Description:FIELD OF THE INVENTION
The present disclosure relates generally to an herbal formulation, and more particularly, the present disclosure relates to an herbal premix formulation for beverage preparation, and a process of preparing the herbal formulation for beverages.

BACKGROUND OF THE INVENTION
Insomnia is a condition described as difficulty in falling sleep or staying asleep. Sleep deprivation is a related condition where lifestyle circumstances prevent individuals from obtaining sufficient sleep despite the physiological ability.

One of the ways of addressing insomnia is to administer synthetically prepared drugs. Available solutions for poor sleep can be divided into prescription drugs and over-the-counter products (OTC).

The latest generation of prescription drugs for inducing sleep is called Z-drugs. These follow Benzodiazepenes, Barbiturates and Opioids as the latest iteration of purportedly safer and more effective molecules.

Other pharmacological routes include antidepressants, antihistamines e.g. Benadryl, and Melatonin a hormone that body generates to regulate the Circadian rhythm.

Benzodiazepines, benzodiazepine receptor agonists and some antidepressants are effective in the short-term treatment of insomnia (≤4 weeks; weak recommendation, moderate-quality evidence). Antihistamines, antipsychotics, melatonin and phytotherapeutics are not recommended for insomnia treatment (strong to weak recommendations, low- to very-low-quality evidence).” Most pharmacological intervention guidelines for insomnia with Z-drugs, Benzodiazepenes and anti-depressants globally consist of a 2–4-week dosage, followed by ‘deprescription’.

Most over-the-counter (OTC) products are made from herbs. They come in different forms, like synthetic pills, capsules, gummies, melts, chews, or as infusions and tea bags that include tea and herbs. Some common herbs found in sleep aids are Valerian Root, Chamomile, Ashwagandha, and Lavender. There are three main challenges with herbal products: not enough dosage for quick relief, relying on a single treatment, and the use of extracts and synthetic ingredients.

CN117502539A discloses an edible product comprising reconstituted plant material. In particular, it relates to an edible product comprising a fibrous plant product and a plant extract applied thereto. Furthermore, the invention relates to a corresponding method for producing said edible product and its use in at least one of food, food supplement, medicine, cosmetics, health products, nutraceuticals or plant therapeutic products. The plants used may be all plants containing one or more substances of interest of the edible product.

US2021169791A1 discloses an oral pouched products including a fleece material with a controlled basis weight. In some embodiments, the oral pouched products may include a material within a porous pouch, wherein the porous pouch includes a fleece material having a basis weight of at least about 35 gsm. In some embodiments, the oral pouched products may include fleece materials have a thickness of at least about 0.2 mm or less than about 0.1 mm. In some embodiments, the pouched products may be designed for rapid or extended release of components contained therein or may be tailored to provide a desired release profile.

US11964049 discloses a composition for oral administration, the composition including: a dispersion medium including: an aqueous solution; and a dispersed phase including: a population of particles, each particle including: a core including: a first active ingredient; and an aqueous solution; a shell, substantially surrounding the core, the shell including: a lipophilic carrier; and a plurality of emulsifying agents; wherein the particle retards the release of the first active ingredient after consumption.

IN202441013555A discloses an herbal composition (100) of a blend that provides a sensorial journey, embodying the essence of holistic well-being with each revitalizing sip. The herbal composition (100) of a blend comprises 40 to 45 weight percentage of Spikenard (102), 12 to 17 weight percentage of Lemon Balm (104), 7 to 12 weight percentage of Ashwagandha (106), 10 to 15 weight percentage of Rhodiola (108), 4 to 8 weight percentage of L-theanine (110), 4 to 8 weight percentage of Passion Flower (112), 3 to 6 weight percentage of Kava (114) and 1 to 5 weight percentage of Skullcap (116). The proposed herbal composition (100) of a blend gently heats at 60℃ and optimizes the extraction process, thereby ensuring the preservation of the herbs' natural properties.

