Abstract: Disclosed herein is a aqueous cannabis nasal spray herbal composition comprising cannabis extract together with herbal extracts comprising lavender, tulsi, brahmi which when combined with cannabis synergise the biological/pharmaceutical activity of cannabis for neuro symptoms described herein.
Description:FIELD OF TECHNOLOGY: Disclosed herein is a cannabis-based composition to calm and for anxiety related symptoms. The said composition is water based and in the form of a nasal spray. The said water-cannabis based nasal spray which works via nasal cavity i.e. follows olfactory pathway meaning they provide “direct brain access” and offers rapid relief and enhanced therapeutic effects. Choice for preferring the nasal spray is to assimilate the drug extremely quickly and directly through the nose for systemic administration. Nasal drug delivery is advantageous when compared with other routes of drug delivery. Nasal administration, with its many advantages, naturally has made researchers interested in the nasal route of drug delivery. Cannabis-water based nasal spray also referred herein as aqueous cannabis based nasal spray of the present invention is used as medical cannabis to regulate mood, sleep, pain, stress responses and many more and the likes. Aqueous cannabis based nasal spray of present invention is further featured by the fact that even a small-dose (about 1 to about 1.5%), the potency is enhanced through the direct nasal delivery to:
a. Calm anxiety,
b. Relief from mental overload,
c. Balanced sleep-wake cycles,
d. Assists in Migraine/Headache management.
e. To manage the pain, stress responses, mood swings and the likes.
WHY USE NASAL SPRAYS: Nasal spray works in “olfactory pathway” meaning they provide “direct brain access” via nasal cavity, wherein the olfactory pathway in humans involves inhaling Odour molecules into the nose, binding them to specialized receptor cells in the olfactory epithelium.
Nasal spray is the most common dosage form for intranasal drug delivery due to the ease of administration and efficient nasal deposition compared to drop instillation. With the nozzle of a spray bottle (device) inserted into the nostril, liquid dosage forms (including solutions, suspensions and emulsions) preferably solutions are atomised into fine droplets for nasal deposition.
Furthermore, formulation of the present invention is characterized by the fact that whatever ingredients being used therein does not provide viscous liquid thereby no hindering in atomization process occurs thereby enhances the penetration and improves the drug adsorption thereby provides the quick relief to the patient.
Nasal sprays is used daily without causing rebound congestion or harming nasal tissue.
Nasal sprays are a safe and gentle option for small kids and old people to relieve from their symptoms.
Nasal sprays are effective remedies are super easy to use; just spray, breathe, and get relieved.
Inventive feature of the present invention lies in the fact that the said nasal spray is water-based formulation thereby making it novel, innovative and non-obvious, much safer and cost effective.
Another most important feature of the invention is to use mostly naturally occurring herbs/substances like Vijaya (Cannabis) Leaf, decoction of fruits, Lavender Extract, glycerine, decoction of leaves like Tulsi, Brahmi and the likes, Citric acid and most important water as a solvent/carrier which makes it safe in all aspects.
Another feature of the invention is that the sid Nasal sprays of present invention provides a very lower dose when compared to other dosage forms Vijaya (Cannabis) known in the art.
Composition or formulation herein means the same said water based nasal spray product
SUMMARY OF THE INVENTION
Disclosed herein is a novel water-based cannabis / cannabinoid formulation as a nasal spray; a pioneering wellness innovation designed to offer rapid relief and enhanced therapeutic effects through the power of Ayurveda and modern science. The said novel and non-obvious water-cannabis based nasal spray comprises a blend of natural ingredients and utilising the cutting-edge nasal delivery technology and stands at the forefront of plant-based medicine. Based on an exhaustive R&D activity the said novel and nonobvious nasal spray of the present invention is crafted with a carefully balanced formula to maximize efficacy, ease and safety.
Disclosed herein is a pharmaceutical composition preferably a nasal spray comprising Vijaya (Cannabis) Leaf (about 1 to about 1.5%), decoction of fruits, Lavender Extract, glycerine, decoction of leaves like Tulsi, Brahmi and the likes, Citric acid and most important water preferably sterile water.
