Title of Invention

STABLE HERBAL LOTION

Abstract

The present invention describes stable herbal topical composition comprising volatile oils like Peppermint ka tel (Mentha oil; Oil of Mentha Piperata) 3 to 13 % w/v, Nilgiri ka tel (Eucalyptus oil; Oil of leaves of plant Eucalyptus globulus) 4 to 14 % w/v , Wintergreen oil (Methyl Salicylate or oil extracted from leaves of plant Goultheria Procumbens) 10 to 20 % w/v, Lavang ka tel (Clove bud oil from plant myrtus caryophyllus) 1 to 7 % w/v, Dalchini ka tel (Cinnamon oil; oil of bark of plant Cinnamomum Cassia) 1 to 7 % w/v in an emulsified lotion form. Further, the present invention discloses a process for preparation of synergistic herbal topical composition in pain relief herbal lotion form.

Full Text

FORM 2 THE PATENTS ACT 1970 (39 of 1970) COMPLETE SPECIFICATION [See section 10; rule 13] "Stable Herbal Lotion" (a) M/s. Lyka Labs Limited (b) 77, Nehru Road, Vile Parle (East), Mumbai - 400 099, Maharashtra, India (c) An Indian Company Registered under the Indian Companies Act 1956 The following specification describes the nature of this invention and the manner in which it is to be performed: GRANTED 28-5-2008 Technical Field of the Invention: The present invention relates to a stable herbal topical composition comprises volatile oils like Peppermint ka tel (Mentha oil; Oil of Mentha Piperata), Nilgiri ka tel (Eucalyptus oil; Oil of leaves of plant Eucalyptus globulus), Wintergreen oil (Methyl Salicylate or oil extracted from leaves of plant Goultheria Procumbens), Lavang ka tel (Clove bud oil from plant myrtus caryophyllus), Dalchini ka tel (Cinnamon oil; oil of bark of plant Cinnamomum Cassia) in an emulsified lotion form. Particularly this invention relates to a process for preparation of the synergistic herbal topical composition in lotion form. More particularly, this invention relates to pain relief herbal lotion. Background and Prior Art Plants have been the primary source of medicine for people of every culture throughout the world. Plants that are used as medicines have been referred to as "herbs" for over 4000 years by European and the Mediterranean cultures. There are several types of herbal medicine systems that are used today; European, Native American, Chinese, Ayurvedic and western herbalism are the most prevalent systems. Herbs have been used for centuries to provide for improved health and well-being of entire civilizations. Even today, nearly 50 % of the thousands of drugs commonly used and prescribed are either derived from a plant source or contain a chemical imitation of a plant compound. Aspirin is a chemical imitation of salicin from the bark of the white willow tree. Penicillin is a mold, an organism produced by the fungus, a primitive plant. Although synthetic drugs have certainly performed miracles and saved lives, virtually all of theses drugs have many side effects ranging from the unpleasant to the lethal. Herbs work synergistically with the body and without disturbing the natural balance of the body. Various topical analgesic formulations have been developed with analgesic drugs like aspirin as well as number of non-steroidal anti-inflammatory agents. Safer and effective transdermal analgesic formulations have been always area of research. There are various prior art available on transdermal analgesic formulations, few of them are mentioned below: United State application number US20030012830 discloses topical composition for the treatment of pain comprising by weight percent of the total weight of the composition: about 1 % to about 70 % of a salicylate-based compound; about 1 % to about 70 % acetone, about 1 % to 30 % of an emollient and about 10% to about 50 % menthol. US 6589543 describes herbal ointment for soothing aches and pains includes a mixture of clove oil, ginger oil, wintergreen oil, peppermint oil, ginger root powder, cayenne powder and petroleum jelly. Other US patent US 5882663 discloses method for providing pain relief includes topically applying to skin tissue an effective amount of higher homologs of isoparaffins, ranging from about C12 to C18. Composition of this patented invention includes isoparaffins in a mixture with at least one from group consisting of salicylate, capsaicin, camphor and menthol. Other constituents may be added to form creams and lotions. Pharmaceutical composition for relieving the pain, itch and swelling in the form of powder, liquid or paste is disclosed in US patent number US 2002192304. Further the said composition contains clove oil, peppermint oil, methyl paraben etc. WO02085394 describes the process of