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Composition To Address Pain And Inflammation

Abstract: The present disclosure discloses a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2. The composition as disclosed herein alleviates pain and inflammation by inhibiting the production of pro-inflammatory markers. A process for preparing the composition of the present disclosure is also provided in the present disclosure.

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Patent Information

Application #
Filing Date
21 June 2019
Publication Number
52/2020
Publication Type
INA
Invention Field
BIOTECHNOLOGY
Status
Email
iprdel@lakshmisri.com
Parent Application

Applicants

ITC LIMITED
ITC LIFE SCIENCES & TECHNOLOGY CENTRE #3. 1st Main, Peenya Industrial Area, Phase-1, Bangalore

Inventors

1. DSOUZA, Avin
Life Sciences and Technology Centre, ITC Limited, #3, 1st Main, Peenya Industrial Area, Phase I, Bangalore 560 058
2. GOPAL, Ganesh
Life Sciences and Technology Centre, ITC Limited, #3, 1st Main, Peenya Industrial Area, Phase I, Bangalore 560 058

Specification

TECHNICAL FIELD
[001] The subj ect matter described herein in general relates to the field of analgesic compositions, and in particular relates to a composition for attenuating inflammation and pain.
BACKGROUND OF INVENTION
[002] Health problems related to joints such as osteoarthritis (OA) and rheumatoid arthritis (RA) are inflammation and oxidative stress related disorders (Rosenbaum et al, Altern Ther Health Med. 2010;16:32-40). OA is an inflammatory degenerative condition of the joints with associated pain and declined mobility, whereas RA is an autoimmune disorder (Caturla et al, J Altern Complement Med. 2011 Nov; 17(11): 1051-63). Appropriate treatment can help prevent disability and improve the joint health. There are two routes for treatment of joint pain, one is a pharmacologic method and the other is a non-pharmacologic method. Inflammation related joint pain is treated with nonsteroidal anti-inflammatory or cyclo-oxygenase-2 inhibitors (Palmer and Toombs., J Am Board Fam Pract. 2004 Nov-Dec; 17 Suppl: S32-42).
[003] Presently, several options are available for treatment of joint pains due to OA and RA. Some of them are acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), glucosamine supplements and chondroitin supplements. However, these are associated with several side-effects, for example, NSAIDs are associated with risks of elevating blood pressure, chances of kidney disorders, stroke or a heart attack. Also, the side effects apparently increase with the age. Since the problems related to joint health are most likely to be manifested in old age, therefore, alternatives to synthetic drugs is certainly the preferred route. [004] US6485752B1 discloses a combination offish oil and rose-hip concentrate for alleviating symptoms of joint pain and stiffness. US9034366B2 discloses a combination offish oil and fish oil-derived choline based, phospholipid bound fatty acid mixture including polyunsaturated EPA and DHA in combination with astaxanthin and pro-inflammatory low molecular weight microbial fermented sodium hyaluronate fragments having a molecular weight of 0.5 to 300 kilodaltons

(kDa) in an oral dosage form. The documents in public knowledge discloses a complex mixture of fish oil and various other active ingredients for providing an effective composition. The search for a simple yet effective composition for alleviating symptoms related to joint pain is therefore yet to be addressed.
SUMMARY OF THE INVENTION
[005] In an aspect of the present disclosure, there is provided a composition
comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract,
wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is
in a range of 1:1.5 to 1:0.2.
[006] In another aspect of the present disclosure, there is provided a process for
preparing a composition comprising: (a) Salvia officinalis extract; and (b)
Andrographis paniculata extract, wherein the Salvia officinalis extract to the
Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process
comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis
paniculata extract; and (iii) contacting the Salvia officinalis extract, and the
Andrographis paniculata extract, to obtain the composition.
[007] These and other features, aspects, and advantages of the present subject
matter will be better understood with reference to the following description and
appended claims. This summary is provided to introduce a selection of concepts in a
simplified form. 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[008] The detailed description is described with reference to the accompanying
figures. The same numbers are used throughout the drawings to reference like
features and components.
[009] Figure 1 depicts the effect Salvia officinalis (Sage) on cell viability in
chondrocytes, in accordance with an embodiment of the present disclosure.
[0010] Figure 2 depicts the effect of Andrographis paniculata on cell viability in
chondrocytes, in accordance with an embodiment of the present disclosure.

