] The present disclosure relates generally to pharmaceutical compositions. More specifically, the disclosure is directed to a pharmaceutical composition for management of SARS-CoV2 comprising Delta-viniferin (8-viniferin). The present disclosure also provides a process of preparing the composition.
BACKGROUND OF THE INVENTION
[0002] Background description 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. [0003] Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2), commonly called coronavirus, is an enveloped positive-sense Ribose Nucleic Acid (RNA) virus known as a human and animal pathogen with a large RNA genome. Coronaviruses are the largest group of viruses belonging to the Nidovirales order including Coronaviridae, Arteriviridae, Mesoniviridae and Roniviridae families. They contain very large genomes for RNA viruses, with some viruses having the largest identified RNA genomes containing up to 33.5 kilobase (kb) genomes. Coronavirus particles contain four main structural proteins namely spike (S), membrane (M), envelope (E) and nucleocapsid (N) proteins and are encoded within the 3' end of the viral genome. SARS-CoV-2 causes an infectious disease called COVID-19 mainly transmitted through droplets generated when an infected person coughs, sneezes or exhales. COVID-19, first detected in Wuhan, China in 2019, is characterized by flu like symptoms and pneumonia primarily affecting the lungs. It is characterized by development of mild to moderate illness in most patients and recovery without hospitalization. The most common symptoms are fever, dry cough and tiredness. The severity of the disease results in difficulty in breathing, shortness of breath, chest pain and even death.
[0004] Coronavirus infection is caused by replication of virus in the host cell. Viral replication is the formation of biological viruses during the infection process

in the target host cells. The virus is incapable of self-replication and only multiplies in an internal cellular environment. Viruses lack subcellular organelles such as nuclei, mitochondria, ribosomes as well as cytoplasmic components that are necessary for the synthesis of their own structural components such as nucleic acids, proteins, carbohydrates and lipids. Viral replication is a complex process involving different mechanisms of the host cell for replication including signaling molecules and signal transduction processes. Although the replicative life cycle of viruses differs between species and category of virus, there are six basic stages that are essential for viral replication namely adhesion, penetration, uncoating, replication, assembly and virion release.
[0005] Scientists around the world are trying different therapies or medications and even repurposing existing drugs to combat the viral spread. A leprosy drug sepsivac, which comprises an immunomodulator and according to the Indian Council of Medical Research's findings helps to treat and even reduce the mortality rate in critically ill patients has been repurposed for use against COVID-19. Similarly, hydroxychlorquine (HCQ) has been one of the controversial drugs in the news. The anti-malarial drug also used to treat certain auto-immune diseases and arthritis conditions has shown immense promise in treating some of the symptoms associated with coronavirus. Even though studies are still underway, warnings have been issued against wide-scale use of the HCQ drugs and in some places it has been reserved for use only in hospital settings and to be administered to frontline workers. In addition, the combination of lopinavir and ritonavir has also shown promising results in reducing the severity of the symptoms in patients with COVID-19. The combination may be effective in preventing the adhesion of virus to host cell and reproduction in the host immune system.
[0006] Most of these drugs including chloroquine, hydroxychloroquine, remdesivir, favipiravir and the recently known EIDD-2801 are under clinical trials. The available compositions may not be effective in reducing the viral infection as they do not match the epidemic virus type, are unstable or less

