DESC:According to one embodiment of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts and one or more pharmaceutically acceptable excipients, where in the pharmaceutical composition is used for the treatment of partial-onset seizures.

The present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the pharmaceutical composition contain hydrophobic release controlling agent with core coated matrix system.

The present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the hydrophobic release controlling agent is Ethyl cellulose.

Present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the coating core matrix system is a tablet design that combines a core matrix tablet with an outer coating to control or modify the drug release pattern, the core matrix contains the active drug dispersed within a matrix of polymers or other excipients, the coating layer acts as a barrier, regulating the rate at which the drug dissolves and diffuses out of the tablet.

Present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the Brivaracetam is used in the percentage from 20-90%, specifically 20-70% and more specifically 20-50% from total weight of the concentration.

Present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the hydrophobic release controlling agent used in the core from 5-20% from total weight of the concentration.

Present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the hydrophobic release controlling agent used in the coating from 1-10% from total weight of the concentration.

Present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the total core coated matrix system in the percentage from 2-10% from total weight of the concentration.
The present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the ratio between the water insoluble polymer to water soluble polymer in the coating is 2.26

The present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the insoluble polymer to the drug in the core is 10:3.

The present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the percentage of water insoluble polymer in coating from 11-25%.

The present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the percentage of water soluble polymer in coating from 5-15%.

Present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the complete dissolution time that is the time for release of at least 80% of the total amount of the drug is between about 7 to about 24 hours, preferably between about 8 to about 20 hours when dissolution is carried out in 900 ml of pH 6 phosphate buffer solution, using USP apparatus type II. at 50 rpm and at 37°C or variations of this as well known to one who is skilled in the art.

The present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the composition is sustained release tablet dosage form.

Present invention provides a pharmaceutical composition, wherein the composition is in the form of a tablet, capsule or caplet.

Present invention relates to a solid controlled release oral pharmaceutical composition comprising the pharmaceutically acceptable excipients is selected from diluents, binders, disintegrant, surfactants, lubricants, glidants, polymer, Plasticizer, solvents and coloring agents and the like or mixture thereof and optionally a pharmaceutical acceptable excipient.

Pharmaceutical composition of present invention is a monolayer tablet, bilayer tablet or tri-layer tablet.

Pharmaceutical composition of present invention is a having two components tablet or capsule and final composition can be tablet in tablet, capsule in capsule, tablet in capsule, mini tablets filled in capsule.

The term “Brivaracetam” used herein refers to a pharmaceutically active molecule as well as its pharmaceutically acceptable salts, esters, amides, prodrugs, metabolites, enantiomers, polymorphs, analogues, etc. that induce a desired pharmacological or physiological effect. The term also includes all polymorphic forms, whether crystalline or amorphous.

The pharmaceutical composition comprises Brivaracetam or its pharmaceutical acceptable salt in an amount from about 1 mg to about 1000 mg, preferably from about 50 mg to about 100 mg. According to one embodiment, Bempedoic acid is present in amount of about 40 mg. According to another embodiment, Bempedoic acid is present in amount of about 30 mg.

The pharmaceutical composition contains Brivaracetam having particle size of D90 less than 200µ (microns).
The pharmaceutical composition of the present invention is a sustained release dosage form.

The pharmaceutical compositions of present invention can be prepared using wet granulation (aqueous or non-aqueous), dry granulation/roller compaction/slugging, direct compression or any other conventional technique used in manufacturing pharmaceutical dosage forms.

The pharmaceutically acceptable excipient is selected from the group comprising diluents, binders, disintegrant, surfactants, lubricants, glidants, polymer, Plasticizer, solvents and colouring agents and/or combinations thereof.
Suitable diluents/fillers include, but are not limited to starch, pregelatinized starch, powdered celluloses, polysaccharides, dibasic calcium phosphate anhydrous or dihydrate/ calcium hydrogen phosphate, magnesium stearate, calcium phosphate, tricalcium phosphate anhydrous, calcium carbonate, calcium citrate, tricalcium citrate, magnesium carbonate, lactose monohydrate, lactose anhydrous, microcrystalline cellulose, mannitol, dextrose, dextrin, maltodextrin, sucrose, sorbitol, xylitol, lactitol. inositol, dextrates, lactitol, maltodextrin, trehalose, and/or combinations thereof. Further, the amount of diluent is preferably in the range of 10% w/w to 90% w/w by weight of the composition.

