A herbal vaginal oil in water emulsion GEL lubricant and method of preparation thereof

Abstract

The present invention provides a lubricant for treating vaginal dryness, maintaining vaginal health, and to improve libido. Specifically, the invention discloses a herbal vaginal lubricant composition comprising an extract of Cucurbita pepo (Pumpkin) seed, aqueous extract of Abelmoschus esculentus (Lady's Finger / Okra), Cucurbita pepo (Pumpkin) seed oil, Shea Butter, Hippophae rhamnoides (Sea Buckthorn) oil and pharmaceutically acceptable excipients, wherein, the herbal vaginal lubricant is an oil-in-water emulsion gel.

Description

[0001] DESCRIPTION

[0002] TITLE OF THE INVENTION: A HERBAL VAGINAL OIL IN WATER EMULSION GEL LUBRICANT AND METHOD OF PREPARATION THEREOF

[0003] FIELD OF INVENTION

[0004] The present invention relates to a herbal lubricant composition for maintaining vaginal health, to improve libido and for treating vaginal dryness. Further, the invention relates to the method of preparing the herbal lubricant composition.

[0005] BACKGROUND OF INVENTION

[0006] The vagina is a muscular tube that serves as the primary reproductive and sexual organ in females, connecting the uterus to the external genitalia. An integral part of the female reproductive system, the vagina plays a crucial role in sexual intercourse, childbirth, and the menstrual cycle. It is pertinent to keep the vagina clean and moisturized. Usually, the vagina is self-lubricated by the fluids produced by the vaginal walls and glands. However, vaginal lubrication is influenced by hormonal changes, particularly estrogen levels. Disruptions in this lubrication process, such as those occurring due to hormonal imbalances or other factors, can lead to conditions like vaginal dryness, impacting sexual well-being and overall vaginal health.

[0007] Vaginal dryness is a condition that arises when there is a noticeable lack of moisture in the vaginal tissues. The medical definition of vaginal dryness is centred around the idea that the vagina's natural moisture content is diminished, leading to discomfort and potential complications. Vaginal dryness may occur due to various factors, such as hormonal changes, particularly during menopause, childbirth, breastfeeding, certain medications, stress, anxiety, or medical conditions like Sjogren's syndrome, thyroid disorders, inflammatory conditions and the like. Estrogen is a hormone crucial for maintaining the health of the vaginal walls and promoting the production of natural lubricants. Vaginal dryness is particularly common during significant hormonal changes, such as menopause, where estrogen levels decrease, or during breastfeeding. Apart from hormonal changes, certain medications, such as those used for allergy relief or as part of cancer treatments, can impact vaginal lubrication. Additionally, as mentioned in the preceding paragraph high levels of stress and autoimmune disorders may also be linked to this condition. The symptoms of vaginal dryness can manifest in various ways, making it essential to recognize and address the issue promptly. Common symptoms include persistent itching, a burning sensation, increased vulnerability to vaginal infections, etc.

[0008] Vaginal dryness often has significant impact on sexual function. The insufficient lubrication resulting from reduced estrogen impacts the vaginal mucosa's thickness, elasticity, and vascularity. This physiological shift contributes to discomfort, irritation, and pain during sexual intercourse, potentially diminishing sexual desire and arousal. Beyond the physical aspects, the emotional and psychological toll is notable, as fear of pain and discomfort may lead to avoidance of sexual activities, affecting relationship dynamics. The multifaceted nature of this condition requires a comprehensive approach, including medical interventions like hormone therapy and lubricants to address physical symptoms.

[0009] Currently, various therapeutic interventions are available for managing vaginal dryness and associated sexual problems. Hormone replacement therapy (HRT) remains a cornerstone, particularly in cases where estrogen deficiency contributes to the condition. Topical estrogen preparations, such as creams, rings, or tablets, are commonly prescribed to directly address localized symptoms while minimizing systemic effects. Non-hormonal alternatives, including vaginal moisturizers and lubricants, provide symptomatic relief by enhancing lubrication and reducing friction during sexual activity. Emerging treatments, such as selective estrogen receptor modulators (SERMs) and tissue-selective estrogen complexes (TSECs), are also being investigated for their potential in addressing vaginal dryness without the systemic impact associated with traditional HRT.

[0010] While various treatments are available for managing vaginal dryness and associated sexual problems, they are not without potential side effects. Hormone replacement therapy (HRT), although effective in alleviating symptoms, may pose risks such as an increased likelihood of blood clots, strokes, and certain cancers. Additionally, some individuals may experience breast tenderness, nausea, or headaches as side effects of HRT. Topical estrogen preparations, while targeting localized symptoms, can occasionally lead to skin irritation or discomfort. Non-hormonal options like vaginal moisturizers may provide only temporary relief and require consistent application. Moreover, individuals with certain allergies may experience adverse reactions to the ingredients in these products. Emerging treatments, such as selective estrogen receptor modulators (SERMs) and tissue-selective estrogen complexes (TSECs), are still under investigation, and their long-term safety and efficacy profiles are not yet fully established.

[0011] A lubricant is a substance used to reduce friction and enhance the ease of movement between surfaces. In the context of sexual health, lubricants are employed to reduce discomfort and improve pleasure during intimate activities.

[0012] An appreciable number of personal lubricant compositions are known and available in the art, and may be known as lubes. These compositions span from jellies to liquids to vaginal suppositories, and vary from being petrolatum, aqueous, oil or silicone-based. Nevertheless, the use of such formulations has one or more disadvantages, and are not comfortable for use. Good Clean Love®, Aloe Cadabra®, Luvena®, AH! YES®, Aquagel®, Sliquid®, Astroglide®, K-Y Jelly®, Pjur®, PINK™, Astroglide® Silicone, Uberlube, K-Y® WARMING® Jelly, Durex® Play® Utopia® are some of the lubricants available in the market. Petroleum-based lubricants, derived from mineral oil or petroleum jelly offer a long-lasting and silky texture but may compromise the integrity of latex contraceptives and pose a risk of irritation. However, petroleum jelly can change the pH (acid) of the vagina, leading to vaginal infections and urinary tract infections (See Brown et la, Obstetrics & Gynecology. 121(4):773~780, April 2013). Water-based lubricants are water-soluble and easy to clean, are compatible with latex contraceptives and sex toys, but may require frequent reapplication, may dry up fast and have the tendency to become sticky. Oil-based lubricants, derived from natural oils like coconut or almond, offer a silky texture, and they do add a nice, slippery dimension to sexual experiences, creating an inviting atmosphere of warmth, intimacy, and sensuality. However, oil-based lubes tend to stain fabrics and can be difficult to wash off. They may also destroy latex of contraceptives, and certain oil-based lubes can increase the risk of urinary tract infections. Silicone-based lubricants are preferred over other category of lubricants as they provide a long-lasting and velvety feel, are latex contraceptivecompatible and resist washout. However, they can leave a sticky residue, and they may not be compatible with silicone sex toys, causing them to deteriorate overtime.