IN201921007509 discloses an herbal composition comprising a) tagar extract; b) jatamansi extract; c) Ashwagandha extract; d) nutmeg extract; e) bramhi extract; and f) shankhpushpi extract for addressing insomnia and insomnia related symptoms. The present invention also relates to a process for preparing the herbal composition.

The known prior arts disclose sleep enhancing/CNS calming/anti-insomnia effects of botanical actives based on plants selected from Nardostachys jatamansi, Ashwagandha, Cinnamon, Spearmint, Peppermint and lemon grass on individual basis wherein combination of Cinnamon, Spearmint, Peppermint and lemon grass for herbal tea product is most prevalent.

However, the prior arts do not disclose or imply the optimal quantity of herbs to be combined, as well as the ideal proportions of each component to prepare a beverage that would be most effective in promoting, enhancing, inducing sleep or improving sleep qualities.

Therefore, there is a need for a combination of herbs to promote sleep, address insomnia, and mitigate its associated symptoms. To meet this need, the current invention proposes an herbal pre-mix formulation designed to induce sleep and alleviate its related symptoms.

SUMMARY OF THE INVENTION

This summary is provided to introduce a selection of concepts in a simplified format that are further described in the detailed description of the disclosure. These and other features, aspects, and advantages of the present disclosure will become better understood with reference to the following description and appended claims. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

In an aspect of the present invention, there is provided herbal pre-mix formulation for beverage preparation, the formulation comprising herbs selected from Himalayan Musk Root (Nardostachys jatamansi), Lemongrass (Cymbopogon citratus), Ashwagandha (Withania somnifera), Cinnamon (Cinnamomum verum), Spearmint (Mentha spicata), and Peppermint (Mentha piperita).

In another aspect of the present invention, there is provided a process for preparing the pre-mix formulation comprises the steps of, cleaning and drying the herbs, size reducing the herbs, wherein the herbs are from Himalayan Musk Root (Nardostachys jatamansi), Lemongrass (Cymbopogon citratus), Ashwagandha (Withania somnifera), Cinnamon (Cinnamomum verum), Spearmint (Mentha spicata), and Peppermint (Mentha piperita), dry blending the synergistically effective amount of the size reduced herbs to obtain a pre-mix, and filling the obtained pre-mix in bags.

OBJECTIVES OF THE INVENTION
The principal objective of the present invention is to provide an herbal pre-mix formulation.

Another objective of the present invention is to provide an herbal pre-mix formulation for beverage preparation.

Yet another objective of the present invention is to provide a process for preparing an herbal pre-mix formulation for beverage preparation.

DETAILED DESCRIPTION OF THE INVENTION

For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments in the specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated composition, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skilled in the art to which this invention belongs. The composition, methods, and examples provided herein are illustrative only and not intended to be limiting.

The articles “a”, “an” and “the” are used to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article.

The terms “comprise” and “comprising” are used in the inclusive, open sense, meaning that additional elements may be included. It is not intended to be construed as “consists of only”.

Throughout this specification, unless the context requires otherwise the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated element or step or group of elements or steps but not the exclusion of any other element or step or group of elements or steps.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of the ordinary skill in the art to which this disclosure belongs.

Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the disclosure, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference.

The terminology and structure employed herein is for describing, teaching, and illuminating some embodiments and their specific features and elements and does not limit, restrict, or reduce the spirit and scope of the invention.

The term “optionally,” as used in the present disclosure, means that a feature or element described as ‘optional’ within the context of the invention is not required for the invention to function as claimed. It indicates that the presence or absence of the described feature or element does not alter the fundamental operation or scope of the invention, and its inclusion or exclusion may be determined based on the specific requirements or preferences of a practitioner skilled in the art or the particular application in question.

