WO2021094989A1 - Homeopathic topical composition - Google Patents

Homeopathic topical composition Download PDF

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Publication number
WO2021094989A1
WO2021094989A1 PCT/IB2020/060686 IB2020060686W WO2021094989A1 WO 2021094989 A1 WO2021094989 A1 WO 2021094989A1 IB 2020060686 W IB2020060686 W IB 2020060686W WO 2021094989 A1 WO2021094989 A1 WO 2021094989A1
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WO
WIPO (PCT)
Prior art keywords
composition
homeopathic
solution
natrum
topical
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Application number
PCT/IB2020/060686
Other languages
French (fr)
Inventor
Vaidehi Parnad GUPTE
Shreekant Nagesh GODOLE
Original Assignee
V P Lyf
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by V P Lyf filed Critical V P Lyf
Priority to CA3161854A priority Critical patent/CA3161854A1/en
Priority to EP20886714.3A priority patent/EP4058039A4/en
Priority to US17/777,170 priority patent/US20220395574A1/en
Publication of WO2021094989A1 publication Critical patent/WO2021094989A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K41/00Medicinal preparations obtained by treating materials with wave energy or particle radiation ; Therapies using these preparations
    • A61K41/0004Homeopathy; Vitalisation; Resonance; Dynamisation, e.g. esoteric applications; Oxygenation of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/04Sulfur, selenium or tellurium; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/20Elemental chlorine; Inorganic compounds releasing chlorine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/42Phosphorus; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/062Ascomycota
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/45Ericaceae or Vacciniaceae (Heath or Blueberry family), e.g. blueberry, cranberry or bilberry
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/87Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

Definitions

  • the present invention relates to a novel homeopathic composition useful for treating pain and/or inflammation comprising tinctures and/or diluted extracts. More particularly, there is provided a composition which contains a synergistic combination of extracts from Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum Palustre and Cissus quadrangularis .
  • the present invention also provides a method of preparation of the homeopathic drug composition for topical application as gel or cream preferably as topical spray composition.
  • One of the basic tenets of homeopathic medicine is that a cure for a disease can be evoked by using a high dilution medicine that resembles, yet is different from, the cause of the disease. Further, topical Allopathic medicines for pain management may have associated side effects like skin irritation and redness.
  • RU02153348 disclose homeopathic drug for treatment of polyarthritis, arthrosis, rheumatism, containing Rhus toxicodendron and colchinicum autumnale differing in that it additionally contains Lithium carbonicum, Hepar sulfuris, Lycopodium clavatum, and Calcarea fluorica.
  • the present invention relates to a new homeopathic composition prepared by using dilute concentrations of substances that modify the frequency of the diluent and produce a corresponding response in the human or animal body when taken externally as a topical administration, specifically a spray composition.
  • Homeopathic compositions have been described as being effective by delivering a small amount of a substance that in large quantities would create the symptom being observed thereby allowing the body to properly develop a response that ultimately is able to eliminate the cause of the symptom being observed.
  • a wide variety of conditions as noted are treated using the homeopathic compositions, including back ache, muscle stiffness, pain reduction, swelling, inflammation, joint pain, localized musculoskeletal injuries like sprain, strains and many others.
  • the invention provides a homeopathic composition
  • a homeopathic composition comprising; i) Terminalia arjuna 2x to 8x; ii) Sticta pulmonaria 2x to 8x; iii) Colchicum autumnale 2x to 8x; iv) Gelsemium sempervirens 2x to 8x; v) Ledum palustre 2x to 8x; and vi) Cissus quadrangularis 2x to 8x.
  • the invention provides a homeopathic topical composition comprising:
  • tinctures and/or homeopathic preparations of herbal extracts selected from the group consisting of Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis, (ii) biochemics; and
  • the homeopathic composition comprises: (i) tinctures and/or homeopathic preparations of herbal extracts selected from the group consisting of Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis,
  • biochemics selected from Natrum muriaticum, Natrum phosphoricum; Magnesium phosphoricum or Natrum sulphuricum;
  • the present invention provides a method of preparation of the homeopathic topical composition; comprising the steps of: a) Mixing the coarse powder of herbs ( Terminalia arjuna, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis ) with 70 % dispensing alcohol and 30 % purified water, setting the mixture in a glass column at room temperature and sealing the mouth of the column and setting aside for 48 hours; b) Adding Sticta pulmonaria under constant stirring to solution of step a; c) adding Natrum muriaticum to the solution of step b) under constant stirring; d) adding a secondary non-aqueous solution of Natrum phosphoricum with stirring for 5 - 10 minutes to the solution of step c); e) adding dispensing alcohol and allowing to disperse in the solution of step d); f) filtering the dispersion as obtained in step e) to obtain a clear solution of the composition; and g) adding
  • the homeopathic composition of the present invention is filled in containers fitted with spray nozzle. In another aspect the homeopathic composition of the present invention is dispensed in cream, ointment or gel base.
  • the homeopathic topical composition are useful in treating pain and/or inflammation, particularly to heal muscular and bone injuries.
  • Another aspect of the invention is a method of treating pain by administering an effective amount of a homeopathic topical composition to a subject in need thereof.
  • tincture and “homeopathic formulation” of an herb refer to extracts of a part, combinations of parts and/or the entirety of the herb as described in Homeopathic Pharmacopoeia of India.
  • the “tincture” can be prepared by exposing a part, parts and/or the entirety of the herb in a solvent, e.g. alcohol, glycerin and/or water.