[0013] Common personal lubricants, including KY jelly and Vaseline, are not ideal due to their consistency and poor lasting quality. Additionally, commercially available lubricants provide only a lubricating effect but do not contain ingredients that can promote vaginal health and / or increase libido.

[0014] In recent years, there has been growing interest in exploring herbal treatments as complementary or alternative options for managing vaginal dryness and associated sexual problems. Herbal remedies derived from plants, such as black cohosh, red clover and evening primrose oil, are among those gaining attention for their potential benefits in addressing hormonal imbalances contributing to vaginal dryness. These botanical extracts often contain phytoestrogens and compounds with estrogen-like effects that may help restore a more balanced hormonal environment. Additionally, certain herbs possess moisturizing and anti-inflammatory properties, potentially providing relief from the physical discomfort associated with vaginal dryness. While research on the efficacy of several herbal treatments is ongoing, some individuals report positive outcomes with minimal side effects compared to traditional pharmaceutical interventions.

[0015] IN202221003548 discloses a herbal vaginal oil composition and method, the said composition comprising a main concoction consisting of plurality of herbal ingredients such as Shatavari, Ashwagandha, Kalonji seeds, Jeshthamadh, Nagarmotha, Anantamol, Brahmi, Vetiver, Manjishtha, Lotus, Neem, Rose, Amla, Aloe vera, Orange, Bhimseni kapoor, Sandalwood, Hirda, Baheda, Hibiscus, Tulsi, and a first set of cold pressed plant oils such as Coconut oil, Castor oil, Mustard oil, Sesame oil; a second set of cold pressed plant oils consisting of Coconut oil, Sesame oil, Castor oil, Olive oil, Mustard oil, Sweet almond oil, Flax seed oil; and Vitamin E.

[0016] CN101361756A discloses a vaginal lubricant composition comprising egg liquid, glycerol, methyl parahydroxybenzoate, propyl p-hydroxybenzoate along with Chinese herbs such as Radix sophorae flavescentis extractive liquid and Cortex phellodendri extracting solution.

[0017] US5015474A discloses method for treating vaginal dryness using eriodictyon fluid / Yerba santa extract along with a lubricant such as glycerine.

[0018] IN-DEL-2010-00100A discloses a herbal composition for enhancing female sexual response via lubricating the vagina , the said composition comprising (a) Manjakini (b) Mimosa pudica, (c) Curcuma comosa, (d) Clitoria ternatea, (e) Symplocos racemosus, (f) Tinospora cordifolia, (g) Santalum album and (h) L-Arginine HCL, wherein the composition is in the form of foam, cream, wash, gel, suppository, pessary, ovule, lotion, ointment, film, tablet, foaming tablet, bio-adhesive tablet, effervescent vaginal tablet, tampon, vaginal spray, aerosol .

[0019] US20130108599A1 discloses a herbal vaginal composition for treating vaginal infections while maintaining the natural vaginal flora, herbal ingredients comprising: coconut oil as the base ingredient, shea butter, neem oil, lavender oil, vitamin E, lactobacillus, green tea, tea tree, ylang ylang, sweet orange, myrrh, frankincense, nirvanas base, and clove oil.

[0020] Larmo et al studied the effects of extracts from herbs such as oil from sea buckthorn on vaginal dryness and mucosal thinning (Larmo PS, YangB, HyssdldJ, Kallio HP, ErkkolaR. Effects of sea buckthorn oil intake on vaginal atrophy in postmenopausal women: a randomized, double-blind, placebo-controlled study. Maturitas. 2014 Nov;79(3):316-21. doi: 10.1016 / j.maturitas.2014.07.010. Epub 2014 Jul 21. PMID: 25104582).

[0021] The use of herbal remedies is grounded in the belief that these natural botanical components can contribute to health and well-being, offering a holistic approach to healing that aligns with nature's inherent properties. While several herbal formulations have been developed to treat vaginal dryness, a major issue, most of the formulations in the prior art are in the form of oil. Such consistency of the lubricant is often associated with short contact time of the lubricant with the mucosa of the vagina and continuous wash out.

[0022] Some agents used in lubricant like VBE, menthol, vasodilators, and various natural extracts, e.g. Sichuan, Jambu, ginger, maca, etc., are known to be skin irritants. Such compositions have the disadvantage of causing irritation to the mucosa, which can be problematic in relation to the vaginal mucosa as irritation may disrupt the sexual experience. Accordingly, there remains a need to deliver a sensory stimulus using a personal lubricant while minimizing the effect of irritation.

[0023] Sexual problems are more common among infertile couples, with an incidence ranging from 5% to 55%. Sexual dysfunction can be the cause of infertility or the result of it. Thus, the use of vaginal lubricant can improve sexual activity and alleviate distress in infertile women. Therefore, there is a need for a natural vaginal lubricant composition which can overcome the disadvantages of Oil, Water, Petrolatum and silicone lubricants, that are effective while providing less irritation to the user, have increased retention time at the application site with bio adhesive properties, while being compatible with pH of the normal physiological environment of a female vagina, latex contraceptives and sex toys.

[0024] OBJECT OF THE INVENTION

[0025] It is an object of the present disclosure to provide a non-hormonal and gentle alternative to traditional treatments for vaginal dryness.

[0026] An object of the present disclosure is to provide a herbal vaginal composition free of synthetic chemicals, to prevent vaginal dryness.

[0027] Another object of the present disclosure is to provide a herbal vaginal lubricant composition with good bio adhesive properties and high retention time at the application site.

[0028] Yet another object of the present disclosure is to provide a herbal vaginal lubricant composition that is compatible with the natural physiological environment of the vagina and is compatible with sex toys and latex contraceptives.

[0029] Still another object of the present disclosure is to provide a herbal vaginal lubricant with anti-inflammatory properties while stimulating sexual arousal.

[0030] Further object of the present disclosure is to provide a method of preparing the herbal vaginal lubricant composition.

[0031] SUMMARY OF THE INVENTION The present invention provides a herbal lubricant composition for maintaining vaginal health and for treating vaginal dryness.

[0032] In one aspect of the invention, there is provided a herbal vaginal lubricant composition comprising an extract of Cucurbita pepo (Pumpkin) seed, aqueous extract of Abelmoschus esculentus (Lady’s Finger / Okra), Cucurbita pepo (Pumpkin) seed oil, Shea Butter, Hippophae rhamnoides (Sea Buckthorn) oil and pharmaceutically acceptable excipients, wherein

[0033] (i) the extract of Cucurbita pepo (Pumpkin) seed is present in a concentration ranging from about 20% v / v to about 30% v / v of the composition;

[0034] (ii) the aqueous extract of Abelmoschus esculentus (Lady ’ s finger / Okra) is present in a concentration ranging from about 3% v / v to about 4% v / v of the composition;

[0035] (iii) Cucurbita pepo (Pumpkin) seed oil is present in a concentration ranging from about 2% v / v to about 5% v / v of the composition;

[0036] (iv) Shea Butter is present in a concentration raging from about 2% w / v to about 5% w / v of the composition;

[0037] (v) Hippophae rhamnoides (Sea Buckthorn) oil is present in a concentration ranging from about 0.25% v / v to about 2% v / v of the composition; and wherein, the herbal vaginal lubricant is an oil-in-water emulsion gel.