BACKGROUND OF THE INVENTION
The biological activity of Cannabis is well known, and has led it to become a “recreational” drug. Cannabis sativa L. (“Cannabis” locally known Vijaya Leaf, Bhang, Bhamgi, Anja, Chapala, Kamagni, Madani etc.) exhibit a wide range of biological activities, primarily due to its unique phyto cannabinoids and other secondary metabolites like terpenoids and flavonoids. These compounds, including Delta-9-tetrahydrocannabinol (THC) is the primary psychoactive cannabinoid and Cannabidiol (CBD) has a low affinity for CB1 and CB2 receptors and is considered an inverse agonist of CB2. This interaction contributes to its non-psychoactive nature and potential anti-inflammatory properties. CBD, interact with the body's endocannabinoid system, influencing various physiological processes.
Cannabis is a genus of flowering plants in the family Cannabaceae that is widely accepted as being indigenous to and originating from the continent of Asia. However, the number of species is disputed, with as many as three species being recognized: Cannabis sativa, C. indica, and C. ruderalis.
Cannabis has shown potential for neuroprotection, anti-inflammatory action, and even antibacterial effects, among other benefits, which are present in much higher concentrations in the female inflorescences than in other parts of the plant. The precise function of these compounds within the plant is largely unknown; it is generally hypothesized that many of the compounds are used defensively to prevent predation by animals and attack by fungi and bacteria. In particular “cannabinoids” any of a group of closely related compounds which include “cannabinol” and the active constituents of cannabis.
The inclusion of Vijaya (Cannabis sativa) leaf brings centuries-old Ayurvedic wisdom into the modern wellness landscape. The cannabinoids interact with the endocannabinoid system (ECS), known for regulating mood, sleep, pain, and stress responses. The ECS plays an important role in multiple aspects of neural functions, including the control of movement and motor coordination, learning and memory, emotion and motivation, addictive-like behaviour and pain modulation, though present in a small-dose (about1% to about 1.5 %), the potency is very much gets enhanced when used through direct nasal delivery.
US20170348276A1 (herein after referred aa “276) discloses a nasal pharmaceutical composition for topical application in the nasal cavity of a subject, comprising: a therapeutically effective amount of a cannabinoid; and a pharmaceutically acceptable excipient, wherein the nasal pharmaceutical composition is a semi-solid or viscous liquid nasal pharmaceutical composition comprising cannabinoid is about 10% w/w, the Castor Oil is about 86% w/w, the Oleoyl Polyoxylglycerides are about 2% w/w of the composition, and the Silicon Dioxide is about 2% w/w of the composition. “276 discloses the viscosity of the nasal pharmaceutical compositions disclosed therein in “276 plays a vital role which is at least about 500 cps and may vary between about 500 cps to about 100,000 cps prior to administration given associated thixotropic properties with some of the novel nasal pharmaceutical compositions, wherein CPS is a unit of measure of dynamic viscosity in the centimetre-gram-second system of units equal to one one-hundredth of a poise (1 P = 100 cP = 1 g x cm-1 x s-1). (The viscosity of water at 700F is 1 centipoise. The lower the number, the less viscous the material).. “236 discloses a nasal spray composition wherein the chemical entities tetrahydrocannabinol (THC) or/and cannabidiol (CBD) is used or used together as chemical entity. There is no disclosure or indication to a person skilled in the art to use the natural herb as an active agent in a nasal herbal composition, therefore, the water-cannabis based herbal composition is novel, inventive and non-obvious and said “236 is not a relevant prior art to the subject matter of the present invention.
US11890311B1(hereinafter referred as “311) discloses a cannabinoid composition, comprising a full spectrum extract of a plant of genus cannabis comprising at least 5% by weight cannabigerol, comprising cannabis terpenes and cannabis flavonoids, and substantially without cannabidiol and tetrahydrocannabinol, which could be oral, sublingual, inhaled, vaporized, or smoked administration preferably a capsule. “311 too don’t neither disclose, nor teach or indicate to a person skilled in the art about a water-cannabis based nasal spray herbal composition.
US11020355B2 (hereinafter referred as “355) discloses a method of encapsulating cannabis-derived compounds in nanosized phospholipid vesicles, wherein a Cannabis sativa-derived formulation is for transmucosal and transdermal delivery. “355 neither discloses not indicate or motivate a person skilled in the art to consider water-cannabis based nasal spray composition, therefore, not relevant to the subject matter of present invention.