preparing the topical anti-inflammatory and analgesic preparation comprising herbal ingredients. The process involves the extraction of herbal ingredients in the solvent; concentrating; filtration of solvent; addition of base oil; removal of solvent by boiling the mixture; resultant extract is allowed to cool; and addition of volatile oils. The process for preparation of compositions comprises individual herb extract or a mixture thereof. Cissus quadragularis (Asthisamhara) and Costus specious (Bramhatirtha) are the essential herbs to provide synergistic compositions. The other herbal ingredients used optionally in the process are Terminalia chebula (Haritaki), Terminali bellerica (Bibhitaka), Emblica officinalis (Amalaki), Melia azadirchta (Nimba), Vitex negundo (Nirgundi), Commiphora mukul (Guggulu). The volatile oils used optinally in the process are Pinus longifolia (Sarala), Camphora officinarum (karpur), Apium graveolens (Ajmoda), Cedrus deodara (Devdaru oil), Eucalyptus globulus (Nilgiri oil), Melaleuca leucadendron (cajuput oil). Corresponding Indian patent for the same is 377/MUM/01. US 6264995 discloses herbal composition reducing inflammation in bones and joints by inhibiting the enzyme cyclooxygenase-2 is prepared from holy basil, turmeric, ginger, green tea, rosemary, huzhang, Chinese goldthread, barberry, oregano and Scutellariae baicalensis. More particularly, the herbal composition of the present invention contains therapeutically effective amounts of the supercritical extracts of ginger, rosemary and oregano, and therapeutically effective amounts of extracts of holy basil, turmeric, green tea, huzhang, Chinese goldthread, barberry, rosemary and Scutellariae baicalensis. The herbal composition can be administered orally, topically or parenterally. Eventhough there are various prior art available on topical analgesic composition but those are the general state of the art and particularly not relevant to the present invention. Claimed volatile oil alone or in combination with each other are available in market either as oils to be applied as it is on the skin of affected part, or as ointments and balm. All these formulations are very oily and give greasy feeling. It is not very easy to wash off. Ointment and balm are thick, not very easily spreadable. Objectives Our main objective is to develop herbal composition comprising a combination of oils in emulsified lotion form which will provide enhanced skin penetration, effective in short time and easy to apply. Summary of the Invention Stable herbal composition in the form of lotion for pain relief wherein the said composition comprises volatile oils like peppermint ka tel (Mentha oil), 3 to 13 % w/v; Nilgiri ka tel, 4 to 14 % w/v; winter green oil, 10 to 20 % w/v; Lavang ka tel, 1 to 7 % w/v, dalchini ka tel, 1 to 7 % w/v with lotion base comprises emulsifier such as anionic surfactants like polysorbate 80, polymeric surfactants like Arlacel P135, fatty alcohols like cetyl alcohol and cetostearyl alcohol, polyglycol ethers like cetomacrogol 1000 either alone or mixture thereof, 1 to 15 % w/v; emollients like Cresmol DH, Arlamol E, humectant like propylene glycol and glycerin 1 to 10 % w/v; thickener / viscosity modifier like Microwax, Magnesium stearate, Xanthun gum, Carboxy methyl cellulose, sodium salt of Carboxy methyl cellulose, Guargum, Hydroxyl propyl methyl cellulose, 0.1 to 8 % w/v; chelating agent like Disodium Edetate, 0.01 to 0.1 % w/v; preservatives such as methyl paraben, propyl paraben, butyl paraben, imidayolidinyl urea, diagolidinyl urea, phenoxy ethanol, citric acid & ethanol, 0.15 to 0.7 % w/v; lubricant like silicone oil, stabilizer like magnesium stearate, magnesium sulphate, 0.5 to 5 % w/v; mineral oil 10 to 20 % w/v and Purified water 40 to 70 % w/v is disclosed herein. Detailed Description The composition of present invention comprises combination of volatile oils in an emulsified lotion form. It contains Peppermint ka tel (Mentha oil; Oil of Mentha Piperata), Nilgiri ka tel (Eucalyptus oil; Oil of leaves of plant Eucalyptus globulus), Wintergreen oil (Methyl Salicylate or Wintergreen oil extracted from leaves of plant Goultheria Procumbens), Lavang ka tel (Clove bud oil from plant myrtus caryophyllus), Dalchini ka tel (Cinnamon oil; oil of bark of plant Cinnamomum Cassia). Such volatile oil alone or in combinations is available in market either as oils to be applied as it is on the skin of affected part, or as ointments and balm but not the claimed composition. All these formulations are very oily and give greasy feeling. It is not very easy to wash off. Ointment