bioavailable and thus, there is a need to develop a composition that is effective in
preventing infection with high stability.
[0007] The inventors of the present disclosure provide a pharmaceutical
composition for management of SARS-CoV2 comprising Delta-viniferin (8-
viniferin).
OBJECTS OF THE INVENTION
[0008] Another object of the present disclosure is to provide a pharmaceutical
composition for management of SARS-CoV2 comprising Delta-viniferin.
[0009] An object of the present disclosure is to provide a pharmaceutical
composition that is stable and has high bioavailability.
[0010] Yet another object of the present disclosure is to provide a process of
preparing the pharmaceutical composition.
SUMMARY OF THE INVENTION
[0011] This summary is provided to introduce a selection of concepts in a
simplified form that are further described below in Detailed Description section.
This summary is not intended to identify key features or essential features of the
claimed subject matter, nor is it intended to be used as an aid in determining the
scope of the claimed subject matter.
[0012] The present disclosure relates to Delta-viniferin as an active ingredient for
management of infection caused by Corona Virus 2 (SARS-CoV-2).
[0013] In an aspect, the present disclosure provides a pharmaceutical composition
for management of SARS-CoV2 comprising Delta-viniferin, an isomer, a
tautomer, a solvate, or a pharmaceutically acceptable salt thereof.
[0014] In an aspect, the present disclosure provides a pharmaceutical formulation
for management of SARS-CoV2 comprising Delta-viniferin, an isomer, a
tautomer, a solvate, or a pharmaceutically acceptable salt thereof; and one or more
pharmaceutically acceptable excipient(s).
[0015] In an embodiment, the excipient may be selected from binders, suspending
agents, diluents, disintegrants, solubilizers, dispersants, stabilizers, suspending

agents, lubricant, pigments, flavors, buffers, preservatives, tackifiers, or
combinations thereof.
[0016] In another aspect, the present disclosure provides a process of preparing a
pharmaceutical composition for management of SARS-CoV2 comprising Delta-
viniferin.
[0017] Other aspects of the invention will be set forth in the description which
follows, and in part will be apparent from the description, or may be learnt by the
practice of the invention.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[0018] The following drawings form part of the present specification and are
included to further illustrate aspects of the present disclosure. The disclosure may
be better understood by reference to the drawings in combination with the detailed
description of the specific embodiments presented herein.
Figure 1 provides docking study results for binding mode analysis and interaction
of Delta-Viniferin at the interface of the SARS-CoV-2 spike SI receptor-binding
domain (red) bound with the human ACE2 receptor (blue).
Figure 2 provides docking study results for binding mode analysis and interaction
of Delta-Viniferin with the active site of Main protease (Mpro) of SARS-CoV-2.
DETAILED DESCRIPTION OF THE INVENTION
[0019] The following is a detailed description of embodiments of the disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.
[0020] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition

of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply. [0021] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0022] In some embodiments, numbers have been used for quantifying weights, percentages, ratios, and so forth, to describe and claim certain embodiments of the invention and are to be understood as being modified in some instances by the term "about." Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements. [0023] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
[0024] As used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the" includes plural reference unless the context

clearly dictates otherwise. Also, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise. [0025] Unless the context requires otherwise, throughout the specification which follow, the word "comprise" and variations thereof, such as, "comprises" and "comprising" are to be construed in an open, inclusive sense that is as "including, but not limited to."
[0026] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. [0027] All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention. [0028] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified.
[0029] The description that follows, and the embodiments described therein, is provided by way of illustration of an example, or examples, of particular embodiments of the principles and aspects of the present disclosure. These examples are provided for the purposes of explanation, and not of limitation, of those principles and of the disclosure.
[0030] It should also be appreciated that the present disclosure can be implemented in numerous ways, including as a system, a method or a device. In

