Description:FIELD OF THE INVENTION
[0001] The present disclosure relates generally to the field of pharmaceutical and veterinary composition. Particularly, the present disclosure provides a formulation for wound healing management. The present disclosure also provides a method of preparation of a formulation for wound healing management. The formulation can be used for different wound healing of domesticated, farm and small animals.

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 presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] The management of wounds depends on the type of wound healing which can include irrigation, mechanical and chemical debridement, the use of antiseptics and antimicrobials, and adherent and nonadherent dressings. Quality of care is a critical requirement for wound healing and 'good' care of wounds has been synonymous with topical prevention and management of microbial contamination. Topical antiseptics are antimicrobial agents that kill, inhibit, or reduce the number of microorganisms and are thought to be essential for wound infection control. However, they have long and commonly been used on wounds to prevent or treat infection, and the merits of antiseptic fluid irrigation have received little scientific study. Unlike antibiotics that act selectively on a specific target, antiseptics have multiple targets and a broader spectrum of activity, which include bacteria, fungi, viruses, protozoa, and even prions. Although certain skin and wound cleansers are designed as topical solutions with varying degrees of antimicrobial activity, concerns have been raised.
[0004] Dressings are a part of a holistic wound management plan with individualized patient goals and aimed to provide the optimal environment for healing processes. Different dressings have been used in veterinary clinical practice to promote healing during different phases of wound healing. Bandage after dressing may cause discomfort for animals.
[0005] Huebner et al. [J. Dairy Sci., 2017, 100, 3922–3929] discloses a topical aluminum bandage spray improves wound healing during the 3 wk following disbudding. The results of this study stated that the use of ALU improved wound healing following cautery disbudding of pre-weaned dairy calves.
[0006] Umar et al. [Drug Des Devel Ther., 2020, 14, 2909-2925] discloses the types and concentrations of polymers and excipients, sprayer types, evaluations, and critical parameters in determining spray ability and film characteristics. The review concludes that both natural and synthetic polymers that have in situ film or viscoelastic properties can be used to optimize topical drug delivery.
[0007] Bakhrushina et al. [Saudi Pharm J., 2023, 31, 154-169] relates to a Spray Film-Forming systems (SFFSs) as promising topical in situ Systems. This review highlights most of the existing requirements and suggestions from studies to standardize the characteristics of SFFSs and classify them based on scientific sources and regulatory documentation, as well as the position of such systems in the pharmaceutical market.
[0008] Most of the marketed preparations are either herbal sprays OR ointments with fly-repellant properties. These preparations are used after wound dressing. However, there is no definite protection for wounds from dust, dirt, microorganisms, and water. The literature on herbal ointment spray against microorganisms is scanty/limited. The currently marketed preparation does not provide sufficient protection to the wound surface. Bandaging is also not a common practice in farms and small animals, due to the licking, and scratching habit. There is a definite need to protect the wound from environmental contaminants. Thereby promoting wound healing. Therefore, there is a need to develop a newer approach for wound healing management.

OBJECTS OF THE INVENTION
[0009] Primary object of the present disclosure is to provide a formulation that overcomes one or more limitations associated with the conventional compositions/formulations.
[00010] An object of the present disclosure is to provide a formulation for wound healing management.
[00011] Another object of the present disclosure is to provide a method of preparation of a formulation for wound healing management.
[00012] Another object of the present disclosure relates to a formulation that provides a protective layer on the wound surface.
[00013] Still another object of the present disclosure is to provide a formulation that avoids the usage of bandage.
[00014] Further object of the present disclosure is to provide an aerosol spray for wound healing management.
[00015] Still further object of the present disclosure is to provide an aerosol spray that protects the wound from bacteria, dirt, and environmental irritants.
[00016] Yet another object of the present disclosure is to study the sealing and healing effects of the topical aerosol spray in management of wound.
[00017] Other objects of the present invention will be apparent from the description of the invention herein below.

SUMMARY OF THE INVENTION
[00018] The present disclosure relates generally to the field of pharmaceutical composition. Particularly, the present disclosure provides a composition for skin care and mental well-being. The present composition can also find its application as a blend in other compositions/formulations.
[00019] An aspect of the present disclosure provides a formulation for wound healing management comprising: 3 to 8 % w/w of one or more antibiotics of the total weight of the formulation; 2 to 10 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more excipient.
[00020] Another aspect of the present disclosure provides a formulation for wound healing management comprising: 1.5 to 3.5 % w/w of a first antibiotic of the total weight of the formulation; 0.1 to 1 % w/w of a second antibiotic of the total weight of the formulation; 1.4 to 3.5 % w/w of a third antibiotic of the total weight of the formulation; 2 to 10 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more solvent.
[00021] Yet another aspect of the present disclosure provides a method of preparation of a formulation for wound healing management comprising: a) dissolving 1.5 to 3.5 % w/w of a first antibiotic in a solvent with agitation to obtain a first solution; b) dissolving 0.1 to 1 % w/w of a second antibiotic and 1.4 to 3.5 % w/w of a third antibiotic in a solvent with agitation to obtain a second solution; c) mixing of the first solution and the second solution to obtain a third solution; d) adding 2 to 10 % w/w of an aluminium powder in a solvent with stirring to obtain a mixture; and e) adding the third solution of step c) in the mixture of step d) with stirring to obtain a formulation for wound healing management.
[00022] 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.

