(s) and/or homeopathic preparation(s) of of the United States (HPUS), with accepted methods of 10 Echinacea Augustifolia and Symphytum Officinale. The mother tincture preparation, and dilution and Succusion to extracts of these herbs at the potencies disclosed below can potentize such ingredients per HPUS instructions and be used as active ingredients which are mixed (optionally requirements. Each herb of the formulations of the invention one or more other active ingredients, if allowed by the can be succussed 20 to 30 times per dilution. The herbal homeopathic formulation, and/or one or more physiologi active ingredients in this formulation can be manufactured 15 cally acceptable carriers and/or excipients may also be by a qualified homeopathic manufacturer following standard added), and then the mixture can be blended with other homeopathic industry guidelines, and preparation of active ingredients in a base to form a homeopathic formulation of ingredients per HPUS procedures. The homeopathic active the invention. ingredients can then be combined with a base, preferably the unique gel base described below. Potency and Dosage Variations of the Homeopathic Formu In this patent application, the terms “tincture' and lations: “homeopathic preparation of an herb refer to extracts of a In the homeopathic formulations of the invention, each of part, combinations of parts and/or the entirety of the herb, the herbal active ingredients can exist in the form of a with the exception that the “tincture' and “homeopathic tincture or diluted tincture preferably subjected to potenti preparation' of Arnica Montana refer to extracts of the 25 Zation based on procedures known in homeopathy, wherein whole Arnica Montana plant. The “tincture' can be prepared the tincture is preferably as defined in HPUS for the par by exposing a part, parts and/or the entirety of the herb in a ticular herb. Examples of potency variations of the herbal solvent, e.g. alcohol and/or water. The “tincture' of an herb active ingredients in the homeopathic formulations of the preferably is a mother tincture of the herb prepared accord invention that can be used are shown in Table 1 below. In ing to the procedures in HPUS. The “homeopathic prepa 30 other words, if one of the herbal active ingredients in Table ration' can be prepared by dilution of the “tincture' with an 1 is selected to be included in a homeopathic formulation of appropriate liquid such as water or alcohol. The “homeo the invention, the extract of the particular herbal active pathic preparation of an herb for the formulation of the ingredient at a potency that falls within the potency range invention is preferably prepared per HPUS procedures, listed in Table 1 for the particular homeopathic herbal active wherein the mother tincture of the herb is serially diluted and 35 ingredient may be used to make the homeopathic formula Subjected to Succussion according to the target potency tion for the corresponding use, either external or internal. using potentization procedures known in the art of home The potencies in Table 1 are presented as decimal potencies, opathy. Also, herbal or unofficial preparations of the herbs which are preferred topically over centesimal, M or Q may be used. For example, non-homeopathically prepared potencies because decimal potencies offer more potency tinctures, or dilution or infusions, or water or alcohol 40 gradations than centesimal, M, or Q potencies, especially at extracts, or powdered plasters, decoctions, poultices, etc., or lower potencies. Decimal potencies also generally receive any other methods of herbal preparations, or whole herbs twice as many energizing Successions as centesimal poten whether unpotentized or undiluted or not can be used as the cies of the same total dilution herbal active ingredients in the formulations of the inven tion. As used herein, as per HPUS, the “tincture' and 45 TABLE 1. “homeopathic preparation' of Arnica Montana is defined differently in a separate HPUS monograph from an extract Potencies of Active Ingredients of “Arnica Montana radix,” because the extract of “Arnica External Use Internal Use Montana radix' is prepared from the root of an Arnica Active Ingredients Potency Range Potency Range Montana plant while the “tincture' and “homeopathic for 50 Bellis Perennis Tinct.** 400X 1 X 400X mulation of Arnica Montana are prepared from the whole Calendula Officinalis Tinct. 400X 1 X 400X Arnica Montana plant. Hamamelis Virginiana Tinct. 400X 1 X 400X Arnica Montana Tinct. 400X 3 X 400X The “potencies’ given in Tables 1 and 2 below are as Hypericum Perforatum Tinct. 400X 3 X 400X defined in HPUS. For instance, an active drug at a potency Aconitum Napellus 3 X 400X 3 X 400X of 1x means that a tincture, preferably as defined in HPUS, 55 Ledum Palustre Tinct. 400X 1 X 400X of the active drug is diluted 1 in 10, e.g. 1 ml of the tincture Bryonia Alba Tinct. 400X 3 X 400X is mixed with 9 ml of a diluent liquid, and then succussed at Ruta Graveolens Tinct. 