  • the “tincture” of an herb preferably is a mother tincture of the herb prepared according to the procedures in Homeopathic Pharmacopoeia of the United States (HPUS).
  • the "homeopathic preparation” can be prepared by dilution of the "tincture” with an appropriate liquid such as water or alcohol.
  • the "homeopathic preparation" of an herb for the formulation of the invention is preferably prepared as per HPUS procedures, wherein the mother tincture of the herb is serially diluted and subjected to succession according to the target potency using potentization procedures known in the art of homeopathy.
  • potency is defined as the strength of a homeopathic remedy which is determined by how many times the remedy has been succussed and diluted during preparation. A number and a letter are associated with the remedy name to indicate which potency scale has been used.
  • An example of the decimal scale would be Arnica Montana 6x.
  • An example of the centesimal scale would be Arnica Montana 30c.
  • An example of the 50 millesimal scale (LM) would be Arnica Montana LM1.
  • an active drug at a potency of lx means that a tincture, preferably as defined in HPUS, of the active drug is diluted 1 in 10, e.g.
  • a potency of 2x means that the active drug having a potency of lx is further diluted 1 in 10 and then succussed at least 10 times yielding the active drug at 2x.
  • herbal extracts are selected from the group consisting of but not limited to Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis.
  • the extracts of these herbs at the potencies disclosed below are used as active ingredients, which are mixed and blended with other ingredients in a vehicle to form a homeopathic composition.
  • the potency of each one of the plurality of active ingredients included in the actives portion may be one of between about tincture to about 100x , between about 1 C to about 30 C, or about LM-1 to about LM-3.
  • the potency of each one of the plurality of active ingredients included in the actives portion may be 8x , preferably 2x to 8x.
  • a topical spray of instant homeopathic composition may include plurality of active ingredients i.e. tinctures and/or homeopathic preparations and biochemics; and a base including a plurality of inactive ingredients.
  • the plurality of active ingredients include tinctures and/or homeopathic preparations of Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis; and biochemics selected from Natrum muriaticum, Natrum phosphoric or Magnesium phosphoricum, Natrum sulphuricum, or Calcarea sulphurica; preferably Natrum muriaticum and Natrum phosphoricum.
  • topical spray homeopathic formulations may include one, all, or any of the following:
  • the active ingredients include tinctures and/or homeopathic preparations selected from the group consisting of but not limited to herbal extracts selected from the group consisting of but not limited to Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis ; and biochemics selected from Natrum muriaticum, Natrum phosphoricum, Magnesium phosphoricum, Natrum sulphuricum, or Calcarea sulphurica.
  • herbal extracts selected from the group consisting of but not limited to Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis ; and biochemics selected from Natrum muriaticum, Natrum phosphoricum, Magnesium phosphoricum, Natrum sulphuricum, or Calcarea sulphurica.
  • Terminalia arjuna is a well known medicinal plant used in the ancient medicine.
  • the bark of the tree is reported to contain many bioactive compounds, which can be tapped for use in the treatment of many diseases.
  • Vagbhata mentions arjuna in the treatment of wounds, hemorrhages and ulcers, applied topically as a powder.
  • Sticta pulmonaria is used in inflammatory rheumatism of the knee joint.
  • Colchicum autumnale (Colchicum) is a toxic autumn-blooming flowering plant .
  • Gelsemium sempervirens ( Gelsemium ) is a twining vine native to warm temperate and tropical America, from Guatemala north to the southeastern USA. All parts of this plant contain the toxic strychnine-related alkaloids gelsemine, gelseminine and sempervirine . At pharmacological doses, G. sempervirens has been reported to show sedative, analgesic and anti- seizure properties.
  • Ledum palustre Commonly known as marsh Labrador tea, northern Labrador tea or wild rosemary, is a flowering plant in the subsection Ledum of the large genus Rhododendron in the family Ericaceae. All parts of the plant contain poisonous terpenes that affect the central nervous system a very valuable remedy for rheumatism
  • Cissus quadrangularis a traditional medicine for joint and bone health (as well as various feminine disorders and menopause), and shows promise in promoting bone growth rates. It is popular as a joint aid for athletes, with preliminary evidence supporting this property of cissus.
  • the process of Cissus quadrangularis extraction used in the composition is cold extraction.
  • Dried Cissus quadrangularis is cleaned and macerated into pieces. 100 gm of Cissus is sonicated with alcohol and water at room temperature, post it settling down it is set in open column with Ethanol and Water if required, the column is set sealed. Post 36 hours the elute is collected and sieved. It is filtered using vaccum filtration post 24 hrs.
  • the inactive ingredients include menthol, alcohol, glycerin and water.
  • Magnesium phosphoricum, Natrum sulphuricum, Calcarea sulphurica are used as it brings in synergistic effect along with the herbs.
  • topical preparations include ointment, cream, gel, spray, etc.
  • the most preferred being application being topical spray for treating pain and/or inflammation.
  • the topical spray compositions of present invention may be applied onto the skin by using a sprayable dispensing device.
  • a sprayable dispensing device Preferably, dispensed in a container such as a bottle or the like, fitted with a pump dispenser / nozzle or a manual metered pump that delivers a metered unit dose on actuation.
  • the composition of the present invention contains a thickening agent or polymeric material dissolved or suspended in a liquid to yield a gel based composition.
  • the observed effectiveness of a given homeopathic preparation can depend upon the method used to administer it to the patient. For example, lower potency (higher concentration) homeopathic ingredients appear to have better results when used as a topical treatment application when compared to high potency ingredients. In contrast, high potency homeopathic ingredients work well when administered orally or internally.
