Title of Invention

A COMPOSITION FOR THE TREATMENT OF BURNS, CUFS AND LIKE WOUNDS

Abstract

Compositions and a method for the fast healing of wounds, lesions, bed sores fissures, burns, cuts, ulcers and the alike are disclosed. The herbal based compositions are in the foam of creams, lotions, gels ointments or the like which when applied topically with the components in the concentrations combine ssp. and extracts of shore ssp., Azedarach ssp. , Celastrus ssp., Pongamlia ssp. pogamia ssp. an zinc ash and a carrier base with extracts dispersed therein. he compositions can also includes the optional components like Glycyrrhizin ssp., Focus ssp., Red chalk, Alum borax pterocarpous ssp., which all of them together of any one of them if included will increase the efficacy of the compositions.

Full Text

FORM 2 THE PATENTS ACT, 1970 (39 of 1970) COMPLETE SPECIFICATION (See Section 10) A COMPOSITION FOR THE TREATMENT OF BURNS, CUFS AND LIKE WOUNDS M/S. CIPLA LIMITED, MUMBAI CENTRAL, MUMBAI-400 008, MAHARASHTRA, India, an Indian Company incorporated under the Companies Act, 1956. The following specification particularly describes and ascertains the nature of this invention, and the manner in which it is to be performed. _ . This invention relates to a medical composition and the use thereof. More, particularly, it relates to a herbal anti-bacterial composition preferably in the form of a cream for effective treatment of wounds, lesions, bed sores, fissures, burns/scalds/cuts/abrasions, cracks on feet and hands, carbuncles, sunburn blisters, ulcers, skin infections such as urticaria eczema, scabies and the like. Many compositions are available for the treatment of wounds, lesions, bed sores, fissures, burns/scalds/cuts/abrasions cracks on feet and hands, carbuncles, sunburn blisters, ulcers, skin infections such as urticaria eczema, scabies, and the like. Moreover, regardless of whether prior art compositions were formed entirely of herbal medicines, entirely of pharmaceutical medicines, or of a combination of both, results with various patients have been mixed at best. The composition of the present invention, and it"s method of use, has provided significantly fast healing of wounds, lesions, bed sores, fissures, burns, cuts, ulcers and the like in a substantial number of patients in tests. The invention also provides an anti-bacterial herbal composition which is easy to use, which is soft, smooth and gives soothing and cooling effect, which possesses analgesic, antiinflammatory, antibacterial and antifungal activities, which prevents and fights infection and promotes fast healing and there remains no scar mark of the burn, cut or the like. The herbal-based composition has a unique formula, combining various herbal and mineral ingredients. It includes five components which, while all previously known, are not known to have ever before combined together as described herein, and which are here present in concentrations and ratios which provide surprisingly effective results and hence is the "preferred" composition. Besides, it can also include certain optional components, which, all of them together or any one of them, if added will increase the efficacy of the composition. In a broad embodiment, the compositions of this invention for topical application for the fast healing of wounds, lesions, bed sores, fissures, burns, cuts, ulcers and like comprises in percentages by weight, the following:- (a) Shorea ssp in a concentration range of 0.3% - 20% (b) Azadirachta ssp in a concentration range of 0.25% - 20% (c) Celastrus ssp in a concentration range of 0.3% - 20% (d) Pongamia ssp in a concentration range of 0.25% - 20% (e) Zinc ash in a concentration range of 0.15% - 20% 1 In other embodiments, the various components include respectively oils. extracted from Shorea robusta, Azadirachta indica, Celastrus paniculatus and Pongamia pinnata. In other embodiments, the following herbal components can also be added, preferably, Glycyrrhiza glabra 0.5%-20%, Ficus infectoria 0.5%-20%, Red Chalk 10%-30%, Alum 1%-15%, Borax 1%-15%, Pterocarpus Santalinus 2%-20%. These are optional, which, all of them together or anyone of them, if added, will increase the efficacy of the composition. Jn yet another broad embodiment, the invention also includes a method for fast healing of wounds, lesions, bed sores, fissures, burns, cuts, ulcers and like which comprises topical application of the composition smoothly and liberally over the cleaned affected area, twice or thrice a day and covered with sterile bandage, if desired. Other embodiments of the compositions of the invention and other aspects of the methods of invention will be described below or will be evident to those skilled in the art from the descriptions herein. The compositions of the present invention unite in a unique mixture, a