Description:FORM 2
THE PATENT ACT, 1970
(39 of 1970)
COMPLETE SPECIFICATION
(See section 10; rule 13)
Composition for Burn relief and preparation thereof
GD Goenka University, Sohna Gurugram Road,
Sohna, Haryana, India, 122103
The following specification fully and particularly describes the invention and a method to carry out the same.
FIELD OF INVENTION
The present invention relates to the pharmaceutical field, particularly relates to a Punarnavine-based composition for problem of slow and inefficient burn wound healing and a method to obtain the same.
BACKGROUND OF INVENTION
Burn injuries are a common and often debilitating problem, requiring effective and timely treatment to promote healing and prevent complications such as infections and scarring. Burns are injuries to the skin and underlying tissues caused by heat, chemicals, electricity, sunlight, or radiation. Burn wound healing is a complex process including inflammation, epithelialization, granulation, neovascularization, and wound contraction. Modern therapies present a large number of options, while traditional therapies are promising effective choices. Plant-based products have been used in the treatment of wounds for centuries worldwide. Here's a list of various approaches used in burn creams to address burn wound healing problems, along with their associated disadvantages:
Silver-based dressings: While silver dressings have potent antimicrobial properties, prolonged use can lead to skin discoloration (argyria), potential toxicity, and the risk of developing bacterial resistance.
Topical antibiotics: Antibiotic ointments can help prevent infections in burn wounds, but overuse of antibiotics can contribute to the emergence of antibiotic-resistant strains of bacteria. Additionally, antibiotic creams may not always be effective against the wide range of bacteria that can infect burn wounds.
Biologic dressings: Biological dressings made from human or animal tissue can promote wound healing, but they can be expensive and may carry a risk of disease transmission, as well as potential rejection reactions.
Skin grafts: While skin grafting can effectively repair burn wounds, it is a surgical procedure that carries risks such as infection, poor graft integration, scarring, and the need for multiple surgeries to achieve optimal outcomes.
Despite their effectiveness in some cases, these conventional approaches have significant limitations and potential drawbacks that make them less than ideal for all burn wound healing scenarios. Plant-based products have been used in the treatment of wounds for centuries worldwide. The most commonly found mechanisms behind the
herbal source products supporting wound healing are mostly their antioxidant, anti-inflammatory, antimicrobial, cell proliferative, and angiogenic effects. However there is not much more studies demonstrated in patients except Aloe vera and Avena sp., herbal treatment still show a lot of promise in the future. It is important not to ignore possible toxic and allergic effects of plants and phytochemical agents, but the studies mostly resulted with antitoxic effects. Several herbs show efficient results with therapies of wounds also in burn wounds, which may be considered as an option for treatment. On the other hand, herbal treatment in burn wounds still needs to have more clinical and pharmaceutical studies to place in modern therapies safely. Few of the prior arts decribes Burn relief formulation and methods of making the same.
J.A. Lopez-De Leon, et al. summarizes the literature on the antimicrobial and clinical effects of silver sulphadiazine and the emerging patterns of resistance. Given the dual components, the review separately focuses on silver and the sulphonamide sulphadiazine. Silver has gained popularity as an ingredient in wound dressings, while silver sulphadiazine has found novel applications as a coating for various catheters and endotracheal tubes. Evidence indicates that silver sulphadiazine is a valuable topical agent for treating burns but has limited efficacy in other applications. Notably, silver itself has emerged as the antimicrobial agent of greatest current interest.
M. Yaghoobi, et al determine the efficacy of topical aloe vera for the treatment of burn wounds. Based on a meta-analysis using duration of wound healing as an outcome measure, the summary weighted mean difference in healing time of the aloe vera group was 8.79 days shorter than those in the control group (P = 0.006). Due to the differences of products and outcome measures, there is paucity to draw a specific conclusion regarding the effect of aloe vera for burn wound healing. However, cumulative evidence tends to support that aloe vera might be an effective interventions used in burn wound healing for first to second degree burns. Further, well-designed trials with sufficient details of the contents of aloe vera products should be carried out to determine the effectiveness of aloe vera.
US5461030A relates to formulations and methods for treating wounds utilizing these formulations. The formulations according to the present invention are useful for treating wounds by accelerating wound healing. These formulations comprise an effective amount of a serum free cellular nutrient medium in combination with an effective amount of at least one cellular growth stimulating compound, e.g. a natural anabolic hormone or transforming growth factor.
