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An Herbal Anti Rashes Topical Formulation

Abstract: ABSTRACT AN HERBAL ANTI RASHES FORMULATION The present invention is related to an herbal anti-rashes formulation. Moreover, the present invention relates to an herbal formulation comprising of Aloe vera gel, oil, antioxidant, Emulsifier, preservative, Fragrance. The present invention is to provide an herbal anti-rashes roll-on formulation for the treatment of inner thigh rashes and the process for preparing the same.

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Patent Information

Application #
Filing Date
28 May 2024
Publication Number
26/2024
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application
Patent Number
Legal Status
Grant Date
2025-06-20

Applicants

1. PATEL RUTU RAJANKUMAR
A/2, Parul Tenament, Opp,Vidhatat society, Rannapark,Ghatlodia,Ahmedabad city,Gujarat,380061
2. GONDALIYA NIYATI DINESHBHAI
17, Bharvi park Street Nikol gam, Odhav road, AHMEDABAD, GUJARAT, INDIA, 382350
3. SORATHIYA DIVYA BHUPATBHAI
B-403,Ananta Greens, Near Bhakti Circle, Behind Pramukh Swami Mandir New Indian Colony ,Nikol, Ahmedabad Gujarat- 382350
4. DR. NISHA HEMANT PARIKH
L. M. College of Pharmacy, Assistance professor, Department of Pharmaceutical Chemistry & Quality Assurance, Navrangpura, Ahmedabad-380009, Gujarat.

Inventors

1. PATEL RUTU RAJANKUMAR
A/2, Parul Tenament, Opp,Vidhatat society, Rannapark, Ghatlodia, Ahmedabad,Gujarat,380061
2. GONDALIYA NIYATI DINESHBHAI
17, Bharvi park Street Nikol gam, Odhav road, AHMEDABAD, GUJARAT, INDIA, 382350
3. SORATHIYA DIVYA BHUPATBHAI
B-403,Ananta Greens, Near Bhakti Circle, Behind Pramukh Swami Mandir New Indian Colony ,Nikol, Ahmedabad Gujarat- 382350
4. DR. NISHA HEMANT PARIKH
L. M. College of Pharmacy, Assistance professor, Department of Pharmaceutical Chemistry & Quality Assurance, Navrangpura, Ahmedabad-380009, Gujarat.
5. DR. TUSHAR MAHENDRABHAI PATEL
L. M. College of Pharmacy, Senior Lecturer, Department of Pharmaceutics, Navrangpura, Ahmedabad-380009, Gujarat.

Specification

Description:FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10; rule 13)
1. TITLE OF THE INVENTION – AN HERBAL ANTI RASHES FORMULATION
2. Applicant(s)
a. NAME: PATEL RUTU RAJANKUMAR
b. NATIONALITY: INDIAN
c. ADDRESS: A/2, Parul Tenament, Opp,Vidhatat society, Rannapark,Ghatlodia,Ahmedabad city,Gujarat,380061

a. NAME: SORATHIYA DIVYA BHUPATBHAI
b. NATIONALITY: INDIAN
c. ADDRESS: B-403,Ananta Greens, Near Bhakti Circle, Behind Pramukh Swami Mandir New Indian Colony ,Nikol, Ahmedabad Gujarat- 382350

a. NAME: GONDALIYA NIYATI DINESHBHAI
b. NATIONALITY: INDIAN
c. ADDRESS: 17, Bharvi Park, Nikol Gam, Odhav road, Ahmedabad, Gujarat, India-382350

a. NAME: DR. NISHA HEMANT PARIKH
b. NATIONALITY: INDIAN
c. ADDRESS: L. M. College of Pharmacy, Department of Pharmaceutical Chemistry & Quality Assurance, Navrangpura, Ahmedabad-380009, Gujarat.
3. PREAMBLE TO THE DESCRIPTION
The following specification particularly describes the invention and the manner in which it is to be performed.