BRIEF DESCRIPTION OF THE DRAWINGS
[00023] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.
[00024] FIG. 1 illustrates antimicrobial effectiveness test for (A) S. aureus inoculated at 0 day, (B) S. aureus recovered at 14th day and (C) S. aureus recovered at 28th day.
[00025] FIG. 2 illustrates antimicrobial effectiveness test for (A) A. brasiliensis inoculated at 0 day, (B) A. brasiliensis recovered at 14th day and (C) A. brasiliensis recovered at 28th day.
[00026] FIG. 3 illustrates post-surgical suture line in case of rumenotomy in (A) Day 1, (B) Day 3, (C) Day 5, (D) Day 7 and (E) Day 9.
[00027] FIG. 4 illustrates a mastiff femal undergo panhysterectomy after being diagnosed for pyometra (A) Day 1, (B) Day 3, (C) Day 5 and (D) Day 7.
[00028] FIG. 5 illustrates a goat with suppurative wound following dog bite in (A) Day 1, (B) Day 3 and (C) Day 7.
[00029] FIG. 6 illustrates open sepsis wound in cat (A) Day 1 (Before application), (B) Day 1 (After application), (C) Day 3, (D) Day 7, (E) Day 11 and (F) Day 13.
[00030] FIG. 7 illustrates open sepsis wound in foot rot in cattle (A) Day 1 (Before application), (B) Day 1 (After application), (C) Day 3, (D) Day 5, (E) Day 7 and (F) Day 11.
[00031] FIG. 8 illustrates maggoted wound in dog (A) Day 1 (within 3 to 5 minutes after spraying), (B) After operated and (C) completely recovered.
[00032] FIG. 9 illustrates retention of spray on the surface of the skin (A) spray line day 1 and (B) Spray line day 5.