In an embodiment, the present invention provides an herbal pre-mix formulation for beverage preparation, the formulation comprising a primary herb selected from Himalayan Musk Root (Nardostachys jatamansi); and secondary herbs selected from Lemongrass (Cymbopogon citratus), Ashwagandha (Withania somnifera), Cinnamon (Cinnamomum verum), Spearmint (Mentha spicata), and Peppermint (Mentha piperita).

In another embodiment, the present invention provides an herbal pre-mix formulation for beverage preparation, the formulation comprising the Himalayan Musk Root is present in a range of 50 % to 60 % w/w, the Lemongrass is present in a range of 20% to 25% w/w, the Ashwagandha is present in a range of 5% to 8 % w/w, the Cinnamon is present in a range of 4% to 8% w/w, the Peppermint is present in a range of 2% to 5% w/w, and the Spearmint is present in a range of 1% to 4% w/w.

In another embodiment, the present invention provides an herbal pre-mix formulation for beverage preparation, wherein the formulation is in the form of an infusion formulation stored in a tea bag and wherein a single tea bag contains more than 5g of the pre-mix formulation.

In another embodiment, the present invention provides an herbal pre-mix formulation for beverage preparation, wherein the formulation is in the form of an infusion formulation stored in a tea bag and wherein a single tea bag contains 7 g to 9 g of the pre-mix formulation.

In a preferred embodiment, the present invention provides an herbal pre-mix formulation for beverage preparation, wherein the formulation is in the form of an infusion formulation stored in a tea bag and wherein a single tea bag contains 8.7 g of the pre-mix formulation.

In another embodiment, the present invention provides an herbal pre-mix formulation for beverage preparation, wherein the formulation is used by steeping the tea bag in hot liquid having temperature from 60 ºC to 90 ºC for 2 min to 10 min for preparing a beverage.

In another embodiment, the present invention provides an herbal pre-mix formulation for beverage preparation, wherein the formulation is having a shelf life of 10 months to 14 months.

In another embodiment, the present invention provides a process for preparing the pre-mix formulation comprises the steps of:
i) cleaning and drying the herbs;
ii) size reducing the herbs, wherein the herbs are from Himalayan Musk Root (Nardostachys jatamansi), Lemongrass (Cymbopogon citratus), Ashwagandha (Withania somnifera), Cinnamon (Cinnamomum verum), Spearmint (Mentha spicata), and Peppermint (Mentha piperita);
iii) dry blending a synergistically effective amount of the size reduced herbs to obtain a pre-mix; and
iv) filling the obtained pre-mix in bags.

In another embodiment, the present invention provides a process for preparing the pre-mix formulation comprises the steps of cleaning and drying the herbs, size reducing the herbs, wherein the herbs are from Himalayan Musk Root (Nardostachys jatamansi), Lemongrass (Cymbopogon citratus), Ashwagandha (Withania somnifera), Cinnamon (Cinnamomum verum), Spearmint (Mentha spicata), and Peppermint (Mentha piperita), dry blending a synergistically effective amount of the size reduced herbs to obtain a pre-mix, and filling the obtained pre-mix in bags, wherein the pre-mix comprises Himalayan Musk Root preferably in a range of 57 % w/w, the Lemongrass in a range of 23% w/w, the Ashwagandha in a range of 7 % w/w, the Cinnamon in a range of 6% w/w, the Peppermint in a range of 3% w/w, and the Spearmint in a range of 3% w/w.

In another embodiment, the present invention provides a process for preparing the pre-mix formulation comprises the steps of cleaning and drying the herbs, size reducing the herbs, wherein the herbs are from Himalayan Musk Root (Nardostachys jatamansi), Lemongrass (Cymbopogon citratus), Ashwagandha (Withania somnifera), Cinnamon (Cinnamomum verum), Spearmint (Mentha spicata), and Peppermint (Mentha piperita), dry blending a synergistically effective amount of the size reduced herbs to obtain a pre-mix, and filling the obtained pre-mix in bags, wherein the drying is performed using methods selected from, but not limited to, solar dehydration, electric dehydration, shade drying to maintain colour and nutritive value, tray drying, microwave drying, multi-layer drying, and vacuum drying, and preferably tray drying at a temperature ranging from 32 ◦C to 38 ◦C for time period of 1h to 3 h.