AN HERBAL ANTI RASHES FORMULATION

FIELD OF THE INVENTION
The present invention is related to an herbal anti-rashes formulation. More particularly, the present invention relates to an oil-in-water herbal anti rashes formulation comprising of Aloe vera gel solution, oil, antioxidant, emulsifier, preservative and fragrance. The present invention also relates to the process for the preparation of the anti-rashes formulation.

BACKGROUND OF THE INVENTION
A rash on the inner thigh or groin area is an uncomfortable experience. Possible causes include eczema, contact dermatitis, chafing, heat rash, hidradenitis suppurativa, jock itch, pityriasis rosea, razor burn, swimmer’s itch and STIs. While inner rashes are a common skin condition. Inner thigh rashes can affect individuals of all ages, genders, and rashes. Some of the common causes of inner thigh rashes is:
• Friction,
• Sweating,
• Allergic reaction to substances like soap, detergent, etc.
• Bacterial and fungal infection such as jock itch, Candia albicans.

The immune response to these factors can cause inflammation, redness, and itching. Some common signs and symptoms include:
• Redness and inflammation in the affected area
• Itching and discomfort
• Pain or burning sensation
• Blisters, bumps, or pimple
• Oozing or crusting
• Swelling or tenderness
• Odor or discharge
• Fever or chills (in case of severe infection)
The existing treatments for inner thigh rashes often involve chemical-based topical medications, such as ketoconazole cream and other allopathic products. While these formulations have proven to be effective, they can be slow to penetrate the skin and may cause discomfort during application. Thus, there is a need for an alternative herbal formulation that is easy to use in daily life, provides quick absorption, and does not cause extreme discomfort.

Currently, application of gels, pastes, ointments, macerated, extracts or drug solutions or other whose purpose is topical application, localized or not, on the skin or organic mucosa is made from multi-dose containers nature. The application is made directly depositing the drug from the dosage form over the treated or targeted area, but without a volumetric control of the amount (dose) to be applied, thus being the patient himself who applies the amount deemed necessary who also extends the medicine to the affected area.

The roll-on distribution system is formed by a ball engaged rotating in an inside cylindrical sleeve engaged in turn, by pressure or screwing, in the neck of the container. Said system is ideal for liquid or gelatinous compounds but not for powders, as the layer of powder that adheres to the ball and which, by rotation, is transferred onto the surface of the body, is soon used up. In fact, in the normal use of similar products, the container is held in a vertical or slightly tilted position, but with the opening wherefrom the powder issues turned upwards. In this position, due to the effect of gravity, the product in powder/liquid/gelatinous form held in the container is on the bottom of the same container, thus obliging the user to turn the container over continuously to allow the distributor ball to come into contact with the powder/liquid or gelatinous form of the active ingredient.

The present invention developed a unique herbal formulation specifically designed to address inner thigh rashes and promote optimal skin health. The roll-on applicator of the herbal inner thighs rashes roll on offers several advantages. Firstly, it allows for precise application directly onto the affected area, ensuring targeted delivery of the product and maximizing its therapeutic effects. Additionally, the roll-on applicator significantly reduces absorption time, facilitating rapid and efficient penetration of the active ingredients into the skin. By minimizing absorption time, the product optimizes the bioavailability of its active compounds, resulting in enhanced effectiveness.

Furthermore, the roll-on applicator design ensures minimal wastage of the product by providing controlled dispensing. This feature ensures that the appropriate dose is applied without any excess product being dispensed or wasted, travel friendly and easy for application on skin. The controlled application not only promotes cost-effectiveness but also encourages efficient utilization of the product.

Hence, there is need to develop the formulation which helps to manage with the problem of irritation of the inner thigh rashes with lesser to no side effects. The inventors of the present invention have developed the formulation which is safe, natural and efficacious and evaluated the potential of herbal ingredients for the treatment of inner thigh rash.

