WO2020240581A1

WO2020240581A1 - Turmeric based aqueous dispersible formulations

Info

Publication number: WO2020240581A1
Application number: PCT/IN2020/050465
Authority: WO
Inventors: Minni Dr. SINGH; Kahan Singh Sh. PANNU
Original assignee: Punjabi University
Priority date: 2019-05-24
Filing date: 2020-05-25
Publication date: 2020-12-03

Abstract

The invention provides a formulation consisting of aqueous dispersible form of turmeric, its method of preparation and product thereof. In particular, the invention discloses a nanoformulation of turmeric with enhanced aqueous dispersibility thereby greater bioavailability of bioactive components of turmeric such as curcuminoids and non-curcuminoids. The formulation has improved stability, shelf-life, non-bitter taste and non-pungent smell.

Description

TURMERIC BASED AQUEOUS DISPERSIBLE FORMULATIONS

FIELD OF THE INVENTION

The invention relates to a formulation comprising an aqueous dispersible form of turmeric, its method of preparation and product thereof. The invention in particular relates to a turmeric nanoformulation product and a preparation method thereof.

CROSS-REFERENCE TO RELATED APPLICATION

This invention takes priority from provisional application No. 20191 1020742 filed on May 24,2019; the entirety of which is incorporated herein as reference.

BACKGROUND OF THE INVENTION

Curcuma sp. (a herbaceous perennial plant) or turmeric is a flowering plant from the ginger family, Zingiberaceae whose roots are extracted and the ground powder is used in most households in cooking as a main spice in curry. Wide varieties of turmeric are known to the mankind from centuries and are particularly used for flavoring, coloring and medicinal purposes.

Turmeric contains a number of phytoconstituents with varying proportions based on the variety of the turmeric plant. The commonly used turmeric in Indian households comprises curcumin in the range of 1.5-3.0%, however some varieties of turmeric have even been reported to have upto 9% curcumin. Of therapeutic interest are two particular classes of phytoconstituents, the curcuminoids (chiefly, curcumins) and non-curcuminoids (chiefly, turmerones). The curcumins have been used as antioxidants, antimicrobial, anti- inflamatory, anti-cancerous, for muscle regeneration, for wound healing etc., while turmerones have their own potential benefits like anti-diabetic, antioxidants, antibacterial, anti-inflamatory, anti-cancerous, anti-fungal etc.

Despite of the known beneficial properties of turmeric, the issues remains with the bitter taste, poor bioavailability and low dispersibility of turmeric in aqueous solutions. Therefore, the need for better dispersibility, enhanced bioavailability and good taste is evident for products derived from or containing turmeric (curcumin and turmerones). The present invention overcomes the drawbacks of the prior art and offers an improved way of utilizing the useful health benefits of turmeric.

The present invention is envisioned to use the benefits of turmeric of which value addition has been done through nanotechnology interventions. The concept of ‘nano’ leads to enhanced dispersibility which is further correlated with enhanced bioavailability. Innumerable works have reported enhanced bio availability of phytoconstituents when encapsulated in nanoemulsions. This means that even low dosages will furnish therapeutic potential and turmeric is power packed with phytoconstituents. What have been focused on till now is curcumins only. The magic of turmerones is just beginning to unfold in the scientific fraternity, the sages already knew it, and that is the very basis of developing formulation of the present invention.

SUMMARY OF THE INVENTION

According to an objective of the invention, it provides for a formulation comprising an aqueous dispersible form of turmeric and its method of preparation thereof.

According to another objective of the invention, it provides for a turmeric nanoformulation, its method of its preparation and products derived thereof.

According to yet another objective of the invention, it provides for an aqueous- dispersible turmeric nanoformulation comprising: an organic phase comprising turmeric powder, edible and co-emulsifiers comprising atleast of glyceryl mono stearate (GMS); an aqueous phase having emulsifiers comprising atleast of DK Ester F-160 added to 25.0% glycerol; wherein the organic phase and the aqueous phase are mixed in a ratio of 1 :5 (v/v) such that glyceryl mono stearate (GMS) and DK Ester F-160 are in ratio 0.6 - 2.0 to 1.6 - 5.0.

According to another objective of the invention, wherein the glycerol is mixed with an edible gum, wherein the edible gum is selected from the group comprising hydroxyl propyl methyl cellulose, gum Arabic, xanthan gum and/or combinations thereof. According to another objective of the invention, the method for preparing an aqueous- dispersible turmeric nanoformulation, the method comprises: preparing an oil phase by dissolving turmeric powder in edible oil; preparing an organic phase by mixing co emulsifiers comprising atleast of glyceryl mono stearate (GMS) with the oil phase; preparing an aqueous phase by adding emulsifiers comprising atleast of DK Ester F-160 to 25.0% glycerol in water; mixing the organic phase and the aqueous phase in a ratio of 1 :5 (v/v) and homogenizing the mixture to get the desired turmeric formulation. ;wherein the glyceryl mono stearate (GMS) and the DK Ester F-160 are in ratio of 0.6 - 2.0 to 1.6 - 5.0.

