DESC:The following specification describes particularly the invention and in the manner in which it is to be performed:
AMORPHOUS SOLID DISPERSIONS OF FINERENONE

FIELD OF THE INVENTION
The present application relates to amorphous solid dispersions of finerenone, their preparative methods and pharmaceutical compositions thereof. The present application also relates to simple, efficient and scalable processes for preparation of crystalline form of Finerenone.

BACKGROUND OF THE INVENTION
Finerenone (I) is a non-steroidal mineralocorticoid receptor antagonist (MRA), developed by Bayer HealthCare Pharmaceuticals for the treatment of diabetic kidney disease (DKD) and heart failure (HF), including chronic HF (CHF). Finerenone is first approved in US (2019) then subsequently approved in Australia (2021), Europe (2022) and Japan (2022). As per US label, it is indicated to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). Finerenone is chemically known as (4S)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide.

WO2008104306A2 (herein after referred as WO’306) first discloses finerenone along with the process for preparation thereof. WO2016016287A1 (herein after referred as WO’287) discloses an improved process for preparation of finerenone along with crystalline modification I of Finerenone. As per US product quality reviews, crystalline drug substance Finerenone exists in only one modification. WO’ 287 discloses a process for preparation of crystalline modification I of Finerenone in example 9, which involves crystallization and polymorph adjustment using denatured ethanol. IN201911048297A (herein after referred as IN’297) discloses the process for preparation of amorphous form of finerenone and its solid dispersions with PVP K90 and HPC.
Finerenone is a BCS class II molecule with low solubility and high permeability. Solubility is one of the critical characteristics of the pharmaceutical substance to show its therapeutic effect. Further amorphous form of finerenone associated with stability issues. Hence it is important to find new polymorphic forms of finerenone to improve its stability and solubility thereby improves its bioavailability.
Further, new polymorphic forms, solvates and solid dispersions of a pharmaceutically useful compound or salts thereof can also provide an opportunity to improve the performance characteristics of a pharmaceutical product. It enlarges the repertoire of materials that a formulation scientist has available for formulation optimization, for example by providing a product with different properties, e.g., better processing or handling characteristics, improved dissolution profile, or improved shelf-life. For at least these reasons, there is a need for additional solid forms of Finerenone, alternate efficient and scalable process for preparation of crystalline modification I of Finerenone.

SUMMARY OF THE INVENTION
Aspects of the present application relate to amorphous solid dispersions of finerenone, their preparative methods and pharmaceutical compositions thereof.
In one aspect, the present application provides amorphous solid dispersion comprising finerenone and one or more pharmaceutically acceptable excipient.
In another aspect, the present application provides a process for preparation of amorphous solid dispersion comprising finerenone and one or more pharmaceutically acceptable excipient; the process comprising;
a) providing a solution comprising finerenone and one or more pharmaceutically acceptable excipients by dissolving in a suitable solvent or mixture threreof,
b) removing solvent from the solution obtained in step (a), and
c) recovering the solid dispersion comprising Finerenone and one or more pharmaceutically acceptable excipients.
In another aspect, the present application provides a pharmaceutical composition comprising amorphous solid dispersion of finerenone and at least one pharmaceutically acceptable carrier.
In another aspect of the present application relate to a process for preparation of crystalline modification I of Finerenone.
In another aspect, the present application provides a process for preparation of crystalline modification I of Finerenone comprising:
d) providing a solution comprising finerenone in a suitable solvent,
e) removing solvent from the solution obtained in step (a), and
f) recovering crystalline modification I of Finerenone.
In another aspect, the present application provides a process for preparation of crystalline modification I of Finerenone comprising:
a) providing a solution comprising finerenone in a suitable solvent;
b) adding an anti-solvent; and
c) recovering crystalline modification I of Finerenone.

BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is powder X-ray diffraction ("PXRD") pattern of amorphous solid dispersion of finerenone prepared according to Example 1.
Figure 2 is powder X-ray diffraction pattern of amorphous solid dispersion of finerenone prepared according to Example 2.
Figure 3 is powder X-ray diffraction pattern of amorphous solid dispersion of finerenone prepared according to Example 3.
Figure 4 is powder X-ray diffraction pattern of amorphous solid dispersion of finerenone prepared according to Example 4.
Figure 5 is powder X-ray diffraction pattern of amorphous solid dispersion of finerenone prepared according to Example 5.
Figure 6 is powder X-ray diffraction pattern of amorphous solid dispersion of finerenone prepared according to Example 6.
Figure 7 is powder X-ray diffraction pattern of amorphous solid dispersion of finerenone prepared according to Example 7.
Figure 8 is powder X-ray diffraction pattern of amorphous solid dispersion of finerenone prepared according to Example 8.
Figure 9 is powder X-ray diffraction ("PXRD") pattern of crystalline modification I of Finerenone prepared according to Example 9.

DETAILED DESCRITPION
Aspects of the present application relate to amorphous solid dispersions of finerenone, their preparative processes and pharmaceutical compositions thereof. The present application also encompasses the use of solid dispersions of finerenone provided herein for the preparation of pharmaceutical dosage forms.
The present application provides a process for preparing amorphous solid dispersion comprising finerenone and one or more pharmaceutically acceptable excipient, the process comprising;
a) providing a solution comprising finerenone and one or more pharmaceutically acceptable excipients by dissolving in a suitable solvent or mixture thereof;
b) removing solvent from the solution obtained in step (a); and
c) recovering amorphous solid dispersion comprising finerenone and one or more pharmaceutically acceptable excipient.
Providing a solution in step (a) includes direct use of a reaction mixture containing finerenone that is obtained in the course of its synthesis or dissolving finerenone and pharmaceutically acceptable excipient in a solvent or a mixture of solvents.
Any physical form of finerenone may be utilized for providing the solution of step (a).
Suitable pharmaceutically acceptable excipients which can be used in step (a) include, but are not limited to: diluents such as starches, pregelatinized starches, lactose, powdered celluloses, microcrystalline celluloses, dicalcium phosphate, tricalcium phosphate, Polyethylene glycol, Copovidone, Soluplus, Silicified microcrystalline cellulose mannitol, sorbitol, sugar and the like; binders such as acacia, guar gum, tragacanth, gelatin, polyvinylpyrrolidones, hydroxypropyl celluloses, hydroxypropyl methylcelluloses such as hydroxypropyl methylcellulose (HPMC), hydroxypropyl methylcellulose acetate succinate (HPMC-AS). hydroxypropyl methylcellulose phthalate (HPMCP), HPMC-15 CPS; pregelatinized starches and the like; disintegrants such as starches, sodium starch glycolate, pregelatinized starches, crospovidones, croscarmellose sodium, colloidal silicon dioxide and the like; lubricants such as stearic acid, magnesium stearate, zinc stearate and the like; glidants such as colloidal silicon dioxide and the like; solubility or wetting enhancers such as anionic or cationic or neutral surfactants; complex forming agents such as various grades of cyclodextrins and resins; release rate controlling agents such as hydroxypropyl celluloses, hydroxymethyl celluloses, hydroxypropyl methylcelluloses, ethylcelluloses, methylcelluloses, various grades of methyl methacrylates such as Eudragit L and Eudragit S, waxes and the like. Other pharmaceutically acceptable excipients that are of use include but are not limited to film formers, plasticizers, colorants, flavoring agents, sweeteners, viscosity enhancers, preservatives, antioxidants, and the like.
In a preferred embodiment, the pharmaceutically acceptable excipients are Eudragit L100, Copovidone and HPMC in various mole ratios.
Suitable solvent of step a) may include but not limited to, alcohols such as methanol, isopropanol and the like; ketones such as acetone, methyl isobutyl ketone and the like; ethers such as diethyl ether, tetrahydrofuran and the like; esters such as ethyl acetate, propyl acetate and the like; water; mixture thereof. Specifically, suitable solvent may be selected from methanol, water, mixture thereof.
In embodiments of step a) may optionally include an anti-oxidant. Suitable anti-oxidant may be selected from one or more of tocopherol, butylated hydroxytoluene (BHT), propyl gallate (OPG), ascorbic acid, butylated hydroxyanisole (BHA), tert-Butylhydroquinone (TBHQ), carotenoids, glutathione, a metabisulfite salt (e.g., sodium), an ethylenediamine-tetraacetate salt (e.g. sodium), ethylenediaminetetraacetic acid, cysteine, methionine, sesamol, and citric acid. Specifically, anti-oxident used in step a) is butylated hydroxytoluene (BHT).
After dissolution in step (a), optionally undissolved particles, if any, may be removed suitably by filtration, centrifugation, decantation, and any other known techniques. The solution can be filtered by passing through paper, glass fiber, or other membrane material, or a clarifying agent such as celite. Depending upon the equipment used and the concentration and temperature of the solution, the filtration apparatus may need to be preheated to avoid premature crystallization.
Step (b) involves removing solvent from the solution obtained in step (a). Suitable techniques which can be used for the removal of solvent include but not limited to evaporation, flash evaporation, simple evaporation, rotational drying such as drying using a rotavapor, spray drying, agitated thin-film drying, agitated nutsche filter drying, pressure nutsche filter drying, freeze -drying, filtration or any other technique known in the art.
Step (c) involves recovering amorphous solid dispersion comprising finerenone and one or more pharmaceutically acceptable excipient. The said recovery can be achieved by using the processes known in the art.
The resulting compound obtained in step (c) may optionally be further dried. Drying can be carried out in a tray dryer, vacuum oven, air oven, cone vacuum dryer, rotary vacuum dryer, fluidized bed dryer, spin flash dryer, flash dryer, or the like. The drying can be carried out at temperatures of less than about 75°C, less than about 50°C, or any other suitable temperatures; at atmospheric pressure or under a reduced pressure; as long as the Finerenone is not degraded in its quality. The drying can be carried out for any desired time until the required product quality is achieved. Suitable time for drying can vary from few minutes to several hours for example from about 30 minutes to about 24 or more hours.
When the active ingredient is hygroscopic or the formulation contains a hygroscopic ingredient, and to increase the stability of the amorphous form or a solid dispersion comprising Finerenone, addition of other carriers such as syloid, methyl cellulose, colloidal silicon dioxide, amorphous silica, micro crystalline cellulose, and the like, in the formulation has been found to be of particular value. Therefore, these ingredients may be combined during the preparation of solid dispersion or after the preparation of amorphous Finerenone or solid dispersion to control hygroscopicity and to improve stability.
In another aspect, the present application provides a pharmaceutical composition comprising amorphous finerenone solid dispersion of the present invention and a pharmaceutically acceptable carrier.
Certain specific aspects and embodiments of the present application will be explained in greater detail with reference to the following examples, which are provided only for purposes of illustration and should not be construed as limiting the scope of the application in any manner. Variations of the described procedures, as will be apparent to those skilled in the art, are intended to be within the scope of the present application.