400X 3 X 400X least 10 times, according to known potentization procedures *Note: in homeopathy. A potency of 2x means that the active drug 1X or 2X may also be used if the formulation of the invention is used as having a potency of 1 x is further diluted 1 in 10 and then 60 a prescription drug. However, care must be taken to prevent toxicity by correct dosing and/or avoiding allergic reaction, when formulating and Succussed at least 10 times yielding the active drug at 2x prescribing. HPUS should be consulted. potency. A potency of 3x means that the active drug having **Tinct. means mother tincture as per HPUS. a potency of 2x is further diluted 1 in 10 and then succussed Decimal (X) potencies above may also be converted to centesimal poten cies (e.g., 400X = 200 C). Potencies higher than 400X (200 C), e.g. 1M, at least 10 times yielding the active drug at 3X potency. In 10M or 50M, can also be used in the homeopathic formulations of the some of the homeopathic formulations of the invention, the 65 invention - either topically or internally. However, higher potencies will be active drugs can be 8 herbs selected from, or all 9 homeo more useful internally. pathic herbs in, the list: Bellis Perennis, Calendula Offici US 7,229,648 B2 7 8 In the homeopathic formulations of the invention having pathic formulations are put in plastic, glass or other con the herbal active ingredients at potencies falling with the tainers following HPUS, GMPs and all OTC regulations. potency ranges listed in Table 1, each of the herbal active ingredients can be present in amounts expressed as percent Each of the homeopathic formulations of the invention age by weight of the finished homeopathic formulation that can be administered in standard homeopathic forms and vary from about 0.1% to about 50%, preferably about 0.2% dosages as determined by an individual seeking pain treat to about 20%, more preferably about 0.3% to about 10%, ment who is knowledgeable about homeopathy or by a and even more preferably about 0.4% to about 8%, of the homeopathic practitioner. For external uses, the homeo total weight of the formulations. For instance, if Bellis pathic formulation of the invention can be applied topically Perennis is used at a potency of 1x, the homeopathic 10 as needed, e.g. 1 to 6, preferably 1 to 4, times a day or every formulation can contain about 0.1% to about 50% by weight 30 minutes at the start of an injury for the first 2 hours. For of the 1x Bellis Perennis. instance, with each topical application, the homeopathic In some of the homeopathic formulations of the invention, formulation can be applied in an amount Sufficient to cover the amounts of the herbal active ingredients can vary from the skin of a painful area to be treated. For internal uses, the 1% to 10% of drug tincture for external use in gel or other 15 base. Higher percentages oftincture may be used up to about amount of the homeopathic formulation to be administered 50% before gels degrade. Equal amounts of the various can be 2 to 4 pilules or tablets a day in weight standardized homeopathic herbal active ingredients may be used, or some by a homeopathic pharmacy, e.g. according to homeopathic homeopathic herbal active ingredients may be supplied in pharmaceutical necessities. With internal administration, the multiple potencies. There is no advantage in varying the use of the formulation should be discontinued once pain weight of each active ingredient within reason because and/or inflammation has stopped, according to classical homeopathic drugs operate on an energetic level, and are homeopathic principles. generally not dose dependent (except as internal LM poten cies). Thus, twice as much of the effective resonant dose will One of the Preferred Formulations of the Invention: not have twice a greater effect than the correct minimal 25 Each 2 oz or 56.7 g of this preferred formulation contains dosage, as a basic concept in homeopathy is the efficacy of 4.536 ml of an active ingredient mixture and 52.16 g of a minimal dosing. According to the Avogadro's number, beyond 12C (24x) not one molecule of the original sub clear gel base, wherein the active ingredient mixture con stance can be found in a formulation. Higher potencies than tains 1.81 g. ethanol. The components of the active ingre 200C (400x) can also be used. However, such potencies will 30 dient mixture used to make the preferred homeopathic have less local physiological effect and more of a psycho formulation are presented in Table 2, while the components logical or systemic symptom effect and will be more useful of two alternative clear gel bases that could be used to make internally. Multiple potencies of the same drug may also be the preferred homeopathic formulation are presented in used, e.g. Arnica 3x, 6.x and 12x, etc., for a potency chord. Table 3. The homeopathic herbal active ingredients in the form of 35 tinctures or diluted tinctures Subjected to potentization are TABLE 2 combined to form an active ingredient mixture. The active ingredient mixture can be supplied as 40% ethanol alcohol Active Ingredient Mixture tincture, although more or less alcohol or water will not HPUS Active Ingredients Potency * % by Weight*** affect the analgesic effectiveness of the finished homeo 40 pathic formulation. The active ingredient mixture is then put Bellis Perennis 1X O.8889 in a base, preferably a clear gel base. Preferably, isopropyl