Title of Invention

A HERBAL COMPOSITION FOR TREATMENT OF ORAL SUB MUCOUS FIBROSIS(OSMF)

Abstract

The present invention discloses phyto composition for the treatment of oral sub mucous fibrosis (OSMF)comprises Ellettaria cardamomum, Cinamomum camphora, Occimum sanctum, Cinamomum zeylonica, Glycerrhiza glabra, Syzygium aromaticum, Mentha arvensis and Curcuma longa. Different types of formulations available are suspension, spray, oil, Mouth wash, Paste, Chewing gum, Gel, Lotion, Tablet, Candy and Boiled drops. These formulations have no side effects or no habit forming characteristics are noticed, easy to use, cost effective, highly effective and long lasting and permanent cure of OSMF.

Full Text

FORM 2 THE PATENT ACT 1970 (39 of 1970) & The Patents Rules, 2003 COMPLETE SPECIFICATION (See section 10 and rule 13) 1. TITLE OF THE INVENTION PHYTO COMPOSITION FOR TREATMENT OF ORAL SUB MUCOUS FIBROSIS (OSMF) 2. APPLICANT (S) (a) NAME: Bakshi Kandarpkumar Janubhai (b) NATIONALITY: an Indian (c) ADDRESS: 11-1 Bimanagar, Satellite Road, Ahmedabad-380 015. Gujarat, India. 3. PREMABLE TO THE DESCRIPTION PROVISIONAL The following specification describes the invention. COMPLETE The following specification particularly describes the invention and the manner in which it is to be performed. The present invention relates to phyto composition for the treatment of oral sub mucous fibrosis (OSMF). This composition is very least expensive compared to any other prevailing treatments. Prior Art: Oral sub mucous fibrosis (OSMF) is an insidious chronic disease affecting any part of the oral cavity and sometime the pharynx. Although occasionally preceded by and/or associated with vesicle formation. It is associated with a juxta-epithelial inflammatory reaction followed by a fibro-elastic change of the lamina propria, with epithelial atrophy leading to stiffness of the oral mucosa and causing trismus and inability to eat. Aetiology: - 1. Dietary Component Vitamin-B deficiency Protein Deficiency 2. Food habit --------► Spicy, hot food (prepared with excessive,use of chilies, pepper) 3. Other habits ► Tobacco, Ghutka, Pan- Masala, Snuff, Quid etc. 2 Experimentally, aeroline, a derivative of areca, can induce fibroblast proliferation and collagen synthesis. There is significant association between areca nut consumption and oral sub mucous fibrosis. Clinical Features: Clinically, symmetrical fibrosis of such sites as the buccal mucosa, soft palate or inner aspects of lips is characteristic. The overlying mucousa may be normal or there may be a vesiculating stomatitis. Oral Sub Mucous fibrosis typically affects the buccal mucosa, lips, retro molar areas and the soft palate. Occasional involvement of the pharynx and esophagus is seen. Early lesions present as a blanching of the mucousa, imparting a mottled, marble-like appearance. Later lesions demonstrate palpable fibrous bands running vertically in the buccal mucousa and in a circular fashion around the mouth opening or lips. As the disease progresses the mucousa becomes so stiff that it cannot be indented with fingers, causing difficulty in eating and considerably restricting the patient's ability to open the mouth (trismus). If the tongue is involved, it becomes stiff and has a diminished size. Mucosal petechiae are seen in more than 10% of cases and most patients of a burning sensation, often aggravated by spicy foods, Salivary 3 flow is diminished and blotchy melanotic mucosal pigmentation is often seen. More than a fourth of affected persons develop precancerous, leukoplakia of one or more oral surfaces. Once present, oral sub mucous fibrosis (OSMF) does not regress, either spontaneously or with cessation of betel quid chewing. OSMF by itself is not carcinogenic but it makes the skin of the mouth prone to cancer. Patients with OSMF must therefore maintain diligent oral hygiene and get a thorough oral examination done at regular intervals at a competent facility. Research has shown that about 5 to 6 percent of cases of OSMF will progress into full-fledged oral cancer. Cure of OSMF was considered near impossible. Most of the available treatments were offering symptomatic relief for short time. On top of it, they are quite expensive. These treatments needed medical supervision or some are to be performed by medical professionals. These treatments are having their limitations and side effects. US2006247159 disclosed methods of treating humans or animals having