  • Table 1 is a listing of all active ingredients (components) that may be used in the various preparations of the instant invention along with the range of dilutions that may be utilized for each.
  • tincture refers to the mother tincture as defined in the HPUS.
  • a homeopathic composition comprising i) Terminalia arjuna 2x to 8x; ii) Sticta pulmonaria 2x to 8x; iii) Colchicum autumnale 2x to 8x; iv) Gelsemium sempervirens 2x to 8 x; v) Ledum palustre 2x to 8x; and vi) Cissus quadrangularis 2 x to 8 x.
  • the composition may comprise biochemics and pharmaceutically acceptable vehicle or carrier.
  • composition of the present invention is an effective formulation that does not have toxicity and tackles pain and inflammation effectively.
  • the present invention i) all the herbs namely Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, LedumP alustere and Cissus quadrangularis are measured to 50 gm individually. Columns are setup and each herb is set in the column with purified water and alcohol in ratio of 30:70. The columns are sealed pack and kept for 48 hours. ii) Biochemics like Natrum muriaticum, Natrum phosphoricum, Magnesium phosphoricum, Natrum sulphuricum, Calc area sulphurica are added to the column of Cissus quadrangularis. iii) Elute is filtered.
  • the present invention relates to a process for the preparation of a homeopathic topical composition
  • a process for the preparation of a homeopathic topical composition comprising the steps of: a) Mixing the coarse powder of herbs ( Terminalia arjuna, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis) with 70 % dispensing alcohol and 30 % purified water, setting the mixture in a glass column at room temperature and sealing the mouth of the column and setting aside for 48 hours; b) adding Sticta pulmonaria under constant stirring to solution of step a) c) adding Natrum muriaticum to the solution of step b) under constant stirring; d) adding a secondary non-aqueous solution of Natrum phosphoricum with stirring for 5 - 10 minutes to the solution of step c); e) adding dispensing alcohol and allowing to disperse in the solution of step d); f) filtering the dispersion as obtained in step e) to
  • glycerin is added to the clear solution of step f) which is sonicated and filtered to obtain the composition.
  • the topical composition of Homeopathy composition Procedure a. 200 ml of Cissus quadrangularis extract made in House and 100 ml of Ledum Palustre added in a beaker, b. Half of 50 ml each of ⁇ Magnesium phosphoricum + Natrum sulphuricum + Calcarea sulphurica ⁇ was added to it (liquids), c. Dispensing Alcohol (70%) + Purified Water (30%) was added, d. The resulting solution was allowed to attain a temperature of 20- 25°C. e. The dispersion as obtained in step (d) was homogenized for 15 minutes at 4200 rpm and stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution,
  • the topical composition of Homeopathy composition is a topical composition of Homeopathy composition
  • Example 3 The topical composition of Homeopathy composition
  • step (k) Glycerin was added to the solution to increase the viscosity. k.
  • the resulting solution was allowed to attain a temperature of 20- 25°C. l.
  • the dispersion as obtained in step (k) was sonicated for 15 minutes stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution.
  • the clear solution obtained above is filled in spray bottles.
  • the composition of the present invention is applied topically by means of a spray.
  • the clear solution obtained above is mixed with gel base for topical administration.
  • the clear solution obtained above is mixed with cream base for topical administration.
  • the formulations according to the present invention exhibited significant decrease of % swelling of the paw compared to the control.
  • the % inhibition of the edema formation by the formulations was maximum with VP2, which is in range of 44.82% to 53.31.
  • Analgesic activity was evaluated against hypernociception induced in the hindpaw by the administration of an intraplantar carrageenan suspension and was measured according to the paw pressure tests of Randall Selitto.
  • Randall Selitto test an analgesy-meter with a cone-shaped paw-presser with a rounded tip, which applies a linearly increasing force to the plantar surface of the paw, was used.
  • the weight in grams (g) required to elicit nociceptive responses such as paw flexion or struggling was defined as the nociceptive threshold.
  • the mechanical evaluation of hypernociception intensity was evaluated 3 hrs after the carrageenan injection.
  • the acute dermal irritation study was performed in accordance with the OECD Guidelines 404 for “Acute dermal irritation/corrosion” on male White New Zealand rabbits (2.5-3 kg). Briefly, approximately 24 hours before the test, around 5 cm x 5 cm of rabbit’s dorsal area of the trunk was clipped for experimental use.
  • 0.5 ml formulation was then applied under a 2.5 cm x 2.5 cm gauze patch and wrapped with occlusive dressing.
  • the test sites were observed and scored for erythema and oedema at 1 h, 24 h, 48 and 72 h post-exposure with formulation.
  • Dermal responses were determined in accordance with OECD guidelines. Erythema and oedema were scored on a scale of 0-4, with 0 showing no effect and 4 representing severe symptoms. Since formulation was expected to be safe, limit test was performed in one rabbit as per OECD guideline 404.

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Abstract

The present invention relates to a novel homeopathic composition useful for treating pain and/or inflammation comprising tinctures and/or diluted extracts. More particularly, there is provided a composition which contains a synergistic combination of extracts from Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum Palustre and Cissus quadrangularis. The present invention also provides a method of preparation of the homeopathic drug composition as topical preparation, preferably as topical spray composition. Cissus quadrangularis extraction is also a novel process used in the composition where in cold extraction is applied for Cissus Quadrangularis.

Description

HOMEOPATHIC TOPICAL COMPOSITION
Field of the Invention
The present invention relates to a novel homeopathic composition useful for treating pain and/or inflammation comprising tinctures and/or diluted extracts. More particularly, there is provided a composition which contains a synergistic combination of extracts from Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum Palustre and Cissus quadrangularis . The present invention also provides a method of preparation of the homeopathic drug composition for topical application as gel or cream preferably as topical spray composition.