[0011] Figure 3 depicts the effect of Salvia officinalis (Sage) and Andrographis
paniculata on lipopolysaccharide (LPS) induced PGE-2 production in chondrocytes,
in accordance with an embodiment of the present disclosure.
[0012] Figure 4 depicts the effect of individual concentrations of Salvia officinalis
(Sage) on lipopolysaccharide (LPS) induced PGE-2 production in chondrocytes, in
accordance with an embodiment of the present disclosure.
[0013] Figure 5 depicts the effect of individual concentrations of Andrographis
paniculata on lipopolysaccharide (LPS) induced PGE-2 production in chondrocytes,
in accordance with an embodiment of the present disclosure.
[0014] Figure 6 depicts the effect of Salvia officinalis (Sage), Andrographis
paniculata and their ratio combination on LPS induced PGE-2 production in
chondrocytes, in accordance with an embodiment of the present disclosure.
[0015] Figure 7 depicts the effect of individual concentrations of Salvia officinalis
(Sage) on lipopolysaccharide (LPS) induced IL-6 production in chondrocytes, in
accordance with an embodiment of the present disclosure.
[0016] Figure 8 depicts the effect of individual concentrations of Andrographis
paniculata on lipopolysaccharide (LPS) induced IL-6 production in chondrocytes, in
accordance with an embodiment of the present disclosure.
[0017] Figure 9 depicts the effect of Salvia officinalis (Sage), Andrographis
paniculata and their ratio combination on LPS induced IL-6 production in
chondrocytes, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0018] Those skilled in the art will be aware that the present disclosure is subject to variations and modifications other than those specifically described. It is to be understood that the present disclosure includes all such variations and modifications. The disclosure also includes all such steps, features, compositions, and compounds referred to or indicated in this specification, individually or collectively, and all combinations of any or more of such steps or features. Definitions

[0019] For convenience, before further description of the present disclosure, certain terms employed in the specification, and examples are delineated here. These definitions should be read in the light of the remainder of the disclosure and understood as by a person of skill in the art. The terms used herein have the meanings recognized and known to those of skill in the art, however, for convenience and completeness, particular terms and their meanings are set forth below. [0020] 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.
[0021] 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".
[0022] 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 element or steps but not the exclusion of any other element or step or group of element or steps. [0023] The term "including" is used to mean "including but not limited to". "Including" and "including but not limited to" are used interchangeably. [0024] Ratios, concentrations, amounts, and other numerical data may be presented herein in a range format. It is to be understood that such range format is used merely for convenience and brevity and should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. For example, a ratio range of Salvia officinalis extract and Andrographis paniculata extract of 1:1.5 to 1:0.2, does not mean to be restrictive to a range of only 1:1.5 to 1:0.2, but it also intends to cover any range falling within the previously mentioned range. The range 1:1.5 to 1:0.2 also intends to cover a range of 1:1.45 to 1:0.3, or 1:1.3 to 1:0.5, or 1:1.2 to 1:0.2. Also, it intends to include any ratio value falling in between the range such as, 1:1.35, 1:0.5, 1:0.75, and so on.
[0025] The term "at least one" is used to mean one or more and thus includes individual components as well as mixtures/combinations.

[0026] The term "at least one solvent" refers to solvent selected from a group of well-known food-grade solvents available in the art. The at least one solvent refers to water which can be used for preparing the composition of the present disclosure. [0027] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this 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.
[0028] The present disclosure is not to be limited in scope by the specific embodiments described herein, which are intended for the purposes of exemplification only. Functionally-equivalent products, compositions, and methods are clearly within the scope of the disclosure, as described herein. [0029] Since there is a considerable amount of undesired effects associated with synthetic compounds used for treating joint problems, there is a constant need to come up with a better solution to address the problem. The present disclosure, therefore, provides an effective solution in form of a composition comprising Salvia officinalis extract and Andrographis paniculata extract. The present disclosure provides a composition that exhibits a synergistic effect in reducing the pain and inflammation, wherein the composition comprises Salvia officinalis extract and Andrographis paniculata extract in a weight ratio range of 1:1.5 to 1:0.2. The composition of the present disclosure comprising a combination of Salvia officinalis (Sage) and Andrographis paniculata is a very promising one for relieving joint pain. It also had very good anti-inflammatory activity than when tested in isolation. [0030] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2. In another embodiment of the present disclosure, the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.45 to 1:0.3. In yet another embodiment of the present disclosure, the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.4

