DESC:Unless otherwise stated, the following terms used in the specification and claims have the meanings given below:
The term " Lumateperone " as used herein includes the base, pharmaceutically acceptable salts, polymorphs, stereoisomers and mixtures thereof, the term "pharmaceutically acceptable salt" means a salt which is acceptable for administration to a patient, such as a mammal (e.g., salts having acceptable mammalian safety for a given dosage regime). Such salts can be derived from pharmaceutically acceptable inorganic or organic bases and from pharmaceutically acceptable inorganic or organic acids.

The term “amorphous” as used herein means Lumateperone or pharmaceutically acceptable salt that is essentially free of crystalline form. The amorphous nature of a solid is generally determined by X-Ray Powder Diffraction (XRPD). The X-ray Powder Diffraction Pattern of an amorphous solid generally represent broad halos devoid of sharp peaks, as will be apparent to the person skilled in the art using conventional XRPD techniques.

The term, "carrier" as used herein refers to diluents, polymers, stabilizing agents, disintegrants, binders, lubricants, glidants, coating agents, preservatives, wetting agents, thickening agents, antifoaming agents, sweetening agents, flavouring agents, antioxidants, solubilizers, plasticizers or dispersing agents and the like. The pharmaceutical compositions of the present invention may be formulated in a conventional manner using one or more pharmaceutically acceptable excipients.

“Essentially free of crystalline form” means in relation to Lumateperone or pharmaceutically acceptable salt that it contains at least 95%, suitably at least about 98%, ideally at least about 99% of Lumateperone or pharmaceutically acceptable salt in amorphous form as measured by X-Ray Powder Diffraction according to conventional methods as further described herein.

The term, "pharmaceutically acceptable excipients" as used herein refers to diluents, disintegrants, binders, lubricants, glidants, coating agents, solvents, co-solvents, preservatives, wetting agents, thickening agents, antifoaming agents, sweetening agents, flavouring agents, antioxidants, solubilizers, plasticizers or dispersing agents and the like. The pharmaceutical compositions of the present invention may be formulated in a conventional manner using one or more pharmaceutically acceptable excipients.

The term “polymer” as used herein refers to any one of the polymers selected from the group comprising of polymethacrylate (EUDRAGIT), polyvinylpyrrolidone-vinyl acetate copolymer, copovidone, microcrystalline cellulose, hydroxypropylcellulose, carboxymethylcellulose, ethylcellulose, cellulose acetate, methylcellulose, hydroxy propyl methyl cellulose acetate succinate (also referred to as HPCMAS), co-polymer N-vinyl-2-pyrrolidone/vinyl acetate (also referred to as PVPVA), polyvinyl pyrrolidone (also referred to as PVP), hypromellose phtalate (also referred to as HPMCP), hypromellose (also referred to as HPMC). graft copolymer of polyethylene glycol, polyvinyl acetate phthalate, Polyvinyl pyrollidone-30 (PVP-30), Polyvinyl pyrrolidone-25 (PVP-25), Polyvinyl pyrollidine-90 (PVP-90), Plasdone S-630, Plasdone S-630 Ultra, Silicon dioxide, Silicon dioxide (Syloid 244FP), Silicon dioxide (Syloid AL-1FP/63FP), Silicon dioxide (Syloid XDP), Colloidal silicon dioxide (Aerosil 200 Pharma), Neusilin, Hydroxypropyl betadex (HPB-Betadex) and Carbapol-974-Ppolyvinyl pyrrolidone, polyvinylacetal diethylaminoacetate (AEA®), polyvinyl acetate phthalate, polysorbate 80, polyoxyethylene-polyoxypropylene copolymers (Poloxamer® 188), polyoxyethylene (40) stearate, polyethyene glycol monomethyl ether, polyethyene glycol, poloxamer 188, pluronic F-68, methylcellulose, hydroxypropylmethyl cellulose phthalate, hydroxypropylmethyl cellulose acetate succinate (HPMC-AS), hydroxypropylmethyl cellulose, hydroxypropyl cellulose SSL(HPC-SSL), hydroxypropyl cellulose SL(HPC-SL), hydroxypropyl cellulose L (HPC-L), croscarmellose sodium (CCS), crospovidone, hydroxyethyl cellulose, Soluplus® (polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (PCL-PV Ac-PEG)), gelucire 44/14, ethyl cellulose, D-alpha-tocopheryl polyethylene glycol 1000 succinate, cellulose acetate phthalate, carboxymethylethylcellulose and the like; cyclodextrins, gelatins, hypromellose phthalates.