Background of the invention
The history of homeopathy dates back to the eighteenth century and the research of the German physician Samuel Hahnemann, who postulated the principle of “like cures like.” In the nineteenth century, Hugo Paul Friedrich Schultz postulated that toxins can have the opposite effect in small doses compared to large doses. In 1888, Schultz showed that very low concentrations of yeast toxins increased yeast growth over 100 fold. At the same time, the psychiatrist Rudolph Arndt developed his “Basic Law of Biology,” which states that weak stimuli slightly accelerate the vital activity, middle-strong stimuli raise it, strong stimuli suppresses it, and very strong stimuli halt vital activity. These separate observations were formulated by Arndt in 1888 into one of the earliest laws of pharmacology representing the homeopathic effect, the Arndt-Schultz rule, which states: every stimulus on a living cell elicits an activity, which is inversely proportional to the intensity of the stimulus. This law was later restated by Ferdinand Hueppe as: for every substance, small doses stimulate, moderate doses inhibit, and large doses kill. Allopathic medicine, with its emphasis on moderate drug doses, works to inhibit undesired physical symptoms and to kill undesired pathogens too. Homeopathic medicine, on the other hand, begins with small doses and moves towards progressively higher dilutions to stimulate the body's own natural electromagnetic forces. One of the basic tenets of homeopathic medicine is that a cure for a disease can be evoked by using a high dilution medicine that resembles, yet is different from, the cause of the disease. Further, topical Allopathic medicines for pain management may have associated side effects like skin irritation and redness.
RU02153348 disclose homeopathic drug for treatment of polyarthritis, arthrosis, rheumatism, containing Rhus toxicodendron and colchinicum autumnale differing in that it additionally contains Lithium carbonicum, Hepar sulfuris, Lycopodium clavatum, and Calcarea fluorica.
The present invention relates to a new homeopathic composition prepared by using dilute concentrations of substances that modify the frequency of the diluent and produce a corresponding response in the human or animal body when taken externally as a topical administration, specifically a spray composition. Homeopathic compositions have been described as being effective by delivering a small amount of a substance that in large quantities would create the symptom being observed thereby allowing the body to properly develop a response that ultimately is able to eliminate the cause of the symptom being observed. A wide variety of conditions as noted are treated using the homeopathic compositions, including back ache, muscle stiffness, pain reduction, swelling, inflammation, joint pain, localized musculoskeletal injuries like sprain, strains and many others.
Currently known topical analgesic products for pain management have many problems like unpleasant physical and social side effects such as strong odors, counter irritation, redness, itching, stinging, cooling, sensitization, staining, burning and anesthesia, etc. Thus, there exists a need for the development of a new, improved topical composition that would reduce the above associated side effects with improved patient compliance. In consideration of the need as indicated above, the inventors of the present invention have done extensive research and conducted several experiments to develop a novel topical homeopathy synergistic composition of herbal extracts with lesser associated side effects thereby rendering the composition according to the present invention as an easy-to-use composition with optimum topical effects. Further, being devoid of lesser associated side effects, instant composition has more patient compliance even if it has repeated continuous long term usage.
Summary of the invention
In one aspect the invention provides a homeopathic composition comprising; i) Terminalia arjuna 2x to 8x; ii) Sticta pulmonaria 2x to 8x; iii) Colchicum autumnale 2x to 8x; iv) Gelsemium sempervirens 2x to 8x; v) Ledum palustre 2x to 8x; and vi) Cissus quadrangularis 2x to 8x.
In other aspect, the invention provides a homeopathic topical composition comprising:
(i) tinctures and/or homeopathic preparations of herbal extracts selected from the group consisting of Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis, (ii) biochemics; and
(iii) pharmaceutically acceptable vehicle or carrier medium for topical application as spray, cream, ointment, or gel for pain and/or inflammation
In another aspect, the homeopathic composition comprises: (i) tinctures and/or homeopathic preparations of herbal extracts selected from the group consisting of Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis,
(ii) biochemics selected from Natrum muriaticum, Natrum phosphoricum; Magnesium phosphoricum or Natrum sulphuricum;
(iii) pharmaceutically acceptable vehicle or carrier medium.
In another aspect, the present invention provides a method of preparation of the homeopathic topical composition; comprising the steps of: a) Mixing the coarse powder of herbs ( Terminalia arjuna, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis ) with 70 % dispensing alcohol and 30 % purified water, setting the mixture in a glass column at room temperature and sealing the mouth of the column and setting aside for 48 hours; b) Adding Sticta pulmonaria under constant stirring to solution of step a; c) adding Natrum muriaticum to the solution of step b) under constant stirring; d) adding a secondary non-aqueous solution of Natrum phosphoricum with stirring for 5 - 10 minutes to the solution of step c); e) adding dispensing alcohol and allowing to disperse in the solution of step d); f) filtering the dispersion as obtained in step e) to obtain a clear solution of the composition; and g) adding glycerin (optionally) to the clear solution of step f) which is sonicated and filtered to obtain the composition.
In another aspect the homeopathic composition of the present invention is filled in containers fitted with spray nozzle. In another aspect the homeopathic composition of the present invention is dispensed in cream, ointment or gel base.
In yet another aspect the homeopathic topical composition are useful in treating pain and/or inflammation, particularly to heal muscular and bone injuries.