[0038] In an aspect of the present invention, the pharmaceutically acceptable excipients are selected from the group consisting of emulsifiers, gelling agents, warming agents, solvents, preservatives and mixtures thereof.

[0039] In another aspect of the present invention, the pH of the herbal vaginal lubricant composition is from about 4.5 to about 7. In yet another aspect of the present invention, there is provided a method of preparing the herbal vaginal lubricant composition, said method comprising:

[0040] (a) mixing Cucurbita tywiPumpkin) seed oil, shea butter, Hippophae rhamnoides (Sea Buckthorn) oil and warming agent to obtain an oil phase;

[0041] (b) dissolving the preservatives in water to obtain a water phase;

[0042] (c) mixing the oil phase in step (a) with the water phase in step (b) and adding an emulsifier to this mixture to obtain an emulsion;

[0043] (d) mixing Cucurbita pepo (Pumpkin) seed extract, Abelmoschus esculentus (Lady’s Finger / Okra) aqueous extract, preservative, solvent and gelling agent to obtain a gel phase; and

[0044] (e) mixing the gel phase obtained in step (d) with the emulsion obtained in step (c) to obtain a herbal oil in water emulsion gel lubricant.

[0045] DETAILED DESCRIPTION OF THE INVENTION

[0046] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0047] Unless the context indicates otherwise, it is specifically intended that the various features of the invention described herein can be used in any combination. Moreover, the present invention also contemplates that in some embodiments of the invention, any feature or combination of features set forth herein can be excluded or omitted.

[0048] All publications, patent applications, patents, and other references mentioned herein are incorporated by reference herein in their entirety for all purposes.

[0049] As used herein, “a,” “an,” or “the” can mean one or more than one. The term “comprising”, which is synonymous with “including”, “containing”, or “characterized by” herein defined as being inclusive or open-ended and does not exclude additional, unrecited elements or method steps, unless the context clearly requires otherwise.

[0050] The term “about” is used herein to mean 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 the context of the present disclosure, the term “about” means within 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, or 0.05% of a given value or range.

[0051] As used herein, the term “herbal” relates to substances, remedies, or products derived from plants, particularly those with medicinal, aromatic, or culinary properties. Herbal elements can include leaves, flowers, stems, roots, seeds, or other plant parts, as well as the whole plant, that possess therapeutic qualities due to the presence of bioactive compounds. Herbal products are often utilized in traditional medicine systems across cultures, and may be prepared in various forms, such as teas, tinctures, extracts, oils, concentrates for topical application.

[0052] As used herein, the term “lubricant” implies a substance for vaginal use, applied to enhance comfort and reduce friction during intimate activities, such as sexual intercourse. Also commonly known as "personal lubricants" or "lubes," these products are designed to alleviate dryness, discomfort, or irritation that may occur during sexual activity. The lubricant serves to reduce friction, allowing for smoother and more pleasurable intimate experiences, while also reducing the risk of irritation or injury. Lubricants of the present disclosure may be formulated in various compositions as sexual wellness products, contributing to increased comfort and satisfaction during intimate moments.

[0053] Accordingly, the present disclosure provides a herbal vaginal lubricant composition comprising seed extract of Cucurbita pepo (Pumpkin), aqueous extract of Abelmoschus esculentus (Lady’s finger / Okra), seed oil of Cucurbita pepo (Pumpkin), shea butter, Hippophae rhamnoides (Sea Buckthorn) oil and pharmaceutically acceptable excipients. The lubricant composition is used for alleviating vaginal dryness.

[0054] Cucurbita pepo (Pumpkin) seed extract is derived from pumpkin seeds and is a concentrated form of the beneficial components found in these seeds. It contains a variety of nutrients, including vitamins, minerals, and antioxidants. Pumpkin seed extract is associated with potential health benefits, particularly in supporting certain aspects of well-being. Notably, the extract is rich in phytosterols, such as betasitosterol. The presence of antioxidants, like carotenoids and tocopherols, in pumpkin seed extract can help neutralize free radicals. The extract provides essential fatty acids, including omega-3 fatty acids and omega-6 fatty acids, which are important for various physiological functions, and are expected to alleviate vaginal dryness by providing essential fatty acids and antioxidants, supporting vaginal tissue health, when included in the herbal lubricant of the present disclosure. The presence of phytosterols, including beta-sitosterol, suggests a potential role in hormonal balance, contributing to the relief of symptoms associated with dryness. Pumpkin seeds are commercially available and the same have been used to obtain the seed extract used in the herbal lubricant composition of the present disclosure. The extract may be obtained by any process conventional in the art, and known to persons of skill in the art, using solvents that are suitable and pharmaceutically acceptable.

[0055] In one embodiment of the present disclosure, Cucurbita pepo (Pumpkin) seed extract is present in a concentration ranging from about 20% v / v to about 30% v / v of the herbal lubricant composition.

[0056] Aqueous extract of Abelmoschus esculentus, commonly known as Okra (Lady’s finger) in India, is a liquid obtained by soaking okra (Abelmoschus esculentus) in water. Okra in itself is a good source of vitamins, including vitamin C, vitamin K, and folate, as well as minerals like potassium and magnesium. Some proponents suggest that Okra water may have potential health benefits due to its mucilaginous (gelatinous) nature, which may help soothe and coat mucus membranes. Additionally, it is rich in antioxidants, including polyphenols, which can help combat oxidative stress. Okra, rich in mucilage and water content, is included in the herbal lubricant of the present disclosure so that it can contribute to alleviating vaginal dryness by promoting natural lubrication and maintaining moisture in the vaginal tissues, potentially providing relief from discomfort and dryness. Its hydrating properties make it a potentially beneficial addition to the herbal lubricant of the present disclosure, aimed at addressing intimate wellness concerns.

[0057] In one embodiment of the present disclosure, the aqueous extract of Abelmoschus esculentus (Lady’s finger / Okra) is present in a concentration ranging from about 3% v / v to about 4% v / v of the herbal lubricant composition.

[0058] Pumpkin seed oil is extracted from the seeds of pumpkin (Cucurbita pepo), which are commercially available. The extract is rich in phytoconstituents, including phytosterols such as beta-sitosterol, antioxidants like carotenoids and tocopherols, and essential fatty acids, including omega-3 fatty acids and omega-6 fatty acids. These constituents collectively contribute to potential benefits, such as providing antioxidant protection against free radicals. Its anti-inflammatory and antioxidant properties make it valuable in medicinal and pharmaceutical formulations, where it may be incorporated to enhance the overall efficacy of products aimed at addressing inflammation, oxidative stress, and certain dermatological conditions. The potential ability of the pumpkin seed oil to nourish and moisturize helps provide relief from dryness and discomfort when used in the herbal lubricant composition of the present disclosure. The commercially available pumpkin seeds can be used to extract the oil, using conventional solvents and processes, known in the art and envisaged by a person of skill in the art. In one embodiment of the present disclosure, Cucurbita pepo (Pumpkin) seed oil is present in a concentration ranging from about 2% v / v to about 5% v / v of the herbal lubricant composition.