and balm is thick, not very easily spreadable. The emulsified lotion form of these volatile oils in combination makes the composition of present invention a unique one. It is water based emulsified thin lotion. It is easy to spread and gives very fast effect. It is non greasy and also easy to wash off giving a cosmetic characteristic to composition. Such compositions provide enhanced skin penetration and achieve therapeutic levels in the target tissues. Lotion being liquid is easily spreadable, thus facilitates massage of painful muscles or joints, acts quickly and relieves pain, reduces swelling by improving blood flow in local area and enables more normal painless functions at work, home and during sports. Such a composition is advantageous with low dermal irritation and skin sensitization. This lotion is recommended in the treatment of chronic arthritis, osteoarthritis of knee joints, frozen shoulder, costo-chondral joint pain, low backache, soft tissue rheumatism and pulled muscles. The present herbal composition comprises volatile oils more particularly Peppermint ka tel 3 to 13 % w/v, Nilgiri ka tel 4 to 14 % w/v, Wintergreen oil 10 to 20 % w/v, Lavang ka tel 1 to 7 % w/v, Dalchini ka tel 1 to 7 % w/v. Further the present formulation is emulsified thin lotion which consist of volatile oil along with pharmaceutically acceptable lotion base such as emulsifiers, humectants, emollient, oil, thickener, preservatives which will help to quickly penetrate into the skin, not impart a greasy feel and effective pain killer in short time. Pharmaceutically acceptable lotion base: Lotion base is oil in water cream composition which is forming base for proposed herbal pain relief lotion. The said lotion base comprises raw materials which are given here. Emulsifier: Emulsions are physically unstable and therefore need to be stabilized. To prevent phase separation or to maintain the droplets on separate entities, emulsifiers or co-emulsifiers are often used in the lotion. These co-emulsifiers prevent the oil phase from coalescing or creaming and keep the emulsion stable; give the formulation its character as lotion by imparting viscosity to the composition The most important criterion in preparing an emulsion is to select suitable emulsifier. This selection is based on the emulsion type (oil/water or water/oil) and further emulsifier must be compatible with oil phase, water phase in the formulation. In this formulation, emulsifier is selected from anionic surfactants like polysorbate 80, polymeric surfactants like Arlacel PI35, fatty alcohols like cetyl alcohol and cetostearyl alcohol, polyglycol ethers like cetomacrogol 1000 or mixture thereof. The emulsifiers are particularly useful in the range of 1 to 15 % w/v, preferably 4 to 10 % w/v. Emollients: Performance of herbal lotion composition would be evaluated in terms of prevention of relief from dryness and ease of spreading. This is achieved by adding emollient into it. In the present invention emollient is selected from silicon oil, cresmol DH, Arlamol E and humectants like propylene glycol and glycerin. Emollients are used in the range of 1 to 10 % w/v, preferably 2 to 5% w/v. Thickener / Viscosity modifier: The oil in water emulsions are generally of thin consistency. The thickeners with low dispersion property as well as minimum neutralization would be selected. In the present invention, the thickeners used are Microwax, Xanthun gum, Magnesium stearate, carboxy methyl cellulose, sodium salt of Carboxy methyl cellulose, Guargum, Hydroxyl propyl methyl cellulose etc. The thickeners are used in the range of 0.1 to 8 % w/v, preferably 0.1 to 3 %. Chelating agent: Disodium edetate is water soluble chelating agent and has the property of surrounding a metal to form very stable complexes that help to keep such metals away in the product. Thus prevents product deterioration, chelating agent are used. In the present invention disodium edetate is used in the range of 0.01 to 0.1 % w/v, preferably 0.05 %. Preservatives: Preservatives are used to retard microbial (bacterial and fungal) contamination in the lotion. High water content makes suitable condition for microbial growth. The preservatives prevent any growth of micro-organisms in the product. The preservatives are selected from methyl paraben, propyl paraben, butyl paraben, imidayolidinyl urea, diagolidinyl urea, phenoxy ethanol, citric acid and ethanol. The preservatives are used in the range of 0.15 % to 0.7 % w/v, preferably 0.15 to 0.22 % w/v. Emulsion stabilizer like magnesium sulphate and magnesium stearate is used in the present