Another aspect of the invention is a method of treating pain by administering an effective amount of a homeopathic topical composition to a subject in need thereof.
These and other aspects and advantages of the present invention will be apparent to those skilled in the art from the following description.
Detailed Description of the Invention
It should be understood that the detailed description and specific examples, while indicating embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art. One skilled in the art, based upon the definitions herein, may utilize the present invention to its fullest extent. The following specific embodiments are to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any way whatsoever.
Unless otherwise defined, all the terms used herein, including the technical and scientific terms, have the meaning as that generally understood by one of ordinary skill in the art to which the present invention relates. Definitions:
For the purpose of the disclosure, listed below are definitions of various terms used to describe the present invention. Unless otherwise indicated, these definitions apply to the terms as they are used throughout the specification and the appended claims, either individually or as part of a larger group. They should not be interpreted in the literal sense. They are not general definitions and are relevant only for this application.
It should be noted that, as used in this specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the content clearly dictates otherwise.
It should be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The terms "tincture" and "homeopathic formulation" of an herb refer to extracts of a part, combinations of parts and/or the entirety of the herb as described in Homeopathic Pharmacopoeia of India. The "tincture" can be prepared by exposing a part, parts and/or the entirety of the herb in a solvent, e.g. alcohol, glycerin and/or water. The "tincture" of an herb preferably is a mother tincture of the herb prepared according to the procedures in Homeopathic Pharmacopoeia of the United States (HPUS). The "homeopathic preparation" can be prepared by dilution of the "tincture" with an appropriate liquid such as water or alcohol. The "homeopathic preparation" of an herb for the formulation of the invention is preferably prepared as per HPUS procedures, wherein the mother tincture of the herb is serially diluted and subjected to succession according to the target potency using potentization procedures known in the art of homeopathy.
The term “potency” is defined as the strength of a homeopathic remedy which is determined by how many times the remedy has been succussed and diluted during preparation. A number and a letter are associated with the remedy name to indicate which potency scale has been used. An example of the decimal scale would be Arnica Montana 6x. An example of the centesimal scale would be Arnica Montana 30c. An example of the 50 millesimal scale (LM) would be Arnica Montana LM1. These are the 3 potency scales currently in use. Further, for instance, an active drug at a potency of lx means that a tincture, preferably as defined in HPUS, of the active drug is diluted 1 in 10, e.g. 1 ml of the tincture is mixed with 9 ml of a diluent liquid, and then succussed at least 10 times, according to known potentization procedures in homeopathy. A potency of 2x means that the active drug having a potency of lx is further diluted 1 in 10 and then succussed at least 10 times yielding the active drug at 2x.
In the present invention, herbal extracts are selected from the group consisting of but not limited to Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis. The extracts of these herbs at the potencies disclosed below are used as active ingredients, which are mixed and blended with other ingredients in a vehicle to form a homeopathic composition.
In an embodiment, the potency of each one of the plurality of active ingredients included in the actives portion may be one of between about tincture to about 100x , between about 1 C to about 30 C, or about LM-1 to about LM-3.The potency of each one of the plurality of active ingredients included in the actives portion may be 8x , preferably 2x to 8x.
In an embodiment, a topical spray of instant homeopathic composition may include plurality of active ingredients i.e. tinctures and/or homeopathic preparations and biochemics; and a base including a plurality of inactive ingredients. The plurality of active ingredients include tinctures and/or homeopathic preparations of Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis; and biochemics selected from Natrum muriaticum, Natrum phosphoric or Magnesium phosphoricum, Natrum sulphuricum, or Calcarea sulphurica; preferably Natrum muriaticum and Natrum phosphoricum.
In another embodiment the topical spray homeopathic formulations may include one, all, or any of the following:
The active ingredients include tinctures and/or homeopathic preparations selected from the group consisting of but not limited to herbal extracts selected from the group consisting of but not limited to Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis ; and biochemics selected from Natrum muriaticum, Natrum phosphoricum, Magnesium phosphoricum, Natrum sulphuricum, or Calcarea sulphurica.
Terminalia arjuna is a well known medicinal plant used in the ancient medicine. The bark of the tree is reported to contain many bioactive compounds, which can be tapped for use in the treatment of many diseases. Vagbhata mentions arjuna in the treatment of wounds, hemorrhages and ulcers, applied topically as a powder.
Sticta pulmonaria is used in inflammatory rheumatism of the knee joint.
Colchicum autumnale (Colchicum) is a toxic autumn-blooming flowering plant .
Gelsemium sempervirens ( Gelsemium ) is a twining vine native to warm temperate and tropical America, from Guatemala north to the southeastern USA. All parts of this plant contain the toxic strychnine-related alkaloids gelsemine, gelseminine and sempervirine . At pharmacological doses, G. sempervirens has been reported to show sedative, analgesic and anti- seizure properties.
Ledum palustre: Commonly known as marsh Labrador tea, northern Labrador tea or wild rosemary, is a flowering plant in the subsection Ledum of the large genus Rhododendron in the family Ericaceae. All parts of the plant contain poisonous terpenes that affect the central nervous system a very valuable remedy for rheumatism
Cissus quadrangularis a traditional medicine for joint and bone health (as well as various feminine disorders and menopause), and shows promise in promoting bone growth rates. It is popular as a joint aid for athletes, with preliminary evidence supporting this property of cissus.
The process of Cissus quadrangularis extraction used in the composition is cold extraction.
Dried Cissus quadrangularis is cleaned and macerated into pieces. 100 gm of Cissus is sonicated with alcohol and water at room temperature, post it settling down it is set in open column with Ethanol and Water if required, the column is set sealed. Post 36 hours the elute is collected and sieved. It is filtered using vaccum filtration post 24 hrs.
