An orodispersible tablet of carbamazepine and its process of preparation.

Abstract

The present invention relates to an orodispersible tablet comprising carbamazepine or pharmaceutically acceptable salts thereof, at least one disintegrant, at least one diluent, at least one binder, at least one lubricant, and one or more pharmaceutically acceptable excipients. The orodispersible tablet prepared using these excipients 5 exhibits desirable properties such as facilitating disintegration, and dissolution of the drug for oral administration. Further, the present invention also relates to the process for preparing the said solid pharmaceutical composition.

Description

[0001] An Orodispersible tablet of Carbamazepine and its process of preparation.

[0002] Field of the Invention

[0003] The present invention relates to a pharmaceutical composition of carbamazepine. The present invention relates to an orodispersible tablet of carbamazepine or pharmaceutically acceptable salt thereof for oral administration. The present invention also relates to the process of the preparation of the same.

[0004] Background of the Invention

[0005] Carbamazepine was first disclosed in US294871 A. Carbamazepine is a dibenzoazepine an anticonvulsant drug and analgesic drug used to control seizures and to treat pain resulting from trigeminal neuralgia. Carbamazepine exerts its effects by lowering polysynaptic nerve response and inhibiting post-tetanic potentiation. In animal studies, carbamazepine was shown to decrease pain caused by infraorbital nerve stimulation. A decrease in the action potential in the nucleus ventralis of the thalamus in the brain and inhibition of the lingual mandibular reflex were observed in other studies after carbamazepine use. Carbamazepine causes the said effects by binding to voltagedependent sodium channels and preventing action potentials, which normally lead to stimulatory effects on nerves. In bipolar disorder, carbamazepine is thought to increase dopamine turnover and increase GABA transmission, treating manic and depressive symptoms.

[0006] Carbamazepine is indicated for the treatment of epilepsy and pain associated with true trigeminal neuralgia. In particular, carbamazepine has shown efficacy in treating mixed seizures, partial seizures with complex symptoms, and generalized tonic-clonic seizures. Additionally, it is also indicated for the managing of manic episodes and mixed manic-depressive episodes caused by bipolar I disorder. Some off-label, unapproved uses of carbamazepine include the treatment of alcohol withdrawal syndrome and restless leg syndrome.

[0007] The IUPAC name of carbamazepine is benzo[b][l] benzazepine- 11 -carboxamide and the chemical structure is as follows

[0008] Carbamazepine belongs to the biopharmaceutics classification system BCS class II drugs with low solubility and high permeability. The plasma half-life of carbamazepine is 12-17 hours after several doses. Carbamazepine is currently available in the market as an oral tablet, chewable tablet, oral suspension, extended-release capsules and extended-release tablet, solutions, suppositories, and prolonged-release tablet. The chewable tablets of Carbamazepine are available in two dose strengths: 100 mg and 200 mg. The suspension is available in dose strength as 100mg / 5ml. Extended-release capsules are available in three dose strengths as: 100 mg, 200 mg, and 300 mg. Extended-release tablets are available in 100 mg, 200 mg, and 400 mg. Prolonged- release tablets are available in two dose strengths: 200mg and 400 mg. Suppositories are available in one dose strength: 250mg.

[0009] CN106265548A discloses an oral dispersible tablet of carbamazepine, which contains sodium carboxymethyl cellulose, lactose, carboxymethyl starch sodium, pulvis talci, and aspartame. The process involves dissolving carbamazepine and the binding agent in ethanol to create a pastille binding agent. Sieving and mixing a combination of filler, lubricant, and disintegrant. Adding the pastille binding agent into the mixture prepared in the above step, and the prepared granules are dried and sieved. The granules are compressed into a tablet.

[0010] CN116473932A discloses an oral tablet of carbamazepine and a preparation method thereof; the tablet is prepared by mixing and tableting component A and component B: wherein, the A component is: carbamazepine, hydroxypropyl methylcellulose and alpha-methyl-L-tyrosine; the component B is as follows: filler, preservative and lubricant. The mixture is directly compressed to form the tablet.