various diseases like dry mouth syndrome, verruciform xanthoma, achlorhydria, mucous cysts, oral submucous fibrosis, oral nevi, cancer of the oral mucosa, maloplakia of the genito-urinary tract, vulvovaginitis, 4 helicobacter pylori infection, duodenal ulcers, peptic ulcers, conditions affecting the uterus and appendicitis by administering a cyclosporine component. Some efforts have also been done to treat different kind of fibrosis from the plant-derived medicine. CN1742939 disclosed composition for effectively curing pulmonary intestinal fibrosis and its preparation method. It is made from 8 Chinese medicinal materials of Scutellaria root, lonicera flower, salvia root, astragalus root, Chinese angelica root and others. WO/2003/084555 disclosed compositions for inhibiting fibrosis. It is intended to provide compositions usable in treating, preventing or ameliorating diseases caused by tissue fibrosis such as nephritis. Namely, compositions for inhibiting fibrosis or foods for inhibiting fibrosis which contain at least one member selected from among Acacia concinna (Willd.) DC, Acacia leucophloea Willd., plants belonging to the genera Stryphnodendron, Anacardium, Ocotea and Cedrella, press juices of these plants and extracts of these plants. Other treatments currently advised by modern medical science are as follows: 5 1. Multivitamin and anti-oxidant Supplementation. 2. Intra-lesional Injections of Steroids into the hard tissue. 3. Excision and Skin Grafting. 4. Surgical removal of hardened bands. 5. Tongue in Cheek (Tongue Flap) and Nasolabial Flap Surgery. 6. Physical Therapy - Electromyography, Spray &* Scratch Exercise, Friction Massage, Transcutaneous Electrical Nerve Stimulation, topical steroidal cream and jelly for local application. All of the above treatments are quite costly and success rate is doubtful in many of above-mentioned treatments. Object of the invention: It has already been proposed that most of the treatment offering symptomatic relief for short time, very expensive and needed medical supervision. So there is a need of the treatment, which can over come such and similar problems. The principal object of this invention is to provide long lasting and permanent cure of oral sub mucous fibrosis (OSMF.). Another object of this invention is no side effects or habit forming. 6 Detail Description: The main object of the present invention is to prepare a phyto composition for the treatment of oral sub mucous fibrosis (OSMF). In the present invention essential oils of Ellettaria cardamomum (Cardamom), Cinamomum camphora (Camphor), Occimum sanctum (Basil), Cinamomum zeylonica (Cinnamon), Glycerrhiza glabra (Liquorice), Syzygium aromaticum (Clove), Mentha arvensis (Spearmint), Curcuma longa (Turmeric) and Excipients in quantity sufficient are used. Cardamom consists of the dried ripe fruits of Elettaria cardamomum Cardamom seeds contain volatile oil to the extent of 2% to 8%. The active constituent of the volatile oil is cineole, terpineol, borneol, terpinene, etc. The other constituents of the cardamon seeds are fixed oil, starch and proteins. It is used as an aromatic, a carminative and stimulant. It is also good flavouring agent and sued in the form of compound tincture. (Kokate, C. K., Purohit, A. P., Gokhale, S. B., Pharmacognosy, Editon 2000, Nirali Prakashan, Chapter 11: Terpenoids. Page no. 3,19-321) Camphor oil is obtained form the wood of Cinnamomum camphora (Nees and Eberm), belonging to family Lauraceae by steam distillation at 80 to 100 psi pressure. It mainly contains safrole, acetaldehyde, dipentent, 7 camphor eugenol, d-pinene, eucalyptol, phellandrene and cineole. The active alkaloids are cinnamic aldehyde and piperitone-N. This oil is used as antiseptic, deodorant, demulcent, analgestic and muscle relaxant agent. (Kokate, C. K., Purohit, A. P., Gokhale, S. B., Pharmacognosy, Editon 2000, Nirali Prakashan, Chapter 11: Terpenoids. Page no. 307) Tulsi's (Occimum sanctum) extracts are used in ayurvedic remedies for common colds, headaches, stomach disorders, inflammation, heart disease, various forms of poisoning, and malaria. The active alkaloids present in Ocimum sanctum are Phenolic acids, Flavanoides, Glycocides, Linolols, Eugenol, Cineol, Methyl Cinnamate. (Kokate, C. K., Purohit, A. P., Gokhale, S. B., Pharmacognosy, Editon 2000, Nirali Brakashan, Chapter 11: Terpenoids. Page no. 340-341). It is used as deodorant, stimulant, astingent, oedema reliever, analgesic and haemostatic agent. Cinnamon consists of the dried inner bark of the shoots of coppiced trees of Cinnamomum zeylanicum belonging" to family Lauraceae. Cinnamon oil contains 60-70% of cinnamaldehyde, 5-10% eugenol, benzaldehyde cuminaldehyde and other terpenes like phellandrene, pinene, cymene, caryophyllene etc. Cinnamon oil is yellow to red in colour with sp. gr. 1.00 to 1.030; optical rotation 0 -2 and refractive index 1.562-1.582°. 