invention. It is used in the range of 0.5 to 5 % w/v, preferably 1 % w/v. Magnesium stearate is added in the lotion as the lubricant and thickener also at the end Lubricants like silicone oil in the range 0.1 to 5 % can be used, preferably 0.1 to 2 % w/v. It gives very smooth emollient feel. Mineral oil is used in the range of 10 to 20 % w/v, preferably 15 % w/v. Purified water: The main ingredient of lotion is water which may be upto 50 % or more. The water in the present invention is purified water for pharmaceutical use. In a preferred embodiment of the present invention, the herbal composition comprises to 9% w/v Nilgiri ka tel, 8% w/v Peppermint ka tel, 15% Wintergreen oil; 2% w/v Lavang ka tel; 2% w/v dalchini ka tel. The present invention will now be further illustrated by the following examples. Example 1 Sr.No. Ingredients Percentage 1. Peppermint ka tel 8% w/v 2. Nilgiri ka tel 9% w/v 3. Wintergreen oil 15%w/w 4. Lavang ka tel 2% w/w 5. Dalchini ka tel 2% w/w 6. Polysorbate 80 1% w/v 7. Xanthan Gum 0.1% w/v 8. Propylene Glycol 3.0% w/v 9. Methyl Paraben 0.1% w/v 10. Propyl Paraben 0.05% w/v 11. Disodium Edetate 0.05% w/v 12. Cetomacrogol 1000 6.70% w/v 13. Purified water q.s. to make 100ml Manufacturing process: 1) Xanthan gum is dispersed in about 30ml of purified water with stirring. Allowed it to soak overnight, covered it and kept aside. 2) Next day, Peppermint ka tel, Nilgiri ka tel, Wintergreen oil, Lavang ka tel, Dalchini ka tel and Polysorbate 80 is mixed. This mixture is heated for 60°C. 3) To solution of step 2, added Cetomacrogol 1000 and heated till Cetomacrogol 1000 melts and dissolved in it. 4) Methyl Paraben and Propyl Paraben is mixed in Propylene Glycol and heated it at 60°C. Then added this solution to solution of step 3 with stirring. 5) Xanthan gum and water dispersion (soaked overnight on previous day) is heated to 60°C and added the dispersion to solution of step 4 with stirring. 6) Disodium Edetate is dissolved in purified water and heated to 60°C. This solution is added to solution of step (5) with stirring. 7) The whole solution is homogenized till temperature of bulk reduces to room temperature. 8) The final volume make up is done with purified water and homogenized again. The pH of this lotion is 3.65 Example 2 Sr.No. Ingredients Percentage 1. Peppermint ka tel 8% w/v 2. Nilgiri ka tel 9% w/v 3. Wintergreen oil 15%w/w 4. Lavang ka tel 2% w/w 5. Dalchini ka tel 2% w/w 6. Polysorbate 80 l%w/v 7. Xanthan Gum 0.1% w/v 8. Propylene Glycol 3.0% w/v 9. Methyl Paraben 0.1% w/v 10. Propyl Paraben 0.05% w/v 11. Disodium Edetate 0.05% w/v 12. Cetyl alcohol 3.60% w/v 13. Purified water q.s. to make 100ml Manufacturing process: 1) Xanthan gum is dispersed in about 30ml of purified water with stirring. Allowed it to soak overnight, covered it and kept aside. 2) Next day, Peppermint ka tel, Nilgiri ka tel, Wintergreen oil, Lavang ka tel, Dalchini ka tel and Polysorbate 80 is mixed. This mixture is heated for 60°C. 3) To solution of step 2, added Cetyl alcohol and heated till Cetyl alcohol melts and dissolved in it. 4) Methyl Paraben and Propyl Paraben is mixed in Propylene Glycol and heated it at 60°C. Then added this solution to solution of step 3 with stirring. 5) Xanthan gum and water dispersion (soaked overnight on previous day) is heated to 60°C and the dispersion obtained is added to solution of step 4 with stirring. 6) Disodium Edetate is dissolved in purified water and heated to 60°C. This solution is added to solution of step (5) with stirring. 7) The whole solution is homogenized till temperature of bulk reduces to room temperature. 8) The final volume make up is done with purified water and homogenized again. The pH of this lotion is 3.65 Example 3 Sr.No. Ingredients Percentage 1. Peppermint ka tel 8% w/v 2. Nilgiri ka tel 9% w/v 3. Wintergreen oil 15%w/w 4. Lavang ka tel 2% w/w 5. Dalchini ka tel 2% w/w 6. Polysorbate 80 l%w/v 7. Xanthan Gum 0.1% w/v 8. Propylene Glycol 3.0% w/v 9. Methyl Paraben 0.1% w/v 10. Propyl Paraben 0.05% w/v 11. Disodium Edetate 0.05% w/v 12. Cetostearyl alcohol 3.6% w/v 13. Purified water q.s. to make 100ml Manufacturing process: 1) Xanthan gum is dispersed in about 30ml of purified water with stirring. Allowed it to soak overnight, covered it and kept aside. 2) Next day, Peppermint ka tel, Nilgiri ka tel, Wintergreen oil, Lavang ka tel, Dalchini ka tel and Polysorbate 80 is mixed. This mixture is heated for 60°C. 3) To solution of step 2, added Cetostearyl alcohol and heated till Cetostearyl alcohol melts and dissolved in it. 4) Methyl Paraben and Propyl Paraben is mixed in propylene Glycol and heated it at 60°C. Then added this solution to solution of step 3 with stirring. 