Suitable binders include, but are not limited to acacia, alginic acid, agar, calcium carrageenan, dextrin, gelatin, liquid glucose, gum, cellulose derivatives such as hydroxypropyl methylcellulose, hydroxypropyl cellulose, methylcellulose, microcrystalline cellulose, sodium carboxymethylcellulose, hydroxypropylmethylcellulose (HPMC), ethyl cellulose, pectin, polyethylene glycol, povidone, Polysorbate 80, starch, pregelatinized starch and/or combinations thereof. Further, the amount of binder is preferably in the range of 0.5% w/w to 50% w/w by weight of the composition.

Suitable disintegrants include, but are not limited to sodium starch glycolate, croscarmellose sodium, cross-linked polyvinylpyrrolidone, calcium and sodium carboxymethylcellulose, pregelatinized starch, magnesium trisilicate, cornstarch, potato starch and/or combinations thereof. Further, the amount of disintegrant is preferably in the range of 1% w/w to 25% w/w by weight of the composition.

Suitable polymer may comprise but not limited to alkyl celluloses, hydroxyalkyl celluloses, ethyl cellulose, cellulose ethers, cellulose esters, nitro celluloses, polymers of acrylic and methacrylic acids and esters thereof, polyamides, polycarbonates, polyalkylenes, polyalkylene glycols, polyalkylene oxides, polyalkylene terephthalates, polyvinyl alcohols, polyvinyl ethers, polyvinyl esters, cellulose acetate, cellulose acetate butyrate, agar acetate, amylose triacetate, poly (vinyl methyl) ether copolymers, poly (orthoesters), polyacetals, poly (glycolic acid), poly (lactic acid), derivatives thereof, co-polymers thereof and a combination thereof. Preferably, the coating polymer is selected from one or more of hydroxypropylmethyl cellulose (HPMC), hydroxypropyl cellulose, hydroxyethyl cellulose, polymers of acrylic and methacrylic acids and esters thereof.

Suitable hydrophobic release controlling agent(s) are selected from but are not limited to polyvinyl acetate dispersion, ethyl cellulose, cellulose acetate, cellulose propionate (lower, medium or higher molecular weight), cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose triacetate, poly (methyl methacrylate), poly (ethyl methacrylate), poly (butyl methacrylate), poly (isobutyl methacrylate), and poly (hexyl methacrylate), poly (isodecyl methacrylate), poly (lauryl methacrylate), poly (phenyl methacrylate), poly (methyl acrylate), poly (isopropyl acrylate), poly (isobutyl acrylate), poly (octadecyl acrylate), waxes such as beeswax, carnauba wax. paraffin wax, niicrocrystalline wax, and. ozokerite; fatty alcohols such as cetostearyl alcohol, stearyl alcohol, cetyl alcohol and myristyl alcohol, and fatty acid esters such as glyceryl monostearate; glycerol monooleate, acetylated monoglycerides, tristearin, tripalmitin, cetyl esters wax, glyceryl palmitostearate, glyceryl behenate, or hydrogenated vegetable oils.

Suitable lubricants/glidants may comprise but not limited to magnesium stearate, colloidal silicon dioxide, aluminum silicate, sodium stearyl fumarate, colloidal silicon dioxide, stearic acid, calcium stearate, zinc stearate, talc, waxes, boric acid, hydrogenated vegetable oil, sodium chlorate, magnesium lauryl sulfate, starch, sodium lauryl sulfate, sodium oleate, sodium acetate, sodium benzoate, polyethylene glycol, fatty acid, fumaric acid, glyseryl palmito sulphate and/or combinations thereof. Further, the amount of lubricant is preferably in the range of 0.01% w/w to 20% w/w by weight of the composition.

Suitable solvents include but are not limited to purified water, methanol, ethanol, isopropyl
alcohol, methylene chloride/ dichloromethane, chloroform, ethyl acetate, acetone and/or
mixtures thereof.