[0059] Shea butter is derived from the nuts of the African shea tree (Vitellaria paradoxa), and is commercially available for use in cosmetics and pharmaceutical dosage forms. It is renowned for its diverse phytoconstituents, including triterpenoids, tocopherols (vitamin E), polyphenols, and fatty acids such as oleic acid and stearic acid. These constituents contribute to its remarkable moisturizing, antiinflammatory and antioxidant properties, making shea butter beneficial for treating dry skin conditions, reducing inflammation, and promoting wound healing. In medicinal and pharmaceutical formulations, it proves effective due to its natural emollient qualities, thereby serving as a base for various skincare products, ointments, and creams. Shea butter, with its emollient and moisturizing properties, was used in the herbal lubricant of the present disclosure to provide a soothing effect and help alleviate vaginal dryness by promoting hydration and supporting the health of the vaginal tissues.

[0060] In one embodiment of the present disclosure shea butter is present in a concentration ranging from about 2% w / v to about 5% w / v of the herbal lubricant composition.

[0061] Sea buckthorn oil is extracted from the berries of the sea buckthorn plant (Hippophae rhamnoides). Rich in phytoconstituents such as carotenoids, tocopherols (vitamin E), flavonoids and omega fatty acids, including omega-7 palmitoleic acid, it exhibits potent antioxidant, anti-inflammatory and skinnourishing properties. These constituents contribute to the oil's therapeutic uses, which include promoting skin health, aiding in wound healing, and supporting cardiovascular health. In medicinal and pharmaceutical formulations, sea buckthorn oil is valued for its ability to address skin conditions like dermatitis and promote tissue regeneration. Additionally, its anti-inflammatory effects make it useful in formulations targeting conditions such as mucosal inflammation. In one embodiment of the present disclosure Hippophae rhamnoides (Sea Buckthorn) oil is present in a concentration from about 0.25% v / v to about 2% v / v of the herbal lubricant composition.

[0062] The herbal lubricant of the present disclosure is an oil-in-water emulsion gel, which additionally includes pharmaceutically acceptable inert excipients such as one or more of emulsifier, gelling agent, warming agent, solvent, pH adjusting agent, buffer, preservatives, and uses water as a base.

[0063] An emulsifier is a substance that stabilizes and promotes the formation of emulsions, which are colloidal dispersions of two immiscible liquids, such as oil and water. Emulsifiers have amphiphilic properties, meaning they have both hydrophobic (water-repelling) and hydrophilic (water-attracting) regions. This dual nature allows emulsifiers to reduce the surface tension between oil and water, enabling the formation and stabilization of finely dispersed droplets of one liquid in the other. Emulsifiers play a crucial role in various industries, including cosmetics and pharmaceuticals, where they enhance the stability, texture and appearance of products that contain immiscible components.

[0064] In an embodiment of the present disclosure, the herbal lubricant includes an emulsifier selected from the group comprising polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, sorbitan monostearate, sorbitan tristearate, sorbitan monooleate, sorbitan trioleate, glyceryl monostearate, glyceryl tristearate, glyceryl monooleate, glyceryl dioleate, cetyl alcohol, stearyl alcohol, oleic acid, palmitic acid, stearic acid, sodium lauryl sulphate, sodium laureth sulphate, sodium stearoyl lactylate, cetearyl alcohol, ceteareth-20, PEG-40 hydrogenated castor oil, PEG-60 almond glycerides, PEG-100 stearate, PEG-8 stearate, PEG-12 distearate, cremophor EL, cremophor RH40, polyoxyethylene (20) sorbitan monolaurate / Tween 20 , lecithin and mixtures thereof.

[0065] In one embodiment of the present disclosure emulsifier is present in a concentration ranging from about 0.5 % v / v to about 3% v / v of the herbal lubricant composition. A gelling agent is a substance that is added to a liquid to transform it into a gel, which is a semi-solid or solid-like material with a three-dimensional network structure. Gelling agents achieve this by interacting with the liquid components, often through mechanisms like hydration, temperature changes or chemical reactions, resulting in the formation of a gel matrix that entraps the liquid. These agents are commonly used in pharmaceuticals and cosmetics industry to modify the consistency and texture of formulations. Gelling agents play a crucial role in creating a variety of products, such as topical gels and other pharmaceutical formulations.

[0066] In an embodiment of the present disclosure, the herbal lubricant includes one or more gelling agents selected from the group comprising agar-agar, alginate, carrageenan, gelatin, guar gum, locust bean gum, xanthan gum, tragacanth gum, gum arabic, pectin, carboxymethyl cellulose (CMC), methyl cellulose, ethyl cellulose, hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), sodium alginate, bentonite, magnesium aluminum silicate, acacia gum, agarose, carrageenans, microcrystalline cellulose (MCC), carboxymethyl starch (CMS), hydroxypropyl methylcellulose (HPMC), methyl hydroxyethylcellulose (MHEC), sodium carboxymethyl cellulose (NaCMC), konjac gum, gellan gum, tragacanthin, polymerised acrylic acid such as commercially available carbopol in various grades and mixtures thereof.

[0067] In one embodiment of the present disclosure gelling agent is present in a concentration ranging from about 0.5 % v / v to about 3% v / v of the herbal lubricant composition.

[0068] A warming agent is a substance that induces a sensation of warmth or heat when applied to the skin or mucous membranes. These agents typically work by causing vasodilation, which is the widening of blood vessels, leading to increased blood flow to the area of application. The sensation of warmth is often perceived due to the enhanced circulation and blood flow. Warming agents can be found in various products, including topical creams, balms, and patches, and are commonly used for their potential soothing effects on sore muscles and joints. Ingredients like capsaicin, menthol, camphor, and certain essential oils are examples of compounds frequently employed as warming agents in various formulations.

[0069] In an embodiment of the present disclosure , the warming agent is selected from the group comprising capsaicin, camphor, vanillyl butyl ether, ethyl nicotinate, tocopherol nicotinate, diethyl malonate, methyl nicotinate, benzyl nicotinate, diethylene glycol dibenzoate, vanillyl propyl ether, hexyl nicotinate, isopropyl nicotinate, vanillyl ethyl ether, isobutylalkylamide, ethyl salicylate, propyl salicylate, methyl salicylate, ethyl vanillin, vanillyl alcohol, isobutylphenylpropanediol, zingerone, ethyl caproate, ethyl caprylate, ethyl caprate, vanillin, piperine, eucalyptol, cinnamaldehyde, cinnamyl alcohol and mixtures thereof. In a preferred embodiment of the present disclosure, the warming agent is tocopherol nicotinate. Tocopherol nicotinate is a chemical compound that combines tocopherol, a form of vitamin E, with nicotinic acid, a form of vitamin B3 (niacin). This compound is often used in cosmetic and skincare formulations for its potential benefits for the skin. Tocopherol, known for its antioxidant properties, helps protect the skin from oxidative stress, while nicotinic acid is associated with potential benefits for circulation and skin health. The combination of these two components in tocopherol nicotinate offers both, antioxidant and vasodilatory effect, making it a popular ingredient in certain topical formulations designed to support skin health.