DETAILED DESCRIPTION OF THE INVENTION
[00033] 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.
[00034] 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 skills 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.
[00035] 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.
[00036] 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”.
[00037] As used herein, the terms “blend”, and “mixture” are all intended to be used interchangeably.
[00038] 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.
[00039] 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.
[00040] 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.
[00041] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[00042] 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.
[00043] The present disclosure is on the premise of a surprising discovery that when one or more antibiotics and aluminium powder as part of a formulation in the weight percentage as defined herein, it exhibits that the antibacterial and aluminum powder provides a protective thin layer on the wound surface to avoid entry of dust and dirt and prevent entry of bacteria. The combination of antibiotics with aluminium powder is a novel formulation. The observed effect is unexpected and surprising.
[00044] The present disclosure relates generally to the field of pharmaceutical and veterinary composition. Particularly, the present disclosure provides a formulation for wound healing management. The present disclosure also provides a method of preparation of a formulation for wound healing management.
[00045] An aspect of the present disclosure provides a formulation for wound healing management comprising: 3 to 8 % w/w of one or more antibiotics of the total weight of the formulation; 2 to 10 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more excipient.
[00046] In a preferred embodiment, the formulation for wound healing management comprising: 4 to 7 % w/w of one or more antibiotics of the total weight of the formulation; 4 to 8 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more excipient. In a more preferred embodiment, the formulation for wound healing management comprising: 5 to 6 % w/w of one or more antibiotics of the total weight of the formulation; 5 to 7 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more excipient.
[00047] In an embodiment, the antibiotics and the aluminium powder provide a protective thin layer on the wound surface.
[00048] In an embodiment, the antibiotic is selected from a group consisting of neomycin, polymyxin, bacitracin zinc and combination thereof.
[00049] In an embodiment, the excipient is selected from a group consisting of a thickening agent, a bulking agent, a lubricant, a solubilizer, a binder, a chelating agent, a colouring agent, a tonicity agent, a buffering agent, a moisturizing agent, a fragrance, an emollient, a humectants, an emulsifier, a diluents, a solvent and a combination thereof.
[00050] In an embodiment, the thickening agent(s) includes but not limited to, carbopol, carbomer, acrylate copolymer, beeswax, emulsifying cresmer wax, sodium acrylate/sodium acryloyl dimethyl taurate copolymer, and combinations thereof. However, a person skilled in the art would appreciate that any other thickening agent(s) can be utilized to serve the intended purpose.
[00051] In an embodiment, the bulking agent(s) include but not limited to, lactose USP, starch 1500, mannitol, sorbitol, maltodextrin, maltitol or other non-reducing sugars; microcrystalline cellulose (e.g., Avicel), dibasic calcium phosphate (anhydrous or dihydrate), sucrose, and combinations thereof. However, a person skilled in the art would appreciate that any other bulking agent(s) can be utilized to serve the intended purpose.
[00052] In an embodiment, the lubricant(s) includes but not limited to, zinc stearate, magnesium stearate, stearic acid, calcium stearate, Vegetable stearin, and combinations thereof. However, a person skilled in the art would appreciate that any other lubricant(s) can be utilized to serve the intended purpose.
[00053] In an embodiment, the solubilizer(s) includes but not limited to, cyclodextrins, pH adjusters, salts and buffers, surfactants, fatty acids, phospholipids, metals of fatty acids, and combinations thereof. However, a person skilled in the art would appreciate that any other solubilizer(s) can be utilized to serve the intended purpose.
[00054] In an embodiment, the binder(s) include but not limited to, cellulosic derivatives (such as methylcellulose, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, hydroxypropylmethyl 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 combinations thereof. However, a person skilled in the art would appreciate that any other binder(s) can be utilized to serve the intended purpose.
[00055] In an embodiment, the chelating agent(s) includes but not limited to, tetrasodium glutamate diacetate (e.g., Dissolvine GL-47-S), EDTA salt, and combinations thereof. However, a person skilled in the art would appreciate that any other chelating agent(s) can be utilized to serve the intended purpose.
[00056] In an embodiment, the colouring agent(s) includes but not limited to, E102 Tartrazine, E104 Quinoline 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, and combinations thereof. However, a person skilled in the art would appreciate that any other colouring agent(s) can be utilized to serve the intended purpose.
[00057] In an embodiment, the tonicity agent(s) includes but not limited to, dextrose, glycerin, mannitol, potassium chloride, sodium chloride, and combinations thereof. However, a person skilled in the art would appreciate that any other tonicity agent(s) can be utilized to serve the intended purpose.
[00058] In an embodiment, the buffering agent(s) 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 combinations thereof. However, a person skilled in the art would appreciate that any other buffering agent(s) can be utilized to serve the intended purpose.
[00059] In an embodiment, the moisturizing agent(s) includes, but are not limited to lactic acid and other hydroxy acids and their salts, glycerin, propylene glycol, butylene glycol, sodium PCA, Carbowax 200, Carbowax 400, Carbowax 800, and combinations thereof. However, a person skilled in the art would appreciate that any other moisturizing agent(s) can be utilized to serve the intended purpose.
[00060] In an embodiment, the fragrance(s) includes, but are not limited to alcohols, aldehydes, ketones, esters, ethers, acetates, nitriles, terpene hydrocarbons, nitrogenous or sulfurous heterocyclic compounds and essential oils. However, naturally occurring plant and animal oils and exudates comprising complex mixtures of various chemical components are also know for use as fragrance materials. The individual perfume raw materials which comprise a known natural oil can be found by reference to Journals commonly used by those skilled in the art such as Perfume and Flavourist; or Journal of Essential Oil Research, or those listed in reference texts such as the book by S. Arctander, Perfume and Flavor Chemicals, 1969, Montclair, New Jersey, USA and re-published by Allured Publishing Corporation Illinois (1994). Additionally, some perfume raw materials are supplied by the fragrance houses (Firmenich, International Flavors & Fragrances, Givaudan, Symrise) as mixtures in the form of proprietary 14 speciality accords. Non-limiting examples of the fragrance materials useful herein include pro- fragrances such as acetal pro-fragrances, ketal pro-fragrances, ester pro-fragrances, hydrolyzable inorganic-organic pro-fragrances, and combinations thereof. However, a person skilled in the art would appreciate that any other fragrance(s) can be utilized to serve the intended purpose.
[00061] In an embodiment, the emollient(s) includes but not limited to, caprylic/caprictriglyceride (e.g., Endimulse 33V), isononylisononanoate, squalane (e.g., neossancesqualane), patauaoil (e.g, oenocarpusbataua fruit oil), and combinations thereof. However, a person skilled in the art would appreciate that any other emollient(s) can be utilized to serve the intended purpose.
[00062] In an embodiment, the humectant(s) includes but not limited to, Glycerine, Propylene Glycol, Butylene glycol, aloe-vera gel, hexylene glycol, 25 glyceryl triacetate, Sodium hyaluronate, and combinations thereof. However, a person skilled in the art would appreciate that any other humectant(s) can be utilized to serve the intended purpose.
[00063] In an embodiment, the emulsifier(s) includes but not limited to, hydrogenated lecithin, C12-16 Alcohols, palmitic acid (e.g., Biophillic™ H) and cetylalcohol, glyceryl stearate, PEG-75 stearate, ceteth-20, steareth-2 (Emulium® Delta), and combinations thereof. However, a person skilled in the art would appreciate that any other emulsifier (s) can be utilized to serve the intended purpose.
[00064] In an embodiment, the 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 combinations thereof. However, a person skilled in the art would appreciate that any other diluent(s) can be utilized to serve the intended purpose.
[00065] In an embodiment, the solvent is selected from a group consisting of methylene dichloride, acetone, isopropyl alcohol and combination thereof.