Calendula Officinalis 1X O.8889 alcohol or propylparaben should not be used in the homeo Hamamelis Virginiana 2X O.8889 Arnica Montana 3X O4445 pathic formulations of the invention. Arnica Montana 6X O4445 If a clear gel base is used in some of the embodiments of 45 Hypericum Perforatum 2X O.8889 the homeopathic formulations, the clear gel base may con Aconitum Napellus 3X O.8889 tain 1–99%, e.g. 8-10% or 50–99%, active ingredients by Ledum Palustre 3X O.8889 weight. However, other bases described may also be sub Bryonia Alba 6X O4445 Bryonia Alba 12X O4445 stituted for the gel base, and other gel bases can also carry Ruta Graveolens 3X O.8889 the active ingredients (see "Other Topical Delivery Sys 50 tems”), but without the same “social invisibility’ emollient Total 8.OOO% and soothing properties of the preferred gel base. *The active ingredient mixture is supplied as 40% ethanol alcohol tincture. These embodiments of the homeopathic formulations of **The potency is as defined in HPUS. the invention can be prepared by blending 1-99%, e.g. ***The percent by weight is based on the total weight of the homeopathic 55 formulation of the invention. For instance, the finished homeopathic for 1–50%, of the active ingredients into 99–1%, e.g. 99-50%, mulation contains 0.8889% by weight of a Bellis Perennis extract at a clear gel base. The percentages may vary from these num potency of 1X prepared as per HPUS. bers if bases (e.g. liniment) other than a clear gel base are used. Preferably, violent agitation or high-speed blending should be avoided in order to prevent changing potencies of TABLE 3 homeopathics. Also, any exposure to direct Sunlight, higher 60 temperatures, Volatile organic compounds, X-rays, and elec Clear Gel Base tromagnetic fields should be avoided while processing, Alternative 1 Alternative 2 storing and shipping in order to prevent theoretical change Ingredients' % by Weight** % by Weight** or neutralization in potencies. All other appropriate delivery Purified Water 89.71% 89.85% forms as mentioned in the HPUS, both internal and external, 65 Vegetable Glycerine (USP) O.92% O.92% can be used to carry the active ingredients of the homeo Carbopol 940 O.60% O.60% pathic formulation of the invention. Preferably, the homeo US 7,229,648 B2 9 10 Herbal Active Ingredient Variations of the Homeopathic TABLE 3-continued Formulations: The preferred homeopathic formulation of the invention Clear Gel Base comprises 9 different herbal active ingredients in 11 different Alternative 1 Alternative 2 potency variations (see Table 2). Some of the formulations Ingredients' % by Weight** % by Weight** of the invention can also be made by not using one of the 9 herbal active ingredients (e.g. see Variation #1 in Table 4 Triethanolamine (Trolamine) O.40% O.40% Methylparaben (NF) O.37% O.23% below). As one or some of the 9 herbal active ingredients is excluded from the formulations, the formulations still have Total 92.00% 92.00% 10 powerful pain relieving and anti-inflammatory properties. The homeopathic formulation of the invention can comprise * Preferably, no other ingredients are used in the clear gel base. 7 herbal active ingredients (e.g. see Variation #2, Table 4), **The percent by weight is based on the total weight of the homeopathic 6 herbal active ingredients (e.g. see Variation #3, Table 4) or formulation of the invention. 5 herbal active ingredients (e.g. see Variation #4, Table 4), This embodiment of the preferred formulation can be 15 with the proviso that the formulation does not contain any other active ingredient or the formulation does not contain made by gently blending 8% of the active ingredient mixture the tincture(s) and/or homeopathic preparation(s) of Echina into 92% of the clear gel base. More preferably, precaution cea Augustifolia and Symphytum Officinale. However, each should be taken to avoid violent agitation or high-speed omission of an herbal active ingredient from the list of 9 blending in order to avoid changing the potencies of the slightly lessens the total product effectiveness. The potency active ingredients, and also to avoid exposure to direct and dosage ranges for both external and internal uses as well Sunshine, high temperatures, Volatile organic compounds, as the ranges of the amounts of the active ingredients in X-rays, and electromagnetic fields while processing and terms of percent by weight (based on the total weight of the storing in order to prevent a theoretical change or neutral homeopathic formulation) described above in the “Potency ization of potency. Optionally, the formulation can be stored and Dosage Variations of the Homeopathic Formulation' in a Suitable plastic or glass container following Good 25 Subsection can also apply to the embodiments of the homeo Manufacturing Practices and all OTC regulations. pathic formulations having herbal active ingredient varia tions described herein (Table 4). The homeopathic formu Variations of the Formula: lations containing the herbal active ingredient variations There are many possible variations of the preferred for shown in Table 4 are all effective in treating pain and/or mulation of the invention that will also have good analgesic inflammation.