EP2658562B1 discloses a composition comprising a therapeutically effective amount of Sanguisorbae officinalis aqueous plant extract and an Ailanthus altissima aqueous plant
extract for use in treating and/or preventing a skin infection in a subject in need thereof, wherein the skin infection is an atopic disease, a contact dermatitis, a nummular dermatitis, a radiation dermatitis, a burn, a non-atopic eczema or a pressure sore.
method for treating at least one of a burn, a wound, a scar and a keloid on a user's skin, comprising:
US9511034B1 discloses a method for treating at least one of a burn, a wound, a scar and a keloid on a user's skin, comprising: applying a first silicone-containing elastomer component to the at least one of the burn, the wound, the scar and the keloid on the user's skin, the first silicone-containing elastomer component comprising: between 0.03-0.09 wt % of a silicone platinum catalyst; between 50-80 wt % of a polydimethylsiloxane;
between 10-25 wt % of a noncrystalline silicone dioxide; and between 0.18-0.49 wt % of a hydroxyl terminated polymethylphenylsiloxane;
Despite their effectiveness in some cases, these conventional approaches have significant limitations and potential drawbacks that make them less than ideal for all burn wound healing scenarios. In contrast, the Punarnavine-based cream offers a potentially safer alternative with no adverse effects and promising wound healing benefits.
OBJECTIVES OF THE INVENTION
The present invention has been developed in response to the present state of the art, and in particular, in response to the problems and needs in the art that have not yet been fully solved by currently available techniques and processes.
Accordingly, the present invention has been developed to provide a Punarnavine-based cream which offers a potentially safer alternative with no adverse effects and promising wound healing benefits.
Therefore, the current invention successfully overcoming all of the above-discussed shortcomings present in the art.
o It is an object of the invention to develop composition includes Punarnavine in a formulated cream that aims to accelerate wound healing, reduce pain, inflammation, and minimize scarring, leveraging its anti-inflammatory, antioxidant, and wound-
healing properties.
It is an object of the invention to ensure formulation consistency and efficacy across different batches and applications, maintaining its therapeutic benefits for burn treatment.
It is an object of the invention to utilize Punarnavine from Boerhavia diffusa. Leveraging the bioactive compound Punarnavine extracted from Boerhavia diffusa, known for its medicinal properties, to enhance the composition's effectiveness in treating burn injuries.
It is an object of the invention to optimize patient comfort and compliance: Formulating the composition as an oil/water (O/W) emulsion to provide a less oily, greasy, and sticky texture, enhancing patient comfort and promoting better adherence to treatment regimens.
It is an object of the invention to promote tissue regeneration and wound closure: Developing a methodical approach for preparing the composition, ensuring proper emulsification and incorporation of active ingredients to maximize collagen production, fibroblast proliferation, and overall tissue regeneration for accelerated wound closure and reduced scarring.
How the foregoing objects are achieved will be clear from the following brief description. In this context, it is clarified that the description provided is non-limiting and is only by way of explanation. Other objects and advantages of the invention will become apparent as the foregoing description proceeds, taken together with the accompanying drawings and the appended claims.
SUMMARY OF THE INVENTION
This summary is provided to introduce a selection of concepts in a simplified format that is further described in the detailed description of the invention. This summary is neither intended to identify key or essential inventive concepts of the invention and nor is it intended for determining the scope of the invention.
Burn injuries present significant challenges in wound healing and often require effective treatments to minimize complications like infections and scarring. This invention addresses these challenges with a novel burn wound healing cream formulated using Punarnavine, a bioactive compound extracted from Boerhavia diffusa. Punarnavine is known for its potent anti-inflammatory, antioxidant, and wound-healing properties. By leveraging these properties, the cream accelerates burn
wound recovery, reduces pain and inflammation, and promotes tissue regeneration.
According to an aspect of the present invention relates to a method for preparing a Punarnavine-based burn wound healing cream comprising three phases: Oil Phase (Phase A), Aqueous Phase (Phase B), and Active Ingredients (Phase C). The cream formulation enhances tissue regeneration, reduces pain and inflammation, and improves overall healing outcomes in burn patients.
In an aspect of the invention the formulation comprises (i) Phase A: Oil Phase (Stearic acid 3ml, Cetyl alcohol 0.03ml, Stearyl alcohol 0.01ml), (ii) Phase B: Aqueous Phase (Distilled water 8.54ml, Glycerin 0.4ml, Triethanolamine 0.06ml, Rose water 2ml), and (iii) Phase C: Active Ingredients and Additives (Punarnavine extract 5g, Preservative (methyl paraben) 0.03ml, Fragrance (lavender oil) 0.20ml).