The inactive ingredients include menthol, alcohol, glycerin and water.
Magnesium phosphoricum, Natrum sulphuricum, Calcarea sulphurica are used as it brings in synergistic effect along with the herbs.
According to an embodiment the examples of topical preparations include ointment, cream, gel, spray, etc. The most preferred being application being topical spray for treating pain and/or inflammation.
The topical spray compositions of present invention may be applied onto the skin by using a sprayable dispensing device. Preferably, dispensed in a container such as a bottle or the like, fitted with a pump dispenser / nozzle or a manual metered pump that delivers a metered unit dose on actuation. According to an embodiment the composition of the present invention contains a thickening agent or polymeric material dissolved or suspended in a liquid to yield a gel based composition. The observed effectiveness of a given homeopathic preparation can depend upon the method used to administer it to the patient. For example, lower potency (higher concentration) homeopathic ingredients appear to have better results when used as a topical treatment application when compared to high potency ingredients. In contrast, high potency homeopathic ingredients work well when administered orally or internally.
The various components included in implementations of homeopathic preparations disclosed here are selected from those officially listed in the Homeopathic Pharmacopoeia of the United States (HPUS) and Homeopathic Pharmacopoeia of India. Table 1 is a listing of all active ingredients (components) that may be used in the various preparations of the instant invention along with the range of dilutions that may be utilized for each. In this table, tincture refers to the mother tincture as defined in the HPUS.
TABLE 1 - Active Ingredient
Figure imgf000011_0001
A wide variety of combinations of potential active ingredients at desired potencies are possible using the ingredients and dilutions listed in Table 1. In the instant invention, various implementations of a topical spray preparation, and/or bottle containing a dispensing dropper preparation and/or in a roll-on bottle and/or in any form of creams or ointments or serums or oils or emulsifications are disclosed. Those of ordinary skill in the art will readily be able to create additional implementations using the principles disclosed herein.
According to an embodiment of the present invention there is provided a homeopathic composition comprising i) Terminalia arjuna 2x to 8x; ii) Sticta pulmonaria 2x to 8x; iii) Colchicum autumnale 2x to 8x; iv) Gelsemium sempervirens 2x to 8 x; v) Ledum palustre 2x to 8x; and vi) Cissus quadrangularis 2 x to 8 x.
According to an embodiment of the present invention the composition may comprise biochemics and pharmaceutically acceptable vehicle or carrier.
The composition of the present invention is an effective formulation that does not have toxicity and tackles pain and inflammation effectively.
TABLE 2 - Actives Composition
Figure imgf000012_0001
Figure imgf000013_0001
Table 3 - Actives Implementation
Figure imgf000013_0002
Table 4 - Actives preparation as per Monograph from HPI Voll (Parti)
Figure imgf000014_0001
TABLE 5 -Base Implementation
Figure imgf000014_0002
Process for the preparation of Composition of the Present invention :
In an aspect, the present invention i) all the herbs namely Terminalia arjuna, Sticta pulmonaria, Colchicum autumnale, Gelsemium sempervirens, LedumP alustere and Cissus quadrangularis are measured to 50 gm individually. Columns are setup and each herb is set in the column with purified water and alcohol in ratio of 30:70. The columns are sealed pack and kept for 48 hours. ii) Biochemics like Natrum muriaticum, Natrum phosphoricum, Magnesium phosphoricum, Natrum sulphuricum, Calc area sulphurica are added to the column of Cissus quadrangularis. iii) Elute is filtered. All elutes are then mixed in equal proportions. All elutes are then mixed in equal proportions. Purified water is added to the mixture of elutes. It is again filtered. Menthol is added by dissolving it in alcohol. Glycerin is added and entire solution is sonicated
In an aspect, the present invention relates to a process for the preparation of a homeopathic topical composition comprising the steps of: a) Mixing the coarse powder of herbs ( Terminalia arjuna, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis) with 70 % dispensing alcohol and 30 % purified water, setting the mixture in a glass column at room temperature and sealing the mouth of the column and setting aside for 48 hours; b) adding Sticta pulmonaria under constant stirring to solution of step a) c) adding Natrum muriaticum to the solution of step b) under constant stirring; d) adding a secondary non-aqueous solution of Natrum phosphoricum with stirring for 5 - 10 minutes to the solution of step c); e) adding dispensing alcohol and allowing to disperse in the solution of step d); f) filtering the dispersion as obtained in step e) to obtain a clear solution of the composition.
In another embodiment of the present invention glycerin is added to the clear solution of step f) which is sonicated and filtered to obtain the composition.
It will be evident to one skilled in the art that the present invention is not limited to the above description or illustrative examples provided below, and that it can be embodied in other specific forms without departing from the essential attributes thereof. It is therefore desired that the description and examples be considered in all respects as illustrative and not restrictive, reference being made to the appended claims, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Accordingly, the following examples are intended to illustrate but not to limit the scope of the present invention.