According to yet another objective of the invention, the turmeric powder is dissolved in the edible oil is an amount ranging from 15% to 70% (w/v).

According to yet another objective of the invention, the edible oil is selected from the group consisting of olive oil, sunflower oil, sesame oil, almond oil, corn oil, orange oil, lime oil, black pepper oil, nutmeg oil, basil oil, rosemary oil, clove oil, grapefruit oil, fennel oil, coriander oil, bergamot oil, cinnamon oil, lemon oil, peppermint oil, garlic oil, thyme oil, marjoram oil, lemongrass oil, ginger oil, cardamom oil, liquid paraffin, cotton seed oil, peanut oil, nut oil, soy oil, rapeseed oil, vitamin E oil, Vitamin E TPGS oil, fish oil, tallow- derived oil, silicone oil, castor oil, squalene oil, and/or their combinations thereof.

According to yet another objective of the invention, the glyceryl mono stearate (GMS) is in the range of 0.6-2.0 gm.

According to yet another objective of the invention, the DK Ester F-160 is in the range of 1.6-5.0 gm.

According to yet another objective of the invention, the size of nanoparticles of the nanoemulsion formulation ranges from 160-300 nm.

According to yet another objective of the invention, the nanoemulsion formulation has a shelf-life of atleast 6 months. The formulation exhibits good bioavailability, has improved stability, shelf-life, non-bitter taste and non-pungent smell. According to yet another objective, the formulation of the invention can be concocted with dairy products, including but not limited to milk. The dairy products of the turmeric formulation can be selected from, but not limited to, milk, buttermilk, yogurt, curd, and the other similar known diary products.

According to yet another objective, the invention provides for preparing a turmeric shot formulation comprises turmeric emulsions with an aqueous base. The nano-formulation of the present invention get uniformly distributed across the liquid volume and lends a smooth physical appearance without any pungent taste. The turmeric shot formulation further comprises water-based flavours and extracts but not limited to clove, cinnamon, ginger, cardamom, other natural homemade flavours and artificial flavours particularly, spicy, masala flavours or the like.

BRIEF DESCRIPTION OF DRAWINGS

In order to understand the invention and to see how it can be carried out in practice, nonlimiting examples and embodiments will now be described with reference to the accompanying drawings, in which:

FIG. 1A - 1 B illustrate Mass Spectra profiles of Turmeric Oil and turmeric formulation in ES positive mode;

FIG. 2A illustrates Chromatogram of Turmeric Oil in LC-MS profiling;

FIG. 2B-2C illustrate mass spectrum of LC peaks of turmeric oil at different retention times;

FIG. 2D illustrates a Chromatogram of turmeric Formulation in LC-MS profiling;

FIG.2E illustrates a mass spectrum of LC peaks of turmeric formulation at different retention times;

FIG.3A illustrates a GC Chromatogram of turmeric oil;

FIG.3B-3C illustrate mass spectrum of GC peaks of turmeric oil at different retention times;

FIG.3D illustrates a GC Chromatogram of turmeric formulation; FIG.3E, 3F, 3G, 3H illustrate mass spectrum of GC peaks of turmeric formulation at different retention times;

FIG.4A and 4B illustrate SEM and TEM micrographs of the nanoformulation respectively;

FIG.5A, 5B, 5C illustrate Size distribution profiles of the turmeric formulation;

FIG.5D illustrates a Zeta potential profile of the turmeric formulation;

FIG.5E - 5F illustrate Stability profile of TurO.1 and Tur0.05 variant respectively as depicted through zeta size measurements;

FIG.6A illustrates comparative analysis profiles of turmeric formulation with other two samples; and

FIG.6B illustrates sensory profile of TurMin variant 1 of the turmeric formulation.

DETAILED DESCRIPTION OF THE INVENTION

All the aspects described herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred aspects, examples and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope herein without departing from the spirit and scope thereof, and the present invention herein includes all such modifications. The invention described herein relates to a nano formulation comprising aqueous dispersible form of turmeric. The invention also relates to a method of preparation of the said formulation using a unique combination of emulsifiers. The unique combination of emulsifiers helps enhance the dispersibility and provides stability to the formulation. Further, in the following description, various aspects of the invention are described. For the purposes of explanation, specific details are set forth in order to provide a thorough understanding of the invention.

