A process for the preparation of solid dispersion 2-{4- [(3S)-piperidin-3-YL] phenyl}-2h- indazole 7-carboxamide 4- methylbenzenesulfonate and its preparation there of

Abstract

The present invention relates to a process for the preparation of solid dispersion of 2-{4-[(3S)-Piperidin-3-yl] phenyl}-2h- indazole 7-carboxamide 4-methyl benzenesulfonate (1) with at least one pharmaceutically acceptable excipient.

Description

[0001] “A PROCESS FOR THE PREPARATION OF SOLID DISPERSION 2-{4- [(3S)-PIPERIDIN-3-YL] PHENYL}-2H- INDAZOLE 7-CARBOXAMIDE 4- METHYLBENZENESULFONATE AND ITS PREPARATION THERE OF”

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to a process for the preparation of solid dispersion of 2-{4-[(3S)-piperidin-3-yl] phenyl }-2H-indazole 7-carboxamide 4- m ethylbenzenesulfonate (1) with at least one pharmaceutically acceptable excipient.

[0004] BACKGROUND OF THE INVENTION

[0005] Niraparib tosylate monohydrate, Niraparib tosylate monohydrate is an orally available poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRC Amut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinumbased chemotherapy. It is chemically designated as (2-{4-[(3 S)-piperidin-3-yl] phenyl }-2H- indazole 7-carboxamide 4-methylbenzenesulfonate hydrate and is chemically represented by the following structural Formula (1).

[0006] Niraparib tosylate monohydrate (1)

[0007] US 8071623 B2 discloses Niraparib and its salts for the first time which discloses a process for the preparation of Niraparib salts. There is no information about the polymorphism of Niraparib.

[0008] US11091459B2 discloses Niraparib tosylate polymorphic forms, crystalline form I, form II (non-stoichiometric hydrate) and form III (anhydrous). There is no information about the polymorphism of Niraparib (1).

[0009] US20210347758A1 discloses Niraparib (1) polymorphic forms Form I, Form II, Form III, Form IV, Form V, and amorphous form.

[0010] Polymorphism is the occurrence of different crystalline forms of a single compound, and it is a property of some compounds and complexes. Thus, polymorphs are distinct solids sharing the same molecular formula, yet each polymorph may have distinct physical properties. Therefore, a single compound may give rise to a variety of polymorphic forms where each form has different and distinct physical properties, such as different solubility profiles, different melting point temperatures and / or different X-ray diffraction peaks. Since the solubility of each polymorph may vary, identifying the existence of pharmaceutical polymorphs is essential for providing pharmaceuticals with predicable solubility profiles. It is desirable to investigate all solid-state forms of a drug, including all polymorphic forms, and to determine the stability, dissolution and flow properties of each polymorphic form.

[0011] Polymorphic forms of a compound can be distinguished in a laboratory by X-ray diffraction spectroscopy and by other methods such as, infrared spectrometry. Additionally, polymorphic forms of the same drug substance or active Pharmaceutical ingredient can be administered by itself or formulated as a drug product (also known as the final or finished dosage form), and are well known in the pharmaceutical art to affect, for example, the solubility, stability, flowability, tractability and compressibility of drug substances.

[0012] SUMMARY OF THE INVENTION

[0013] In one aspect, the present application provides a process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of: a) dissolving Niraparib tosylate (1) in a solvent or mixture of solvents, b) adding at least one pharmaceutically acceptable excipient to the solution obtained in step-a), and c) isolating the solid dispersion of Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient.

[0014] In another aspect, the present application provides a process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of:

[0015] A) dissolving Niraparib tosylate (1) in a solvent or mixture of solvents,

[0016] B) adding at least one pharmaceutically acceptable excipient in a solvent to the mixture obtained in step A), and

[0017] C) isolating the solid dispersion of Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient.

