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Herbal Sweetener Composition

Abstract: The present invention discloses a herbal sweetener composition comprising an extract of Glycyrrhiza (Glycyrrhiza glabra) in an amount in the range from 2-15%, and a plurality of excipients.

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Patent Information

Application #
Filing Date
06 August 2015
Publication Number
06/2017
Publication Type
INA
Invention Field
FOOD
Status
Email
vishal@inttladvocare.com
Parent Application
Patent Number
Legal Status
Grant Date
2023-07-26
Renewal Date

Applicants

DABUR INDIA LIMITED
8/3, Asaf Ali Road, New Delhi 110002

Inventors

1. J.L.N. SASTRY
DRDC, No. 22, Site-IV, Sahibabad-201010, Ghaziabad, U.P. India
2. PANKAJ KUMAR GUPTA
DRDC, No. 22, Site-IV, Sahibabad-201010, Ghaziabad, U.P. India
3. ASHUTOSH PAREEKH
DRDC, No. 22, Site-IV, Sahibabad-201010, Ghaziabad, U.P. India

Specification

FIELD OF THE INVENTION
The present invention relates to a sweetener composition and more particularly to a herbal sweetener composition comprising glycyrrhiza extract.
BACKGROUND OF THE INVENTION
A major health concern for people today is reducing calories in their diet while enjoying all natural and great tasting foods and beverages. Sugar is one of the necessities of the human life and there is a huge demand for sugar in the food industry. Sucrose is the main source of sugar consumed due to its pure sweet taste. However, it elevates the blood glucose levels in the human body, a condition which can be dangerous to certain individuals suffering from hyperglycemia. In addition, sucrose has a relatively high content of calories and can be undesirable from a dieting standpoint. Therefore there is a continued interest in non-sugar, natural sweeteners for food, cosmetic, pharmaceuticals and so forth.
We live in an age of modern convenience and great advancement, but mankind's ongoing battle with health disorders shows no signs of diminishing. Further, as a result of the fast paced urban lifestyle, changing diet patterns, lack of exercise, stress etc, many people in developing countries become susceptible to obesity related health problems like diabetes, dyslipidemia, heart disease, hypertension, stroke etc. The most alarming of them is Diabetes. The World Health Organization (WHO) has commented that there is an apparent epidemic of diabetes which is strongly related to lifestyle and economic change. India leads the world with largest number of diabetic subjects earning the dubious distinction of being termed the “diabetes capital of the world”. Besides, the so called “Asian Indian Phenotype” and genetic factors, the primary driver of the epidemic of diabetes is the rapid epidemiological transition associated with changes in dietary patterns and decreased physical activity. Consumption of sugar sweetened beverages may be counted among the dietary causes of metabolic disorders such as diabetes. Hence, artificial sweeteners such as Saccharin, Sucralose and Aspartame may be used as alternatives to table sugar. Thus, substituting sugar with low calorie, natural sweetener may be an efficacious health and weight management strategy.
Conforming to the consumer health consciousness and growing trend, natural sweeteners such as steviosides and mogrosides are becoming more and more popular. The sweetness of steviosides is 200-350 times of that of sucrose, but the calorific value is merely 1/300 of that of sucrose. It is proven by a large number of drug experiments that steviosides have no toxic side effects and contain no carcinogens and have increased safety without any harmful effect discovered, so far. Regular intake of steviosides can achieve the effect of preventing hypertension, diabetes, obesity, heart disease, dental decay and other diseases and therefore, steviosides are a type of ideal sweetener that are capable of replacing sucrose. Although the sweet taste of steviosides is similar to that of granulated sugar, an unpleasant taste of bitterness and astringency remains as an aftertaste. Therefore, it is preferred that a sweetener does not contain a large amount of steviosides.
The sweetness of mogrosides is about 300 times of that of sucrose and most of the sweet taste is attributed to mogroside V. However, mogrosides are mostly obtained in the form of a powder extract of Luo Han Guo fruit which has a unique Chinese herbal medicine taste associated with it. Therefore, when the Luo Han Guo fruit extract is used in foods and beverages as a sweetener, a suppressing ingredient is generally needed to suppress the Chinese herbal medicine taste of the Luo Han Guo fruit extract.
In view of the above discussion, there is a need for a sweetener composition which is formulated from natural ingredients that not only provides comparable sweetness to that of the sucrose but also overcomes the aforementioned drawbacks of the non-sugar based sweeteners.