US10946054B1(hereinafter referred as “054) discloses an emulsion consisting essentially of a cannabis extract, a Ceylon cinnamon bark oil, a black pepper extract, and lecithin wherein Cannabis plants are subjected to extraction, and the resulting extract is supplemented with additional ingredients to achieve a desired profile. “054 neither discloses not indicate to a person skilled in the art to use water-cannabis based basal spray for medicinal use.
US2020170950A1 (hereinafter referred as “950) discloses compositions comprising cannabinoids or cannabis-derived compounds to be used in the preparation of beverages, foodstuffs and other products particularly to compositions comprising a cannabinoid or a cannabis-derived compound, inulin and pectin. However; Inulin being a natural polysaccharide and Pectin being a plant-based polysaccharide, undergoes gelation in situ when in contact with calcium cations on the nasal mucosal surface. “950 neither indicate nor teaches to a person skilled in the art to consider cannabis for water based nasal spray for rapid recovery of said symptom described herein before and after.
US11779562B2 (hereinafter referred as “562) discloses a pharmaceutical composition comprising a Cannabis extract and optionally one or more pharmaceutically acceptable carriers, diluents, adjuvants, excipients or any combination thereof, the Cannabis extract comprising 9-Tetrahydrocannabinol (THC) in an amount of from 50% to 90% by weight of the Cannabis extract; Cannabidiol (CBD) in an amount of up to 10% by weight of the Cannabis extract; Cannabinol (CBN) in an amount of up to 10% by weight of the Cannabis extract; and a terpene fraction in an amount of more than 1% by weight of the Cannabis extract, the terpene fraction comprising: a nerolidol being absent or in an amount of from about 0.01% to about 20% by weight of the terpene fraction; beta-myrcene in an amount of up to 40% by weight of the terpene fraction; linalool in an amount of at least 5% by weight of the terpene fraction; alpha-pinene in an amount of from 0.001% to 20% by weight of the terpene fraction; and beta-pinene in an amount of from 0.001% to 80% by weight of the terpene fraction. “562 never disclose or motivate or indicate to a person skilled in the art to use cannabis in combination with other herbal extracts for a water based nasal spray for the rapid treatment of symptoms described hereinbefore and hereinafter.
Thus, there is a dire need for a water based cannabis based composition and alternative means of administration of said cannabis water-based drug that does not require various modes of uses as mentioned herein before. As per the inventors of the present invention, the proposed alternative form of administration is convenient to the user, discreet, increased bioavailability over known forms of administration, and at least is safe, economical compared to other known methods.
Here it is to be noticed that though the “Nasal Administration” is known since long for administration of hormone-based drugs for instant relief to the patient. However, “water based Cannabis composition” as nasal based means remains as a new aspect of the present invention, wherein it works in “olfactory pathway” meaning they provide “direct brain access” via nasal cavity.
FEATURES OF THE INVENTION
Unique key feature of the present invention is to introduce a water-based novel, safe and economical / commercially feasible cannabis / cannabinoid formulation as a nasal spray.
Another key feature of the present invention is that the said water based nasal spray disclosed therein is fast acting over the other formats like tablet, Sublingual Drops, topical oil and the likes.
Another key feature of the present invention is that the said nasal spray disclosed therein has direct brain access via nasal cavity i.e. olfactory pathway thereby provides quick relief to the patients.
One more feature of the present invention is that the said nasal spray disclosed therein is an ideal for emergencies like panic attacks, migraines, and sudden spikes of stress or pain.
Still another feature of the present invention is to use cannabis together with more herbs as described herein which in a single composition synergise the pharmaceutical effect of cannabis compared to when cannabis is used as a single entity.
Superiority of the present invention is best understood by the comparison of the products available in the market as described herein below:
TABLET: “Trailokya Vijaya Vati” available as tablet comprising Cannabis Vijaya leaf effective for chronic conditions (pain & anxiety) having slow onsite action of 30-60 minutes further characterised by slow – disintegration in stomach before absorption, furthermore featured by 10-15% bioavailability (oral; undergoes first-pass metabolism).