5) Xanthan gum and water dispersion (soaked overflight on previous day) is heated to 60°C and added the dispersion to solution of step 4 with stirring. 6) Disodium Edetate is dissolved in purified water and heated to 60°C. Added this solution to solution of step (5) with stirring. 7) The whole solution is homogenized till temperature of bulk reduces to room temperature. 8) The final volume make up is done with purified water and homogenized again. The pH of this lotion is 3.65 Example 4 1 Sr.No. Ingredients Percentage 1. Peppermint ka tel 8% w/v 2. Nilgiri ka tel 9% w/v 3. Wintergreen oil 15%w/w 4. Lavang ka tel 2% w/w 5. Dalchini ka tel 2% w/w 6. Arlacel P 135 4% w/v 7. Cresmol DH 4% w/v 8. Arlamol E 2% w/v 9. Microwax 3% w/v 10. Magnesium stearate 1% w/v 11. Silicon oil 2% w/v 12. Liquid Paraffin 15% w/v 13. Propyl Paraben 0.02% w/v 14. Glycerine 3% w/w 15. > Magnesium Sulphate 0.7% w/v 16. Methyl Paraben 0.2% w/v 17. Purified water q.s. to make 100ml Manufacturing process: 1) Peppermint ka tel, Nilgiri ka tel, Wintergreen oil, Lavang ka tel, Dalchini ka tel is mixed and heated this mixture for 60°C 2) Arlamol P135, Cresmol DH, Arlamol E, Mixrowax, Magnesium Stearate, Silicon Oil, Liquid Paraffin, Propyl Paraben is mixed together and heated this oil phase to 60°C to melt solids and allowed to mix with swirling. 3) Methyl Paraben and Magnesium Sulphate is dissolved in Purified water and heated at 60°C. 4) Water phase of step 3 is mixed into oil phase of step 2 with stirring. Stirring is continued till complete emulsification. 5) Volatile oils of step 1 are added into lotion of step 4 while at 60°C. 6) Stirring is continued till the temperature of the bulk reduces to room temperature. 7) The final volume make up is done with Purified water and homogenized. Stability study is carried out for the claimed herbal composition at accelerated conditions and the results obtained are satisfactory. Stability study of the claimed herbal lotion is carried out at 40° C, 75 % RH for 12 weeks. After the stability study, physical characteristics of the herbal lotion and volatile oils percentage in the herbal lotion are found to be within the acceptable limit. While the present invention is described above in connection with preferred or illustrative embodiments, these embodiments are not intended to be exhaustive or limiting of the invention. Rather, the invention is intended to cover all alternatives, modifications and equivalents included within its scope, as defined by the appended claims. We claim, 1. Stable herbal composition in the form of lotion for pain relief wherein the said composition comprises volatile oils like peppermint ka tel, 3 to 13 % w/v; Nilgiri ka tel, 4 to 14 % w/v; winter green oil, 10 to 20 % w/v; Lavang ka tel 1 to 7 % w/v, dalchini ka tel 1 to 7 % w/v with lotion base comprises emulsifier such as anionic surfactants like polysorbate 80, polymeric surfactants like Arlacel P135, fatty alcohols like cetyl alcohol and cetostearyl alcohol, polyglycol ethers like cetomacrogol 1000 either alone or mixture thereof, 1 to 15 % w/v; emollients like silicon oil, cresmol DH, Arlamol E, humectants like propylene glycol and glycerin 1 to 10 % w/v; thickener / viscosity modifier like Microwax, Magnesium stearate, Xanthun gum, Carboxy methyl cellulose, sodium salt of Carboxy methyl cellulose, Guargum, Hydroxyl propyl methyl cellulose, 0.1 to 8 % w/v; chelating agent like Disodium Edetate, 0.01 to 0.1 % w/v; preservatives such as methyl paraben, propyl paraben, butyl paraben, imidayolidinyl urea, diagolidinyl urea, phenoxy ethanol, citric acid & ethanol, 0.15 to 0.7 % w/v; lubricant like silicone oil, 0.1 to 5 % ; stabilizer like magnesium sulphate, magnesium stearate 0.5 to 5 % w/v; mineral oil 10 to 20 % w/v and Purified water 40 to 70 % w/v. 2. Stable herbal composition as claimed in claim 1 wherein the preferred composition comprises volatile oils like peppermint ka tel (Mentha oil), 8 % w/v; Nilgiri ka tel, 9 % w/v; winter green oil, 15 % w/v; Lavang ka tel 2 % w/v, dalchini ka tel 2 % w/v with lotion base comprises emulsifier such as anionic surfactant like polysorbate 80, polymeric surfactants like Arlacel P135, fatty alcohols like cetyl alcohol and cetostearyl alcohol, polyglycol ethers like cetomacrogol 1000 either alone or mixture thereof, 4 to 10 % w/v; emollients like silicon oil, cresmol DH, Arlamol E, humectants like propylene glycol and glycerin 3 to 5 % w/v; thickener / viscosity modifier like Microwax, Magnesium stearate, Xanthun gum, Carboxy