Abstract: The present disclosure relates to a pharmaceutical composition for promoting healing of a wound, said composition including: Curcuma longa extract in an amount ranging from 1% to 8% by weight of the composition; Rubia cordifolia extract in an amount ranging from 1% to 8% by weight of the composition; Nanocurcumin in an amount ranging from 1% to 8% by weight of the composition; Centella asiatica extract in an amount ranging from 1% to 8% by weight of the composition; Panax notoginseng extract in an amount ranging from 1% to 8% by weight of the composition; a pharmaceutically acceptable excipient in an amount ranging from 60% to 95% by weight of the composition. In an embodiment, the composition is formulated into a cream.
DESC:FIELD OF INVENTION
[0001] The present disclosure relates generally to the field of pharmaceutical compositions. Particularly, the present disclosure relates to compositions that may aid in promoting healing of a wound and a method of preparation thereof.
BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the present invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Wound healing refers to a living organism's replacement of destroyed or damaged tissue by newly produced tissue. Healing is the interaction of a complex cascade of cellular events which results in resurfacing, reconstitution, and restoration of the tensile strength of injured skin. Wound healing is achieved through four precisely and highly programmed phases viz. Hemostasis (vascular constriction, platelet aggregation, degranulation, and fibrin formation (thrombus)), Inflammation (neutrophil infiltration, monocyte infiltration and differentiation to macrophage, lymphocyte infiltration), Proliferation (re-epithelialization, angiogenesis, collagen synthesis, ECM formation), and Remodeling (collagen remodeling, vascular maturation and regression). For a wound to heal successfully, all four phases must occur in the proper sequence and time frame. It is a natural restorative response to tissue injury but the natural way of healing may lack quality, promptness and aesthetics. Many factors can interfere with one or more phases of this process, leading to improper or impaired wound healing.
[0004] Presence of infection in the wounded area may lead to slow healing. Under these circumstances the body is occupied with fighting the infection off and protecting the wound, consequently delaying the restorative response of the cells. Thus, there is a need to provide a composition suitable for fighting of infection along with wound healing.
[0005] Significant efforts have been put forward towards finding new and improved compositions containing natural products, however, none of the current approaches/treatments seems to satisfy the existing needs, and are either proved ineffective or led to serious long term side-effects.
[0006] There is, therefore, an unmet need in the art to develop a new and improved composition that may aid in promoting healing of a wound and overcome the problems associated with the existing compositions thereof. The present invention satisfies the existing as well as others needs.
OBJECTS
[0007] An object of the present disclosure is to provide a composition for promoting healing of a wound.
[0008] It is an object of the present disclosure to provide a composition that has anti-microbial properties and improved skin permeability.
[0009] It is an object of the present disclosure to provide a composition that is devoid of any side-effects.
[00010] It is an object of the disclosure to provide a composition that exhibits superior storage stability and synergistic activity /functional reciprocity.
[00011] It is an object of the disclosure to provide a composition that is easy to prepare and economical.
[00012] Another object of the present disclosure is to provide a process of preparing a composition for promoting healing of a wound.
[00013] Other objects of the present disclosure will be apparent from the description of the invention herein below.
SUMMARY
[00014] The present disclosure relates generally to the field of pharmaceutical compositions. Particularly, the present disclosure relates to compositions that may aid in promoting healing of a wound and a method of preparation thereof.
[00015] A pharmaceutical composition for promoting healing of a wound, said composition comprising: Curcuma longa extract in an amount ranging from 1% to 8% by weight of the composition; Rubia cordifolia extract in an amount ranging from 1% to 8% by weight of the composition; Nanocurcumin in an amount ranging from 1% to 8% by weight of the composition; Centella asiatica extract in an amount ranging from 1% to 8% by weight of the composition; Panax notoginseng extract in an amount ranging from 1% to 8% by weight of the composition; a pharmaceutically acceptable excipient in an amount ranging from 60% to 95% by weight of the composition.