To further clarify the advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which is illustrated in the appended figures. It is appreciated that this figure depicts only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail with the accompanying figure.
BRIEF DESCRIPTION OF FIGURES
These and other features, aspects, and advantages of the present invention will become better understood when the following detailed description is read with reference to the accompanying figures in which like characters represent like parts throughout the figures, wherein:
Figure 1, illustrates a view of flow chart of the preparation of cream for the present invention.
Figure 2, illustrates a view of image of cream prepared for the present invention.
Figure 3, illustrates a view of Comparative Analysis of Burn Wound Healing in Control and Treatment Groups for the present invention.
Further, skilled artisans will appreciate that elements in the figures are illustrated for simplicity and may not have been necessarily been drawn to scale. For example, the
flowcharts illustrate the method in terms of the most prominent steps involved to help to improve understanding of aspects of the present invention. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the figures with details that will be readily apparent to those of ordinary skill in the art having benefit of the description herein.
DETAILED DESCRIPTION OF THE INVENTION
For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the figures and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be restrictive thereof.
Reference throughout this specification to “an aspect”, “another aspect” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrase “in an embodiment”, “in another embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.
The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method. Similarly, one or more devices or systems or elements or structures or components proceeded by "comprises... a" does not, without more constraints, preclude the existence of other devices or other systems or other elements or other structures or other components or additional devices or additional systems or additional elements or additional structures or additional components.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The system, methods, and examples provided herein are illustrative only and not intended to be limiting.
The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items.
The terms “having”, “comprising”, “including”, and variations thereof signify the presence of a component.
Now the present invention will be described below in detail with reference to the following embodiment.
Burn injuries are a common and often debilitating problem, requiring effective and timely treatment to promote healing and prevent complications such as infections and scarring. Traditional approaches to burn wound care typically involve the use of various creams and dressings, some of which may be accompanied by adverse side effects or limited efficacy but this invention relates to a novel burn wound healing cream formulated with Punarnavine, a bioactive compound extracted from the medicinal plant Boerhavia diffusa. The cream leverages the potent anti-inflammatory, antioxidant, and wound-healing properties of Punarnavine to accelerate the recovery process of burn wounds. The formulation is designed to provide a natural and effective alternative to conventional burn treatments, promoting tissue regeneration, reducing pain and inflammation, and minimising scar formation. The Punarnavine-based cream significantly enhances wound closure rates and improves overall healing outcomes in burn patients. This innovative herbal remedy offers a safe and efficacious option for managing burn injuries, with minimal side effects and enhanced patient comfort.
Source of biological materials
The Punarnavine compound is purchased from local vendor of Delhi NCR, India.
EXAMPLES
Example 1: Method of Preparation of punarnavine based composition
To prepare the oil phase (Phase A), begin by weighing 3 grams of stearic acid, 0.03 grams of cetyl alcohol, and 0.01 grams of stearyl alcohol. Place these ingredients into
a beaker and heat them to a temperature of 70-75°C using a hot plate or water bath. Stir the mixture until all components are thoroughly melted and mixed.
Next, for the aqueous phase (Phase B), weigh 8.73 grams of distilled water along with rose water and glycerin. In a separate beaker, heat the distilled water, 2 grams of rose water, and 0.4 grams of glycerin to the same temperature range of 70-75°C. Add 0.06 grams of triethanolamine to this heated mixture and stir until it is completely dissolved.
For the emulsification process, slowly add the aqueous phase (Phase B) to the oil phase (Phase A) while continuously stirring. Use a homogenizer to ensure proper emulsification, continuing to stir until the mixture becomes homogeneous and creamy. Maintain the temperature at 70-75°C during this process.
Once the emulsion is stable, gradually cool the mixture to 40-45°C for the cooling and addition of active ingredients (Phase C). Add 5 grams of Punarnavine extract, 0.03 grams of preservative, and 0.20 grams of fragrance, stirring well to incorporate all ingredients evenly. Continue stirring until the mixture reaches room temperature, then transfer it to a suitable airtight container for storage. (Fig 1)
Example 2: Comparative Analysis of Burn Wound Healing in Control and Treatment Groups.