In another embodiment, the present invention provides a process for preparing the pre-mix formulation comprises the steps of cleaning and drying the herbs, size reducing the herbs, wherein the herbs are from Himalayan Musk Root (Nardostachys jatamansi), Lemongrass (Cymbopogon citratus), Ashwagandha (Withania somnifera), Cinnamon (Cinnamomum verum), Spearmint (Mentha spicata), and Peppermint (Mentha piperita), dry blending a synergistically effective amount of the size reduced herbs to obtain a pre-mix, and filling the obtained pre-mix in bags, wherein the size reduction is performed using grinding mills, pulverisers, roller cutting mills, preferably roller cutting mills, wherein the dry blending is performed using ribbon blenders or blade blenders, wherein the size reduced herbs having the particle size of 200 micrometre to 2000 micrometre.

In a preferred embodiment, the present invention provides a process for preparing the pre-mix formulation, wherein the size reduction is performed using grinding mills, pulverisers, roller cutting mills, preferably roller cutting mills, wherein the dry blending is performed using ribbon blenders or blade blenders, wherein the size reduced herbs having the particle size preferably of 500 micrometres to 1500 micrometre.

The pre-mix formulation is a blend of different parts of herbs, wherein the parts are broken or crushed, fine ground, coarse powder, wherein the pre-mix formulation of 7 g to 10 g is filled and stored. The pre-mix formulation of 7 g to 10 g is filled in a packaging pouch or string attached bag, wherein the filling is performed using gravitational filling mechanism or automated sealing mechanism, wherein the packing pouch/bag is selected from non-woven fabric, polylactic acid, paper, soilon, preferably a cotton cheese cloth permeable to a liquid and designed to release an infusion of the premix when immersed in the liquid for preparing the beverage.

EXAMPLES
Example 1 - Product experience and consumer acceptance
To gain acceptance from consumers, a detailed series of surveys and trials were conducted with different combinations of herbs. This process involved both the inventors and the consumers. The purpose of these activities was to improve the factors that affect consumer approval, which were identified as:

Effectiveness
The product should induce measurable sleepiness without inducing unconsciousness (‘knocking out’) quickly, upon the very first use. Should improve quality of sleep and wakefulness upon repeated use.

Taste / flavour and aroma
The product should have a pleasing flavour that supports ritualistic consumption. Should have a strong aroma that promotes aromatherapy effects.

Ease of use
The product should be easy to prepare and gratifying to consume. Should be easy to integrate into consumers’ lifestyle.

Safety
The product should use ingredients that are thoroughly studied through systematic research for safety and use them well within established safe doses. Should allow high quality of ingredients through standardization and testing for contaminants.

Example 2 - Trials of Blends
To optimize the formulation, trials of blends were prepared, assessed and presented in table 1. The data required for the survey was collected from the users/respondents by organoleptic evaluation method. The following information was collected from the answers of the 55 respondents.

Table 1 - Trials of Blends
Blend Primary herb(s) Secondary herb(s) Grammage
Blend 1 Jatamansi (2 gm.) Licorice (.4 gm.)
Ashwagandha (.3 gm.)
Nutmeg (.1 gm.)
Spearmint (.1 gm.) 2.9 gm.
Blend 2 Jatamansi (4 gm.) Lemongrass (1 gm.)
Licorice (.8 gm.)
Ashwagandha (.5 gm.)
Nutmeg (.3 gm.)
Spearmint (.3 gm) 6.9 gm.
Blend 3 Jatamansi (5 gm.) Lemongrass (2 gm.)
Ashwagandha (.6 gm.)
Cinnamon (.5 gm.)
Peppermint (.3 gm.)
Spearmint (.3 gm.) 8.7 gm.