[00016] In an embodiment, the pharmaceutically acceptable excipient is selected from any or a combination of a thickener, a bulking agent, a solubilizer, a binder, a disintegrant, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, a lubricant, a diluent and a solvent. In an embodiment, the thickener is selected from any or a combination of carbopol, carbomer, acrylate copolymer, beeswax, emulsifying cresmer wax, sodium acrylate/sodium acryloyl dimethyl taurate copolymer. In an embodiment, the thickener is present in an amount ranging from 40% to 80% by weight of the composition. In an embodiment, the preservative is selected from any or a combination of benzyl alcohol, butanol or ethanol, isopropyl alcohol, benzalkonium chloride, sodium benzoate, potassium sorbate, phenoxyethanol, p-hydroxybenzoic acid esters, sorbic acid, benzoic acid, propionic acid or salts thereof. In an embodiment, the preservative is present in an amount ranging from 10% to 30% by weight of the composition. In an embodiment, the composition is formulated in to a cream, a lotion, a gel, a spray, an ointment, a granule, a paste, a powder, foam and a film.
[00017] Another aspect of the present disclosure relates to a cream formulation for promoting healing of a wound, said formulation comprising: Curcuma longa extract in an amount ranging from 1% to 8% by weight of the formulation; Rubia cordifolia extract in an amount ranging from 1% to 8% by weight of the formulation; Nanocurcumin in an amount ranging from 1% to 8% by weight of the formulation; Centella asiatica extract in an amount ranging from 1% to 8% by weight of the formulation; Panax notoginseng extract in an amount ranging from 1% to 8% by weight of the formulation; a pharmaceutically acceptable excipient in an amount ranging from 60% to 95% by weight of the formulation.
[00018] In an embodiment, the pharmaceutically acceptable excipient is selected from any or a combination of a thickening agent, a bulking agent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, a solvent and a co-solvent.
[00019] Other aspects, advantages, and salient features of the invention will become apparent to those skilled in the art from the following detailed description, which, taken in conjunction with the exemplary embodiments of the invention.
DETAILED DESCRIPTION
[00020] The embodiments herein and the various features and advantageous details thereof are explained more comprehensively with reference to the non-limiting embodiments that are detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of the ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
[00021] Unless otherwise specified, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. By means of further guidance, term definitions may be included to better appreciate the teaching of the present invention.
[00022] As used in the description herein, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[00023] As used herein, the terms “comprise”, “comprises”, “comprising”, “include”, “includes”, and “including” are meant to be non- limiting, i.e., other steps and other ingredients which do not affect the end of result can be added. The above terms encompass the terms “consisting of” and “consisting essentially of”.
[00024] As used herein, the terms “composition”, “blend”, or “mixture” are all intended to be used interchangeably.
[00025] The terms “weight percent”, “vol-%”, “percent by weight”, “% by weight”, and variations thereof, as used herein, refer to the concentration of a substance as the weight of that substance divided by the total weight of the composition and multiplied by 100. It is understood that, as used here, “percent”, “%”, and the like are intended to be synonymous with “weight percent”, “vol-%”, etc.
[00026] The term ‘therapeutically effective amount’ used throughout the present disclosure denotes an amount sufficient to produce the desired effects without causing side-effects.
[00027] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about”. Accordingly, in some embodiments, the numerical parameters set forth in the written description are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable.
[00028] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.
[00029] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[00030] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
[00031] The present disclosure relates generally to the field of pharmaceutical compositions. Particularly, the present disclosure relates to compositions that may aid in promoting healing of a wound and a method of preparation thereof.
[00032] A pharmaceutical composition for promoting healing of a wound, said composition comprising: Curcuma longa extract in an amount ranging from 1% to 8% by weight of the composition; Rubia cordifolia extract in an amount ranging from 1% to 8% by weight of the composition; Nanocurcumin in an amount ranging from 1% to 8% by weight of the composition; Centella asiatica extract in an amount ranging from 1% to 8% by weight of the composition; Panax notoginseng extract in an amount ranging from 1% to 8% by weight of the composition; a pharmaceutically acceptable excipient in an amount ranging from 60% to 95% by weight of the composition.
