DESC:FIELD OF THE INVENTION:
The present invention relates to a spray bandage formulation, and more particularly to a curcumin based spray bandage formulation.

BACKGROUND OF THE INVENTION:
Wounds are typically caused due to injury to body tissues, affecting the epithelial, connective, and muscular tissue. This damage impairs the body's first line of defense, making it vulnerable to bacterial infections, dirt, and external agents. Bacterial infections can lead to tissue swelling, erythema, and edema. If not treated, it may result in further complications including gangrene, tetanus infection and may require amputation. Proper and immediate wound care is essential to prevent complications, and different wounds require specific treatment approaches.
Primarily, the recommended action in first aid in wound injury includes cleaning the wound of any debris and shielding the wound immediately for further care. For wound care, different types of bandages are used to protect the wounds from infection, absorb the exudate, help manage pain and promote healing. There are various types of bandages in the market including adhesive bandages or gauze bandages, hydrocolloid dressings, hydrogels, foam dressings, transparent film dressings, etc. The selection of bandages is based on the necessity of wound care.
The traditional bandages are gauge bandages that sometimes fit too tight or too loose on the wound. Loose bandages fail to achieve aseptic conditions, and tight bandages can cause skin irritation and sores due to pressure and hindrance in normal blood flow in area of injury. Further, the bandages trap moisture and therefore may get wet. Additionally, these bandages are required to be reapplied as they are washed out or the medicinal formula does not remain active for individuals with an active lifestyle. These bandages further need extra protection during swimming, showering, etc. The traditional bandages therefore increase chances of microbial growth in moist conditions and further block free exchange of air to the wound.
The self-adhesive bandages are relatively flexible with stretchy material and are widely used in sports medicine, veterinary care, and wound management. They are easy to apply and remove without causing skin irritation. These bandages, however, lose stickiness over time. Further, the adhesive properties deteriorate if exposed to dirt, moisture, or excessive stretching. Furthermore, these are not ideal for very small wounds for minor cuts and abrasions.
The Chinese application CN217510535U to Zhang Boyin and others teaches a high-fastening elastic tension-reducing sewing-free adhesive tape. It includes double-layer self-adhesive elastic bandage strips that are bonded together and stretched to provide high-fastening retraction force, moving the skin on the two sides of wound oppositely, to close the wound and generate pressure in the wound. Such bandages can slip or loosen if not applied properly. They can cause restricted circulation if wrapped too tightly and are not suitable for highly exudating wounds.
The US patent application US2011098621A1 to Fabo Tomas and others discloses a transparent film dressing for protection of skin surrounding a wound. The stiffening layer of this dressing makes it possible to accurately adapt it to cover all skin surrounding the wound by cutting the dressing along the marked contour. However, transparent film dressings are not suitable for wounds with high exudate. They do not adhere well to moist or oily skin and are difficult to remove without causing skin irritation.
Thus, there is a need for a viable alternative to traditionally used gauge bandages and adhesive bandages to solve the problems associated with them. There is a need for bandages that provide wound care including aseptic care for obstruction from microorganisms, air exchange to the wound and no moisture trapping at the wound site.