In another aspect, the present application relates to a process for preparation of crystalline modification I of Finerenone.
In another aspect, the present application provides a process for preparation of crystalline modification I of Finerenone comprising:
a) providing a solution comprising finerenone in a suitable solvent,
b) removing solvent from the solution obtained in step (a), and
c) recovering crystalline modification I of Finerenone.
Providing a solution in step (a) includes direct use of a reaction mixture containing finerenone that is obtained in the course of its synthesis.
Any physical form of finerenone including solvates, hydrates, anhydrous or amorphous may be utilized for providing the solution of step (a).
Suitable solvent of step a) may include but not limited to, alcohols such as methanol, isopropanol and the like; ketones such as acetone, methyl isobutyl ketone and the like; ethers such as diethyl ether, tetrahydrofuran and the like; esters such as ethyl acetate, propyl acetate and the like; halogenated hydrocarbons such as dichloromethane, chloroform, carbon tetrachloride and the like; polar aprotic solvents such as dimethyl sulfoxide, dimethylformamide and the like; water; mixture thereof. Preferably, suitable solvent may be selected from dichloromethane, isopropyl alcohol, ethyl acetate, dimethyl sulfoxide, acetone, or mixture thereof.
After dissolution in step (a), optionally undissolved particles, if any, may be removed suitably by filtration, centrifugation, decantation, and any other known techniques. The solution can be filtered by passing through paper, glass fiber, or other membrane material, or a clarifying agent such as celite. Depending upon the equipment used and the concentration and temperature of the solution, the filtration apparatus may need to be preheated to avoid premature crystallization.
Step (b) involves removing solvent from the solution obtained in step (a). Suitable techniques which can be used for the removal of solvent include but not limited to evaporation, flash evaporation, simple evaporation, rotational drying such as drying using a rotavapor, spray drying, agitated thin-film drying, freeze -drying or any other technique known in the art.
The resulting compound obtained in step (c) may optionally be further dried. Drying can be carried out in a tray dryer, vacuum oven, air oven, cone vacuum dryer, rotary vacuum dryer, fluidized bed dryer, spin flash dryer, flash dryer, or the like. The drying can be carried out at temperatures of less than about 75°C, less than about 50°C, or any other suitable temperatures; at atmospheric pressure or under a reduced pressure; as long as the Finerenone is not degraded in its quality. The drying can be carried out for any desired time until the required product quality is achieved. Suitable time for drying can vary from few minutes to several hours for example from about 30 minutes to about 24 or more hours.

