The present invention pertains among others to lyophilized powder and non-aqueous liquid dosage form of Belinostat thereof. In particular, the invention concerns a method for the preparation of Belinostat in lyophilized powder form using alkali salts to improve the solubility and Polyols, amino acids (excluding arginine and lysine), monosaccharides, oligo/poly saccharides, and cyclodextrins to improve dilution and reconstitution stability. The invention also relates to a method for the preparation of Belinostat non-aqueous liquid dosage form using alcohols, glycol, diol, triol, polyoxyehtylene ether, polyethylene glycol ether and their derivatives. pH adjusting agents, suitable stabilizers and/or anti-oxidants.

BACKGROUND OF THE INVENTION
The following description includes information that may be useful in understanding the present invention. It is not an admission that any such information is prior art, or relevant, to the presently claimed inventions, or that any publication specifically or implicitly referenced is prior art.
Histones are part of the core proteins of nucleosomes. Acetylation and deacetylation of these proteins play a role in the regulation of gene expression. There are two classes of enzymes involved in determining the state of acetylation of histones, histone acetyl transferases (HATs) and histone deacetylases (HDACs). HDACs have been found to be important in the epigenetic regulation of cancer progression and inhibition of these molecules in preclinical studies induces cancer cell apoptosis and prevents tumor growth (Grunstein M. Nature, 1997, 389, 349-52, Lin et al. Nature, 1998,391,811-4).
Several structural classes of HDAC inhibitors have been identified including the following: 1) short-chain fatty acids, 2) hydroxamic acids 3) cyclic tetrapeptides 4) cyclic peptides and 5) benzamides. HDAC inhibitors invariably inhibit proliferation of transformed cells in culture, and a subset has been shown to inhibit tumor growth in animal models.
Belinostat is a novel histone deacetylase (HDAC) inhibitor that is being developed in various solid tumors and hematologic malignancies. Belinostat has been investigated as a single agent and in groups with further chemotherapies and biological agents, in the management of solid tumors and lymphoma.

Belinostat inhibits the activity of histone deacetylase (HDAC) thus prevents the removal of acetyl groups from the lysine residues of histones and some non-histone proteins. In vitro, Belinostat caused the accumulation of acetylated histones and other proteins increased the expression of tumor-suppressor genes. It ultimately induces cell cycle arrest, inhibition of angiogenesis and/or apoptosis of some transformed cells (Brahma N Singh et al., Future Oncol. 2011 Dec; 7(12): 1415-1428.).
Belinostat is under global development with Spectrum Pharmaceuticals, currently approved by the U.S. Food and Drug Administration with indications for relapsed or refractory peripheral T-cell lymphoma on July 2014.
Belinostat is a white to off-white powder. It is slightly soluble in distilled water (0.14 mg/mL), polyethylene glycol 400 (about 1.5 mg/mL), and freely soluble in ethanol (> 200 mg/mL). The pKa values are 7.87 and 8.71 by potentiometry and 7.86 and 8.59 by UV.
Most of potentially useful HDAC compounds including Belinostat endure various formulation challenges including low solubility in aqueous solutions, physical and/or chemical instability in aqueous solutions and upon later dilutions. Various studies have done with different researchers to improvise the aqueous solubility and stability of Belinostat with different amino acids (like arginine, lysine, Glycine/NaOH etc.), buffers (phosphate buffer etc.), excipients (like Meglumine, HP-beta-cyclodextrins etc.) and combination thereof as mentioned in US patent 8835501.
Belinostat was known to have limited long-term chemical stability in solutions at pH above 8.5. In order to obtain a product with overall stability, the present invention provides a Belinostat lyophilized powder preparation, non-aqueous liquid dosage form of Belinostat and a method for

producing the same. Specifically, the present invention is focused to improve the stability of the product after reconstitution of the Belinostat lyophilized powder is improved by an experimental study.
In particular, the inventors have screened through a number of tests and have finally obtained the following technical scheme for achieving the object of the present invention:

BRIEF SUMMARY OF THE INVENTION
In one general aspect there is provided a parenteral pharmaceutical dosage form comprising Belinostat or a pharmaceutically acceptable salt thereof.
In another general aspect, there is provided a lyophilized powder form and non-aqueous liquid dosage form of Belinostat or a pharmaceutically acceptable salt thereof.
In another general aspect, there is provided a stable, soluble ready to use non- aqueous pharmaceutical composition of Belinostat or a pharmaceutically acceptable salt thereof comprising pharmaceutically acceptable excipients.
In another general aspect, there is provided methods to improve the solubility profile of Belinostat or a pharmaceutically acceptable salt thereof.
In yet another general aspect there is provided methods to stabilize Belinostat after reconstitution with water for injection and further dilution.
Further, in this general aspect, the dosage form may include solubilizers for example alkali salts and amino acids excluding arginine and lysine.
In another general aspect the dosage form may include stabilizers for example Polyols, amino acids (excluding arginine and lysine), monosaccharides, oligo/poly saccharides, and cyclodextrins.
Further in this general aspect, the non-aqueous liquid dosage form comprise solvents & co-solvents, for example alcohol such as ethyl alcohol, isopropanol, n-butanol and a glycol such as

DETAILED DESCRIPTION OF THE INVENTION
The present invention provides improved pharmaceutical formulations of Belinostat indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
The present invention discloses novel formulations of Belinostat that increase its stability and maintain solubility for extended periods of time in solution.
Belinostat is slightly soluble in aqueous solutions such as normal saline and undergoes degradation once dissolved. The instability and limited solubility of Belinostat in aqueous solution creates serious inconvenience in both manufacturing and clinical use of Belinostat drug product.
The present invention provides innovative solutions to the above problems associated with Belinostat.
The pharmaceutical formulations as developed by the Inventors of the present invention are provided as Lyophilized Powder and concentrated non-aqueous liquid form that is stable and suitable for parenteral administration.
The term "pharmaceutically acceptable" refers to an ingredient that is useful in preparing a pharmaceutical composition that is generally safe, non-toxic, and neither biologically nor otherwise undesirable, and includes those acceptable for human pharmaceutical use.
The term "Stable and suitable pharmaceutical composition" is referred to any pharmaceutical composition having sufficient physical and chemical stability to have utility as a pharmaceutical

product. Preferably, a stable pharmaceutical composition has sufficient stability to allow storage at a convenient temperature for a reasonable period of time subsequent to reconstitution with a suitable diluting fluid. For purposes of the present invention stable pharmaceutical composition includes reference to pharmaceutical compositions with specific ranges of impurities as described herein.
Preferably, a stable pharmaceutical composition is one which has minimal degradation of the active ingredient, e.g., it retains at least about 80% of un-degraded active, preferably at least about 90%, and more preferably at least about 95%, after storage at 15-30°C for a defined period oftime.
Preferably, a stable pharmaceutical composition is one which has impurity B level (degradation product of the active ingredient), e.g., it retains at least about <1.0% of impurity B, preferably at least about <0.5% and more preferably at least about 0.2% after storage at 15-30°C for a defined period oftime.
Preferably, a stable pharmaceutical composition is one which has impurity E level (degradation product of the active ingredient), e.g., it retains at least about <1.0% of degraded active, preferably at least about <0.5% and more preferably at least about 0.2% after storage at 15.30°C for a defined period oftime.
While the pH of contemplated formulations may vary widely between 1 and 14, it is preferred that the pH is suitable for parenteral administration, and especially suitable for injection. Therefore, preferred pH values will be in the range of 8-11, preferably between 9 and 11. The non-aqueous solution of Belinostat or its pharmaceutical^ acceptable salt, according to the present invention have a pH, in the range of about 3.0 to 7.0. .

When the pH of the non-aqueous solution of the present invention was adjusted in the range of about 3.5 to 6.5, preferably about 4.0 to 6.0. and the solution exhibited satisfactory chemical and physical stability. In one specific embodiment, the pH of the solution was adjusted to about 5.0.
In present invention, concentrated non-aqueous solution form and/or lyophilized form of Belinostat formulations can be prepared in an entirely solubilized and stable form suitable for injection. Envisaged non-aqueous solutions can be prepared as concentrates that are diluted with suitable diluents prior to use, for example, within 48 hours of use.
In present invention, methods were provided that Belinostat solutions can be prepared in which Belinostat is not only soluble at pharmaceutically useful concentration, but also stable (i.e., remains physically/chemically unchanged) over substantial periods of time. Suitable Methods and solvents were described in the present invention.
Particularly, Present invention provides methods in which the solubility of Belinostat in an aqueous solution can be significantly increased over heretofore known formulations by preparing an aqueous single phase solvent system that includes Belinostat, alkali salts and water.
The Belinostat-containing compositions according to several preferred aspects of the invention include an amount of an alkali salts required for solubility. For purposes of the present invention, "Solubilizing amount" shall be understood to include those amounts which increase or enhance the solubility of the Belinostat in the compositions described herein. The presence of one or more alkali salts described herein thus contributes, at least in part to the long term stability of the composition.

Within this guideline, suitable alkali salts concentrations in the compositions can range from about 0.5 mg/mL to about 50.0 mg/mL. and preferably from about 5.0mg/mL to about 35.0 mg/mL or from about 5.0 mg/mL to about 20.0 mg/mL. In some other embodiments, the concentration of the alkali salts in the Belinostat-containing composition is about l5mg/mL.
Suitable alkali salts are included in which they are pharmaceutically acceptable for use in human formulations although not limited to those currently regarded as safe by any regulatory authority. For example, alkali salts include but not limited to Sodium hydroxide, Potassium hydroxide, Calcium hydroxide and Magnesium hydroxide. Preferably, the composition according to the invention comprises Sodium hydroxide.
The inventors unexpectedly found that the alkali salts including Sodium hydroxide, Potassium hydroxide, Calcium hydroxide and Magnesium hydroxide, nevertheless preferably sodium hydroxide provide a medium for solubilization of Belinostat, i.e., the sodium hydroxide solubilizes Belinostat in a quantity that is higher than the solubilization of Belinostat in other solubilizers.
Particularly, Present invention provides methods in which the stability of Belinostat in an aqueous solution can be significantly increased over heretofore known formulations by preparing an aqueous single phase solvent system that includes Belinostat and stabilizers wherein stabilizer is selected from the group of Polyols, amino acids (excluding arginine and lysine), monosaccharides, oligo/poly saccharides, and cyclodextrins.
Suitable Polyols include those which are pharmaceutically acceptable for use in human formulations although not limited to those currently regarded as safe by any regulatory authority. For example, Polyols include but not limited to Sorbitol, Mannitol, Maltitol, Lactitol, Xylitol,

Isomalt- and Erythritol. Preferably: the composition according to the invention comprises Mannitol. Suitable Polybls concentrations in the compositions can range from about 10.0 mg/mL to about 250.0mg/mL, and preferably from about lO.Omg/mL to about 200.0 mg/mL or from about lO.Omg/mL to about 150.0 mg/mL. In some other embodiments, the concentration of the polyols in the Belinostat-containing composition is from about 20 mg/mL to about 120.0 mg/mL
Examples of amino acids include but not limited to Alanine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine and valine excluding arginine and lysine. Suitable amino acids concentrations in the compositions can range from about 10.0 mg/mL to about 250.0mg/mL, and preferably from about 20.0mg/mL to about 200.0 mg/mL or from about 20.0 mg/mL to about 150.0 mg/mL. In some other embodiments, the concentration of the aminoacids BeMnostat containing composition is from about l25mg/mL
Examples of monosaccharides include but not limited to Glucose or dextrose, Fructose, Galactose, Mannose and Ribose and deoxyribose. Preferably, the composition according to the invention comprises Mannose. Suitable monosaccharides concentrations in the compositions can range from about 10.0 mg/mL to about 250.0mg/mL, and preferably from about lO.Omg/mL to about 200.0 mg/mL or from about lO.Omg/mL to about 200.0 mg/mL. In some other embodiments, the concentration of the Polyols in the Belinostat containing composition is from about 20mg/mL to about 150.0 mg/mL
Examples of oligo/polysaccharides include but not limited to Maltose and Sucrose. Suitable Polysaccharides concentrations in the compositions can range from about 10.0 mg/mL to about 250.0mg/mL, and preferably from about 10.0 mg/mL to about 200.0 mg/mL or from about 10.0

mg/mL to about 150.0 mg/mL. In some other embodiments; the concentration- of the polysaccharides in the Belinostat-containing composition is from about 20mg/mL to about 120.0 mg/mL.
An additional key aspect of the formulations including lyophilized form and non-aqueous form of the present invention is that they have low moisture content. For instance, the stable formulations of the present invention can have a moisture content that is less than, 5%, by weight or volume of the formulation.
Suitable formulations of the present invention for parenteral administration include cyclodextrin. One or more modified or unmodified cyclodextrins can be employed to stabilize and increase the water solubility of Beljnostat formulation of the present invention. Useful cyclodextrins for this purpose include beta-cyclodextrins preferably hydroxy propyl beta cyclodextrin. The term "beta-cyclodextrin" as used herein refers to cyclic alpha- 1,4-linked oligosaccharides of a D-glucopyranose containing a relatively hydrophobic central cavity and hydrophilic outer surface.
In another embodiment, hydroxy propyl beta cyclodextrin herein referred to as "HPpCD". Particular efficacy has been observed in the present invention utilizing hydroxypropyl-beta-cyclodextrin; however, other substituted and unsubstituted beta-cyclodextrins can also be used in the practice of the invention.
In yet another embodiment, the w/w ratios of HPpCD to the active can range from about 1:10 to about 2:10, particularly from about 0.5:5.0 to about 1.0:5.
The compositions of the present invention can be administered by any route, preferably in the form of a pharmaceutical composition adapted to such a route, as illustrated below and are

dependent on the condition being treated. The formulations can be, for example, administered parenterally particularly intravenously.
The solubilizers used in the non-aqueous liquid dosage form present invention include, but are not limited to, ethanol, isopropanoL n-butanol, glycol, diol, triol, poly oxyehtylene ether and a poly ethylene glycol ether and their derivatives and pH adjusting agents, suitable stabilizers and/or anti-oxidants.
The persons skilled in the art will understand that when the solvent system is described as non-aqueous, this merely indicates that water is not specifically added to the formulation. There can be some water present in the formulation due to its presence in some of the commercial components used, and water may also be absorbed from the environment into the formulation. Formulations containing these incidental amounts of water are included within the scope of the application.
The glycol is preferably selected from the group consisting of propylene glycol (PG), polyethylene glycol (PEG), polypropylene glycol (PPG), tetra glycol and suitable mixtures thereof. Suitable glycol concentrations in the compositions can range from about 10% V/V to about 100% V/V, and preferably from about 50%V/V to about 95%V/V or from about 80%V/V to about 95%V/V. In some other embodiments, the concentration of the glycol in the Belinostat-containing composition is from about 80%V/V to about 90%V/V.
The diol is preferably selected from the group consisting straight chain, branched, or cyclic aliphatic diol and suitable mixtures thereof. Suitable diol concentrations in the compositions can range from about 0.1%V/V to about 20%V/V, and preferably from about 0.1%V/V to about 15%V/V or from about 0.5%V/V to about 10%V/V. In some other embodiments, the

concentration of the diol in the Belinostat-containing composition is from about 1%V/V to about 10%V/V.
The trio! is preferably selected from the group consisting a straight chain, branched, or cyclic aliphatic triol and suitable mixtures thereof. Suitable triol concentrations in the compositions can range from about O.I%V/V to about 30%V/V, and preferably from about 0.1%V/V to about 20%V/V or from about 0.5%V/V to about 20%V/V. In some other embodiments, the concentration of the diol in the Belinostat-containing composition is from about 1%V/V to about 10%V/V.
The glycol is preferably selected from the group consisting of polyethylene glycols, propylene glycol, tetra glycol and mixtures thereof. Polyethylene glycol (e.g. PEG 300 and PEG 400) is an excipient which is widely used in pharmaceutical formulations. Preferably, the polyethylene glycol has a molecular weight in the range from 200 to 600. More preferably, the polyethylene glycol has a molecular weight of about 300-400 (PEG 300 or PEG 400). A person skilled in the art will know that a polyethylene glycol having a molecular weight above 600 is likely to be solid and cannot be used in non-aqueous systems.
Alternatively, the compositions of the present invention can be in powder form, or preferably lyophilized powder form, for reconstitution in the appropriate pharmaceutical^ acceptable carrier at the time of delivery.
Reconstitution of Lyophilized Belinostat Formulations
The lyophilized Belinostat formulations of the presently disclosed subject matter display rapid reconstitution times in a pharmaceutical^ acceptable diluent. In one embodiment, the

lyophilized Belinostat formulations are reconstituted in a pharmaceutically acceptable diluent in less than about I80seconds.
In one embodiment, the lyophilized Belinostat formulations are reconstituted in a pharmaceutically acceptable diluent in less than about 25seconds.
In one embodiment, the lyophilized Belinostat formulations are reconstituted in a pharmaceutically acceptable diluent in less than about 20 seconds.
In another embodiment, the lyophilized Belinostat formulations are reconstituted in a pharmaceutically acceptable diluent in less than about 15seconds.
In yet another embodiment, the lyophilized Belinostat formulations are reconstituted in a pharmaceutically acceptable diluent in less than about 10 seconds.
The lyophilized Belinostat formulations of the presently disclosed subject matter can be reconstituted by adding the pharmaceutically acceptable diluent(s) to the lyophilized Belinostat formulation to provide the desired concentration for direct administration or further dilution for administration by infusion.
Pharmaceutically acceptable diluents of the presently disclosed subject matter include, but are not limited to, sterile water for injection, 0.9% sodium chloride solution for injection, solution. In one embodiment, the lyophilized Belinostat formulations are reconstituted in 0.9% sterile sodium chloride solution for injection. In another embodiment, the lyophilized Belinostat formulations are reconstituted in sterile water for injection.
In some embodiments, the volume of the pharmaceutically acceptable diluent(s) added to the lyophilized Belinostat formulation is from about 5mL to about 50mL. In some embodiments, the volume of the pharmaceutically acceptable diluent(s) added to the lyophilized Belinostat formulation is from about 5 mL to about 50 mL.

In one embodiment, the volume of the pharmaceutical!)' acceptable diluent(s) added
to the lyophilized Belinostat formulation is about 10 mL.
The lyophilized Belinostat formulations of the presently disclosed subject matter can
be reconstituted by any suitable methods known to one of ordinary skill in the art.
Upon reconstitution in a pharmaceutically acceptable diluent, when provided in a
vial, the Belinostat formulations of the presently disclosed subject matter include Belinostat at a
concentration of from about lOmg/mL to about lOOmg/mL, e.g.. from about 20mg/mL to about
80mg/mL, or from about 40mg/mL to about 60mg/mL, or about 50mg/mL.
In another embodiment, the present invention provides a method for preparing a lyophilized form of Belinostat formulation. The lyophilized Belinostat formulation is stable and is ready to be diluted once and administered to a patient. The typical method comprises the steps of:
i). Dissolve sodium hydroxide in 80% water, and mixed to get clear solution
ii). Add and dissolve respective stabilizers/bulking agents to get clear solution
iii). Add and dissolve Belinostat slowly and observe for solubility to obtain clear solution and
check the pH.
iv). Make up the volume to 100% with water for injection.
v). Filter the bulk solution using 0.2 micron PVDF filter membrane.
vi). Fill lOmL of bulk solution into 30mL clear glass vial and partially stopper with 20 mm two
leg rubber stopper.
vii) Load partially stoppered vials into lyophilizer and run the lyophilization cycle with
predetermined parameters.

The following examples further illustrate the invention but should not be construed as in any way limiting its scope. In particular, the processing conditions are merely exemplary and can be readily varied by one of ordinary skill in the art.

Below table shows ihe formula composition for experimentation performed to achieve aqueous solubility of Belinostat with sodium hydroxide to desired concentration (50mg/mL), in other embodiments combination of sodium hydroxide with other suitable excipients are used to stabilize the lyophilized drug product.
Manufacturing procedure:
Batch quantity of sodium hydroxide is dissolved in 80% water, and mixed to get clear solution; to this respective stabilizers/bulking agents tike mannitol (F-2), Fructose (F-3), Histidine (F-4) and glutamine (F-5) are added and dissolved to get clear solution. After obtaining clear solution, drug substance is added slowly and observed for solubility and clarity of solutions.
parameters for the lyophilization cycle is tabulated below

At the end of lyophilization process, the vials were stoppered and sealed. The sealed vials were tested for description, drug content and impurities and tabulated in the below table 4.
Test Results:
The above results reveals that Belinostat dissolved using alkali alone (F-l) shown highest degradation compared to other formulations, however the formula composition (F-i) added with stabilizer, like mannitol, fructose, glutamine and histidine has shown improved stability. This is a clear evident that, combination of alkali salts and stabilizer like polyol or monosaccharides and amino acids support the Belinostat product stability.

Among all. F-2 and F-3 formulations (IVIannitol and Fructose) have shown promising results in
terms of impurities, pH. and other quality parameters, hence F-2 and F-3 formulations are taken
for further evaluation.
From the above experimentation, the inventors of the present invention can able to achieve
desired aqueous solubility of Belinostat only with use of sodium hydroxide, and it-is observed
that, the drug product stability is significantly improved when formulated in combination with
mannitol or Fructose or HP-beta-cyclodextrin.
In the present invention inventors have surprisingly found that formulation with sodium
hydroxide, mannitol or cyclodextrin increases the stability of the end product as level of impurity
B and Impurity E over a period of time.
Batch quantity of sodium hydroxide is dissolved in 80% water, and mixed to get clear solution; to this respective stabilizers/ bulking agents like Fructose (012), mannitol (013), and HP-beta-cyclodextrins (015) are added and dissolved to get clear solution. After obtaining clear solution, drug substance is added slowly and observed for solubility and clarity of solutions.

From the above studies, we could able to achieve desired aqueous solubility of Belinostal with use of sodium hydroxide alone, and it is observed that, the drug product stability is significantly improved when formulated in combination with mannitol or Fructose or HP-beta-cycIodextrins when compared with sodium hydroxide alone formulation, among these three formulations batch number 12, i.e. fructose formulation has more impurity that that of mannitol and HP-beta cyclodextrins formulations.
Owing to the enhanced stability, the inventive formulations may be stored for a long time before being administered to the patient.
Studies/ experimentation extended to develop a stable, scalable non-aqueous formulation alternate to lyophilized formulation, where there are multiple advantages with ready to dilute solutions over lyophilized formulations; like ready to dilute no reconstitution required, time saving, cost reduction, etc.
Below table represents formula composition for development of non-aqueous formulations for Belinostat.

Batch quantity of polyethylene glycol 400 has taken in a glass beaker, to this batch quantity of propylene glycol and ethanol is added and dissolved to get uniform solutions, to this batch quantity of l-thio glycerol is added only for 016A batch and mixed to get uniform solution, then batch quantity of drug substance is added slowly to above solution under mixing to get clear solutions, after some time we observed complete solubility and hence they were tested for assay & related substances to check the compatibility and solutions stability in non-aqueous liquid formulations, and the results are tabulated below.
From above test results the impurities in the batch manufactured without antioxidant 1-thioglycerol) has more compared to the batch manufactured with antioxidant (1-thioglycerol) and the results are promising, hence further development will focus to improve the drug product stability in non-aqueous formulations.
Where the new non-aqueous formulation for Belinostat will avoid multiple processing like Lyophilization, re-constitution and cost reduction in processing when compared to available marketed lyophilized formulation (Beleodaq).

1. A stable and soluble pharmaceutical composition of Belinostat or a pharmaceutically
acceptable salt thereof comprising a solubilizer, which is an alkali salt.
2. The pharmaceutical composition of claim 1. wherein the composition further contains a
stabilizer.
3. The pharmaceutical composition of claim I, wherein alkali salts are selected from
Sodium hydroxide, Potassium hydroxide, Calcium hydroxide and Magnesium hydroxide.
4. The pharmaceutical composition of claim 2, wherein stabilizers are selected from
Polyols, amino acids (excluding Arginine and Lysine), monosaccharides, oligo/poly saccharides, and cyclodextrins.
5. The pharmaceutical composition of claim 2, wherein polyols are selected from the group
consisting of Sorbitol, Mannitol, Maltitol, Lactitol, Xylitol, Isomaltand Erythritol.
6. The pharmaceutical composition of claim 2, wherein amino acids are selected from the
group consisting of Alanine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine and valine.
7. The pharmaceutical composition of claim 2, wherein monosaccharides are selected from
the group consisting of Glucose or dextrose, Fructose, Galactose, Mannose and Ribose and deoxyribose.
8. The pharmaceutical composition of claim 2, wherein oligo/polysaccharides are selected
from the group consisting of Maltose and Sucrose.

9. A stable pharmaceutical composition comprising Belinostal and process of its preparation
as herein described with reference to the examples accompanying the specification.
10. A stable and soluble pharmaceutical composition of Belinostat or a pharmaceutically acceptable salt thereof comprising sodium hydroxide, Mannitol, Fructose and glutamine.
11. A stable and soluble pharmaceutical composition of Belinostat or a pharmaceutically acceptable salt thereof comprising amino acids excluding of Arginine and Lysine.
12. The stable lyophilized pharmaceutical composition according to claim 1, wherein after reconstitution, the pH of the stable lyophilized pharmaceutical composition is between 9.0 andl 1.0
13. A stable, non-aqueous liquid pharmaceutical composition, comprising Belinostat or a pharmaceutically acceptable salt thereof, and at least one solvent as solubilizerand stabilizer.
14. The stable, non-aqueous liquid pharmaceutical composition of claim 13, wherein the composition is a ready to dilute formulation.
15. The stable, non-aqueous liquid pharmaceutical composition of claim 13, wherein the solubilizer is selected from the group comprising of alcohols, glycols, diols and triol. Alcohols selected from ethanol, isopropanol, n-butanol.
16. The stable, non-aqueous liquid pharmaceutical composition of claim 13, wherein the composition further comprises pH adjusting agents, stabilizers and/or anti-oxidants.
17. The non-aqueous liquid pharmaceutical composition of claim 13, wherein the glycol selected from the propylene glycol (PG), polyethylene glycol (PEG), polypropylene glycol (PPG), polyethylene glycol ether and their derivatives.

18. The non-aqueous liquid pharmaceutical composition of claim 13. wherein thediol selected from straight chain, branched, or cyclic aliphatic diol.
19. The non-aqueous liquid pharmaceutical composition of claim 13, wherein the triol selected from straight chain, branched, or cyclic aliphatic triol.