The term “solid dispersion” refers to a system in a solid state comprising at least two components, wherein one component is dispersed throughout the other component or components. The term “solid dispersion” as used herein, refers to stable solid dispersions comprising amorphous drug substance and one or more polymers or carriers. Further the term “solid dispersion” as used herein also refers to stable solid dispersions comprising amorphous drug substance and one or more polymers or carriers with or without adsorbent/absorbent. By “amorphous drug substance,” it is meant that the amorphous solid contains drug substance in a substantially amorphous solid state form i.e. at least about 80% of the drug substance in the dispersion is in an amorphous form. More preferably at least about 90% and most preferably at least about 95% of the drug substance in the dispersion is in amorphous form.

The term "diluent" employed in a composition of the present invention is capable for providing bulkiness to obtain a desired pharmaceutical composition. The diluents of instant invention includes, but are not limited to inorganic phosphates such as dibasic calcium phosphate, calcium sulphate or dicalcium phosphate dihydrate; sugars such as lactose, lactose hydrate, lactose monohydrate, lactose anhydrate, sucrose, dextrose, erythritol, lactilol, xylitol, sorbitol, mannitol or malitol; cellulose or cellulose derivatives such as microcrystalline cellulose; Avicel, Avicel PH 101, Avicel PH 102 or Avicel PH 103, maize starch, Starcap-1500, Starlac and galenIQ-721.

The term "Lubricant" employed in a composition of the present invention is capable of preventing the ingredients from clumping together and from sticking to the apparatus on which it is formed, for example, preventing adherence to the face of the upper punch (picking) or lower punch (sticking) of a compression machine. Preferred lubricants of instant invention includes, but are not limited to fatty acids or fatty acid derivatives such as calcium stearate, magnesium stearate, glyceryl monostearate, glyceryl palmitostearate, sodium lauryl sulfate, sodium stearyl fumarate, zinc stearate, stearic acid or hydrogenated vegetable oil; polyalkylene glycols such as polyethylene glycol (PEG) or sodium benzoate and the like.

The term "Glidant" employed in a composition of the present invention is capable for providing bulkiness to obtain a desired pharmaceutical composition. The Glidant of instant invention includes, but are not limited to inorganic phosphates such as talc, dibasic calcium phosphate, Colloidal Silicon dioxide (fumed silica), hydrophilic silica, Sodium Carboxymethyl starch calcium sulphate or dicalcium phosphate dihydrate; sugars such as lactose, lactose hydrate, lactose monohydrate, lactose anhydrate, sucrose, dextrose, erythritol, lactilol, xylitol, sorbitol, mannitol or malitol; cellulose or cellulose derivatives such as microcrystalline cellulose; Avicel, Avicel PH 101, Avicel PH 102 or Avicel PH 103, maize starch, Starcap-1500, Starlac and galenIQ-721.

The term "Disintegrant" employed in a composition of the present invention is capable of facilitating the breakup of a pharmaceutical composition prepared from the composition when placed in contact with an aqueous medium. The disintegrants of instant invention includes, but are not limited to alginic acid or sodium alginate; cellulose or cellulose derivatives such as carboxymethylcellulose sodium, Sodium Carboxymethyl starch, croscarmellose sodium, powdered cellulose, croscarmellose sodium; iron exchange resin such as amberlite, gums such as agar, locust bean, karaya, pectin and tragacanth, crospovidone (cross-linked homopolymer of N-vinyl-2-pyrrolidinone, i.e., cross-linked l-ethenyl-2-pyrrolidinone); Pregelatinized starch, sodium starch glycolate or starch.

The term "composition" or "pharmaceutical composition" or “dosage form” as used herein synonymously include solid dosage forms such as granules, multiunit particulate systems (MUPS), pellets, spheres, tablets, capsules, mini-tablets, beads, particles and the like; and liquid dosage forms such as solutions, suspensions, emulsions, colloids and the like, meant for oral administration.