TABLE 4 Examples of Variation of Active Ingredients

VARLATION #1 VARLATION #2 VARLATION #3 VARLATION #4 Bellis Perennis Bellis Perennis Bellis Perennis Bellis Perennis Calendula Officinalis Hamamelis Virginiana Arnica Montana Arnica Montana Hamamelis Virginiana Arnica Montana Hypericum Perforatum Hypericum Perforatum Arnica Montana Hypericum Perforatum Aconitum Napellus Aconitum Napellus Hypericum Perforatum Aconitum Napellus Ledum Palustre Ruta Graveolens Aconitum Napellus Ledum Palustre Ruta Graveolens Ledum Palustre Ruta Graveolens Ruta Graveolens

45 therapeutic properties, but have lesser efficacy and/or utility The above variations of herbal active ingredients may be for reasons including: (1) Potential toxicity and/or allergic used in any potency or dosage or percentage described in the reaction when using lower potency (less diluted tincture and subsection of "Potency and Dosage Variations of the 1XX) of Arnica, and/or Ruta, and/or Aconitum; and (2) Homeopathic Formulations” (e.g. see Table 1 for the lesser topical analgesic strength if just used in higher poten 50 potency examples). However, the potencies described in the cies such as 12x and higher. Although most homeopathic preferred formulation are most effective (see Table 2). philosophical literature indicates that the higher dilutions and potentizations are more powerful when used “inter Drug Delivery Methods: nally, the literature does not describe higher potency as 55 Gels are the preferred vehicles of dispensing the homeo being more powerful topically. However, the effectiveness pathic formulations of the invention. Gels are more accu of the preferred homeopathic formulation of the invention rately called jellies because they are compounds of water demonstrates that the lowest decimal potencies (1x, 2x, 3X) soluble ingredients, usually clear, of a uniform semisolid are more effective as an external topical analgesic when consistency. Gels maintain a uniformity that is useful in combined with slightly higher low potencies (6x, 12x) as the 60 keeping active ingredients in the homeopathic formulations right combination of drugs with correct analgesic properties. evenly dispersed in their aqueous base. Brownian motion The homeopathic formulations of the invention can be builds up networks in gels and restores their shape when varied in terms of the potency and dosage, or in terms of the they have been ruptured by stresses (e.g. settling or shaking). ingredients. All requirements for manufacturing the other 65 The longer the dosage contacts the skin (i.e. nerve endings), embodiments of the homeopathic formulations of the inven the longer the duration of action. As the preferred formula tion are the same as described for the preferred formulation. tion of the invention is in a gel base that soothes and US 7,229,648 B2 11 12 smoothes the skin without socially objectionable odor, one Extremely rapid pain relief, within approximately 30 is less likely to want to wash away the homeopathic formu seconds to 2/2 minutes of an initial application, was detected lation from the skin. in most test cases of either acute or chronic pain. After the extremely rapid onset of pain relief, the degree of pain relief Other Topical Delivery Systems: would keep increasing up to a maximum after about 10–40 In addition to the preferred gel base, various other gel minutes, depending on test Subjects. Typically the first base formulations can carry the active ingredients in the application would relieve most pain. In some of the test homeopathic formulations of the invention with varying Subjects having difficult-to-treat pain, total pain relief was degrees of Success. However, the use of glycerine and achieved at 10 to 15 minutes. The formulation of the calendula (1X) and other homeopathics in a water gel base 10 invention worked with a rapidity not previously described in of the preferred formulation is very emollient, non-drying, the topical homeopathic, allopathic or OTC literature. The and soothing to the skin. Other carrier bases may also be formulation was effective on both pain, e.g. arthritic pain or used to deliver the active ingredients topically Such as: muscle sprains, traditionally treated by OTC analgesics, as water, alcohol, waterfalcohol, cream ointment, Salves, well as difficult-to-treat non-typical pain, e.g. pain associ lotion, liniment, tinctures, cream gel, lotion ointment, rub. 15 ated with Lyme disease, previously not described in the spray, aerosol, lotion spray, balm rub, gel ointment, lotion literature for the individual herbal active ingredients in the cream, poultice, plaster, infusion, decoction and other herbal formulation tested. methods of preparation. However, the gel delivery system One application of the formulation of the invention in does work best. most cases would yield about 4–16 hours of pain relief with Internal Use of the Homeopathic Formulations: an average of about 8 hours, enabling Subject to get an Any of the homeopathic formulations of the invention extended period of uninterrupted rest and sleep. Thus, the will also have similar pain relieving and/or anti-inflamma homeopathic formulations of the invention are also effective tory properties when taken internally, but the specific local in treating insomnia secondary to pain. This relief duration analgesic and/or anti-inflammatory action will not be as far exceeds the relief times of other OTC topical allopathic pronounced. The active ingredients of the homeopathic 25 analgesics, as well as available homeopathic OTC topical formulations may be used with any of the standard delivery and oral products. Clinical testing showed many cases of systems used in oral homeopathy in any acceptable combi total or permanent local pain and inflammation relief after nation Such as: tablets, drops, pills, Sugar pills, water, first application, with pain intensity scores dropping from 10 glycerin, milk Sugar and cane Sugar vehicles, alcohol, medi (the worst pain) to 5 or much less, and moving toward total cated powders, medicated globules (pellets, pilules), cones, 30 pain resolution in many cases. Other Subjects with pain