SUBLINGUAL DROPS: “SleepWell” available as Sublingual Drops (under tongue) in the market as liquid comprising extract of Cannabis Vijaya Leaf with calming herbs and helps in mild to moderate insomnia, anxiety, restlessness etc. featured by 40-45% (moderate) bioavailability (sublingual; partially bypasses liver).
TOPICAL OIL: “Yolo pain relief oil” available as Herbal oil comprising infusion with Cannabis Vijaya leaf extract and essential oils furnishing relief for localized pain, joint, muscle, or nerve pain inflammation with low bioavailability but having systemic – working and fast relief when applied on the skin.
There has not been any cannabis product comprising water as a carrier in the form of a nasal spray for rapid relief of symptoms described hereinbefore and hereinafter and the innovators of the present invention provides a solution in the said technology domain by disclosing herein a water based cannabis nasal spray which ensures suitable bioavailability at respective receptors providing a fast relief to patients of the said set of symptoms described herein.
Composition comprising cannabis and the other herbal ingredients which synergise pharmaceutical activity of cannabis and using the water as a solvent also referred herein as a carrier of the said cannabis based composition which is administered through nasal route has an enhanced pharmaceutical activity.
NASAL SPRAY disclosed herein is a pharma-grade nasal formulation comprising Vijaya leaf extract together with other herbal products described herein characterised by highly efficous having very high – rapid action on pain, stress, anxiety, headaches with higher bioavailability that bypasses liver, but having direct absorption through nasal mucosa characterised by its intranasal mode and is easily sprayed inside the nose for fast central nervous system (CNS) action providing fast relief in about 5 to 10 minutes thereby providing the relief in acute symptoms – migraines, anxiety attacks, stress surges, headaches and is fastest acting over all the formats disclosed in the prior art and having direct brain access via nasal cavity (olfactory pathway) thereby proving itself an ideal option for emergencies in panic attacks, migraines, and sudden spikes of stress or pain.
The invention is best understood by the few examples comprising different range of the main content with constituents.
OBJECTS OF THE INVENTION:
It is an object of the present invention to develop Cannabis water based nasal spray having very high – rapid action on pain, stress, anxiety, headaches with higher bioavailability, and having direct absorption through nasal mucosa characterised by its intranasal mode and work in “olfactory pathway” meaning they provide “direct brain access” via nasal cavity, wherein the olfactory pathway transmits smell information from the nasal cavity to the brain.
Another object of the present invention is to provide an aqueous cannabis nasal spray further featured by the fact that even a small-dose becomes sufficient through the direct nasal delivery to provide the relief to the patient.
It is a general object of the present invention to provide Cannabis water based nasal spray comprising unit operations like decoction, extraction by soxhlation and the likes and distillation to obtain Cannabis and other herbal materials therapeutic active substance in the form of an extract. Any part of the plant of cannabis is used for extraction of active product as an extract. Preferably leaf decoction/extraction is used for obtaining pharmaceutically active material. The said water based nasal spray composition for nasal absorption also comprises soothing agent, ensuring gentle application, a natural preservative to maintain product integrity, calming effect proving agent, a revered adaptogen, cognitive function enhancer and stress and anxiety reducer and a pH balancer.
Integrity herein also means homogeneity, bioactivity, and safety of plant-derived materials designated for human consumption.
It is a specific object of the present invention to provide the process for the preparation of Cannabis water based nasal spray composition comprising decoction or extraction by Soxhlation and the likes of Cannabis leaf, decoction of fruits, water, glycerine, potassium sorbate, lavender extract, decoction of leaves like tulsi, brahmi and pH balancer selected from citric Acid and the likes.
In an aspect of the present invention the said water-based cannabis nasal spray comprises a composition and the said composition comprises extract from the herbal materials used therein in the said water-based cannabis nasal spray.
In another aspect of the present invention the decoction/extraction of the respective plant material is carried out by standard extraction method known in the literature such as decoction, Soxhlation and the likes using a solvent preferably water for cannabis based aqueous nasal spray of the present invention.
The nasal spray of the present invention is described herein as a composition, formulation or the likes.
DETAILED DESCRIPTION OF THE INVENTION
Cannabis plants produce a diverse array of secondary metabolites, including cannabinoids, terpenes and terpenoids, sterols, triglycerides, alkanes, squalenes, tocopherols, carotenoids and alkaloids. The mix of these secondary metabolites varies depending on several factors, including Cannabis variety, part of the Cannabis plant involves various operations* like decoction, distillation, extraction by soxhlation, method of extraction, processing of the extract, and season.
