DESC:Form 2
The Patent Act 1970
(39 of 1970)
&
The Patent Rules, 2003
COMPLETE SPECIFICATION
(see section 10 and rule 13)
1. TITLE OF THE INVENTION
HERBAL ORAL SPRAY FORMULATION AND PREPARATION METHOD THEREOF
2. APPLICANT(S)
Name Nationality Address
MAYONS PHARMACEUTICALS PRIVATE LIMITED Indian Octroi No. 4, Old Kamptee Road, Kalamna Basti, Kalamna, Nagpur 440026, Maharashtra, India.

3. PREAMBLE TO THE DESCRIPTION
The following specification describes the invention and the manner in which it is to be performed.

FIELD OF THE INVENTION-
The present invention is related to an herbal oral spray formulation, which increases immunity and improves oral hygiene. The herbal oral spray comprises of extracts of bark of Aspidosperma, leaves of Ocimum Sanctum, rhizomes of Curcuma Longa, stem of Tinospora Cordifolia, whole plant of Echinacea Angustifolia and fresh bark of Azadirachta Indica. The invention further discloses the method of preparation of oral spray formulation.

BACKGROUND OF THE INVENTION
Herbal formulation, also known as herbal medicine or phytotherapy, refers to the use of plants or plant extracts for medicinal purposes. This practice has been integral to human culture for thousands of years, with ancient civilizations relying heavily on the healing properties of various herbs. Today, herbal formulations continue to play a significant role in healthcare, offering a natural and often holistic approach to wellness.

Over the centuries, herbal knowledge evolved as societies exchanged ideas and traded botanical resources. With advancements in science and technology, researchers began to analyze the chemical constituents of plants, leading to a better understanding of their medicinal properties. This scientific exploration paved the way for the development of standardized herbal formulations, where specific plant extracts are combined in precise ratios to enhance efficacy and safety.

In the contemporary era, herbal formulations are utilized in various forms, including teas, tinctures, capsules, tablets, spray and topical preparations. They are commonly used to manage a wide range of health conditions, from minor ailments like colds and headaches to chronic diseases such as diabetes and cardiovascular disorders. Additionally, many people incorporate herbal supplements into their wellness routines to support overall health and prevent illness.

Oral spray formulations represent a versatile and convenient method of administering pharmaceuticals, herbal, or other active ingredients through the oral mucosa. They typically consist of a solution, suspension, or emulsion of the active ingredient(s) in a suitable vehicle, along with excipients to enhance stability, solubility, and bioavailability.

Herbal oral sprays have gained significant popularity in recent years due to their convenience, effectiveness, and natural ingredients. The development of oral spray formulations has evolved to address various therapeutic needs, ranging from pain management and allergy relief to immunity booster to hormone therapy and nutritional supplementation.

Oral spray formulations offer several advantages over traditional dosage forms such as tablets or capsules, including rapid onset of action, improved bioavailability, convenient and portable and dose flexibility. Overall, oral spray formulations offer a promising avenue for the delivery of pharmaceuticals and other active ingredients, providing patients with a convenient, effective, and patient-friendly alternative to traditional dosage forms.

Aspidosperma also known as quebracho blanco, Aspidosperma is traditionally used for its anti-inflammatory and antimicrobial properties. It may help in reducing oral inflammation and fighting against oral pathogens.

Tulsi (Ocimum Sanctum), or holy basil, is renowned for its immunomodulatory and antibacterial effects. It can support the immune system and combat oral bacteria, thereby promoting oral health.

Curcuma Longa (Turmeric) contains curcumin, a potent anti-inflammatory and antioxidant compound. It may help in reducing inflammation in the oral cavity and supporting immune function.

Tinospora Cordifolia (Guduchi) is valued in traditional medicine for its immunomodulatory and antimicrobial properties. It may help in boosting the body's defense mechanisms and preventing oral infections.

Echinacea Angustifolia is commonly used to support immune function and enhance the body's resistance to infections. It may contribute to overall oral health by strengthening the immune system.