not etc. The delivery system is relatively unimportant. However, regarded as normally treatable by topical analgesics liquid systems will retain more volatile essences found in the obtained significant long duration of pain relief with 1 or 2 low potency botanical tincture starting materials, and will or more applications of the formulation. contact more nerve endings in the mucosa. Effective broad spectrum relief, including difficult-to-treat The homeopathic formulations of the invention are also 35 cases, was achieved with the formulation. The formulation effective in treating pain and/or inflammation when admin was found to be effective in treating pain and inflammation istered parenterally, Such as intravenously, or with any other from Lyme disease, hematomas, degenerative joint disease, method of homeopathic and/or herbal and/or allopathic drug migraine headache, insect bites, carpal tunnel syndrome, administration, Such as intramuscular injections. Further facial neuralgia, Vagal nerve irritation, neuritis from radia more, each of the homeopathic formulations of the invention 40 tion burn, menstrual cramps, stomach pain from influenza, can also be administered in Suppository form (anal or etc. The formulation was also found extremely effective vaginal) where the ingredients can be actively and quickly against pain, Such as rheumatism, arthritis, stiffness; head, absorbed, and would have a strong systemic effect on pain. neck and back injury; sprains, strains, etc., customarily However, influence on local pain will be less pronounced treated not very effectively with some prior art topical and focused than local topical application of the homeo 45 analgesics. Many cases of acute and chronic pain, inflam pathic formulation, especially if the homeopathic formula mations, edema, bruises and injuries were totally resolved or tion is made in a gel base. The formulation could also be significantly relieved faster and better than any other topical taken nasally, or as eyedrops, or eardrops for pain and therapy known. inflammation. It would, of course, have to be prepared in The pain relief achieved with the formulation of the appropriate potency, and carried in a safe and effective base 50 invention was long lasting in most cases. Pain relief was as, for example, described in OTC and HPUS literature. obtained even after discontinuance of the application of the formulation. Clinical testing showed many cases with a Human Test Results: permanent resolution for both acute and long term chronic A homeopathic formulation containing the herbal active pain conditions. The formulation was found to be effective ingredients of Table 2 in a clear gel base of Table 3 was 55 in several Subjects having chronic pain of many years administered to at least 47 human adult Subjects having pain duration or had tried various kinds of medical therapies or pain associated with inflammation to test the effectiveness without significant relief. For instance, in one case of 8 years of the formulation in treating pain and/or inflammation. In right shoulder pain from Lyme disease, “permanent' relief the majority of the Subjects, testing was conducted under within 3 minutes of first topical application of the formula physician Supervision (see Table 5), while testing was done 60 tion of the invention was obtained. Several test subjects in the remaining 12 Subjects not under physician Supervision achieved complete pain relief for months after discontinu (see Table 6). The formulation was applied topically to the ance of the application of the formulation, even where pain affected area of the body. For headaches, the formulation was of months or years duration before the formulation was was applied to the cervical area and painful areas of the used. Such a result had not been known to be achievable head. Except for 2 subjects, the formulation was found to be 65 with other topical agents in either OTC or prescription highly effective in treating pain and/or inflammation (see status. OTC topical analgesics (both homeopathic and allo Tables 5 and 6). pathic) typically only offer very limited short term tempo US 7,229,648 B2 13 14 rary relief. Often the sensitizing, e.g. menthol, or irritating, various causes. Cases of Successfully treated inflammation e.g. capsaicin, or allergenic, e.g. salicylate, nature of many included rheumatoid arthritic knees, Lyme arthritis pain, OTC drugs prevent their long term usage because the side Swollen knee, sprains, stiffness, blisters, tendonitis, insect effects of the drug will warrant their discontinuance. In bites (e.g. hornet bite), headaches associated with Vagal contrast, multiple applications of the homeopathic formula nerve irritation, facial neuralgia, and neuritis from radiation tion of the invention over a long period, e.g. about 6 months burn. to a year, are well accepted by the users with no apparent side effects. Multiple cases of localized “permanent reso The formulations of the invention have additional advan lution, or vast improvement lasting several months, were tages over currently available OTC drugs. The formulations observed with the formulation of the invention. 10 do not have strong odors or irritating effects as Some of the Treatments with the formulation of the invention also OTC drugs, making the formulations more acceptable to resulted in rapid anti-inflammatory effects. Typically, anti users. Furthermore, currently available OTC drugs tend to inflammatory effects would start in approximately 30 sec lose their effectiveness upon repeated administrations. In onds to 30 minutes after a topical application of the formu contrast, the formulations of the invention do not exhibit any lation of the invention depending on the cause. When using 15 refractory period upon repeated administrations. The the formulation, many test Subjects had range of motion absence of reduced effectiveness upon repeated administra restored in restricted joints. The formulation helped various tions makes the formulations especially effective in long cases of inflammation, Swelling, redness, and edema of term therapies of pain and/or inflammation.