Suitable plasticizers include but are not limited to, dibutyl sebacate; vegetable oil, e.g., castor
oil or glycerol/glycerin; or a glyceryl ester of a fatty acid, e.g., glyceryl triacetate or glyceryl
monoricinoleate, polyethylene glycol, triethyl citrate, acetyl tributyl citrate, talc and/or mixtures thereof.

The pharmaceutical compositions of the present invention are meant for oral administration.

The compositions can be in the form of tablets, capsules, tablets filled in capsule, mini tablets
filled in capsule, sachets containing powder or granules, pellets, and the like.

The pharmaceutical compositions of present invention can be a monolayer tablet, bilayer tablet
or trilayer tablet.

The present invention also provides kits which include one or more compositions described
herein, in suitable packaging, and can further comprise written material that can include instructions for use and other related literature.

The pharmaceutical composition of the present invention is meant for once daily or twice daily administration.

Core coating matrix systems is a technique used in tablet manufacturing to modify the release rate of a drug from the tablet, It involves incorporating a polymer matrix into the tablet, which acts as a barrier to control the diffusion of the drug out of the tablet, this can be achieved either by incorporating the polymer into the tablet core (monolithic matrix) or by applying a polymer coating to the tablet surface (reservoir matrix), this can be achieved by a core tablet it contains the active drug, along with other necessary ingredients, such as binders and diluents, a controlled-release coating- this layer is applied to the core tablet, acting as a barrier that regulates the rate at which the drug dissolves and is released into the body. Hydrophilic polymers, Hydrophobic polymers are used in this coating matrix systems.

It's a technique used in tablet manufacturing to modify the release rate of a drug from the tablet, It involves incorporating a polymer matrix into the tablet, which acts as a barrier to control the diffusion of the drug out of the tablet, this can be achieved either by incorporating the polymer into the tablet core (monolithic matrix) or by applying a polymer coating to the tablet surface (reservoir matrix).

The pharmaceutical compositions of the present invention may be film coated with various film coating materials known in the art e.g. commercially available Opadry®. The coating may contain film-forming agents, pigments/opacifier such as iron oxide, titanium dioxide, zinc oxide, a plasticizer and one or more other pharmaceutically acceptable excipient.

Examples of film-forming agents include polyvinyl alcohol, ethylcellulose, hydroxypropyl methylcellulose, hydroxypropylcellulose, methylcellulose, carboxymethyl cellulose, hydroxy methylcellulose, hydroxyethyl cellulose, cellulose acetate, hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, cellulose acetate trimellitate; waxes such as polyethylene glycol; methacrylic acid polymers such as Eudragit®. Alternatively, commercially available coating compositions comprising film-forming polymers marketed under various trade names, such as Opadry® may also be used.

According to one embodiment, the pharmaceutical compositions of the present invention can be in the form of modified release dosage form which include, but not limited to, controlled release, sustained release, extended release, prolonged release dosage form. Various rate controlling agents/techniques known in the art may be used to control the release of the drug from the dosage form.

Suitable release controlling agents, include but are not limited to, cellulose derivatives such as hydroxypropylmethylcellulose, hydroxypropylcellulose, hydroxyethyl cellulose, ethylcellulose, microcrystalline cellulose, methylcellulose, carboxymethylcellulose, alginate,
poly(alkylcyanoacrylate), polyethylene, poly(ethylene-co-vinylacetate), poly (hydroxyethyl
methacrylate), poly (hydroxypropylethyl methacrylate), poly (methyl methacrylate), polyurethane, poly (vinyl alcohol), polyvinyl acetate, poly (acrylic acid), polyvinylpyrrolidone, poly (ethylene oxide), poloxamer, polymethacrylates, gums, waxes, collagen, silicon and/or
combinations thereof.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the pharmaceutical composition is used for the treatment of partial-onset seizures.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the pharmaceutical composition contain hydrophobic release controlling agent with core coated matrix system.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the hydrophobic release controlling agent is Ethyl cellulose.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the Brivaracetam is used in the percentage from 20-90%, specifically 20-70% and more specifically 20-50% from total weight of the concentration.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the hydrophobic release controlling agent used in the core from 5-15% from total weight of the concentration.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the hydrophobic release controlling agent used in the coating from 1-10% from total weight of the concentration.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the coating core matrix system is a tablet design that combines a core matrix tablet with an outer coating to control or modify the drug release pattern, the core matrix contains the active drug dispersed within a matrix of polymers or other excipients, the coating layer acts as a barrier, regulating the rate at which the drug dissolves and diffuses out of the tablet.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the ratio between the water insoluble polymer to water soluble polymer in the coating is 2.26

