DESC:FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION
(See section 10; rule 13)
Title: A NUTRACEUTICAL FORMULATION AND ITS METHOD OF PREPARATION
APPLICANT DETAILS:
(a) NAME: Zywie Ventures Pvt Ltd.
(b) NATIONALITY: Indian
(c) ADDRESS: 5, Dashrath Singh Estate, Caves Road, Near Jogeshwari Caves, Jogeshwari East, Mumbai 400060 India.
PREAMBLE TO THE DESCRIPTION:
The following specification particularly describes the nature of this invention and the manner in which it is to be performed.
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A NUTRACEUTICAL FORMULATION AND ITS METHOD OF PREPARATION
Field of the Invention
The present invention provides a nutraceutical formulation and its method of preparation. Particularly, the invention provides a biotin enriched nutraceutical formulation and its method of preparation.
Background of the Invention The following background discussion includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art. Dietary supplements are intended to add to or supplement the diet and are different from conventional food. Generally, to the extent a product is intended to treat, diagnose, cure, or prevent diseases, it is a drug, even if it is labeled as a dietary supplement. Supplements are ingested and come in many forms, including tablets, capsules, soft gels, gel caps, powders, bars, gummies, and liquids. Nutraceuticals are products, which other than nutrition are also used as medicine. A nutraceutical product may be defined as a substance, which has physiological benefit or provides protection against chronic disease. Nutraceuticals may be used to improve health, delay the aging process, prevent chronic diseases, increase life expectancy, or support the structure or function of the body. Nowadays, nutraceuticals have received considerable interest due to potential nutritional, safety and therapeutic effects. Recent studies have shown promising results for these compounds in various complications. Biotin is one of the most required B vitamins and is also known as vitamin B7. This vitamin is utilized in a vast array of metabolic activities in humans and other creatures, especially pertaining to the consumption of carbohydrates, fatty acids, and amino acids.
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Biotin is necessary for the proper functioning of enzymes that transport carboxyl units and fix carbon dioxide, and is required for various metabolic functions, including gluconeogenesis, lipogenesis, fatty acid biosynthesis, propionate metabolism, and catabolism of branched-chain amino acids. Thus, there is a need of an effective method for producing pure biotin extract based on 100% natural source, which is highly efficient to provide enriched nutrition. There is also a need of extract with enriched hair receptor activating polyphenols, which is better than a synthetic biotin.
Object(s) of the Invention:
A primary objective of the present invention is to overcome the drawbacks associated with the prior art.
Yet another object of the present invention is to provide a nutraceutical extract based on biotin derived from Sesbania Agati.
Yet another object of the present invention is to provide a nutraceutical formulation comprising nutraceutical extract based on biotin derived from Sesbania Agati.
Yet another object of the present invention is to provide a 100% natural sesbania grandiflora extract and its method of preparation.
Yet another object of the present invention is to provide a method of processing sesbania leaves to obtain Biotin(0.5%).
Summary of the Invention:
In an embodiment, the invention provides a method of processing Sesbania grandiflora to extract Biotin or method of extracting Biotin from Sesbania grandiflora, comprising the steps of:
a)
Extraction of Sesbania leaves powder with aqueous alcohol wherein the aqueous alcohol comprises water and alcohol in 90:10 ratio; wherein extraction temperature is 50-60 degrees and the extraction is performed for 4 to 6Hr. each wash;
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b)
Drying the exhausted material obtained from step (a) in a tray dryer by adding Tapioca powder present in an amount ranging from 2 to 3% to obtain the Biotin enriched sesbania Extract powder.
In another aspect of the Invention, the invention provides a nutraceutical formulation comprising:
a)
atleast Sesbania grandiflora leaf extract obtained from claim 1 comprising 0.5% biotin and 2% hair receptor activating polyphenols;
b)
Tapioca powder present in an amount ranging from 2 to 3% is being used as a drying aid.
