FIELD OF THE INVENTION
The present invention is related to a topical formulation for pain
management. Further, the present invention relates to formulation
comprising herbal ingredients. The present invention discloses a stable
formulation and manufacturing method thereof which is used in the
management of pain without any side effects.
PRIOR ART OF THE INVENTION
WO 2002041832 provided a topical composition for treating preventing skin irritation induced by a retinoid, which composition has comfrey. There is also provided a method treating and/or preventing skin irritation induced by a retinoid, which method comprises applying to the skin an effective amount of comfrey.
US 5958418 relates to a natural herbal composition of effective amounts of Aloe Vera, Capsicum, Golden Seal, Comfrey Root and water, to its method of use for external application to affected parts of the body for eliminating muscular pain and to its method of preparation.

EP 2364714 comprises a carrier medium a carrier medium, menthol (0.1-1 wt. %), horse chestnut seed extract (1-5 wt.%), white willow bark extract (1-5 wt.%), Arnica tincture (2-8 wt.%), rosemary oil (0.25-5 wt.%) and St. John's wort oil (1-5 wt.%).
US 20110038965 provide a topical formulation including (i) comfrey or a
comfrey-derived compound, or an analogue or derivative thereof and (ii)
*
a penetration enhancer, and optionally including tannic acid, or an analogue or derivative thereof. The present invention also provides a topical formulation including (i) comfrey or a comfrey-derived compound, or an analogue or derivative thereof, and (ii) tannic acid, or an analogue or derivative thereof, optionally including a penetration enhancer.
US 20110212193 ointment may include about 45 weight percent of herb-infused oil, water or alcohol, or any desired combination thereof, about 30 weight percent purified water, about 10 weight percent emulsifier wax, about 5 weight percent menthol, about 3 weight percent dimethyl isosorbide, about 2 weight percent glycerin, about 2 weight

percent hydrogenated methyl abietate, about 0.5 weight percent lonicera caprifolium and lonicera japonica extract, about 0.5 weight percent tocopherol, about 0.35 weight percent vanillyl butyl ether, about 0.35 weight percent xanthan gum, about 0.3 weight percent citric acid 50% aqueous solution, and about 0.25 weight percent menthyl lactate, the herb-infused oil, water or alcohol including a 1:5 dilution of herbal extracts in a solvent, wherein the herbal extracts are of German 'Chamomile (Matricaria recutita), Valerian (Valeriana officinalis), Ginger (Zingiber officinale Roscoe), Peppermint (Mentha piperita), Feverfew (Tanacetum parthenium), and Lemon Balm (Melissa officinalis).
CN 104490976 discloses itching relieving eczema treatment drug relates to itching relieving pharmaceutical compositions. The compound comfrey itching relieving eczema treatment drug comprises raw materials of, by mass percentage, 0.1% to 5% of comfrey extract, 2% to 22% of medicated oil, 0.5% to 10% of allantoin and 100% of matrix. The medicated oil comprises raw materials of, by mass ratio, 2-3 of menthol, 1-2 of thymol, 0.5-1 of borneol, 1-2.5 of wintergreen oil and 2-5 of

paeonol. The compound comfrey itching relieving eczema treatment drug is prepared by dividing the raw materials into water phases (glycerol, water, sodium hydroxide and potassium hydroxide), oil phases (octadecanol, stearic acid, monoglyceride and vaseline) and medicated oil (menthol, thymol, borneol, wintergreen oil and paeonol), heating the water phases and allantoin in to 60 DEG C to 100 DEG C in a pot with water, heating the oil phases to 60 DEG C to 100 DEG C in a pot with oil, stirring the medicated oil for solving, mixing and stirring the water phases with the oil phases uniformly, adding the medicated oil, mixing and stirring uniformly for emulsification and cooling to room temperature.
None of the prior art disclosed a formulation which can comprehensively used in treating the pain related to sore muscles, joint pain, tennis elbow, lower back pain, sprain, strain, osteoarthritic pain and also in the pain of knee replacement therapy.
OBJECTIVES OF THE INVENTION

The object of the present invention is to provide a stable formulation for pain management.
Another object of the present invention is to provide an ayurvedic or herbal formulation.
Yet another object of the present invention is to provide a stable formulation with no side effects in the long use.
Another object of the present invention is to provide a method of manufacture of the preferred embodiment.
Another object of the present invention is to provide £ stable herbal formulation comprising Comfrey or comfrey-derived compounds, virgin Linseed oil, Oil of wintergreen and pudina satva (menthol).
DETAILED DESCRIPTION OF THE INVENTION
The present invention is related to a surprising synergistic action of the
herbal ingredients with judiciously defined concentration. It is has been
discovered that the formulation provide high efficacy when used in the
management of pain due to various etiologies.