[00033] In an embodiment, the pharmaceutically acceptable excipient is selected from any or a combination of a thickener, a bulking agent, a solubilizer, a binder, a disintegrant, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, a lubricant, a diluent and a solvent. In an embodiment, the thickener is selected from any or a combination of carbopol, carbomer, acrylate copolymer, beeswax, emulsifying cresmer wax, sodium acrylate/sodium acryloyl dimethyl taurate copolymer. In an embodiment, the thickener is present in an amount ranging from 40% to 80% by weight of the composition. In an embodiment, the preservative is selected from any or a combination of benzyl alcohol, butanol or ethanol, isopropyl alcohol, benzalkonium chloride, sodium benzoate, potassium sorbate, phenoxyethanol, p-hydroxybenzoic acid esters, sorbic acid, benzoic acid, propionic acid or salts thereof. In an embodiment, the preservative is present in an amount ranging from 10% to 30% by weight of the composition. In an embodiment, the composition is formulated in to a cream, a lotion, a gel, a spray, an ointment, a granule, a paste, a powder, foam and a film.
[00034] Curcuma longa is a shrub belonging to the family of Zingiberaceae and is a native to India. The root of the shrub is the most important. It is one of the oldest spices with various medicinal applications.
[00035] Rubia cordifolia or Indian madder is a climber flowering plant of the Rubiaceae species. It is a perennial plant with ovate leaves and white/green flowers, where the leaves develop into black colored mature fruits.
[00036] Centella asiatica or Indian pennywort is a perennial creeper plant belonging to the Apiaceae family and is native to Asia. It typically grows in tropical regions around water and possesses small rounded fan shaped leaves and white or red flowers. It has been employed for culinary and medicinal purposes.
[00037] Panax notoginseng (San qi) is a species of the genus Panax, and it is commonly referred to in English as Chinese ginseng or also called as San qi. P. notoginseng grows naturally in China. It has been one of the most acclaimed herbs in China and used for treatment of cardiovascular disorders.
[00038] In an embodiment, the size of nanocurcumin ranges from about 200nm to about 500nm.
[00039] In an embodiment, the composition may comprise whole of Centella asiatica, whole of Curcuma longa, whole of Rubia cordifolia, whole of Panax notoginseng (San qi), part of Centella asiatica, part of Curcuma longa, part of Rubia cordifolia, part of Panax notoginseng, extract of Centella asiatica, extract of Curcuma longa, extract of Rubia cordifolia, extract of Panax notoginseng or combinations thereof. The extract or part may be obtained from root, leaves, shoot, fruits, rhizome, seed, stem, barks, flower, sap or bud of the plant and combinations thereof.
[00040] With regards to extract of any or a combination of Centella asiatica, Curcuma longa, Rubia cordifolia and San qi, commercially available extract thereof can be used for realizing the composition of the present disclosure. Extracts may be available in concentrated liquid or dried powder form. However, extract prepared by any other method for isolation and extraction of active compounds, as known to or appreciated by a person skilled in the art, for example, maceration, soxhlet extraction, microwave-assisted extraction (MAE), ultrasound-assisted extraction (UAE), supercritical fluid extraction (SFE) and the likes can be used to serve its intended purpose, as laid down in the present disclosure.
[00041] In accordance with an embodiment, the composition of the present disclosure is realized by using extracts commercially procured from following manufactures:
Sr. No. INGREDIENTS Manufacturer
1 Curcuma longa extract Herbo Nutra, UP, India
2 Rubia cordifolia extract Herbo Nutra, UP, India
3 Nanocurcumin Herbo Nutra, UP, India
4 Centella asiatica extract Herbo Nutra, UP, India
5 San qi (Panax notoginseng) extract Herbo Nutra, UP, India
[00042] In an embodiment, thickener includes but not limited to, carbopol, carbomer, acrylate copolymer, beeswax, emulsifying CresmerWax, sodium acrylate/sodium acryloyl dimethyl taurate copolymer (0.2-1.2% w/w) and mixtures thereof. However, a person skilled in the art would appreciate that any other flavoring agent(s) can be utilized to serve the intended purpose.
[00043] In an embodiment, bulking agent(s) include but not limited to, lactose USP, Starch 1500, mannitol, sorbitol, maltodextrin, malitol or other non-reducing sugars; microcrystalline cellulose (e.g., Avicel), dibasic calcium phosphate (anhydrous or dihydrate), sucrose, etc. and mixtures thereof. However, a person skilled in the art would appreciate that any other bulking agent(s) can be utilized to serve the intended purpose.
[00044] In an embodiment, solubilizer(s) includes but not limited to, cyclodextrins, pH adjusters, salts and buffers, surfactants, fatty acids, phospholipids, metals of fatty acids and the likes. However, a person skilled in the art would appreciate that any other solubilizer(s) can be utilized to serve the intended purpose.