TABLE 5

RESULTS OF CLINICAL TESTS CONDUCTED UNDER PEHYSICAN SUPERVISION FOR PREVIOUSLY PHYSICAN DIAGNOSED SYMPTOMS

Pain Duration of Duration Pain Relief Total Subjective Before Pain Relief. After After Number of Outcome After Test Symptom Pain Product Product Product Product Discontinuance Subject Description Intensity Application Application Application Applications of Product Use MS2 Left elbow pain 5 2 Hours Within &60 Pern. Pain free (post trauma) Seconds; complete relief in 5 min. F/53 Migraine 7 1 Hour Within approx. 3 min.: “Perm. Pain free headache complete relief & restful sleep F/72 Left knee severe 9 1 Year Within approx. 2 min.: “Perm. Pain free pain (Lyme complete disease) relief M40 Right shoulder 6 6 Weeks Within 31 min.: 8 Hours Pain returned pain complete relief gradually F.38 Fibromyalgia 5 3 Years Within 35 min.: 8 Hours Pain returned moderate relief gradually F/55 Fibromyalgia 7 10 Years No relief NA At least 1 NA M61 Right hand pain 6 2 Years Within 32 min.: Pern. Pain free (Lyme disease) moderate relief F28 Right foot insect 6 1 Day Within &30 Pern. Pain free bite Seconds; total relief F.66 Neck pain 5 5 Years Within &2 24 Hours 50% Pain relief (degenerative minutes; joint disease) moderate relie M61 Right knee pain 7 2 Years Within &5 24 Hours Loved product. (Lyme disease) minutes; near Pain returned complete relie gradually F23 Left flank pain 8 1 Year Within &5 10 Hours Moderate, long (fibromyalgia) minutes; near term pain relief complete relie M66 Right Shoulder 6 8 Years Within &3 Pern. Pain free pain (Lyme minutes; disease) complete relie F.49 Right carpal 6-7 6 Month Within &5 8–10 Hours 7 Good tunnel syndrome minutes; improvement moderate relie F.48 Rheumatoid 7-8 1 Year Within &5 8–10 Hours. 1 Pain returned arthritis minutes; near gradually complete relie M60 Legs (babesiosis) 4-5 1 Year No relief NA At least 1 NA F27 Neck shoulder 6-7 2 Months Within &1 24 Hours 1 Pain returned pain (Lyme minute; excellent gradually disease) relief F.46 Right knee pain 7-8 2 Months Within &60 Pern. 1 Pain free (Lyme disease) Seconds; excellent rel ief US 7,229,648 B2 15 16