In another aspect, the present application provides a process for preparation of crystalline modification I of Finerenone comprising:
a) providing a solution comprising finerenone in a suitable solvent;
b) adding an anti-solvent; and
c) isolating crystalline modification I of Finerenone.
Providing a solution in step (a) includes direct use of a reaction mixture containing finerenone that is obtained in the course of its synthesis.
Any physical form of finerenone including solvates, hydrates, anhydrous or amorphous may be utilized for providing the solution of step (a).
Suitable solvent of step a) may include but not limited to, alcohols such as methanol, isopropanol and the like; ketones such as acetone, methyl isobutyl ketone and the like; ethers such as diethyl ether, tetrahydrofuran and the like; esters such as ethyl acetate, propyl acetate and the like; halogenated hydrocarbons such as dichloromethane, chloroform, carbon tetrachloride and the like; polar aprotic solvents such as dimethyl sulfoxide, dimethylformamide and the like; water; mixture thereof. Preferably, suitable solvent may be selected from dichloromethane, dimethyl sulfoxide, ethyl acetate or mixture thereof.
After dissolution in step (a), optionally undissolved particles, if any, may be removed suitably by filtration, centrifugation, decantation, and any other known techniques. The solution can be filtered by passing through paper, glass fiber, or other membrane material, or a clarifying agent such as celite. Depending upon the equipment used and the concentration and temperature of the solution, the filtration apparatus may need to be preheated to avoid premature crystallization.
Suitable anti-solvent of solvent of step b) may include but not limited to, aliphatic hydrocarbon solvents such as hexane, heptane and the like; aromatic hydrocarbon solvents such as benzene, toluene and the like; ethers such as diethyl ether, diisopropyl ether, tetrahydrofuran and the like; esters such as ethyl acetate, propyl acetate and the like; water; mixture thereof. Specifically, suitable anti solvent may be selected from hexane, diisopropyl ether, water or mixture thereof.
Isolation of crystalline modification I of Finerenone in step c) may be performed by any technique known in the art. Specifically, crystalline modification I of Finerenone may be isolated from the mixture of step b) by filtration followed by drying.
The resulting compound obtained in step (c) may optionally be further dried. Drying can be carried out in a tray dryer, vacuum oven, air oven, cone vacuum dryer, rotary vacuum dryer, fluidized bed dryer, spin flash dryer, flash dryer, or the like. The drying can be carried out at temperatures of less than about 75°C, less than about 50°C, or any other suitable temperatures; at atmospheric pressure or under a reduced pressure; as long as the Finerenone is not degraded in its quality. The drying can be carried out for any desired time until the required product quality is achieved. Suitable time for drying can vary from few minutes to several hours for example from about 30 minutes to about 24 or more hours.
Certain specific aspects and embodiments of the present application will be explained in greater detail with reference to the following examples, which are provided only for purposes of illustration and should not be construed as limiting the scope of the application in any manner. Variations of the described procedures, as will be apparent to those skilled in the art, are intended to be within the scope of the present application.
In one embodiment, the amorphous solid dispersions disclosed in this application are highly stable under different conditions at 25°C / 60% RH and 40°C / 75% RH in both open and closed conditions, details are given below.
Stability Data:
Table 1:
ASD (API : Polymer) Initial After 3 month 25°C / 60% RH open After 3 month 25°C / 60% RH closed After 3 months 40 °C / 75% RH closed
Co-Povidone (1:1) Amorphous Amorphous Amorphous Amorphous
Co-Povidone (1:2) Amorphous Amorphous Amorphous Amorphous
HPMC (1:1) Amorphous Amorphous Amorphous Amorphous
HPMC (1:1) Amorphous Amorphous Amorphous Amorphous
HPMC (1:2) Amorphous Amorphous Amorphous Amorphous
HPMC (1:3) Amorphous Amorphous Amorphous Amorphous
Eudragit L100 (1:2) Amorphous Amorphous Amorphous Amorphous