SUMMARY OF THE INVENTION:
The present invention relates to a curcumin based spray bandage formulation that includes 0.5 - 5 % w/w of an active antiseptic agent, 17 - 52 % w/w of a first solvent, 1.2 - 4.8 % w/w of a polymer, 0.1 - 5 % w/w of an emollient, 12 - 23 % w/w of a second solvent, 0.1 - 0.4 % w/w of a fragrance, and 35 - 38 % w/w of a propellant.
The active antiseptic agent is Curcuma Longa 95 % IH. The polymer is selected from PVPK 30, polyvinyl alcohol and polyvinyl polymer (Mowital B 30 HH/Drovin B30). The first solvent is selected from ethyl alcohol, methylated spirit, isopropyl alcohol and dimethyl sulfonamide. The second solvent is selected from acetone, methylene chloride, n-pentane, hexane and other volatile solvents. The emollient is selected from castor oil, propylene glycol and butylene glycol. The emollient is preferably castor oil.
In an embodiment, the curcumin based spray bandage formulation includes 4 % w/w Curcuma longa 95 % IH, 38.3 % w/w Isopropyl alcohol, 2.8 % w/w Mowital B 30 HH/Drovin B30 IH, 0.4 % w/w Castor oil IH, 17.3 % w/w Methylene chloride IH, 0.2 % w/w Perfume IH, and 37 % w/w Propellant LPG IH.
The curcumin based spray bandage formulation is applied by spraying from an aluminum can on a wound from a distance of 5 cm. The spray forms a protective film over the wounded area within 20-30 sec.
The process of preparation of the curcumin based spray bandage formulation includes several steps. The first step of solvent addition includes adding 17 - 52 % w/w of first solvent and 12 - 23 % w/w of second solvent in a main manufacturing tank. The second step of polymer addition includes stirring the solution mixture at 100 rpm and adding 1.2 - 4.8 % w/w of a polymer to it and mixing slowly with continuous stirring.
The third step of active antiseptic agent addition includes keeping the solution obtained for 8 hours for soaking and adding 0.5 - 5 % w/w of active antiseptic agent to it and stirring for 5-30 minutes. The fourth step of excipient addition includes mixing 0.1 - 5 % w/w of emollient and a 0.1 - 0.4 % w/w of fragrance agent with the solution, and stirring till complete dissolution of the fragrance agent, and further stirring the solution for 30 min.
The spray bandage formulation, enriched with the healing properties of curcumin, creates a protective layer that mimics natural skin. It effectively aids in wound healing by shielding cuts, abrasions, and wounds from infections while promoting recovery.
DESCRIPTION OF THE INVENTION:
The present invention relates to a curcumin based spray bandage formulation for wound healing. The present invention also relates to a process of preparation of the curcumin based spray bandage formulation.
References in the specification to "one embodiment" or "an embodiment" means that a particular feature, structure, characteristic, or function described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment.
References in the specification to “preferred embodiment” means that a particular feature, structure, characteristic, or function described in detail thereby omitting known constructions and functions for clear description of the present invention.
The foregoing description of specific embodiments of the present invention has been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the present invention to the precise forms disclosed and obviously many modifications and variations are possible in light of the above teaching.
The present invention discloses a curcumin based spray bandage formulation that facilitates convenient and effective wound protection. The formulation is sprayed on a wound and it forms a thin protective film over the wound. This film acts as a barrier, repelling water and preventing the entry of dirt, dust, and bacteria that could lead to infections. The spray bandage creates a sterile environment, facilitates healing, and offers an effective solution for wound care.
In accordance with the present invention, the curcumin based spray bandage formulation includes:
a) an active antiseptic agent 0.5 - 5 % w/w,
b) a first solvent 17 - 52 % w/w,
c) a polymer 1.2 - 4.8 % w/w,
d) an emollient 0.1 - 5 % w/w,
e) a second solvent 12 - 23 % w/w,
f) a fragrance 0.1 - 0.4 % w/w, and
g) a propellant 35 - 38 % w/w.
In accordance with the present invention, the active antiseptic agent is 95% Curcuma longa extract (95% Curcumin Powder). The first solvent is selected from Ethyl alcohol, Methylated spirit, Isopropyl alcohol, Dimethyl sulfonamide and the like. The second solvent is selected from Acetone, Methylene chloride, N-Pentane, Hexane, other volatile solvents and the like. The polymer is selected from PVPK 30, Polyvinyl alcohol, Polyvinyl polymer (Mowital B 30 HH/Drovin B30) and the like. The emollient is selected from Castor oil, Propylene glycol, butylene glycol and the like. The fragrance is selected from mild and skin-safe fragrances / essential oils having antimicrobial properties, including lavender oil, tea tree oil, chamomile oil, eucalyptus oil, calendula extract and the like. The propellant is selected from Liquefied petroleum Gas (LPG) or Dimethyl ether (DME) or the like. The ingredients of the curcumin based spray bandage formulation are obtained from commercially available sources.
Now a preferred process for the preparation of the curcumin based spray bandage formulation in accordance with the present invention is disclosed. The process of preparation of the curcumin based spray bandage formulation includes several steps. In a first step of solvent addition, a predefined amount of first solvent and a predefined amount of a second solvent is added in a main manufacturing tank. In a second step of polymer addition, the solution mixture is stirred at a predefined rpm and a predefined amount of a polymer is added to it and mixed slowly with continuous stirring.