OBJECTIVE OF THE INVENTION
The main objective of the present invention is to provide an herbal anti-rashes formulation.

Another objective of the present invention is to provide an herbal anti-rashes formulation of aloe vera gel solution.

Another objective of the present invention is to provide an herbal anti-rashes formulation of natural ingredient for treating inner thigh rash.

Another objective of the present invention is to provide an herbal anti-rashes formulation providing quick relief and promoting skin healing.

Another objective of the present invention is to provide an herbal anti-rashes formulation which has controlled and hygienic application on the affected area and is ease to use and is portable.

Yet another object of the present invention is to provide an herbal anti-rashes formulation of natural ingredients which has better patient compliance.

SUMMARY OF THE INVENTION
The main aspect of the present invention is to provide an herbal anti-rashes formulation.

Another main embodiment of the present invention is to provide an herbal anti-rashes formulation comprising of Aloe vera gel, oil, antioxidant, Emulsifier, preservative, Fragrance.

The other aspect of the present invention is to provide an herbal anti-rashes formulation and the process for preparing the same.

BREIF DESCRIPTION OF DRAWINGS
Figure 1: illustrates results for the skin irritation study.
Figure 2: illustrates effect of roll-on formulation.

DESCRIPTION OF THE INVENTION
The main embodiment of the present invention is to provide an herbal anti-rashes formulation.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described.

As used herein, whether in a transitional phase or in the body of a claim, the terms “comprise(s)” and “comprising” are to be interpreted as having an open-ended meaning. That is, the terms are to be interpreted synonymously with the phrases “having at least” or “including at least”. When used in the context of a process, the term “comprising” means that the process includes at least the recited steps, but may include additional steps. When used in the context of a composition, the term “comprising” means that the composition includes at least the recited features or components, but may also include additional features or components.

As used herein, the singular forms “a,” “an” and “the” specifically also encompass the plural forms of the terms to which they refer, unless the content clearly dictates otherwise.

The following terms shall have, for the purposes of this application, the respective meanings set forth below.

"Optional" or "optionally' means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where the event occurs and instances where it does not.

The term “about” is used herein to means approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” or “approximately” is used herein to modify a numerical value above and below the stated value by a variance of 20%.

As used herein, the term "formulation" unless otherwise defined refers to liquid or gel or solution for topical pharmaceutical dosage form.

The term “emulsifier” used herein is defined as is a substance that encourages the suspension of one liquid in another.

The term “anti-oxidant” used herein is defined as an ingredient or a substance that protects the skin from deleterious effects acting due to the free-radicals and helps in maintenance of healthy skin.

The term “preservative” used herein means a substance or a chemical that is added to pharmaceuticals to prevent decomposition by microbial growth or by undesirable chemical changes.

The present invention overcomes the aforesaid drawbacks of the above, and other objects, features and advantages of the present invention will now be described in greater detail. Also, the following description includes various specific details and are to be regarded as merely exemplary. Accordingly, those of ordinary skill in the art will recognize that: without departing from the scope and spirit of the present disclosure and its various embodiments there may be any number of changes and modifications described herein.
As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible sub ranges and combinations of sub ranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, et cetera As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, etc. As will also be understood by one skilled in the art all language such as “up to,” “at least,” and the like include the number recited and refer to ranges which can be subsequently broken down into sub ranges as discussed above.

Nothing in this disclosure is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term "comprising" means "including, but not limited to.

The main embodiment of the present invention is to provide an herbal anti-rashes formulation comprising of Aloe vera gel, oil, antioxidant, Emulsifier, preservative, Fragrance.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein said Aloe vera gel used in the range of 1 to 150 ml, more preferably 50 to 100 ml, more preferably 50 to 70 ml.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein said oil can be selected from Jojoba oil, Coconut oil, Rose oil, Tea Tree oil, Moringa oil, Castor Oil, Lemon Oil, Jasmine, more preferably coconut oil.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein the said oil used is in the range of 1 to 50 ml, more preferably in the range of 1 to 20 ml, most preferably 11 ml.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein antioxidant can be selected from saffron, ginger, vitamin E, cinnamon and black pepper, more preferably vitamin E.