Even though, physically stable, some ASDs are showing chemical degradation due to the oxidizing nature of polymer. However, the degradation problem was resolved by preparing ASD’s by mixing with 2% BHT. The results were given below:
Table 2:
ASD (API : Polymer) Initial Purity
Purity after 1 month in 25 °C / 60% RH with 2% BHT
HPMC (1:3) 99.71 99.61
Co povidone (1:2) 99.71 99.61
Results: ASDs were prepared with antioxidant (2%BHT) were appeared to be stable in 25 °C / 60% RH with high purity.

DEFINITIONS
The following definitions are used in connection with the present invention unless the context indicates otherwise. The term “amorphous” refers to a solid lacking any long-range translational orientation symmetry that characterizes crystalline structures although; it may have short range molecular order similar to a crystalline solid.
The term "about" when used in the present application preceding a number and referring to it, is meant to designate any value which lies within the range of ±10%, preferably within a range of ±5%, more preferably within a range of ±2%, still more preferably within a range of ±1 % of its value. For example "about 10" should be construed as meaning within the range of 9 to 11, preferably within the range of 9.5 to 10.5, more preferably within the range of 9.8 to 10.2, and still more preferably within the range of 9.9 to 10.1.
All percentages and ratios used herein are by weight of the total composition and all measurements made are at about 25°C and about atmospheric pressure, unless otherwise designated. All temperatures are in degrees Celsius unless specified otherwise. As used herein, “comprising” means the elements recited, or their equivalents in structure or function, plus any other element or elements which are not recited. The terms “having” and “including” are also to be construed as open ended. All ranges recited herein include the endpoints, including those that recite a range “between” two values. Whether so indicated or not, all values recited herein are approximate as defined by the circumstances, including the degree of expected experimental error, technique error, and instrument error for a given technique used to measure a value.
Certain specific aspects and embodiments of the present application will be explained in greater detail with reference to the following examples, which are provided only for purposes of illustration and should not be construed as limiting the scope of the application in any manner. Reasonable variations of the described procedures are intended to be within the scope of the present invention. While particular aspects of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

EXAMPLES
Example-1: Preparation of amorphous solid dispersion of finerenone and Eudragit L100 (1:2)
Finerenone (3 g) and Eudragit L100 (6 g), were dissolved in methanol (300 mL) at 50°C. The reaction mixture is stirred for 30 minutes at the same temperature then filtered. The resulting solution is to spray dried at 60°C to obtain the title compound (7.5 g). PXRD pattern is shown in Figure 1.