Table 2 - Participant break-up
Gender \ Age bracket 20-29 30-39 40-49 50-59 Total
F 9 10 4 4 27
M 9 16 2 1 28
Total 18 26 6 5 55

Table 3 – Efficacy rating of blends
Efficacy Taste
Stress Latency Fragmentation Duration
Blend 1 2 1.83 2 1.67 4.3
Blend 2 4.11 3.6 3.62 3.29 2.08
Blend 3 4.14 4.22 4.08 3.89 3.86

Accordingly, the present invention yielded an infusion bag to be infused in boiling hot water for 5 minutes, to be consumed 30-60 minutes before bedtime. The product is designed to be acutely effective – the average user experiences relaxation and calming of senses within minutes of consuming the infusion, while the gentle soporific effect is achieved in 30-60 minutes. For long-term improvement of sleep and wakefulness and to promote quality sleeping habits, the product to be used as part of a 30-day ritual, but also recommend using it on a need-basis on one-off stressful nights.

Efficacy
For efficacy, across tests, Himalayan Musk Root (Jatamansi) and Indian Valerian Root (Tagara) were found to be the most promising. Combinations of these with various secondaries of complementary effects as well as base flavour profiles were tested over 3-6 months. The herbs were combined in various proportions in infusion bags and tested them for flavour and efficacy. Himalayan Musk Root offered a superior flavour profile across tests and the fact that the intense flavour of Valerian Root might, lead to headaches, digestive trouble and other intolerances among certain people. A 5-gm dose of Himalayan Musk Root was found to be effective both acutely as well as over longer courses.

The flavour and efficacy testing process allowed us to narrow down herbs that would support Himalayan Musk Root both with complementary effects as well as flavour profiles.

As a result, a citrus, minty flavour profile with woody, earthy undertones that scored highly across flavour testing was achieved through the combination of
- 5 gm. Himalayan Musk Root
- 2 gm. Lemongrass
- 0.6 gm. Ashwagandha
- 0.5 gm. Cinnamon
- 0.3 gm. Peppermint
- 0.3 gm. Spearmint

Water was identified as the obvious choice for extraction medium, not only for its universal palatability but also because of its superior capabilities as an extraction medium.

There are two common beverage preparation methods based on extraction in hot water from which the preparation process for improved sleep/sleep qualities was derived:

Infusion:
i. Suspending herbal materials in warm water (typically 60-90 º C), commonly for 2-10 minutes (though traditionally steeping duration can range from a few seconds (for certain teas) to even months (for certain liqueurs).
ii. Typical for herbal teas and tisanes that involve volatile botanicals, including Green Tea, Lemon, Chamomile and Rose petals among others.
Decoction:
i. Boiling plant matter in water (typically 90-150º C) for 5-15 minutes (for teas, though traditionally boiling can run for hours).
ii. Typical for hard plant materials such as root and bark, including Licorice, Ashwagandha, Dandelion root as well as the traditional Indian milk tea, among others.

A few factors that influenced both flavour and effectiveness (strength of infusion) were identified in this process:
1. Size of infused herb particles
2. Temperature of infusion medium (water)
3. Duration of infusion
4. Water-to-herb ratio.

The higher temperature (boiling water), longer steeping (10-15 minutes) and particle sizes as small as 500 micrometres to 1500 micrometre were optimal for strength, flavour considerations and practicalities of both consumer acceptability as well as conventional manufacturing capabilities brought to an optimum at 5 minutes, 250-300 ml. boiling hot water (>90o C).

Thus, the process yielded an infusion bag format to be infused in boiling hot water (90 ºC or higher) for 5 minutes, to be consumed 30-60 minutes before bedtime.