Vitamin E is an antioxidant that can help protect the skin from damage caused by free radicals. It can also help improve skin elasticity and reduce the appearance of fine lines and wrinkles. Vitamin E may help reduce inflammation in the skin, which can be beneficial for people with conditions such as acne or eczema.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein the said antioxidant used is in the range of 1 to 20 ml, more preferably in the range of 1 to 10 ml, most preferably 3 ml.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein said Emulsifier can be selected from acacia, span 20, span 60, polysorbate 20, polysorbate 80, sodium laurate sulfate and tragacanth, more preferably polysorbate 80.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein the said emulsifier used is in the range of 1 to 50 ml, more preferably in the range of 1 to 20 ml and most preferably 11 ml.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein the said preservative can be selected from benzalkonium chloride, benzoic acid, benzyl alcohol, parabens, sorbic acid and chlorobutanol, more preferably benzyl alcohol.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein the said preservative used is in the range of 1 to 20 ml, more preferably in the range of 1 to 10 ml and most preferably 2 ml.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein Fragrance can be selected from rose oil, citronella oil, lemon grass oil and eucalyptus oil, more preferably rose oil.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein the said Fragrance used is in the range of 1 to 10 ml, more preferably 1 to 5 ml, most preferably 3 ml.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein the step to prepare the herbal anti rashes formulation comprises the following steps:
a. Mixing aloe vera gel and purified water with electronic homogenizer to prepare a homogenized aloe vera gel solution in one beaker;
b. Mixing the solution of step (a) with polysorbate 80 in another beaker,
c. Mixing coconut oil with Vitamin E with electronic homogenizer in a separate beaker;
d. Adding slowly the solution of step (c) in the solution of step (b);
e. Mixing the solution of step (d) continuously;
f. Adding benzyl alcohol to the solution of step (e);
g. Adding rose oil to the solution of step (f).
h. Storing the prepared emulsion of step (g) in a container.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein said formulation comprising 1 to 150 ml of aloe vera gel, 1 to 50 ml of oil, 1 to 20 ml of antioxidant, 1 to 50 ml of Emulsifier, 1 to 20 ml of preservatives and 1 to 10 ml of Fragrance.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein said formulation comprising 50 to 70 ml of aloe vera gel, 1 to 20 ml of oil, 1 to 10 ml of antioxidant, 1 to 20 ml of Emulsifier, 1 to 10 ml of preservatives and 1 to 5 ml of Fragrance.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein the said formulation is oil-in-water emulsion.

Another embodiment of the present invention is to provide an herbal anti-rashes formulation, wherein the said formulation is in the form of liquid which is filled in a roll-on device.

As per one embodiment, the present invention is used for treating inner thigh rashes, diaper rash in children and older people as well as is used for providing relief for period rash also.

The invention is further illustrated by the following examples which are provided to be exemplary of the invention and do not limit the scope of the invention. While the present invention has been described in terms of its specific embodiments, certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the present invention.

EXAMPLES:
EXAMPLE 1: TRIAL BATCHES FOR THE HERBAL ANTI-RASHES ROLL-ON FORMULATION
Trails were conducted with different emulsifier such as acacia, xanthan gum and polysorbate 80. Also a combination of rose oil and jojoba oil was used for the selection of fragrance.
Sr.No INGREDIENTS F1X F2X
1. Aloe vera gel solution 74% 60%
2. Coconut oil 11% 18%
3. Xanthan gum 5% 8 %
4. Benzyl alcohol 2% 2%
5. Vitamin E oil 5% 8%
6. Fragrance (rose oil) q.s. q.s.
7. Jojoba oil 0% 1%
Table 1: Trial batches with xanthan gum for the herbal anti-rashes roll-on formulation