Example-2: Preparation of amorphous solid dispersion of finerenone and Copovidone (1:2)
Finerenone (1.5 g) and Copovidone (3 g), were dissolved in methanol (150 mL) and water (10 mL) at 65°C. The resulting solution filtered and then spray dried at 65°C to obtain the title compound (3 g). PXRD pattern is shown in Figure 2.

Example-3: Preparation of amorphous solid dispersion of finerenone and Copovidone (1:1)
Finerenone (0.5 g) and Copovidone (0.5 g), were dissolved in methanol (50 mL) and water (5 mL) at 65°C. The resulting solution filtered to separate the undissolved particles. The resulting solution is evaporated under vacuum at 65°C for about 30 minutes to obtain the title compound. PXRD pattern is shown in Figure 3.

Example-4: Preparation of amorphous solid dispersion of finerenone and HPMC (1:1)
Finerenone (0.5 g) and HPMC (0.5 g), were dissolved in methanol (60 mL) at 65°C. The resulting solution is evaporated under vacuum at 65°C for about 1 hour to obtain the title compound. PXRD pattern is shown in Figure 4.

Example-5: Preparation of amorphous solid dispersion of finerenone and HPMC (1:2)
Finerenone (0.25 g) and HPMC (0.5 g), were dissolved in methanol (60 mL) at 65°C. The resulting solution is evaporated under vacuum at 65°C for about 45 minutes to obtain the title compound. PXRD pattern is shown in Figure 5.

Example-6: Preparation of amorphous solid dispersion of finerenone and HPMC (1:3)
Finerenone (0.5 g) and HPMC (1.5 g), were dissolved in methanol (120 mL) at 65°C. The resulting solution is evaporated under vacuum at 65°C for about 30 minutes to obtain the title compound. PXRD pattern is shown in Figure 6.

Example-7: Preparation of amorphous solid dispersion of finerenone and HPMC (1:3) with 2% BHT
Finerenone (1 g) and HPMC (3 g), were dissolved in methanol (150 mL) at 25°C. A solution of Butylated hydroxytoluene (BHT) (30 mg) in water (15 mL) was added to the above reaction mixture at same temperature. The reaction mixture was then filtered to separate the undissolved particles. The resulting solution was subjected to spray drying at 60°C for about 2 hours to obtain the title compound. PXRD pattern is shown in Figure 7.

Example-8: Preparation of amorphous solid dispersion of finerenone and Copovidone (1:2) with 2% BHT
Finerenone (1 g) and Copovidone (2 g), were dissolved in methanol (150 mL) at 25°C. A solution of Butylated hydroxytoluene (BHT) (30 mg) in water (15 mL) was added to the above reaction mixture at same temperature. The reaction mixture was then heated to 55 °C and then filtered to obtain the clear solution. The resulting solution was subjected to spray drying at 65°C for about 1 hours to obtain the title compound. PXRD pattern is shown in Figure 8.

Example-9: Process for preparation of crystalline modification I of Finerenone:
Example-9 (a):
Finerenone (0.2 g) was dissolved in dichloromethane (10 mL) at room temperature. The reaction mixture was filtered and then concentrated under reduced pressure at 45 °C. The resulting solid was dried under reduced pressure at room temperature for 20 minutes to obtain the title compound. PXRD pattern is shown in Figure 9.

Example-9 (b):
Finerenone (0.25 g) was dissolved in a solution of 15% IPA-DCM (15 mL) at room temperature. The reaction mixture was filtered and then concentrated under reduced pressure at 45 °C. The resulting solid was dried reduced pressure at room temperature for 20 minutes to obtain the title compound. PXRD pattern is shown in Figure 9.

Example-9 (c):
Finerenone (0.2 g) was dissolved in acetone (15 mL) at room temperature. The reaction mixture was filtered and then concentrated under reduced pressure at 45 °C. The resulting solid was dried under reduced pressure at room temperature for 20 minutes to obtain the title compound. PXRD pattern is shown in Figure 9.