[00045] In an embodiment, binder(s) include but not limited to, cellulosic derivatives (such as methylcellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, etc), polyacrylates (such as Carbopol, polycarbophil, etc), Povidone (all grades), Polyox of any molecular weight or grade, irradiated or not, maize starch, povidone, copovidone, corn starch, starch, polyvinylpyrrolidone (PVP), microcrystalline cellulose (Avicel@ -Avicel 101), and the like. However, a person skilled in the art would appreciate that any other binder(s) can be utilized to serve the intended purpose.
[00046] In an embodiment, disintegrant(s) includes but not limited to, croscarmellose sodium, Crospovidone, sodium starch glyconate, citric acid, calcium carbonate, pregelatinized starch and mixture thereof. However, a person skilled in the art would appreciate that any other disintegrant(s) can be utilized to serve the intended purpose.
[00047] In an embodiment, glidant(s) includes but not limited to, colloidal silicon dioxide, precipitated silicon dioxide, fumed silica (CAB-O-SIL M-5P, trademark of Cabot Corporation), stearowet and sterotex, silicas (such as SILOID and SILOX silicas—trademarks of Grace Davison Products, Aerosil—trademark of Degussa Pharma), higher fatty acids, the metal salts thereof, hydrogenated vegetable oils and the like. However, a person skilled in the art would appreciate that any other glidant(s) can be utilized to serve the intended purpose.
[00048] In an embodiment, flavoring agent(s) includes but not limited to, fruit aromas such as orange, banana, strawberry, cherry, wild cherry, lemon; cardamom, anis, mint, menthol, vanillin, and ethyl vanillin, and other similar aromas such as coffee, or the mixtures thereof. However, a person skilled in the art would appreciate that any other flavoring agent(s) can be utilized to serve the intended purpose.
[00049] In an embodiment, colouring agent(s) includes but not limited to, E102 Tartrazine, E104 Quin- oline Yellow, E110 Sunset Yellow FCF, E120 - Cochineal, carminic acid, Carmines, E122 Azorubine (Carmoisine), E123 Amaranth, E124 Ponceau 4R (Cochineal Red A), E127 Erythrosine, E129 Allura Red, E131 Patent Blue, or the mixtures thereof. However, a person skilled in the art would appreciate that any other colouring agent(s) can be utilized to serve the intended purpose.
[00050] In an embodiment, tonicity agent(s) includes but not limited to, dextrose, glycerin, mannitol, potassium chloride and sodium chloride or the mixtures thereof. However, a person skilled in the art would appreciate that any other tonicity agent(s) can be utilized to serve the intended purpose.
[00051] In an embodiment, sweetening agent(s) includes but not limited to, sucralose, acesulfame-K, aspartame, saccharine or saccharine sodium and calcium salts, sodium cyclamate, sucrose, fructose, glucose, sorbitol, or the mixtures thereof. However, a person skilled in the art would appreciate that any other sweetening agent(s) can be utilized to serve the intended purpose.
[00052] In an embodiment, buffer system includes but not limited to, sodium citrate, potassium citrate, sodium citrate di-hydrate, citric acid, citric acid monohydrate, sodium bicarbonate, potassium bicarbonate, sodium di-hydrogen phosphate and potassium di-hydrogen phosphate and the likes or combination thereof. However, a person skilled in the art would appreciate that any other buffer system can be utilized to serve the intended purpose.
[00053] In an embodiment, preservative(s) includes but not limited to, sodium benzoate, potassium sorbate, phenoxyethanol, p-hydroxybenzoic acid esters, sorbic acid, benzoic acid, propionic acid or salts thereof; Alcohols such as benzyl alcohol, butanol or ethanol, isopropyl alcohol and quaternary ammonium compounds such as benzalkonium chloride, sodium benzoate and mixture thereof. However, a person skilled in the art would appreciate that any other preservative(s) can be utilized to serve the intended purpose.
[00054] In an embodiment, lubricant(s) includes but not limited to, zinc stearate, magnesium stearate, stearic acid, calcium stearate, Vegetable stearin and mixture thereof. However, a person skilled in the art would appreciate that any other lubricant(s) can be utilized to serve the intended purpose.