[0070] In an embodiment of the present disclosure, tocopherol nicotinate is present in a concentration ranging from about 0.5% w / v to about 3% w / v of the herbal lubricant composition.

[0071] A solvent is a substance, typically liquid, capable of dissolving another substance, known as a solute, to form a homogeneous solution. Solvents are integral components in various processes, including chemical reactions, industrial manufacturing, and laboratory procedures. They facilitate the dissolution of solutes by breaking down their molecular bonds and dispersing the solute molecules throughout the solvent. Common solvents include water, alcohols, ethers, and hydrocarbons, each chosen based on the nature of the solute and the desired properties of the resulting solution. In an embodiment of the present disclosure, the herbal lubricant includes one or more solvents selected from ethanol, methanol, isopropanol, acetone, ethyl acetate, methylene chloride, chloroform, diethyl ether, hexane, toluene, benzene, acetonitrile, dimethyl sulfoxide (DMSO), dimethylformamide (DMF), ethyl ether, cyclohexane, n-hexane, dichloromethane, butanol, butyl acetate, pentane, ethylbenzene, xylene, propylene glycol, glycerol, dimethyl acetamide (DMAc), dimethyl sulfoxide (DMSO), dimethyl carbonate, 1,4-di oxane, tetrahydrofuran (THF) and mixtures thereof.

[0072] In a preferred embodiment of the present disclosure, the solvent is propylene glycol. Propylene glycol is a synthetic organic compound with the chemical formula C3H8O2. It is a colorless, odorless liquid that is widely used in various industries. Propylene glycol is a type of glycol, belonging to the alcohol chemical class, and it is often used as a humectant, solvent, and antifreeze agent. In the pharmaceutical and cosmetic industries, it serves as a common ingredient in medications, skincare products, and personal care items. Its ability to attract and retain water makes it valuable in products where moisture retention is essential. In an embodiment of the present disclosure, propylene glycol is present in a concentration ranging from about 2% v / v to about 5% v / v of the herbal lubricant composition.

[0073] Preservatives are substances added to products to inhibit or prevent the growth of microorganisms, such as bacteria, fungi, and molds. These additives help extend the shelf life of various goods by protecting them from spoilage, decay or contamination caused by microbial activity. In cosmetic products, preservatives contribute to product stability, preventing undesirable changes in texture, color, flavor and odor. Additionally, preservatives are commonly used in pharmaceuticals and other formulations to maintain the integrity and efficacy of the product over time. While preservatives are crucial for product safety and longevity, their use is carefully regulated to ensure they are safe for application and do not pose harm to human health.

[0074] In an embodiment of the present disclosure, the preservatives that may be used in the herbal lubricant of the present disclosure may be selected from benzoic acid, sorbic acid, parabens (methylparaben, ethylparaben, propylparaben, butylparaben), sodium benzoate, potassium sorbate, benzyl alcohol, chlorobutanol, phenol, thimerosal, formaldehyde, bronopol, imidazolidinyl urea, diazolidinyl urea, quatemium-15, methylisothiazolinone, ethylisothiazolinone, sodium propionate, sodium metabisulfite, sodium bisulfite, citric acid, tartaric acid, malic acid, benzoic acid, dehydroacetic acid, triclosan, triclocarban, chlorhexidine, phenylmercuric acetate, phenylmercuric nitrate, methylmercuric chloride, boric acid, sodium borate, benzalkonium chloride, cetylpyridinium chloride, benzethonium chloride, ethylenediaminetetraacetic acid (EDTA), and propyl gallate. In a preferred embodiment of the present disclosure, the preservatives are selected from methyl paraben, sorbic acid and phenoxy ethanol. In an embodiment of the present disclosure, methyl paraben nicotinate is present in a concentration ranging from about 0.2% w / v of the herbal lubricant composition.

[0075] In another embodiment of the present disclosure, sorbic acid is present in a concentration of about 0.1% w / v of the herbal lubricant composition.

[0076] In another embodiment of the present disclosure, phenoxy ethanol is present in a concentration ranging from about 0.2% v / v to about 0.3% v / v of the herbal lubricant composition.

[0077] In an embodiment, the present disclosure provides a herbal vaginal lubricant composition comprising an extract of Cucurbita pepo (Pumpkin) seed, aqueous extract of Abelmoschus esculentus (Lady’s Finger / Okra), Cucurbita pepo (Pumpkin) seed oil, Shea Butter, Hippophae rhamnoides (Sea Buckthorn) oil and pharmaceutically acceptable excipients, wherein:

[0078] (i) the extract of Cucurbita pepo (Pumpkin) seed is present in a concentration ranging from about 20% v / v to about 30% v / v of the composition;

[0079] (ii) the aqueous extract of Abelmoschus esculentus (Lady’ s finger / Okra) is present in a concentration ranging from about 3% v / v to about 4% v / v of the composition;

[0080] (iii) Cucurbita pepo (Pumpkin) seed oil is present in a concentration ranging from about 2% v / v to about 5% v / v of the composition;

[0081] (iv) Shea Butter is present in a concentration raging from about 2% w / v to about 5% w / v of the composition; and

[0082] (v) Hippophae rhamnoides (Sea Buckthorn) oil is present in a concentration ranging from about 0.25% v / v to about 2% v / v of the composition.

[0083] In yet another embodiment, the present disclosure provides a herbal vaginal lubricant composition comprising:

[0084] (i) Cucurbita pepo (Pumpkin) seed extract present in a concentration from about 20% v / v to about 30% v / v of the composition;

[0085] (ii) Abelmoschus esculentus (Lady’s finger / Okra) aqueous extract present in a concentration from about 3% v / v to about 4% v / v of the composition;

[0086] (iii) Cucurbita pepo (Pumpkin) seed oil is present in a concentration from about 2% v / v to about 5% v / v of the composition;

[0087] (iv) Shea Butter is present in a concentration from about 2% w / v to about 5% w / v of the composition;

[0088] (v) Hippophae rhamnoides (Sea Buckthorn) oil is present in a concentration from about 0.25% v / v to about 2% v / v of the composition; (vi) Propylene glycol in a concentration from about 2% v / v to about 5% v / v of the composition;

[0089] (vii) Methyl paraben in a concentration of about 0.2% w / v of the composition;

[0090] (viii) Sorbic acid in a concentration of about 0.1% w / v of the composition;

[0091] (ix) Phenoxy ethanol in a concentration from about 0.2% v / v to about 0.3% v / v of the composition;

[0092] (x)Tocopherol nicotinate in a concentration from about 0.5% w / v to about 3% w / v of the composition;

[0093] (xi)Emulsifying agent in a concentration from about 0.5% v / v to about 3%v / v of the composition;

[0094] (xii) Gelling agent in a concentration from about 0.5%v / v to about 3%v / v of the composition and

[0095] (xiii) Purified water.

