Description:FORM 2

THE PATENTS ACT, 1970
(39 of 1970)

AND

THE PATENTS RULES, 2003
(See Section 10; rule 13)

COMPLETE SPECIFICATION

A FORMULATION FOR WOUND HEALING MANAGEMENT FOR PROLONGED TREATMENT OF OPEN WOUNDS
VETOQUINOL INDIA ANIMAL HEALTH PRIVATE LIMITED
INDIAN
5TH AND 6TH FLOOR, HAMILTON BUILDING, B-WING, HIRANANDANI BUSINESS PARK, GHODBUNDER ROAD, THANE – 400607, MAHARASHTRA, INDIA.
The following specification particularly describes the invention and manner in which
it is to be performed.

FIELD OF THE INVENTION
[0001] The present invention is a Patent of Addition of the granted patent- 562669 (Patent Application Number- 202321076660, dated-09/11/2023). The present invention relates to an open wound management formulation. More particularly, it pertains to a formulation for prolonged treatment of thermal wounds and for treatment of mild superficial or open wounds in animals without afflicting the risk of any form of infection on the wound.

BACKGROUND OF THE INVENTION
[0002] In rural veterinary medicine, superficial wounds are among the most frequently encountered clinical presentations, often resulting from mechanical trauma, horn injuries, barbed wire lacerations, or minor post-surgical lesions. Left untreated or improperly managed, such wounds can lead to secondary infections, fly strike, and chronic ulceration, contributing to economic losses, animal discomfort, and prolonged recovery.

[0003] The present dosage for healing thermal wounds in animals comprises one or more sprays, ointments, or application powders with fly repellent properties. These preparations are used after wound dressing.

[0004] However, there is no definite wound protection from dust, dirt, microorganisms, and water. The conventional products of herbal ointment spray against microorganisms are 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

[0005] To overcome the above-mentioned problems, conventional wound healing management compositions include antibiotic properties and elements to prevent infections on thermal wounds. However, such antibiotic wound healing compositions are composed of potent and strong formulations suitable for serious wounds.

[0006] Additionally, the wound healing management compositions with antibiotic properties are useful for severe thermal burns and wounds. Prolonged usage of wound healing management compositions with antibiotic properties renders the skin of the animals prone to allergic reactions due to the potent formulation of the wound healing management compositions with antibiotic properties.

[0007] Moreover, long-term and prolonged care and healing of thermal wounds require a mild dosage, and often the prolonged usage develops resistance of the skin towards the antibiotic properties of the wound healing management compositions. This in turn increases the risk of infections during prolonged consumption and may deteriorate the recovery rate of the thermal wound.

[0008] Additionally, existing wound healing management compositions are suitable for applications on severe burns and thermal wounds due to faster application and recovery rate. However, for superficial wound healing, usage of existing wound healing management compositions would render antibiotic resistance causing various side effects.

[0009] Furthermore, the conventional wound healing management compositions with antibiotic properties primarily provide anti-bacterial protection to the wounded area, and in turn don’t provide complete protection against parasitic and microbial infections occurring on the wounded area of the animals.

[0010] In the research paper titled “Evaluation of horn bud wound healing following cautery disbudding of pre-weaned dairy calves treated with aluminum-based aerosol bandage” authored by K.L. Huebner, A.K. Kunkel, and others, emphasizes the importance of wound healing following disbudding in dairy calves, a critical factor often overlooked in previous research on pain response and animal welfare. By demonstrating that a topical aluminum bandage spray significantly improves wound recovery within three weeks, it suggests that dairy producers and veterinarians should incorporate such treatments into routine calf care. While pain response post-disbudding has been extensively studied, wound healing itself may serve as a more direct indicator of long-term welfare concerns, as delayed recovery could have lasting effects on production and overall health. Given that traditional pain assessment methods may not fully capture the nuances of healing-related discomfort, the findings call for a broader perspective on post-disbudding care. Implementing effective topical treatments could lead to better outcomes for dairy calves, enhancing both their well-being and productivity in the industry. However, this paper nowhere discloses a composition with anti-microbial properties suitable for prolonged care and healing of thermal wounds in animals.