[0018] In another aspect, the present invention provides an alternative process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of

[0019] I) dissolving Niraparib free base (2) in a solvent or mixture of solvents,

[0020] II) adding a solution of p-toluene sulfonic acid to the solution obtained in step I),

[0021] III) adding at least one pharmaceutically acceptable excipient to the mixture obtained to step-II), and

[0022] IV) optionally, adding second solvent to the reaction mixture obtained in step III), and

[0023] V) isolating the solid dispersion of Niraparib tosylate (1).

[0024] In another aspect, the present invention provides a process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of: i) dissolving Niraparib free base (2) in a solvent or mixture of solvents, ii) adding at least one pharmaceutically acceptable excipient to the solution obtained in step-a), iii) isolating the solid dispersion of Niraparib free base, iv) adding a solution of p-toluene sulfonic acid to step iii), and v) isolating the solid dispersion of Niraparib tosylate (1). In further aspect, the present invention provides solid dispersion of Niraparib tosylate (1) obtained according to the present invention is having purity greater than 99% by HPLC, preferably greater than 99.5% by HPLC, more preferably greater than 99.9% by HPLC with total impurities less than 1.0%, preferably less than 0.5%.

[0025] BRIEF DESCRIPTION OF THE DRAWINGS:

[0026] Figure 1: Illustrates characteristic Powdered X-Ray Diffraction (PXRD) pattern of amorphous solid dispersion of Niraparib tosylate (1) with Polyvinylpyrrolidone (PVP).

[0027] Figure 2: Illustrates characteristic Powdered X-Ray Diffraction (PXRD) pattern of amorphous solid dispersion of Niraparib tosylate (1) with Copovidone

[0028] Figure 3: Illustrates characteristic Powdered X-Ray Diffraction (PXRD) pattern of amorphous solid dispersion of Niraparib tosylate (1) with hydroxypropyl beta cyclodextrin (HPpCD)

[0029] Figure 4: Illustrates characteristic Powdered X-Ray Diffraction (PXRD) pattern of amorphous solid dispersion of Niraparib tosylate (1) with Polyvinylpyrrolidone (PVP), after one month.

[0030] Figure 5: Illustrates characteristic Powdered X-Ray Diffraction (PXRD) pattern of amorphous solid dispersion of Niraparib tosylate (1) with Copovidone, after one month.

[0031] Figure 6: Illustrates characteristic Powdered X-Ray Diffraction (PXRD) pattern of amorphous solid dispersion of Niraparib tosylate (1) with hydroxypropyl beta cyclodextrin (HPpCD), after one month.

[0032] DETAILED DESCRIPTION OF THE INVENTION

[0033] As used herein, the term “solid dispersion” refers to dispersion of drug in a solid matrix where the matrix is either a small molecule or polymer. Preferably solid dispersion relates to a molecular dispersion where the API (active pharmaceutical ingredient) and polymer molecules are uniformly but irregularly dispersed in a nonordered way. In other words, in a solid dispersion, the two or more components (polymer and API) form a homogeneous one-phase system, where the particle size of the API in the solid dispersion is reduced to its molecular size.

[0034] As used herein, the term “excipient” refers to play a significant role in stabilizing solid dispersions, maximizing bioavailability, and overcoming absorption issues associated with poorly soluble drugs.

[0035] In the present application, solid dispersion and premix are used interchangeably to describe solid states disclosed herein.

[0036] In the first embodiment, the present invention provides a process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of a) dissolving Niraparib tosylate (1) in a solvent or mixture of solvents, b) adding at least one pharmaceutically acceptable excipient to the solution obtained in step-a), and c) isolating the solid dispersion of Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient.

[0037] In the process of the first embodiment, the suitable solvent used in step-a) is selected from alcohol solvents such as methanol, ethanol, 1 -propanol, 2-propanol, 1 -butanol, 2 -butanol, and the like or its mixture thereof.