The inventor also discovered that the ingredients of the present formulation does not interact with each other either physically or chemically as identified in the preliminary stability report of the formulation. The amount of ingredients used in the preferred embodiments varies but in most of the painful conditions the preferred concentrations can manage the pain.
Comfrey is a perennial herb of the family Boraginaceae with a black, turnip-like root and large, hairy broad leaves that bears small bell-shaped white, cream, purple or pink flowers. It is native to Europe, growing in damp, grassy places, and is widespread throughout the British Isles on river banks and ditches. Comfrey has long been recognized by both organic gardeners and herbalists for its great usefulness and versatility. Comfrey has been used to treat a wide variety of ailments ranging from bronchial problems, broken bones, and gastric and varicose ulcers.
The comfrey may be a crude comfrey leaf or root product, a comfrey root or leaf extract or any combination thereof.

The comfrey used in the present formulation may be either used as crude or as extract either aqueous or alcoholic. The comfrey of the present invention may be derived from any part of the comfrey plant. These parts include the flowers, leaves, roots, seeds and stems. Preferably, the comfrey is extracted from the leaves and roots of the plant. The comfrey extract may be in the form of a liquid or powder. Further, comfrey used in any form and from any part will be free of pyrrolizidine alkaloids.
Comfrey will be used in the topical.composition in a concentration not lower than 0.5%, preferably the concentration may be in between 2 % to 15 % and more preferably the concentration may be in the range 8% to 12%.
The present invention also encompasses the Comfrey-derived compounds which includes, but • not limited to, allantoin, choline, mucilage, beta-carotene, asparagine, phenolic acid (e.g., rosemarinic acid, chlorogenic acid, caffeic acid and lithospermic acid), rosmaric acid, volatile oil, tannin, a steroidal saponin, a triterpene and vitamin B12.

Virgin linseed oil has been suggested for relief of osteoarthritis, as it is a rich source of PUFAs, in particular alpha-linolenic acid (ALA), an omega-3 fatty acid. It is a rich source of lignans. Lignans are found in plants and have various documented biological properties, including antimitotic, antifungal, and antioxidant properties. Although the use of linseed oil in pain is documented in the prior art but none of the prior art comprises the use of linseed oil along with the comfrey, oil of wintergreen and pudina satva.
The concentration of linseed oil used in the concentration 0.5% to 6%, more preferable 1% to 4%.
Oil of wintergreen helps in fighting pain due to spasms and also due to osteoarthritis and rheumatoid arthritis. This oil fights in two ways. First, it improves the circulation of blood when applied topically to the affected area. This activity brings warmth to the affected area and also helps to clear obstructions in the flow of blood and it does not let toxins like uric acid accumulate at that spot. Secondly, when reaches in the

blood circulation, it increases urination. This speeds up the removal of toxins like uric acid from the body through urination.
Oil of wintergreen, in the present formulation, is in.the concentration between 5% to 15 %, more preferably 8% to 12%.
Menthol is an organic compound made synthetically or obtained from peppermint or other mint oils. The natural form of menthol ((l)-mehthol) exists as one pure stereoisomer and is the preferred form for analgesic effects.
Menthol's ability to chemically trigger the cold-sensitive TRPM8 receptors in the skin is responsible for the well-known cooling sensation that it provokes when inhaled, eaten, or applied to the skin. Menthol has analgesic properties that are mediated through a selective activation of K-opioid receptors. Typically, ice is applied to the skin to create a cold response in order to reduce pain because cold reduces the pain threshold. Menthol creates a chemical action on cold receptors rather than a physical action, resulting in a cold response. Patel and colleagues provide an excellent review of the mechanisms behind

menthol. (Patel T, Ishiuji Y, Yosipovitch G. Menthol: a refreshing look at this ancient compound. J Am Acad Dermatol. 2007; 57(5):873-878.)
Menthol as pudina satva used in the present formulation used in the concentration of 2% to 10 %, more preferably 3% to 5%.
The present invention encompasses all the dosage form used for topical administration such as cream, ointment, gels, lotions, serums, spray and other topical formulations disclosed in the prior art.
The present invention can be formulated, but not limited to, in the following manner:

PROCEDURE:-
1) AQUEOUS PHASE:
• Take 25 Kg of Purified Water and add Sodium Methyl Paraben Stir to get dissolve then add Sodium Propyl Paraben stir to get dissolve.
• Add Comfrey Root Extract in to above solution with continuous stirring for 20 Minutes suspension formed.
21GELPHASE:
• Take Polyethylene Glycol in a SS container heat to about SOX-GOT now add Butylated Hydroxy Toluene stir to get clear solution. Cool the solution to about 30°C.
• Add the Carbomer 940 to above solution with constant stirring to get uniform gel like mass form.

• Transfer the Aqueous phase in to the gel phase with constant stirring.
• Take oil of winter green in another SS vessel and Menthol with constant stirring to get dissolve and transfer to above gel mass with continuous stirring.
• Now add virgin linseed oil to above gel mass and stir to get
• uniform.
• Check the pH of the above bulk and adjust the pH between 5.00 to 7.00 with Triethanolamine.
• Make up the final weight with purified water up to 100 Kg.
• Check the final pH ranges between 5.00 to 7.00.

We Claim:
1) A topical pharmaceutical formulation comprising at least a Comfrey derived compound, Oil of Winter Green, Linseed Oil and Menthol, along with the pharmaceutically acceptable excipients for the management of pain and inflammation.
2) The Comfrey derived compounds as claimed in claim comprises Comfrey root extract, allantoin, choline, mucilage, beta-carotene, asparagine, phenolic acid (e.g., rosemarinic acid, chlorogenic acid, caffeic acid and lithospermic acid), rosmaric acid, volatile oil, tannin, a steroidal saponin, a triterpene and vitamin B12 or the combination thereof.
3) The pharmaceutically acceptable excipients as claimed in claim 1 Gel Base, Preservative, Antioxidant, Solvent, and pH adjuster.
4) Comfrey root extract as claimed in claim 2 is in the range 2% to 15%, preferably 10%.
5) Linseed oil, as claimed in claim 1, used in the concentration 0.5% to 6%, more preferable 1% to 4%.
6) Oil of wintergreen, as claimed in claim 1, is in the concentration between 5% to 15 %, more preferably 8% to 12%.

7) Menthol, as claimed in claim 1, is used in the concentration of 2% to 10%, more preferably 3% to 5%.
8) Process of manufacture a formulation as claimed in claim 1 in the following manner:

S. No. Material Name Label Claim UOM Quantity
Required for
100 Ltr.
1. Comfrey Root Extract 10.0% Kg 10.000
2. Oil of Winter Green 10.0% Kg 10.000
3. Virgin Linseed Oil 3.0% Kg 3.150
4. Menthol 5.0% Kg 5.150
5. Carbomer940 Kg 1.200
6. Sodium Methyl Paraben - Kg 0.100
7. Sodium Propyl Paraben - Kg 0.050
8. Butylated Hydroxy Toluene - Kg 0.100
9. Propylene Glycol - Kg 40.000
10. Triethanolamine - Kg 1.400
11. Purified Water - Kg q.sto 100 Kg

PROCEDURE:-
1) AQUEOUS PHASE:
• Take 25 Kg of Purified Water and add Sodium Methyl Paraben Stir to get dissolve then add Sodium Propyl Paraben stir to get dissolve.
• Add Comfrey Root Extract in to above solution with continuous stirring for 20 Minutes suspension formed.
2\ GELPHASE-.
• Take Polyethylene Glycol in a SS container heat to about 50°C-
60°C now add Butylated Hydroxy Toluene stir to get clear solution.
Cool the solution to about 30°C.
4
• Add the Carbomer 940 to above solution with constant stirring to get uniform gel like mass form.
• Transfer the Aqueous phase in to the gel phase with constant stirring.
• Take oil of winter green in another SS vessel and Menthol with constant stirring to get dissolve and transfer to above gel mass with continuous stirring.
• Now add virgin linseed oil to above gel mass and stir to get uniform.

• Check the pH of the above bulk and adjust the pH between 5.00 to 7.00 with Triethanolamine.
• Make up the final weight with purified water up to 100 Kg.
• Check the final pH ranges between 5.00 to 7.00.