Turmeric is composed of volatile oil and curcuminoids that impart it aroma and antioxidant nature. Turmeric is also a very good source of omega-3 fatty acids and alfa-linolenic acid. Turmeric is known to possess its beneficiary effects of anti-inflamatory, anti-mutagenic, anti-cancer, antimicrobial and antioxidant activities to treat number of diseases and disorders. Turmeric has been widely accepted as an herbal medicine for the treatment of arthiritis, chronic anterior uveitis, conjunctivitis, skin cancer, small pox, chicken pox, wound healing, urinary tract infections, liver ailment, menstrual difficulties, dyspeptic conditions, gallbladder complaints, cancer, cardiovascular disease, Crohn’s disease, tropical pancreatitis, idiopathic orbital inflammatory pseudotumor, oral lichen planus, vitiligo, psoriasis, acute coronary syndrome, diabetes, lupus nephritis, renal conditions, acquired immunodeficiency syndrome, b-thalassemia, biliary dyskinesia, Dejerine-Sottas disease, cholecystitis, and chronic bacterial prostatitis. Curcumin has been identified as active ingredient of turmeric and is the widely studied nutraceutical (Sahdeo Prasad et al..Turmeric, the Golden Spice: From Traditional Medicine to Modern, 201 1 ).

The term“Emulsifier” and“Co-emulsifier” used herein refers to a chemical molecule with one hydrophilic and the other lipophilic end. The food grade emulsifiers are used to increase the stability and miscibility of hydrophobic and hydrophilic moiety.

According to the embodiments of the invention, Emulsifiers and Co-emulsifiers include, but not limited to, glyceryl stearate, stearyl alcohol, cetyl alcohol, stearic acid dimethicone, a silicone (siloxane) surfactant, polysorbates, sodium laureth), phospholipids, for example lecithin, polyoxyethylene sorbitan mono- or tristearate, monolaurate, monopalmitate, mono- or trioleate, a mono- or diglyceride and other known food grade emulsifiers and/or their combinations thereof.

According to the exemplary embodiments of the invention, the emulsifiers and co emulsifiers used in the present invention are selected from, but not limited to, DK Ester F- 160 and glyceryl mono-stearate.

The term“DK Ester F-160” used herein refers to a known food grade emulsifier used majorly in the preparation of food products. DK Ester is a nonionic surface active agent and is an ester compound consisting of sucrose and fatty acids. The mixture corresponds to the varied nature of the emulsifier. DK Ester is sucrose esters of fatty acids also commonly referred to as sucrose esters or sugar esters are used for food application. DK Ester F-160 can be used as an emulsifying agent which is known to increase the solubility of food in water.

The term“Glyceryl monostearate” used herein refers to one of the widely used emulsifiers in the production of ice creams, margarine and spreads. The emulsifier is known to increase the water stable dispersion and improve heat shock resistance of the food items. According to embodiments of the present invention Glyceryl monostearate works as a co emulsifier, aiding DK Ester F-160 as the emulsifier.

The invention provides a unique solution for existing limitations with turmeric usage for example, challenges of dispersibility of turmeric in aqueous formats such as milk, buttermilk, and the likes. Also, the formulation of the present invention overcomes the existing drawback related to bitter taste of turmeric which usually limits its consumption to a large extent.

According to an embodiment of the invention, it relates to a stable nano-formulation of turmeric, which is rich in phenolic components, which are well known as polyphenols. These polyphenols have antioxidant properties due to their radical scavenging activity or they act as free radical terminators. The antioxidants play a major role in human body but for a healthy body, there has to be a balance between antioxidants and pro-oxidants. Diversion of the ratio towards pro-oxidants leads to oxidative stress in the body. This oxidative stress can give rise to severe disorders like malignancies, cardiovascular disorders, diabetes, neurological disorders, renal diseases, aging, liver or respiratory disorders, skin diseases, inflammatory disorders etc. The formulation of the present invention provides for an anti-oxidant rich health supplement. The formulation can be used as nutraceutical food supplement as it provides upto 9.0% of curcumin along with non- curcuminoid components.

According to various studies, turmeric has proven to be an effective nutritional supplement. Many studies show that it has major benefits for the body and brain. It offers tremendous anti-inflammatory properties as well. It helps the body to fight foreign invaders and also has a role in repairing damage. Turmeric has anti-inflammatory properties and has proven to helpful in a number of health conditions, including reduced pain in people with osteoarthritis and rheumatoid arthritis. It may also reduce cholesterol and triglyceride levels. Turmeric has also shown benefits and improved certain heart disease, cancer, metabolic syndrome, Alzheimer's and various degenerative conditions as well.

Another embodiment of the invention relates to a stable nano-formulation of aqueous dispersible form of turmeric, which is used as an additive in dairy based foods such as milk, lassi, yoghurt, and the other similar known dairy products, in-order to develop functional foods.

The commercial value of the product of the present invention is immense and long-term. The present invention provides a nutraceutical formulation that can be used with all known turmeric varieties. Also, under the FSSAI- Food Safety and Standards Authority of India, the product according to present invention satisfies all criteria to be classified as a nutraceutical. After the characterization of the formulation, it is apparent that it contains substantial concentrations of curcuminoids and non-curcuminoids, along with a unique ratio of emulsifiers which makes it a stable health promoting composition of natural bioactives (curcuminoids and non-curcuminoids).