to 1:0.4. In one another embodiment of the present disclosure, the Salvia officinalis extract to the Andrographispaniculata weight ratio is in a range of 1:1.35 to 1:0.45. [0031] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andr ogr aphis paniculata extract, wherein the Salvia officinalis extract to the Andr ogr aphis paniculata weight ratio is in a range of 1:1.4 to 1:0.4.
[0032] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andr ogr aphis paniculata extract, wherein the Salvia officinalis extract to the Andr ogr aphis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition. In another embodiment of the present disclosure, the Salvia officinalis extract has a weight percentage in a range of 0.002-0.005% with respect to the composition. In yet another embodiment of the present disclosure, the Salvia officinalis extract has a weight percentage in a range of 0.002-0.004%) with respect to the composition. [0033] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andr ogr aphis paniculata extract, wherein the Salvia officinalis extract to the Andr ogr aphis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the Andrographispaniculata extract has a weight percentage in a range of 0.001-0.005%) with respect to the composition. In another embodiment of the present disclosure, the Andrographis paniculata extract has a weight percentage in a range of 0.002-0.005%) with respect to the composition. In yet another embodiment of the present disclosure, the Andrographis paniculata extract has a weight percentage in a range of 0.002-0.004%) with respect to the composition.
[0034] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005%) with respect to the composition, and wherein

the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005% with respect to the composition.
[0035] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract. In another embodiment of the present disclosure, the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 38-60% with respect to the Salvia officinalis extract.
[0036] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract. In another embodiment of the present disclosure, the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 8-15% with respect to the Andrographis paniculata extract. [0037] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract, and wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract.
[0038] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005%) with respect to the composition, and wherein

the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract. [0039] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract. [0040] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005%) with respect to the composition, and wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65%> with respect to the Salvia officinalis extract, and wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20%> with respect to the Andrographis paniculata extract.
[0041] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the composition further comprises at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof. [0042] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof,

wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2.
[0043] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; (b) Androgr aphis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Androgr aphis paniculata weight ratio is in a range of 1:1.4 to 1:0.4.
[0044] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; (b) Androgr'aphis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Androgr aphis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, and wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition. [0045] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; (b) Androgr'aphis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Androgr aphis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, and wherein the Androgr aphis paniculata extract has a weight percentage in a range of 0.001-0.005% with respect to the composition. [0046] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; (b) Androgr'aphis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Androgr aphis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, and wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract.

[0047] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Androgr aphis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, and wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract.
[0048] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, and wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005%) with respect to the composition.
[0049] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, and wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65%> with respect to the Salvia officinalis extract, and wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract.
[0050] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof,

wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, and wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Androgr aphis paniculata extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract, and wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract.
[0051] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; and (iii) contacting the Salvia officinalis extract, and the Andrographis paniculata extract, to obtain the composition. [0052] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; and (iii) contacting the Salvia officinalis extract, and the Andrographis paniculata extract at a temperature in a range of 25-37°C, to obtain the composition.
[0053] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one solvent; and (iv) contacting the Salvia

officinalis extract, and the Andrographis paniculata extract with the at least one solvent, to obtain the composition.
[0054] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one solvent; and (iv) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent at a temperature in a range of 25-37°C, to obtain the composition. [0055] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one solvent; and (iv) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent at a temperature in a range of 25-37°C, to obtain the composition, and wherein the at least one solvent is water.
[0056] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one excipient; (iv) obtaining at least one solvent; and (v) contacting the Salvia officinalis extract, the Andrographis paniculata extract, and the at least one excipient with the at least one solvent, to obtain the composition. [0057] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; (b) Andrographis

paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one excipient; and (iv) contacting the Salvia officinalis extract, the Andrographis paniculata extract, and the at least one excipient, to obtain the composition.
[0058] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one excipient; and (iv) contacting the Salvia officinalis extract, the Andrographis paniculata extract, and the at least one excipient at a temperature in a range of 25-37°C, to obtain the composition.
[0059] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one excipient; (iv) obtaining at least one solvent; and (v) contacting the Salvia officinalis extract, the Andrographis paniculata extract, the at least one excipient, and the at least one solvent to obtain the composition. In another embodiment, the at least one solvent is water.
[0060] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; (b) Andrographis

paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one excipient; (iv) obtaining at least one solvent; and (v) contacting the Salvia officinalis extract, the Andrographis paniculata extract, the at least one excipient with the at least one solvent at a temperature in a range of 25-37°C, to obtain the composition.
[0061] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; and (iii) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent, to obtain the composition, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition.
[0062] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; and (iii) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent, to obtain the composition, wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005% with respect to the composition. [0063] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process

comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; and (iii) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent, to obtain the composition, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract.
[0064] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; and (iii) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent, to obtain the composition, wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005%) with respect to the composition, and wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract. [0065] . In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; and (iii) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent, to obtain the composition, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65%> with respect to the Salvia officinalis extract, and wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005%) with respect to the composition, and wherein the Andrographis paniculata extract comprises

andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographispaniculata extract.
[0066] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one solvent; and (iv) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent, to obtain the composition, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract. [0067] . In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one solvent; and (iv) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent, to obtain the composition, wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005%) with respect to the composition, and wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract.
[0068] . In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one solvent; and (iv) contacting the Salvia

officinalis extract, and the Andrographis paniculata extract with the at least one solvent, to obtain the composition, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract, and wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001 -0.005% with respect to the composition, and wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract.
[0069] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one excipient; and (iv) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one excipient, to obtain the composition.
[0070] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one excipient; and (iv) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one excipient, to obtain the composition, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Salvia officinalis

extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract.
[0071] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one excipient; and (iv) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one excipient, to obtain the composition, wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract. [0072] . In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one excipient; and (iv) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one excipient, to obtain the composition, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition, and wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract, and wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005%) with respect to the composition, and wherein the Andrographis paniculata extract comprises

andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographispaniculata extract.
[0073] In embodiment of the present disclosure, there is provided a process for preparing a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof; and (d) at least one solvent, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, said process comprising: (i) obtaining Salvia officinalis extract; (ii) obtaining Andrographis paniculata extract; (iii) obtaining at least one excipient; (iv) obtaining at least one solvent; and (v) contacting the Salvia officinalis extract, the Andrographis paniculata extract, the at least one excipient with the at least one solvent at a temperature in a range of 25-37°C, to obtain the composition. In another embodiment of the present disclosure, the at least solvent is water. [0074] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; and (b) Andrographis paniculata extract, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the composition inhibits Interleukin-6 (IL-6) production, and Prostaglandin E2 (PGE-2) production.
[0075] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition inhibits Interleukin-6 (IL-6) production, and Prostaglandin E2 (PGE-2) production.
[0076] In an embodiment of the present disclosure, there is provided a composition comprising: (a) Salvia officinalis extract; (b) Andrographis paniculata extract; and (c) at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2, wherein the composition inhibits Interleukin-6 (IL-6) production, and Prostaglandin E2 (PGE-2) production.
[0077] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is in form of a powder.