this specification, these implementations, or any other form that the invention may
take, may be referred to as processes. In general, the order of the steps of the
disclosed processes may be altered within the scope of the invention.
[0031] The headings and abstract of the invention provided herein are for
convenience only and do not interpret the scope or meaning of the embodiments.
[0032] The following discussion provides many example embodiments of the
inventive subject matter. Although each embodiment represents a single
combination of inventive elements, the inventive subject matter is considered to
include all possible combinations of the disclosed elements. Thus if one
embodiment comprises elements A, B, and C, and a second embodiment
comprises elements B and D, then the inventive subject matter is also considered
to include other remaining combinations of A, B, C, or D, even if not explicitly
disclosed.
[0033] The term, "therapeutically effective amount" as used herein refers to an
amount of the composition effective in producing the desired therapeutic response
in a subject suffering from a disease or disorder.
[0034] As used herein, the term "excipient" or "pharmaceutically acceptable
excipient" refers to diluents, adjuvants, carriers or vehicles with which a
compound of the disclosure is administered.
[0035] As used herein, the term "isolated" means that the active component of the
disclosure is separated from other components of either (a) a natural source, such
as a plant or cell, or (b) a synthetic organic chemical reaction mixture and an
isolated compound may be for example, 10%, 20%, 30%, 40%, 50%, 60%, 70%,
80%, 85%, 90%, 95%, 97%, 98%, or 99% pure.
[0036] As used herein, the term "isomer" refers to any stereoisomer, enantiomer
or diastereomer of the compound of the present disclosure.
[0037] As used herein, the term "pharmaceutically acceptable" means approved
by a regulatory authority of the National or the State Government of India or
listed in the U.S. Pharmacopeia or other generally recognized pharmacopeia for
use in animals and more particularly in humans.

[0038] As used herein, the term "pharmaceutically acceptable salt" includes but is not limited to salts of acidic-basic groups that may be present in the compound used in present disclosure.
[0039] As used herein, the term "stereomerically pure" means a composition that comprises one stereoisomer of a compound and is substantially free of other stereoisomers of that compound.
[0040] As used herein, the term "in-silico analysis" refers to analysis of the activity of the composition or compound to analyze the interaction with proteins using a computer simulation.
[0041] The term, "subject" as used herein refers to an animal, preferably a mammal, and most preferably a human. The term "mammal" used herein refers to warm-blooded vertebrate animals of the class 'mammalia', including humans, characterized by a covering of hair on the skin and, in the female, milk-producing mammary glands for nourishing the young, the term mammal includes animals such as cat, dog, rabbit, bear, fox, wolf, monkey, deer, mouse, pig and human. [0042] The term, 'management', or 'treatment' as used herein refers to alleviate, slow the progression, attenuation, prophylaxis or as such treat the existing disease or condition. Treatment also includes treating, preventing development of, or alleviating to some extent, one or more of the symptoms of the diseases or condition.
[0043] In an embodiment, the present disclosure provides a pharmaceutical composition for management of SARS-CoV2 comprising Delta-viniferin, an isomer, a tautomer, a solvate, or a pharmaceutically acceptable salt thereof. [0044] Delta-viniferin is a natural resveratrol dehydrodimer isolated from stressed grapevine (Vitis viniferd) leaves and can also be found in Rheum maximowiczii. It is known for its inhibitory effects against HIV-1 integrase and antiviral activity against HIV. The publication entitled "Plant-Derived Purification, Chemical Synthesis, and In Vitro/In Vivo Evaluation of a Resveratrol Dimer, Viniferin, as an HCVReplication Inhibitor" reported the anti-HCV activity of viniferin. [0045] Without being bound to theory, it is noted that Delta-viniferin inhibits the attachment of Sl-RBD of the coronavirus to the host ACE2 receptor of a subject

(with free binding energy of -9.97 kcal/mol) and binds with the ACE2
hydrophobic pocket (with free binding energy of -11.72kcal/mol). In-silico
analysis revealed that Delta-viniferin effectively binds to the ACE2 protein at two
positions namely ACE2/Spike interface and at a hydrophobic pocket of the ACE2
domain through hydrogen bonds with a good docking energy. It also shows good
affinity (with free binding energy of -11.09kcal/mol) to main proteases (Mpro) of
the coronavirus which results in antiviral activity in the viral cells.
[0046] The active component, 8-viniferin, may be prepared into compositions that
enhance solubility and cellular absorption of the active. The composition of the
disclosure may be safe without inducing any adverse effects and is effective
against activation of coronaviruses as well as other viruses due to specific activity
of 8-viniferin.
[0047] In an embodiment, the composition may comprise Delta-viniferin in a
weight percentage range of about 0.001%> to about 90% w/w of the composition.
In an embodiment, the composition may comprise Delta-viniferin in at least 0.1%>
w/w, at least 1% w/w, at least 5% w/w, at least 10%> w/w, at least 20% w/w, at
least 30%o w/w, at least 40% w/w, at least 50% w/w, at least 60% w/w, at least
70%o w/w, at least 80% w/w or at least 90% w/w of the composition.
[0048] In an embodiment, the composition may further comprise one or more
pharmaceutically acceptable excipient(s), additive(s) or carrier(s).
[0049] In an embodiment, the composition may comprise the excipient(s),
additive(s) or carrier(s) in a weight percentage range of about 10% to about 99.9%
w/w of the composition.
[0050] In an embodiment, the excipient or additive may be selected from binders,
polymer, suspending agents, diluents, disintegrants, solubilizers, dispersants,
stabilizers, suspending agents, pigments, flavors, buffers, gelling agents, lubricant,
preservatives, or the like, or combinations thereof. However, a person skilled in
the art would appreciate that any other excipient(s) or additive(s) can be utilized to
serve the intended purpose without departing from the scope and spirit of the
disclosure.

[0051] In an embodiment, the carrier may be selected from a solvent such as water, ethanol, and the like. However, a person skilled in the art would appreciate that any other carrier(s) can be utilized to serve the intended purpose without departing from the scope and spirit of the disclosure.
[0052] According to an embodiment of the disclosure, the active ingredient is basic in nature to which it is not restricted but is capable of forming a wide variety of salts with various inorganic and organic acids. The acids that may be used to prepare pharmaceutically acceptable acid salts of such compounds are those that form non-toxic acid addition salts, i.e., salts containing pharmacologically acceptable anions, including but not limited to sulfuric, acetic, nitrate, hydrochloride, hydrobromide, acetate, phosphate, citric, oxalic, hydroiodide, maleic, sulfate, bisulfate, acid phosphate, isonicotinate, lactate, salicylate, citrate, acid citrate, tartrate, tannate, pantothenate, bitartrate, ascorbate, succinate, maleate, gentisinate, fumarate, gluconate, glucoronate, saccharate, formate, benzoate, glutamate, methasulfonate, ethanesulfonte, benzenesulfonate, p-toluenesulfonate, mesylate, hydroxy methyl sulfonate, and palmoate salts. [0053] Similarly, the active ingredient is acidic in nature to which it is not restricted but is capable of forming a wide variety of salts by ionizable hydrogens combining with different inorganic and organic bases to form the respective salts. Such a pharmaceutically acceptable salt may be made with a base which affords a pharmaceutically acceptable cation, which includes alkali metal salts (especially sodium and potassium), alkaline earth metal salts (especially calcium and magnesium), aluminum salts and ammonium salts, as well as salts made from physiologically acceptable organic bases such as trimethylamine, triethylamine, morpholine, pyridine, piperidine, picoline, dicyclohexylamine, N,N'-dibenzylethylenediamine, 2-hydroxyethylamine, bis-(2-hydroxyethyl)amine, tri-(2-hydroxyethyl)amine, procaine, dibenzylpiperidine, dehydroabietylamine, N,N'-bisdehydroabietylamine, glucamine, N-methylglucamine, collidine, quinine, quinoline, and basic amino acids such as lysine and arginine. [0054] The term solvate includes hydrates, including monohydrates, dihydrates, sesquihydrates, or tetrahydrates.

[0055] In an embodiment, the composition may comprise Delta-viniferin in a
stereomerically pure form.
[0056] In an embodiment, Delta-viniferin may be isolated from a natural source or
may be synthesized in the laboratory.
[0057] In an embodiment, the present disclosure provides a pharmaceutical
formulation for management of SARS-CoV2 comprising Delta-viniferin, an
isomer, a tautomer, a solvate, or a pharmaceutically acceptable salt thereof; and
one or more pharmaceutically acceptable excipient(s).
[0058] In an embodiment, the excipient may be present in a range of about 10%
w/w to about 99.9%w/w of the formulation.
[0059] In an embodiment, the binder may be any pharmaceutically acceptable
substance that can bind the active ingredient, non-limiting examples include,
hydroxypropylcellulose, hydroxyethylmethyl cellulose, microcrystalline cellulose,
polyvinylpyrrolidone, gum arabica, povidone, corn starch, or the like, or
combinations thereof.
[0060] In an embodiment, the disintegrant may be any pharmaceutically
acceptable substance capable of disintegrating or breaking down the formulation
for dissolution of active ingredient, non-limiting examples include crospovidone,
microcrystalline cellulose, sodium starch glyconate, citric acid, or the like, of
combinations thereof.
[0061] In an embodiment, the buffer may be a phosphate buffer or the like.
[0062] In an embodiment, diluent(s) includes but not limited to, microfine
cellulose, lactose, starch, pregelatinized starch, calcium carbonate, calcium
sulfate, sugar, dextrates, dextrin, dextrose, dibasic calcium phosphate dihydrate,
tribasic calcium phosphate, kaolin, magnesium carbonate, magnesium oxide,
maltodextrin, mannitol, potassium chloride, powdered cellulose, sodium chloride,
sorbitol, talc, fats, oils, or the like, or combinations thereof.
[0063] In an embodiment, flavor(s) includes but is not limited to, fruit aromas
such as orange, banana, strawberry, cherry, wild cherry, lemon; cardamom, anis,
mint, menthol, vanillin, and ethyl vanillin, and other similar aromas, sodium
benzoate, or the like, or combinations thereof.

[0064] In an embodiment, stabilizer(s) includes but is not limited to, EDTA
disodium, sodium gluconate, or the like, or combinations thereof.
[0065] In an embodiment, preservative(s) includes but is not limited to, potassium
sorbate, phenoxyethanol, DMDM, p-hydroxybenzoic acid esters, sorbic acid,
benzoic acid, propionic acid or salts thereof, or the like.
[0066] In an embodiment, lubricant(s) includes but is not limited to, zinc stearate,
magnesium stearate, stearic acid, calcium stearate, Vegetable stearin and mixture
thereof, or the like.
[0067] In an embodiment, the pharmaceutical formulation can be administered
orally, for example in the form of pills, tablets, coated tablets, capsules, granules
or elixirs. Administration, however, can also be carried out rectally, for example
in the form of suppositories, or parenterally, for example intravenously,
intramuscularly or subcutaneously, in the form of injectable sterile solutions or
suspensions, or topically, for example in the form of ointments or creams or
transdermally, in the form of patches, or in other ways, for example in the form of
aerosols or nasal sprays.
[0068] For the production of oral dosage forms of the active, such as pills, tablets,
coated tablets and hard gelatin capsules, it is possible to use, for example, lactose,
corn starch or compounds thereof, gum arabica, magnesia or glucose, etc.
Pharmaceutically acceptable excipients that can be used for soft gelatin capsules
and suppositories are, for example, fats, waxes, natural or hardened oils, etc.
Suitable pharmaceutically acceptable excipients for the production of solutions,
for example injection solutions, or of emulsions or syrups are, for example, water,
physiological sodium chloride solution or alcohols, for example, ethanol, propanol
or glycerol, sugar solutions, such as glucose solutions or mannitol solutions, or a
mixture of the said solvents.
[0069] In an embodiment, the pharmaceutical formulation invention is prepared as
Solid Disprersions to enhance solubility and Cellular absorption.
[0070] In an embodiment, the pharmaceutical formulation is safe without
inducing any adverse effects and effective against activation of coronaviruses as
well as other viruses due to specific activity of Delta-viniferin.