8 (Kokate, C. K., Purohit, A. P., Gokhale, S. B., Pharmacognosy, Editon 2000, Nirali Prakashan, Chapter 11: Terpenoids. Page no. 334-336) Active alkaloids present in cinnamon are cinnamic acid, methyl chaviclol and gamma-terpine. It is used as anti-carcinogenic, antiseptic, astringent and stimulant agent. Liquorice consists of dried, peeled or unpeeled, root and stolon of Glycyrrhiza glabra. The chief constituent of liquorice is a triterpenoid saponin known as glycyrrhizin (glycyrrhizic acid), which is a potassium and calcium salt of glycyrrhizinic acid. (Kokate, C. K., Purohit, A. P., Gokhale, S. B-, Pharmacognosy, Editon 2000, Nirali Prakashan, Chapter 8: Drugs Containing Glycosides Page no. 210) Other active alkaloids are isoliquiritagenin, glabridin, dicouryl coumarin and liquoricidin. It acts as demulcent, refrigerant, nervine, stimulant, emollient, and analgesic agent. Clove consists of dried flower buds of Syzygium aromaticum having synonym Eugenia caryophyllus, family Myrtaceae. Clove contains about 15 to 20 % volatile oil, 10% to 13% of tannin (gallotannic acid), resin, chromone and eugenin. Oil of clove is colourless to pale yellow in colour. It has specific gravity of 1.038 - 1.06, refractive index of 1.527 to 1.535 and it boils at 250° C. Clove is used as a dental analgesic, carminative, 9 stimulant, flavouring agent, an aromatic and antiseptic. The oil is used in perfumery and also in the manufacture of vanillin. (Kokate, C. K., Purohit, A. P., Gokhale, S. B., Pharmacognosy, Editon 2000, Nirali Prakashan, Chapter 11: Terpenoids. Page no. 365-368) * Spearmint consists of dried leaves and flowering tops of the plant known as Mentha arvensis belonging to family Labiatae. It contains mainly volatile oil about 0.5 to 1.0% resin and tannins. Spearmint oil is obtained by steam distillation of the herb and is. yellowish in colour and having characteristic aromatic taste of mint. Spearmint oil has specific gravity 0.930 to 0.940, optical rotation 48° to 59° and refractive index 1.4820 to 1.4900. (Kokate, C. K., Purohit, A. P., Gokhale, S. B., Pharmacognosy, Editon 2000, Nirali Prakashan, Chapter 11: Terpenoids. Page no. 317-318) The active alkaloids present in spearmint oil are rutin, gallic acid and menthol. This oil has germicidal and antispasmodic effect. Turmeric consists of dried as well as fresh rhizomes of the plant Curcuma longa belonging to family Zingiberaceae. Turmeric contains about 5% of volatile oil, resin, abundant zingiberaceous starch grains and yellow colouring substances known as cucuminoids. The chief component of curcuminoids is known as curcumin (50-60%). Curcumin and other 10 related curcuminoids are reported to be responsible for the yellow colour in some species. Volatile oil content ranges from 1 to 6.5% and composed of mono and sesquiterpenes such as a and p pinene, a-phellandrene, camphor, camphene, zingiberence and a, p curcumenes. Apart from traditional uses, curcumin has been proved as anti-inflammatory drug. Antiarthritic agent has been also isolated from C. acromatica. (Kokate, C. K., Purohit, A. P., Gokhale, S. B., Pharmacognosy, Editon 2000, Nirali Prakashan, Chapter 11: Terpenoids. Page no. 389-391) In the present invention Ellettaria cardamomum 1.0 - 60.0%, Cinamomum camphora 1.0 - 60.0%, Occimum sanctum 1.0 - 60.0 %, Cinamomum zeylonica 1.0 - 80.0 %, Glycerrhiza glabra 1.0 - 60.0 %, Syzygium aromaticum 1.0 - 80.0 %, Mentha arvensis 1.0 - 60.0 % * Excipients in quantity sufficient is used. More preferably Ellettaria cardamomum 10-15%, Cinamomum camphora 10-15%, Occimum sanctum 10-15%, Cinamomum zeylonica 10-15%, Glycerrhiza glabra 10-15%, Syzygium aromaticum 10-15%, Mentha arvensis 10-15%, is used. Instead of Ellettaria cardamomum ethanol extract, oil or Oleoresin of Curcuma longa can be used. 11 Different types of dosages are invented such like Suspension, Spray, Oil, Mouth wash, Paste, Chewing gum, Gel, Lotion, Tablet, Candy and Boiled drops. The invention is illustrated more in detail in the following examples. The examples describe and demonstrate embodiments within the scope of the present invention. These examples are given solely for the purpose of illustration and are not to be construed as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope. Example 1: Process of formulating Suspension/ Spray /Mouth wash 1. All oils are mixed in a sterile stainless steel vessel. 