Brief description of drawings:
Figure 1: shows 1H NMR analysis of the formulation provided by the present invention
Figure 2: shows comparison of standard biotin as compared to the biotin obtained by the present invention when the extraction was done for 6 hours. Figure 2: shows comparison of standard biotin as compared to the biotin obtained by the present invention when the extraction was done for 4 hours.
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 embodiment illustrated in the drawings and 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 system, 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.
It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be restrictive thereof. Throughout the patent specification, a convention employed is that in the appended drawings, like numerals denote like components.
Reference throughout this specification to “an embodiment, “another embodiment, “an implementation, “another implementation” or similar language means that a particular
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feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrase “in an embodiment, “in another embodiment, “in one implementation, “in another implementation, and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.
The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method.
The Invention provides a nutraceutical extract based on biotin derived from Sesbania Agati. Additionally, the invention provides a nutraceutical formulation based on the same.
In an embodiment, the extract is prepared based on the encapsulation technology, which comprises a biotin derived from Sesbania Agati.
In an embodiment, the extract is standardized for 0.5% plant based biotin.
The extract is 100% natural sesbania grandiflora extract, comprises 0.5% plant based biotin and 2% hair receptor activating polyphenols which makes it better than synthetic biotin.
The extract is useful in hair care & skin Care. As per the stability Study, the extract was found stable at high temperatures upto 120?, making it suitable for all applications.
The in Silico Study established that the extract contains 2% hair receptor activating polyphenols which makes it better for hair health.
In an embodiment, the extract is prepared by green solvents. In an embodiment, the method comprises aqueous Ethanol which provides Highest Biotin Content .
The nutraceutical formulation comprises following components:
c)
atleast Sesbania grandiflora leaf extract obtained from claim 1 comprising 0.5% biotin and 2% hair receptor activating polyphenols;
d)
Tapioca powder present in an amount ranging from 2 to 3% is being used as a drying aid.
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In an aspect, the Invention provides a method of processing sesbania leaves to obtain Biotin(0.5%).
Experiments shows that 200 mg/kg dosage significantly reduced the increased blood sugar levels and exhibited antihyperlipidemic and reduced insulin resistance.
The sesbania Extract is obtained by the steps of:
a) Extraction of Sesbania leaves powder with aqueous alcohol wherein the aqueous
alcohol comprises water and alcohol in 90:10 ratio;
wherein extraction temperature is 50-60 degrees and the extraction is performed for
4 hours or 6 hours each wash;
b) Drying the exhausted material obtained from step (a) in a tray dryer to obtain the
Biotin enriched sesbania Extract powder. The extraction is performed for 3 cycles.
In an embodiment,the Drying of the exhausted material is performed in a tray dryer by adding Tapioca powder present in an amount ranging from 2 to 3% to obtain the Biotin enriched sesbania Extract powder.
The extraction solvent comprises aqueous Ethanol in 90:10 ratio.
In another aspect of the invention, the invention provides an efficient process for the extraction of Biotin from sesbania leaves. The process comprises charging approx. 30kg of sesbania leaves charge in a vertical extractor followed by extraction with aqueous Ethanol at extraction temp. of 50-60 degree Celsius and extraction time of 4 hours or 6 hours each wash.
In an embodiment, approx. 1200 lit of aqueous ethanol is used for washing the dry leaves material. The extracted material was obtained as 5.1 kg.
The various factors which are involved in obtaining Biotin enriched sesbania Extract powder is the specific combination of the extraction solvent, temperature and the extraction time that helps in enriching the Biotin content.
In an embodiment, through various experiments, following parameters were found significant to achieve the desirable qualities:
•
Type of Solvent: Water: Ethanol- 90:10- Biotin 0.5%. Water :Ethanol (90:10) shows highest extraction capacity
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•
Selection of temperature: Temperature at 50-60 degree celsius shows the highest extraction rate.