[0078] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is in form of a drink. [0079] In an embodiment of the present disclosure, there is provided a composition as described herein, wherein the composition is in form of a health supplement. [0080] Although the subject matter has been described with reference to specific embodiments, this description is not meant to be construed in a limiting sense. Various modifications of the disclosed embodiments, as well as alternate embodiments of the subject matter, will become apparent to persons skilled in the art upon reference to the description of the subject matter. It is therefore contemplated that such modifications can be made without departing from the spirit or scope of the present subject matter as defined.
EXAMPLES
[0081] The disclosure will now be illustrated with working examples, which is intended to illustrate the working of disclosure and not intended to take restrictively to imply any limitations on the scope of the present disclosure. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods, devices and materials are described herein. It is to be understood that this disclosure is not limited to particular methods, and experimental conditions described, as such methods and conditions may apply.
[0082] The working examples described herein clearly depict the effect of a synergistic composition comprising Salvia officinalis extract and Andrographis paniculata extract on alleviating joint related pain and inflammation. The present section describes the effect of the composition of the present disclosure on inhibiting pro-inflammatory markers PGE-2 and IL-6 in chondrocyte cells. The ability to suppress the pro-inflammatory markers indicates the potential of the composition to suppress pain and inflammation.
Material and Methods

Human Chondrocytes (HCH) Culture
[0083] Human Chondrocytes (HCH) was obtained from PromoCell (Cat # C-12710). The cells were cultured in Chondrocyte Growth Medium Supplement Mix (Cat # C-39635) with 10% fetal bovine serum (FBS, Gibco) and 1% of penicillin/streptomycin (Invitrogen) at 37°C in an incubator containing 5% CO2. Cell viability
[0084] Viability of cells were determined by reduction of (Thiazolyl Blue Tetrazolium Blue (MTT) (Sigma) to formazan. Cells were seeded in culture plates and cultured for 24 hours. After treatment, the media was immediately changed to serum- free medium and cultured for 24 hours. MTT assay was performed. MTT (2 mg/ml in PBS) was added to each well. Cells were incubated at 37°C for 30 min and dimethyl sulfoxide (DMSO) (100 ul) was added to dissolve the formazan crystals. The absorbance was measured at 560 nm using an ELISA reader (Thermo Fisher, Germany).
PGE2 immunoassay
[0085] Cells were seeded into each well of 12-well plates until 80% confluent. The cells were then maintained in serum-free media and treated with natural compounds for 24 hours. After an incubation period of 16 hours, the amount of PGE2 released into the medium was determined. To measure PGE2, PGE2 EIA kit was used (Enzo Life sciences; Cat no- ADI-900-001). Briefly, samples were incubated with PGE2 EIA conjugate (cat no- 80-0002) and PGE2 EIA antibody (cat no- 80-0003) at room temperature for 2 hours at 500 rpm on a plate shaker. Excess reagents were washed off and substrate (cat no- 80-0075) was added. After a short incubation time the enzyme reaction was stopped and yellow color generated was read on a microplate reader at 405 nm.
IL-6 cytokine production
[0086] Cells were seeded into each well of 12-well plates until 80% confluent. IL-6 secretion was stimulated with 5 ug/ml lipopolysaccharide (LPS). This treatment stimulates the inflammatory conditions. Simultaneously the cells were treated with the extracts or composition of the present disclosure for 24 hours. To quantify IL-6

production, culture supernatants were collected and the levels of secreted cytokines were determined using an ELISA kit (R&D Systems, Cat No. DY206-05 USA).
Example 1
Effects of individual extracts on chondrocyte cell viability [0087] The present example depicts the effect of individual extracts on cell viability in chondrocytes. Salvia officinalis extract was procured commercially from a vendor, the extract is based on leaves of Salvia officinalis. Salvia officinalis extract comprises ursolic acid having 50% weight with respect to the extract. Andrographispaniculata extract was commercially procured from a vendor, the extract is based on whole aerial plant Andrographis paniculata. Andrographis paniculata extract comprises andrographolides having 10% weight with respect to the extract. [0088] The method for determining the cell viability has been mentioned in the Material and Method section. Figure 1 and Figure 2 depicts the effect of Salvia officinalis extract and Andrographis paniculata extract on the chondrocyte cell viability, respectively. As can be observed from Figure 1, the Salvia officinalis extract up to 40ug/ml was found to be non-toxic to the cells. From Figure 2, it can be observed that the Andrographis paniculata extract was found to be non-toxic to the cells up to 80ug/ml.
Example 2
Preparation of Salvia officinalis extract, Andrographis paniculata extract, and
the combination comprising Salvia officinalis extract and Andrographis
paniculata extract
[0089] The respective extracts {Salvia officinalis extract and Andrographis
paniculata extract) were dissolved in distilled water in an amount required to obtain
a particular concentration of the extract, followed by filter sterilization before
treating cells. For example, for preparing a composition comprising a combination
of 32ug/ml Salvia officinalis extract and 16ug/ml Andrographis paniculata extract,
4/5th volume of 40ug/ml Salvia officinalis extract was mixed with l/5th volume of
80ug/ml Andrographis paniculata extract. For preparing the stocks of 40ug/ml