[0096] In another embodiment of the present disclosure, there is provided a method of preparing the herbal vaginal lubricant composition in the form of an oil-in-water emulsion gel.

[0097] Prior art discloses various lubricants in the form of emulsions and other forms. However, as indicated in the background of the invention, commercially available lubricants have several drawbacks. While oil-in-water emulsions have found widespread applications in pharmaceutical and cosmetic formulations, these emulsions are thermodynamically unstable systems. They tend to separate out into water and oil phases over time, via various physicochemical mechanisms, including coalescence, gravitational separation, flocculation, Ostwald ripening and phase separation. Emulsions can be confined to oil droplets in a three-dimensional aqueous network called hydrogels to provide stability by preventing coalescence and flocculation. However, hydrogels are incompatible with hydrophobic compounds such as oils present in the herbal composition. The inventors of the present disclosure have addressed these drawbacks by providing the herbal lubricant composition in the form of an oil-in-water emulsion gel that has good thermal stability and ability to solubilise both hydrophobic and hydrophilic compounds. Spread ability of the herbal vaginal lubricant of the present disclosure is a significant parameter. Spread ability indicates that the lubricant is easily spreadable, and comes out of containers while applying only small amount of shear. With decrease in viscosity, spread ability increases. Thus, there is a need to have the right viscosity that can provide a gel that is easy to apply, and yet which does not get washed away, or that does not drip upon application. The present inventors have been able to design such a herbal lubricant gel that meets this criteria of desired spread ability and viscosity.

[0098] A typical healthy vaginal environment is moist and acidic. An acidic environment with pH of around 4 is microbicidal for many sexually transmitted diseases. However, with vaginal dryness, the lactobacillus, an important microbe necessary for keeping the vagina moist, cannot function properly, leading to change in pH, and therefore issues such as infections. The World Health Organisation recommends lubricant having pH below 7.0, for optimal vaginal health. In an embodiment of the present disclosure, the herbal vaginal lubricant has a pH of about 4.5 to about 7.0.

[0099] An advantage of the herbal vaginal lubricant of the present disclosure is attributed to the fact that the lubricant is present in the form of an oil-in-water gel emulsion. The ingredients of the lubricant are both hydrophilic and hydrophobic / lipophilic in nature. Therefore, the formulation of herbal vaginal lubricant in the form of the gel emulsion is helpful in absorption of the active ingredients, both hydrophilic and lipophilic, through the vaginal mucosa. The gelling nature of the herbal lubricant helps in increased retention time at the application site, thereby ensuring that the lubricating effect lasts longer and is not drained or easily removed from the vaginal lumen. In one embodiment, the herbal lubricant stays in the vaginal lumen for a significant time post application, until wiped / washed out. Further, the gel also provides a matrix effect, helping in controlled or sustained release of the components from the same, thereby ensuring longer lasting effects of the components, i.e. moisturisation, anti-inflammatory and lubrication. The herbal lubricant is easy to administer and can be applied to multiple areas in and around the vagina, such as pubic hair, clitoral hood, clitoris, urethral opening, outer labia, inner labia and the vagina itself. In one embodiment, the herbal lubricant is administered by simply pouring a small amount into sanitised hands and spreading over areas of the vagina affected by dryness. In another embodiment, the herbal lubricant is administered via an applicator.

[0100] Since the herbal lubricant is in the form of gel emulsion it does not affect sex toys made of silicon and latex contraceptives, and does not leave a sticky residue unlike silicon, water and oil-based lubricants. Further, since it contains all natural ingredients, the herbal lubricant provides nutrient substances required to improve the blood flow to the vagina and clitoris, which facilitates vaginal lubrication and stimulates the libido.

[0101] The herbal vaginal lubricant of the present disclosure is completely natural, devoid of any synthetic chemicals, safe for application in and around the vagina, non- sticky, has a low dosage requirement, is compatible with vaginal environment and has a long-lasting effect.

[0102] The present disclosure is further illustrated by reference to the following examples which are for illustrative purposes only, and do not limit the scope of the invention in any manner.

[0103] Examples

[0104] Example 1: Preparation of herbal vaginal lubricant

[0105] Herbal vaginal lubricant according to the present disclosure was prepared using the ingredients in respective amounts disclosed in Table 1 below:

[0106] Table 1

[0107] Step 1 : A gel phase was prepared by mixing of the gelling agent with hydrophilic ingredients comprising Cucurbita pepo (Pumpkin) seed extract, Abelmoschus esculentus (Lady’s Finger / Okra) aqueous extract, preservative and Propylene glycol in an amount disclosed in the above table 1, at a moderate speed using a stirrer at room temperature. Triethanolamine was then added to the gel phase.

[0108] Step 2: An oil phase was prepared by mixing Cucurbita pepo (Pumpkin) seed oil, shea butter, Hippophae rhamnoides (Sea Buckthorn) oil and tocopherol nicotinate at room temperature in a stirrer. The oil phase was then heated at 70°C-75°C to ensure a fine dispersion.

[0109] The water phase comprised of preservatives sorbic acid, phenoxy ethanol and methyl paraben was mixed in water in a concentration mentioned in table 1 and was heated at 70°C-75°C to ensure proper dissolution. The water phase and oil phase were cooled to room temperature and were then mixed together under continuous stirring at. Lecithin and Tween 20 was added to this mixture to obtain the final oil- in-water emulsion.

[0110] Step 3: The obtained oil- in -water emulsion in step 2 was added to the gel phase obtained in step 1, dropwise with continuous stirring using a homogenizer to obtain the herbal lubricant composition. Example 2: Characterisation of the herbal vaginal lubricant

[0111] The vaginal lubricant prepared in Example 1 was tested for its effectiveness with respect to various parameters related to vaginal healthcare

[0112] Example 2.1 - Physical examination

[0113] Visual inspection was conducted on samples weighing about 5g stored in 5 individual containers after 48 hours of storage.

[0114] The characteristics of the samples observed are elucidated in Table 2 below.

[0115] Table 2

[0116] Example 2.2 - Spreadability

[0117] Spread ability of the herbal vaginal lubricant prepared in Example 1 was determined using the slip and drag method. 350mg of the lubricant of Example 1 was placed on a glass slide and thereafter it was covered with another glass slide such that the lubricant is sandwiched between the two glass slides. A weight was placed on the top of this glass slide for 5 minutes to expel air and to provide a uniform film of the lubricant gel between the slides. The time (in seconds) required by the top slide to cover a distance of 5 cm on the bottom glass slide was noted.

