WO2025186842A1 - "a curcumin based powder spray formulation" - Google Patents

Abstract

The present invention discloses a formulation of curcumin basedpowder spray that includes 95% Curcuma longa 2-6 %w/w, isopropyl myristate 01-0.2 %w/w, Aluminum Starch Octynyl Succinate 3-7 %w/w, n-pentane 18.7-22.7 %w/w and propellant 68-72 %w/w. Also disclosed is a process for preparation of the formulation of curcumin based antiseptic powder spray. This powder spray of the present invention is applied by spraying the same from an aluminum can directly on to a wound site to provide antiseptic protection without physically touching the wound. The powder spray is enhanced with the healing properties of turmeric (Curcuma longa), forming a protective layer on the wound site, effectively treating deep wounds, cuts, and abrasions from infections.

Description

“A CURCUMIN BASED POWDER SPRAY FORMULATION”

FIELD OF THE INVENTION:

The present invention relates to a powder spray formulation, more particularly to a curcumin based powder spray formulation.

BACKGROUND OF THE INVENTION:

Typically, any type of injury to a human body, leads to damage to tissues, which are called wounds. Injuries may be due to surgery, accident, natural calamities, violence, animal attack, burning or other similar reason. The severity of an injury depends on the reason for the wound formation, the weapon or the causative agent of the injury, and the tissues affected by the injury.

There are different types of tissues in a human body such as connective tissue, muscular tissue, nervous tissue and epithelial tissue that get damaged when an injury happens. A skin or mucous membrane injury leads to damage to the epithelial tissue. The damage in the tissue causes an easy opening for bacteria such as Pseudomonas sp., Staphylococcus sp., and other microorganisms to enter the wound site.

Infections caused by such bacteria and microorganisms may lead to reddening and inflammation to the wound site, as well as pus formation if the wound is not treated right away. In severe cases, it may result in further complications such as gangrene and tetanus infection. Therefore, immediate and proper care of a wound injury and use of antiseptics on the wound site is of utmost importance to avoid further complications. Antiseptics are chemical agents that slow down or inhibit the growth of bacteria or other microorganisms on external body surfaces. Conventionally, antiseptics such as peroxides are used for wound cleaning that destroy the bacteria on the wound site.

However, typical antiseptic agents are liquid formulations and require a substrate such as cotton for application to wound site. Further, there is an issue related to physically touch the wound site while applying the liquid formulations, causing risks of contamination. Contamination of the wound site may increase the pace of the bacterial infection to the wound. Further, as the formulations are liquid, they pose a risk to drip off the skin due to factors such as gravity.

Another way to treat the wound is by using antiseptic powders to help cleanse and protect the skin from infection. These sprays are often used for their antibacterial properties and can help to prevent infection by killing harmful bacteria on the skin’s surface. The antiseptic powder sprays commonly available in the market are formulated using Povidone-iodine, Benzalkonium chloride, silver sulfadiazine, etc.

However, these powder antiseptic formulations can sometimes be too drying, especially when used on larger or sensitive areas of the skin. This can lead to cracked skin or hinder the natural healing process, potentially making the wound more susceptible to further injury or infection. Further, the antiseptic components used in this formulation pose some side effects on the patient’s skin. For example, povidone-iodine can cause mild skin irritation, especially if used on sensitive or broken skin. This can include redness, itching, or a rash. In sensitive individuals it may cause hives, swelling, difficulty breathing, or more severe skin reactions. Other side effects include burning and stinging sensation, staining of skin and clothes, etc.

The PCT application W00100251A1 to Patel Dinesh Shantilal and Kurani Shashikant Prabhudas discloses an antiseptic and anti-microbial pharmaceutical composition comprising feracrylum formulated in different forms such as, solution, spray, powder. This formulation is mainly intended to be used as an anti-microbial and antiseptic agent. However, feracrylum does not have antimicrobial properties and needs to be used with any other antiseptic agent such as povidine-iodine. It is mainly used as a hemostatic agent to control bleeding, as it helps promote clot formation at the site of injury.

Thus, there is a need for a viable alternative to liquid antiseptic formulations to solve the problems associated with conventional antiseptics. There is a need for antiseptic formulations that do not require physical touch for application to the wound site and do not fall off or drip off of the wound site once applied.

SUMMARY OF THE INVENTION:

The present invention relates to a curcumin based powder spray formulation that includes an active antiseptic agent in an amount ranging from 02-06 %w/w; a humectant or a moisturizer in an amount ranging from 0.1-0.5 %w/w; a bulk additive in an amount ranging from 03-07 %w/w; a solvent in an amount ranging from 18.7-22.7 %w/w; and a propellant in an amount ranging from 68-72 %w/w.

The active antiseptic agent is 95% Curcuma Longa extract/powder. The humectant or moisturizer is selected from Isopropyl Myristate, Glycerin, Propylene glycol, and the like. The bulk additive is selected from Aluminum Starch Octenyl Succinate, Stearalkonium Hectorite and the like. The solvent is selected from alkanes such as n-pentane, N hexane and acetone. The propellant is selected from Liquid Petroleum Gas (LPG), Dimethyl ether (DME) and the like.