[0011] The commercially available solid and liquid oral dosage forms of carbamazepine present many challenges as the dosing frequency of marketed tablets of carbamazepine is thrice a day which leads to patient non-compliance and difficulty in swallowing for pediatric and geriatrics, dysphagic, bedridden, psychiatric, or neurological patients. Carbamazepine is a bitter drug with poor solubility in liquids. Therefore, by formulating an orodispersible tablet of carbamazepine, the aforementioned problems can be resolved. Unlike oral liquid dosage forms, orodispersible tablet ensure dose accuracy and are more stable. The present invention discloses the formulation of an orodispersible tablet of carbamazepine to achieve benefits such as faster disintegration, improved palatability, and good patient compliance.

[0012] Summary of the Invention

[0013] In accordance with the present invention, an orodispersible tablet of carbamazepine is prepared. An orodispersible tablet comprises carbamazepine or pharmaceutically acceptable salts thereof, at least one diluent, at least one disintegrant, at least one binder, at least one lubricant, and one or more pharmaceutically acceptable excipient.

[0014] Another embodiment of the present invention is to provide taste-masking properties, present pleasant palatability, and good patient compliance. Another embodiment of the present invention, is to provide a process for the preparation of an orodispersible tablet of pregabalin preferably a wet granulation method.

[0015] Further, another embodiment of the present invention which effectively treat epilepsy and pain associated with true trigeminal neuralgia, treating mixed seizures, partial seizures with complex symptoms, and generalized tonic-clonic seizures, manic episodes and mixed manic-depressive episodes caused by bipolar I disorder, alcohol withdrawal syndrome and restless leg syndrome.

[0016] Objects of the Invention

[0017] The principal object of the present invention is to provide an orodispersible tablet of carbamazepine or pharmaceutically acceptable salts thereof.

[0018] It is an object of the present invention to provide an orodispersible tablet, which is beneficial in overcoming swallowing challenges for paediatric and geriatric patients and presents pleasant palatability and for patients with dysphagia.

[0019] It is further another object of the present invention to provide an orodispersible tablet comprising carbamazepine or its pharmaceutically acceptable salts thereof with faster disintegration and dissolution rate.

[0020] Yet another object of the present invention is to provide a stable and uniform orodispersible tablet of carbamazepine or its pharmaceutically acceptable salt thereof. Detailed description of the Invention

[0021] The invention is further illustrated by the following examples, which are by no means intended to limit the scope of the invention but are given by way of illustration.

[0022] The term “Orodispersible tablet” refers to “a solid dosage form containing medical substances which disintegrate rapidly when placed upon the tongue.

[0023] The term “about” is used herein to mean approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term "about", as and when used in this specification, means ±10 % of the mentioned value.

[0024] The term “% w / w” is intended to mean the percentage of an ingredient(s) / the total percentage by weight of the composition (100%). Here the % w / w is to be calculated against the total weight of the composition.

[0025] The main embodiment of the present invention is an orodispersible tablet comprised of carbamazepine or pharmaceutically acceptable salts thereof, at least one disintegrant, at least one diluent, and at least one binder. In addition, the orodispersible tablet further comprises one or more pharmaceutically acceptable excipients selected from a glidant, sweetener, flavoring agent, and lubricant.

[0026] The preferred embodiment of the invention is an orodispersible tablet suitable for oral administration comprising carbamazepine or pharmaceutically acceptable salts thereof, is present in an amount from about 40%w / w to about 60%w / w, preferably in the range from about 45%w / w to about 55%w / w. The D90 particle size of carbamazepine or a pharmaceutically acceptable salt thereof in the range from about 200pm to about 310 pm, preferably in the range from about 230pm to about 290pm.

[0027] As per one embodiment of the present invention, a diluent is selected from the group consisting of microcrystalline cellulose, dextrates, dextrose, fructose, starch, pregelatinized starch, sucrose, maltose, maltodextrin, sugar alcohols, hydrolysed starches, dicalcium phosphate or any combinations thereof. In the present invention, combination of mannitol and pregelatinized starch is preferred as diluent in the range from about 15%w / w to about 65%w / w, preferably in the range from about 25%w / w to about 55%w / w. Mannitol is present in the range from about 10%w / w to about 40%w / w, preferably in the range from about 15%w / w to about 30%w / w. Pregelatinized starch is present in the range from about 10%w / w to about 30%w / w, preferably in the range from about 15%w / w to about 25%w / w. Mannitol is preferred as diluent as it imparts multifunctional benefits such as easy availability, good aqueous solubility and wetting properties and cooling effect in the mouth. Pregelatinized starch is preferred as diluent it produces granules with appropriate size and contributes to good compressibility.