The term "stable" as used herein refers to formulations that substantially retain the label amount of the therapeutically active ingredient during storage for commercially relevant times, and the drug-related impurity contents in the formulations remain within acceptable limits.

The term "oral dosage forms" includes all conventional oral solid dosage forms like a tablet, capsule, Oral disintegrating films or tablets, syrups, suspension, granules, pill, caplet, pellets, powder or sachet, or any other orally ingestible dosage form comprising Lumateperone or its salts as an active ingredient mixed with other pharmaceutically acceptable excipients.

The terms “prevent” and “preventing” as used herein refers the prevention of the recurrence, spread or onset. It is not intended that the present disclosure be limited to complete prevention. In some embodiments, the onset is delayed, or the severity of the disease is reduced.

The articles "a" and "an" are used in this disclosure to refer to one or more than one (i.e., to at least one) of the grammatical object of the article. By way of example, "a diluent" means one diluent or more than one diluent.

Throughout this specification and the appended claims, it is to be understood that the words "comprise", “have”, “contain” and "include" and variations such a "comprises", "comprising", "having", "containing" "includes", "including" are to be interpreted inclusively, unless the context requires otherwise. That is, the use of these words may imply the inclusion of an element or elements not specifically recited.

The term “particles” refers to individual drug substance particles whether the particles exist singly or are agglomerated. Thus, a composition comprising particulate Lumateperone may contain agglomerates that are well beyond the size limit of about 500 µm specified herein. However, if the mean size of the primary drug substance particles (i.e., Lumateperone) comprising the agglomerate are less than about 500 µm individually, then the agglomerate itself is considered to satisfy the particle size constraints defined herein and the composition is within the scope of the invention.

The “Lumateperone particles” refers to particles of Lumateperone that do not include an added excipient. Lumateperone particles are different than “particles containing Lumateperone”, which are particles that contain Lumateperone and at least one added excipient. Lumateperone particles of the disclosure exclude a polymeric, wax or protein excipient and are not embedded, contained, enclosed or encapsulated within a solid excipient. Lumateperone particles of the disclosure may, however, contain impurities and byproducts typically found during preparation of Lumateperone. Even so, Lumateperone particles comprise at least 95%, at least 96%, at least 97%, at least 98%, at least 99% or 100% Lumateperone, or a pharmaceutically acceptable salt thereof, meaning the Lumateperone particles consist of or consist essentially of substantially pure Lumateperone or pharmaceutically acceptable salt thereof.

According to embodiment of the present invention relates to an oral solid dispersions comprising Lumateperone or a pharmaceutical acceptable salt thereof, atleast one carrier and optionally one or more pharmaceutically acceptable excipients.

According to embodiment of the present invention relates to stable pharmaceutical compositions comprising Lumateperone or pharmaceutically acceptable salt thereof in amorphous form, one or more polymers and optionally one or more pharmaceutically acceptable excipients.

In one embodiment, the present invention relates to solid dispersion comprising amorphous Lumateperone p-tosylate dispersed in polymer matrix and optionally one or more pharmaceutically acceptable excipients.

In one embodiment, the solid dispersions of Lumateperone p-tosylate of the present invention can be made by any of numerous methods that result in a solid dispersion comprising an amorphous Lumateperone p-tosylate. Several approaches can be used for the preparation of solid dispersion which includes spray drying, fusion method, solvent evaporation, hot-melt extrusion, particle size reduction, supercritical fluid (SCF) processes, kneading, inclusion complexes, electrostatic spinning method, melt crystallization and surface-active carriers.

According to embodiment, the present invention relates to a stable solid composition comprising amorphous solid dispersion of Lumateperone or pharmaceutically acceptable salt thereof having particle size (D90) less than 200µm, one or more polymer and optionally one or more pharmaceutical acceptable excipients.

According to embodiment, present invention to provide a particle size distribution of the Lumateperone tosylate solid dispersion may have from D10 = 10 µm, D50 = 200 µm and D90 = 400µm, wherein the 10th volume percentile particle size (D10) is less than about 50 µm, the 50th volume percentile particle size (D50) is less than about 200 µm, or the 90th volume percentile particle size (D90) is less than about 400 µm, or any combination thereof.

According to embodiment, present invention to provide a particle size distribution of the Lumateperone tosylate solid dispersion may have particle size (D90) is less than 500 µm, preferably less than 200 µm, and more preferably less than100 µm are combination thereof.