Salvia officinalis extract, 40ug of the extract was dissolved in 1ml of water, similarly, for preparing 80ug Andrographis paniculata extract, 80ug of the extract was dissolved in 1 ml of water.
[0090] In order to prepare a composition comprising Salvia officinalis extract and Andrographis paniculata extract, the extracts were weighed, dissolved in distilled water (at least one solvent), and mixed at a temperature in a range of 25-37°C to obtain the composition. Through this process various combinations were prepared and the same is provided in Table 1 below.
Example 3
Effect of individual extracts as well as combination of the extracts on
Prostaglandin E-2 (PGE-2) production in chondrocytes
[0091] Since the composition's primary effect is to work as a pain and inflammation
reliever, the effect of the composition was checked on the inhibition of a well
established pro-inflammatory marker Prostaglandin E-2 (PGE-2). The effect of the
composition on PGE-2 was checked on chondrocyte cells using a protocol as
described in Material and Method section.
[0092] Figure 3 depicts the individual effect of Salvia officinalis extract (20ug/ml
and 40ug/ml) and Andrographis paniculata extract (40ug/ml and 80ug/ml) on PGE-
2 inhibition. Figure 3 compares the PGE-2 inhibition of the composition of the
present disclosure as well as extracts to well-known analgesic diclofenac. Figure 4
and Figure 5 depicts the individual effect of difference concentrations of Salvia
officinalis extract and Andrographis paniculata extract on PGE-2 inhibition,
respectively. It was observed that both the extracts displayed an increased inhibition
of PGE-2 on increasing the concentrations. Also, the individual effect of the extracts
would provide a way of assessing the synergistic effect of a composition comprising
different combination of the two extracts.
[0093] Figure 6 depicts the effect of various combinations of Salvia officinalis
extract (Sage) and Andrographis paniculata extract (Andrographis) on PGE-2
inhibition. Five different combinations of the extracts were tested for a synergistic
effect in inhibiting production of PGE-2 inhibition, Salvia officinalis extract and

Andrographispaniculata extract in a weight ratio of 1:8, 1:3, 1:2, 1:1.33, and 1:0.5. On analysing Figures 4, 5, and 6, it was observed that the ratios 1:1.33, and 1:0.5 exhibited a synergistic effect (combination of the two extracts is more than the additive effect of individual extracts at the respective concentration) in inhibiting production of PGE-2 in chondrocyte cells. The synergistic effect has been clearly depicted in Table 1 below.
[0094] It was further observed that the combinations having ratios 1:8, 1:3, and 1:2 did not display synergistic inhibitory effect. Thus, it is justified to mention that a mere combination of the two extracts did not yield the synergistic effect, it is the combination within a specific weight ratio range that yielded the synergistic effect. The combinations I, II, and III had the weight ratios of the two extracts {Salvia