The emulsifiers used according to exemplary the embodiments of the invention are DK Ester F-160 and glyceryl monostearate. The ratio in which these emulsifiers have been used in 0.6 - 2.0 to 1 .6 - 5.0. This unique ratio of the emulsifiers makes the formulation stable for upto 6 months, heat stable and also efficient to withstand sterilization conditions. The combination of emulsifiers used in the present invention also provides uniform dispersion of the turmeric in aqueous formats such milk, buttermilk or the like.

According to the embodiments of the invention, it provides a nutraceutical product formulation possessing health benefits of bioactive compounds present in the turmeric. The formulation of the present invention is an aqueous dispersible nanoformulation of turmeric with improved stability, shelf-life and non-bitter taste.

According to another embodiment, the present invention provides a whole turmeric product. The whole turmeric consists two particular classes of phytoconstituents, the curcuminoids and non-curcuminoids. The curcuminoids mainly comprise curcumins, demethoxycucumins, bisdemothoxycurcumins and non-curcuminoids comprise turmerones, Ar-Turmerone, a-turmerone, eucalyptol etc. The curcuminoids and non- curcuminoids found in turmeric are responsible for healing properties and are of great therapeutic interest. The present invention overcomes the existing challenges of indispersibility of curcuminoids and non-curcuminoids found in turmeric and improves the same with Nanotechnology intervention.

According to an embodiment, invention provides an aqueous-dispersible turmeric nanoemulsion formulation comprising: an organic phase comprising turmeric powder, edible oil and co-emulsifiers further comprising atleast of glyceryl mono stearate (GMS); an aqueous phase having emulsifiers comprising atleast of DK Ester F-160 added to 25.0% glycerol in water; wherein the organic phase and the aqueous phase are mixed in a ratio of 1 :5 (v/v) such that glyceryl mono stearate (GMS) and DK Ester F-160 are in ratio 0.6 - 2.0 to 1.6 - 5.0.

According to another embodiment of the invention, the edible oil is selected from the group consisting of olive oil, sunflower oil, sesame oil, almond oil, corn oil, orange oil, lime oil, black pepper oil, nutmeg oil, basil oil, rosemary oil, clove oil, grapefruit oil, fennel oil, coriander oil, bergamot oil, cinnamon oil, lemon oil, peppermint oil, garlic oil, thyme oil, marjoram oil, lemongrass oil, ginger oil, cardamom oil, liquid paraffin, cotton seed oil, peanut oil, nut oil, soy oil, rapeseed oil, vitamin E oil, Vitamin E TPGS oil, fish oil, tallow- derived oil, silicone oil, castor oil, squalene oil, and/or their combinations thereof.

According to another embodiment of the invention, the size of nanoparticles of the nanoemulsion of the inventive formulation ranges from 160-300 nm.

According to another embodiment of the invention, the formulation of the invention has a shelf-life of atleast 6 months.

According to an exemplary embodiment, invention provides an aqueous- dispersible turmeric nanoformulation comprising: an organic phase comprising turmeric powder, edible oil and co-emulsifiers further comprising atleast of glyceryl mono stearate (GMS); an aqueous phase having emulsifiers comprising atleast of DK Ester F-160 added to 25.0% glycerol in water; wherein the organic phase and the aqueous phase are mixed in a ratio of 1 :5 (v/v) such that glyceryl mono stearate (GMS) and DK Ester F-160 are in ratio 0.6 - 2.0 to 1 .6 - 5.0. The turmeric powder is dissolved in edible oil is an amount in the range of 15% to 70% (w/v). The edible oil used in the invention is olive oil. The glyceryl mono stearate (GMS) ranges from 0.60-2.0 gm and DK Ester F-160 ranges from 1.6-5.0 gm. The glycerol in the aqueous phase can be mixed with an edible gum including, but not limited to hydroxyl propyl methyl cellulose, gum Arabic, xanthan gum and/or combinations thereof.