The process of preparation of the curcumin based powder spray formulation includes the following steps: a) adding 0.1- 0.5 %w/w of humectant and 18.7-22.7 %w/w of solvent in a main manufacturing tank followed by constant stirring; b) adding 3-7 %w/w of bulk additive followed by mixing and continuous stirring; c) adding 2-6 %w/w of the active antiseptic agent to the solution obtained in the previous step with constant stirring for 20 mins.

The curcumin based powder spray formulation of the present invention uniformly spreads onto the affected/injured area with curcumin powder enabling a thin powder coat on the wound surface thereby absorbing excessive secretions from wound and aiding in drying up the wound faster. The formulation enables curcumin to penetrate deeper and protects the wound from sepsis. The formulation has antiinflammatory along with antiseptic action thus aiding in healing wound faster, avoid pus pocket formation and form a dry cover on wound.

DESCRIPTION OF THE INVENTION:

The present invention relates to a curcumin based antiseptic powder spray formulation. The present invention also relates to a process of preparation of the curcumin based powder spray 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 antiseptic powder spray formulation that facilitates convenient and effective wound protection. The formulation is sprayed on a wound and it forms a thin protective coating over the wound. The formulation shields the wounds from infections and promotes faster healing.

In one aspect, the present invention discloses a curcumin based powder spray formulation.

In another aspect, the present invention describes a process of preparation of the curcumin based powder spray formulation. In yet another aspect, the present invention discloses the packaging of the formulation of curcumin based powder spray.

In accordance with a preferred embodiment, the present invention discloses a curcumin based powder spray formulation that includes: a) an active antiseptic agent 02-06 %w/w; b) a humectant or moisturizer 0.1-0.5 %w/w; c) a bulk additive 03-07 %w/w; d) a solvent 18.7-22.7 %w/w; and e) a propellant 68-72 %w/w.

In accordance with this preferred embodiment, the active antiseptic agent is 95% Curcuma longa extract (95% Curcumin Powder). The humectant or moisturizer is selected from Isopropyl Myristate, Glycerin, Propylene glycol, and the like. The bulk additive is selected from Aluminum Starch Octenyl Succinate, Stearalkonium Hectorite and the like. The solvent is selected from alkanes such as n-pentane, N hexane and Acetone. The propellant is selected from Liquid Petroleum Gas (LPG), Dimethyl ether (DME) and the like. The ingredients of the curcumin based powder spray formulation are obtained from commercially available sources.

Now a preferred process for the preparation of the formulation of a curcumin based antiseptic powder spray in accordance with the present invention is disclosed. The process for preparing the formulation of curcumin based powder spray includes a plurality of steps as described below.

In a first step, 0.1- 0.5 %w/w of humectant and 18.7-22.7 %w/w of solvent is taken in a main manufacturing tank. In a second step, the solution mixture is stirred constantly, and 3-7 %w/w of bulk additive is added to it and mixed slowly with continuous stirring. In a third step, the active 2-6 %w/w Curcuma longa (95%) is added to the solution obtained in the second step with constant stirring for 20 mins.

In a fourth step, the solution sample obtained from the previous step is bulk tested for quality control. In a fifth step, the base is filled, the propellant is charged, and the final product is tested for quality control.

In accordance with the present invention, the formulation of curcumin based powder spray 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 formulation of curcumin based antiseptic powder spray of the present invention is applied by spraying from the aluminum can on a wound from a distance of about 5 cm. 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.

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 comeum and ensure better absorption. Additionally, micronized curcumin ensures a uniform distribution within the formulation, thereby enhancing consistency, reduces skin irritation, and ensures spreadability. Micronization also enables lower concentrations of curcumin to achieve optimal therapeutic effects, thus minimizing the required dose. The antiseptic powder spray of the present invention uniformly spreads the affected/injured area with curcumin powder enabling a thin powder coat on the wound surface thereby absorbing excessive secretions from wound and aiding in drying up the wound faster. The formulation enables curcumin to penetrate deeper and protects the wound from sepsis. The active ingredients act as anti-inflammatory along with antiseptic action thus aiding in healing wound faster, avoid pus pocket formation and form a dry cover on wound. The bulk additive in the formulation of the present invention adds a free-flowing property to the formulation enabling uniform spreading of the formulation that dries quickly. Further the additive prevents the clogging of the spray pump in use.