Azadirachta Indica (Neem) is well-known for its antibacterial, antifungal, and antiviral properties. It can help in combating oral pathogens and maintaining oral hygiene.

Marketed formulation ‘Vi-Fend Immunity Oral Spray Grape’ comprises of Ascorbic Acid, Elderberry Extract, Acerola Extract and Zinc. Plant-based wellness support formula is a safe and effective way to optimize immunity with the perfect blend of science and nature. The edible sprays are made with extracts from plant-based ingredients with active compounds that help fight cold/flu, support the cellular system and boost metabolism with their strong antioxidant properties.

‘Immuno Plus Spray’ discloses use of Ocimum Sanctum, Curcuma Longa, Tinospora Cordifolia, Echinacea Angustifolia, Azadirachta to increases immunity and improves oral hygiene.

Unlike some conventional oral sprays that may contain synthetic chemicals or artificial additives, the herbal oral spray formulation utilizes natural herbal extracts known for their therapeutic properties. Oral sprays offer a convenient and portable way to deliver active ingredients directly to the oral cavity. With just a few sprays, users can easily incorporate the herbal oral spray into their daily oral care routine, whether at home or on the go.

There is still a need for oral spray formulation that offers a holistic approach and regular use of herbal extracts, which may help in supporting the body's immune defenses, reducing oral inflammation, preventing oral infections, and promoting overall oral health.

OBJECTIVE OF THE INVENTION
The main objective of the present invention is to provide herbal oral spray formulation, which increases immunity and improves oral hygiene.

Another objective of the present invention is to provide a herbal oral spray formulation comprising extracts of bark of Aspidosperma, leaves of Ocimum Sanctum, rhizomes of Curcuma Longa, stem of Tinospora Cordifolia, whole plant of Echinacea Angustifolia and fresh bark of Azadirachta Indica.

Another objective of the present invention is to provide a herbal oral spray formulation having synergistic activity of extracts when combined together.

Another objective of the present invention is to provide a herbal oral spray formulation exhibiting oral antiulcer activity.

Another objective of the present invention is to provide a process for preparation of herbal oral spray formulation.

SUMMARY OF THE INVENTION
Main embodiment of the present invention provides a herbal oral spray formulation comprising extracts of bark of Aspidosperma, leaves of Ocimum Sanctum, rhizomes of Curcuma Longa, stem of Tinospora Cordifolia, whole plant of Echinacea Angustifolia and fresh bark of Azadirachta Indica.

Another embodiment of present invention relates to a herbal oral spray formulation comprising;
a) Extract of Aspidosperma;
b) Extract of Ocimum Sanctum;
c) Extract of Curcuma Long;
d) Extract of Tinospora Cordifolia;
e) Extract of Echinacea Angustifolia; and
f) Extract of Azadirachta Indica.

In an aspect of the embodiment, the extract of Aspidosperma; Ocimum Sanctum; Curcuma Long; Tinospora Cordifolia; Echinacea Angustifolia; and Azadirachta Indica are present in weight ratio of 1:2:2:2:2:1.

In an aspect of the embodiment, the extracts are hydroalcoholic extracts.

In an aspect of the embodiment, the herbal oral spray formulation increases immunity and improves oral hygiene.

In another aspect of the embodiment, the formulation is used for the treatment or prevention of oral infections, inflammations, or conditions.

In another aspect of the embodiment, the formulation is provided in a spray bottle capable of delivering a metered dose.

In an aspect of the embodiment, the extract of bark of Aspidosperma is present in concentration of 10 % v/v.

In an aspect of the embodiment, the extract of leaves of Ocimum Sanctum is present in concentration of 20 % v/v.

In an aspect of the embodiment, the extract of rhizomes of Curcuma Longa is present in concentration of 20 % v/v.

In an aspect of the embodiment, the extract of stem of Tinospora Cordifolia is present in concentration of 20 % v/v.

In an aspect of the embodiment, the extract of whole plant of Echinacea Angustifolia is present in concentration of 20 % v/v.

In an aspect of the embodiment, the extract of fresh bark of Azadirachta Indica is present in concentration of 10 % v/v.