In a third step of active antiseptic agent addition, the solution obtained is kept for a predefined time for soaking and a predefined amount of active antiseptic agent is added to it and stirred for a predefined time. In the next step that is a fourth step of excipient addition, a predefined amount of emollient and a predefined amount of fragrance agent is mixed with the solution, and stirred till complete dissolution of the fragrance agent, and further the solution is finally stirred for a predefined time.
In accordance with the present invention, in the first step of solvent addition, the predefined amount of first solvent is 17 - 52 % w/w and the predefined amount of second solvent is 12 - 23 % w/w. In the second step of polymer addition, the solution mixture is stirred at a predefined rpm of 100 rpm and the predefined amount of polymer is 1.2 – 4.8 % w/w.
In the third step of active antiseptic agent addition, the predefined time for soaking is 8 hours, the predefined amount of active antiseptic agent is 0.5 - 5 % w/w and the predefined time is 5-30 minutes. In the fourth step of excipient addition, the predefined amount of emollient is 0.1 - 5 % w/w and the predefined amount of fragrance agent is 0.1 - 0.4 % w/w, and the solution is stirred for a predefined time of 30 min.
The solution prepared by the method of the present invention is further tested for quality control. First the base formulation, that is the formulation prepared by the method of the present invention is filled into an aluminum can. Next, a predefined amount of propellant is crimped and charged into the canister. Once the product is fully assembled, it undergoes rigorous testing for quality control. The predefined amount of propellant is 35 - 38 % w/w.
In accordance with a preferred embodiment, the curcumin based spray bandage formulation of the present invention is packaged in a 50 x 150 mm aluminum can having 1 inch Majesty valve with Cosmos Actuator and 35 mm PP cap.
In accordance with the present invention, the curcumin based spray bandage formulation is applied by spraying from the aluminum can on a wound from a distance of about 5 cm. The spray forms a protective film over the wounded area within 20 to 30 sec.
The film formed after spraying the formulation consisting of polymer along with the actives inhibits the entry of water in the wound thus making the formulation water repellant. Thus, the film prevents the entry of water and dirt in the wound. The polymer with the organic solvents in the formulation allows the polymer to be easily applied as a coating or film. When the polymer solution is exposed to air, the solvent evaporates due to lower vapour pressure in the air. As the solvent evaporates, the concentration of the polymer increases. The polymer chains come close together as the solvent continues to evaporate. The intermolecular forces between the polymer chains like Van der Waals forces or hydrogen bonding (in the case of polyvinyl alcohol) play lead to the formation of a solid film.
The polymer chains entangle and create a continuous network, once a critical concentration is reached and enough solvent is evaporated. This leads to the formation of a coherent film. The drying time is influenced by environmental conditions such as temperature, humidity, and airflow. In the formulation of the present invention, solvents and micronized actives enhance the film strength, flexibility, and durability. This creates chemical bonds between polymer chains that further stabilize the film structure. The resulting film exhibits properties like flexibility, yellowish colour, and water resistance.
In accordance with the present invention, the film formed on the wound by curcumin based spray bandage formulation stays till 72 hours. The film gradually wears off and detaches on its own as the wound heals. In case of chronic wounds, it is required to reapply the curcumin based spray bandage formulation after the initial film wears off.
In accordance with the present invention, the active antiseptic agent, 95% Curcuma longa extract is micronized. The particle size of curcumin extract is between 1 to 500 micrometers. Micronization enhances the bioavailability and efficacy of the formulation. Their higher dissolution rate leads to more effective therapeutic action.
Micronized curcumin has enhanced permeability through the skin barrier when applied topically on wound. This is because the particles are capable of reaching deeper skin layers by penetrating the stratum corneum and ensure better absorption. Additionally, micronized curcumin ensures a uniform distribution within the formulation, thereby enhancing consistency, reduces skin irritation, and improves the film quality by preventing breakage and uneven spreading. Micronization also enables lower concentrations of curcumin to achieve optimal therapeutic effects, thus minimizing the required dose.
In accordance with a preferred embodiment of the present invention, the preferred emollient is Castor oil. Castor oil has antimicrobial properties and prevents bacteria from reaching the wound. Castor oil keeps the wound moist, promotes healing and prevents cracking of the wound. The ricinoleic acid in castor oil has anti-inflammatory properties that aid in relieving pain. Castor oil aids in new skin tissues maturation and aids in increased blood flow to the wound.
In accordance with the present invention, curcumin and castor oil contributes to faster healing. Curcumin has anti-inflammatory action, antiseptic action, anti-microbial action, and wound contraction. Curcumin increases collagen production at the wound site. It also promotes the differentiation of fibroblasts into myofibroblasts that leads to commencement of the healing process and helps the wound heal more quickly.
These and other embodiments will be apparent to those of skill in the art and others in view of the following detailed description of some embodiments. It should be understood, however, that this summary, and the detailed description illustrate only some examples of various embodiments and are not intended to be limiting to the invention as claimed.