Sr.No INGREDIENTS F1X F2X
1. Aloe vera gel solution 74% 60%
2. Coconut oil 11% 18%
3. Acacia 5% 8 %
4. Benzyl alcohol 2% 2%
5. Vitamin E oil 5% 8%
6. Fragrance (rose oil) q.s. q.s.
7. Jojoba oil 0% 1%
Table 2: Trial batches with acacia for the herbal anti-rashes roll-on formulation

Observation: The emulsion formed with acacia (batch F1A) and xanthan gum (batch F1X) were not elegant, more viscous, and less stable, so its use was skipped and selected polysorbate 80 for further trial. Fragrance of rose oil alone was more acceptable, then the combination of rose oil and Jojoba oil, so we selected rose oil alone in the formulation.

Further, after optimizing the excipients different amounts and concentration of excipients were studied and the following table shows the trial batches for the same.
Sr.No INGREDIENTS F1 F2 F3 F4 F5
1. Aloe vera gel solution 74% 60% 60% 60% 70%
2. Coconut oil 11% 18% 16% 21% 11%
3. Polysorbate 80 5% 8% 9% 11% 11%
4. Benzyl alcohol 2% 2% 2% 2% 2%
5. Vitamin E oil 5% 9% 10% 3% 3%
6. Fragrance (Rose oil) Q.S Q.S Q.S Q.S Q.S
Table 3: Trial batches for the herbal anti-rashes roll-on formulation
Observation:
Sr.No. BATCH NUMBER OBSERVATION
1. F1 Proper Emulsion not formed
2. F2 Proper Emulsion not formed
3. F3 Proper Emulsion not formed
4. F4 Proper Emulsion not formed
5. F5 Stable Emulsion formed
Table 4: Results for the trial batches for the herbal anti-rashes roll-on formulation
Result: In the F5 formulation the ratio of oil phase, water phase and emulsifier works well and give stable and homogenous emulsion. Thus, F5 batch was optimized for the further evaluation.

EXAMPLE 2: FORMULATION OF THE HERBAL ANTI-RASHES ROLL-ON FORMULATION
Sr. No. Ingredients Quantity (in ml) Quantity (in %v/v)
1 Aloe vera gel solution (30% w/v) 70 70%
2 Coconut oil 11 11%
3 Vitamin E 3 3%
4 Polysorbate 11 11%
5 Benzyl alcohol 2 2%
6 Fragrance (Rose oil) q.s 100 3%
Table 5: Formulation of the herbal anti-rashes roll-on formulation
Process of preparation:
a. Mixing aloe vera gel and purified water with electronic homogenizer to prepare a homogenized aloe vera gel solution in one beaker;
b. Mixing the solution of step (a) with polysorbate 80 in another beaker,
c. Mixing coconut oil with Vitamin E with electronic homogenizer in a separate beaker;
d. Adding slowly the solution of step (c) in the solution of step (b);
e. Mixing the solution of step (d) continuously;
f. Adding benzyl alcohol to the solution of step (e);
g. Adding rose oil to the solution of step (f).
h. Storing the prepared emulsion of step (g) in a container.

EXAMPLE 3: EVALUATION OF PARAMETERS OF THE ROLL-ON FORMULATION
Example 3.1: pH of the final roll on formulation
The pH of the final roll on formulation was measured by using digital pH meter.
Result: The pH of the final formulation was found to be 5.67.

Example 3.2: Viscosity of the final roll on formulation
The viscosity of the final herbal anti-rashes formulation was measured by Ostwald viscometer.
Result: The viscosity of the final formulation is 1 cp.