In another embodiment, the present invention relates to a herbal oral spray formulation comprising
a) 10 % v/v extract of bark of Aspidosperma;
b) 20 % v/v extract of leaves of Ocimum Sanctum;
c) 20 % v/v extract of rhizomes of Curcuma Long;
d) 20 % v/v extract of stem of Tinospora Cordifolia;
e) 20 % v/v extract of whole plant of Echinacea Angustifolia; and
f) 10 % v/v extract of fresh bark of Azadirachta Indica and
g) Solvent;
Wherein the precent concentration are with respect to total weight of the formulation.

In another aspect of embodiment, the solvent is alcohol.

In another aspect of embodiment, the formulation exhibits oral antiulcer activity.

In another embodiment, the present invention relates to process for preparation of a herbal oral spray formulation comprises step of
a) Mixing specified quantities of extracts of bark of Aspidosperma, leaves of Ocimum Sanctum, rhizomes of Curcuma Longa, stem of Tinospora Cordifolia, whole plant of Echinacea Angustifolia and fresh bark of Azadirachta Indica together to form final oral spray formulation.

In another embodiment, the present invention relates to process for preparation of a herbal oral spray formulation comprises step of
a) Preparation of standardised herbal extracts of Aspidosperma, Ocimum Sanctum, Curcuma Longa, Tinospora Cordifolia, Echinacea Angustifolia and Azadirachta Indica individually;
b) Mixing standardised herbal extracts in specified quantities to form spray formulation.

DESCRIPTION OF THE INVENTION
The present invention is related to an herbal oral spray formulation, which increases immunity and improves oral hygiene. The herbal oral spray comprises of extracts of bark of Aspidosperma, leaves of Ocimum Sanctum, rhizomes of Curcuma Longa, stem of Tinospora Cordifolia, whole plant of Echinacea Angustifolia and fresh bark of Azadirachta Indica. The invention further discloses the method of preparation of oral spray 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 pertains.

The term “comprising”, which is synonymous with “including”, “containing”, or “characterized by” here is defined as being inclusive or open-ended, and does not exclude additional, unrecited elements or method steps, unless the context clearly requires otherwise.

The term “a” and “an” refers to one or to more than one (i.e., to at least one) of the grammatical object of the article. The information provided in this document, and particularly the specific details of the described exemplary aspects, is provided primarily for clearness of understanding and no unnecessary limitations are to be understood from there.

As used herein, the term “about” means that the numerical value is approximate and small variations would not significantly affect the practice of the disclosed embodiments. Where a numerical limitation is used, unless indicated otherwise by the context, “about” means the numerical value can vary by ±10% and remain within the scope of the disclosed embodiments.

As used herein, the terms “treat,” or “treatment” mean both therapeutic treatment or prophylactic or preventative measures wherein the object is to prevent or slow down (lessen) an undesired physiological condition, disorder or disease, or obtain beneficial or desired clinical results. For purposes of this invention, beneficial or desired clinical results include, but are not limited to, alleviation of symptoms; diminishment of extent of condition, disorder or disease; stabilized (i.e., not worsening) state of condition, disorder or disease; delay in onset or slowing of condition, disorder or disease progression; amelioration of the condition, disorder or disease state or remission (whether partial or total), whether detectable or undetectable; an amelioration of at least one measurable physical parameter, not necessarily discernible by the patient; or enhancement or improvement of condition, disorder or disease.

An ‘Oral formulation’ refers to a pharmaceutical preparation designed to be administered through the mouth. It is one of the most common routes of drug delivery due to its ease of use, patient acceptance, and versatility.

A ‘Oral spray formulation’ refers to a versatile and convenient method of administering pharmaceuticals, herbal, or other active ingredients through the oral mucosa. They typically consist of a solution, suspension, or emulsion of the active ingredient(s) in a suitable vehicle, along with excipients to enhance stability, solubility, and bioavailability.