SUMMARY OF THE INVENTION
In view of the diabetes epidemic affecting large sections of the urban population and the preference among current consumers for a healthier lifestyle, there is a need for natural low calorie alternatives to sucrose. The present invention is broadly related to a sweetener composition formulated from natural ingredients.
In accordance with an embodiment of the invention there is provided a herbal sweetener composition, comprising an extract of Glycyrrhiza (Glycyrrhiza glabra).
In accordance with another embodiment of the invention, the herbal sweetener composition further comprises excipients, wherein the extract of Glycyrrhiza (Glycyrrhiza glabra) is present in an amount in the range from 2-15%.
In accordance with another embodiment of the invention, the herbal sweetener composition comprises excipients selected from the group consisting of a diluent, anti-microbial preservative, disintegrant, sweetener, lubricant, glidant and combinations thereof, and is in the form of a tablet.
In accordance with yet another embodiment of the invention, the diluent is present in an amount in the range from 67.3-93.8%, the anti-microbial preservative is present in an amount in the range from 0.1-0.4%, the disintegrant is present in an amount in the range from 2-10%, the sweetener is present in an amount in the range from 0.5-5%, the lubricant is present in an amount in the range from 0.1-1.5% and the glidant is present in an amount in the range from 0.25-1%.
DETAILED DESCRIPTION OF THE INVENTION
Discussed below are some representative embodiments of the present invention. The invention in its broader aspects is not limited to the specific details and representative methods. The illustrative examples are described in this section in connection with the embodiments and methods provided. The invention according to its various aspects is particularly pointed out and distinctly claimed in the attached claims read in view of this specification.
It is to be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to a composition containing “a compound” includes a mixture of two or more compounds. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The expression of various quantities in terms of “%” or “% w/w” means the percentage by weight of the total solution or composition unless otherwise specified.
All cited references are incorporated herein by reference in their entireties. Citation of any reference is not an admission regarding any determination as to its availability as prior art to the claimed invention.
The present invention, in its product and process aspects, is described in detail as follows:
A member of the pea and bean family (Leguminosae/Fabaceae), Glycyrrhiza glabra is best known for its use in making liquorice-flavoured confectionery. Its scientific name is taken from the Greek for sweet root (glykys, meaning sweet, and rhiza, meaning root). It is cultivated for its rhizomes (underground stems) that contain the compound glycyrrhizin, which is 50 times sweeter than sugar. Also well-known as a medicinal plant, G. glabra is used in the production of cough mixtures and throat lozenges, as well as an ingredient to mask the unpleasant taste of some medicines.
Most natural and artificial non-sugar sweeteners that are increasingly being preferred by health conscious consumers leave an annoying aftertaste or have deleterious side effects. Hence, there is a continued interest in developing low calorie sweetener compositions that not only taste similar to sucrose but also provide all the benefits of low-calorie diet, without leaving a bitter aftertaste. Accordingly the present inventors have developed a sweetener composition, comprising an extract of Glycyrrhiza (Glycyrrhiza glabra) in an amount in the range from 2-15%.
The herbal sweetener composition further comprises excipients selected from the group consisting of a diluent, anti-microbial preservative, disintegrant, sweetener, lubricant, glidant and combinations thereof, and is in the form of a tablet.
A diluent, also called as filler, is often added to tablet formulations to provide better tablet properties, such as improved cohesion, improved compression manufacturing and adjusting weight of the tablet as per dye capacity. Non-limiting examples of diluents that can be used in the present invention include lactose, sorbitol, isomalt, mannitol and so forth, each of which can be used individually or in combination in an amount in the range from 67.3-93.8%. Lactose (IUPAC name: ß-D-galactopyranosyl-(1?4)-D-glucose) is a disaccharide sugar derived from galactose and glucose that is found in milk. Sorbitol (IUPAC name: (2S,3R,4R,5R)-Hexane-1,2,3,4,5,6-hexol), also known as glucitol, is a sugar alcohol with a sweet taste which the human body metabolizes slowly. Isomalt is an equimolar mixture of two disaccharides, each composed of two sugars: glucose and mannitol (a-D-glucopyranosido-1,6-mannitol) and also glucose and sorbitol (a-D-glucopyranosido-1,6-sorbitol). Mannitol, (2R,3R,4R,5R)-Hexan-1,2,3,4,5,6-hexol also known as mannite or manna sugar, is a white, crystalline solid that looks and tastes sweet like sucrose.