[0038] In the process of the first embodiment, the suitable pharmaceutically acceptable excipient used in step-b) is selected from but not limited to polyvinylpyrrolidone, (povidone or PVP; PVP of different grades like K-IS, K-30, K-60, K-90 and K-120 may be used), polyvinylpolypyrrolidone, crospovidone, copovidone, Eudragit, Soluplus, polyethylene glycol (macrogol or PEG), polyethylene glycol-6000 (PEG- 6000), hydroxymethyl cellulose, ethyl hydroxyethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose (HPC), hydroxypropyl cellulose acetate succinate, hydroxypropyl methyl cellulose (hypromellose or HPMC), hydroxypropyl methylcellulose acetate succinate (HPMC-AS), hydroxyethyl methyl cellulose succinate (HEMCS), hydroxypropyl cellulose acetate succinate (HPCAS), hydroxypropyl methylcellulose phthalate (HPMC-P), hydroxypropyl methylcellulose acetate phthalate, microcrystalline cellulose (MCC), sulfo butyl ether-P-cyclodextrin (SBECD), hydroxypropyl beta cyclodextrin (HPpCD), salcaprozate sodium, sodium caprylate, and the like.

[0039] In the process of the first embodiment, isolating involves removal of solvent is carrying out by suitable techniques which includes but not limited to decantation, evaporation under reduced pressure, flash evaporation, vacuum drying, concentrating the reaction mixture, atmospheric distillation, distillation under reduced pressure, distillation by using a rotational distillation device such as Buchi rotavapor, agitated thin film drying (ATFD), melt extrusion, spray drying, freeze drying (lyophilization), spray-freeze drying, cooling the clear solution to lower temperatures to precipitate the solid followed by filtration by gravity or suction, thin film drying, centrifugation or any other suitable techniques known in the art.

[0040] In the process of the first embodiment, drying solid dispersion of Niraparib tosylate (1) by a suitable drying equipment such as tray dryer, vacuum oven, rotatory cone dryer, air oven, fluidized bed dryer, spin flash dryer, flash dryer, or the like. The drying can be carried out at atmospheric pressure or under reduced pressures at temperatures of less than about 100°C, less than about 60°C, less than about 40°C, or any other suitable temperatures. The drying can be carried out for any period required for obtaining a desired quality, such as from about 15 minutes to 10 hours or longer.

[0041] Solid dispersion of Niraparib tosylate (1) prepared according to the present invention can be further micronized or milled in conventional techniques to get the desired particle size to achieve desired solubility profile based on different forms of pharmaceutical composition requirements. Techniques that may be used for particle size reduction include, but are not limited to ball milling, roll milling and hammer milling, and jet milling. Milling or Micronisation may be performed before drying, or after the completion of drying of the product.

[0042] In the process of the first embodiment, the present invention provides the ratio of the amount of Niraparib tosylate (1) within the solid form to the amount of the excipient which ranges from about 1 : 0.1 to about 1 :5 (w / w).

[0043] In the second embodiment, the present invention provides a process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of:

[0044] A) dissolving Niraparib tosylate (1) in a solvent or mixture of solvents,

[0045] B) adding at least one pharmaceutically acceptable excipient in a solvent to the mixture obtained in step A), and

[0046] C) isolating the solid dispersion of Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient.

[0047] In the process of the second embodiment, the suitable solvent used in step-A) is same as defined in the first embodiment.

[0048] In the process of the second embodiment, the suitable pharmaceutically acceptable excipient used in step-B) is same as defined in the first embodiment.

[0049] In the process of the second embodiment, isolating involves removal of solvent from the mixture in step-C) is same as defined in the first embodiment.

[0050] In the third embodiment, the present invention provides a process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of:

[0051] I) dissolving Niraparib free base (2) in a solvent or mixture of solvents,

[0052] II) adding a solution of p-toluene sulfonic acid to the mixture obtained in step I),

[0053] III) adding at least one pharmaceutically acceptable excipient to the mixture obtained in step-II), and

[0054] IV) isolating the solid dispersion of Niraparib tosylate (1).

[0055] In the process of the third embodiment, the suitable solvent used in step-I) is selected from alcohol solvents such as methanol, ethanol, 1 -propanol, 2-propanol, 1 -butanol, 2 -butanol, and the like; polar aprotic solvents such as dimethyl formamide, dimethyl sulfoxide, dimethyl acetamide and the like; or its mixture thereof.