According to another embodiment, invention provides a method for preparing an aqueous- dispersible turmeric nanoformulation, the method comprising: preparing an oil phase by dissolving turmeric powder in edible oil; preparing an organic phase by mixing co emulsifiers comprising atleast of glyceryl mono stearate (GMS) with the oil phase; preparing an aqueous phase by adding emulsifiers comprising atleast of DK Ester F-160 to 25.0% glycerol in water; mixing the organic phase and the aqueous phase in a ratio of 1 :5 (v/v) and homogenizing the mixture to get the desired turmeric nanoformulation; wherein the GMS and the DK Ester F-160 are in ratio of 0.6 - 2.0 to 1.6 - 5. According to another exemplary embodiment, invention provides a method for preparing an aqueous- dispersible turmeric nanoformulation, the method comprising preparing an oil phase by dissolving turmeric powder in edible oil in the range of 15% to 70% (w/v); preparing an organic phase by adding 0.67-2.0 gm of glyceryl mono stearate (GMS) to 16.7 ml of oil phase at temperature of 58-62°C with continuous stirring between 350-400 rpm; preparing an aqueous phase by adding 1.67-5.0 gm DK Ester F-160 to 83.3ml of 25.0% glycerol in water and/or combinations of glycerol with edible gums at temperature between 30-40°C with continuous stirring between 600-800rpm;mixing the organic phase and the aqueous phase in a ratio of 1 :5 (v/v) with continuous stirring <400 rpm at 35-38C to form the nanoemulsion, and homogenizing the said nanoemulsion to get the desired turmeric formulation. The glyceryl mono stearate (GMS) and DK Ester F-160 are in ratio of 0.67-2.0 to 1.67-5.0. A well-known concoction, by adding turmeric (haldi) in warm milk, used particularly during (a) injuries, (b) joint pains (particularly, rheumatoid arthritis), (c) flu, (d) controlling sugar levels (for diabetics), and almost any ailment/discomfort in the body. And nowadays, for glowing skin as well. However, there are two major limitations that have prevented the optimal utilization of milk (other diary products) mixed with turmeric for oral consumption, namely, 1 ) turmeric settles at the bottom and is not uniformly distributed throughout the milk volume 2) Its pungent taste. Due to these limitations, it is difficult to extract the best out of the portion of turmeric consumed. The present invention overcomes this limitation and accordingly provides aqueous dispersible turmeric formulation for milk and other dairy products.

According to another embodiment of the invention, it provides for flavoured turmeric formulation (TurMilO.1 variant) comprising turmeric emulsions, sugar, milk, food grade emulsifiers, edible oil. The formulation further comprises additional food grade flavors selected from, but not limited to, kashmiri kesar or other natural identical flavoring substances; and additional permitted synthetic food colors selected from but not limited to E-102, E-1 10, E-122 or the like. In another embodiment, the invention provides an unflavoured turmeric milk formulation (TurMil0.05 variant) which comprises low sugar content and low added flavours along with the other components of the turmeric milk formulation (TurMilO.1 variant) described in the previous embodiment. This unflavoured turmeric milk formulation is most suitable of elderly customers, diabetic patients and for the individual who likes low sugar and less artificial flavoring products.

In another exemplary embodiment of the invention, the dairy products of the turmeric formulation can be selected from, but not limited to, milk, buttermilk, yogurt, curd, and the other similar known dairy products.

According to another embodiment, the invention provides for preparing a turmeric shot formulation comprises turmeric emulsions with an aqueous base. The nano-formulation of the present invention get uniformly distributed across the liquid volume and lends a smooth physical appearance without any pungent taste. The turmeric shot formulation further comprises water-based flavours and extracts but not limited to clove, cinnamon, ginger, cardamom, other natural homemade flavours and artificial flavours particularly, spicy, masala flavours or the like.

According to another exemplary embodiment, the turmeric shot comprises food grade synthetic colors. These flavours and colors are used to enhance the flavour and make the product more consumable for a variety of consumers.

According to another embodiment of the invention, depending on the volume of the bottle used for packaging, single use shot, or a multiple use may be developed.

According to another embodiment, the invention provides the method of making the turmeric formulation. According to specific embodiment, the formulation of the invention can be concocted with dairy products, including but not limited to milk.

The invention according to embodiments stated above will hereinafter be described specifically by Examples. However, it should not be construed that the invention is limited to or by them.

Example 1 (TurMil 0.11:

Components used: Turmeric powder, Olive Oil, Glycerol Monostearate, Glycerol, DK-ester F-160 [(Sucrose Fatty Acid Ester), deionized water.

Methods:

Preparation of oil phase and organic phase: a) Turmeric infused olive oil·. Turmeric infused olive oil, hereafter referred to as turmeric oil, is prepared by dissolving turmeric powder in olive oil (carrier) at 16.7% (w/v), under gentle stirring conditions maintained at 40°C for 6h, followed by holding under stationary conditions overnight (16h). The mixture is centrifuged at 5000rpm for 10 min between 25- 30°C, and the oil layer collected. Choice of the edible oil is based on triglyceride length and viscosity, important parameters for stability of formulations.

b) Organic phase : Added 0.67 gm of glyceryl mono stearate, also known as glycerol monostearate (GMS) to 16.7 ml of turmeric oil, maintained at temperature between 58- 62°C, under continuous stirring between 350-400 rpm. GMS will dissolve in the oil in 4-6 min.

Preparation of aqueous phase (also known as water phase):

Added 1.67 gm of DK Ester F-160 to 83.3ml of 25.0% glycerol in water, maintained between 40-45°C, under continuous stirring between 600-800rpm. Allow this mixture, now called the aqueous phase (AP) to stand at the said temperature range.

Preparation of the coarse emulsion (for 100ml):

Lower the temperature of the AP to between 35-38°C and maintain it. Under mild agitation/stirring conditions (<400 rpm), slowly add OP to AP, and continue stirring for 30 min. Thereafter, stop stirring and allow the mixture to stand overnight at ambient temperatures, between 30-35°C, for maturation to occur.