*Wherein decoction is a method of extraction that involves boiling plant materials in a solvent to extract their active ingredients. The solvent is selected based on the solubility of the active material to be extracted and boiling temperature of the solvent. This process is particularly effective for plant parts that require high temperatures to release beneficial compounds.
Further, distillation is a purification process comprising recovering or removing solvent and other volatile materials to obtain active plant material as an extract.
Soxhlet extraction is a technique used to extract a desired component from a solid material using a liquid solvent. It involves placing the solid preferably in powdered form in a thimble within a Soxhlet apparatus and circulating a solvent through it repeatedly until the desired compound is extracted.
After cannabis is harvested, these compounds are isolated by means of an extraction process. Cannabinoids are natural products that are largely exclusive to the cannabis plant.
There are several varieties of Cannabis plants, which have been described under two distinct naming conventions. One of these conventions identifies three distinct species of Cannabis plant, namely Cannabis sativa Linnaeus, Cannabis indica LAM., and Cannabis ruderalis. Another convention identifies all Cannabis plants as belonging to the Cannabis sativa L. species, with the various varieties divided amongst several subspecies, including: Cannabis sativa ssp. sativa and ssp. indica. As used herein, the term “Cannabis” refers to any and all of these plant varieties preferably Cannabis sativa.
In the present invention, plant parts preferably leaf of the said Cannabis plant is used as a raw source which is subjected for the various unit operations like decoction, distillation, extraction by soxhlation and the likes using a solvent and the said solvent is selected from organic solvent, water or mixture thereof. Preferably solvent is water.
Preferably, decoction of Bhrami and Tulsi leaves along with flower of lavender is obtained by soxhlation with organic solvent, water or mixture thereof as an extractant followed by distillation of the solvent, wherein said solvent is selected from organic solvent, water or mixture thereof, preferably sterile water, alcohol preferably ethanol and/ or mixture thereof.
Unlike oral or topical methods, nasal delivery offers significantly higher bioavailability, allowing active compounds to bypass the digestive system and enter the bloodstream almost instantly via “olfactory pathway” meaning they provide “direct brain access” via nasal cavity, wherein the olfactory pathway, it transmits smell information from the nasal cavity to the brain.
This leads to:
• Faster onset of action
• Water based product
• More consistent and effective results
• Lower required doses for desired efficacy and providing the same therapeutic benefit.
• Cost effective
The pharmaceutical composition also referred herein as an herbal composition described herein above is responsible for delivering therapeutic cannabis / cannabinoids directly via nasal absorption;
Disclosed herein is a pharmaceutical also referred as herbal composition of the Present invention is crafted with a carefully balanced formula to maximize efficacy and safety. However, variation in the quantification falls under the scope of the invention.
The dispersion medium for the said pharmaceutical also referred as herbal composition comprising a novel nasal spray comprises any of the conventional solvent or carrier systems, preferably water preferably sterile water.
Pharmaceutical composition also referred as an herbal composition of the present invention is packed as a nasal spray into a preservative-free, airless multi-dose device disclosed or available in public domain able to accurately deliver doses of the novel and inventive pharmaceutical/herbal composition of the present invention.
In an embodiment disclosed herein is a pharmaceutical composition also referred herein as a herbal composition comprising a nasal spray and the said nasal spray composition comprises about 90 to about 95% solvent as an active agent carrier, about 1 to about 5% soothing agent for gentle application, about 0.5% to about 5% alkali metal sorbate natural preservative to maintain product integrity, about 0.1% to about 5 % Lavender Extract for calming aromatic properties, about 0.1 % to about 5 % Tulsi for stress and immune response; about 0.1 % to about 5% Brahmi to enhance cognitive function and reduce anxiety, about 0.5 to about 1.5% Vijaya (Cannabis) Leaf Extract and a suitable quantity of citric acid to manage desired pH.