number of herbal and mineral components. While these components may have been used in various medicinal compositions in the past, the individual components have not been used together or when the components herein have been used in prior art compositions, they may have been used in different concentrations. The present invention is based on the discovery that, combined in the unique combinations of this invention, the components interact synergistically to produce a topical medicament which, when applied on wounds, lesions, bed sores, fissures, burns, cuts, ulcers and the like, gives soothing and cooling effect, prevents and fights infection and promotes fast healing and there remains-no scar mark of the burn, cut or the like. There are often several techniques for obtaining the active ingredients of- the plant components of the present invention, and often several different parts of the plant which may be sources of active ingredients. In each case effective amounts of the active ingredients will be obtained, although the yield may vary according to the method of extraction used. Since the invention is not intended to be limited by the manner in which the active ingredients are extracted from the plants, the term "extract" will be defined herein as any portion or product of the plant which contains the active ingredient(s). Thus the term "extract" will mean any material (2) obtained from the identified plant which is or contains an ingredient active in the present compositions, and may include essential oils extracted from the plants leaves, bark, etc. by dissolution, finely divided leaves or portions of leaves, powders formed from plant bark, etc. Numerous descriptions exist in the literature of the various ways in which to obtain extract from the defined plant, and those will be well understood by persons skilled in the art. The various extracts and the herbs from which they can be obtained are all available commercially from domestic or foreign sources, such as natural and ethnic food stores, botanical and herbal gardens and commercial herb dealers. In addition, numerous texts describe how various herbs can be found in the wild or cultivated and processed; see, e.g., Bown, Encyclopedia of Herbs and their Uses, (1995) and Stuart (ed.,), the Encyclopedia of Herbs and Herbalism, (1979). The compositions are best understood by the descriptions of their components. A. Shorea ssp Shorea ssp. are in the Dipterocarpaceae family. The various species of shorea usually grow as sub-deciduous trees. The bark is reddish brown or grey, smooth or longitudinally fissured. They are known to contain tannins of the pyrogallol type. The bark on incision also yields a resin which oozes as a whitish liquid, but soon becomes brown on drying. The resin on dry distillation yield an essential oil which contains homocatechol monomethyl ether, other oxygenated aromatic compounds and hydrocarbons. Shorea species are used as anti-bacterials, astringents and stimulants. It has been a component of native medications intended to treat ulcers, eczema and other skin diseases. The preferred species for the present invention is shorea robusta. However, the shorea ssp. may be any shorea species which functions in the present compositions in a manner generally equivalent to shorea robusta in similar concentrations. It will be understood that some adjustment of concentrations may be necessary between the different acceptable species, due to their various efficacies and to limitations imposed by potential reactions with other components which could eliminate some of the shorea component from the compositions. The extract from the shorea ssp. bark is used as the component of the present invention. The extract will be present in a concentration range of about 0.3% - 20%, preferably about 0.7%. (3) B. Azadirachta ssp Azadirachta ssp. are in the Meliaceae family. The various species by Azadirachta usually grow as moderate sized decidious tree upto 12 m high. Bark is dark grey with long shallow vertical fissures. The principal compounds present are nimbin, nimbidinin, nimbinin, nimbidic acid, nimbinene and 6-desacetyl nimbinene. In the present invention the preferred species is Azadirachta indica. The bark has anti-bacterial and healing properties. It is used in treating various skin diseases like eczema, ringworm etc. It is known to have a cleansing and healing effect by the release of toxins from the body through the pores of the skin. It is also known to be useful in rheumatism, lumbago and leucorrhoea. The extract of Azadirachta ssp. bark will be present in a concentration in the range of about 0.25% - 20%, preferably about 0.5%. C. Celastrus ssp. Celastrus ssp (false or climbing bittersweet) are in the celastraceae family. These are twining shrubs, growing to heights of 60ft (18 m). The