[00055] In an embodiment, diluent(s) includes but not limited to, microfine cellulose, lactose, starch, pregelatinized starch, calcium carbonate, calcium sulfate, sugar, dextrates, dextrin, dextrose, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, kaolin, magnesium carbonate, magnesium oxide, maltodextrin, mannitol, potassium chloride, powdered cellulose, sodium chloride, sorbitol, talc and mixture thereof. However, a person skilled in the art would appreciate that any other diluent(s) can be utilized to serve the intended purpose.
[00056] In an embodiment, solvent(s) includes but not limited to, methanol, ethanol, n-propanol, isopropanol, hexane, heptane, petroleum ether, cyclohexane, diethyl ether, diisopropyl ether, ethyl acetate, methyl acetate, ethyl formate, methyl formate, isobutyl acetate, n-butyl acetate, methylene chloride, ethylene chloride, chloroform, carbon tetrachloride, acetone, ethyl methyl ketone, diisobutyl ketone, methyl isobutyl ketone, 1,4- dioxane, toluene, ammonia solution, glacial acetic acid, ammonium hydroxide, sodium hydroxide, calcium hydroxide, calcium carbonate, potassium hydroxide, potassium carbonate, water and the likes. However, a person skilled in the art would appreciate that any other solvent(s) or a combination of solvent(s) can be utilized to serve the intended purpose.
[00057] In an embodiment, the wound includes, but is not limited to, an abrasion, scratch, surgical wound, puncture, or incision.
[00058] The pharmaceutical compositions detailed herein can be manufactured in one or several dosage forms. In an embodiment, pharmaceutical dosage form is selected from any or a combination of capsule, tablets or caplets; pills; powders such as a sterile packaged powder, a dispensable powder, and an effervescent powder; capsules including both soft or hard gelatin capsules such as HPMC capsules, lozenges, a sachet, a sprinkle, a reconstitutable powder or shake, a troche, granules, liquids such as suspensions, emulsions, semisolids, or gels. In an embodiment, the formulation may be in a solid, a liquid and a semi-solid form. In an embodiment, the solid may be nano-particles or microparticles. In an embodiment, the composition may be formulated into a cream, a lotion, a gel, a spray, an ointment, a granule, a paste, a powder, foam and a film. In a specific embodiment, the formulation is a nanoparticles based cream. However, any or a combination of pharmaceutical dosage form(s), as known to or appreciated by a person skilled in the art, can be utilized to serve its intended purpose.
[00059] In an embodiment, the present disclosure relates to a process of preparing a pharmaceutical composition for promoting healing of a wound, the method includes following steps:
Step 1: Preparation of Water Phase
Required amount of water is taken and flocare (Sodium Acrylate/Sodium Acryloyl Dimethyl Taurate copolymer) is dissolved in it to form a clear gel solution.
Step 2: Preparation of Extract Phase
Curcuma longa extract, Rubia cordifolia extract, Nanocurcumin, Centella asiatica extract and San qi (Panax notoginseng) extract are taken in a separate vessel, mixed, and water is added into the mixture in a ratio ranging from 1:5 to 1:15 and kept for about 5-15 hrs. To the above mixture sodium benzoate is added and mixture is filtered to obtain a filtrate. The above filtrate obtained is added into the water phase premix gel solution and continuously stir to obtain a cream composition/formulation.
[00060] Another aspect of the present disclosure relates to a cream formulation for promoting healing of a wound, said formulation comprising: Curcuma longa extract in an amount ranging from 1% to 8% by weight of the formulation; Rubia cordifolia extract in an amount ranging from 1% to 8% by weight of the formulation; Nanocurcumin in an amount ranging from 1% to 8% by weight of the formulation; Centella asiatica extract in an amount ranging from 1% to 8% by weight of the formulation; Panax notoginseng extract in an amount ranging from 1% to 8% by weight of the formulation; a pharmaceutically acceptable excipient in an amount ranging from 60% to 95% by weight of the formulation.
[00061] In an embodiment, the pharmaceutically acceptable excipient is selected from any or a combination of a thickening agent, a bulking agent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, a solvent and a co-solvent.
[00062] Formulation of the present disclosure exhibited superior storage stability and functional reciprocity/strong synergy there between, and hence, the formulation of the present disclosure holds the potential for widespread usage for wound healing.