officinalis extract to Andrographispaniculata extract) outside the disclosed range of 1:1.5 to 1:0.2, therefore, a synergistic inhibition was not observed.
Example 4
Effect of individual extracts as well as combination of the extracts on Interleukin-6 (IL-6) production in chondrocytes
[0095] After studying the inhibitory potential of the composition comprising Salvia officinalis extract to Andrographis paniculata extract on PGE-2, the present example depicts the effect of individual extracts as well as combination on inhibition of another pro-inflammatory marker IL-6. The process for carrying out the experiments were detailed in Material and Method section.
[0096] Figure 7 and Figure 8 depict the individual effects of Salvia officinalis extract (Sage) and Andrographis paniculata extract (Andrographis) on the inhibition of IL-6, respectively. It was observed that the extracts displayed an increase in inhibition percentage upon an increase in the concentration. As a next obvious step, the effect of different combinations of the extracts were checked on IL-6 inhibition. [0097] Figure 9 depicts the IL-6 inhibition pattern on various compositions comprising different ratios of the extracts. The following weight ratios {Salvia officinalis extract: Andrographis paniculata extract) were covered as a part of the study: 1:8, 1:3, 1:2, 1:1.33, and 1:0.5. Table 2 as depicted below summarises the effect of different combinations on IL-6 inhibition.

[0098] It was observed from Table 2 that the weight ratios {Salvia officinalis extract: Andrographispaniculata extract) 1:1.33 and 1:0.5 displayed a synergistic effect in inhibiting production of IL-6 from chondrocyte cells, whereas the other ratios did not display a synergistic inhibition. As was observed in Example 3, the present example also proves that the combination of the two extracts has to be in a particular weight ratio for observing the synergistic effect of the combination. As the combinations I, II, and III did not comprise the extracts in the disclosed weight ratio {Salvia officinalis extract: Andrographis paniculata extract) range of 1:1.5 to 1:0.2, a synergistic effect could not be observed.
[0099] Summarizing the results obtained in Examples 2 and 3, it can be stated that the composition comprising Salvia officinalis extract and Andrographis paniculata extract in specific weight ratio range displayed a synergistic inhibition of pro-inflammatory markers PGE-2 (Example 2) and IL-6 (Example 3). The synergistic inhibition of the pro-inflammatory markers is expected to bring about an attenuation in pain and inflammation. The criticality of the weight ratio was also observed in Examples 3 and 4, wherein the combinations I, II, and III displayed a non-synergistic effect due to the presence of Salvia officinalis extract and Andrographis paniculata extract outside the disclosed ranges.
Example 5
Formulation comprising the composition of the present disclosure
[00100] The formulation of the present disclosure refers to a composition
comprising Salvia officinalis extract and Andrographis paniculata extract in
disclosed weight ratio range of 1:1.5 to 1:0.2 {Salvia officinalis extract and

Andrographis paniculata extract). Table 3 below depicts a formulation comprising the composition of the present disclosure along with different excipients. Table 3: Formulation
[00101] The formulation as disclosed in Table 3 is only one of the many possible
formulations that can be prepared using the composition of the present disclosure.
The composition of the present disclosure could be incorporated in all food products
such as juices, powder beverages, milk-based beverages, biscuits, and ready-to-eat
mixes.
[00102] Process for preparing the formulation comprising the composition of the
present disclosure - The components were weighed appropriately as mentioned in
Table 3 above and mixed to obtain a uniform formulation. The mixing was done at
a temperature in a range of 25-37°C to obtain the formulation.
Advantages of the present disclosure
[00103] The present disclosure discloses a composition comprising Salvia
officinalis extract and Andrographis paniculata extract in specific weight ratio
ranges. The study detailed in the present disclosure discloses the potential of the
composition of the present disclosure to alleviate pain and inflammation by
inhibiting the production of pro-inflammatory markers like PGE-2 and IL-2. The

composition being herbal in nature holds enormous potential in being formulated as a part of a variety of consumable products. Also, being herbal in nature, the composition is associated with minimal risk of undesired effects. The composition of the present disclosure can be included in various formats ranging from different liquid and solid food categories.