[0056] In the process of the third embodiment, a solution of p-toluene sulfonic acid in step- II), comprises dissolving p-toluene sulfonic acid in a suitable solvent or a mixture of solvents

[0057] In the process of third embodiment, the suitable pharmaceutically acceptable excipient used in step-III) is same as defined in the first embodiment.

[0058] In the process of the third embodiment, isolating involves removing the solvent from the mixture used in step-IV) is same as defined in the first embodiment.

[0059] In the fourth embodiment, the present invention provides a process for the preparation of solid dispersion of Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of: i) dissolving Niraparib free base (2) in a solvent or mixture of solvents, ii) adding at least one pharmaceutically acceptable excipient to the mixture obtained in step-i), iii) isolating the solid dispersion of Niraparib free base (2), iv) adding a solution of p-toluenesulfonic acid to step iii), and v) isolating the solid dispersion of Niraparib tosylate (1).

[0060] In the process of fourth embodiment, the suitable solvent used in step-i) is same as defined in the third embodiment.

[0061] In the process of the fourth embodiment, a solution of p-toluene sulfonic acid in step-iv), comprises dissolving p-toluene sulfonic acid in a suitable solvent or a mixture of solvents

[0062] In the process of the fourth embodiment, the suitable pharmaceutically acceptable excipient used in step-ii) is same as defined in the first embodiment.

[0063] In the process of the fourth embodiment, isolating involves removing the solvent from the mixture used in step-iii) and in step-v) is same as defined in the first embodiment.

[0064] In the present invention, the starting material Niraparib tosylate (1) can be used in the form of amorphous or crystalline or any other physical form.

[0065] In the present invention, the starting material Niraparib free base (2) can be used in the form of amorphous or crystalline or any other physical form.

[0066] In the present invention, the pharmaceutically acceptable excipient used for the preparation of solid dispersion can be amorphous, crystalline or any other solid-state form.

[0067] In the process of the present invention the resulting solid dispersion of Niraparib tosylate (1) can be amorphous, crystalline or a mixture thereof.

[0068] The solid dispersion of Niraparib tosylate (1) of the present invention can be further micronized or milled to achieve desired particle size distribution to make suitable formulation.

[0069] In the fifth embodiment, the present invention provides solid dispersion of Niraparib tosylate (1) obtained according to the present invention is having purity greater than 99% by HPLC, preferably greater than 99.5% by HPLC, more preferably greater than 99.9% by HPLC with total impurities less than 1.0%, more preferably less than 0.5%.

[0070] In the sixth embodiment, the present invention provides solid dispersion of Niraparib tosylate (1) obtained according to the present invention is having loss on drying less than 5.0% (w / w), preferably less than 3.0% (w / w), more preferably less than 2.0% (w / w).

[0071] In the seventh embodiment, the physical stability of solid dispersion of Niraparib tosylate (1) with different ratios of excipients was determined by storing the samples at 40°C / 75% relative humidity (RH), 25°C / 60% relative humidity (RH) and 2-8°C. The samples were tested by PXRD analysis. The solid dispersion of Niraparib tosylate (1) with different ratios of excipients was found to be physically stable at 40°C / 75% relative humidity (RH), 25°C / 60% relative humidity (RH) conditions and 2-8°C up to 6 months

[0072] Therefore, the objective of the present invention is achieved through the preparation of storage stable solid dispersion of Niraparib tosylate (1).

[0073] In the sixth embodiment, pharmaceutical composition comprising solid dispersion of Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient is formulated in a manner suitable for the route of administration to be used.

[0074] As used herein, the term "pharmaceutical compositions" include tablets, pills, powders, liquids, suspensions, emulsions, granules, capsules, suppositories, or injection preparations.

[0075] P-XRD Method of Analysis:

[0076] PXRD analysis of solid dispersion of Niraparib tosylate (1) was carried out by using BRUKER / D8 ADVANCE diffractometer using Cu Ka radiation of wavelength 1.5406 A° and continuous scan speed of 0.037min.