[00063] Still another aspect of the present disclosure relates to a method of promoting healing of a wound in a subject, said method comprising administering to a subject in need thereof an effective amount of pharmaceutical composition, said composition including:Curcuma longa extract in an amount ranging from 1% to 8% by weight of the composition; Rubia cordifolia extract in an amount ranging from 1% to 8% by weight of the composition; Nanocurcumin in an amount ranging from 1% to 8% by weight of the composition; Centella asiatica extract in an amount ranging from 1% to 8% by weight of the composition; Panax notoginseng extract in an amount ranging from 1% to 8% by weight of the composition; a pharmaceutically acceptable excipient in an amount ranging from 60% to 95% by weight of the composition. In an embodiment, the wound is a surface wound. In an embodiment, the wound is an open wound. In an embodiment, the wound is any of an abrasion, a laceration, a puncture, an avulsion and an incision. In an embodiment, an effective amount of said composition is administered to a subject in need thereof to enhance proliferation of endothelial cells and fibroblasts. In an embodiment, an effective amount of said composition is administered to a subject in need thereof to enhance migration of endothelial cells towards the wound and close it.
[00064] Another aspect of the present disclosure relates to a pharmaceutical composition for use in promoting healing of a wound, said composition including: Curcuma longa extract in an amount ranging from 1% to 8% by weight of the composition; Rubia cordifolia extract in an amount ranging from 1% to 8% by weight of the composition; Nanocurcumin in an amount ranging from 1% to 8% by weight of the composition; Centella asiatica extract in an amount ranging from 1% to 8% by weight of the composition; Panax notoginseng extract in an amount ranging from 1% to 8% by weight of the composition; a pharmaceutically acceptable excipient in an amount ranging from 60% to 95% by weight of the composition. In an embodiment, the wound is a surface wound. In an embodiment, the wound is an open wound. In an embodiment, the wound is any of an abrasion, a laceration, a puncture, an avulsion and an incision. In an embodiment, an effective amount of said composition is administered to a subject in need thereof to enhance proliferation of endothelial cells and fibroblasts. In an embodiment, an effective amount of said composition is administered to a subject in need thereof to enhance migration of endothelial cells towards the wound and close it.
[00065] Still further aspect of the present disclosure relates to use of a pharmaceutical composition for manufacture of a medicament for promoting healing of a wound said composition including: Curcuma longa extract in an amount ranging from 1% to 8% by weight of the composition; Rubia cordifolia extract in an amount ranging from 1% to 8% by weight of the composition; Nanocurcumin in an amount ranging from 1% to 8% by weight of the composition; Centella asiatica extract in an amount ranging from 1% to 8% by weight of the composition; Panax notoginseng extract in an amount ranging from 1% to 8% by weight of the composition; a pharmaceutically acceptable excipient in an amount ranging from 60% to 95% by weight of the composition. In an embodiment, the wound is a surface wound. In an embodiment, the wound is an open wound. In an embodiment, the wound is any of an abrasion, a laceration, a puncture, an avulsion and an incision. In an embodiment, an effective amount of said composition is administered to a subject in need thereof to enhance proliferation of endothelial cells and fibroblasts. In an embodiment, an effective amount of said composition is administered to a subject in need thereof to enhance migration of endothelial cells towards the wound and close it.
[00066] In an embodiment, the composition is administered topically. In an embodiment, the method involves application of the composition on the affected area, optionally, covering the area and leaving the affected area unperturbed till the wound is healed. In an embodiment, the composition is applied in and around the wounded cells.
[00067] In an embodiment, the composition is applied once or multiple times. In an embodiment, the composition is applied continuously for a long period of time, or intermittently applied with an interval of air exposure of the wounded cells.
[00068] In an embodiment, the composition is applied directly on the wound or applied onto a carrier which is then contacted with the wound. Preferably, before application of the composition the wound is cleaned and/or disinfected.
[00069] In an embodiment, the disclosure provides a dressing material comprising the composition for wound healing. The dressing material may be a bandage, gauze, fiber, cloth or sponge. The dressing material may be infused, layered or injected with the composition.
[00070] In an embodiment, the composition possesses anti-microbial activity and increased skin permeability. The anti-microbial effect further promotes quicker healing of the wounds by avoiding infections by pathogens on the exposed wounds. In an embodiment, the composition exhibits re-epithelialization, vascular proliferation, fibroblast proliferation and PMN-neutrophilic infiltration.