[0011] In another research paper titled “Aluminum powder as a dry dressing in exposure treatment of thermal burns” authored by A W Farmer, M D Maxman, I R Chasmar, and W R Franks demonstrates that aluminum powder can serve as an effective dry dressing in the exposure treatment of thermal burns. Its excellent thermal conductivity aids in rapid heat dissipation from burn sites, potentially limiting the depth of thermal injury. Additionally, aluminum's inherent antimicrobial and anti-inflammatory properties contribute to reduced infection rates and improved healing outcomes. However, this paper nowhere discloses a composition with anti-microbial properties suitable for prolonged care and healing of thermal wounds in animals.

[0012] Therefore, in light of the above-mentioned problems, an improved formulation of thermal wound management composition for prolonged usage and for preventing microbial and parasitic infections is required.

OBJECT OF THE INVENTION
[0013] The objective of the present invention is to provide an antimicrobial and anti-parasitic thermal and open wound management formulation.
[0014] Yet another objective of the present invention is to provide a cost-effective and mild thermal and open wound management formulation.
[0015] Yet another objective of the present invention is to provide a mild thermal and open wound management formulation suitable for prolonged usage without harming or causing an allergic reaction to the skin.
[0016] Yet another objective of the present invention is to provide a thermal and open wound management formulation with aluminum powder and other ingredients that increase the prophylactic application for low-risk and superficial thermal wounds.
[0017] Yet another objective of the present invention is to increase barrier formation capabilities of the aluminum powder used in the formulation.

SUMMARY OF THE INVENTION
[0018] Within the scope of this application, it is expressly envisaged that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, in the claims and/or in the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible.
[0019] The present invention generally relates to a formulation for wound healing management for prolonged treatment of thermal and open wounds. The formulation comprising a 5% to 10 % w/w of an aluminum powder of a total weight of the formulation, a 75% to 80% w/w of a first solvent of the total weight of the formulation, a 8% to 10% w/w of a second solvent of the total weight of the formulation, and a 3% to 5% w/w of a third solvent of the total weight of the formulation. The first, second, and third solvents providing a physicochemical cleansing system for preventing microbial infections.
[0020] In an embodiment of the present invention, the first solvent being methylene dichloride, the second solvent being acetone, and the third solvent being Isopropyl alcohol (IPA).
[0021] In another embodiment of the present invention, the aluminum powder forms a protective thin layer on the wound surface, and the aluminum powder being in a micro ionized powder form.
[0022] In another embodiment of the present invention, the formulation being provided in one or more dosage form, wherein the dosage form is selected from a group consisting of aerosol spray, gel, ointment, emulsion, suspension, creams, lotion, paste, foam, film, nanoparticles, microparticles, granules or powder.
[0023] In another embodiment of the present invention, the formulation is administered topically on the wounded part of body on a wound of a size ≤25 cm.
[0024] In another embodiment of the present invention, the wound size reduces in 14 days with a mean reduction efficiency of 87.3%.
[0025] In another embodiment of the present invention, the formulation is prepared at an ambient temperature of 15-25 degree Celsius at 25-60% RH.
[0026] In another embodiment of the present invention, the thermal wounds being mild superficial wounds.
[0027] In another aspect of the present invention, is a method of preparation of a formulation for wound healing management for prolonged treatment of thermal and open wounds. The method comprising steps of firstly adding a 75% to 80% w/w of a first solvent. Secondly adding a 8% to 10% w/w of a second solvent. Thirdly, adding a 3% to 5% w/w of a third solvent. Fourthly, adding and stirring 5% to 10 % w/w of aluminum powder to a mixture of the first, second, and third solvents to obtain a physicochemical cleansing system for preventing microbial infections. Finally, drying the mixture to obtain a formulation for wound healing management for prolonged treatment of superficial thermal wounds.
[0028] In an embodiment, the first solvent being methylene dichloride, the second solvent being acetone, and the third solvent being Isopropyl alcohol (IPA).
[0029] In an embodiment, the wound healing formulation has a pH in the range of 3.5 to 4.5.
[0030] In an embodiment, the method is carried out at a temperature in the range of 15 to 25 °C with RH in the range of 25 to 60 %.
[0031] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