Oral spray offers several advantages over other oral dosage forms, such as tablets or capsules. The key benefits of Oral spray:

Oral sprays are absorbed directly through the mucous membranes in the mouth, allowing for faster absorption and onset of therapeutic effects compared to oral tablets or capsules, which must pass through the gastrointestinal tract. This can be particularly beneficial for medications requiring quick action, such as pain relief or allergy treatment.

By bypassing the digestive system and avoiding first-pass metabolism in the liver, oral sprays can enhance the bioavailability of certain drugs, leading to more predictable and consistent therapeutic outcomes. This means that a higher proportion of the active ingredient reaches systemic circulation, potentially resulting in increased efficacy and reduced dosage requirements.

Oral sprays are compact, portable, and easy to administer, making them ideal for patients who have difficulty swallowing tablets or capsules, such as children, the elderly, or individuals with swallowing disorders. The spray format also eliminates the need for water or other liquids for administration, enhancing convenience and accessibility.

Oral spray formulations can be easily adjusted to deliver precise doses of active ingredients, allowing for individualized therapy and titration to achieve optimal therapeutic outcomes. This is particularly important for medications with narrow therapeutic windows or those requiring careful dosage adjustment based on patient response.

Oral sprays can be directed to specific areas within the oral cavity, allowing for targeted delivery of medications to localized sites of action, such as the throat or gums. This targeted approach may enhance the efficacy of certain treatments, such as those for oral infections or inflammatory conditions.

Oral sprays offer a discreet and socially acceptable method of medication administration, allowing patients to take their medication without drawing attention or causing discomfort in public settings. This can be particularly beneficial for medications that may be stigmatized or sensitive in nature.

The term herein used “Extracts” refers to ‘Standardised extracts. Standardized extracts refer to herbal extracts that have been processed and tested to ensure a consistent concentration of specific active compounds. This standardization process ensures that each batch of the extract contains a uniform amount of the active ingredients, providing consistent efficacy and safety.

Main embodiment of the present invention provides a herbal oral spray formulation comprising extracts of bark of Aspidosperma, leaves of Ocimum Sanctum, rhizomes of Curcuma Longa, stem of Tinospora Cordifolia, whole plant of Echinacea Angustifolia and fresh bark of Azadirachta Indica.

Another embodiment of present invention relates to a herbal oral spray formulation comprising;
a) Extract of Aspidosperma;
b) Extract of Ocimum Sanctum;
c) Extract of Curcuma Long;
d) Extract of Tinospora Cordifolia;
e) Extract of Echinacea Angustifolia; and
f) Extract of Azadirachta Indica.

In an aspect of the embodiment, the extract of Aspidosperma; Ocimum Sanctum; Curcuma Long; Tinospora Cordifolia; Echinacea Angustifolia; and Azadirachta Indica are present in weight ratio of 1:2:2:2:2:1.

In an aspect of the embodiment, the extracts are hydroalcoholic extracts.

In an aspect of the embodiment, the herbal oral spray formulation increases immunity and improves oral hygiene.

In another aspect of the embodiment, the formulation is used for the treatment or prevention of oral infections, inflammations, or conditions.

In another aspect of the embodiment, the formulation is provided in a spray bottle capable of delivering a metered dose.

Aspidosperma is a genus of flowering plants in the Apocynaceae family, commonly known as the “quebracho” trees. One species within this genus, Aspidosperma quebracho-blanco, is particularly well-known for its medicinal properties. The bark of Aspidosperma contains various bioactive compounds, including alkaloids such as aspidospermine, quebrachine, and aspidosamine. These alkaloids are believed to be responsible for the medicinal effects of the plant. Aspidosperma extracts may also possess antimicrobial, anti-inflammatory, and antioxidant properties, contributing to their potential therapeutic benefits beyond respiratory health. Aspidosperma bark extract contains bioactive compounds with immunomodulatory properties. These compounds may help regulate the immune system, enhancing its ability to defend against pathogens and maintain overall health. By supporting immune function, Aspidosperma bark extract could potentially reduce the risk of infections and promote resilience to illness.

In an aspect of the embodiment, the extract of bark of Aspidosperma is present in concentration of 10 % v/v.