2. Organic food grade emulsifier is added to the mass of pre-mix of oils ingredients kept in sterile stainless steel vessel. 3. Mixture of Oils and emulsifier is agitated for pre-defined time under normal temperature and pressure. 4. Quantity sufficient DM and ionized water is added to pre-agitated pre-mix of oil and emulsifier and agitated for 15 - 30 minutes. 5. The emulsion / solution is kept 24 - 48 hours for cooling and filtered and packed. 12 Example 2: Process of formulating Oil 1. All oils are mixed in a sterile stainless steel vessel. 2. Quantity sufficient organic food grade emulsifier is added to the mass of pre-mix of various oil ingredients kept in sterile stainless steel vessel. 3. Mixture of Oils and emulsifier is agitated for 15-30 minutes under normal temperature and pressure. 4. The mixture is kept for cooling for 24 - 48 hours and filtered and packed. Example 3: Process of formulating Gel / Lotion 1. Melt the PEG 400 and PEG 3350 on a hot plate. 2. Warm the mixture to about 65°C. 3. Remove from the hot plate and stir until congealed. 4. Add all oils to this mixture very slowly with turbulent mixing at Approx. 1300 RPM and bring the temperature to 70°C. 5. Continue mixing with same speed, until homogenous. 6. Mix Ca(OH)2, Copper gluconate, Glycerin, Sorbitol solution, Sodium Saccharin (soluble), Methyl p-hydroxy benzoate, Sodium 13 alginate, Flavor, Food grade colour in D.M. & ionized water and add this mixture to homogenous mixture prepared in step 5. 7. Continue mixing for 10-30 minutes at the same speed till desired gel is formed. 8. The gel is then subjected to more stirring till desired consistency and clarity is obtained. Example 4: Process for preparation of Chewing Gum 1. The gum base are melted together and filtered. 2. Ingredient oils, powdered sugar, glucose syrup and flavoring agent are slowly added to the gum base until the warm mix thickens like dough. 3. Dough prepared in step 2 is blend to make it smooth and form the gum. 4. The gum is cut or molded into the appropriate shape; it is lightly sprinkled with powdered sweetener to keep it from sticking to machinery or packaging. 6. The gum is cooled for up to 48 hours to properly set. 14 7. For Candy coated gum, gum is sprayed with liquid sweetener allowed to dry and then sprayed again. This process is repeated several times until the candy shell reaches the proper thickness. 8. High speed machines carefully wrap and package the gum in airtight wrappers. Example 5: Process for preparation of Candy / Tablets / Boiled drop 1. Candies are prepared by mixing oils, Corn Syrup, Ca(OH)2, Copper gluconate, Flavor, sugar in water to form syrup. 2. Boil it until it starts to caramelize. 3. Depending on the solvent and the end result of the process, the product may be called candy, caramel, toffee, fudge, praline, tablet or taffy. Example 6: Process for preparation of Paste: 1. Mixture of oils, glycerin, flavoring agent (peppermint, wintergreen, anise, cinnamon or such like) and food colors are used. 2. Mix the ingredients thoroughly in a bowl. 3. Add quantity sufficient water to make the concoction "tooth-pasty". 15 The advantages of these dosages are as follows: 1. No side effects or habit forming are noticed. 2. Very easy to use. 3. Very short time to get rid of major symptoms. 4. Long lasting and permanent cure 5. Least expensive if compared to modern treatment. 6. Patients suffering from OSMF for more than 10-15 years have been treated successfully. 16 We Claim: 1. Phyto composition for the treatment of oral sub mucous fibrosis (OSMF) comprises Ellettaria cardamomum 1.0 - 60.0%, Cinamomwn camphora 1.0 - 60.0%, Occimum sanctum 1.0 - 60.0 %, Cinamomwn zeylonica 1.0 - 80.0 %, Glycerrhiza glabra 1.0 -60.0 %, Syzygium aromaticum 1.0 - 80.0 %, Mentha arvensis 1.0 -60.0 % Excipients in quantity sufficient. 