A ratio of 1 :5 (v/v) of Organic phase and Aqueous Phase is used to make the formulation. Preparation of the nanoemulsion :

Dilute the coarse emulsion in water (1 :2), and feed the mixture into a high pressure homogenizer or a microfluidizer, @ 15,000 psi (nearly 1000 bar) for 2 cycles, to get the desired turmeric formulation. This formulation may or may not be subjected to vacuum evaporation to remove the water added for diluting the coarse emulsion. During product development in the laboratory, both machines were used, and furnished same results.

In Examples 2, 3 and 4, the same protocol was followed as that for turmeric nanoformulation in Example 1 , however instead of adding turmeric powder in olive oil (carrier) at 16.7% (w/v), 33.4% (w/v), 50.1 % (w/v) and 66.8 % (w/v) were added to yield higher content of turmeric in the formulation and they showed similar results.

Example 5 (TurMin 0.05):

Methods:

IB Preparation of oil phase and organic phase: a) Turmeric infused olive oil·. Turmeric infused olive oil, hereafter referred to as turmeric oil, is prepared by dissolving turmeric powder in olive oil (carrier) at 16.7% (w/v), under gentle stirring conditions maintained at 40°C for 6h, followed by holding under stationary conditions overnight (16h). The mixture is centrifuged at 5000rpm for 10 min between 25- 30°C, and the oil layer collected. Choice of the edible oil is based on triglyceride length and viscosity, important parameters for stability of formulations.

b) Organic phase : Added 0.335 gm of glyceryl mono stearate, also known as glycerol monostearate (GMS) to 16.7 ml of turmeric oil, maintained at temperature between 58- 62°C, under continuous stirring between 350-400 rpm. GMS will dissolve in the oil in 4-6 min.

Preparation of aqueous phase (also known as water phase):

Added 0.835 gm of DK Ester F-160 to 83.3ml of 25.0% glycerol in water, maintained between 40-45°C, under continuous stirring between 600-800rpm. Allow this mixture, now called the aqueous phase (AP) to stand at the said temperature range.

Preparation of the coarse emulsion (for 100ml):

A ratio of 1 :5 (v/v) of Organic phase and Aqueous Phase is used to make the formulation.

Preparation of the nanoemulsion (Turmeric Formulation TurMilO.1):

Dilute the coarse emulsion in water (1 :2) and feed the mixture into a high pressure homogenizer or a microfluidizer, @ 15,000 psi (nearly 1000 bar) for 2 cycles, to get the desired turmeric formulation. This formulation may or may not be subjected to vacuum evaporation to remove the water added for diluting the coarse emulsion. During product development in the laboratory, both machines were used, and furnished same results. In Examples 6, 7 and 8, the same protocol was followed as that for turmeric nanoformulation in Example 5, however instead of adding turmeric powder in olive oil (carrier) at 16.7% (w/v), 33.4% (w/v), 50.1 % (w/v) and 66.8 % (w/v) were added to yield higher content of turmeric in the formulation and they showed similar results.

According to another embodiment of the invention, the formulation of the invention can be consumed as such in the form of turmeric shots to derive various health benefits of turmeric.

Example 9:

Methods: Two phases are prepared, Organic phase and Aqueous Phase, and thereafter mixed in the ratio 1 :5 as described for the making Example 1 .

These are standalone formulations to be consumed as it is. The methods of preparation are similar to those of Example 1. Variants 0.1 , 0.15 and 0.2 with increased concentrations of GMS and Sucrose fatty acid ester which leads to different textures and mouthfeel of the different variants and also different costs. TurShot0.2 is a richer and creamier variant, with a fuller mouth feel. TurShot0.15, the third variant can be suitably derived from the above. A comparison of all the above variants is stated Table 1 below.

Table 1 : Illustrating the different components of TurShot Variants. Higher concentrations are prepared for specific variants and their sub variant can be developed, based on potency of turmeric in oil, in which case the addition of turmeric is done sequentially. This is because shots demand a higher potential.

Given below are characteristics of the turmeric formulations, which proves the use and presence of the turmeric as a whole (comprising curcuminoids and non-curcuminoids) in the invention, as opposed to using only curcumin.

1. Mass Spectra Profiles:

Mass Spectra profiles of the turmeric oil sample and turmeric Formulation sample were analysed in Electrospray ionization (ES) positive mode. FIG. 1A and FIG. 1 B represent the values of the components of the turmeric found in both turmeric oil and turmeric formulation respectively.

2. Liquid Chromatography- Mass Spectrometry (LC-MS) Profiles:

Turmeric oil and turmeric formulation have been analyzed for their Liquid Chromatography- Mass Spectrometry (LC-MS) Profiles. FIG. 2A shows the Chromatogram of Turmeric Oil. FIG. 2B-2C show the mass spectrum of LC peaks of turmeric oil at different retention times. Similarly, the graph shown in FIG. 2D is the Chromatogram of Turmeric Formulation and FIG. 2E shows the Mass spectrum of LC peaks of turmeric formulation at different retention times

As seen from the MS and LC-MS profiles of both turmeric oil, and turmeric formulation, there is presence of both classes of phytoconstituents in turmeric oil and the formulation (since the formulation is prepared using turmeric oil).