We conducted a comparative study involving two groups of subjects with burn injuries. The control group, represented in the top row, did not receive any treatment, while the treatment group, shown in the bottom row, was administered a Punarnavine-based cream (fig 3). The healing process was observed and documented over 15 days. On day 0, both groups exhibit similar initial burn injuries. By day 3, the untreated control group's wounds show significant inflammation and redness, whereas the treated group's wounds show reduced inflammation. By day 6, the control group's wounds begin to scab but heal slowly, while the treated group's wounds show rapid healing with significant scab formation. On day 9, the control group's wounds slightly reduced in size, but the treated group's wounds are noticeably smaller, indicating accelerated healing. By day 12, the untreated wounds show further but slow reduction, while the treated wounds are significantly healed with only small marks remaining. By day 15, the control group's wounds are still evident, though reduced, whereas the treated group's wounds are nearly completely healed. This comparison suggests that the Punarnavine-based cream significantly accelerates the healing process of burn wounds, demonstrating its potential efficacy in promoting wound healing.
While the invention has been described with respect to specific composition which include presently preferred modes of carrying out the invention, those skilled in the art will appreciate that there are numerous variations and permutations of the above described embodiments that fall within the spirit and scope of the invention. It should be understood that the invention is not limited in its application to the details of construction and arrangements of the components set forth herein.
Variations and modifications of the foregoing are within the scope of the present invention. Accordingly, many variations of these embodiments are envisaged within the scope of the present invention.
The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of 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 embodiments were chosen and described in order to best explain the principles of the present invention and its practical application, and 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 omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient, but such omissions and substitutions are intended to cover the application or implementation without departing from the spirit or scope of the present invention.
CLAIMS
We Claim,
1. A composition comprising a therapeutically effective amount of Punarnavine for use in treating burns, comprises of;
(i) Phase A: Oil Phase
? Stearic acid: 3%
? Cetyl alcohol: 0.03%
? Stearyl alcohol: 0.01%
(ii) Phase B: Aqueous Phase
? Distilled water: 8.54%
? Glycerin: 0.4%
? Triethanolamine: 0.06%
? Rose water: 2%
(iii) Phase C: Active Ingredients and Additives
? Punarnavine extract: 5%
? Preservative (methyl paraben): 0.03%
? Fragrance (lavender oil): 0.20%
2. The composition as claimed in claim 1, wherein said composition comprises of;
(i) Phase A: Oil Phase
? Stearic acid: 3ml
? Cetyl alcohol: 0.03ml
? Stearyl alcohol: 0.01ml
(ii) Phase B: Aqueous Phase
? Distilled water: 8.54ml
? Glycerin: 0.4ml
? Triethanolamine: 0.06ml
? Rose water: 2ml
(iii) Phase C: Active Ingredients and Additives
? Punarnavine extract: 5g
? Preservative (methyl paraben): 0.03ml
? Fragrance (lavender oil): 0.20ml
3. The composition as claimed in claim 1, wherein said Punarnavine is a bioactive compound extracted from Boerhavia diffusa plant extract.
4. The composition as claimed in claim 1, wherein said composition is in cream form.
5. The composition as claimed in claim 1, wherein said composition is oil/water (O/W) emulsion type, which is less oily, less greasy and less sticky in nature.
6. The composition as claimed in claim 1, wherein said composition promotes collagen production, fibroblast proliferation, and overall tissue regeneration, leading to faster wound closure and reduced scarring.
7. A method of preparing the composition claimed in claim 1, comprising the steps of;
(i) Preparation of Oil Phase (Phase A)
o Weigh the 3ml stearic acid, 0.03 ml cetyl alcohol, and 0.01ml stearyl alcohol.
o Place the ingredients in a beaker and heat to 70-75°C using a hot plate or water bath.
o Stir until all components are melted and mixed thoroughly.
(ii) Preparation of Aqueous Phase (Phase B)
o Weigh the 8.54ml distilled water, 2 ml rose water and 0.4ml glycerin.
o In a separate beaker, heat the distilled water, rose water and glycerin to 70-75°C.
o Add 0.06ml triethanolamine to the heated distilled water, rose water and glycerin mixture and stir until completely dissolved.
(iii) Emulsification
o Slowly add the aqueous phase (Phase B) to the oil phase (Phase A) while continuously stirring.
o Use a homogenizer to ensure proper emulsification. Continue stirring until the mixture becomes homogeneous and creamy.
o Maintain the temperature at 70-75°C during emulsification.