[0077] The process described in the present invention is demonstrated in examples illustrated below. These examples are provided as illustration only and therefore should not be construed as limitation of the scope of the invention.

[0078] Examples

[0079] Example 1: Preparation of amorphous solid dispersion of Niraparib tosylate (1) with Polyvinylpyrrolidone (PVP)

[0080] Niraparib tosylate (8 g) was added to methanol (60 vol) at room temperature. To this Polyvinylpyrrolidone (PVP) (2 g) was added and stirred. Spray dried the obtained solution using spray dryer through following conditions:

[0081] Inlet Temperature : 80°C Outlet Temperature : 80°C

[0082] Aspirator : 70%

[0083] Feeding rate : 16 mL / min

[0084] N2 Pressure : 2.5 kg / cm2

[0085] Yield: 59%; The PXRD pattern of the obtained compound is shown in figure 1.

[0086] Example 2: Preparation of amorphous solid dispersion of Niraparib tosylate (1) with hydroxypropyl cellulose (Copovidone)

[0087] Niraparib tosylate (8 g) was added to Methanol (60 vol) at room temperature. To this Copovidone (2 g) were added and stirred. Spray dried the obtained solution using spray dryer through following conditions: Inlet Temperature : 80°C

[0088] Outlet Temperature : 80°C

[0089] Aspirator : 70%

[0090] Feeding rate : 16 mL / min

[0091] N2 Pressure : 2.5 kg / cm2

[0092] Yield: 49.5%; The PXRD pattern of the obtained compound is shown in figure-2.

[0093] Example 3: Preparation of amorphous solid dispersion of Niraparib tosylate (1) with hydroxypropyl beta cyclodextrin (HPpCD)

[0094] Niraparib tosylate (8 g) was added to Methanol (60 vol) at room temperature. To this hydroxypropyl beta cyclodextrin (HPpCD) (2 g) were added and stirred. Spray dried the obtained solution using spray dryer through following conditions:

[0095] Inlet Temperature : 80°C

[0096] Outlet Temperature : 80°C

[0097] Aspirator : 70%

[0098] Feeding rate : 16 mL / min

[0099] N2 Pressure : 2.5 kg / cm2

[0100] Yield: 49.5%; The PXRD pattern of the obtained compound is shown in figure-3.

[0101] Example 4: Preparation of amorphous solid dispersion of Niraparib tosylate

[0102] (1) with Polyvinylpyrrolidone (PVP)

[0103] Niraparib free base (8 g) was added to methanol (60 mL) at room temperature and stirred to get a clear solution. To this Polyvinylpyrrolidone (PVP) (2 g) was added and stirred to get amorphous solid dispersion of Niraparib, then methanol was added to the obtained solid to get clear solution. To this p-toluene sulfonic acid was added.

[0104] Spray dried the obtained solution using spray dryer through following conditions:

[0105] Inlet Temperature : 80°C

[0106] Outlet Temperature : 80°C

[0107] Aspirator : 70%

[0108] Feeding rate : 16 mL / min

[0109] N2 Pressure : 2.5 kg / cm2

[0110] Yield: 65%

[0111] Example 5: Preparation of amorphous solid dispersion of Niraparib tosylate (1) with Polyvinylpyrrolidone (PVP)

[0112] Niraparib free base (8 g) was added to methanol (60 mL) at room temperature and stirred to get a clear solution. To this aqueous p-toluene sulfonic acid and Polyvinylpyrrolidone (PVP) (2 g) were added to the reaction mixture and stirred. Spray dried the obtained solution using spray dryer through following conditions: Inlet Temperature : 80°C

[0113] Outlet Temperature : 80°C

[0114] Aspirator : 70%

[0115] Feeding rate : 16 mL / min

[0116] N2 Pressure : 2.5 kg / cm2

[0117] Yield: 70%

Claims

We claim:

1. A process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of: a) dissolving Niraparib tosylate (1) in a solvent or mixture of solvents, b) adding at least one pharmaceutically acceptable excipient to the solution obtained in step-a), and c) isolating the solid dispersion of Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient.