Curcuminoids are non-volatile compounds, whereas turmerones are volatile. The aroma of turmeric is associated with turmerones. MS profiling indicated the presence of the compounds in the samples under study. LC-MS technique is used to ascertain the compounds and is used for non-volatile compounds. It is for this reason that in the LC-MS profiles shown in FIGS. 2A-2E, the abundance is of curcuminoids.

3. Gas Chromatography- Mass Spectrometry (GC-MS) Profiles: Gas Chromatography-Mass Spectrometry (GC-MS) is used for volatile compounds. In this study Turmeric oil and turmeric formulation have been analyzed for their Gas Chromatography- Mass Spectrometry (GC-MS) Profiles. FIG. 3A shows the GC Chromatogram of turmeric oil. Further, FIG. 3B and 3C show mass spectrum of GC peaks of turmeric oil at different retention times.

Table 2, below, enlists the identified compounds in turmeric oil during GC-MS profiling:

Similarly, the GC-MS profiles for turmeric formulation sample have been analyzed and which showed an abundance of turmerones in the sample. FIG. 3D shows the GC Chromatogram of turmeric formulation. Further, FIG. 3E - 3H show mass spectrum of GC peaks of turmeric formulation at different retention times.

Table 3, below, enlists the identified compounds in the turmeric formulation during the GC- MS profiling:

4. Structure of nanodroplets in the formulation:

Scanning Electron Microscopy (SEM) and Transmission Electron Microscopy (TEM) are techniques used to visualize the structure of the nanodroplets in the formulation. SEM reveals the surface structure whereas TEM reveals the detailed structure of the inside (similar to a cut cross section). FIG. 4A and 4B show the, both clearly showing spherical droplets with a coating of the surfactant (emulsifier).

5. Physical characteristics of turmeric formulations

Three essential parameters of nanoformulations are Zeta-size, Pdl (Polydispersity index) and Zeta- potential. Bioengineering a formulation means achieving the desired size and controlling the size of the nanodroplets, whilst retaining the stability. To achieve aqueous dispersibility, a size between 150-200nm (nanometer) is desirable. Pdl depicts the uniformity of formulations. A Pdl below 0.45 confirms the monodisperse nature of the formulation and is desirable. Zeta potential is a measure of the surface charge on the nanodroplets. A potential higher than + 30mV (milliVolt) is desirable. All these parameters when studied over a period of several months depict the stability of the formulations. A typical size distribution profile is shown in the FIG. 5A-5C, and that of zeta potential is shown in FIG. 5D. The Tur variants (turmeric formulation) have a stability of 6 months and more. The Tur0.2 variant is stable for one year. FIG. 5E and 5F show the Stability profile of TurO.1 and Tur0.05 variant respectively as depicted through zeta size measurements.

6. Comparative sensory profiles

A detailed sensory analysis of the turmeric formulation TurMin variant 1 has been done with another samples taken from another companies, here labeled as S1.V and S2.A. FIG. 6A shows the comparative analysis profiles and FIG. 6B shows the sensory profile of TurMin variant 1 for the criteria of appearance, taste, sweetness, taste etc.

Therefore, the present invention utilizes the therapeutic, health and wellness benefits offered by turmeric which value addition done through nanotechnology interventions.

The variants of turmeric nanoformulation according to the various embodiments of the present invention are suitable for people from all walks of life. This can be consumed by for all including, but not limited to sportspersons, athletes, those with inflammatory conditions, and as an immunity enhancer by practically everyone.

Claims

CLAIMS:

1. An aqueous- dispersible turmeric nanoformulation comprising: an organic phase comprising turmeric powder, edible oil and co-emulsifiers further comprising atleast of glyceryl mono stearate (GMS); an aqueous phase having emulsifiers comprising atleast of DK Ester F-160 added to 25.0% glycerol in water; wherein the organic phase and the aqueous phase are mixed in a ratio of 1 :5 (v/v) such that glyceryl mono stearate (GMS) and DK Ester F-160 are in ratio 0.6 - 2.0 to 1.6 - 5.0.

2. The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 , wherein the turmeric powder is dissolved in the edible oil is an amount ranging from 15% to 70% (w/v).

3. The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 , wherein the edible oil is selected from the group consisting of olive oil, sunflower oil, sesame oil, almond oil, corn oil, orange oil, lime oil, black pepper oil, nutmeg oil, basil oil, rosemary oil, clove oil, grapefruit oil, fennel oil, coriander oil, bergamot oil, cinnamon oil, lemon oil, peppermint oil, garlic oil, thyme oil, marjoram oil, lemongrass oil, ginger oil, cardamom oil, liquid paraffin, cotton seed oil, peanut oil, nut oil, soy oil, rapeseed oil, vitamin E oil, Vitamin E TPGS oil, fish oil, tallow-derived oil, silicone oil, castor oil, squalene oil, and/or their combinations thereof.