[0028] As per one embodiment of the present invention, a suitable disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, cross-linked polyvinylpyrrolidone, croscarmellose, magnesium aluminium silicate, low- substituted hydroxypropyl cellulose, natural, modified or pregelatinized starch or any combinations thereof. In the present invention, Crospovidone is preferred as disintegrant in the range from about 0.5 %w / w to about 10 %w / w, preferably in the range from about 1 %w / w to about 5 %w / w. Crospovidone act by a wicking mechanism; drawing water into the tablet through capillary action due to its porous particle morphology, resulting in secondary swelling and rupture of interparticulate bonds and tablet disintegration. As per one embodiment of the present invention, a binder is selected from the group consisting of microcrystalline cellulose, sodium carboxymethylcellulose, polyvinyl alcohol, starch, polyethylene glycol, sorbitol, hydroxyl propyl methylcellulose, povidone, hydroxyl propyl cellulose or any combinations thereof. In the present invention, povidone is preferred as the binder in the range from about 0.05 %w / w to about 3.5 %w / w, preferably in the range from about 0.5 %w / w to 2.5 %w / w. Binders hold the ingredients in a tablet together to ensure that tablets and granules can be formed with the required mechanical strength.

[0029] As per one embodiment of the present invention, a lubricant is selected from the group consisting of magnesium stearate, calcium stearate, stearic acid, and talc or any combination thereof. Magnesium stearate is preferred as lubricant in the present invention in the range from about 0.1 %w / w to about 10 %w / w, preferably in the range from about 0.5 %w / w to about 5 %w / w. Lubricants are added in formulating orodispersible tablets to improve their flow properties during the manufacturing process and prevent sticking.

[0030] As per one embodiment of the present invention, a glidant is selected from the group consisting of talc, colloidal silicon dioxide, magnesium stearate, silica gel, precipitated silica, or any combination thereof. In the present invention, Colloidal anhydrous silica is preferred as a glidant in the range from about 0.05 %w / w to about 5 %w / w, preferably in the range from about 0.1 %w / w to about 1 %w / w.

[0031] As per one embodiment of the present invention, a sweetener is selected from the group consisting of aspartame, saccharin, and sucralose or any combinations thereof. In the present invention, sodium saccharin is preferred as a sweetener in the range from about 0.01 %w / w to about 1 %w / w, preferably in the range from about 0.05 %w / w to about 0.5 %w / w.

[0032] As per one embodiment of the present invention, a flavoring agent is selected from the group consisting of peppermint, cherry, and orange or any combinations thereof. In the present invention, orange flavour is preferred as flavouring agent in the range from about 0. l%w / w to about 5%w / w, preferably in the range from about 0.5%w / w to about 3%w / w.

[0033] As per one embodiment of the present invention, the orodispersible tablet of carbamazepine is used for the treatment of epilepsy and pain associated with true trigeminal neuralgia, treating mixed seizures, partial seizures with complex symptoms, and generalized tonic-clonic seizures, manic episodes, and mixed manic-depressive episodes caused by bipolar I disorder, alcohol withdrawal syndrome, and restless leg syndrome.

[0034] As per one embodiment of the present invention, the orodispersible tablet comprising an antiepileptic drug or its pharmaceutically acceptable salts thereof, present in an amount from about 40%w / w to about 60%w / w, preferably in the range from about 45%w / w to about 55%w / w, a combination of diluent is present in the range from about 15%w / w to about 65%w / w, preferably in the range from about 25%w / w to about 55%w / w, a disintegrantis present in the range from about 0.5 %w / wto about 10 %w / w, preferably in the range from about 1 %w / w to about 5%w / w, a binder is present in the range from about 0.05%w / w to about 3.5%w / w, preferably in the range from about 0.5%w / w to about 2.5%w / w, a lubricant is present in the range from about 0.1%w / w to about 10 %w / w, preferably in the range from about 0.5%w / w to about 5 %w / w, a glidant is present in the range from about 0.05%w / w to about 5 %w / w, preferably in the range from about 0.1 %w / w to about 1 %w / w, a sweetener is present in the range from about 0.01%w / w to about l%w / w, preferably in the range from about 0.05%w / w to about 0.5%w / w, a flavouring agent is present in the range from about 0.1%w / w to about 5%w / w, preferably in the range from about 0.5%w / w to about 3%w / w.