2. A process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of: a) dissolving Niraparib tosylate (1) in a solvent or mixture of solvents, b) adding at least one pharmaceutically acceptable excipient in a solvent to the mixture obtained in step a), and c) isolating the solid dispersion of Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient.

3. A process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of: i) dissolving Niraparib free base (2) in a solvent or mixture of solvents, ii) adding a solution of p-toluene sulfonic acid to the solution obtained in step i), iii) adding at least one pharmaceutically acceptable excipient to the mixture obtained to step-ii), and iv) optionally, adding second solvent to the reaction mixture obtained in step iii), and v) isolating the solid dispersion of Niraparib tosylate (1).

4. A process for the preparation of solid dispersion comprising Niraparib tosylate (1) with at least one pharmaceutically acceptable excipient, comprising the steps of: i) dissolving Niraparib free base (2) in a solvent or mixture of solvents, ii) adding at least one pharmaceutically acceptable excipient to the solution obtained in step-a), iii) isolating the solid dispersion of Niraparib free base, iv) adding a solution of p-toluene sulfonic acid to step iii), and v) isolating the solid dispersion of Niraparib tosylate (1).

5. The process as claimed in any of the proceeding claims, the suitable solvent used in step-a) is selected from alcohol solvents such as methanol, ethanol, 1 -propanol, 2- propanol, 1 -butanol, 2-butanol, and the like or its mixture thereof.

3. polar aprotic solvents such as dimethyl formamide, dimethyl sulfoxide, dimethyl acetamide and the like; or its mixture thereof.

6. The process as claimed in any of the proceeding claims, the suitable pharmaceutically acceptable excipient used in step-b) is selected from but not limited to polyvinylpyrrolidone, (povidone or PVP; PVP of different grades like K-IS, K-30, K-60, K-90 and K-120 may be used), polyvinylpolypyrrolidone, crospovidone, copovidone, Eudragit, Soluplus, polyethylene glycol (macrogol or PEG), polyethylene glycol-6000 (PEG- 6000), hydroxymethyl cellulose, ethyl hydroxyethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose (HPC), hydroxypropyl cellulose acetate succinate, hydroxypropyl methyl cellulose (hypromellose or HPMC), hydroxypropyl methylcellulose acetate succinate (HPMC-AS), hydroxy ethyl methyl cellulose succinate (HEMCS), hydroxypropyl cellulose acetate succinate (HPCAS), hydroxypropyl methylcellulose phthalate (HPMC-P), hydroxypropyl methylcellulose acetate phthalate, microcrystalline cellulose (MCC), sulfo butyl ether-P-cyclodextrin (SBECD), hydroxypropyl beta cyclodextrin (HPpCD), salcaprozate sodium, sodium caprylate, and the like.

7. The process as claimed in any of the proceeding claims, removal of solvent is carrying out by suitable techniques which includes but not limited to decantation, evaporation under reduced pressure, flash evaporation, vacuum drying, concentrating the reaction mixture, atmospheric distillation, distillation under reduced pressure, distillation by using a rotational distillation device such as Buchi rotavapor, agitated thin film drying (ATFD), melt extrusion, spray drying, freeze drying (lyophilization), spray-freeze drying, cooling the clear solution to lower temperatures to precipitate the solid followed by filtration by gravity or suction, thin film drying, centrifugation or any other suitable techniques known in the art.

8. The process as claimed in claim 1 and 2, wherein the amorphous solid dispersion of Niraparib tosylate (1) with Polyvinylpyrrolidone (PVP) is characterized by its X- ray powder diffraction (XRD) pattern as illustrated in figure-1, Copovidone ischaracterized by its X-ray powder diffraction (XRD) pattern as illustrated in figure- 2, and hydroxypropyl beta cyclodextrin (HPpCD) is characterized by its X-ray powder diffraction (XRD) pattern as illustrated in figure-3.

9. The process as claimed in any of the proceeding claims, solid dispersion of Niraparib tosylate (1) is having total impurities less than 1.0%, preferably less than0.5%.

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