Another important constituent of the herbal composition is a anti-microbial preservative, which is added to increase the shelf life of the pharmaceutical substance by preventing the growth of microorganisms. Non-limiting examples of the anti-microbial preservatives that can be used in the present invention, include potassium sorbate, sodium benzoate, sodium methylparaben, methylparaben, benzoic acid, sorbic acid and so forth, each of which can be used individually or in combination, in an amount in the range from 0.1-0.4%. Methylparaben, also methyl paraben, (IUPAC name: Methyl 4-hydroxybenzoate) one of the parabens, is a preservative with the chemical formula CH3(C6H4(OH)COO). It is the methyl ester of p-hydroxybenzoic acid.
Yet another important constituent of the herbal sweetener tablet is a disintegrant, which is always added to tablet to induce breakup of tablet when it comes in contact with aqueous fluid and this process of desegregation of constituent particles before the drug dissolution occurs, is known as disintegration process. Non-limiting examples of the disintegrants that can be used in the present invention include, croscarmellose sodium, crospovidone, sodium starch glycolate, polacrillin potassium and so forth, each of which can be used individually or in combination, in an amount in the range from 2-10%. Croscarmellose sodium is an internally cross-linked sodium carboxymethylcellulose, wherein the cross-linking reduces water solubility while still allowing the material to swell (like a sponge) and absorb many times its weight in water, thereby accelerating the dissolution of the tablet. Crospovidone (cross linked polyvinyl N-pyrrolidone) is an inert and insoluble white to light yellow free-flowing powder. It has hygroscopic, or water-attracting properties with excellent swelling characteristics. It is this swelling characteristic that makes it useful as a disintegrant in pharmaceutical dosage forms.
The herbal sweetener composition contains sweeteners selected from the group consisting of neotame, sucralose and combinations thereof, and present in an amount in the range from 0.5-5%. Neotame is an artificial sweetener that is between 7,000 and 13,000 times sweeter than sucrose. In the European Union, it is known by the E number E961. Sucralose is a non-nutritive sweetener. The majority of ingested sucralose is not broken down by the body, so it is non-caloric. In the European Union, it is also known under the E number E955. Sucralose is about 320 to 1,000 times sweeter than sucrose, twice as sweet as saccharin, and three times as sweet as aspartame. It is stable under heat and over a broad range of pH conditions. Therefore, it can be used in baking or in products that require a longer shelf life.
Still another important ingredient present in the herbal sweetener composition is a lubricant, which acts by reducing friction by interposing an intermediate layer between the tablet constituents and the die wall during compression and ejection. Non-limiting examples of the lubricants that can be used in the present invention include magnesium stearate, talc, sodium stearyl fumarate, polyethylene glycol 6000 and so forth, each of which can be used individually or in combination in an amount in the range from 0.1-1.5%. Talc is a mineral composed of hydrated magnesium silicate with the chemical formula H2Mg3(SiO3)4 or Mg3Si4O10(OH)2.
It is recommended to add a glidant to the herbal sweetener formulation to improve the flow properties of the material which is to be fed into the die cavity and aid in particle rearrangement within the die during the early stages of compression. Non-limiting examples of glidants that can be used in the present invention include colloidal silicon dioxide, starch and so forth, each of which can be used individually or in combination in an amount in the range from 0.25-1%.
Process for preparing extract of Glycyrrhiza (Glycyrrhiza glabra)
The herb was extracted with a Hydro-alcoholic mixture (Herb to Solvent in a ratio of 1:6) over a period of one hour at a temperature between 60°- 65 °C. The extraction was repeated four times and the combined extracts were filtered, concentrated and washed with water. The extract was re-dissolved in alcohol, filtered and concentrated. It was then dried under vacuum to get the final extract.