Ocimum sanctum, commonly known as Holy Basil or Tulsi, is a revered herb in traditional medicine systems such as Ayurveda. The leaves of Ocimum sanctum are rich in bioactive compounds including flavonoids, terpenoids, phenolic compounds, and essential oils. Ocimum sanctum exhibits antimicrobial, anti-inflammatory and antioxidant activity. The extract of Ocimum sanctum leaves is used in traditional medicine for managing various health conditions, including respiratory disorders, digestive issues, stress, anxiety, and skin ailments. It is also believed to support immune function and promote longevity.

In an aspect of the embodiment, the extract of leaves of Ocimum Sanctum is present in concentration of 20 % v/v.

Curcuma longa, commonly known as turmeric, is a popular herbal formulation with a rich history of medicinal use. Turmeric is a member of the ginger family and is native to Southeast Asia, where it has been cultivated for thousands of years. The rhizomes of Curcuma longa contain a group of bioactive compounds known as curcuminoids, with curcumin being the most well-studied and prominent compound. Curcumin has been extensively researched for its various health benefits, including its potent anti-inflammatory, antioxidant, antimicrobial, and anticancer properties. Curcumin acts as a powerful antioxidant, scavenging free radicals and protecting cells from oxidative damage. This property is believed to contribute to its potential role in preventing chronic diseases and aging-related conditions.

In an aspect of the embodiment, the extract of rhizomes of Curcuma Longa is present in concentration of 20 % v/v.

Tinospora cordifolia, commonly known as Giloy or Guduchi, is a herbaceous vine native to the Indian subcontinent and parts of Southeast Asia. It belongs to the family Menispermaceae and is highly valued in traditional Ayurvedic medicine for its medicinal properties. The stem of Tinospora cordifolia is the most commonly used part of the plant for therapeutic purposes. The stem contains a variety of bioactive compounds, including alkaloids, diterpenoid lactones (such as tinosporin), glycosides, steroids, and polysaccharides. In Ayurveda, the stem of Tinospora cordifolia is considered a potent rasayana (rejuvenative) and is used to promote longevity, enhance immunity, and improve overall health. It is renowned for its immunomodulatory, anti-inflammatory, antioxidant, antipyretic, and anti-diabetic properties.

In an aspect of the embodiment, the extract of stem of Tinospora Cordifolia is present in concentration of 20 % v/v.

Echinacea angustifolia, commonly known as narrow-leaved purple coneflower, is a perennial herbaceous plant native to North America, particularly the central United States. It belongs to the Asteraceae family, which includes daisies and sunflowers. Echinacea angustifolia is believed to enhance the activity of the immune system, helping the body fight off infections such as the common cold, flu, and upper respiratory tract infections. The plant contains compounds with anti-inflammatory properties, which may help reduce inflammation and alleviate symptoms associated with conditions such as arthritis and inflammatory skin conditions. It is rich in antioxidants, which help neutralize harmful free radicals in the body and protect cells from oxidative damage.

In an aspect of the embodiment, the extract of whole plant of Echinacea Angustifolia is present in concentration of 20 % v/v.

Azadirachta indica, commonly known as neem, holds significant importance in traditional herbal medicine due to its diverse therapeutic properties Azadirachta indica bark is characterized by its bitter taste and strong, pungent aroma. It contains a variety of bioactive compounds, including triterpenoids (such as azadirachtin), flavonoids, nimbin, nimbidin, and various alkaloids. These constituents contribute to the medicinal properties of neem bark, including its antibacterial, antifungal, antiviral, anti-inflammatory, antipyretic, and analgesic effects. Neem bark preparations are employed to support digestive health, boost immunity, and address parasitic infections.

In an aspect of the embodiment, the extract of fresh bark of Azadirachta Indica is present in concentration of 10 % v/v.