(iv) Cooling and Addition of Active Ingredients (Phase C)
o Once the emulsion is stable, gradually cool the mixture to 40-45°C.
o Add the 5g punarnavine extract, 0.03 ml preservative, and 0.02ml fragrance and Stir well to incorporate all ingredients evenly.
o Continue stirring until the mixture reaches room temperature and transferred to a suitable air-tight container.
Dated, this 04/08/2024
G D Goenka University
APPLICANT
ABSTRACT
Composition for Burn relief and preparation thereof
The present invention relates to a novel burn wound healing cream formulated with Punarnavine, a bioactive compound extracted from the medicinal plant Boerhavia diffusa. The cream leverages the potent anti-inflammatory, antioxidant, and wound-healing properties of Punarnavine to accelerate the recovery process of burn wounds. The formulation is designed to provide a natural and effective alternative to conventional burn treatments, promoting tissue regeneration, reducing pain and inflammation, and minimising scar formation. The Punarnavine-based cream significantly enhances wound closure rates and improves overall healing outcomes in burn patients. This innovative herbal remedy offers a safe and efficacious option for managing burn injuries, with minimal side effects and enhanced patient comfort. , Claims:We Claim,
1. A composition comprising a therapeutically effective amount of Punarnavine for use in treating burns, comprises of;
(i) Phase A: Oil Phase
? Stearic acid: 3%
? Cetyl alcohol: 0.03%
? Stearyl alcohol: 0.01%
(ii) Phase B: Aqueous Phase
? Distilled water: 8.54%
? Glycerin: 0.4%
? Triethanolamine: 0.06%
? Rose water: 2%
(iii) Phase C: Active Ingredients and Additives
? Punarnavine extract: 5%
? Preservative (methyl paraben): 0.03%
? Fragrance (lavender oil): 0.20%
2. The composition as claimed in claim 1, wherein said composition comprises of;
(i) Phase A: Oil Phase
? Stearic acid: 3ml
? Cetyl alcohol: 0.03ml
? Stearyl alcohol: 0.01ml
(ii) Phase B: Aqueous Phase
? Distilled water: 8.54ml
? Glycerin: 0.4ml
? Triethanolamine: 0.06ml
? Rose water: 2ml
(iii) Phase C: Active Ingredients and Additives
? Punarnavine extract: 5g
? Preservative (methyl paraben): 0.03ml
? Fragrance (lavender oil): 0.20ml
3. The composition as claimed in claim 1, wherein said Punarnavine is a bioactive compound extracted from Boerhavia diffusa plant extract.
4. The composition as claimed in claim 1, wherein said composition is in cream form.
5. The composition as claimed in claim 1, wherein said composition is oil/water (O/W) emulsion type, which is less oily, less greasy and less sticky in nature.
6. The composition as claimed in claim 1, wherein said composition promotes collagen production, fibroblast proliferation, and overall tissue regeneration, leading to faster wound closure and reduced scarring.
7. A method of preparing the composition claimed in claim 1, comprising the steps of;
(i) Preparation of Oil Phase (Phase A)
o Weigh the 3ml stearic acid, 0.03 ml cetyl alcohol, and 0.01ml stearyl alcohol.
o Place the ingredients in a beaker and heat to 70-75°C using a hot plate or water bath.
o Stir until all components are melted and mixed thoroughly.
(ii) Preparation of Aqueous Phase (Phase B)
o Weigh the 8.54ml distilled water, 2 ml rose water and 0.4ml glycerin.
o In a separate beaker, heat the distilled water, rose water and glycerin to 70-75°C.
o Add 0.06ml triethanolamine to the heated distilled water, rose water and glycerin mixture and stir until completely dissolved.
(iii) Emulsification
o Slowly add the aqueous phase (Phase B) to the oil phase (Phase A) while continuously stirring.
o Use a homogenizer to ensure proper emulsification. Continue stirring until the mixture becomes homogeneous and creamy.
o Maintain the temperature at 70-75°C during emulsification.
(iv) Cooling and Addition of Active Ingredients (Phase C)
o Once the emulsion is stable, gradually cool the mixture to 40-45°C.
o Add the 5g punarnavine extract, 0.03 ml preservative, and 0.02ml fragrance and Stir well to incorporate all ingredients evenly.
o Continue stirring until the mixture reaches room temperature and transferred to a suitable air-tight container.