EXAMPLES
The present invention is more particularly described in the following examples that are intended as illustrations only, since numerous modifications and variations within the scope of the present invention will be apparent to those of skill in the art. Unless otherwise noted, all parts, percentages and ratios reported in the following examples are on a weight basis and all reagents used in the examples were obtained or are available from the chemical suppliers.

Examples 1-4
Table 1 and 2, lists the constituents of the herbal sweetener compositions and their amounts. The unit of each value is weight percent of the composition.
Table 1. Composition of herbal sweetener composition.
No Ingredients Example 1 Example 2
1 Extract of Glycyrrhiza (Glycyrrhiza glabra) 2.00 5.00
2 Lactose/ Sorbitol/ Isomalt/ Mannitol 92.45 86.70
3 Methylparaben 0.10 0.15
4 Sodium Benzoate 0.10 0.15
5 Croscarmellose sodium 4.00 6.00
6 Neotame 0.75 1.00
7 Magnesium stearate 0.30 0.50
8 Colloidal silicon dioxide 0.30 0.50

Table 2. Composition of herbal sweetener composition
No Ingredients Example 3 Example 4
1 Extract of Glycyrrhiza (Glycyrrhiza glabra) 10.00 12.50
2 Lactose/ Sorbitol/ Isomalt/ Mannitol 78.1 75.80
3 Crospovidone 3.00 4.50
4 Croscarmellose sodium 4.70 3.00
5 Talc 0.25 0.25
6 Sucralose 3.00 2.50
7 Sodium Benzoate 0.15 0.20
8 Magnesium stearate 0.30 0.50
9 Colloidal silicon dioxide 0.50 0.75

Process for preparing a herbal sweetener composition (for examples 1 and 2):
Table 1. lists the constituents of the herbal sweetener composition and their amounts to be used for preparing the same. Extract of Glycyrrhiza (Glycyrrhiza glabra), diluent, Methylparaben and Sodium Benzoate were sieved through a mesh of size 30, weighed, and mixed in a mixing vessel to form a first mixture. Croscarmellose sodium, neotame, magnesium stearate and colloidal silicon dioxide were sieved through a mesh of size 60, weighed, and mixed in a mixing vessel to form a second mixture. The first mixture and the second mixture were mixed to form a third mixture. The third mixture was punched into tablets using a suitable machine, such as a tableting machine. The term “tableting machine” used herein refers to a machine that compresses powders or mixtures into tablets of uniform shape and size.

Process for preparing a herbal sweetener composition (for examples 3 and 4):
Table 2. lists the constituents of the herbal sweetener composition and their amounts to be used for preparing the same. Extract of Glycyrrhiza (Glycyrrhiza glabra), diluent, Crospovidone and Croscarmellose sodium were sieved through a mesh of size 30, weighed, and mixed in a mixing vessel to form a first mixture. Talc, sucralose, sodium benzoate, magnesium stearate and colloidal silicon dioxide were sieved through a mesh of size 60, weighed, and mixed in a mixing vessel to form a second mixture. The first mixture and the second mixture were mixed to form a third mixture. The third mixture was punched into tablets using a suitable machine, such as a tableting machine.

Sensory Analysis
A study was carried out to compare the sweetness, mouth-feel and aftertaste of the herbal sweetener of the present invention with that of a commercially available sucralose based sweetener. The comparison was performed by thirteen semi-trained panelists at Dabur India Limited. The panelists scored the aforementioned attributes on a 1-5 point scale (Table 3), and the results are presented in Table 4 and Table 5.
Table 3: Scores on a 5 point scale
Score Level
1 Worst
2 Bad
3 Okay
4 Good
5 Excellent