EXAMPLES:
Only a few examples and implementations are disclosed. Variations, modifications, and enhancements to the described examples and implementations and other implementations can be made based on what is disclosed.
Examples are set forth herein below and are illustrative of different amounts and types of reactants and reaction conditions that can be utilized in practicing the disclosure. It will be apparent, however, that the disclosure can be practiced with other amounts and types of reactants and reaction conditions than those used in the examples, and the resulting devices various different properties and uses in accordance with the disclosure above and as pointed out hereinafter.

Example 1: Curcumin Based Spray Bandage Formulation
The curcumin based spray bandage formulation having Curcuma Longa IH (4.0% w/w) and solvents, excipients and propellant q.s. to 100.00 % w/w is as provided below:
Sr No Active Ingredients % w/w for 75g
1 Curcuma longa 95 % IH 4 3
2 Isopropyl Alcohol 38.3 28.725
3 Mowital B 30 HH/Drovin B30 IH 2.8 2.1
4 Castor Oil IH 0.4 0.3
5 Methylene Chloride IH 17.3 12.975
6 Perfume IH 0.2 0.15
7 Propellant LPG IH 37 27.75

Example 2: Preparation of Curcumin based Spray Bandage Formulation
1. 38.3 % w/w of isopropyl alcohol (IPA) and 17.3 % w/w of methylene chloride IH were taken in the main manufacturing tank.
2. The mixture was stirred at 100 rpm and 2.8 % w/w of polyvinyl polymer, Mowital B 30 HH/Drovin B30 IH was added to it and mixed slowly with continuous stirring.
3. The solution obtained was kept for 8 hours for soaking and 4 % w/w of Curcuma longa 95% IH was added to it and stirred for 15 minutes.
4. 0.4 % w/w castor oil IH and 0.2 % w/w fragrance agent were mixed with the solution and stirred till complete dissolution, and finally stirred for 30 min.
5. The solution obtained was tested for quality control.
6. The base formulation was filled in 50 x 150 mm aluminum can that has 1 inch Majesty valve with Cosmos Actuator and 35 mm PP cap. 37 % w/w LPG was crimped and charged, and the final product was tested for quality control.

IPA, Mowital B 30 HH/Drovin B30 IH, Methylene Chloride IH, fragrance agent IH, Propellant LPG IH, Curcuma longa 95% IH and castor oil IH were obtained from commercially available sources.