[0035] As per one embodiment of the present invention, the orodispersible tablet comprising carbamazepine or its pharmaceutically acceptable salts thereof, present in an amount from about 40%w / w to about 60%w / w, preferably in the range from about 45%w / w to about 55%w / w, a combination of mannitol and pregelatinized starch is present in the range from about 15%w / w to about 65%w / w, preferably in the range from about 25%w / w to about 55%w / w, Crospovidone is present in the range from about 0.5 %w / w to about 10 %w / w, preferably in the range from about 1 %w / w to about 5%w / w, povidone is preferred as binder in the range from about 0.05%w / w to about 3.5%w / w, preferably in the range from about 0.5%w / w to about 2.5%w / w, magnesium stearate is preferred as lubricant in the range from about 0. l%w / w to about 10 %w / w, preferably in the range from about 0.5%w / w to about 5 %w / w, colloidal anhydrous silica is suitable glidant present in the range from about 0.05%w / w to about 5 %w / w, preferably in the range from about 0.1 %w / w to about 1 %w / w, sodium saccharin is preferred as sweetener in the range from about 0.01 %w / w to about 1 %w / w, preferably in the range from about 0.05 %w / w to about 0.5 %w / w, orange flavour is flavouring agent present in the range from about 0. l%w / w to about 5%w / w, preferably in the range from about 0.5%w / w to about 3%w / w.

[0036] As per one embodiment of the present invention, the ratio of diluent to disintegrant is in the range from about 5: 1 to about 25: 1, preferably in the range from about 10: 1 to about 20: 1. As per preferred embodiment of the present invention, the ratio of combination of mannitol and pregelatinized starch to Crospovidone is in the range from about 5: 1 to about 25: 1, preferably in the range from about 10: 1 to about 20: 1.

[0037] Another embodiment of the present invention is to prepare orodispersible tablet of carbamazepine or its pharmaceutically acceptable salts thereof by wet granulation process, which is one of the most economical methods.

[0038] As per one another embodiment, the disintegrating time of orodispersible tablet of carbamazepine is less than 3 minutes, preferably less than 2 minutes. As per another embodiment of the present invention, 90% of carbamazepine is released from said tablets in 60 minutes, preferably more than 90% is released within 45 minutes.

[0039] As per one embodiment of the present invention, the stability study of an orally disintegrating tablet of carbamazepine or its pharmaceutically acceptable salts thereof was carried out by placing tablets in Alu-Alu / PVC-PVDC-Blister and HDPE bottle with CR cap and was stored under the storage condition of 25°C / 60% RH and 40°C / 75% RH for 1 month. The orodispersible tablet of carbamazepine delivered acceptable physical and chemical properties in said packaging condition in stability studies.

[0040] As per one embodiment of the present invention, the wet granulation method is used to manufacture the orodispersible tablet of carbamazepine. Carbamazepine, Pregelatinized Starch, mannitol was sieved separately and co-sifted through sieve #25. mannitol, crospovidone, sodium saccharin, colloidal anhydrous silica, and orange flavor were sieved separately through 40# sieve. Magnesium stearate was separately passed through 60# sieve. Binder solution was prepared by taking povidone and sufficient quantity of purified water to make light viscous binder solution. Dry-mixture was prepared by taking sifted quantity of carbamazepine, pregelatinized starch, mannitol and mixed properly in rapid mixer granulator for 10 minutes at slow impeller speed. Previously prepared binder solution was mixed with dry mixture with continuous mixing in rapid mixer granulator for 5 minutes at slow impeller speed. The dough mass thus obtained was checked for its granulation characteristics. The granulated blend was dried in a dryer at 50°C ± 5°C up to 2.5% loss on drying and then sieved first through 30# and remaining granules were milled through 1.5mm screen and blend was passed through 30## sieve. To this resulting mixture, crospovidone, mannitol, sodium saccharine, colloidal anhydrous silica and orange flavour were added and mixed for 15 minutes in blender. To this final mixture, magnesium stearate was added and mixed properly for 5 minutes. The final mixture was compressed to tablet dosage form. The stability study of orodispersible tablet of carbamazepine or its pharmaceutically acceptable salts thereof was carried out by placing tablets in Alu- Alu / PVC-PVDC-Blister and HDPE bottle with CR cap and was stored under the storage condition of 25°C / 60% RH and 40°C / 75% RH for 1 month. The orodispersible tablet of carbamazepine delivered acceptable physical and chemical properties in said packaging condition in stability studies.