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the insoluble polymer to the drug in the core is 10:3.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the percentage of water insoluble polymer in coating from 11-25%.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the percentage of water soluble polymer in coating from 5-15%.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the complete dissolution time that is the time for release of at least 80% of the total amount of the drug is between about 7 to about 24 hours, preferably between about 8 to about 20 hours when dissolution is carried out in 900 ml of pH 6 phosphate buffer solution, using USP apparatus type II. at 50 rpm and at 37°C or variations of this as well known to one who is skilled in the art.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the total core coated matrix system in the percentage from 2-10% from total weight of the concentration.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients where in the composition is sustained release tablet dosage form.

In one of the embodiments of the present invention relates to the controlled release oral pharmaceutical compositions comprising Brivaracetam or its pharmaceutically acceptable salts thereof wherein the controlled release formulation dissolution profile of Brivaracetam controlled release tablet is evaluated in the phosphate buffer pH 6.4 media with volume of 900ml using type –II paddle apparatus, wherein the speed of paddle is 50 RPM samples were retrieved at the time points 1, 2, 4, 6, 8, 10, 12 & 16 Hrs.

Table 1.
Dissolution profiles of Brivaracetam sustained release tablet 50mg, 100mg, 150mg and 200 mg.
Strength 50 mg 100 mg 150 mg 200 mg
Batch number BRCTX5-
0289-064 BRCTX1-
0280-046 BRCTX7-
0302-067 BRCTX3-
0302-071
Time point(Hrs) % drug release
1 28 26 26 23
2 50 37 39 37
4 59 54 57 55
6 71 66 69 68
8 79 74 78 79
10 86 80 85 85
12 91 85 90 91
16 97 93 98 97

Examples
The following examples are for the purpose of illustration of the invention only and are not intended in any way to limit the scope of the present invention.
Example-1:
Manufacturing Formula:
S. No. Ingredients Qty per Unit (mg)
100 mg 200 mg
Pre Lubrication
1 Brivaracetam 100.00 200.00
2 Lactose Anhydrous (Super tab 21 AN) 40.00 80.00
3 Lactose Monohydrate (Flowlac 100) 20.00 40.00
4 Microcrystalline cellulose (Hicel XLM 90) 20.00 40.00
5 Croscarmellose sodium 20.00 40.00
6 Ethyl cellulose MP - 45 30.00 60.00
7 Colloidal silicon Di oxide
(Aerosil 200 Pharma) 10.00 20.00
Lubrication
8 Magnesium stearate (Ligamed MF-2V) 30.00 60.00
Uncoated Tablet weight 270.00 540.00
Ethyl cellulose coating (5.0% w/w weight build up)
9 Ethyl cellulose N-10 8.50 17.00
10 Hydroxy propyl methyl cellulose (HPMC E 15 LV Premium) 3.75 7.50
11 Dibutyl sebacate 1.25 2.50
12 Isopropyl Alcohol : Dichloro Methane (70:30 ratio) Q.S. Q.S.
Ethyl cellulose coated tablet weight 283.50 567.00
Film coating (2.0% w/w weight build up)
13 Opadry II Purple 85F200021 5.67 --
14 Opadry II Grey 85F275014 -- 11.34
15 Purified water Q.S. Q.S.
Film Coated Tablet weight 289.17 578.34