Example 3.3: Phase separation by centrifugation
The oil-in water emulsion prepared was checked for the phase separation for the final herbal anti-rashes formulation.
Result: No change in droplet size

Example 3.4: Droplet size
The droplet size for the final herbal anti-rashes formulation was checked using Malvern particle size analyzer.
Result: The droplet size of the final roll-on formulation was 2870 ± 100 nanometer (2.87 ± 0.1 micron)

Example 3.5: Zeta potential
The Zetasizer measures the zeta potential of colloidal systems, such as emulsions, which was used to measure the zeta potential of the final formulation.
Result: The value of zeta potential of the emulsion formulation is: (-21.9 ± 0.2) mV. A zeta potential value of (-21.9) mV indicates that there is a high degree of electrostatic repulsion between the particles in emulsion.

EXAMPLE 4: SKIN IRRITATION STUDY OF THE ROLL-ON FORMULATION
Procedure:
Skin irritation of formulation will be evaluate using the Albino rats weighing 200 ± 50 g will be selected and randomly divided into three groups each containing six animals. The following schedule of treatment will be administered:

Group I: No medication (Normal control)
Group II: 0.8% v/v aqueous solution of formalin (Positive control)
Group III: Herbal inner thighs rashes roll on (Test)

The rats will be given free access to water and food and keep under observation for 24 h. All rats’ backs will be shaved: Group I will receive no medication (Normal).The Group II will serve as 0.8% v/v aqueous solution of formalin (Positive control), while Group III will receive the Herbal inner thighs rashes roll on (test).
Sr. no. Groups Treatment Doses No. of animals Route of administration OBSERVATION
(erythema/edema)
1) Normal No Medication - 6 rats - 0 (No erythema/edema)
2) Positive Control Aqueous solution of formalin 0.8% v/v 6 rats Topical 1 (Slight erythema/ edema)
3) Test Herbal inner thighs rashes roll on 5 rolls 6 rats Topical 0 (No erythema/edema)
Table 6: Skin irritation study for 24 hours of the formulation of the herbal anti-rashes roll-on formulation

The formulation will be washed after 24 hours and skin will be examined for any sign and symptoms i.e., change in color, change in skin morphology, any sign of erythema and edema. The animals will be applied with fresh Herbal inner thighs rashes roll on or fresh formalin solution, each day up to 6 days. The resulting reactions will be compared against control group. The mean erythema and edema scores will be recorded on the basis of their degree of severity caused by application of formulations:
No erythema/edema = 0,
Slight erythema/ edema = 1,
Moderate erythema/edema = 2
Severe erythema/edema = 3.
Results:
Sr. No. Treatment Dose Observation (erythema/edema)
1 hr 24 hr 48 hr 72 hr 4th
Day 5th
Day 6th Day
1 No medication - 0 0 0 0 0 0 0
2 Aqueous
solution of formalin 0.8% v/v 1 1 1 0 0 0 0
3 Herbal inner thighs rashes roll on 5 rolls 0 0 0 0 0 0 0
Table 7: Skin irritation study for 6 days of the formulation of the herbal anti-rashes roll-on formulation
As shown in the Figure 1, application of 0.8% v/v aqueous solution of formalin showed irritation on the skin, whereas application of herbal anti-rashes roll on does not cause any irritation on the skin.

EXAMPLE 5: ANTI-RASH EFFECT OF THE ROLL-ON-FORMULATION
Procedure:
Anti-rash effect of formulation will be evaluate using the Albino rats weighing 200 ± 50 g will be selected and randomly divided into Four groups each containing six animals. The following schedule of treatment will be administered:
Group I: No medication
Group II: 0.8% v/v aqueous solution of formalin
Group III: Herbal inner thighs rashes roll on (Test)
Group IV: ketoconazole (Reference)
Sr. no. Groups Treatment Doses No. of animals Route of administration
1. Group I No medication - 6 rats -
2. Group II Aqueous solution of formalin 0.8% v/v 6 rats Topical
3. Group III Herbal inner thighs rashes roll on 5 rolls 6 rats Topical
4. Group IV Ketoconazole 0.5 mg 6 rats Topical
Table 8: Study table for the Anti-rash effect of the formulation
The rats will be given free access to water and food and keep under observation for 24 h. All rats’ backs will be shaved: Group I will No medication. Group II will receive 0.8% v/v aqueous solution of formalin. The Group III will serve as Herbal inner thighs rashes roll on (Test) while Group IV will ketoconazole (Reference).