I/We Claim:
1. A composition comprising:
a) Salvia officinalis extract; and
b) Andrographis paniculata extract,
wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.5 to 1:0.2.
2. The composition as claimed in claim 1, wherein the Salvia officinalis extract to the Andrographis paniculata weight ratio is in a range of 1:1.4 to 1:0.4.
3. The composition as claimed in claim 1, wherein the Salvia officinalis extract has a weight percentage in a range of 0.001-0.005% with respect to the composition.
4. The composition as claimed in claim 1, wherein the Andrographis paniculata extract has a weight percentage in a range of 0.001-0.005% with respect to the composition.
5. The composition as claimed in claim 1, wherein the Salvia officinalis extract comprises ursolic acid having a weight percentage in a range of 35-65% with respect to the Salvia officinalis extract.
6. The composition as claimed in claim 1, wherein the Andrographis paniculata extract comprises andrographolides having a weight percentage in a range of 5-20% with respect to the Andrographis paniculata extract.
7. The composition as claimed in claim 1, wherein the composition further comprises at least one excipient selected from a group consisting of sweetener, preservative, stabilizer, emulsifier, flavouring agent, coloring agent, and combinations thereof.
8. A process for obtaining a composition as claimed in claim 1, said process comprising:

a) obtaining Salvia officinalis extract;
b) obtaining Andrographis paniculata extract; and
c) contacting the Salvia officinalis extract, and the Andrographis paniculata extract, to obtain the composition.

9. A process for obtaining a composition as claimed in claim 1, said process
comprising:
a) obtaining Salvia officinalis extract;
b) obtaining Andrographis paniculata extract;
c) obtaining at least one solvent; and
d) contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent, to obtain the composition.
10. A process for obtaining a composition as claimed in claim 7, said process
comprising:
a) obtaining Salvia officinalis extract;
b) obtaining Andrographis paniculata extract;
c) obtaining at least one excipient; and
d) contacting the Salvia officinalis extract, the Andrographis paniculata extract, and the at least one excipient, to obtain the composition.

11. The process as claimed in claim 8, wherein contacting the Salvia officinalis extract, and the Andrographis paniculata extract is done at a temperature in a range of 25-37°C, to obtain the composition.
12. The process as claimed in claim 9, wherein contacting the Salvia officinalis extract, and the Andrographis paniculata extract with the at least one solvent is done at a temperature in a range of 25-37°C, to obtain the composition.
13. The process as claimed in claim 10, wherein contacting the Salvia officinalis extract, the Andrographis paniculata extract, and the at least one excipient is done at a temperature in a range of 25-37°C, to obtain the composition.
14. The composition as claimed in any one of the claims 1-7, wherein the composition inhibits Interleukin-6 (IL-6) production, and Prostaglandin E2 (PGE-2) production.

Documents

Application Documents

# Name Date
1 201941024856-FORM 18 [11-05-2023(online)].pdf 2023-05-11
1 201941024856-STATEMENT OF UNDERTAKING (FORM 3) [21-06-2019(online)].pdf 2019-06-21
2 201941024856-FORM 1 [21-06-2019(online)].pdf 2019-06-21
2 Correspondence by Agent_Form1,Form26_22-07-2019.pdf 2019-07-22
3 201941024856-DRAWINGS [21-06-2019(online)].pdf 2019-06-21
3 201941024856-FORM-26 [19-07-2019(online)].pdf 2019-07-19
4 201941024856-DECLARATION OF INVENTORSHIP (FORM 5) [21-06-2019(online)].pdf 2019-06-21
4 201941024856-Proof of Right (MANDATORY) [19-07-2019(online)].pdf 2019-07-19
5 201941024856-COMPLETE SPECIFICATION [21-06-2019(online)].pdf 2019-06-21
6 201941024856-DECLARATION OF INVENTORSHIP (FORM 5) [21-06-2019(online)].pdf 2019-06-21
6 201941024856-Proof of Right (MANDATORY) [19-07-2019(online)].pdf 2019-07-19
7 201941024856-DRAWINGS [21-06-2019(online)].pdf 2019-06-21
7 201941024856-FORM-26 [19-07-2019(online)].pdf 2019-07-19
8 201941024856-FORM 1 [21-06-2019(online)].pdf 2019-06-21
8 Correspondence by Agent_Form1,Form26_22-07-2019.pdf 2019-07-22
9 201941024856-FORM 18 [11-05-2023(online)].pdf 2023-05-11
9 201941024856-STATEMENT OF UNDERTAKING (FORM 3) [21-06-2019(online)].pdf 2019-06-21