[00066] While one or more embodiments of the present disclosure enumerates and describes a list of excipients that may be used in the composition/formulation to serve an intended purpose, it should be appreciated that one or more excipient(s) may also serve more than one function, obviating the need of inclusion of separate excipients for the specified purpose. Although several embodiments of the present disclosure names few of the commonly used excipients, any other excipient(s) known to or appreciated by a skilled person can also be used to realize the advantageous compositions of the present disclosure. Examples of useful excipients which can optionally be added to the composition are described in the Handbook of Pharmaceutical Excipients, 3rd edition, Edited by A. H. Kibbe, Published by: American Pharmaceutical Association, Washington DC, ISBN: 0- 917330-96-X, and in Handbook of Pharmaceutical Excipients (4th edition), Edited by Raymond C Rowe - Publisher: Science and Practice.
[00067] In an embodiment, the formulation comprises one or more dosage form. The dosage form is selected from a group consisting of aerosol spray, gel, ointment, emulsion, suspension, creams, lotion, paste, foam, film, nano-particles, microparticles, granules or powder. Preferably, the dosage form is aerosol spray, gel, ointment, cream, lotion and paste. More preferably, the dosage form is aerosol spray. The formulation is administered topically.
[00068] Another aspect of the present disclosure provides a formulation for wound healing management comprising: 1.5 to 3.5 % w/w of a first antibiotic of the total weight of the formulation; 0.1 to 1 % w/w of a second antibiotic of the total weight of the formulation; 1.4 to 3.5 % w/w of a third antibiotic of the total weight of the formulation; 2 to 10 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more solvent.
[00069] In a preferred embodiment, the formulation for wound healing management comprising: 2 to 3 % w/w of a first antibiotic of the total weight of the formulation; 0.1 to 0.8 % w/w of a second antibiotic of the total weight of the formulation; 2 to 3 % w/w of a third antibiotic of the total weight of the formulation; 4 to 8 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more solvent. In a more preferred embodiment, the formulation for wound healing management comprising: 2.5 to 3 % w/w of a first antibiotic of the total weight of the formulation; 0.1 to 0.5 % w/w of a second antibiotic of the total weight of the formulation; 2 to 2.5 % w/w of a third antibiotic of the total weight of the formulation; 5 to 7 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more solvent.
[00070] Still another aspect of the present disclosure provides a method of preparation of a formulation for wound healing management comprising: a) dissolving 1.5 to 3.5 % w/w of a first antibiotic in a solvent with agitation to obtain a first solution; b) dissolving 0.1 to 1 % w/w of a second antibiotic and 1.4 to 3.5 % w/w of a third antibiotic in a solvent with agitation to obtain a second solution; c) mixing of the first solution and the second solution to obtain a third solution; d) adding 2 to 10 % w/w of an aluminium powder in a solvent with stirring to obtain a mixture; and e) adding the third solution of step c) in the mixture of step d) with stirring to obtain a formulation for wound healing management.
[00071] In an embodiment, the first antibiotic, the second antibiotic and the third antibiotic are neomycin, polymyxin and bacitracin zinc respectively.
[00072] In an embodiment, the wound healing formulation in step e) has a pH in the range of 3.5 to 4.5.
[00073] In an embodiment, the method is carried out at a temperature in the range of 20 to 30 °C, preferably at a temperature in the range of 23 to 27 °C with RH in the range of 45 to 65 %, preferably RH in the range of 50 to 60 %.
[00074] Polymyxin B is one of a group of closely related substances produced by various strains of Bacillus polymyxa. The activity of polymyxin B is sharply restricted to gram-negative bacteria.
[00075] Neomycin, isolated from Streptomyces fradiae, has antibacterial activity in vitro against a wide range of gram-negative and gram-positive organisms.
[00076] Bacitracin, an antibiotic substance derived from cultures of Bacillus subtilis (Tracy), exerts antibacterial action in vitro against a variety of gram-positive and a few gram-negative organisms.
[00077] In an embodiment, the present formulation contains neomycin, bacitracin, and polymyxin, antibiotics that work by stopping the growth of bacteria.
[00078] Aluminium-based aerosol bandage sprays are commonly used as a protective bandage over wounds, and the product claims that the product works as a waterproof barrier protectant and does not damage wound tissues. It claims that the product works as a waterproof barrier protectant, does not damage wound tissues, adheres to the skin, allows the skin to oxygenate, and acts as a dry barrier against mud, debris, and sensitivity to sunlight. The exact mechanism of action for ALU is currently unknown, and the product may be acting at one of several stages in the healing of thermal wounds. In superficial burn wounds, the stages of wound healing include haemostasis, inflammation, proliferation, and maturation and remodelling of the tissues, including wound contraction, granulation, and re-epithelialization. The difference between burn wounds and other traumatic wounds is that they are characterized by fundamental damage to vital tissues, which complicates the normal wound healing response, as cells and vasculature are often destroyed, leading to a region of coagulative necrosis. The aluminium may be acting as a drying or astringent agent to accelerate wound contracture or reduce inflammation/infection associated with coagulative necrosis. It is not known how ALU would affect healing of other types of wounds. Aluspray forms a waterproof aluminium powder barrier for wounds and sensitive skin. The fine mist completely covers the wound and can be applied without damaging the wound tissue. It contains a proprietary carrier that helps the protective formula to adhere to the skins and allows the wound to breathe which is essential for good healing. Aluspray forms a protective barrier against moisture, micro-organisms, dirt, flies, ideal post castration and post dehorning.
[00079] In the present invention, it is often observed that the wound is contaminated with different microorganisms, such as gram-positive and gram-negative bacteria, aerobic and anaerobic bacteria and sometimes viruses may delay the wound healing process. Therefore, it is essential to control infection at the site of a wound. Hence the present antibiotic combination will clean the infection and aluminum powder form a protective layer coating (Over the wound surface). Thus, the mechanism of the present invention involve that the combination of antibiotics and the aluminum powder is a newer approach that provides a protective thin layer on the wound surface to avoid entry of dust and dirt and prevent entry of bacteria.
[00080] The present invention provides protection against physical, chemical and biological barriers stopping the infection and keeping the dirt and bacteria out while allowing the wound to heal faster. It gives the spray-seal-heal with antibacterial activity.
(A) Biological barrier: Neomycin, Polymixin B and bacitracin zinc offers broad spectrum bactericidal effect indicating its antibacterial property.
(B) Physical barrier: Makes a protective layer on line or site of wounds act as catalyst in collagen formation, reduces cellular permeability and avoids extra granulation indicating its coating property.
(C) Chemical barrier: Sealing of wounds- does not allow fly to sit on wounds indicating its fly repellant property.
[00081] Still another aspect of the present disclosure relates to a method for wound healing management, said method comprising administering to a subject in need thereof a formulation comprising: 3 to 8 % w/w of one or more antibiotics of the total weight of the formulation; 2 to 10 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more excipient. In another embodiment, formulation comprises: 1.5 to 3.5 % w/w of a first antibiotic of the total weight of the formulation; 0.1 to 1 % w/w of a second antibiotic of the total weight of the formulation; 1.4 to 3.5 % w/w of a third antibiotic of the total weight of the formulation; 2 to 10 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more solvent.
[00082] Still further aspect of the present disclosure relates to use of a formulation for wound healing management of a subject, said formulation comprising: 3 to 8 % w/w of one or more antibiotics of the total weight of the formulation; 2 to 10 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more excipient. In another embodiment, said formulation comprises: 1.5 to 3.5 % w/w of a first antibiotic of the total weight of the formulation; 0.1 to 1 % w/w of a second antibiotic of the total weight of the formulation; 1.4 to 3.5 % w/w of a third antibiotic of the total weight of the formulation; 2 to 10 % w/w of an aluminium powder of the total weight of the formulation; and rest being one or more solvent.
[00083] 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 spirit and scope of the embodiments as described herein.
EXAMPLES
[00084] The present invention is further explained in the form of following examples. However, it is to be understood that the following examples are merely illustrative and are not to be taken as limitations upon the scope of the invention.
Example 1
(A) FORMULATION
Table 1: A formulation of the present invention.
Sr. No. Ingredients Kg
1 Neomycin Sulphate I.P. Eq to Neomycin 2.800
2 Polymyxin B sulfate USP Eq. to Polymyxin 0.300
3 Bacitracin Zinc 2.400
4 Methylene Dichloride 73.500
5 Acetone 10.000
6 Isopropyl alcohol (IPA) 5.000
7 Aluminum powder 6.000
Total 100.000