[0118] Spreadability was calculated by using the following formula.

[0119] Spreadability (S) =MxL

[0120] T where M=Weight tied to the upper slide; L=Length of glass slides; T=Time taken to separate the slides

[0121] The herbal vaginal lubricant of Example 1 showed a spreadability of 60-62 seconds. This indicates that the sample had low viscosity.

[0122] Example 2.3 - pH determination pH of the herbal vaginal lubricant of Example 1 was determined using a digital pH meter. The test was repeated thrice for accuracy, and pH of the lubricant was found to be 4.5, 5.57 and 6.5.

[0123] Example 2.4 - Phase separation study

[0124] Approximately 10 g of the herbal lubricant of Example 1 was transferred into a 15 mL centrifuge tube and centrifuged at 3000 rpm for 30 minutes. No phase separation was observed. This was taken as an indicator of the stability of the emulsion, as it does not separate upon application of force (centrifugation).

[0125] Example 2.5 - Storage Stability test

[0126] The sample prepared in example 1 was stored at 25±2°C and 40±2°C, respectively for 12 weeks. In vitro visual stability changes in appearance, texture, change in pH, phase separation and change in colour were evaluated every 3 weeks. No change was observed in the aforementioned parameters upto 12 weeks.

[0127] Example 2.6 - Swelling index

[0128] Swelling index determined the swelling ability of the herbal vaginal lubricant. To determine the swelling index, one gram of the herbal vaginal lubricant, an oil-in- water emulsion gel, of example 1 was taken on a porous aluminium foil and placed separately in a 50 ml beaker containing 10 ml of 0.1 N NaOH. The sample was then removed from beaker at different time intervals and kept on a dry place for some time, after which it was reweighed.

[0129] Swelling index was determined using the below formula: Swelling index (SW) % = [(Wt-Wo)ZWo] x 100

[0130] Where, Wt = Weight of swollen gel after time t,

[0131] Wo = Original weight of the gel at time zero.

[0132] Swelling index of the herbal vaginal lubricant oil-in-water emulsion gel was found to be 90%.

[0133] Example 2.7 - Rheological study

[0134] Viscosity of the herbal virginal lubricant of Example 1 was determined at 25 °C using a cone and plate Brookfield viscometer (Brookfield Digital Rheometer Model DV-III, DV3T™ Rheometer, USA). About 0.5 gram of the herbal vaginal lubricant of Example 1 was applied to the plate and left for equilibrium. Measurements were made at 25°C at shear rates ranging from 97.80 to 97.88 S-1without standard deviation. Viscosity was determined from the rheogram and was found to be 2824. OcP The low viscosity results are consistent with example 2.2, wherein the herbal vaginal lubricant showed a spreadability of 60-62 seconds.

[0135] Example 2.8 - Adhesion test

[0136] About 80mg of the herbal vaginal lubricant of Example 1 was placed at the centre of an agar plate (1.5% w / w agar in pH 4.5 citrate buffer) and a 50g weight was placed over the sample for 1 minute. The agar plate was attached to a USP disintegration test apparatus and moved up and down in the buffer, or simulated vaginal fluid (SVF, prepared using method described in AKA-ANY-GRAH, A.; BOUCHEMAL, K.; KOFFI, A.; AGNELY, E; ZHANG, M.; DJABOUROV, M.; PONCHEL G. Formulation of mucoadhesive vaginal hydrogels insensitive to dilution with vaginal fluids. Eur J. Pharm. Biopharm., v. 76, n.2, p.296-303, 2010.) at 37 °C ± 1°C. The plate remained immersed in the solution during the whole test. The residence time of gels on the plate (adhesion time) was visually determined and found to be 60 minutes.

[0137] Example 3: Skin irritation test

[0138] A small amount of the herbal lubricant of Example 1 was applied inside the forearm of a human volunteer, just enough to cover the skin lightly. After about 20 minutes, excess lubricant was wiped off slightly, leaving enough for the lubricant to be present on skin. The lubricant was left on the skin for 12-24 hours, ensuring ample time for the lubricant to interact with skin.

[0139] After 12 - 48 hours of application of the lubricant, the area on which the lubricant was applied was visually inspected for any signs of irritation, such as redness, itching, swelling, or any other form of discomfort or allergic reaction. The applied area showed no visible signs of irritation or reaction, nor any change in colour or skin morphology, demonstrating that the lubricant is safe for human use.

[0140] Example 4: Test Survey The herbal vaginal lubricant of Example 1 was tested for its effectiveness with respect to various parameters listed in Table 3 below. 25 female subjects of different age groups, were provided with the herbal vaginal lubricant and were requested to administer sufficient quantity every night. The subjects were handed over the questionnaire elaborated in Table 3 to mark their observations over a period of one month.

[0141] Table 3

[0142] Statistical analysis was conducted using the response from the subjects for various parameters assessed in Table 3. Mean and standard deviation of the response from subjects were analyzed for each parameter. The results are shown in Table 4 below. Table 4

[0143] One sample T test was conducted by formulating the following hypothesis:

[0144] Null hypothesis (HO): the gel is not effective (i.e., the mean score is not significantly different from a neutral value) Alternative hypothesis (Hl): the gel is effective (i.e., the mean score is significantly higher than the neutral value).

[0145] On a scale of 1-3, the following mean score values were assigned:

[0146] 1 = Not effective

[0147] 2 = Neutral 3 = Effective

[0148] The following mean score values were assigned to the hypothesis HO: p < 2 (The gel is not effective or neutral)

[0149] Hl : p > 2 (The gel is effective)

[0150] Standard significance level (a)=0.05

[0151] The t value was calculated using below formula: t = (x - uo)

[0152] (s / n)

[0153] Where x is the sample mean, po is the hypothetical mean (2 in this case), s is the sample standard deviation, and n is the sample size (25).

[0154] The P value was calculated using the t-distribution with 24 degrees of freedom. The results are shown is Table 5 below.

[0155] Table 5

[0156] PO.OOOl for all

[0157] It was observed that for all parameters, the p-value is less than 0.0001, which is much smaller than the significance level of 0.05, which indicated that the null hypothesis (gel is not effective) can be rej ected for all parameters. The above results suggest that the gel is effective across all measured parameters. The mean scores were significantly higher than the neutral value of 2 for all the parameters, indicating that users found the gel to be effective in improving various aspects of sexual health and comfort.