Example-9 (d):
Finerenone (0.3 g) was dissolved in dichloromethane (10 mL) at room temperature. The reaction mixture was filtered and n-hexane (10 mL) was added in a dropwise manner at room temperature. The resulting suspension was stirred at room temperature of 2 hours and then filtered. The solid obtained was dried under reduced pressure at room temperature for 1 hour to obtain the title compound. PXRD pattern is shown in Figure 9.

Example-9 (e):
Finerenone (0.25 g) was dissolved in dimethylsulfoxide (2 mL) at room temperature. The reaction mixture was filtered water (20 mL) was added in a dropwise manner to the filtered solution at room temperature. The resulting suspension was stirred at room temperature of 2 hours and then filtered. The solid obtained was dried under reduced pressure at room temperature for 1 hour to obtain the title compound. PXRD pattern is shown in Figure 9.

Example-9 (f):
Finerenone (0.3 g) was dissolved in ethyl acetate (30 mL) at 50-55 °C under sonication. The reaction mixture was filtered and di-isopropyl ether (30 mL) was added in a dropwise manner to the filtered solution at room temperature. The resulting suspension was stirred at room temperature of 2 hours and then filtered. The solid obtained was dried under reduced pressure at room temperature for 1 hour to obtain the title compound. PXRD pattern is shown in Figure 9.
Dated this 1st day of June 2023
Signature: ____________ Dr. B. Dinesh Kumar
Dr. Reddy’s Laboratories Limited.

,CLAIMS:We Claim:
1. A process for preparation of amorphous solid dispersion comprising Finerenone and one or more pharmaceutically acceptable excipient; the process comprising;
a) providing a solution comprising finerenone and one or more pharmaceutically acceptable excipients by dissolving in a suitable solvent or mixture threreof,
b) removing solvent from the solution obtained in step (a), and
c) recovering the solid dispersion comprising Finerenone and one or more pharmaceutically acceptable excipients.
2. The process as claimed in claim 1, where in pharmaceutically acceptable excipient is selected from one or more of co-povidone, HPMC and Eudragit.
3. The process as claimed in claim 1, where in the Finerenone and pharmaceutically acceptable excipient ratio is varying from 1:1 to 1:3.
4. The process as claimed in claim 1, where in stage a) further comprises an anti-oxidant selected from pharmaceutically acceptable excipient is selected from one or more of tocopherol, butylated hydroxytoluene (BHT), propyl gallate (OPG), ascorbic acid, butylated hydroxyanisole (BHA), tert-Butylhydroquinone (TBHQ), carotenoids, glutathione, a metabisulfite salt (e.g., sodium), an ethylenediamine-tetraacetate salt (e.g. sodium), ethylenediaminetetraacetic acid, cysteine, methionine, sesamol, and citric acid.
5. The process as claimed in claim 1, where anti-oxidant of stage a) is butylated hydroxytoluene (BHT).
6. The process as claimed in claim 1, where the solvent is selected from methanol, isopropanol, acetone, methyl isobutyl ketone, diethyl ether, tetrahydrofuran, ethyl acetate, propyl acetate, water; mixture thereof.
7. A process for preparation of crystalline modification I of Finerenone comprising:
a) providing a solution comprising finerenone in a suitable solvent,
b) removing solvent from the solution obtained in step (a), and
c) recovering crystalline modification, I of Finerenone.8.
8. A process for preparation of crystalline modification I of Finerenone comprising:
a) providing a solution comprising finerenone in a suitable solvent;
b) adding an anti-solvent; and
c) isolating crystalline modification, I of Finerenone.
9. The process as claimed in claim 7 or 8, where in solvent is selected form methanol, isopropanol, acetone, methyl isobutyl ketone, ethyl acetate, propyl acetate, dichloromethane, chloroform, carbon tetrachloride, dimethyl sulfoxide, dimethylformamide or mixture thereof. Anti-solvent selected from hexane, heptane, benzene, toluene, diethyl ether, diisopropyl ether, tetrahydrofuran, ethyl acetate, water; mixture thereof.
10. A pharmaceutical composition comprising any of the solid forms of Finerenone as claimed in claims 1-9, and a pharmaceutically acceptable carrier.