Example 3: Evaluation of Efficacy of Curcumin based Spray Bandage Formulation on Lacerated wounds and Abrasion on OPD basis
The Curcumin based Spray Bandage Formulation was evaluated on subjects having Lacerated wounds and Abrasion. The results of the same are provided in table 1 below.
Subject Sample size: 30
Subject age: 18-60 years
Wound type: Abrasions - 17, Lacerations - 13
Treatment regimen period: 15 days
Evaluation criteria Subject Follow - up
Day 0 Day 3 Day 5 Day 7 Day 10 Day 14
Spray Application 30 25 14 2 0 0
Wound Closure 0 5 8 16 1 0
Re-epithelialization 0 25 5 0 0 0
Pain Assessment 30 4 0 0 0 0
Infection Status 0 2 0 0 0 0
Scar Formation 0 0 0 5 12 15
Adverse Events 0 0 0 0 0 0
Table 1: Evaluation of Curcumin based Spray Bandage Formulation on subjects having Lacerated wounds and Abrasion
The assessment of the Curcumin based Spray Bandage Formulation on subjects having lacerated wounds and abrasion based on the evaluation criteria is provided below:
a) Wound type: 56% of wounds treated were abrasions while 44% wounds were lacerated wounds
b) Spray application: Spray was applied on all wounds on Day 0. Spray was required to be applied on 83% wounds on Day 3. There was no need to apply the spray on 54% wounds on Day 5. On Day 7, 93% of the subjects did not need treatment with spray at all.
c) Wound closure: 5 wounds closed on Day 3 itself. On Day 5, 44% of wounds were closed. On Day 7, 96% of wounds were completely healed/closed.
d) Re-epithelialization: In 83% wounds, granulation started on Day 3 itself. On Day 5, all wounds started showing granulation / Healing.
e) Pain assessment: On day 0, pain was present in all wounds. Only 13% of wounds showed pain and inflammation on Day 3. From Day 5, no subject presented pain and Inflammation.
f) Infection status: Only 6.5% of the wounds show minor pus formation on Day 3. On Day 5, all wounds were healing, and no sepsis was observed.
g) Scar Formation: All the wounds healed. Scar formation started from day 7.
h) Adverse events: No Subjects showed any adverse events during 15-day treatment regimen.
The subject reported outcome of the product / treatment satisfaction based on the application of the Curcumin based Spray Bandage Formulation on a scale of 1-5 is provided in table 2 below:
Patient Reported Outcome
(On the Scale of 1 - 5) Day 0 Day 3 Day 5 Day 7
1 0 0 0 0
2 0 0 0 0
3 2 0 0 0
4 6 2 0 0
5 22 28 30 30
Scale 5 Percentile Satisfaction 73% 93% 100% 100%
Table 2: Subject reported outcome of the product / treatment satisfaction based on the application of the Curcumin based Spray Bandage Formulation
Example 4: Comparison of Efficacy of Curcumin based Spray Bandage Formulation with Povidone-Iodine
The efficacy of the wound treatment with Curcumin based Spray Bandage Formulation was compared with the wound treatment with broad spectrum topical antiseptic Povidone-Iodine. Table 3 below provides the comparison of efficacy of Curcumin based Spray Bandage Formulation with Povidone Iodine.
Parameter Curcumin based Spray Bandage Formulation Povidone-Iodine Statistical Significance
Time for complete healing 7.2 days 9.8 days p < 0.001
Wound size reduction (on Day 7) 65% 50% p = 0.002
Infection rate 5% 15% p = 0.03
Pain Inflammation score (on Day 3) 2.5 4 p = 0.001

Interpretation:
The p-value is the probability of obtaining results as extreme as or more extreme than the observed data, assuming the null hypothesis is true. It helps assess whether the observed effect is due to random chance or a true underlying difference. A p-value below a commonly used threshold, such as 0.05, is considered statistically significant. This suggests that the likelihood of observing such results under the null hypothesis is low, providing evidence to reject the null hypothesis in favour of the alternative hypothesis.
Efficacy: Treatment with "Curcumin based Spray Bandage Formulation" demonstrates statistically significant improvements over Povidone-Iodine in all measured parameters:
a) Faster wound healing (2.6 days earlier on an average).
b) Greater reduction in wound size at Day 7 (15% more reduction).
c) Lower infection rates (5% in wounds treated with Curcumin based Spray Bandage Formulation vs. 15% in wounds treated with Povidone-Iodine).
d) Reduced subject-reported pain scores (1.5 points lower on average).