In a general embodiment of the present invention, there is provided a novel cannabis / cannabinoid formulation as a nasal spray comprising:
• (Cannabis) Leaf
• soothing agent, ensuring gentle application
• natural preservative to maintain product integrity
• calming agent with aromatic properties;
• A revered adaptogen in Ayurveda, supporting stress and immune response;
• Traditionally used herbs to enhance cognitive function and reduce anxiety;
• (pH) balancer
In a specific embodiment of the present invention, there is provided a water based novel cannabis / cannabinoid formulation as a nasal spray comprising:
• Vijaya (Cannabis) Leaf (about 1 to about 1.5%)
• Bhrami leaf, tulsi leaf and lavender flower
• Sterile Water (about 94.5%) – Ensures a clean and safe medium for nasal absorption;.
• Glycerine (about 2%) – Acts as a soothing agent, ensuring gentle application;
• Potassium Sorbate (about 1%) – A natural preservative to maintain product integrity;
• Lavender (about 0.5 %) – Known for its calming and aromatic properties;
• Tulsi (about 0.5%) – A revered adaptogen in Ayurveda, supporting stress and immune response;
• Brahmi (about 0.5%) – Traditionally used herbs to enhance cognitive function and reduce anxiety;
• Citric Acid in Q.s. to act as a (pH) balancer.
In a still another embodiment leaf part of the cannabis plant is used as a source of active ingredient responsible for the desired pharmaceutical activity.
A preservative to maintain product integrity is selected from the group comprising Potassium Sorbate, benzalkonium chloride (BKC), benzoic acid, and sodium benzoate and mixture thereof and the like which shall perform the same function preferably Potassium Sorbate as it is a natural preservative as it is derived from sorbic acid, which is found in certain fruits and berries.
Products imparting calming and aromatic properties is selected from the group comprising turmeric, rosemary, Lavender, valerian, chamomile, echinacea, gingko biloba, and ginseng or mixture thereof and the like preferably Lavender Extract.
A revered adaptogen in Ayurveda, Unani and the like is selected from the group comprising Sabja, Tulsi and the likes preferably Tulsi.
Traditionally used herbs to enhance cognitive function and reduce anxiety is selected from the group comprising Ashwagandha, Tulsi, Bramhni, Chamomile, Valerian and the like preferably Bramhni.
(pH) balancer / pH regulator is selected from the group comprising sodium citrate, calcium acetate, and various acids like lactic acid, oxalic acid, and tartaric acid preferably citric acid and the likes.
EXPERIMENTAL: Invention is best understood by providing the following set of three examples including negative sample examples along with optimised one, which clearly indicates the importance of right choice and the proportion of the ingredients used therein, that provides the desired therapeutic activity.
Particulars Sample I Sample 2 Present invention (Final sample)
Formulation Sterile Water 92.5%
Glycerin 4%
Potassium Sorbate 1%
Tulsi 1%
Vijaya (Cannabis) Leaf 1.5%
Citric Acid Q.s. Sterile Water 96%
Potassium Sorbate 1%
Lavender Extract 0.5%
Tulsi 1%
Brahmi 1%
Vijaya (Cannabis) Leaf 0.5%
Citric Acid Q.s. Sterile Water 94.5%
Glycerin 2%
Potassium Sorbate 1%
Lavender Extract 0.5%
Tulsi 0.5%
Brahmi 0.5%
Vijaya (Cannabis) Leaf 1%
Citric Acid Q.s.
Manufacturing Arrived at the finished products by using the process of Decoction of fruits and leaves and Vijaya leaf of the above to sterile water. Arrived at the finished products by using the process of Decoction of fruits and leaves and Vijaya leaf of the above to sterile water, further reducing the concentrate Arrived at the finished products by using the process of distillation/ soxhelation of Vijaya leaf with water. Further adding Decoction of and leaves of Tulsi and Bhrami along wi th flower of lavender, to the above to distilled water.