(B) METHOD OF PREPARATION
[00085] The composition of the present invention was prepared by weighing of 2.8 Kg Neomycin Sulphate, 0.3 Kg of Polymyxin B sulfate and 2.4 kg of Bacitracin zinc and 6 Kg of aluminium powder as shown in above Table 1. Methylene di chloride was taken into SS vessel with constant stirring and 0.3 Kg of Polymyxin B sulfate and 2.4 kg of Bacitracin zinc were added with continuous agitation till it got dissolved to obtain a first solution which was transferred into main manufacturing tank. Further, acetone and IPA were taken in SS vessel and 2.8 Kg Neomycin Sulphate was dissolved into it with continuous agitation till it got dissolved and obtained a second solution and the same was transfered to manufacturing tank. The first solution and the second solution were mixed with constant stirring for a period of 5 minutes to obtain a third solution. 6 Kg of aluminium powder was added in a methylene di chloride with continuous stirring to obtain a mixture which is mixed with the third solution with continuous stirring for a period of 5 minutes to obtain the final formulation.
Process parameters:
Appearance: Grey colored solution.
Odor: Unpleasant
pH: 3.5 to 4.5
Temperature: 25 ±2? and RH 55% ±5%.
(C) PACKING:
[00086] The prepared formulation as shown in Table 1 was further filled and sealed in a suitable can for aerosol spray preparation. Gas was filled in the can and leake test was performed. Further batch coding and final packing was carried out. Two type of packing was carried out as shown in Table 2. Further, standard parameters are shown in Table 3.
Table 2: Packaging of the formulation.
Packing S.No. In ml In gm
1 125 74
2 75 44