seeds contain various carboxylic fatty acids, the terpenoid paniculatadiol, various alkaloids, and the esters malkangunin and malkanguniol. The preferred species is celastrus paniculatus. Dried barks from the celastrus ssp. have in the past been used as emetics and diuretics. The seeds are given in rheumatism, gout paralysis and also as a powerful neuromuscular stimulant. The extracts of the seeds of celastrus ssp. will be present in the composition in the range of about 0.3% - 20%, preferably about 0.6%. P. Pongamia ssp. Pongamia ssp. are in the Fabaceae family. It is a medium-sized glabrous tree, upto 18m high. The bark is greyish green or brown, smooth or covered with tubercles. Pongamia ssp. bark contain furanoflavonoids and chromenoflavones karanjin, pongaflavones, pongachromenes. Chromenochalcones are also found. The preferred species is pongamia pinnata. (4) The extracts of Pongamia ssp are given internally in beriberi. Also used in. treating diarrhoea and in cough. Reported to be given internally in bleeding piles. The extracts of the bark of Pongamia pinnata will be present in the composition in the range of about 0.25% - 20%, preferably about 0.5%. E. Zinc ash The final component, Zinc ash is a soft white tasteless and odourless powder, changing to pale yellow by heat. It is prepared by oxidizing and roasting carbonate of Zinc. It is insoluble in water, soluble without effervescence in dilute acids and in ammonia water. Zinc ash has been used internally as a nervine tonic, sedative antispasmodic and astringent. It has specific control over epilepsy, cholera, whooping cough, asthma and hysteria. Also given in gonorrhea, leucorrhoea and spermatorrhea. Zinc ash will be present in the composition in the range of about 0.15% -20%, preferably about 0.3%. Optional Components 1. Glvcvrrhiza ssp Glycyrrhiza ssp are in the Fabaceae family. They are herbs or small shrubs upto 1m high with light brown roots. They are known to contain glycyrrhizin which on hydrolysis yields glycyrrhetic acid and D-glucuronic acid. They also contain coumarins like umbelliferone, chalcones and an alkaloid lycorine. The preferred species is glycyrrhiza glabra. It is cooling and slightly astringent. Moreover, when combined with Pterocarpus santalinus, it nourishes the skin, thereby providing a healing effect. The extracts-of Glycyrrhiza ssp are used in bronchial troubles and also as a diuretic and a mild laxative. The extracts of the roots of Glycyrrhiza glabra will be present in the range of about 0.3%-20% preferably about 3.0%. 2. Ficus sso Ficus ssp are in the Urticaceae family. The fruit is edible. They are known to contain tannins. The bark is used as a gargle and also used in treating diseases of the female generative organs. The preferred species is Ficus infectoria. The extracts of the bark of Ficus infectoria will be present in the range of about 0.5% - 20%, preferably about 2.0%. (5) 3. Red chalk Red chalk (Red Ochre) consists of the mixture of the hydrated sesqui-oxides of iron with various earthy materials principally Kaolin and Quartz. It has astringent, cooling properties. It is used as an antidote to arsenical poisoning. Red chalk will be present in the composition in the range of 10%-30%. 4. Alum Alum is colourless transparent crystal with sweetish astringent taste. It is purified by dissolving in boiling water, straining the solution and evaporating it so as to obtain crystals. It is useful in leucorrhea, and is used in treating chronic diarrhoeas. Alum will be present in the composition in the range of 1%-15%. 5. Borax Borax occurs as a natural deposit and is purified by dissolving in water, straining through cloth, evaporating to dryness and crystallizing. It is composed of boric acid and soda. It has been used in treating chronic bronchitis and also in conditions of dysmenorrhoea. Borax will be present in the composition in the range of 1%-15%. 6. Pterocarpus SSP Pterocarpus ssp are in the Papilionaceae family. The wood of this plant is used for agricultural implement and the leaves are used as cattle fodder. The wood contains santalin or santalic acid. They also contain santal pterocarpin and homopterocarpin alongwith colouring matter. The wood is used in treating haemorrhages, dysentery, bleeding piles and also used as a diuretic. The preferred species is Pterocarpus santalinus. The extracts of the wood of Pterocarpus ssp will be present in the composition in the range of about 2%-20%. Balance of the composition The balance of the composition is made up primarily of a topical carrier base, of which there are many formulations known. Typical "inert" bases are composed of purified water thickened with neutral organic oils such as stearates, oleates, (6) paraffins, glycols, etc. They often also contain perfumes, colorants, stabilizers,. emulsifiers, etc. Typically