Examples in accordance with the present invention Example 1:
The topical composition of Homeopathy composition
Figure imgf000016_0001
Procedure: a. 200 ml of Cissus quadrangularis extract made in House and 100 ml of Ledum Palustre added in a beaker, b. Half of 50 ml each of { Magnesium phosphoricum + Natrum sulphuricum + Calcarea sulphurica} was added to it (liquids), c. Dispensing Alcohol (70%) + Purified Water (30%) was added, d. The resulting solution was allowed to attain a temperature of 20- 25°C. e. The dispersion as obtained in step (d) was homogenized for 15 minutes at 4200 rpm and stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution,
Filtered twice to get clear solution f. 100 ml of extract made In House of Terminalia Arjuna was added to the above solution g. 100 ml of mother tincture of Sticta pulmonaria and gelsemium was added to the above solution h. 100 ml of extract made In House of Colchicum were added to the solution i. The resulting solution was allowed to attain a temperature of 20- 25°C. j. The dispersion as obtained in step (i) was sonicated for 15 minutes stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution, k. Other half of 50 ml each of { Magnesium Phosphoricum + Natrum Sulphuricum + Calcarea Sulphurica} added to it (liquids) l. The resulting solution was allowed to attain a temperature of 20- 25°C. m. The dispersion as obtained in step (1) was sonicated for 15 minutes stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution, Elute:
Cissus quadrangularis 200 ml Q Ledum palustre 100 ml Q Terminalia arjuna 100 ml Q Sticta pulmonaria 100 ml Q
Gelsemium 100 ml Q Colchicum 100 ml Q
10 mg of Menthol dissolved in 100 ml of Purified Water Example 2:
The topical composition of Homeopathy composition
Figure imgf000018_0001
Procedure: a. 200 ml of Cissus quadrangularis extract made in House and 100 ml of Ledum palustre extract made In House was added in a beaker b. Half of 50 ml each of { Magnesium phosphoricum + Natrum sulphuricum + Calcarea sulphurica} was added to it (liquids), c. Dispensing Alcohol (70%) + Purified Water (30%) was added, d. The resulting solution was allowed to attain a temperature of 20- 25°C. e. The dispersion as obtained in step (d) was homogenized for 15 minutes at 4200 rpm and stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution,
Filtered twice to get clear solution f. 100 ml of extract made In House of Terminalia Arjuna was added to the above solution g. 100 ml of mother tincture of Sticta pulmonaria and Gelsemium was added to the above solution h. 100 ml of extract made In House of Colchicum were added to the solution i. The resulting solution was allowed to attain a temperature of 20- 25°C. The dispersion as obtained in step (e) was sonicated for 15 minutes stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution, j. Other Half of 50 ml each of {Magnesium Phosphoricum + Natrum Sulphuricum + Calcarea Sulphurica} added to it (liquids) k. The resulting solution was allowed to attain a temperature of 20- 25°C. l. The dispersion as obtained in step (j) was sonicated for 15 minutes stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution,
Elute:
Cissus quadrangularis 200 ml Q
Ledum palustre 100 ml Q
Terminalia arjuna 100 ml Q
Sticta pulmonaria 100 ml Q
Gelsemium 100 ml Q Colchicum 100 ml Q
20 mg of Menthol dissolved in 100 ml of Purified Water
Example 3: The topical composition of Homeopathy composition
Figure imgf000020_0001
Procedure: a. 200 ml of Cissus quadrangularis extract made In House was and 100 ml of Ledum palustre extract made In House added in a beaker b. Half of 50 ml each of {Magnesium phosphoricum + Natrum sulphuricum + Calcareasulphurica} was added to it (liquids), c. Dispensing Alcohol (70%) + Purified Water (30%) was added, d. The resulting solution was allowed to attain a temperature of 20- 25°C. The dispersion as obtained in step (e) was homogenized for 15 minutes at 4200 rpm and stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution, Filtered twice to get clear solution e. 100 ml of mother tincture of Terminalia Arjuna was added to the above solution f. 100 ml of mother tincture of Sticta pulmonaria was added to the above solution g. 100 ml of mother tincture of each Gelsemium and Colchicum were added to the solution h. The resulting solution was allowed to attain a temperature of 20- 25°C. The dispersion as obtained in step (g) was sonicated for 15 minutes stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution, i. Other half of 50 ml each of { Magnesium Phosphoricum + Natrum Sulphuricum + Calcarea Sulphurica} added to it (liquids) j. Glycerin was added to the solution to increase the viscosity. k. The resulting solution was allowed to attain a temperature of 20- 25°C. l. The dispersion as obtained in step (k) was sonicated for 15 minutes stirred for 120 minutes and filtered one or more times through PES filter to obtain a clear solution.
Elute:
Cissus quadrangularis 200 ml Q Ledum palustre 100 ml Q Terminalia arjuna 100 ml Q Sticta pulmonaria 100 ml Q Gelsemium 100 ml Q Colchicum 100 ml Q
20 mg of Menthol dissolved in 100 ml of Purified Water 10 ml of Glycerin The clear solution obtained above is filled in spray bottles. The composition of the present invention is applied topically by means of a spray. In embodiment the clear solution obtained above is mixed with gel base for topical administration.
In embodiment the clear solution obtained above is mixed with cream base for topical administration.
Evaluation of Anti-inflammatory and Analgesic activity of topical formulations:
VP3 formulation (Comparative):
Figure imgf000022_0001
VP2 formulation according to the present invention:
Figure imgf000022_0002
Experiment 1 Anti-inflammatory activity of Formulations on carrageenan-induced paw edema in rats Anti-inflammatory activity of different formulations was evaluated in carrageenan-induced paw edema in male Sprague-Dawley rats weighing about 225g. Thirty minutes before carrageenan injection, the formulations VP2, VP3 were applied on the left hind paw of the rats at the dose of 0.35ml. Control group received vehicle only.
Each group had 6 animals.