[00071] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.
EXAMPLE
[00072] A PHARMACEUTICAL CREAM FORMULATION
TABLE 2: A Pharmaceutical Cream Formulation
S. No. Ingredients/Herbs Amount (in gm)
1. Curcuma longa extract 0.1
2. Rubia cordifolia extract 0.1
3. Nanocurcumin 0.1
4. Centella asiatica extract 0.1
5. San qi (Panax notoginseng) extract 0.1
6. Sodium Acrylate/Sodium Acryloyl Dimethyl Taurate copolymer (Flocare™ PSD 30) 1.50
7. Sodium benzoate 0.50
Total 2.5 gm
[00073] METHOD OF PREPARATION
All the ingredients were weighed accurately as per Table 2 above.
Preparation of Water Phase:
Required amount of water was taken and Sodium Acrylate/Sodium Acryloyl Dimethyl Taurate copolymer (Flocare™ PSD 30) was dissolved in it to form a clear gel solution.
Preparation of Extract Phase:
Curcuma longa extract, Rubia cordifolia extract, Nanocurcumin, Centella asiatica extract and San qi (Panax notoginseng) extract were taken in a separate vessel, mixed, and water was added in the mixture in a ratio of 1:10 and kept for about 8-10 hrs. To the above mixture sodium benzoate was added and mixture was filtered to obtain a filtrate.
The above filtrate obtained was added into the water phase premix gel solution and continuously stirred to obtain a cream formulation.
[00074] EFFICACY
[00075] IN VITRO EFFICACY BY MIGRATION ASSAY IN KERATINOCYTES
Human keratinocytes (HaCaT) in DMEM+10% FBS were plated at density of 5x105 cells/well to achieve confluent layer, and were manually scratched. Cells were treated with Epidermal Growth Factor (EGF, standard), Nanocurcumin, Rubia cordifolia extract and San qi, at different concentrations for 24 to 48 hrs. Estimation of cell migration at different time-points using Image J software was recorded by capturing images. The analysis for quantitative assessment of area of wound closure was performed using Image J Tool software. The wound healing potential was evaluated by increase in cell migration by test extract as compared to untreated control.
Table 3: % Increase in cell migration w.r.t Control
Groups
Concentrations % Increase in cell migration w.r.t Control
24 Hour
48 Hour
Untreated (Control) - 0 0
EGF
(Standard)
(ng/ml)
100 96.7 79.1
250 72.4 77.5
500 61.8 86.8
Nano curcumin (µg/ml)
0.1 26.1 35.5
0.5 21.6 28.1
1 13 9.5
Rubia cardifolia (µg/ml)
0.1 29.1 31.3
0.5 22.6 34.8
1 5.2 -2.6
San Qi (µg/ml)
0.1 17.3 29.3
0.5 10.8 26.3
1 4 -12.3
ADVANTAGES
[00076] The present disclosure provides a composition for promoting healing of a wound.
[00077] The present disclosure provides a composition that has anti-microbial properties and improved skin permeability.
[00078] The present disclosure provides a composition that is devoid of any side-effects.
[00079] The present disclosure provides a composition that exhibits superior storage stability and synergistic activity /functional reciprocity.
[00080] The present disclosure provides a composition that is easy to prepare and economical.
WE CLAIMS:
1. A pharmaceutical composition for promoting healing of a wound, said composition comprising:
Curcuma longa extract in an amount ranging from 1% to 8% by weight of the composition;
Rubia cordifolia extract in an amount ranging from 1% to 8% by weight of the composition;
Nanocurcumin in an amount ranging from 1% to 8% by weight of the composition;
Centella asiatica extract in an amount ranging from 1% to 8% by weight of the composition;
Panax notoginseng extract in an amount ranging from 1% to 8% by weight of the composition;
a pharmaceutically acceptable excipient in an amount ranging from 60% to 95% by weight of the composition.
2. The composition as claimed in claim 1, wherein the pharmaceutically acceptable excipient is selected from any or a combination of a thickener, a bulking agent, a solubilizer, a binder, a disintegrant, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, a lubricant, a diluent and a solvent.