Table 3: Standard parameters of the formulation.
S. No. Test Standards
1. Solution (Every can) 11±0.5 gm per Can (Pack: 75ml/44gm)
19±0.5 gm per Can ( Pack:125ml/74gm)
2. Propellant 33± 1.0 gm (Pack: 75ml/44gm)
55± 1.0 gm (Pack: 125ml/74 gm)

(D) ANTIMICROBIAL EFFECTIVENESS TEST:
[00087] The formulation of the present invention was challenged with high concentration of micro-organism (105 to 106 cfu) – Staphylococcus aureus ATCC6538, Escherichia coli ATCC8739, Pseusomonas aeruginosa ATCC9027, Candida albicans ATCC 10231 and Aspergillus brasiliensis ATCC16404.
Sample preparation
[00088] 10 ml of sample was taken and 0.1 ml of E.coli having 108 CFU/ml was added to make final concentration of 106 CFU/ml in product. 10 ml of sample was taken and 0.1 ml of S.aureus having 108 CFU/ml was added to make final concentration of 106 CFU/ml in product. 10 ml of sample was taken and 0.1 ml of P.aeruginosa having 108 CFU/ml was added to make final concentration of 106 CFU/ml in product. 10 ml of sample was taken and 0.1 ml of C.albicans having 108 CFU/ml was added to make final concentration of 106 CFU/ml in product. 10 ml of sample was taken and 0.1 ml of A.brasiliensis having 108 CFU/ml was added to make final concentration of 106 CFU/ml in product.
[00089] The present liquid aerosol spray formulation fall in category 2 type as per USP.
[00090] Acceptance criteria for category 2:
(i) Bacteria: NLT 2.0 log reduction from the initial count at 14 days, and no increase from the 14 days count at 28 days.
(ii) Yeast and mold: No increase from the initial calculated count at 14 and 28 days
[00091] The results of the present study showed that for all micro-oragnism, 5 log reduction was obtained which indicated that preservative added in product is likely to be efficient as shown in Table 4 and FIG.s 1 and 2. FIG. 1 (A) showed S. aureus inoculated at 0 day. Count obtained in dilution 104 is 68 and 77. Average is 72.5. Hence final count is 7.25x105. FIG. 1 (B) showed S. aureus recovered at 14th day. Count obtained at 14th day is Nil. Hence final count is zero. FIG. 1 (C) showed S. aureus recovered at 28th day. Count obtained at 28th day is Nil. Hence final count is Nil. FIG. 2 (A) showed A. brasiliensis inoculated at 0 day. Count obtained in dilution 104 is 52 and 69. Average is 60.5. Hence final count is 6.05x105. FIG. 2 (B) showed A. brasiliensis recovered at 14th day. Count obtained at 14th day is Nil. Hence final count is Nil. FIG. 2 (C) showed A. brasiliensis recovered at 28th day. Count obtained at 28th day is Nil. Hence final count is Nil.
Table 4: Results of antimicrobial effectiveness test.
Name of Micro-organism Initial Count Recovery Count Log of Initial Count (A) Log of recovery count (B) Log reduction
S. aureus 14th day 7.25x105 Nil 5.86 Nil 5.86
S. aureus 28th day Nil Nil 5.86
P. aeruginosa 14th day 4.6x105 Nil 5.66 Nil 5.66
P. aeruginosa 28th day Nil Nil 5.66
E. coli 14th day 5.1x105 Nil 5.71 Nil 5.71
E. coli 28th day Nil Nil 5.71
C. albicans 7th day 7.7x105 Nil 5.89 Nil 5.89
C. albicans 14th day Nil Nil 5.89
A. brasiliensis 7th day 6.05x105 Nil 5.78 Nil 5.78
A. brasiliensis 14th day Nil Nil 5.78