Claims

CLAIMS1. A herbal vaginal lubricant composition comprising an extract of Cucurbita pepo (Pumpkin) seed, aqueous extract of Abelmoschus esculentus (Lady’s Finger / Okra), Cucurbita pepo (Pumpkin) seed oil, Shea Butter, Hippophae rhamnoides (Sea Buckthorn) oil and pharmaceutically acceptable excipients, wherein(vi) the extract of Cucurbita pepo (Pumpkin) seed is present in a concentration ranging from about 20% v / v to about 30% v / v of the composition;(vii) the aqueous extract of Abelmoschus esculentus (Lady ’ s finger / Okra) is present in a concentration ranging from about 3% v / v to about 4% v / v of the composition;(viii) Cucurbita pepo (Pumpkin) seed oil is present in a concentration ranging from about 2% v / v to about 5% v / v of the composition;(ix) Shea Butter is present in a concentration raging from about 2% w / v to about 5% w / v of the composition;(x) Hippophae rhamnoides (Sea Buckthorn) oil is present in a concentration ranging from about 0.25% v / v to about 2% v / v of the composition; and wherein, the herbal vaginal lubricant is an oil-in-water emulsion gel.

2. The herbal composition as claimed in claim 1, wherein said pharmaceutically acceptable excipients are selected from the group consisting of emulsifiers, gelling agents, warming agents, solvents, preservatives and mixtures thereof.

3. The herbal composition as claimed in claim 2, wherein emulsifiers are selected from the group comprising polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, sorbitan monostearate, sorbitan tristearate, sorbitan monooleate, sorbitan trioleate, glyceryl monostearate, glyceryl tristearate, glyceryl monooleate, glyceryl dioleate, cetyl alcohol, stearyl alcohol, oleic acid, palmitic acid, stearic acid, sodium lauryl sulphate,sodium laureth sulphate, sodium stearoyl lactylate, cetearyl alcohol, ceteareth-20, PEG-40 hydrogenated castor oil, PEG-60 almond glycerides, PEG- 100 stearate, PEG-8 stearate, PEG- 12 distearate, cremophor EL, cremophor RH40, lecithin, polyoxyethylene (20) sorbitan monolaurate and mixtures thereof.

4. The herbal composition as claimed in claim 3, wherein the emulsifier is present in a concentration ranging from about 0.5% v / v to about 3% v / v of the composition.

5. The herbal composition as claimed in claim 2, wherein the gelling agents are selected from the group comprising agar-agar, alginate, carrageenan, gelatin, guar gum, locust bean gum, xanthan gum, tragacanth gum, gum arabic, pectin, carboxymethyl cellulose (CMC), methyl cellulose, ethyl cellulose, hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), sodium alginate, bentonite, magnesium aluminum silicate, acacia gum, agarose, carrageenans, microcrystalline cellulose (MCC), carboxymethyl starch (CMS), hydroxypropyl methylcellulose (HPMC), methyl hydroxy ethylcellulose (MHEC), sodium carboxymethyl cellulose (NaCMC), konjac gum, gellan gum, tragacanthin, polymerised acrylic acid and mixtures thereof.

6. The herbal composition as claimed in claim 5, wherein the gelling agent is present in a concentration ranging from about 0.5% v / v to about 3% v / v of the composition.

7. The herbal composition as claimed in claim 2, wherein the warming agents are selected from the group comprising capsaicin, camphor, vanillyl butyl ether, ethyl nicotinate, tocopherol nicotinate, diethyl malonate, methyl nicotinate, benzyl nicotinate, diethylene glycol dibenzoate, vanillyl propyl ether, hexyl nicotinate, isopropyl nicotinate, vanillyl ethyl ether, isobutylalkylamide, ethyl salicylate, propyl salicylate, methyl salicylate, ethyl vanillin, vanillyl alcohol, isobutylphenylpropanediol, zingerone, ethyl caproate, ethyl caprylate, ethyl caprate, vanillin, piperine, eucalyptol, cinnamaldehyde, cinnamyl alcohol, and mixtures thereof.

8. The herbal composition as claimed in claim 7, wherein the warming agent is tocopherol nicotinate.

9. The herbal composition as claimed in claim 8, wherein tocopherol nicotinate is present in a concentration ranging from about 0.5% w / v to about 3% w / v of the composition.

10. The herbal composition as claimed in claim 2, wherein the solvents are selected from the group comprising ethanol, methanol, isopropanol, acetone, ethyl acetate, methylene chloride, chloroform, diethyl ether, hexane, toluene, benzene, acetonitrile, dimethyl sulfoxide (DMSO), dimethylformamide (DMF), ethyl ether, cyclohexane, n-hexane, dichloromethane, butanol, butyl acetate, pentane, ethylbenzene, xylene, propylene glycol, glycerol, dimethyl acetamide (DMAc), dimethyl sulfoxide (DMSO), dimethyl carbonate, 1,4-dioxane, tetrahydrofuran (THF) and mixtures thereof.

11. The herbal composition as claimed in claim 10, wherein the solvent is propylene glycol.

12. The herbal composition as claimed in claim 11, wherein propylene glycol is present in a concentration ranging from about 2% v / v to about 5%v / v of the composition.

13. The herbal composition as claimed in claim 2, wherein the preservatives are selected from the group comprising benzoic acid, sorbic acid, parabens (methylparaben, ethylparaben, propylparaben, butylparaben), sodium benzoate, potassium sorbate, benzyl alcohol, chlorobutanol, phenol, thimerosal, formaldehyde, bronopol, imidazolidinyl urea, diazolidinyl urea, quatemium-15, methylisothiazolinone, ethylisothiazolinone, sodium propionate, sodium metabisulfite, sodium bisulfite, citric acid, tartaric acid, malic acid, benzoic acid, dehydroacetic acid, triclosan, triclocarban, chlorhexidine, phenylmercuric acetate, phenylmercuric nitrate, methylmercuric chloride, boric acid, sodium borate, benzalkonium chloride, cetylpyridinium chloride, benzethonium chloride, ethylenediaminetetraacetic acid (EDTA), and propyl gallate.

14. The herbal composition as claimed in claim 13, wherein the preservatives are selected from either methyl paraben, sorbic acid and phenoxy ethanol or a mixture thereof.

15. The herbal composition as claimed in claim 14, wherein:(i) methyl paraben nicotinate is present in a concentration ranging from about 0.2% w / v of the composition,(ii) sorbic acid is present in a concentration ranging from about 0.1% w / v of the composition, and(iii) phenoxy ethanol is present in a concentration ranging from about 0.2% v / v to about 0.3% v / v of the composition.

16. The herbal composition as claimed in claim 1, wherein the pH of the lubricant is from about 4.5 to about 7.

17. A method of preparing the herbal vaginal lubricant composition as claimed in claims 1-16, said method comprising:(f) mixing Cucurbita pepo(Pumpkin) seed oil, shea butter, Hippophae rhamnoides (Sea Buckthorn) oil and warming agent to obtain an oil phase;(g) dissolving the preservatives in water to obtain a water phase;(h) mixing the oil phase in step (a) with the water phase in step (b) and adding an emulsifier to this mixture to obtain an emulsion;(i) mixing Cucurbita pepo (Pumpkin) seed extract, Abelmoschus esculentus (Lady’s Finger / Okra) aqueous extract, preservative, solvent and gelling agent to obtain a gel phase; and(j) mixing the gel phase obtained in step (d) with the emulsion obtained in step (c) to obtain a herbal oil in water emulsion gel lubricant.

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