In another embodiment, the present invention relates to a herbal oral spray formulation comprising
a) 10 % v/v extract of bark of Aspidosperma;
b) 20 % v/v extract of leaves of Ocimum Sanctum;
c) 20 % v/v extract of rhizomes of Curcuma Long;
d) 20 % v/v extract of stem of Tinospora Cordifolia;
e) 20 % v/v extract of whole plant of Echinacea Angustifolia; and
f) 10 % v/v extract of fresh bark of Azadirachta Indica and
g) Solvent;
Wherein the precent concentration are with respect to total weight of the formulation.

In another aspect of embodiment, the solvent is alcohol.

In another aspect of embodiment, the formulation exhibits oral antiulcer activity.

In another embodiment, the present invention relates to process for preparation of a herbal oral spray formulation comprises step of
a) Mixing specified quantities of extracts of bark of Aspidosperma, leaves of Ocimum Sanctum, rhizomes of Curcuma Longa, stem of Tinospora Cordifolia, whole plant of Echinacea Angustifolia and fresh bark of Azadirachta Indica together to form final oral spray formulation.

In another embodiment, the present invention relates to process for preparation of a herbal oral spray formulation comprises step of
a) Preparation of standardised herbal extracts of Aspidosperma, Ocimum Sanctum, Curcuma Longa, Tinospora Cordifolia, Echinacea Angustifolia and Azadirachta Indica individually;
b) Mixing standardised herbal extracts in specified quantities to form spray formulation.

Extraction is the process of separating active compounds from plant materials to create concentrated forms of these substances for use in various applications, including herbal oral spray formulations. The goal of extraction is to isolate the desired phytochemicals, such as alkaloids, flavonoids, terpenes, and other bioactive compounds, while minimizing the presence of unwanted substances. The quality and efficacy of the final product heavily depend on the extraction method used, as different techniques can yield different concentrations and profiles of active ingredients.

Several types of extraction methods are commonly employed in the preparation of herbal extracts for oral sprays. These include:

Solvent Extraction: This method involves using solvents such as water, ethanol, methanol, or a combination of these to dissolve the active compounds from the plant material. The choice of solvent affects the solubility and selectivity of the extraction, with polar solvents like water being suitable for hydrophilic compounds and non-polar solvents like ethanol being effective for lipophilic compounds. Solvent extraction is versatile and widely used due to its efficiency in extracting a broad range of phytochemicals.

Steam Distillation: Primarily used for extracting essential oils, steam distillation involves passing steam through plant material to vaporize volatile compounds, which are then condensed back into liquid form. This method is suitable for obtaining aromatic compounds and is commonly used for herbs with high essential oil content.

Each extraction method has its own advantages and is chosen based on the specific requirements of the herbal oral spray formulation, such as the type of active compounds desired, the stability of these compounds, and the intended use of the final product. The selection of the appropriate extraction technique ensures the optimal efficacy and quality of the herbal oral spray.

Although the invention has been described with reference to specific embodiments, this description is not meant to be construed in a limiting sense. Various modifications of the disclosed embodiments, as well as alternate embodiments of the invention, will become apparent to persons skilled in the art upon reference to the description of the invention. It is therefore contemplated that such modifications can be made without departing from the spirit or scope of the present invention as defined.

EXAMPLES
Example 1 – Herbal oral spray formulation according to the invention.
SN Ingredients Quantity (%v/v)
1 Extract of bark of Aspidosperma 10
2 Extract of leaves of Ocimum Sanctum 20
3 Extract of rhizomes of Curcuma Longa 20
4 Extract of stem of Tinospora Cordifolia 20
5 Extract of whole-plant of Echinacea Angustifolia 20
6 Extract of fresh stem of Azadirachta Indica 10
Table no. 1 - Herbal oral spray formulation

Manufacturing process for herbal oral spray formulation –
1) Standardized herbal hydroalcoholic extracts were prepared.
2) All the herbal extracts were mixed together effectively to obtain final formulation.
3) Alcohol content of final formulation was checked.