According to embodiment, present invention to provide a particle size distribution of the Lumateperone tosylate solid dispersion may have particle size (D90) is less than 100 µm, preferably less than 50 µm, and more preferably less than 10 µm are combination thereof.
In one embodiment, the present invention relates to a pharmaceutical capsule dosage form composition comprising amorphous solid dispersion of Lumateperone or pharmaceutically acceptable salt thereof having D90 less than 500µm and one or more pharmaceutically acceptable excipients.

In one embodiment, the present invention relates to a pharmaceutical capsule dosage form composition comprising amorphous solid dispersion of Lumateperone or pharmaceutically acceptable salt thereof having D90 less than 200µm and one or more pharmaceutically acceptable excipients.

In certain exemplary embodiments, the pharmaceutical composition comprises, Lumateperone or its pharmaceutically acceptable salt thereof, as generally described below. Some preferred, but non-limiting examples of suitable pharmaceutically acceptable organic and/or inorganic acids are hydrochloric acid, hydrobromic acid, sulphuric acid, nitric acid, acetic acid and citric acid, as well as other pharmaceutically acceptable acids.

In one embodiment, the present invention relates to a stable solid dispersion comprising Lumateperone or pharmaceutically acceptable salt thereof, one or more polymers and optionally one or more pharmaceutical acceptable excipients; wherein Lumateperone or pharmaceutically acceptable salt thereof is amorphous form.
In another embodiment, the oral solid dispersion is in the form of capsules comprising Lumateperone or pharmaceutically acceptable salts or derivatives thereof, one or more polymers and optionally one or more pharmaceutical acceptable excipients.

According embodiment, the present invention relates to oral solid dispersions of Lumateperone, wherein said composition comprises on a total of 100 % by weight: comprising of Lumateperone or its pharmaceutical salt;
(1) at least one carrier;
(2) Optionally one or more Disintegrants;
(3) Optionally one or more Glidants;
(4) Optionally one or more Lubricants;

According embodiment, the present invention relates to oral solid dispersion of Lumateperone, wherein said composition comprises on a total of 100 % by weight: comprising from about 1 % to about 60 % of Lumateperone or its pharmaceutical salt thereof in crystalline or amorphous form;
(1) from about 1 % to about 90 % one or more polymers;
(2) from about 1 % to about 5 % one or more Disintegrants;
(3) from about 1.5 % to about 10 % one or more Glidants;
(4) from about 2 % to about 10 % one or more Lubricants;
(5) optionally one or more pharmaceutical acceptable excipients;

According embodiment, the present invention relates to oral solid dispersion capsule comprising of Lumateperone, wherein said composition comprises on a total of 100 % by weight: comprising from about 1 % to about 60 % of Lumateperone or its pharmaceutical salt thereof in crystalline or amorphous form;
(1) from about 1 % to about 90 of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer (Soluplus);
(2) from about 0 % to about 15 % of croscarmellose sodium;
(3) from about 0 % to about 10 % of talc;
(4) from about 0 % to about 5 % of magnesium stearate; and
(5) optionally one or more pharmaceutical acceptable excipients;

According embodiment, solid dispersion of Lumateperone or pharmaceutically acceptable salt thereof has a particle size distribution with the D90 is less than 500 µm, preferably less than 300 µm, more preferably less than 200 µm.

Particle size analysis can be carried out via different methods. Non-limiting examples of the methods include, but are not limited to, sieve technique, wet dispersion method with laser diffraction analysis, dry dispersion method with laser diffraction analysis, or a combination thereof. Particle size analysis is not limited to the methods described herein and can be carried out using any method known to one skilled in the art. In one embodiment, particle size analysis can be performed via a sieve technique. In another embodiment, particle size analysis can be performed using a wet dispersion method (e.g., water as the dispersing agent, and analysis by laser diffraction using, e.g., Sympatec equipment). In yet another embodiment, particle size analysis can be performed using a dry dispersion method and analyzed by laser diffraction using, e.g., Sympatec equipment.

The pharmaceutical compositions as mentioned above can be prepared by using any suitable method known in the art such as, spray coating, spray drying and solvent evaporation.