2. Phyto composition for the treatment of oral sub mucous fibrosis (OSMF) as claimed in claim 1 wherein more preferably Ellettaria cardamomum 10-15 %, Cinamomum camphora 10-15 %, Occimum sanctum 10-15 '%, Cinamomum zeylonica 10-15 %, Glycerrhiza glabra 10-15 %, Syzygium aromaticum 10-15 %, Mentha arvensis 10-15% are used. 3. Phyto composition for the treatment of oral sub mucous fibrosis as claimed in claim 1 and claim 2wherein instead of Ellettaria cardamomum Curcuma longa is used. 4. Phyto composition for the treatment of oral sub mucous fibrosis as claimed in claim 3 wherein Ethanol extract, oil or Oleoresin of Curcuma longa is used. 17 5. Phyto composition for the treatment of oral sub mucous fibrosis as claimed in claim 1 wherein composition is in form of Suspension, Spray, Oil, Mouth wash, Paste, Chewing gum, Gel, Lotion, Tablet, Candy and Boiled drops 6. A process for preparation of phyto composition for the treatment of oral sub mucous fibrosis (OSMF) in form of Suspension/Spray/Mouth wash comprising following steps: (a) mixing all oils in a sterile stainless steel vessel; (b) adding organic food grade emulsifier to the mass of pre-mix of oils ingredients; (c) agitating under normal temperature and pressure; (d) adding quantity sufficient DM and ionized water and agitating for 15 minutes; (e) keeping it 24 hours for cooling then filtering and packing. 7. A process for preparation of phyto composition for the treatment of oral sub mucous fibrosis in form of oil comprising following steps: (a) mixing of all oils in a sterile stainless steel vessel; 18 (b) adding quantity sufficient organic food grade emulsifier and agitating for 30 minutes under normal temperature and pressure; (c) keeping for cooling for 24 hours, filtering and packing. 8. A process for preparation of phyto composition for the treatment of oral sub mucous fibrosis in form of gel / lotion comprising following steps: (a) melting the PEG 400 and PEG 3350 on a hot plate and warming up to 65°C; (b) removing from the hot plate and stirring until congealed; (c) adding all oils to this mixture very slowly with turbulent mixing at Approx. 1300 RPM, bring the temperature to 70°C and continue mixing until it gets homogenous; (d) mixing Ca(OH)2, Copper gluconate, Glycerin, Sorbitol solution, Sodium Saccharin (soluble), Methyl p-hydroxy benzoate, Sodium alginate, Flavor, Food grade color in D.M. & ionized water and adding this mixture to homogenous mixture prepared in step (c). (e) mixing for 10-30 minutes at the same speed till gel is formed. 19 9. A process for preparation of phyto composition for the treatment of oral sub mucous fibrosis in form of chewing gum comprising following steps: (a) melting and filtering gum; (b) mixing oils, powdered sugar, glucose syrup and flavoring to the gum base until the warm mix thickens like dough and bending to make it smooth; (c) cutting or molding gum molded into the appropriate shape; sprinkling with powdered sweetener coated gum or for coated gum spraying with liquid sweetener and cooing for up to 48 hours; 10. A process for preparation of phyto composition for the treatment of oral sub mucous fibrosis in form of candy / tablets / boiled drop comprising following steps: (a) mixing oils, Corn Syrup, Ca(OH)2, Copper gluconate, Flavor, sugar in water to form syrup; (b) boiling it until it starts to caramelize. (c) boiling it at different level to gives different types of forms like candy, tablet, boiled drops etc. 20 11. A process for preparation of phyto composition for the treatment of oral sub mucous fibrosis in form of paste comprising following steps: (a) mixing all oils, glycerin, flavoring agent (peppermint, wintergreen, anise, cinnamon or whatever) and food colour in a bowl; (b) adding quantity sufficient water to make the concoction tooth-pasty. 12. Phyto composition for the treatment of oral sub mucous fibrosis and method for preparation thereof as substantially herein describes with foregoing description and examples. Dated this 10th day of January 2007. 21 Nilam K. Gadani Patent Agent For & on behalf of the Applicant ABSTRACT The present invention discloses phyto composition for the treatment of oral sub mucous fibrosis (OSMF) comprises Ellettaria cardamomum, Cinamomum camphora, Occimum sanctum, Cinamomum zeyionica, Glycerrhiza glabra, Syzygium aromaticum, Mentha arvensis and Curcuma longa. Different types of formulations available are Suspension, Spray, Oil, Mouth wash, Paste, Chewing gum, Gel, Lotion, Tablet, Candy and Boiled drops. These formulations have no side effects or no habit forming characteristics are noticed, easy to use, cost effective, highly effective and long lasting and permanent cure of OSMF.