Characterization for herbal oral spray formulation –
• Physicochemical characterization

SR.NO TEST STANDARD
1. Description Light orange color liquid
2. Alcohol Content 15% v/v
3. pH Below 7
4. Specific Gravity NMT 1.2
5. Weight/ml NMT 1.2
6 Quantity per dose (ml in each 5 sprays) 1ml
Table no. 2 - Physicochemical characterization of herbal oral spray formulation

• Oral Antiulcer activity
Fifty-four Wistar albino rats (either sex) weighing between 250-300g were selected for the study. Animals were housed in standard laboratory conditions, in a room maintained under 12:12 hour light-dark cycle and had free access to food and water. Animals were divided into three groups each containing 6 rats. Group I was considered as control, i.e. ulcer was induced but treatment was not provided, Group II was Aspidosperma extract (Hydro-alcoholic) treated, Group III was Ocimum sanctum extract (Hydro-alcoholic) treated, Group IV was treated with Curcuma longa extract, (Hydro-alcholic) Group V was Tinospora cardifolia extract, (Hydro-alcoholic) treated, Group VI was Echinaceae angustifolia extract (Hydro-alcoholic) treated, Group VII was treated with Azadirachta indica extract (Hydro-alcoholic), Group VIII animals were treated with Herbal oral spray formulation and Group IX was considered standard wherein animals were treated with Marketed formulation (Lary Spray).

On the third day ulcer area in the labial mucosa was clinically visible. At that time ulcer area was measured and then treatment was started in group II to IX. On day seven area was measured and compared statistically. Reduction in the ulcer area of the group VIII treated with herbal oral spray formulation was very significant with p<0.01 and p was 0.0056 for Post-test by Kruskal-Wallis Non-parametric method which is considered to be very significant. Reduction in area was also observed in group IX which was treated with the standard marketed formulation but the reduction was not statistically significant when compared to the control on the same day. Also, the difference between the ulcer area of group VIII and IX was statistically insignificant.

Also, Ulcer area of group VIII and group IX measured on day 15 were compared with control. Herbal oral spray formulation treated group showed very significant reduction in ulcer area with the p<0.01 and p was 0.0015 for Post-test by Kruskal-Wallis Non-parametric method which is considered to be very significant. Visually there was complete healing of the ulcers (Figure 1). On day 15 group IX treated also showed significant reduction in the ulcer area compared to control with p<0.05. However, there was insignificant difference when herbal oral spray formulation treated and the group treated with Standard marketed preparation. There was little reduction in the ulcer area when group II to VII were treated with the extracts individually at the same dose level as compared to the herbal oral spray formulation having mixture of all the extracts. This indicates synergistic activity of extracts when they are combined.

Time Point Ulcer Surface Area (Cm2) †
Group I (Control) Group II Group III Group IV Group V Group VI Group VII Group VIII (Treated with Herbal oral spray formulation) Group IX (Treated with commercial Lary Spray)
Day 3 1.88±0.19 1.93±0.23 1.88±0.2 1.95±0.35 1.89±0.25 1.88±0.18 1.95±0.123 1.88±0.25 1.94±0.23
Day 7 1.73±0.26 1.71±0.05 1.58±0.56 1.68±0.23 1.43±0.65 1.45±0.35 1.45±0.65 1.1±0.15** 1.47±0.32
Day 15 1.36±0.16 1.15±0.15 0.96±0.93 1.23±0.45 0.92±0.65 1.05±0.98 0.92±0.23 0.47±0.17** 0.63±0.19*
†Mean of 6 observations ± S. D
** When compared with Control, difference was very significant p<0.01
*When compared with Control, difference was significant p<0.05
Table 3 - Ulcer Surface Area

We Claim,
1. A Herbal oral spray formulation comprising;
a) Extract of Aspidosperma;
b) Extract of Ocimum Sanctum;
c) Extract of Curcuma Long;
d) Extract of Tinospora Cordifolia;
e) Extract of Echinacea Angustifolia; and
f) Extract of Azadirachta Indica.

2. The formulation as claimed in claim 1, wherein the extract of Aspidosperma; Ocimum Sanctum; Curcuma Long; Tinospora Cordifolia; Echinacea Angustifolia; and Azadirachta Indica are present in weight ratio of 1:2:2:2:2:1.