[0032] BRIEF DESCRIPTION OF DRAWINGS
[0033] The illustrated embodiments of the subject matter will be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. The following description is intended only by way of example and simply illustrates certain selected embodiments of devices, systems, and methods that are consistent with the subject matter of the present invention.
[0034] Figure 1: A flowchart of the process of manufacturing the thermal and open wound management formulation for prolonged use.
[0035] Figure 2a, 2b: Images of the healing properties of claimed thermal and open wound management formulation on superficial wounds.
[0036] Figures 3: Images of the healing properties of claimed thermal and open wound management formulation on superficial wounds.

[0037] DETAILED DESCRIPTION OF THE INVENTION
[0038] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings and flowchart. The embodiments are in such detail as to communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit, and scope of the present disclosure as defined by the appended claims.
[0039] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the embodiments of the present invention. It will be apparent to one skilled in the art that embodiments of the present invention may be practiced without some of these specific details. If the specification states a component or feature “may”, “can”, “could”, or “might” be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.
[0040] As used in the description herein and throughout the claims that follow, 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.
[0041] Although any methods similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, the exemplary methods are now described. The described embodiments are merely exemplary of the disclosure, which may be embodied in various forms.
[0042] 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 outlined 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 outlined in the specific examples are reported as precisely as practicable.
[0043] 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 value is incorporated into the specification as if it were individually recited herein.
[0044] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments. 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.
[0045] 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.
[0046] Various modifications to the embodiment will be readily apparent to those skilled in the art, and the generic principles herein may be applied to other embodiments. However, an ordinary skill in the art will readily recognize that the present disclosure is not intended to be limited to the embodiments illustrated but is to be accorded with the widest scope consistent with the principles and features described herein.
[0047] The present invention provides a formulation for wound healing management for the prolonged treatment of thermal and open wounds. In one embodiment, the thermal wounds are minor, non-infected, or prophylactic wounds. In one embodiment, the wound is a superficial wound of size of ≤25 cm.
[0048] The thermal and open wound management formulation comprising an aluminum powder, said aluminum powder ranging from 5% to 10 % w/w of a total weight of the formulation. The formulation also comprising a first solvent, a second solvent, and a third solvent. The first solvent ranges from 75% to 80% w/w of the total weight of the formulation. In one embodiment, the second solvent ranges from 8% to 10% w/w of the total weight of the formulation. In another embodiment, the third solvent ranges from 3% to 5% w/w of the total weight of the formulation. Furthermore, the first, second, and third solvents provide a physicochemical cleansing system for preventing microbial infections on the superficial thermal wounds. In one embodiment, the formulation is prepared at an ambient temperature of 15-25 degree Celsius at 25-60% RH. In another embodiment, the thermal and open wound management formulation being prepared in a holding tank with a mechanical stirrer and an inbuild homogenizer. In one embodiment, the wound healing formulation has a pH in the range of 3.5 to 4.5.
[0049] In a preferred embodiment, the first solvent is methylene dichloride, the second solvent is acetone, and the third solvent is Isopropyl alcohol (IPA). In an embodiment, the composition of the formulation for thermal wound management is provided as:
Ingredient Composition
Aluminium Powder 6%
Methylene Dichloride 79%
Acetone 10%
IPA (Isopropyl Alcohol) 5%