Documents:

53-mum-2007-abstract(11-09-2007).doc

53-mum-2007-abstract(11-09-2007).pdf

53-MUM-2007-ABSTRACT(11-1-2007).pdf

53-MUM-2007-ABSTRACT(AMENDED)-(11-9-2007).pdf

53-MUM-2007-ABSTRACT(GRANTED)-(20-11-2008).pdf

53-mum-2007-abstract.doc

53-mum-2007-abstract.pdf

53-mum-2007-cancelled pages(11-09-2007).pdf

53-MUM-2007-CLAIMS(11-1-2007).pdf

53-mum-2007-claims(granted)-(11-09-2007).doc

53-mum-2007-claims(granted)-(11-09-2007).pdf

53-MUM-2007-CLAIMS(GRANTED)-(20-11-2008).pdf

53-mum-2007-claims.doc

53-mum-2007-claims.pdf

53-mum-2007-correspondence(11-09-2007).pdf

53-mum-2007-correspondence(ipo)-(16-10-2007).pdf

53-MUM-2007-CORRESPONDENCE(IPO)-(27-1-2009).pdf

53-mum-2007-description (complete).pdf

53-MUM-2007-DESCRIPTION(COMPLETE)-(11-1-2007).pdf

53-MUM-2007-DESCRIPTION(GRANTED)-(20-11-2008).pdf

53-mum-2007-form 1(11-01-2007).pdf

53-mum-2007-form 18(07-12-2007).pdf

53-MUM-2007-FORM 2(COMPLETE)-(11-1-2007).pdf

53-mum-2007-form 2(granted)-(11-09-2007).doc

53-mum-2007-form 2(granted)-(11-09-2007).pdf

53-MUM-2007-FORM 2(GRANTED)-(20-11-2008).pdf

53-MUM-2007-FORM 2(TITLE PAGE)-(11-1-2007).pdf

53-MUM-2007-FORM 2(TITLE PAGE)-(GRANTED)-(20-11-2008).pdf

53-mum-2007-form 26(10-01-2007).pdf

53-mum-2007-form 3(10-01-2007).pdf

53-MUM-2007-FORM 3(11-1-2007).pdf

53-mum-2007-form 5(10-01-2007).pdf

53-MUM-2007-FORM 5(11-1-2007).pdf

53-mum-2007-form 9(18-01-2007).pdf

53-mum-2007-form-1.pdf

53-mum-2007-form-2.pdf

53-MUM-2007-MARKED COPY(11-1-2007).pdf

53-MUM-2007-MARKED COPY(11-9-2007).pdf

53-MUM-2007-SPECIFICATION(AMENDED)-(11-9-2007).pdf