According embodiment of the present invention relates to the process of preparation of an solid dispersion of Lumateperone having reduced particle size is disolved in solvent followed by addition of polymer. The obtained reaction mixture was stirred to obtain a clear solution and filtered. The obtained filtrate was concentrated under vacuum, washed with solvent and dried.

According embodiment of the present invention relates to the process of preparation of an solid dispersion composition of Lumateperone was dissolved in solvent and followed by addition of Carrier, the obtained reaction mixture was stirred to obtain a clear solution and filtered, the obtained solution was dried in a spray dryer to obtain solid product, encapsulate the resulting mixture into a gelatin capsule; and Optionally applying one or more coatings to the gelatin capsule.

According embodiment, the present invention composition relates to the oral stable pharmaceutical composition comprising Lumateperone or its pharmaceutical salt thereof having better stability, good purity profile, dissolution profile and better bioavailability.

In an embodiment, the Lumateperone can be administered from about 5 mg/day to about 100 mg/day.

In an embodiment, the Lumateperone Tosylate solid dispersion comprising 60 mg of Lumateperone Tosylate and pharmaceutically acceptable excipients, wherein the composition is devoid of sugar alcohol and the amount of Lumateperone Tosylate is equivalent to 42 mg of Lumateperone base.
In an embodiment, the Lumateperone Tosylate solid dispersion comprising 30 mg of Lumateperone Tosylate and pharmaceutically acceptable excipients, wherein the composition is devoid of sugar alcohol and the amount of Lumateperone Tosylate is equivalent to 21 mg of Lumateperone base.

In an embodiment, the Lumateperone Tosylate solid dispersion comprising 15 mg of Lumateperone Tosylate and pharmaceutically acceptable excipients, wherein the composition is devoid of sugar alcohol and the amount of Lumateperone Tosylate is equivalent to 10.5 mg of Lumateperone base.

The pharmaceutical composition is meant for once daily, twice daily or thrice daily administration.

According embodiment, the present invention relates to the oral stable composition comprising Lumateperone or its pharmaceutical salt thereof, having dissolution more than 90% within 45 minutes.

According embodiment, the present invention relates to the oral stable composition comprising Lumateperone or its pharmaceutical salt thereof, having dissolution more than 98% within 30 minutes.

According embodiment, the present invention relates to the pharmaceutical composition comprising Lumateperone or its pharmaceutical salt thereof for the treatment central nervous system disorders.

According embodiment, the present invention relates to the pharmaceutical composition comprising Lumateperone or its pharmaceutical salt thereof for the treatment of Schizophrenia.

According embodiment, the present invention relates to the pharmaceutical composition comprising Lumateperone or its pharmaceutical salt thereof for the treatment of Depressive episodes associated with bipolar I or II disorder as monotherapy and as adjunctive therapy with lithium or valproate.

According embodiment, the present invention relates to the pharmaceutical composition comprising Lumateperone or its pharmaceutical salt thereof for the treatment of sleep disorders.

According embodiment, the present invention relates to the pharmaceutical composition comprising Lumateperone or its pharmaceutical salt thereof for the treatment of behavioral disorders associated with dementia.

In another embodiment, the present invention relates to a pharmaceutical stable dosage form composition comprising immediate release capsule.

In another embodiment, the present invention relates to a pharmaceutical stable dosage form composition comprising immediate release tablet.

The process details of the invention are provided in the examples given below, which are provided by way of illustration only and therefore should not be construed to limit the scope of the invention.

Example 1: Lumateperone tosylate solid dispersion:
S.no Ingredients Category Quantity in Mg %
Ex 1 Ex 2 Ex 3
1 Lumateperone tosylate API 60 60 60 23
2 Polyvinyl acetate phthalate polymer 139.7 164.4 180 10 -90
4. Croscarmellose sodium Disintegrant 51.2 30 8 0 - 10
5. Talc Glidant 2.56 0.8 4 0 - 10
6. Magnesium stearate Lubricant 2.56 0.8 4 0 -5
Total 256 256 256 100

MANUFACTURING PROCESS:
i. Lumateperone tosylate was dissolved in solvent and followed by addition of Carrier.
ii. The obtained reaction mixture was stirred to obtain a clear solution and filtered.
iii. The obtained solution was dried in a spray dryer to obtain solid product.
iv. Encapsulate the resulting mixture into a gelatin capsule; and
v. Optionally applying one or more coatings to the gelatin capsule.