Then, 0.1 ml of 1% carrageenan in physiological saline was injected into the paw subplantarly. Immediately,!, 2, 3 and 4hours after the carrageenan injection, the thickness of the paw was measured using a digital vernier caliper, and the percent swelling of the paw and the percent inhibition of the edema formation were calculated as follows:
% swelling at a timepoint = [(paw thickness - initial paw thickncssj/initial paw thickness] x 100 % inhibition = [1- (% swelling of drug-treated group/% swelling of control group)] x 100
The results are represented in table 6
Table 6. Effect of formulations on carrageenan-induced paw edema
Figure imgf000023_0001
* p <0.05 vs. control group (One-way ANOVA, followed by Dunnett's post hoc test)
As can be seen in Table 6, the formulations according to the present invention exhibited significant decrease of % swelling of the paw compared to the control. The % inhibition of the edema formation by the formulations was maximum with VP2, which is in range of 44.82% to 53.31.
In formulation without Sticta and Colchicum, there was significant drop in the activity noted.
Experiment 2
Analgesic activity of Formulations on carrageenan-induced paw edema in rats
Analgesic activity was evaluated against hypernociception induced in the hindpaw by the administration of an intraplantar carrageenan suspension and was measured according to the paw pressure tests of Randall Selitto. In the Randall Selitto test, an analgesy-meter with a cone-shaped paw-presser with a rounded tip, which applies a linearly increasing force to the plantar surface of the paw, was used. The weight in grams (g) required to elicit nociceptive responses such as paw flexion or struggling was defined as the nociceptive threshold. The mechanical evaluation of hypernociception intensity was evaluated 3 hrs after the carrageenan injection.
The results are represented in table 7.
Table 7. The mechanical evaluation of formulations against hypernociception intensity (A withdrawal threshold in grams)
Figure imgf000024_0001
* p <0.05 vs. control group (One-way ANOVA, followed by Dunnett's post hoc test)
As can be seen in Table 7, the formulations according to the present invention exhibited significant attenuation of D withdrawal threshold compared to the control group.
Maximum attenuation was observed with the formulationVP2.
Experiment 2
Skin irritation study in rabbits
The acute dermal irritation study was performed in accordance with the OECD Guidelines 404 for “Acute dermal irritation/corrosion” on male White New Zealand rabbits (2.5-3 kg). Briefly, approximately 24 hours before the test, around 5 cm x 5 cm of rabbit’s dorsal area of the trunk was clipped for experimental use.
0.5 ml formulation was then applied under a 2.5 cm x 2.5 cm gauze patch and wrapped with occlusive dressing. The test sites were observed and scored for erythema and oedema at 1 h, 24 h, 48 and 72 h post-exposure with formulation. Dermal responses were determined in accordance with OECD guidelines. Erythema and oedema were scored on a scale of 0-4, with 0 showing no effect and 4 representing severe symptoms. Since formulation was expected to be safe, limit test was performed in one rabbit as per OECD guideline 404.
Table 8
Figure imgf000025_0001
As can be seen in Table 8, formulation did not show any signs of irritations till 72 hrs post-exposure. Thus the topical formulation of the present invention is safe.
Although shown and described in what is believed to be the most practical and preferred embodiments, departures from the specific formulation and process described may be apparent to those skilled in the art and may be used without departing from the scope of the present invention.

Claims

Claims:
1. A homeopathic composition comprising; i) Terminalia arjuna 2x to 8x; ii) Sticta pulmonaria 2x to 8x; iii) Colchicum autumnale 2x to 8x; iv) Gelsemium sempervirens 2x to 8x v) Ledum palustre 2x to 8x; and vi) Cissus quadrangularis 2x to 8x.
2. A homeopathic composition comprising a) Tinctures or homeopathic preparation of herbal extracts comprising; i) Terminalia arjuna ; ii) Sticta pulmonaria, iii) Colchicum autumnale; iv) Gelsemium sempervirens, v) Ledum palustre and vi) Cissus quadrangularis b) biochemics; and c) pharmaceutically acceptable vehicle or carrier
3. The homeopathic composition as claimed in claim 2 wherein the biochemics is selected from Natrum muriaticum, Natrum phosphoric, Magnesium phosphoricum, Natrum sulphuricum,or Calcarea sulphurica.
4. The homeopathic composition as claimed in claim 2 wherein the pharmaceutically acceptable vehicle or carrier is selected from menthol, alcohol, glycerin or water.
5. The homeopathic composition as claimed in claims 1 to 4 wherein the formulation is in the form of spray, cream, ointment or gel.
6. The process for preparing homeopathic composition as claimed in claim 2 comprising steps of: a) Mixing the coarse powder of herbs Terminalia arjuna, Colchicum autumnale, Gelsemium sempervirens, Ledum palustre and Cissus quadrangularis with 70 % dispensing alcohol and 30 % purified water, setting the mixture in a glass column at room temperature and sealing the mouth of the column and setting aside for 48 hours; b) Adding Sticta pulmonaria under constant stirring to solution of step a); c) adding Natrum muriaticum to the solution of step b) under constant stirring; d) adding a secondary non-aqueous solution of Natrum phosphoricum with stirring to the solution of step c); e) adding dispensing alcohol and allowing to disperse in the solution of step d); f) filtering the dispersion obtained in step e) to obtain a clear solution of the composition.
7. The process for preparing homeopathic composition as claimed in claim 6 where in glycerin is added to the clear solution of step (f) which is sonicated and filtered to obtain the composition.
8. The process for preparing homeopathic composition as claimed in claim 6 and 7 wherein the composition is mixed with gel base or cream base to give topical gel formulation and topical cream formulation respectively.
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