Table 4. Taste Evaluation
Panelists Sweetness Mouth-feel Aftertaste Overall
Sample A Sample B Sample A Sample B Sample A Sample B Sample A Sample B
1 4 3 2 3 3 5 3 4
2 4 4 3 4 3 3 3 4
3 5 4 3 4 3 3 3 4
4 3 3 2 3 3 4 3 4
5 5 4 3 3 3 3 4 3
6 4 5 4 3 4 5 4 5
7 3 5 3 3 3 3 3 4
8 4 4 3 3 4 3 4 3
9 5 5 4 5 3 4 4 5
10 4 4 3 3 3 3 4 3
11 3 3 2 3 3 4 3 3
12 3 5 3 4 3 3 3 4
13 3 4 2 3 3 3 3 4
Total 50 53 37 44 41 46 44 50
Average 3.85 4.08 2.85 3.38 3.15 3.54 3.38 3.85
Sample A = Commercially available sucralose based sweetener
Sample B = Herbal sweetener of the present invention (Example 2)

Table 5. Taste Evaluation
Panelists Sweetness Mouth-feel Aftertaste Overall
Sample A Sample C Sample A Sample C Sample A Sample C Sample A Sample C
1 4 4 2 3 3 3 3 4
2 4 3 3 4 3 4 3 4
3 5 5 3 3 3 3 3 4
4 3 2 2 2 3 3 3 3
5 5 5 3 3 3 3 4 4
6 4 5 4 4 4 4 4 4
7 3 3 3 3 3 3 3 3
8 4 5 3 3 4 3 4 4
9 5 5 4 4 3 4 4 3
10 4 4 3 3 3 3 4 3
11 3 3 2 3 3 3 3 4
12 3 4 3 3 3 3 3 4
13 3 3 2 3 3 4 3 4
Total 50 51 37 41 41 43 44 48
Average 3.85 3.92 2.85 3.15 3.15 3.31 3.38 3.69
Sample A = Commercially available sucralose based sweetener
Sample C = Herbal sweetener of the present invention (Example 4)
It is evident from the average scores of the sensory analysis that the herbal sweeteners of the present invention are superior to the commercially available sucralose based sweetener in terms of sweetness, mouthfeel, aftertaste and overall sensory experience.
While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is thereof intended to cover in the appended claims such changes and modifications that are within the scope of the invention.

CLAIMS:
We claim:
1. A herbal sweetener composition, comprising an extract of Glycyrrhiza (Glycyrrhiza glabra) and excipients.
2. The herbal sweetener composition as claimed in claim 1, wherein the extract of Glycyrrhiza (Glycyrrhiza glabra) is present in an amount in the range from 2-15%.
3. The herbal sweetener composition, as claimed in claims 1 or 2, wherein the excipients are selected from the group consisting of a diluent, an anti-microbial preservative, a disintegrant, a sweetener, a lubricant, a glidant and combinations thereof, and the composition is in the form of a tablet.
4. The herbal sweetener composition, as claimed in claim 3, wherein the diluent is selected from the group consisting of lactose, sorbitol, isomalt, mannitol and combinations thereof, and present in an amount in the range from 67.3-93.8%.
5. The herbal sweetener composition, as claimed in claim 3, wherein the anti-microbial preservative is selected from the group consisting of potassium sorbate, sodium benzoate, sodium methylparaben, methylparaben, benzoic acid, sorbic acid and combinations thereof, and present in an amount in the range from 0.1-0.4%.
6. The herbal sweetener composition, as claimed in claim 3, wherein the disintegrant is selected from the group consisting of croscarmellose sodium, crospovidone, sodium starch glycolate, polacrillin potassium and combinations thereof, and present in an amount in the range from 2-10%.
7. The herbal sweetener composition, as claimed in claim 3, wherein the sweetener is selected from the group consisting of neotame, sucralose and combinations thereof, and present in an amount in the range from 0.5-5%.
8. The herbal sweetener composition as claimed in claim 3, wherein the lubricant is selected from the group consisting of magnesium stearate, talc, sodium stearyl fumarate, polyethylene glycol 6000 and combinations thereof, and present in an amount in the range from 0.1-1.5%.
9. The herbal sweetener composition as claimed in claim 3, wherein the glidant is selected from the group consisting of colloidal silicon dioxide, starch and combinations thereof, and present in an amount in the range from 0.25-1%.