Manufacturing Process:
Sifting
i. Co-sift colloidal silicon di oxide and microcrystalline cellulose (Hicel XLM 90) through sieve no. #40.
ii. Co sift Ethyl Cellulose MP-45 with step no. i through sieve no. #40.
iii. Co sift Lactose Anhydrous (Super tab 21 AN), Brivaracetam, Lactose Monohydrate (Flow lac 100) and Croscarmellose sodium through sieve no. #30.
iv. Co sift step no. ii and step no. iii through sieve no. #30.
v. Re sift the blend of step no. iv through sieve no. #30.
vi. Sift the magnesium stearate through sieve no. #60
Blending and Lubrication
vii. Load the sifted material of step v into a suitable blender and mix for 20 minutes at 10 ± 2 rpm (Set 10 RPM).
viii. Add the step vi sifted material of Magnesium stearate to step-vii blend and mix for 5 minutes at 10 ± 2 rpm (Set 10 RPM).
Compression
ix. Compress the lubricated blend of step viii with compression machine parameters presented in Table.

Ethyl cellulose Coating:
x. Disperse the Ethyl Cellulose N-10, Hydroxy Propyl Methyl Cellulose E15 and Dibutyl Sebacate in Isopropyl Alcohol and Dichloromethane (in 70:30 ratios with 5% solids) under stirring and continue stirring for another 45 minutes till uniform dispersion is achieved.
xi. Load the uncoated tablets of step-ix in coating pan and pre-warm the tablets for 10 minutes at product temperature 30°C – 40°C and coat the tablets for 5.0% ± 0.5% w/w (4.5% w/w – 5.5% w/w) with coating parameters presented in following table.
xii. After achieving the desired weight gain dry the coated tablets for 10 minutes at product temperature 30°C – 40°C.
Film coating:
i. Disperse the Opadry II Purple 85F200021 for 100 mg and Opadry II Grey 85F275014 for 200 mg in Purified water (with 12 % solids) under stirring and continue stirring for another 45 minutes till uniform dispersion is achieved.
ii. Load the Coated tablets of step-xii in coating pan and pre-warm the tablets for 10 minutes at product temperature 30°C – 40°C and coat the tablets for 2.0% ± 0.5% w/w with coating parameters presented in following table.
After achieving the desired weight gain dry the coated tablets for 10 minutes at product temperature 30°C – 40°C.
,CLAIMS:1) A controlled release composition comprising Brivaracetam or its pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients, where in the pharmaceutical composition contain hydrophobic release controlling polymer with core coated matrix system.

2) The controlled release composition comprising Brivaracetam as claimed in claim 1, where in the hydrophobic release controlling polymer is Ethyl cellulose.

3) The controlled release composition comprising Brivaracetam as claimed in claim 1, where in the hydrophobic release controlling polymer used in the core from 5-15% from total weight of the concentration.

4) The controlled release composition comprising Brivaracetam as claimed in claim 1, where in the hydrophobic release controlling agent used in the coating from 1-10% from total weight of the concentration.

5) The controlled release composition comprising Brivaracetam as claimed in claim 1, where in the total core coated matrix system in the percentage from 2-10% from total weight of the concentration.

6) The controlled release composition comprising Brivaracetam as claimed in claim 1, where in the Brivaracetam is used in the percentage from 20-90%, specifically 20-70% and more specifically 20-50% from total weight of the concentration.

7) The controlled release composition comprising Brivaracetam as claimed in claim 1, where in the pharmaceutically acceptable excipient are diluents, binders, disintegrant, surfactants, lubricants, glidants, polymer, plasticizer, solvents and colouring agents and/or combinations thereof.
8) The controlled release composition comprising Brivaracetam as claimed in claim 1, where in the pharmaceutically acceptable excipient are lactose anhydrous, microcrystalline cellulose, croscarmellose sodium, ethyl cellulose, colloidal silicon di oxide, magnesium stearate, hydroxy propyl methyl cellulose, dibutyl sebacate, isopropyl alcohol : dichloro methane.

9) The controlled release composition comprising Brivaracetam as claimed in claim 1, where in the pharmaceutical composition is in the form of a tablet, capsule or caplet.

10) The process for preparation of controlled release composition as claimed in claim 1, co-sift the Brivaracetam with ingredients, blending and lubricating the above mixture, compress the lubricated blend, prepare ethyl cellulose coating layer with ingredients and film coating the tablet and blending with siutable parameters.