Efficacy Effective for chronic conditions (pain & anxiety) Effective for chronic conditions (pain & anxiety) Effective for chronic conditions (pain & anxiety)
Bioavailability 60-70% (directly into the brain and blood stream) 60-70% (directly into the brain and blood stream) 60-70% (directly into the brain and blood stream)
Delivery Method Nasal spray Nasal spray Nasal spray
Onset of Action 5 to 15 minutes 5 to 15 minutes 5 to 15 minutes
Best For Chronic anxiety, pain, stress, Migraines/headaches Chronic anxiety, pain, stress, Migraines/headaches Chronic anxiety, pain, stress, Migraines/headaches
Observation Desired Results were not achieved as viscosity increased leading to stickiness because of the additional glycerine and darkened colour because of the decoction process which was not appealing. Even though efficacy was achieved, Relief from pain, anxiety and lack of deep sleep was successfully attained, user’s experience was not pleasant. Desired Results were not achieved as darkened colour which was not appealing. Even efficacy was reduced due to lowering of the quantity of Vijaya Leaf Extract, Relief from anxiety and lack of sleep was successfully attained, however user’s experience was not pleasant. Desired Results have been achieved, with respect to colour and the thickness of the solution. Efficacy was achieved, Relief from pain, anxiety and lack of deep sleep was successfully attained, user’s experience under the investigation was satisfactory.
Conclusion More viscous, sticky nature and dark colour and hence not appealable thus shall result into commercial failure. More viscous, dark colour and hence not appealable, reduced efficacy, not desired results thus shall result into commercial failure. Meeting with all expectation and hence Commercially successful.
, Claims:1. A nasal spray herbal composition comprising 1-1.5% cannabis, 2% soothing agent ensuring gentle application, 1% to maintain product integrity, 0.5% aromatic calming agent with aromatic properties, 0.5% stress immuniser to enhance cognitive function supporting stress and immune response, 0.5% cognitive function to enhance cognitive function and reduce anxiety, pH balancing agent and 94.5% solvent.
2. The herbal composition according to claim 1 wherein cannabis is Cannabis Sativa also referred as Vijaya.
3. The nasal spray herbal composition according to claim 2 wherein cannabis extract is used and the said extract is extracted from the leaves of the said cannabis plant.
4. The nasal spray herbal composition according to claim 1 wherein Soothing is Glycerine.
5. The nasal spray composition according to claim 1 where in to maintain product integrity is selected from the group comprising Potassium Sorbate, benzalkonium chloride (BKC), benzoic acid, and sodium benzoate and mixture thereof preferably Potassium Sorbate.
6. The nasal spray composition according to claim 1 wherein Calming agent is selected from the group comprising turmeric, rosemary, valerian, chamomile, echinacea, gingko biloba, and ginseng or mixture thereof, preferably Lavender Extract.
7. The nasal spray composition according to claim 1 wherein stress immuniser to enhance cognitive function is selected from the herbs like Tulsi, Sabja and the like preferably Tulsi.
8. The nasal spray composition according to claim 1 wherein cognitive function to enhance cognitive function and reduce anxiety is selected from group comprising Ashwagandha, Tulsi, Chamomile, Valerian and the like which can perform the same function preferably Bramhni.
9. The nasal spray composition according to claim 1 wherein pH balancing agent is selected from the group comprising sodium citrate, calcium acetate, and various acids like lactic acid, oxalic acid, and tartaric acid preferably citric acid.
| # | Name | Date |
|---|---|---|
| 1 | 202511066681-STATEMENT OF UNDERTAKING (FORM 3) [12-07-2025(online)].pdf | 2025-07-12 |
| 2 | 202511066681-POWER OF AUTHORITY [12-07-2025(online)].pdf | 2025-07-12 |
| 3 | 202511066681-FORM FOR STARTUP [12-07-2025(online)].pdf | 2025-07-12 |
| 4 | 202511066681-FORM FOR SMALL ENTITY(FORM-28) [12-07-2025(online)].pdf | 2025-07-12 |
| 5 | 202511066681-FORM 1 [12-07-2025(online)].pdf | 2025-07-12 |
| 6 | 202511066681-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [12-07-2025(online)].pdf | 2025-07-12 |
| 7 | 202511066681-EVIDENCE FOR REGISTRATION UNDER SSI [12-07-2025(online)].pdf | 2025-07-12 |
| 8 | 202511066681-DECLARATION OF INVENTORSHIP (FORM 5) [12-07-2025(online)].pdf | 2025-07-12 |
| 9 | 202511066681-COMPLETE SPECIFICATION [12-07-2025(online)].pdf | 2025-07-12 |
| 10 | 202511066681-FORM-9 [14-07-2025(online)].pdf | 2025-07-14 |
| 11 | 202511066681-FORM 18 [14-07-2025(online)].pdf | 2025-07-14 |