(E) FIELD TRIAL OF FORMULATION (AEROSOL SPRAY) IN THE MANAGEMENT OF DIFFERENT WOUNDS IN DOMESTICATED ANIMALS, FARM AND SMALL ANIMALS
[00092] The objective of this study is to evaluate the sealing and healing effects of the Topical aerosol spray of the present invention in management of wound.
[00093] Aerosol spray (Wound healing spray) of the present invention was used for treatment of open, surgical and maggoted wounds in small and large animal practice. A total of 20 routine cases of wounds (open, maggoted and surgical) from day to day OPD were selected for the study. Most of the cases from panjarapole animals were treated as inpatients were as some small and large animals were treated as outpatients as per depending upon the convenience of the owner. Spraying was conducted with start to end and end to start, also top to bottom and bottom to top method. This provided complete wound sealing and coverage on the surface of the wound. The dressings were conducted on every alternate days as, 1, 3, 5, 7, 9 and so on depending upon the size and nature of the wound. The efficacy of the study were done by evaluation of parameters VIZ; Days required for completion of healing, capacity to protect from flies, degree of controlling exudation and maggoticidal action.
[00094] As per recommended usage suggested, aerosol spray of present invention was used after shaking 10-20 times keeping a straight direction so as the solution gets uniformly mixed before application. Aerosol spray of the present invention forms protective barrier (Film formation) on wound surface that protect wound form entry of dust and dirt. It also allows wound to oxygenate (Breath) which is important for wound healing.
(i) Management of surgical aseptic wound after rumenotomy:
[00095] The sealing spray was applied on the post-surgical suture line in case of rumenotomy in individually operated animals on every alternate days (1, 3, 5, 7, 9, 11…) till normal recovery. Post operatively, complete healing was observed within 9 to 12 days in large animal. From FIG. 3, it can be seen that the healthy tissue formation on 7th day onward in large animal.
(ii) Management of surgical wound in panhysterectomy in female dog
[00096] A mastiff female dog undergone panhysterectomy after being diagnosed for pyometra. The surgical wound healing observations as shown in FIG. 4. Effective healing of suture line was observed from day 5th and showed complete recovery on 7th day. Post operatively, complete healing was observed within 7 to 9 days in small animal. From FIG. 4, it can be seen that the healthy tissue formation from 5th day in small animal. It seems that the spray is effective surgical wound healer. While treatment procedure, no evidence of fly’s around the uncovered surgical suture line were seen after use of sealing spray. Hence reducing the chances of maggot infestation.
(iii) Management of dog bite wound in goat
[00097] A goat with suppurative wound following dog bite was successfully treated with healing spray. As fistulous wound, spray content was guided with ear buds to reach deep into the open tract of the wound. The septic wounds treated with the spray showed effective healing from day 3rd with no evidence of exudation at the wound site (FIG. 5). The wound surface remained dry. Effective healing was observed in most of the animals within 8 to 15 days depending upon the depth, site and area of wound. Overall, it seems that the healing spray used for septic wound had effective penetration promoting faster healing and protective coverage at the infected site.
(iv) Open sepsis wound in cat
[00098] A cat presented with chronic suppurative wound on the right lateral abdominal region. Excessive suppurative discharge from the infective wound was observed. Affected area was cleaned and dressed with wound healing spray. Effectively, the suppuration was reduced considerably from 5th day onward and showed granulation with reduced sepsis (FIG. 6). Almost effective healing was evident till 13th days.
(v) Open sepsis wound in foot rot in cattle
[00099] A cow presented with foot rot lesions at right fore limb and foot rot with maggot infestation at left fore limb. Complete healing of left fore limb with maggots was attained on 11th day and that with only foot rot lesions in right fore limb healed up at 9th day as shown in FIG. 7.
(vi) Management of maggoted wound in dog
[000100] A case of Labrador male dog with history of chronic non healing scrotal wound with maggot infestation was presented and considerable loss of tissue at the affected site were evident. Initially, treated with wound healing spray at site of deep seated holes on the scrotal tissues. Maggots started excavating the wound within 3 minutes but complete death of the maggots was not attained as few to some maggots remained alive at the site. Although tissue damage for scrotum was much more and pet was also not cooperative causing additional damage to scrotal tissues by self licking. Hence, dog was operated for scrotal amputation which later recovered effectively. As per routine practice, the cases with maggot infestation were treated with spray at the infected site.
[000101] After spraying, excavation of maggots took place within 3 to 5 minutes but complete death of the maggots was not so potent.
• Few to Some Maggots remained alive and present within or on the wound for some period.
• However the healing effect was found promoting.
• Re infestation of the maggots was not observed at the treatment site.
[000102] Considering the uniform and complete wound coverage property with effective fly repelling property makes the spray better option to counter act the maggoted wounds in large and small animal practice (FIG. 8).
(vii) Retention of spray on the surface of the skin
[000103] After uniformly spaying the wound site it was observed that the spray line remained intact for 36 to 48 hours. Hence alternate day dressings can be manageable while using the sealing spray. None of the animal treated with spray showed any allergens, urticaria, irritation, redness, oedema and cellulitis.
[000104] Spray line at the surface of the surgical closure remained intact from day first to day 5th. This cow was not dressed for 5 days. Intact wound healer spray line can be easily appreciated till day 5 as shown in FIG. 9. This indicates the evidence of sealing at wound site.
(viii) Farm and small animals
[000105] The formulation of the present invention was also applied on the farm and small animals having post-surgical dressing, maggot infested wound, septic wound and the formulation was found very effective.
[000106] The foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.