Example 2: Lumateperone tosylate solid dispersion:
S.no Ingredients Category Quantity in Mg %
Ex 1 Ex 2 Ex 3
1 Lumateperone tosylate API 60 60 60 23
2 Hypromellose polymer 139.7 164.4 180 10 -90
4. Croscarmellose sodium Disintegrant 51.2 30 8 0 - 10
5. Talc Glidant 2.56 0.8 4 0 - 10
6. Magnesium stearate Lubricant 2.56 0.8 4 0 -5
Total 256 256 256 100

MANUFACTURING PROCESS:
vi. Lumateperone tosylate was dissolved in solvent and followed by addition of polymer.
vii. The obtained reaction mixture was stirred to obtain a clear solution and filtered.
viii. The obtained solution was dried in a spray dryer to obtain solid product.
ix. Encapsulate the resulting mixture into a gelatin capsule; and
x. Optionally applying one or more coatings to the gelatin capsule.

Example 3: Lumateperone tosylate solid dispersion:

S.no Ingredients Category Quantity in Mg %
Ex 1 Ex 2 Ex 3
1 Lumateperone tosylate API 60 60 60 23
2 Soluplus Matrix agent 139.7 164.4 180 10 -90
4. Croscarmellose sodium Disintegrant 51.2 30 8 0 - 10
5. Talc Glidant 2.56 0.8 4 0 - 10
6. Magnesium stearate Lubricant 2.56 0.8 4 0 -5
Total 256 256 256 100

MANUFACTURING PROCESS:

i. Lumateperone tosylate was dissolved in solvent and followed by addition of polymer Soluplus (caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer).
ii. The obtained reaction mixture was stirred to obtain a clear solution, filtered and dried in a spray dryer to obtain solid product.
xi. The solid product obtained in above step is optionally co-sifted with the diluents, Disintegrant, Glidant and Lubricant;
iii. Encapsulate the resulting mixture into a gelatin capsule; and
iv. Optionally applying one or more coatings to the gelatin capsule.
,CLAIMS:1. A pharmaceutical composition comprises the solid dispersion of Lumateperone or its pharmaceutically acceptable salts and one or more pharmaceutically acceptable excipients, one or more polymer or matrix forming agent or carrier.

2. The pharmaceutical composition as claimed in claim 1, where in the composition comprising a solid dispersion of Lumateperone and a polymer, wherein the Lumateperone is dispersed or dissolved in the polymer.

3. The pharmaceutical composition as claimed in claim 1, where in the composition comprising Lumateperone or pharmaceutically acceptable salt thereof and one or more pharmaceutical excipients are diluent, disintegrant, glidant and lubricant.

4. The pharmaceutical composition as claimed in claim 1, where in the composition comprising Lumateperone or pharmaceutically acceptable salt thereof and
(1) At least 1 % to 90 % one or more polymers;
(2) 1 % to 5 % one or more Disintegrants;
(3 1.5 % to 10 % one or more Glidants;
(4) 2 % to 10 % one or more Lubricants;
(5) Optionally one or more pharmaceutical acceptable excipients.

5. The pharmaceutical composition as claimed in claim 1, where in the polymers is selected from hydrophobic or hydrophilic polymers.

6. The pharmaceutical composition as claimed in claim 1, where in the polymer is used in the composition is caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer or one or more pharmaceutically acceptable excipients.

7. The pharmaceutical composition as claimed in claim 1, wherein the particle size of Lumateperone D90 is less than 500 µm, preferably less than 300 µm, more preferably less than 200 µm.

8. The pharmaceutical composition as claimed in claim 1, wherein the composition is in the form of tablet or capsule comprising Lumateperone or pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients.

9. A process for the preparation of the pharmaceutical composition as claimed in claim 1, comprising Lumateperone was dissolved in solvent and followed by addition of polymer, the obtained reaction mixture was stirred to obtain a clear solution and filtered, dried in a spray dryer to obtain solid product, encapsulate the resulting mixture into a gelatin capsule and optionally applying one or more coatings.

10. The pharmaceutical composition as claimed in claim 1, where in the composition is used for the treatment of Schizophrenia in adults and Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults.