This patent application claims priority to these Indian patent applications numbered 3815/CHE/2012 filed on Sept 13, 201%and 1969/CHE/2013 filed on May 02, 2013.

FIELD OF THE INVENTION:

The present invention relates process for the preparation of pure amorphous Form of Vilazodone Hydrochloride, 5-[4-[4-(5-cyano-lH-indol-3-yl)butyl]-l -piperazinyl]-2-benzofurancarboxamide HC1.

BACKGROUND OF THE INVENTION:

Vilazodone Hydrochloride, 5-[4-[4-(5-cyano-1 H-indol-3-yl)butyl]-1 -piperazinyl]-2-benzofurancarboxamide hydrochloride, having the Formula-I is approved, under the trade name VIIBRYD®, by the United States Food and Drug Administration. VIIBRYD® is indicated for the treatment of major depressive disorder.

Formula-I

Vilazodone hydrochloride was first disclosed in US 5532241 and this patent does not disclose any polymorphic form of Vilazodone hydrochloride. The melting point of Vilazodone hydrochloride disclosed in this patent is in the range of 269-272° C.

US 7834020 discloses pure crystals of Vilazodone hydrochloride forms like I, II, III, IV, V, VI, VII, VIII, IX, X, XI, XIII, XIV, XV, XVI and amorphous form. WO 2012131706 discloses amorphous form of Vilazodone hydrochloride.

The present invention provides process for the preparation of amorphous form of Vilazodone hydrochloride and solid dispersion of Vilazodone hydrochloride.

OBJECT AND SUMMARY OF THE INVENTION:

Principle object of the present invention is to provide process for the preparation of amorphous form of Vilazodone Hydrochloride, 5-[4-[4-(5-cyano-lH-indol-3-yl)butyl]-l-piperazinyl]-2-benzofurancarboxamide hydrochloride.

One aspect of the present invention is to provide a process for the preparation of pure amorphous form of Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in an organic solvent,

b) spray drying, and

c) isolating pure amorphous Vilazodone hydrochloride.

One more aspect of the present invention provides, process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of alcoholic solvent, water miscible organic solvent and water,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

One more aspect of the present invention is to provide a process for the preparation of Vilazodone hydrochloride solid dispersion, comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of water and water miscible organic solvent,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

One more aspect of the present invention provides, process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of ethereal solvent, water miscible organic solvent and water,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

One more aspect of the present invention provides, process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone free base in a mixture of water and water miscible organic solvent,

b) adding hydrochloric acid solution,

c) removing the solvent by spray drying, and

d) isolating amorphous Vilazodone hydrochloride.

Another aspect of the present invention provides, process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of water and solvent wherein solvent is selected from formic acid and acetic acid,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

One more object of the present invention is to provide Vilazodone hydrochloride in the form of a solid dispersion.

Yet another object of the present invention is to provide process for the preparation of Vilazodone hydrochloride solid dispersion.

BRIEF DESCRIPTION OF THE DRAWINGS:

Further objects of the present invention together with additional features contributing thereto and advantages accruing there from will be apparent from the following description of preferred embodiments of the invention which are shown in the accompanying drawing figures wherein :

Figure 1: illustrates the powder X-ray diffraction pattern of pure amorphous Vilazodone hydrochloride.

DETAILED DESCRIPTION OF THE INVENTION:

The present invention relates to pure amorphous form of Vilazodone Hydrochloride, 5-[4-[4-(5-cyano-1 H-indol-3-yl)butyl]-1 -piperazinyl]-2-benzofurancarboxamide HC1.

Instrumentation:

Powder X-ray Diffraction (VXRD)

The said polymorph of the present invention is characterized by their X-ray powder diffraction pattern. Thus, the X-ray diffraction patterns of said polymorphs of the invention were measured on BRUKER DSDiscover powder diffractometer equipped with goniometer of 0/20 configuration and Lynx Eye detector. The Cu-anode X-ray tube was operated at 40kV and 30mA. The experiments were conducted over the 20 range of 2.0°-50.0°, 0.030° step size and 0.4 seconds step time.

The main aspect of the present invention is to provide pure amorphous form of Vilazodone hydrochloride.

The pure amorphous form of Vilazodone hydrochloride is further characterized by the Powder X-ray diffraction as depicted in Figure 1.

Another aspect of the present invention is to provide a process for the preparation of pure amorphous form of Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in an organic solvent,

b) spray drying, and

c) isolating pure amorphous Vilazodone hydrochloride.

In one embodiment of the present invention, organic solvent is alcoholic solvent and selected from methanol, ethanol and isopropanol, preferably methanol.

In one more embodiment of the present invention, Vilazodone hydrochloride used in the present invention is selected from the group consisting of but not limited to crystalline or any solvate.

One more aspect of the present invention provides, process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of alcoholic solvent, water miscible organic solvent and water,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

In one embodiment of the present invention, alcoholic solvent is selected from methanol, ethanol and isopropanol, preferably methanol.

In another embodiment of the present invention, water miscible organic solvent is polar solvent such as acetonitrile, acetone, preferably acetonitrile.

One more aspect of the present invention provides, process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of ethereal solvent, water miscible organic solvent and water,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

In one embodiment of the present invention, ethereal solvent is such as tetrahydrofuran.

In another embodiment of the present invention, water miscible organic solvent is polar solvent such as acetonitrile, acetone, preferably acetonitrile.

One more aspect of the present invention is to provide a process for the preparation of Vilazodone hydrochloride solid dispersion, comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of water and water miscible organic solvent,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

In one embodiment of the present invention, water miscible organic solvent is polar solvent such as acetonitrile, acetone, tetrahydrofuran, methanol, ethanol, isopropanol, acetic acid, formic acid, preferably acetonitrile and methanol.

In another embodiment of the present invention, Vilazodone hydrochloride used in this invention is anhydrous crystalline Vilazodone hydrochloride, hydrate crystalline Vilazodone hydrochloride or crystalline Vilazodone hydrochloride hemihydrate, preferably crystalline Vilazodone hydrochloride hemihydrate.

As per the present invention, Vilazodone hydrochloride anhydrous, hydrate or hemihydrate, preferably hemihydrate is dissolved in mixture of water and water miscible organic solvent like polar solvent such as acetonitrile, acetone, tetrahydrofuran, methanol, ethanol, isopropanol, acetic acid, formic acid, preferably acetonitrile at 30-55°C, preferably at 40-45°C. The resulting solution is filtered through hyflow and the filtrate is cooled and evaporated in a spray drier. The isolated product is dried to get amorphous Vilazodone hydrochloride.

One more aspect of the present invention provides, process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone free base in a mixture of water and water miscible organic solvent,

b) adding the hydrochloric acid solution,

c) removing the solvent by spray drying, and

d) isolating amorphous Vilazodone hydrochloride.

In one embodiment of the present invention, water miscible organic solvent is acetonitrile, acetone, tetrahydrofuran, methanol, ethanol, isopropyl alcohol, acetic acid and formic acid, preferably acetonitrile.
Another aspect of the present invention provides, process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of water and solvent wherein solvent is selected from formic acid and acetic acid,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

Vilazodone hydrochloride or Vilazodone free base used in this invention is prepared by the procedures disclosed in prior art, for example as disclosed in US 5532241 and US 7834020.

One more aspect of the present invention is to provide Vilazodone hydrochloride in the form of a solid dispersion. The solid dispersion of the Vilazodone hydrochloride consists of Vilazodone hydrochloride and Pharmaceutical excipients. The term "dispersion" as used herein refers generally to solid dispersion, unless specified otherwise. It may be used interchangeably and synonymously for "pre-mix" or "admixture" to name a few. It consists of at least two different components, generally a hydrophilic matrix comprising a dispersing agent(s) and a hydrophobic drug. The matrix can be either crystalline or amorphous. The drug can be dispersed molecularly, in amorphous particles or in crystalline particles.

In one embodiment of the present invention, Pharmaceutical excipients can be polysaccharides, such as hydroxypropyl methyl cellulose (HPMC), carboxymethyl cellulose (CMC, especially sodium and calcium salts), methyl cellulose, hydroxyethyl cellulose, ethyl hydroxyethyl cellulose, hydroxypropyl cellulose (HPC); microcrystalline cellulose, polyvinyl pyrrolidone, copovidone, polyvinyl acetate (PVAC), polyvinyl alcohol (PVA), polymers of acrylic acid and their salts, polyacrylamide, polymethacrylates, vinyl pyrrolidone-vinyl acetate copolymers (such as Kollidon® VA64, BASF and Plasdone S-630), polyalkylene glycols, such as polypropylene glycol or preferably polyethylene glycol, co-block polymers of polyethylene glycol, especially co-block polymers of polyethylene glycol and polypropylene glycol (Pluronic®, BASF), polyethylene oxide and mixtures of the polymers mentioned. Preferable substances used as excipients are polyvinyl pyrrolidone, and Plasdone S-630.

One more aspect of the present invention is to provide a process for the preparation of Vilazodone hydrochloride solid dispersion, comprising the steps of:

a) dissolving Vilazodone hydrochloride in an organic solvent,

b) contacting the solution with Pharmaceutical excipients,

c) spray drying, and

d) isolating Vilazodone hydrochloride solid dispersion.

In one embodiment of the present invention, organic solvent is alcoholic solvent and selected from methanol, ethanol and isopropanol, preferably methanol.

One more aspect of the present invention is to provide a process for the preparation of Vilazodone hydrochloride solid dispersion, comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of water and water miscible organic solvent,

b) contacting the solution with pharmaceutical excipients,

c) removing the solvent by spray drying, and

d) isolating Vilazodone hydrochloride solid dispersion.

In one embodiment of the present invention, water miscible organic solvent is polar solvent such as acetonitrile, acetone, tetrahydrofuran, methanol, ethanol, isopropanol, acetic acid, formic acid, preferably acetonitrile and methanol.

One more aspect of the present invention is to provide a process for the preparation of Vilazodone hydrochloride solid dispersion, comprising the steps of:

a) dissolving Vilazodone free base in mixture of water and water miscible organic solvent,

b) adding the hydrochloric acid solution,

c) contacting the solution with pharmaceutical excipients,

d) removing the solvent by spray drying, and

e) isolating Vilazodone hydrochloride solid dispersion.

In one embodiment of the present invention, water miscible organic solvent is polar solvent such as acetonitrile, acetone, tetrahydrofuran, methanol, ethanol, isopropanol, acetic acid, formic acid, preferably acetonitrile and methanol.

In one embodiment of the present invention, Vilazodone hydrochloride used in the present invention is selected from the group consisting of but not limited to crystalline or any solvate.

Vilazodone hydrochloride and Vilazodone free base used in this invention is prepared by the procedures disclosed in prior art, for example as disclosed in US 5532241 and our co pending Indian patent application IN 3660/CHE/2012.

Physical stability of amorphous form

The physical stability of amorphous form of Vilazodone hydrochloride was determined by subjecting approximately l.Og of the sample to different stress conditions such as storing a) at 60°C under vacuum, b) at 80°C under vacuum c) at 70% and d) 90% relative humidity. The samples were tested by PXRD analysis. The results are shown in Table 1.

Table 1

No change was observed upon drying upto 80°C and exposure to 70 % relative humidity for 15h and becomes deliquescent upon exposure to 90% relative humidity.

Indicative stability of Vilazodone hydrochloride amorphous form

The physical and chemical stability of amorphous Vilazodone hydrochloride was determined by storing approximately l.Og of the sample under different stress conditions at 5±3°C, 25°C/60% and 40°C/75% relative humidity up to 3 months. The samples were tested for physical stability by PXRD, water content by Karl-Fischer titrator and HPLC for final purity and degradation. The results are given in the following Table 3.

Table 3

The native amorphous form was found to be physically and chemically stable upto 3 months in 5±3°C and 25°C/60% relative humidity conditions. The PXRD pattern remains same as initial with moisture content in the range of 4-8 % w/w and there is no degradation observed in HPLC analysis. However, amorphous form upon storage under accelerated conditions (40°C/75% relative humidity) was found to be physically unstable converts to crystalline form IV with no chemical degradation.

Indicative stability of Vilazodone hydrochloride premix amorphous form

The physical stability of premix amorphous vilazodone hydrochloride was determined by storing approximately 1.0g of the sample under long term (25°C/60% relative humidity) and accelerated (40°C/75% relative humidity) conditions up to 3 months. The samples were tested by PXRD and results are given in the following Table 4.

Table 4

The PXRD pattern remains same as initial after 3months. The premix amorphous form was found to be physically stable up to 3 months in both accelerated and long term conditions.

Vilazodone prepared according to the invention may be used in the preparation of suitable dosage form such as granules, pellets, tablets, mini-tablets, chewable tablets, orally disintegrating tablets, capsules, suspensions, solutions or emulsions. Other dosage forms included within the scope of the invention, but not restricted to extended or modified release tablets or capsules etc.

The following examples/compositions are provided to illustrate the process of the present invention. They, are however, not intended to limiting the scope of the present invention in any way and several variants of these examples would be evident to person ordinarily skilled in the art.

Experimental procedure:

Example 1:

Process for the preparation of pure amorphous Vilazodone hydrochloride.

Vilazodone hydrochloride (5 g) was suspended in methanol (1000 ml) at 25-30°C and heated to 60-65°C. The suspension was stirred for 0.5h to get clear solution. The clear solution was filtered through hyflo to remove any undissolved particulate and subjected to spray drying in a Mini Spray Dryer (Model Buchi-290) to yield pure amorphous Vilazodone hydrochloride. Example 2:

Process for the preparation of pure amorphous Vilazodone hydrochloride. Vilazodone hydrochloride (2 g) was suspended in methanol (400 ml) at 25-30°C and heated to 60-65°C The suspension was stirred for 0.5h to get clear solution. The clear solution was filtered through hyflo to remove any undissolved particulate and distilled under reduced pressure to 100 ml at 60°C. The solution was then subjected to spray drying in a Mini Spray Dryer (Model Buchi-290) to yield pure amorphous Vilazodone hydrochloride. Example 3:

Process for the preparation of Vilazodone hydrochloride solid dispersion. Vilazodone hydrochloride (1 g) was suspended in methanol (200 ml) at 25-30°C and heated to 60-65°C. The suspension was stirred for 0.5h to get clear solution. To the above solution, Plasdone S-630 (3g) was added and stirred for 0.5h. The clear solution was filtered through hyflo to remove any undissolved particulate and subjected to spray drying in a Mini Spray Dryer (Model Buchi-290) to obtain amorphous Vilazodone hydrochloride solid dispersion. Example 4:

Process for the preparation of Vilazodone hydrochloride solid dispersion. Vilazodone hydrochloride (1 g) was suspended in methanol (200 ml) at 25-30°C and heated to 60-65°C. The suspension was stirred for 0.5h to get clear solution. To the above solution, polyvinyl pyrrolidone PVP-K30 (3g) was added and stirred for 0.5h. The clear solution was filtered through hyflo to remove any undissolved particulate and subjected to spray drying in a Mini Spray Dryer (Model Buchi-290) to obtain amorphous Vilazodone hydrochloride solid dispersion.

Example 5:

Process for the preparation of amorphous Vilazodone hydrochloride.

Vilazodone hydrochloride (5 g) was dissolved in a mixture of methanol, acetonitrile and water (5:1:1) (350 ml) at 50-60°C. The resulting solution was cooled to 40-45 °C and evaporated in a spray drier. The isolated product was dried to get 3.0 g of amorphous Vilazodone hydrochloride. (Purity by HPLC 99.8 %)

Example 6:

Process for the preparation of amorphous Vilazodone hydrochloride.

Vilazodone hydrochloride (25 g) was dissolved in a mixture of tetrahydrofuran, acetonitrile and water (1:1:1) (1500 ml) at 40-45 °C. The resulting solution was cooled to 25-30°C and evaporated in a spray drier. The isolated product was dried to get 17.0 g of amorphous Vilazodone hydrochloride. (Purity by HPLC 99.8 %)

Example 7:

Process for the preparation of amorphous Vilazodone hydrochloride.

Vilazodone hydrochloride (5 g) was dissolved in a mixture of tetrahydrofuran, acetonitrile and water (1:3:2 (300 ml) at 40-45°C. The resulting solution was cooled to 25-30°C and evaporated in a spray drier. The isolated product was dried to get 3.0 g of amorphous Vilazodone hydrochloride. (Purity by HPLC 99.8 %)

Example 8:

Process for the preparation of amorphous Vilazodone hydrochloride.

Vilazodone hydrochloride (5 g) was dissolved in a mixture of formic acid and water (5:2) (35 ml) at 25-30°C. The resulting solution was cooled to 25-30°C and evaporated in a spray drier. The isolated product was dried to get 3.0 g of amorphous Vilazodone hydrochloride. (Purity by HPLC 99.8 %)
Example 9:

Process for the preparation of amorphous Vilazodone hydrochloride.

Vilazodone hydrochloride (5 g) was dissolved in a mixture of acetonitrile and water (1:1) (300 ml) at 40-45°C. The resulting solution was cooled to 25-30°C and evaporated in a spray drier. The isolated product was dried to get 3.0 g of amorphous Vilazodone hydrochloride. (Purity by HPLC 99.8 %)

Example 10:

Process for the preparation of amorphous Vilazodone hydrochloride.

Vilazodone hydrochloride (6 g) was dissolved in a mixture of acetonitrile and water (1:1) (360 ml) at 40-45°C. The resulting solution was filtered through hyflow and the filtrate was cooled to 25-30°C and evaporated in a spray drier at 100°C. The isolated product was dried to get 3.8 g of amorphous Vilazodone hydrochloride.

Example 11:

Process for the preparation of amorphous Vilazodone hydrochloride.

Vilazodone hydrochloride (5 g) was dissolved in methanol (1000 ml) at 55-60°C. The resulting solution was cooled to 25-30°C and evaporated in a spray drier. The isolated product was dried to get 3.0 g of amorphous Vilazodone hydrochloride. (Purity by HPLC 99.8 %)

Example 12:

Process for the preparation of Vilazodone hydrochloride solid dispersion.

Vilazodone hydrochloride (6 g) along with Plasdone S-630 (6 g) was dissolved in a mixture of acetonitrile and water (1:1) (360 ml) at 40-45°C. The resulting solution was filtered through hyflow and cooled to 25-30 °C and evaporated in a spray drier. The isolated product was dried to get 5.2 g of amorphous Vilazodone hydrochloride solid dispersion.

Example 13:

Process for the preparation of Vilazodone hydrochloride solid dispersion.

Vilazodone hydrochloride (5 g) along with Plasdone-S-630 (5 g) was dissolved in a mixture of methanol and water (6:1) (350 ml) at 55-60 °C. The resulting solution was filtered through hyflow and the filtrate was cooled to 40-45 °C and evaporated in a spray drier. The isolated product was dried to get 6.2 g of amorphous Vilazodone hydrochloride solid dispersion. (Purity by HPLC 99.58 %)

Example 14:

Process for the preparation of Vilazodone hydrochloride solid dispersion.

Vilazodone hydrochloride (5 g) along with Plasdone S-630 (5 g) was dissolved in a mixture of Acetonitrile and water (1:1) (360 ml) at 40-45 °C. The resulting solution was filtered through hyflow and the filtrate was cooled to 25-30 °C and evaporated in a spray drier at 100 °C. The isolated product was dried to get 7.3 g of amorphous Vilazodone hydrochloride solid dispersion.

Example 15:

Process for the preparation of amorphous Vilazodone hydrochloride.

Vilazodone free base (5 g) was suspended in a mixture of acetonitrile (150 ml) and water (150 ml) at 40-45°C. hydrochloric acid (35%) (1.29 ml) was added to the suspension at 40-50°C to get a clear solution. The resulting solution was stirred for 30 min at 40-50°C and cooled to 25-30°C and evaporated in a spray drier. The isolated product was dried to get 2.7 g of amorphous Vilazodone hydrochloride.

Example 16:

Process for the preparation of amorphous Vilazodone hydrochloride solid dispersion.

Vilazodone free base (5 g) was suspended in a mixture of acetonitrile (150 ml) and water (150 ml) at 40-45°C. Hydrochloric acid (35%) (1.29 ml) was added to the reaction mixture at 40-50°C to get a clear solution. The resulting solution was stirred for 30 min at 40-50°C and Plasdone S-630 (5 g) was added. The solution cooled to 25-30°C and evaporated in a spray drier. The isolated product was dried to get 6 g of amorphous Vilazodone hydrochloride solid dispersion.

Example 17:

Process for the preparation of amorphous Vilazodone hydrochloride solid dispersion.

Vilazodone free base (30 g) was suspended in a mixture of acetonitrile (900 ml) and water (900 ml) at 40-45°C. Hydrochloric acid (35%) (7.6 ml) was added to the reaction mixture at 40-50°C to get a clear solution. The resulting solution was stirred for 30 min at 40-50°C and Plasdone S-630 (90 g) was added. The solution cooled to 25-30°C and evaporated in a spray drier. The isolated product was dried to get 80 g of amorphous Vilazodone hydrochloride solid dispersion.

Example 18:

Process for the preparation of Vilazodone hydrochloride solid dispersion.

Vilazodone hydrochloride (5 g) along with Plasdone S-630 (15 g) was dissolved in a mixture of Acetonitrile and water (1:1) (305 ml) at 45-50 °C. The resulting solution was filtered through hyflow and the filtrate was cooled to 25-30 °C and evaporated in a spray drier at 90 °C. The isolated product was dried to get 13 g of amorphous Vilazodone hydrochloride solid dispersion.

Example 19:

Unit Composition:

*Premix comprises vilazodoneHCl and copovidone (1:3 w/w) Brief Manufacturing Process:

1) Sift Vilazodone HC1 Premix and microcrystalline cellulose together through suitable sieveand blend;

2) Compact the blend step 1) in a roll compactor;

3) Mill the compacted material as obtained in step 2) through suitable sieve;

4) Sift microcrystalline cellulose, colloidal silicon dioxide and croscarmellose sodium, sodium chloride and sodium stearylfumarate through suitable seive;

5) Mix the ingredients of step no 4 in a blender;

6) Compress the blend of step 5) into tablets by using suitable toolings;

7) Coat the tablets of step 6) with Opadry™.

Example 20:

Unit Composition:

Non aqueous solvent system DCM: IPA (60:40 w/w) Brief Manufacturing Process:

1) Sift VilazodoneHCl, macrocrystalline cellulose, lactose together through suitable sieve and blend;

2) Sift Sodium stearylfumarate through suitable sieve and blend with step no 1 ingredients;

3) Compress the blend of step 1) into tablets using suitable toolings;

Coat the tablets of step 3) with Opadry™.

We claim:

1. A process for the preparation of amorphous form of Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of water and water miscible organic solvent,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride;

wherein Vilazodone hydrochloride is crystalline Vilazodone hydrochloride hemihydrate.

2. A process for the preparation of Vilazodone hydrochloride solid dispersion, comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of water and water miscible organic solvent,

b) contacting the solution with pharmaceutical excipients,

c) removing the solvent by spray drying, and

d) isolating Vilazodone hydrochloride solid dispersion.

3. The process according to claim 2, wherein water miscible organic solvent is selected from acetonitrile, acetone, tetrahydrofuran, methanol, ethanol, isopropyl alcohol, acetic acid and formic acid.

4. A process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of alcoholic solvent, water miscible organic solvent and water,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

5. The process according to claim 4, wherein alcoholic solvent is selected from methanol, ethanol and isopropanol

6. The process according to claim 4, wherein water miscible organic solvent is polar solvent such as acetonitrile and acetone.

7. A process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of ethereal solvent, water miscible organic solvent and water,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

8. The process according to claim 7, wherein, ethereal solvent is tetrahydrofuran.

9. The process according to claim 7, wherein water miscible organic solvent is polar solvent such as acetonitrile and acetone.

10. A process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone free base in a mixture of water and water miscible organic solvent,

b) adding the hydrochloric acid solution,

c) removing the solvent by spray drying, and

d) isolating amorphous Vilazodone hydrochloride.

11. The process according to claim 10, wherein water miscible organic solvent is acetonitrile, acetone, tetrahydrofuran, methanol, ethanol, isopropyl alcohol, acetic acid and formic acid.

12. A process for the preparation of amorphous Vilazodone hydrochloride comprising the steps of:

a) dissolving Vilazodone hydrochloride in mixture of water and solvent wherein solvent is selected from formic acid and acetic acid,

b) removing the solvent by spray drying, and

c) isolating amorphous Vilazodone hydrochloride.

13. A process for the preparation of Vilazodone hydrochloride solid dispersion, comprising the steps of:

a) dissolving Vilazodone free base in mixture of water and water miscible organic solvent,

b) adding the hydrochloric acid solution,

c) contacting the solution with pharmaceutical excipients,

d) removing the solvent by spray drying, and

e) isolating Vilazodone hydrochloride solid dispersion.