TABLE 5-continued

RESULTS OF CLINICAL TESTS CONDUCTED UNDER PEHYSICAN SUPERVISION FOR PREVIOUSLY PHYSICAN DIAGNOSED SYMPTOMS

Pain Duration of Duration Pain Relief Total Subjective Before Pain Relief. After After Number of Outcome After Test Symptom Pain Product Product Produc Product Discontinuance Subject Description Intensity Application Application Application Applications' of Product Use

M31 Left wrist sprain 6-7 1 Week Within &60 24 H OS Moderate long Seconds; excellent term pain relief relief F.60 Left elbow pain 7-8 6 Years Within 3 24 H OS “Took the edge (Lyme disease) minutes; of moderate relief F81 Right hip 8-9 3 Years Within &2 24 H OS Pain returned (babesiosis) minutes: 75% gradually relief MS1 Pain in both 6-7 1 Year Within &2 12 H OS Pain returned knees (degen. minutes; gradually joint disease) moderate relief F.36 Left ankle sprain 7-8 2 Weeks Within &1 8 H OS Pain returned minute: 90% gradually better Facial neuralgia 1 Multiple 50% Improved 2 Weeks One each on 2 episodes office visits Cervical spine 5 Intermittent 50% Relief at 10 1 Increased range pain minutes of motion Vertex headache 5 Constant 15% Improved in At least 1 (vagal nerve 15 minutes irritation) Same Vertex headache 5 Constant 45% Improved At least 1 Subject as (vagal nerve over a week above irritation) Pain in right 10 Constant 20% Relief in 3 upper extremity minutes; 25% rhomboids & relief in 4 minutes trapezius bilateral, left Scapula F.31 Chronic migraine 9 1 Day 50% Relief in 20 min. headache with 1 application; 80% relief in 30 mins. with 2nd application Same One recurrence 5 100% Relief in 10 mins. Subject as of headache above M Muscle 10 Constant After 8 days Multiple Right flank pain strain sprain in muscle strain intermittent right flank lessened by 75% quadriceps; at right flank; tendonitis in right pain lessened by knee 50% in right knee Same Stiffness and 5 Intermittent 10% Relief in 15 Multiple Continued to Subject as pain in minutes use product above quadriceps; tendonitis; clicking right knee Right lower rib 10 10 Days 50% Relief in 10 Cage, minutes: 60% 1. Intercostal relief neuritis with 2nd 2" radiation burn application F/52 Acute right ankle 10 Acute injury Relief started 1 Hour sprainstrain; within 5 minutes: right forearm 40% relief after bruise & 35 minutes hematoma; left upper arm bruise & hermatoma Same 1 Bilateral upper 3 Weeks Multiple, at Minimal pain & Subject as extremities least twice discomfort above pain 95% daily resolved: edema 90% resolved US 7,229,648 B2 17 18