•
Selection of extraction time: The suitable extraction time is 6 hours and the biotin content after 6 hours of extraction process does not show significant increase in the extract content.
The Invention is further described with the help of non-limiting examples:
Example 1:
Selection of solvent:
Various experiments have been performed with various solvents to determine the enrichment of the Biotin. The following experiments shows that 90:10 Water: Ethanol gives maximum yield.
Reagents
Percentage of yield
90:10 water : Ethanol
17%
70:30 water : Ethanol
4.5%
Water 100%
10%
Example 2:
Effect of Temperature:
Various experiments have been performed to determine the effect of varying temperature.
The following experiments shows that extraction temp. At 50-60 degrees demonstrates maximum yield.
Temperature
Percentage of yield
Extraction temp. at 50 -60 degrees
17%
Extraction temp. at 60-70 degrees
16.5%
Extraction temp. at 70 -80degrees
10 %
Example 3:
Effect of Extraction time:
The following experiments have been performed to determine the effect of extraction time.
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The results of various experiments shows that the most effective extraction time is 4 hours or 6 hours which yields maximum extract content. The extract content after 4 hours of extraction process does not show significant increase.It becomes stable.
Extraction time
Percentage of yield
Extraction time at 4 hours each wash
18%
Extraction time at 6 hours each wash
17%
Extraction time at 5 hours each wash
12%
Extraction time at 7 hours each wash
17 %
Thus, by reducing the solute-solvent interaction time at 60?C, a better yield was obtained.
HPLC analysis
The standard biotin peaked at 9.287 minutes while the biotin obtained by the present invention when the extraction was done for 6 hours, was at 9.293 minutes (Figure 2). Upon calculation, it was found that the formulation of the present invention showed 0.54% of the biotin content when the extraction was done for 4 hours. When the time of extraction was reduced to 4 hours, the biotin content further increased to 0.81% (shown in Figure 3).
Example 4:
The stability study of the composition is performed. The results as mentioned below shows that the formulation has passed the srability test.
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Example 5:
1H NMR and Radiocarbon C14 analysis
As per the 1H NMR analysis (Figure 1), the structure of biotin derived from standardized SesZen-BioTM was markedly different from that of synthetic molecules in terms of cyclic and aliphatic chains. The cyclic ring was identified, while the aliphatic CH2 groups were not showing in the 1H NMR spectrum for SesZen-BioTM. Hence, natural biotin has lower molecular complexity, which might lead to better permeability, which is expected in plant-based biotin. Additionally, as per the radioactive C14 analysis, it was seen that 100% of the carbon present in SesZen-BioTM belongs to the natural environment and is not of synthetic origin. ,CLAIMS:We Claim:
1.
A method of processing Sesbania grandiflora extract to extract Biotin, comprising the steps of:
a)
Extraction of Sesbania leaves powder with aqueous alcohol wherein the aqueous alcohol comprises water and alcohol in 90:10 ratio; wherein extraction temperature is 50-60 degrees and the extraction is performed for 4 hours or 6 hours each wash;
b)
Drying the exhausted material obtained from step (a) in a tray dryer by adding Tapioca powder present in an amount ranging from 2 to 3% to obtain the Biotin enriched sesbania Extract powder.
2.
The method as claimed in claim 1, wherein the extraction is performed for 3 cycles.
3.
The method as claimed in claim 1, wherein the extraction solvent comprises aqueous Ethanol in 90:10 ratio.
4.
The method as claimed in claim 1, wherein the sesbania leaves are present in an amount of approximately 30kg.
5.
The method as claimed in claim 1, wherein approximately 1200 lit of aqueous ethanol is used for washing the dry leaves material.
6.
A nutraceutical formulation comprising:
a)
atleast Sesbania grandiflora leaf extract obtained from claim 1 comprising 0.5% biotin and 2% hair receptor activating polyphenols;
b)
Tapioca powder present in an amount ranging from 2 to 3% is being used as a drying aid.