methyl cellulose, sodium salt of Carboxy methyl cellulose, Guargum, Hydroxyl propyl methyl cellulose, 0.1 to 3 % w/v; chelating agent like Disodium Edetate, 0.05 % w/v; preservatives such as methyl paraben, propyl paraben, butyl paraben, imidayolidinyl urea, diagolidinyl urea, phenoxy ethanol, citric acid and ethanol, 0.15 to 0.22 % w/v; lubricant like silicone oil, 0.1 to 2 %; stabilizer like magnesium sulphate, magnesium stearate 1 % w/v; mineral oil 15 % w/v and Purified water 43.9 to 68.92 % w/v. 3. Stable herbal composition as claimed in claim 1 and 2 wherein the said composition comprises Peppermint ka tel, 8% w/v; Nilgiri ka tel, 9% w/v; Wintergreen oil, 15% w/w; Lavang ka tel, 2% w/w; Dalchini ka tel, 2% w/w; Polysorbate 80, 1% w/v; Xanthan Gum, 0.1% w/v; Propylene Glycol, 3.0% w/v; Methyl Paraben, 0.1% w/v; Propyl Paraben, 0.05% w/v; Disodium Edetate, 0.05% w/v; Cetomacrogol 1000, 6.70% w/v and Purified water, q.s. to make 100ml. 4. Stable herbal composition as claimed in claim 1 wherein the said composition comprises Peppermint ka tel, 8% w/v; Nilgiri ka tel, 9% w/v; Wintergreen oil, 15% w/w; Lavang ka tel, 2% w/w; Dalchini ka tel, 2% w/w; Polysorbate 80, 1% w/v; Xanthan Gum, 0.1% w/v; Propylene Glycol, 3.0% w/v; Methyl Paraben, 0.1% w/v; Propyl Paraben, 0.05% w/v; Disodium Edetate, 0.05% w/v; Cetyl alcohol, 3.60% w/v and Purified water, q.s. to make 100ml. 5. Stable herbal composition as claimed in claim 1 wherein the said composition comprises Peppermint ka tel, 8% w/v; Nilgiri ka tel, 9% w/v; Wintergreen oil, 15% w/w; Lavang ka tel, 2% w/w; Dalchini ka tel, 2% w/w; Polysorbate 80, 1% w/v; Xanthan Gum, 0.1% w/v; Propylene Glycol, 3.0% w/v; Methyl Paraben, 0.1% w/v; Propyl Paraben, 0.05% w/v; Disodium Edetate, 0.05% w/v; Cetostearyl alcohol, 3.6% w/v and Purified water, q.s. to make 100ml. 6. Stable herbal composition as claimed in claim 1 wherein the said composition comprises Peppermint ka tel, 8% w/v; Nilgiri ka tel, 9% w/v; Wintergreen oil, 15% w/w; Lavang ka tel, 2% w/w; Dalchini ka tel, 2% w/w; Arlacel P 135, 4% w/v; Cresmol DH, 4% w/v; Arlamol E, 2% w/v; Microwax, 3% w/v; Magnesium stearate, 1% w/v; Silicon oil, 2% w/v; Liquid Paraffin, 15% w/v; Propyl Paraben, 0.02% w/v; Glycerine, 3% w/w; Magnesium Sulphate, 0.7% w/v; Methyl Paraben, 0.2% w/v and Purified water, q.s. to make 100ml. 7. A process for preparing a stable herbal lotion according to any of claims 1 to 7, which comprises following steps; a. dispersing Xanthan gum in about 30ml of purified water with stirring and allowing it to soak overnight, by covering it and keeping aside; b. mixing Peppermint ka tel, Nilgiri ka tel, Wintergreen oil, Lavang ka tel, Dalchini ka tel and Polysorbate 80, followed by heating upto 60°C; c. adding Cetomacrogol 1000 optionally Cetyl alcohol optioanlly Cetostearyl alcohol to solution of step (b), and heating till Cetomacrogol 1000 or Cetyl alcohol or Cetostearyl alcohol melts and dissolves in it; d. mixing Methyl Paraben and Propyl Paraben in Propylene Glycol and heating it at 60°C and then adding this solution to solution of step (c) with stirring; e. heating Xanthan gum and water dispersion (soaked overnight on previous day) to 60°C and adding the dispersion to solution of step (d) with stirring; f. dissolving Disodium Edetate in purified water and heating to 60°C and adding this solution to solution of step (e) with stirring; g. homogenizing whole solution till temperature of bulk reduces to room temperature; h. making up final volume with purified water and homogenizing it again and making the pH of this lotion at 3.65; Or a. mixing Peppermint ka tel, Nilgiri ka tel, Wintergreen oil, Lavang ka tel, Dalchini ka tel and heating this mixture for 60°C; b. mixing Arlamol PI35, Cresmol DH, Arlamol E, Mixrowax, Magnesium Stearate, Silicon Oil, Liquid Paraffin, Propyl Paraben together and heating this oil phase to 60°C to melt solids and allowing to mix with swirling; c. dissolving Methyl Paraben and Magnesium Sulphate in Purified water and heating at 60°C; d. mixing water phase of step (c) into oil phase of step (b) with stirring and stirring is continued till complete emulsification; e. adding volatile oils of step (a) into lotion of step (d) while at 60°C; f. continuing stirring till the temperature of the bulk reduces to room temperature; g. making up the final volume with purified water and homogenizing it. 8. Stable herbal composition in the form of lotion for pain relief as substantially described herein with reference to foregoing examples 1 to 4. Dated this 10th day of May 2004 Dr. Gopakumar G. Nair Agent for the Applicant