ADVNATEGES OF THE INVENTION
[000107] The formulation of the present invention effectively protects the wound from bacteria, dirt, and environmental irritants.
[000108] The formulation of the present invention provides a protective layer on the wound surface.
[000109] The present formulation does not require usage of bandage.
[000110] It seems that formulation performs both as healing as well as sealing for the wound very effectively.
[000111] Retention on site of application was sufficiently optimum for sealing & and healing.
[000112] No allergic reactions found at the site of application.

, Claims:1. A formulation for wound healing management comprising:
3 to 8 % w/w of one or more antibiotics of the total weight of the formulation;
2 to 10 % w/w of an aluminium powder of the total weight of the formulation; and
rest being one or more excipient.

2. The formulation as claimed in claim 1, wherein the antibiotics and the aluminium powder provide a protective thin layer on the wound surface.

3. The formulation as claimed in claim 1, wherein the antibiotic is selected from a group consisting of neomycin, polymyxin, bacitracin zinc and combination thereof.

4. The formulation as claimed in claim 1, wherein the excipient is selected from a group consisting of a thickening agent, a bulking agent, a lubricant, a solubilizer, a binder, a chelating agent, a colouring agent, a tonicity agent, a buffering agent, a moisturizing agent, a fragrance, an emollient, a humectants, an emulsifier, a diluents, a solvent and a combination thereof.

5. The formulation as claimed in claim 1, wherein the formulation comprises one or more dosage form.

6. The formulation as claimed in claim 1, wherein the dosage form is selected from a group consisting of aerosol spray, gel, ointment, emulsion, suspension, creams, lotion, paste, foam, film, nano-particles, microparticles, granules or powder.

7. The formulation as claimed in claim 1, wherein the formulation is administered topically.

8. A formulation for wound healing management comprising:
1.5 to 3.5 % w/w of a first antibiotic of the total weight of the formulation;
0.1 to 1 % w/w of a second antibiotic of the total weight of the formulation;
1.4 to 3.5 % w/w of a third antibiotic of the total weight of the formulation;
2 to 10 % w/w of an aluminium powder of the total weight of the formulation; and
rest being one or more solvent.

9. A method of preparation of a formulation for wound healing management comprising:
a) dissolving 1.5 to 3.5 % w/w of a first antibiotic in a solvent with agitation to obtain a first solution;
b) dissolving 0.1 to 1 % w/w of a second antibiotic and 1.4 to 3.5 % w/w of a third antibiotic in a solvent with agitation to obtain a second solution;
c) mixing of the first solution and the second solution to obtain a third solution;
d) adding 2 to 10 % w/w of an aluminium powder in a solvent with stirring to obtain a mixture; and
e) adding the third solution of step c) in the mixture of step d) with stirring to obtain a formulation for wound healing management.

10. The method as claimed in claim 8, wherein the first antibiotic, the second antibiotic and the third antibiotic are neomycin, polymyxin and bacitracin zinc respectively.
11. The method as claimed in claim 8, wherein the solvent is selected from a group consisting of methylene dichloride, acetone, isopropyl alcohol and combination thereof.

12. The method as claimed in claim 8, wherein the wound healing formulation in step e) has a pH in the range of 3.5 to 4.5.

13. The method as claimed in claim 8, wherein the method is carried out at a temperature in the range of 20 to 30 °C with RH in the range of 45 to 65 %.