3. The composition as claimed in claim 2, wherein the thickener is selected from any or a combination of carbopol, carbomer, acrylate copolymer, beeswax, emulsifying cresmer wax, sodium acrylate/sodium acryloyl dimethyl taurate copolymer.
4. The composition as claimed in claim 3, wherein the thickener is present in an amount ranging from 40% to 80% by weight of the composition.
5. The composition as claimed in claim 2, wherein the preservative is selected from any or a combination of benzyl alcohol, butanol or ethanol, isopropyl alcohol, benzalkonium chloride, sodium benzoate, potassium sorbate, phenoxyethanol, p-hydroxybenzoic acid esters, sorbic acid, benzoic acid, propionic acid or salts thereof.
6. The composition as claimed in claim 5, wherein the preservative is present in an amount ranging from 10% to 30% by weight of the composition.
7. The composition as claimed in claim 1, wherein the composition is formulated in to a cream, a lotion, a gel, a spray, an ointment, a granule, a paste, a powder, foam and a film.
8. A cream formulation for promoting healing of a wound, said formulation comprising:
Curcuma longa extract in an amount ranging from 1% to 8% by weight of the formulation;
Rubia cordifolia extract in an amount ranging from 1% to 8% by weight of the formulation;
Nanocurcumin in an amount ranging from 1% to 8% by weight of the formulation;
Centella asiatica extract in an amount ranging from 1% to 8% by weight of the formulation;
Panax notoginseng extract in an amount ranging from 1% to 8% by weight of the formulation;
a pharmaceutically acceptable excipient in an amount ranging from 60% to 95% by weight of the formulation.
9. The formulation as claimed in claim 1, wherein the pharmaceutically acceptable excipient is selected from any or a combination of a thickening agent, a bulking agent, a solubilizer, a binder, a disintegrant, a chelating agent, a glidant, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a preservative, lubricant, a solvent and a co-solvent.
| # | Name | Date |
|---|---|---|
| 1 | 202111017459-STATEMENT OF UNDERTAKING (FORM 3) [14-04-2021(online)].pdf | 2021-04-14 |
| 2 | 202111017459-PROVISIONAL SPECIFICATION [14-04-2021(online)].pdf | 2021-04-14 |
| 3 | 202111017459-FORM 1 [14-04-2021(online)].pdf | 2021-04-14 |
| 4 | 202111017459-DECLARATION OF INVENTORSHIP (FORM 5) [14-04-2021(online)].pdf | 2021-04-14 |
| 5 | 202111017459-FORM-26 [15-06-2021(online)].pdf | 2021-06-15 |
| 6 | 202111017459-ENDORSEMENT BY INVENTORS [14-04-2022(online)].pdf | 2022-04-14 |
| 7 | 202111017459-CORRESPONDENCE-OTHERS [14-04-2022(online)].pdf | 2022-04-14 |
| 8 | 202111017459-COMPLETE SPECIFICATION [14-04-2022(online)].pdf | 2022-04-14 |
| 9 | 202111017459-RELEVANT DOCUMENTS [05-07-2024(online)].pdf | 2024-07-05 |
| 10 | 202111017459-RELEVANT DOCUMENTS [05-07-2024(online)]-1.pdf | 2024-07-05 |
| 11 | 202111017459-POA [05-07-2024(online)].pdf | 2024-07-05 |
| 12 | 202111017459-POA [05-07-2024(online)]-1.pdf | 2024-07-05 |
| 13 | 202111017459-MSME CERTIFICATE [05-07-2024(online)].pdf | 2024-07-05 |
| 14 | 202111017459-FORM28 [05-07-2024(online)].pdf | 2024-07-05 |
| 15 | 202111017459-FORM-26 [05-07-2024(online)].pdf | 2024-07-05 |
| 16 | 202111017459-FORM 18A [05-07-2024(online)].pdf | 2024-07-05 |
| 17 | 202111017459-FORM 13 [05-07-2024(online)].pdf | 2024-07-05 |
| 18 | 202111017459-FORM 13 [05-07-2024(online)]-1.pdf | 2024-07-05 |
| 19 | 202111017459-FER.pdf | 2025-07-04 |
| 20 | 202111017459-FORM 3 [05-10-2025(online)].pdf | 2025-10-05 |
| 1 | 202111017459_SearchStrategyNew_E_SearchHistory(10)E_03-07-2025.pdf |