Documents:

538-mum-2004-abstract(28-05-2008).doc

538-mum-2004-abstract(28-05-2008).pdf

538-mum-2004-abstract.doc

538-mum-2004-abstract.pdf

538-mum-2004-cancelled pages(28-05-2008).pdf

538-mum-2004-claims(granted)-(28-05-2008).doc

538-mum-2004-claims(granted)-(28-05-2008).pdf

538-mum-2004-claims.doc

538-mum-2004-claims.pdf

538-mum-2004-correspondence(28-05-2008).pdf

538-mum-2004-correspondence(ipo)-(29-07-2008).pdf

538-mum-2004-correspondence-received-041206.pdf

538-mum-2004-correspondence-received-250504.pdf

538-mum-2004-correspondence-received.pdf

538-mum-2004-descripiton (complete).pdf

538-mum-2004-description (provisonal).pdf

538-mum-2004-form 1(10-05-2004).pdf

538-mum-2004-form 1(25-05-2004).pdf

538-mum-2004-form 18(05-12-2006).pdf

538-mum-2004-form 2(granted)-(28-05-2008).doc

538-mum-2004-form 2(granted)-(28-05-2008).pdf

538-mum-2004-form 26(25-05-2004).pdf

538-mum-2004-form 3(10-05-2004).pdf

538-mum-2004-form 3(28-05-2008).pdf

538-mum-2004-form-1.pdf

538-mum-2004-form-18.pdf

538-mum-2004-form-2.doc

538-mum-2004-form-2.pdf

538-mum-2004-form-26.pdf

538-mum-2004-form-3.pdf