Advantageously, the curcumin based spray bandage formulation of the present invention is an antiseptic solution that is enhanced with the healing properties of curcumin, forming a protective layer resembling natural skin, effectively treating and shielding wounds, cuts, and abrasions from infections, and promoting faster healing. The natural antiseptic properties of Haridra help to disinfect the wound, prevent bacterial growth and reduce the risk of infections, ensuring optimal wound care and protection. The innovative formula containing 4% curcumin has antiseptic qualities, and it aids in wound care while maintaining flexibility similar to skin, reducing discomfort during application and movement.
The formulation is waterproof and prevents water from entering the wound. It thus prevents the problems of moisture retention caused by traditional gauze bandages. The bandage spray of the present invention offers water resistance, ensuring durability even in damp conditions.
The spray form of the formulation allows easy and convenient application, ensuring the affected area is adequately covered with protective solution, promoting optimal wound care and healing. The formulation disappears from the wound upon healing, and hence prevents the problems associated with removal of a bandage. The formulation is exceptionally durable, and it remains intact even during sweating, making it a reliable option for those having an active lifestyle.

The embodiments were chosen and described in order to best explain the principles of the present invention and its practical application, to thereby enable others, skilled in the art to best utilize the present invention and various embodiments with various modifications as are suited to the particular use contemplated.
It is understood that various omission and substitutions of equivalents are contemplated as circumstance may suggest or render expedient, but such are intended to cover the application or implementation without departing from the scope of the present invention.
,CLAIMS:We claim:
1. A curcumin based spray bandage formulation comprising:
a) 0.5 - 5 % w/w of an active antiseptic agent,
b) 17 - 52 % w/w of a first solvent,
c) 1.2 - 4.8 % w/w of a polymer,
d) 0.1 - 5 % w/w of an emollient,
e) 12 - 23 % w/w of a second solvent,
f) 0.1 - 0.4 % w/w of a fragrance, and
g) 35 - 38 % w/w of a propellant.
2. The curcumin based spray bandage formulation as claimed in Claim 1, wherein the active antiseptic agent is Curcuma longa 95 % IH.
3. The curcumin based spray bandage formulation as claimed in Claim 1, wherein the polymer being selected from PVPK 30, polyvinyl alcohol and polyvinyl polymer (Mowital B 30 HH/Drovin B30).
4. The curcumin based spray bandage formulation as claimed in Claim 1, wherein the first solvent being selected from ethyl alcohol, methylated spirit, isopropyl alcohol and dimethyl sulfonamide; and the second solvent being selected from acetone, methylene chloride, n-pentane, hexane and other volatile solvents.
5. The curcumin based spray bandage formulation as claimed in Claim 1, wherein the emollient being selected from castor oil, propylene glycol and butylene glycol.
6. The curcumin based spray bandage formulation as claimed in Claim 5, wherein the emollient preferably being castor oil.
7. The curcumin based spray bandage formulation as claimed in Claim 1, wherein the composition including:
a) 4 % w/w Curcuma longa 95 % IH;
b) 38.3 % w/w Isopropyl Alcohol;
c) 2.8 % w/w Mowital B 30 HH/Drovin B30 IH;
d) 0.4 % w/w Castor Oil IH;
e) 17.3 % w/w Methylene Chloride IH;
f) 0.2 % w/w Perfume IH; and
g) 37 % w/w Propellant LPG IH.
8. The curcumin based spray bandage formulation as claimed in Claim 1, wherein the formulation being applied by spraying from an aluminum can on a wound from a distance of 5 cm; such that the spray forming a protective film over the wounded area within 20-30 sec.
9. A process of preparation of the curcumin based spray bandage formulation as claimed in Claim 1, wherein the process including:
a) a first step of solvent addition, further including adding 17 - 52 % w/w of first solvent and 12 - 23 % w/w of second solvent in a main manufacturing tank;
b) a second step of polymer addition, further including stirring the solution mixture at 100 rpm and adding 1.2 - 4.8 % w/w of a polymer to it and mixing slowly with continuous stirring;
c) a third step of active antiseptic agent addition, including keeping the solution obtained for 8 hours for soaking and adding 0.5 - 5 % w/w of active antiseptic agent to it and stirring for 5-30 minutes; and
d) a fourth step of excipient addition, including mixing 0.1 - 5 % w/w of emollient and a 0.1 - 0.4 % w/w of fragrance agent with the solution, and stirring till complete dissolution of the fragrance agent, and further stirring the solution for 30 min.

Dated this 09th day of March 2024.

For MIDASCARE PHARMACEUTICALS PVT LTD

Mahurkar Anand Gopalkrishna
IN/PA-1862
(Agent for Applicant)