Rashes are produced by formalin solution in all rats. After that (after 3 days or 4 day of experiment) different medications are applied to two groups of rate, one with Herbal inner thighs rashes roll on and other one is ketoconazole each day up to 6 days.

The skin will be examined for any sign and symptoms i.e., change in colour, change in skin morphology, any sign of erythema and edema. The mean erythema and edema scores will be recorded on the basis of their degree of severity caused by application of formulations:
No erythema/edema = 0,
Slight erythema/ edema = 1,
Moderate erythema/edema = 2
Severe erythema/edema = 3.

Results:
Sr. No. Treatment Dose Observation (erythema/edema)
1 hr 24 hr 48 hr 72 hr 4th
Day 5th
Day 6th Day
1. No medication - 0 0 0 0 0 0 0
2. Aqueous
solution of formalin 0.8% v/v 0 0 1 1 1 1 1
3. Herbal inner thighs rashes roll on 5 rolls 0 0 1 0 0 0 0
4. Ketoconazole 0.5 mg 0 0 1 1 1 0 0
Table 9: Result showing the effect of the roll-on formulation on the Rash
Figure 2 shows the results for the same.

EXAMPLE 6: STABILITY STUDY OF THE ROLL-ON FORMULATION
The stability study of the final formulation was conducted at 40 °C AND 75% RH for 6 months

Sr No. Period (months) pH Viscosity (CENTIPOISE) Appearance Volume (loss of solution) Change in globule size
1. 0 5.67 1 White milky 10 No change
2. 3 5.65 0.99 White milky 10 No change
3. 6 5.66 0.97 White milky 10 No change
Table 10: Stability study data for the herbal anti-rashes roll-on formulation

Result: The formulation is stable for 6 months.
, Claims:CLAIMS
We claim,
1. An Herbal Anti Rashes Formulation comprising Aloe vera gel, oil, antioxidant, Emulsifier, preservative, Fragrance.

2. The Herbal Anti Rashes Formulation as claimed in claim 1, wherein said Aloe vera gel used in the range of 1 to 150 ml, more preferably 50 to 100 ml, more preferably 50 to 70 ml.

3. The Herbal Anti Rashes Formulation as claimed in claim 1, wherein said oil can be selected from Jojoba oil, Coconut oil, Rose oil, Tea Tree oil, Moringa oil, Castor Oil, Lemon Oil, Jasmine, more preferably coconut oil.

4. The Herbal Anti Rashes Formulation as claimed in claim 1, wherein antioxidant can be selected from saffron, ginger, vitamin E, cinnamon and black pepper, more preferably vitamin E.

5. The Herbal Anti Rashes Formulation as claimed in claim 1, wherein said Emulsifier can be selected from acacia, span 20, span 60, polysorbate 20, polysorbate 80, sodium laurate sulfate and tragacanth, more preferably polysorbate 80.

6. The Herbal Anti Rashes Formulation as claimed in claim 1, wherein preservative can be selected from benzalkonium chloride, benzoic acid, benzyl alcohol, parabens, sorbic acid and chlorobutanol, more preferably benzyl alcohol.

7. The Herbal Anti Rashes Formulation as claimed in claim 1, wherein Fragrance can be selected from rose oil, citronella oil, lemon grass oil and eucalyptus oil, more preferably rose oil.

8. The Herbal Anti Rashes Formulation as claimed in claim 1, wherein said formulation comprising 1 to 150 ml of aloe vera gel, 1 to 50 ml of oil, 1 to 20 ml of antioxidant, 1 to 50 ml of Emulsifier, 1 to 20 ml of preservatives and 1 to 10 ml of Fragrance.