[0050] In one embodiment, the aluminum powder forms a protective thin layer on the wound surface. In another embodiment, the aluminum powder is provided in a micro-ionized powder form. In another embodiment, the formulation is provided in one or more dosage form, wherein the dosage form is selected from a group consisting of aerosol spray, gel, ointment, emulsion, suspension, creams, lotion, paste, foam, film, nanoparticles, 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. Furthermore, the formulation is administered topically on the wounded part of body.
[0051] In one embodiment, the aluminum particles remain the functional cornerstone of the formulation. When applied, they form a uniform, occlusive film that covers the wound site. It also acts as a physical barrier that protects against dirt, pathogens, and fly infestation. The aluminum powder also acts as a moisture-regulating layer that encourages natural healing and prevents desiccation.
[0052] The exact mechanism of action for thermal and open wound sealing by aluminum powder 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 hemostasis, inflammation, proliferation, and maturation and remodeling of the tissues, including wound contraction, granulation, and re-epithelialization. The aluminum 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 aluminum powder would affect the healing of other types of wounds. The present formulation forms a waterproof aluminum 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. The aluminum powder forms a protective barrier against moisture, micro-organisms, dirt, flies, ideal post castration and post dehorning.
[0053] In an embodiment, the first solvent, Methylene Dichloride, acts as a fast-evaporating, low-surface-tension solvent that ensures rapid film deposition and uniform distribution, and thereby prevents infection on the surface of the wound. In another embodiment, the second solvent, acetone, is volatile, bacteriostatic, and causes drying of the thermal wound. In another embodiment, the third solvent, Isopropyl Alcohol (IPA) is effective against a wide range of microbes as it causes membrane disruption in microbes and thereby prevents infection of the thermal wound by preventing microbial penetration. In another embodiment, the formulation spray demonstrated effective repellence against flies, a common source of wound contamination in livestock, and thereby increases the healing ability of the thermal wounds.
[0054] EXAMPLES
[0055] The present invention is further explained in the form of the 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.
Ingredient Composition
Aluminium Powder 6%
Methylene Dichloride 79%
Acetone 10%
IPA (Isopropyl Alcohol) 5%