Key considerations of the process of industrial production were as follows:
- It was required to achieve similar particle sizes.
- The unique grammage (8.7 grams, as against 1.5-3 gm. in an average tea bag) required unconventional manufacturing capabilities – since popularly used tea-filling machines are not programmed for such grammages, the filling of infusion bags done manually in a standardized, hygienic and scalable manner (GMP certification).
- To ensure safe and hygienic supply of infusion bags to consumers, the product need to be vacuum packed in food-grade packaging pouches / sachets, and then stored in carton boxes for transportation. The larger size of infusion bags led to unconventional packaging material and process choices.
- The cotton muslin cheesecloth infusion bags – chosen for being free from microplastics, thus being the superior (albeit expensive) choice. This also required changes in the manufacturing process – while conventional infusion bags are heat-sealed, stitched or glued together, Sleep therapy infusion bads needed tying into a knot using strings that were included in the design of the infusion bag. Across a series of trials, the infusion bag was optimized.

Quality analysis
To ensure quality of herbs, high quality testing standards were set in place to ensure every batch is tested for heavy metals, microorganisms (bacterial, fungal) as well as common contaminants. , Claims:1. An herbal pre-mix formulation for beverage preparation, the formulation comprising:
a primary herb selected from Himalayan Musk Root (Nardostachys jatamansi); and secondary herbs selected from Lemongrass (Cymbopogon citratus), Ashwagandha (Withania somnifera), Cinnamon (Cinnamomum verum), Spearmint (Mentha spicata), and Peppermint (Mentha piperita).

2. The pre-mix formulation as claimed in claim 1, wherein the Himalayan Musk Root is present in a range of 50 % to 60 % w/w, the Lemongrass is present in a range of 20% to 25% w/w, the Ashwagandha is present in a range of 5% to 8 % w/w, the Cinnamon is present in a range of 4% to 8% w/w, the Peppermint is present in a range of 2% to 5% w/w, and the Spearmint is present in a range of 1% to 4% w/w.

3. The pre-mix formulation as claimed in claim 1, wherein the formulation is in the form of an infusion formulation stored in the tea bags, and wherein a single tea bag contains more than 5 g of the pre-mix formulation.

4. The pre-mix formulation as claimed in claims 1 to 3, wherein the single tea bag contains 7 g to 9 g, preferably 8.7 g of the pre-mix formulation.

5. The pre-mix formulation as claimed in claims 1 to 3, wherein the formulation is used by steeping the tea bag in a hot liquid having temperature from 60 ºC to 90 ºC for 2 min to 10 min for preparing a beverage.

6. The pre-mix formulation as claimed in claim 1, wherein the formulation having a shelf life of 10 months to 14 months.

7. A process for preparing the pre-mix formulation comprises the steps of:
i) cleaning and drying the herbs;
ii) size reducing the herbs, wherein the herbs are from Himalayan Musk Root (Nardostachys jatamansi), Lemongrass (Cymbopogon citratus), Ashwagandha (Withania somnifera), Cinnamon (Cinnamomum verum), Spearmint (Mentha spicata), and Peppermint (Mentha piperita);
iii) dry blending the size reduced herbs to obtain a pre-mix; and
iv) filling the obtained pre-mix in bags.

8. The process as claimed in claim 5, wherein the pre-mix comprises Himalayan Musk Root preferably in a range of 57 % w/w, the Lemongrass in a range of 23% w/w, the Ashwagandha in a range of 7 % w/w, the Cinnamon in a range of 6% w/w, the Peppermint in a range of 3% w/w, and the Spearmint in a range of 3% w/w.

9. The process as claimed in claim 5, wherein the drying is performed using methods selected from, but not limited to, solar dehydration, electric dehydration, shade drying, tray drying, microwave drying, multi-layer drying, and vacuum drying, and preferably tray drying at a temperature ranging from 32 ◦C to 38 ◦C for time period of 1h to 3 h.

10. The process as claimed in claim 5, wherein the size reduction is performed using grinding mills, pulverisers, roller cutting mills, preferably roller cutting mills, wherein the dry blending is performed using ribbon blenders or blade blenders, wherein the size reduced herbs having the particle size of 500 micrometre to 1500 micrometre.