9. The Herbal Anti Rashes Formulation as claimed in claim 1, wherein said formulation comprising 50 to 70 ml of aloe vera gel, 1 to 20 ml of oil, 1 to 10 ml of antioxidant, 1 to 20 ml of Emulsifier, 1 to 10 ml of preservatives and 1 to 5 ml of Fragrance.

10. A process for the preparation of the herbal anti rashes formulation as claimed in claim 1, wherein the step to prepare the herbal anti rashes formulation comprises the following steps:
a. Mixing aloe vera gel and purified water with electronic homogenizer to prepare a homogenized aloe vera gel solution in one beaker;
b. Mixing the solution of step (a) with polysorbate 80 in another beaker,
c. Mixing coconut oil with Vitamin E with electronic homogenizer in a separate beaker;
d. Adding slowly the solution of step (c) in the solution of step (b);
e. Mixing the solution of step (d) continuously;
f. Adding benzyl alcohol to the solution of step (e);
g. Adding rose oil to the solution of step (f).
h. Storing the prepared emulsion of step (g) in a container.

Dated this 28th May, 2024

Documents

Orders

Section Controller Decision Date
15 Sudhakar Bommeda 2025-03-03
15 Sudhakar Bommeda 2025-06-20

Application Documents

# Name Date
1 202421041411-STATEMENT OF UNDERTAKING (FORM 3) [28-05-2024(online)].pdf 2024-05-28
2 202421041411-REQUEST FOR EARLY PUBLICATION(FORM-9) [28-05-2024(online)].pdf 2024-05-28
3 202421041411-PROOF OF RIGHT [28-05-2024(online)].pdf 2024-05-28
4 202421041411-POWER OF AUTHORITY [28-05-2024(online)].pdf 2024-05-28
5 202421041411-FORM-9 [28-05-2024(online)].pdf 2024-05-28
6 202421041411-FORM 1 [28-05-2024(online)].pdf 2024-05-28
7 202421041411-DRAWINGS [28-05-2024(online)].pdf 2024-05-28
8 202421041411-DECLARATION OF INVENTORSHIP (FORM 5) [28-05-2024(online)].pdf 2024-05-28
9 202421041411-COMPLETE SPECIFICATION [28-05-2024(online)].pdf 2024-05-28
10 202421041411-FORM 18A [29-05-2024(online)].pdf 2024-05-29
11 202421041411-FER.pdf 2024-07-31
12 202421041411-FORM 3 [13-11-2024(online)].pdf 2024-11-13
13 202421041411-OTHERS [03-12-2024(online)].pdf 2024-12-03
14 202421041411-FER_SER_REPLY [03-12-2024(online)].pdf 2024-12-03
15 202421041411-CLAIMS [03-12-2024(online)].pdf 2024-12-03
16 202421041411-SER.pdf 2024-12-09
17 202421041411-OTHERS [23-01-2025(online)].pdf 2025-01-23
18 202421041411-FER_SER_REPLY [23-01-2025(online)].pdf 2025-01-23
19 202421041411-US(14)-HearingNotice-(HearingDate-18-02-2025).pdf 2025-01-29
20 202421041411-Correspondence to notify the Controller [10-02-2025(online)].pdf 2025-02-10
21 202421041411-Annexure [10-02-2025(online)].pdf 2025-02-10
22 202421041411-Written submissions and relevant documents [01-03-2025(online)].pdf 2025-03-01
23 202421041411-Annexure [01-03-2025(online)].pdf 2025-03-01
24 202421041411-FORM-8 [11-03-2025(online)].pdf 2025-03-11
25 202421041411-NBA Approval Submission [18-06-2025(online)].pdf 2025-06-18
26 202421041411-PatentCertificate20-06-2025.pdf 2025-06-20
27 202421041411-IntimationOfGrant20-06-2025.pdf 2025-06-20

Search Strategy

1 SearchStrategyE_10-07-2024.pdf

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