Documents

Orders

Section Controller Decision Date

Application Documents

# Name Date
1 343-del-2015-GPA-(04-03-2015).pdf 2015-03-04
1 343-DEL-2015-IntimationOfGrant26-07-2023.pdf 2023-07-26
2 343-DEL-2015-PatentCertificate26-07-2023.pdf 2023-07-26
2 343-del-2015-Correspondence Others-(04-03-2015).pdf 2015-03-04
3 PROVISIONAL SPECIFICATION.pdf 2015-03-12
3 343-DEL-2015-Written submissions and relevant documents [30-11-2022(online)].pdf 2022-11-30
4 GENERAL POWER OF ATTORNEY.pdf 2015-03-12
4 343-DEL-2015-FORM-26 [16-11-2022(online)].pdf 2022-11-16
5 343-del-2015-Form-1-(27-04-2015).pdf 2015-04-27
5 343-DEL-2015-Correspondence to notify the Controller [11-11-2022(online)].pdf 2022-11-11
6 343-DEL-2015-US(14)-HearingNotice-(HearingDate-16-11-2022).pdf 2022-10-19
6 343-del-2015-Correspondence Others-(27-04-2015).pdf 2015-04-27
7 343-DEL-2015-NBA Approval Submission [18-07-2022(online)].pdf 2022-07-18
7 343-del-2015-Form-5-(20-10-2015).pdf 2015-10-20
8 343-del-2015-Correspondence Others-(20-10-2015).pdf 2015-10-20
8 343-DEL-2015-CLAIMS [02-03-2020(online)].pdf 2020-03-02
9 OnlinePostDating.pdf 2016-06-08
9 343-DEL-2015-FER_SER_REPLY [02-03-2020(online)].pdf 2020-03-02
10 343-DEL-2015-OTHERS [02-03-2020(online)].pdf 2020-03-02
10 Description(Complete) [20-07-2016(online)].pdf 2016-07-20
11 343-DEL-2015-FER.pdf 2019-09-03
11 Form 18 [25-07-2016(online)].pdf 2016-07-25
12 343-DEL-2015-FER.pdf 2019-09-03
12 Form 18 [25-07-2016(online)].pdf 2016-07-25
13 343-DEL-2015-OTHERS [02-03-2020(online)].pdf 2020-03-02
13 Description(Complete) [20-07-2016(online)].pdf 2016-07-20
14 343-DEL-2015-FER_SER_REPLY [02-03-2020(online)].pdf 2020-03-02
14 OnlinePostDating.pdf 2016-06-08
15 343-DEL-2015-CLAIMS [02-03-2020(online)].pdf 2020-03-02
15 343-del-2015-Correspondence Others-(20-10-2015).pdf 2015-10-20
16 343-del-2015-Form-5-(20-10-2015).pdf 2015-10-20
16 343-DEL-2015-NBA Approval Submission [18-07-2022(online)].pdf 2022-07-18
17 343-del-2015-Correspondence Others-(27-04-2015).pdf 2015-04-27
17 343-DEL-2015-US(14)-HearingNotice-(HearingDate-16-11-2022).pdf 2022-10-19
18 343-DEL-2015-Correspondence to notify the Controller [11-11-2022(online)].pdf 2022-11-11
18 343-del-2015-Form-1-(27-04-2015).pdf 2015-04-27
19 GENERAL POWER OF ATTORNEY.pdf 2015-03-12
19 343-DEL-2015-FORM-26 [16-11-2022(online)].pdf 2022-11-16
20 PROVISIONAL SPECIFICATION.pdf 2015-03-12
20 343-DEL-2015-Written submissions and relevant documents [30-11-2022(online)].pdf 2022-11-30
21 343-DEL-2015-PatentCertificate26-07-2023.pdf 2023-07-26
21 343-del-2015-Correspondence Others-(04-03-2015).pdf 2015-03-04
22 343-DEL-2015-IntimationOfGrant26-07-2023.pdf 2023-07-26
22 343-del-2015-GPA-(04-03-2015).pdf 2015-03-04
23 343-DEL-2015-RENEWAL OF PATENTS [13-06-2025(online)].pdf 2025-06-13

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