(B) METHOD OF PREPARATION
[0056] In one embodiment, a method of preparation of a formulation for wound healing management for prolonged treatment of thermal and open wounds, said method comprising steps of adding 75% to 80% w/w of a first solvent; then adding 8% to 10% w/w of a second solvent; and then adding 3% to 5% w/w of a third solvent; and finally adding and stirring 5% to 10 % w/w of aluminum powder to a mixture of the first, second, and third solvents to obtain a physicochemical cleansing system for preventing microbial infections. The whole mixture is created by continuous stirring in a SS vessel.
Process parameters:
Appearance: Grey colored solution.
Odor: Unpleasant
pH: 3.5 to 4.5
Temperature: 15-25℃ and with moderate humidity and frequent fly prevalence—typical semi-arid zones and ideal for testing wound barrier efficacy.
(C) PRODUCT PACKAGING
The formulation is packaged in a 75 mL aluminum aerosol cans containing micronized aluminum particles suspended in a hydrocarbon propellant.
Parameter Specification Batch Tested
Aluminum purity ≥99.5% ALSP0525
Particle size (D50) 9.6 μm Verified
Morphology Lamellar flakes Confirmed
Propellant type Hydrocarbon blend Safe class-A
(D) TEST PROCEDURE AND RESULTS:
Treatment Protocol
• Wound sites cleaned with sterile saline.
• The thermal wound formulation sprayed from 15 cm distance for 3–5 seconds.
• Application repeated once daily for 14 days.
• No additional antiseptic or systemic antibiotic was administered.
Data Collection and Monitoring
• Wound dimensions recorded at Day 0, 3, 7, and 14.
• CRFs documented pain, redness, swelling, and discharge.
RESULTS
[0057] Laboratory Analysis: Aluminum powder analysis results:
Parameter Result Spec Limit Status
Aluminum content 99.6% ≥99.5% PASS
D10 2.8 μm ≤5 μm PASS
D50 9.6 μm 10±2 μm PASS
D90 23.1 μm ≤25 μm PASS
Morphology Flaky & lamellar Qualitative PASS
These results confirm manufacturing control and batch homogeneity.
[0058] Clinical Field Data: Average initial wound size was 14.2 cm² (±3.5). Healing metrics are presented below:
Day Mean Wound Area (cm²) Std. Dev % Reduction
0 14.2 3.5 -
3 10.6 2.8 25.4%
7 5.9 2.0 58.5%
14 1.8 1.2 87.3%
Statistical analysis yielded a p-value < 0.01, indicating significant reduction by Day 14. Wound size reduction from 14.2 cm² at baseline (Day 0) to 1.8 cm² by Day 14
No animals exhibited: Allergic reactions, Delayed healing, and Irritation or secondary infection.
[0059] Wound healing involves a cascade of biochemical and cellular events. The efficacy of topical agents depends not only on their pharmacological action but also on their ability to support these natural phases:
a. Hemostasis- Aluminum powder accelerates surface drying.
b. Inflammation- Physical barrier prevents microbial load and reduces inflammation.
c. Proliferation- Maintains a moist wound bed favorable for keratinocyte migration.
d. Remodeling- Barrier prevents disruption during final epithelial regeneration.
[0060] The above clinical results demonstrate that the present thermal and open wound healing formulation provides overall healing of the thermal and open wounds by treating all the above-mentioned four dimensions, particularly due to the lamellar morphology of the aluminum powder that aids in physical shielding.
[0061] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions, or examples, which are comprised to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.
ADVANTAGES OF THE INVENTION
a. The invention provides a wound healing management solution suitable for frequent use in food-producing animals without risk of antimicrobial resistance or regulatory non-compliance.
b. The invention provides retention of aluminum-based barrier function which physically shields the wound and prevents external contamination.
c. The invention provides a synergistic solvent system of IPA, Acetone, and Methylene Dichloride which provides surface cleansing, rapid drying, and antiseptic action.
d. The invention also provides a ready-to-use, sprayable format suitable for field, farm, and over-the-counter use without medical supervision for treating superficial wounds.
e. The invention also eliminates secondary infection, irritation, or adverse reaction.
f. The invention also provides rapid drying, excellent fly repellence, and protective barrier formation.
g. The invention also provides enhanced user confidence for frequent application without concerns of antibiotic resistance.
, Claims:CLAIMS
I/ We Claim:
1. A formulation for wound healing management for prolonged treatment of thermal and open wounds, said formulation comprising:
5% to 10 % w/w of an aluminum powder of a total weight of the formulation;
75% to 80% w/w of a first solvent of the total weight of the formulation;
8% to 10% w/w of a second solvent of the total weight of the formulation; and
3% to 5% w/w of a third solvent of the total weight of the formulation;
wherein said first, second, and third solvent providing a physicochemical cleansing system for preventing microbial infections.
2. The formulation as claimed in claim 1, wherein said first solvent being methylene dichloride, said second solvent being acetone, and said third solvent being Isopropyl alcohol (IPA).
3. The formulation as claimed in claim 2, wherein said aluminum powder forms a protective thin layer on the wound surface, wherein said aluminum powder being in a micro ionized powder form.
4. The formulation as claimed in claim 1, wherein the formulation being provided in one or more dosage form, wherein the dosage form is selected from a group consisting of aerosol spray, gel, ointment, emulsion, suspension, creams, lotion, paste, foam, film, nanoparticles, microparticles, granules or powder.
5. The formulation as claimed in claim 1, wherein the formulation is administered topically on the wounded part of body, wherein the wound being of a size ≤25 cm.
6. The formulation as claimed in claim 1, wherein the wound size reduces in 14 days with a mean reduction efficiency of 87.3%.
7. The formulation as claimed in claim 1, wherein the formulation is prepared at an ambient temperature of 15-25 degree Celsius at 25-60% RH.
8. The formulation as claimed in claim 1, wherein the thermal wounds being mild superficial wounds.
9. A method (100) of preparation of a formulation for wound healing management for prolonged treatment of thermal and open wounds, said method comprising steps of:
Adding (102) 75% to 80% w/w of a first solvent;
Adding (103) 8% to 10% w/w of a second solvent;
Adding (104) 3% to 5% w/w of a third solvent;
adding and stirring (105) 5% to 10 % w/w of aluminum powder to a mixture of said first, second, and third solvents to obtain a physicochemical cleansing system for preventing microbial infections; and
drying (106) the mixture to obtain a formulation for wound healing management for prolonged treatment of superficial thermal wounds.
10. The method as claimed in claim 9, wherein said first solvent being methylene dichloride, said second solvent being acetone, and said third solvent being Isopropyl alcohol (IPA), wherein the wound healing formulation has a pH in the range of 3.5 to 4.5, and wherein the method is carried out at a temperature in the range of 15 to 25 °C with RH in the range of 25 to 60 %.
Dated: 01 July 2025