3. The formulation as claimed in claim 1, wherein the extracts are hydroalcoholic extracts.

4. The formulation as claimed in claim 1, wherein the formulation is used for the treatment or prevention of oral infections, inflammations, or conditions.

5. The formulation as claimed in claim 1, wherein the formulation is provided in a spray bottle capable of delivering a metered dose.

6. A Herbal oral spray formulation comprising;
a) 10 % v/v extract of Aspidosperma;
b) 20 % v/v extract of Ocimum Sanctum;
c) 20 % v/v extract of Curcuma Long;
d) 20 % v/v extract of Tinospora Cordifolia;
e) 20 % v/v extract of whole plant of Echinacea Angustifolia;
f) 10 % v/v extract of fresh bark of Azadirachta Indica; and
g) Solvent;
Wherein the precent concentration are with respect to total weight of the formulation.

7. The formulation as claimed in claim 6, wherein the solvent is alcohol.

8. The formulation as claimed in claim 6, wherein the formulation exhibits oral antiulcer activity.

9. A process for preparation of a herbal oral spray formulation comprises step of;
a) Preparation of standardised herbal extracts of Aspidosperma, Ocimum Sanctum, Curcuma Longa, Tinospora Cordifolia, Echinacea Angustifolia and Azadirachta Indica individually;
b) Mixing standardised herbal extracts in specified quantities to form spray formulation.

Dated this 13th day of August 2024

Vijaykumar Shivpuje,
IN/PA 1096
Agent for the applicant

HERBAL ORAL SPRAY FORMULATION AND PREPARATION METHOD THEREOF

ABSTRACT

The present invention relates to herbal oral spray formulation, which increases immunity and improves oral hygiene. The herbal oral spray comprises of extracts of bark of Aspidosperma, leaves of Ocimum Sanctum, rhizomes of Curcuma Longa, stem of Tinospora Cordifolia, whole plant of Echinacea Angustifolia and fresh bark of Azadirachta Indica. The invention further discloses the method of preparation of oral spray formulation.

,CLAIMS:We Claim,
1. A Herbal oral spray formulation comprising;
a) Extract of Aspidosperma;
b) Extract of Ocimum Sanctum;
c) Extract of Curcuma Long;
d) Extract of Tinospora Cordifolia;
e) Extract of Echinacea Angustifolia; and
f) Extract of Azadirachta Indica.

2. The formulation as claimed in claim 1, wherein the extract of Aspidosperma; Ocimum Sanctum; Curcuma Long; Tinospora Cordifolia; Echinacea Angustifolia; and Azadirachta Indica are present in weight ratio of 1:2:2:2:2:1.

3. The formulation as claimed in claim 1, wherein the extracts are hydroalcoholic extracts.

4. The formulation as claimed in claim 1, wherein the formulation is used for the treatment or prevention of oral infections, inflammations, or conditions.

5. The formulation as claimed in claim 1, wherein the formulation is provided in a spray bottle capable of delivering a metered dose.

6. A Herbal oral spray formulation comprising;
a) 10 % v/v extract of Aspidosperma;
b) 20 % v/v extract of Ocimum Sanctum;
c) 20 % v/v extract of Curcuma Long;
d) 20 % v/v extract of Tinospora Cordifolia;
e) 20 % v/v extract of whole plant of Echinacea Angustifolia;
f) 10 % v/v extract of fresh bark of Azadirachta Indica; and
g) Solvent;
Wherein the precent concentration are with respect to total weight of the formulation.

7. The formulation as claimed in claim 6, wherein the solvent is alcohol.

8. The formulation as claimed in claim 6, wherein the formulation exhibits oral antiulcer activity.

9. A process for preparation of a herbal oral spray formulation comprises step of;
a) Preparation of standardised herbal extracts of Aspidosperma, Ocimum Sanctum, Curcuma Longa, Tinospora Cordifolia, Echinacea Angustifolia and Azadirachta Indica individually;
b) Mixing standardised herbal extracts in specified quantities to form spray formulation.

Dated this 13th day of August 2024