TABLE 5-continued

RESULTS OF CLINICAL TESTS CONDUCTED UNDER PEHYSICAN SUPERVISION FOR PREVIOUSLY PHYSICAN DIAGNOSED SYMPTOMS

TABLE 6

RESULTS OF TESTS DONE BY INDIVIDUALS FORTREATMENT OF SYMPTOMS

TABLE 6-continued

RESULTS OF TESTS DONE BY INDIVIDUALS FORTREATMENT OF SYMPTOMS

30 The invention claimed is: lus at a potency of 3x, Ledum Palustre at a potency of 3x. 1. A topical formulation comprising herbal active ingre Bryonia Alba at potencies of 6 x and 12x and Ruta Gra dients and a base Suitable for topical penetration of the skin, veolens at a potency of 3x. wherein the herbal active ingredients comprise tinctures 5. A topical formulation for topical use comprising herbal and/or homeopathic preparations of 8 or all of Bellis Peren 35 active ingredients and a base Suitable for topical penetration nis, Calendula Officinalis, Hamamelis Virginiana, Arnica Montana, Hypericum Perforatum, Aconitum Napellus, of the skin, wherein the herbal active ingredients comprise Ledum Palustre, Bryonia Alba and Ruta Graveolens. and/or homeopathic preparations of Bellis Perennis, Calen 2. The formulation of claim 1, the herbal active ingredi dula Officinalis, Hamamelis Virginiana, Arnica Montana, ents comprising tinctures and/or homeopathic preparations 40 Hypericum Perforatum, Aconitum Napellus, Ledum Palus of 8 or all of Bellis Perennis at a potency ranging from tre, Bryonia Alba and Ruta Graveolens. tincture-400x, Calendula Officinalis at a potency ranging 6. The formulation of claim 5, the herbal active ingredi from tincture-400x, Hamamelis Virginiana at a potency ents comprising tinctures and/or homeopathic preparations ranging from tincture-400x, Arnica Montana at a potency of Bellis Perennis at a potency ranging from tincture 400x, ranging from tincture-400x, Hypericum Perforatum at a 45 Calendula Officinalis at a potency ranging from tinc potency ranging from tincture-400x, Aconitum Napellus at a ture–400x, Hamamelis Virginiana at a potency ranging from potency ranging from 3x-400x, Ledum Palustre at a tincture-400x, Arnica Montana at a potency ranging from potency ranging from tincture-400x, Bryonia Alba at a tincture-400x, Hypericum Perforatum at a potency ranging potency ranging from tincture 400xand Ruta Graveolens at from tincture-400x, Aconitum Napellus at a potency ranging a potency ranging from tincture-400x. 50 from 3X-400x, Ledum Palustre at a potency ranging from 3. The formulation of claim 1, the herbal active ingredi tincture-400x, Bryonia Alba at a potency ranging from ents comprising tinctures and/or homeopathic preparations tincture-400xand Ruta Graveolens at a potency ranging of 8 or all of Bellis Perennis at a potency ranging from from tincture-400x. 1X-400x, Calendula Officinalis at a potency ranging from 1X-400x, Hamamelis Virginiana at a potency ranging from 55 7. The formulation of claim 5, the herbal active ingredi 1X-400x, Arnica Montana at a potency ranging from ents comprising tinctures and/or homeopathic preparations 3X-400x, Hypericum Perforatum at a potency ranging from of Bellis Perennis at a potency ranging from 1 x 400x, 3X-400x, Aconitum Napellus at a potency ranging from Catendula Officinalis at a potency ranging from 1X-400x. 3X-400x, Ledum Palustre at a potency ranging from Hamamelis Virginiana at a potency ranging from 1X-400x. 1x 400x, Bryonia Alba at a potency ranging from 3x 400x 60 Arnica Montana at a potency ranging from 3X-400x, and Ruta Graveolens at a potency ranging from 3X-400x. Hypericum Perforatum at a potency ranging from 3X-400x. 4. The formulation of claim 1, the herbal active ingredi Aconitum Napellus at a potency ranging from 3X-400x, ents comprising tinctures and/or homeopathic preparations Ledum Palustre at a potency ranging from 1X-400x, Bryo of 8 or all of Bellis Perennis at a potency of 1x, Calendula nia Alba at a potency ranging from 3x 400x and Ruta Officinalis at a potency of 1x, Hamamelis Virginiana at a 65 Graveolens at a potency ranging from 3X-400x. potency of 2x, Arnica Montana at potencies of 3x and 6x. 8. The formulation of claim 5, the herbal active ingredi Hypericum Perforatum at a potency of 2x, Aconitum Napel ents comprising tinctures and/or homeopathic preparations US 7,229,648 B2 21 22 of Bellis Perennis at a potency of 1x, Calendula Officinalis 10. The formulation of claim 2, further comprising at a potency of 1x, Hamamelis Virginiana at a potency of 2x. wherein the base is a gel base comprising water, glycerine, a polyacrylic add resin thickener, triethanolamine and meth Arnica Montana at potencies of 3x and 6x, Hypericum ylparaben. Perforatum at a potency of 2x, Aconitum Napellus at a 11. The formulation of claim 5, further comprising potency of 3x, Ledum Palustre at a potency of 3x, Bryonia wherein the base is a gel base comprising water, glycerine, Alba at potencies of 6xand 12x and Ruta Graveolens at a a polyacrylic acid resin thickener, triethanolamine and meth potency of 3x. ylparaben. 12. The formulation of claim 8, further comprising 9. The formulation of claim 1, further comprising wherein to wherein the base is a gel base comprising water, glycerine, the base is a gel base comprising water, glycerine, a poly a polyacrylic acid resin thickener, triethanolamine and meth acrylic acid resin thickener, triethanolamine and methylpa ylparaben. raben.