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 Powder Spray Formulation

The formulation of curcumin based powder spray having 95% Curcuma longa IH (4.0 %w/w) and solvents, excipients and propellant q.s. to 100.00 %w/w is as provided below: Example 2: Preparation of Curcumin based powder spray formulation

0.3 %w/w of Isopropyl Myristate IH and 20.7 %w/w of N-Pentane IH were taken in a main manufacturing tank. Next the solution mixture is stirred constantly and 5 %w/w of Aluminum Starch Octenyl Succinate IH is added to it and mixed slowly with continuous stirring. After stirring, the active 4 %w/w Curcuma longa (95%) is added to the solution with constant stirring for 20 mins. The solution sample obtained from the previous step is bulk tested for quality control. The solution obtained was tested for quality control. 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. 70 %w/w LPG was crimped and charged, and the final product was tested for quality control. Example 3: Evaluation of Efficacy of Curcumin based powder spray Formulation on Lacerated wounds and Abrasion on OPD basis

The Curcumin based powder spray 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 - 15, Lacerations - 15

Treatment regimen period: 15 days Table 1: Evaluation of Curcumin based powder spray Formulation on subjects having Lacerated wounds and Abrasion

The assessment of the Curcumin based powder spray formulation on subjects having lacerated wounds and abrasion based on the evaluation criteria is provided below: a. Wound type: 50% of wounds treated were abrasions; the other 50% wounds were lacerated wounds b. Spray application: Spray was applied on all wounds on Day 0. Spray was required to be applied on 53% wounds on Day 6. There was no need to apply the spray on 76% wounds on Day 8. On Day 10, 90% of the subjects did not need treatment with powder spray at all. c. Wound closure: 2 wounds closed on Day 4 itself. On Day 6 50% of wounds were closed. On Day 8, 100% of wounds were completely healed/closed. d. Re-epithelialization: In 40% wounds, granulation started on Day 4 itself. On Day 6, all wounds started showing granulation / healing. e. Pain assessment: On day 0, pain was present in all wounds. Only 27% of wounds showed pain and inflammation on Day 4. From Day 5, no subject presented pain and Inflammation. f. Infection status: Only 13% of the wounds show minor pus formation on Day 2. 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:

Table 2: Subject reported outcome of the product / treatment satisfaction based on the application of the Curcumin based powder spray Formulation

Example 4: Comparison of Efficacy of Curcumin based Spray Bandage Formulation with Povidone Iodine

The efficacy of the wound treatment with Curcumin based powder spray 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 powder spray formulation with Povidone Iodine.

Interpretation:

Efficacy: Treatment with "Curcumin Powder Spray" demonstrates statistically significant improvements over Povidone-Iodine in all measured parameters: a. Faster wound healing (1.8 days earlier on an average). b. Greater reduction in wound size on Day 8 (12% more reduction). c. Lower infection rates (5% in wounds treated with Curcumin powder Spray Formulation vs. 15% in wounds treated with Povidone-Iodine). d. Reduced subject-reported pain scores (1.5 points lower on average).

Advantageously, the formulation of curcumin based powder spray of the present invention is an antiseptic powder spray that is enhanced with the healing properties of turmeric, forming a coat of natural antiseptic on the wound, effectively treating and shielding wounds, cuts, and abrasions from infections. The formulation of curcumin based powder spray has a targeted delivery on the site of infection or wound, thus provides precise protection only to the wounded area of the skin, unlike traditional antiseptics that require broad application.

The curcumin based powder spray of the present invention, allows application of the antiseptic powder onto the wound without touching the wound site, thus limiting chances of infections to the wound. The formulation of curcumin based antiseptic spray is able to treat deep wounds due to its targeted delivery, thus providing antiseptic protection to wound sites that are out of reach of traditional antiseptic formulations. The formulation of curcumin based powder spray is easy to use and requires no expertise of application, ensuring fast accessibility.

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

CLAIMS:

1. A curcumin based powder spray formulation comprising: a) an active antiseptic agent in an amount ranging from 02-06 %w/w; b) a humectant or a moisturizer in an amount ranging from 0.1- 0.5 %w/w; c) a bulk additive in an amount ranging from 03-07 %w/w; d) a solvent in an amount ranging from 18.7-22.7 %w/w; and e) a propellant in an amount ranging from 68-72 %w/w.

2. The curcumin based powder spray formulation as claimed in Claim

1, wherein the active antiseptic agent is 95% Curcuma Longa extract/powder.

3. The curcumin based powder spray formulation as claimed in Claim

1, wherein the humectant or moisturizer is selected from Isopropyl Myristate, Glycerin, Propylene glycol, and the like.

4. The curcumin based powder spray formulation as claimed in Claim

1, wherein the bulk additive is selected from Aluminum Starch Octenyl Succinate, Stearalkonium Hectorite and the like.

5. The curcumin based powder spray formulation as claimed in Claim

1, wherein the solvent is selected from alkanes such as n-pentane, N hexane and acetone.

6. The curcumin based powder spray formulation as claimed in Claim

1, wherein the propellant is selected from Liquid Petroleum Gas (LPG), Dimethyl ether (DME) and the like.

7. A process of preparation of the curcumin based powder spray formulation as claimed in Claim 1, wherein the process including: a) adding 0.1- 0.5 %w/w of humectant and 18.7 - 22.7 %w/w of solvent in a main manufacturing tank followed by constant stirring; b) adding 3-7 %w/w of bulk additive followed by mixing and continuous stirring; c) adding 2-6 %w/w of the active antiseptic agent to the solution obtained in the previous step with constant stirring for 20 mins.