[0071] In an embodiment, the formulation may be sustained release or immediate
release formulation. In an embodiment, the formulation may be coated or
uncoated.
[0072] The dosage unit for the composition may be determined by a trained
physician based on the severity of the condition, age, gender, weight, mode of
administration, medical history and other factors.
[0073] In an embodiment, the present disclosure provides a pharmaceutical solid
dispersion composition comprising Delta-viniferin. Various techniques are well
known in the art for preparing solid dispersion compositions including, but not
limited to solution-evaporation, melt-extrusion, spray-drying, or lyophilization.
Any of the known methods may be employed for preparing the composition.
[0074] In another embodiment, the present disclosure provides a process of
preparing a pharmaceutical composition for management of SARS-CoV2
comprising Delta-viniferin. In another embodiment, the present disclosure
provides a process of preparing a pharmaceutical formulation for management of
SARS-CoV2 comprising Delta-viniferin.
[0075] In another embodiment, the present disclosure provides a method of
treatment, amelioration or prevention of SARS-CoV2 in a subject by
administering the subject with a therapeutically effective amount of the
composition.
[0076] In yet another embodiment, the present disclosure provides use of the
composition for the management of coronavirus and associated conditions in a
subject.
[0077] In an embodiment, the composition of the present disclosure may be
administered alone or in combination with other therapeutic agents for treatment
of coronavirus and associated conditions.
[0078] While the foregoing describes various embodiments of the disclosure,
other and further embodiments of the disclosure may be devised without departing
from the basic scope thereof. The scope of the invention is determined by the
claims that follow. The invention is not limited to the described embodiments,
versions or examples, which are included to enable a person having ordinary skill

in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art. EXAMPLES
[0079] 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 vary. [0080] EXAMPLE 1: In-silico Receptor Docking Assessment of Compound [0081] The in-silico analysis of Delta-viniferin was achieved using X-ray crystal structure of spike protein and M protease (PDB ID: 6LU7) of SARS-CoV2. The in-silico analysis revealed that Delta-viniferin shows high free binding affinity especially with ACE2 protein (refer Figure 1) with free binding energy of -9.97 kcal/mol and M protease (refer Figure 2) with free binding energy of -11.09kcal/mol.
[0082] From the foregoing, it will be appreciated that, although specific embodiments of the invention have been described herein merely for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention and should not be construed so as to limit the scope of the invention or the appended claims in any way.

We Claim:

1. A pharmaceutical composition, said composition comprises
a. Delta-viniferin, an isomer, a tautomer, a solvate, or a
pharmaceutically acceptable salt thereof in an amount of 0.1% to
about 90% w/w of the composition; and
b. Pharmaceutically acceptable excipient in an amount of 10% to
about 99.9%) w/w of the composition.
2. The composition as claimed in claim 1, wherein the Pharmaceutically acceptable excipient is selected from the group consisting of binders, polymer, suspending agents, diluents, disintegrants, solubilizers, dispersants, stabilizers, suspending agents, pigments, flavors, buffers, gelling agents, lubricant, preservatives, or the like, or combinations thereof.
3. The composition as claimed in claim 1, wherein the composition is formulated as Solid Disprersions to enhance solubility and Cellular absorption.
4. The composition as claimed in claim 1, wherein the composition is formulated as sustained release or immediate release formulation.
5. The composition as claimed in claim 2, wherein the binder is selected from the group consisting of hydroxypropylcellulose, hydroxyethylmethyl cellulose, microcrystalline cellulose, polyvinylpyrrolidone, gum arabica, povidone, corn starch, or combinations thereof.
6. The composition as claimed in claim 2, wherein the disintegrant is selected from the group consisting of crospovidone, microcrystalline cellulose, sodium starch glyconate, citric acid, or combinations thereof.
7. The composition as claimed in claim 2, wherein the buffer is phosphate buffer.
8. The composition as claimed in claim 2, wherein the stabilizer is selected from the group consisting of EDTA disodium, sodium gluconate, or combinations thereof.

9. The composition as claimed in claim 2, wherein the preservative is selected from the group consisting of potassium sorbate, phenoxyethanol, DMDM, p-hydroxybenzoic acid esters, sorbic acid, benzoic acid, propionic acid or salts thereof, or combinations thereof.