4. The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 , wherein the glyceryl mono stearate (GMS) is in the range of 0.6-2.0 gm.

5. The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 , wherein the DK Ester F-160 is in the range of 1.6-5.0 gm.

6. The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 , wherein the glycerol is mixed with an edible gum.

7. The aqueous-dispersible turmeric nanoformulation as claimed in claim 6, wherein the edible gum is selected from the group comprising hydroxyl propyl methyl cellulose, gum Arabic, xanthan gum and/or combinations thereof.

8. The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 , wherein the size of nanoparticles in the nanoformulation ranges from 160-300 nm.

9. The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 , wherein the formulation has a shelf-life of atleast 6 months.

10. The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 , wherein the emulsifiers and co-emulsifiers can be selected from the group consisting of glyceryl stearate, stearyl alcohol, cetyl alcohol, stearic acid dimethicone, a silicone (siloxane) surfactant, polysorbates, sodium laureth, phospholipids, lecithin, polyoxyethylene sorbitan mono- or tristearate, monolaurate, monopalmitate, mono- or trioleate, a mono- or diglyceride and/or their combinations thereof.

1 1 . The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 , wherein the turmeric nanoformulation is concocted with dairy products for oral consumption.

12. The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 1 , wherein the dairy products are be selected from the group comprising milk, buttermilk, yogurt, curd and/or combinations thereof.

13. The aqueous-dispersible turmeric nanoformulation as claimed in claim 1 , wherein the turmeric nanoformulation is concocted with an aqueous base for oral consumption.

14. The aqueous-dispersible turmeric nanoformulation as claimed in claim 13, wherein the aqueous base is water.

15. A method for preparing an aqueous-dispersible turmeric nanoformulation, the method comprises: preparing an oil phase by dissolving turmeric powder in edible oil; preparing an organic phase by mixing co-emulsifiers comprising atleast of glyceryl mono stearate (GMS) with the oil phase; preparing an aqueous phase by adding emulsifiers comprising atleast of DK Ester F-160 to 25.0% glycerol in water; mixing the organic phase and the aqueous phase in a ratio of 1 :5 (v/v) and homogenizing the mixture to get the desired turmeric nanoformulation; wherein the GMS and the DK Ester F-160 are in ratio of 0.6 - 2.0 to 1 .6 - 5.0.

16. The method for preparing an aqueous-dispersible turmeric nanoformulation as claimed in claim 15, wherein the turmeric powder is dissolved in the edible oil is an amount in the range of 15% to 70% (w/v).

17. The method for preparing an aqueous-dispersible turmeric nanoformulation as claimed in claim 15, wherein the edible oil is selected from the group consisting of olive oil, sunflower oil, sesame oil, almond oil, corn oil, orange oil, lime oil, black pepper oil, nutmeg oil, basil oil, rosemary oil, clove oil, grapefruit oil, fennel oil, coriander oil, bergamot oil, cinnamon oil, lemon oil, peppermint oil, garlic oil, thyme oil, marjoram oil, lemongrass oil, ginger oil, cardamom oil, liquid paraffin, cotton seed oil, peanut oil, nut oil, soy oil, rapeseed oil, vitamin E oil, Vitamin E TPGS oil, fish oil, tallow-derived oil, silicone oil, castor oil, squalene oil, and/or their combinations thereof.

18. The method for preparing an aqueous-dispersible turmeric nanoformulation as claimed in claim 15, wherein the glyceryl mono stearate (GMS) is in the range of 0.6-2.0 gm.

19. The method for preparing an aqueous-dispersible turmeric nanoformulation as claimed in claim 15, wherein the DK Ester F-160 is in the range of 1 .6-5.0 gm.

20. The method for preparing an aqueous-dispersible turmeric nanoformulation as claimed in claim 15, wherein the glycerol is mixed with an edible gum.

21 . The method for preparing an aqueous-dispersible turmeric nanoformulation as claimed in claim 20, wherein the edible gum is selected from the group comprising hydroxyl propyl methyl cellulose, gum Arabic, xanthan gum and/or combinations thereof.

22. The method for preparing an aqueous-dispersible turmeric nanoformulation as claimed in claim 15, wherein the formulation has a shelf-life of atleast 6 months.

23. The method for preparing an aqueous-dispersible turmeric nanoformulation as claimed in claim 15, wherein the emulsifiers and co-emulsifiers can be selected from the group consisting of glyceryl stearate, stearyl alcohol, cetyl alcohol, stearic acid dimethicone, a silicone (siloxane) surfactant, polysorbates, sodium laureth, phospholipids, lecithin, polyoxyethylene sorbitan mono- or tristearate, monolaurate, monopalmitate, mono- or trioleate, a mono- or diglyceride and/or their combinations thereof.