such bases are referred to as "cream bases," and any such base is suitable, as long as no ingredient of the base is reactive with any of the primary components of the composition. Other materials which may be present include preservatives, emulsifiers and antifoaming agents. As with the carrier base, any one or more of these materials are useful, and their presence or absence is a matter of the formulator"s choice, as long as no ingredient is reactive with any of the primary components of the composition. The compositions of this invention may be made by a number of different methods, all of which consist of steps to formulate the base followed by dispersion of the critical extract components. For instance, in one such procedure a portion of the aqueous phase of the base is first formed at elevated temperature (about 80°C-85°C [175°-185°F]). The oil phase of the base is formed by melting of solid paraffins, fatty acids and salts, etc., also at elevated temperatures (about 70°C [160°F]). The two phases are then blended together, during which the various extracts are incorporated and dispersed. Blending of the phases and extracts consists of homogenization at about 65°C-70°C (150°-160°F) with slow stirring and gradual cooling with additional cold water until the mixture is uniform in consistency and congealed. The base pH will be maintained in the range of about 4.5-6.0. The compositions are then ready for packaging. The efficacy of formulations of the present compositions were tested by medical practitioners with very satisfactory results. In the tests described below, the composition used had the formula identified as "preferred" in the "Summary of the Invention" section above. Test 1: This test involved 51 women with episiotomy wounds, following full term normal vaginal delivery of whom 49 completed the test. 24 patients (average age 28:76 + 4.85 years) received routine local treatment (Group A) and 25 patients (average age 27.33 ± 3.90 years) received the test composition (Group B). Among the patients of group A, 54% were primigravidae and 46% were second gravidae. Among the patients of group B, 40% were primigravidae and 60% were second gravidae. Application of the composition was thrice daily. The patients were assessed daily for the first five days followed by assessment on the 7th, 10th, 15th, 20th and 25th day and subsequently weekly for 2 weeks. (7) The parameters assessed were pain, tenderness, incidence of gaping wound, total score of healing, time taken for healing. The results are presented in table 1. Table 1 Patient group Pain score Tenderness Healing time (days) Incidence of Gaping wound (%) A 13.04+4.02 14.95 + 4.30 21.46 ±5.21 13.0% B 5.92 ±2.76 8.08+1.98 17.50 ±2.95 0% The other parameters like edema, erythema also decreased significantly in the group B. It will be evident that the composition of this invention has been shown to be effective in terms of wound healing and analgesia in the patients with episiotomy wounds. Test 2: This test involved patients with chronic vascular ulcers, diabetic ulcers and posttraumatic ulcers in poorly vascularized limbs. The patients were initially on routine therapy with anti-bacterials Betadine, Bactrazine, Aserbine. They showed improved healing with the test composition, the healing time ranging from 1 week to complete healing within 3 weeks. It will be evident that there are numerous embodiments of this invention which, while not expressly described above, are clearly within the scope and spirit of the invention. The above descriptions are therefore to be considered exemplary only, and the actual scope of the invention is to be determined solely by the appended claims. (8) We Claim, 249/B/1999, 1. An herbal anti-bacterial composition for fast healing in the forum gel, cream, lotion, comprising, shoreaRobusta SSP in concentration of 0.25% - 20%,of 0.3% to 20%, and Azadirachta species 0.25% - 20%, celastrus in the concentration 0.3% to 20%, pongamia species 0.25% to 20%, Zinc ash in the range of 0.15% to 20%, glycyrrlila speceies 0.5% to 20%, ficus ssp. In the range of 0.5% to 20%, red chalk 10% to 30%, Alum in the range 1% to 15%, Borax in the range of 1% to 15%, 2. An herbal anti - bacterial composition such as here in described with reference to an accompanying examples,

Documents:

249-bom-1999-cancelled pages(28-9-2007).pdf

249-bom-1999-claims(granted)-(28-9-2007).doc

249-bom-1999-claims(granted)-(28-9-2007).pdf

249-bom-1999-correspondence(22-2-2008).pdf

249-bom-1999-correspondence(ipo)-(12-3-2008).pdf

249-bom-1999-form 13(22-2-2008).pdf

249-bom-1999-form 18(29-12-2005).pdf

249-bom-1999-form 1a(5-4-1999).pdf

249-bom-1999-form 2(granted)-(28-9-2007).doc

249-bom-1999-form 2(granted)-(28-9-2007).pdf

249-bom-1999-other document(1-4-1999).pdf

249-bom-1999-power of attorney(11-1-2001).pdf