[0041] The invention is further illustrated by the following examples, which are by no means intended to limit the scope of the invention but are given by way of illustration.

[0042] Example 1

[0043] The orodispersible tablet was manufactured according to the method defined below using the formulation having the ingredients shown in Table I for different dose strengths are lOOmg and 200mg of Carbamazepine:

[0044] TABLE-I Manufacturing Process:

[0045] Carbamazepine, pre-gelatinized starch, mannitol were sieved separately through sieve#25. Crospovidone, sodium saccharine, colloidal anhydrous silica, and orange flavour were sieved separately through 40# sieve. Magnesium stearate was separately sieved through 60# sieve. Previously sifted quantity of carbamazepine, pre-gelatinized starch, mannitol then added in blender and blended together for 10 minutes. To this mixture, crospovidone, sodium saccharin, colloidal anhydrous silica and orange flavour and blended for 15 minutes in blender. Magnesium stearate in specified quantity was added to final mixture and blended for 15 minutes.

[0046] Blend flow was poor, further compression activity not performed. In order to optimize blend, flow it was necessary to change formulation.

[0047] Example 2

[0048] The orodispersible tablet was manufactured according to the method defined below using the formulation having the ingredients shown in Table II for different dose strengths are lOOmg and 200mg of Carbamazepine:

[0049] Table II

[0050]

[0051] Manufacturing Process:

[0052] Carbamazepine, pregelatinized starch, mannitol was co-sifted and sieved separately through Sieve#25. Mannitol, Crospovidone, sodium saccharin, colloidal anhydrous silica, and orange flavour were sieved through 40# sieve. Magnesium stearate was separately sieved through 60# sieve. Binder solution was prepared by taking povidone K30 and sufficient quantity of purified water to make light viscous binder solution. Carbamazepine, pregelatinized starch, mannitol was mixed properly in rapid mixer granulator for 10 min at slow impeller speed to form dry-mixture. Binder solution prepared in earlier step was mixed with dry mixture in rapid mixer granulator with continuous mixing for 5 minute and further mixture was granulated for 2 minute at slow impeller speed. The resultant dough mass was checked for proper granulation characteristics. The granulated blend thus obtained was dried in a dryer at 50°C ± 5°C up to 2.5% loss on drying and sieved first through 30# sieve and remaining granules were milled through 1.5mm screen and further passed through 1.5mm screen and all blend was passed through 30# sieve. This dried and sieved mixture was pre-lubricated by mixing Crospovidone, mannitol, Sodium saccharine, Colloidal anhydrous silica and orange flavour and mixed in blender for 15 minutes. To this final mixture, magnesium stearate was added and mixed properly for 5 minutes. Disintegration time was more than 3 minutes. It was necessary to increase the concentration of disintegrant.

[0053] Example 3

[0054] The orodispersible tablet was manufactured according to the method defined below using the formulation having the ingredients shown in Table III for different dose strengths are lOOmg and 200mg of Carbamazepine:

[0055] Table III

[0056] Manufacturing Process:

[0057] Carbamazepine, pregelatinized Starch, mannitol is sieved separately and co-sifted through sieve #25. Mannitol, Crospovidone, sodium saccharine, Colloidal anhydrous silica, and orange flavor were sieved separately through 40# sieve. Magnesium stearate was separately through 60# sieve. Binder solution was prepared by taking povidone K30 and sufficient quantity of purified water to make light viscous binder solution. Dry-mixture was prepared by taking sifted quantity of carbamazepine, pregelatinized starch, mannitol and mixed properly in rapid mixer granulator for 10 minutes at slow impeller speed. Previously prepared binder solution was mixed with dry mixture with continuous mixing in rapid mixer granulator for 5 minutes at slow impeller speed. The dough mass thus obtained was checked for its granulation characteristics. The granulated blend was dried in a dryer at 50°C ± 5°C up to 2.5% loss on drying and then sieved first through 30# and remaining granules were milled through 1.5mm screen and passed all blend through 30## sieve. To this resulting mixture, Crospovidone, mannitol 200 SD, Sodium saccharine, Colloidal anhydrous silica and orange flavour were added and mixed for 15 minutes in blender. To this final mixture, magnesium stearate was added and mixed properly for 5 minutes. The final mixture was compressed to tablet dosage form. The stability study of orodispersible tablet of carbamazepine or its pharmaceutically acceptable salts thereof was carried out by placing tablets in Alu-Alu / PVC-PVDC-Blister and HDPE bottle with CR cap and was stored under the storage condition of 25°C / 60% RH and 40°C / 75% RH for 1 month. The orodispersible tablet of carbamazepine delivered acceptable physical and chemical properties in said packaging condition in stability studies.

[0058] All the physical and chemical parameters of tablets were found satisfactory.

[0059] Example-4: The dissolution profile of the tablet prepared according to Example 3

[0060] The conditions of dissolution are as follows:

[0061] Product name: Carbamazepine 200 mg orodispersible tablet

[0062] Apparatus: USP II (Paddle) apparatus

[0063] Rate of rotation: 75 RPM

[0064] Volume: 900 mL

[0065] Temperature:37°C

[0066] Dissolution medium: water + 1.0 % SLS The orodispersible tablet of carbamazepine was analysed for its dissolution profile and measured in 900ml of water + 1.0 % SLS in USP II (Paddle) apparatus and the active ingredient of the tablet is released is more than 90% in 45 minutes.

[0067] Example 5: The tablets prepared according to example 3 were subjected to a stability study of 25°C / 60% RH and 40°C / 75% RH for 1 month. Results are tabulated below:

[0068] Carbamazepine 200 mg orodispersible tablet

Claims

Claims:

1. An orodispersible tablet of carbamazepine for oral administration comprising: a) Carbamazepine or pharmaceutically acceptable salts thereof, is present in an amount ranging from about 40%w / w to about 60%w / w, preferably in the range from about 45%w / w to about 55%w / w; b) at least one diluent; and c) one or more pharmaceutically acceptable excipients.

2. The orodispersible tablet according to claim 1, wherein the diluent is selected from the group consisting of microcrystalline cellulose, dextrates, dextrose, fructose, starch, pregelatinized starch, sucrose, maltose, maltodextrin, sugar alcohols, hydrolysed starches, dicalcium phosphate or any combinations thereof.

3. The orodispersible tablet according to claim 2, wherein the diluent is the combination of mannitol and pregelatinized starch present in the range from about 15%w / w to about 65%w / w, preferably in the range from about 25%w / w to about 55%w / w.

4. The orodispersible tablet according to claim 2, wherein the diluent is mannitol present in the range from about 10%w / w to about 40%w / w, preferably in the range from about 15%w / w to about 30%w / w.

5. The orodispersible tablet according to claim 2, wherein the diluent is pregelatinized starch present in the range from about 10%w / w to about 30%w / w, preferably in the range from about 15%w / w to about 25%w / w.

6. The orodispersible tablet according to claim 1, wherein the disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, cross-linked polyvinylpyrrolidone, croscarmellose, magnesium aluminium silicate, low-substituted hydroxypropyl cellulose, natural, modified or pregelatinized starch or any combinations thereof.

247. The orodispersible tablet according to claim 6, wherein the disintegrant is crospovidone present in the range from about 0.5 %w / w to about 10 %w / w, preferably in the range from about 1 %w / w to about 5 %w / w.

8. The orodispersible tablet according to claim 1, wherein the ratio of diluent to disintegrant is in the range from about 5:1 to about 25: 1, preferably in the range from about 10: 1 to about 20:1.

9. The orodispersible tablet according to claim 1, wherein the binder is selected from the group consisting of microcrystalline cellulose, sodium carboxymethylcellulose, polyvinyl alcohol, starch, polyethylene glycol, sorbitol, hydroxyl propyl methyl cellulose, povidone, hydroxyl propyl cellulose or any combinations thereof.

10. The orodispersible tablet according to claim 9, wherein the binder is povidone present in the range from about 0.05%w / w to about 3.5%w / w, preferably in the range from about 0.5%w / w to 2.5%w / w.

11. The orodispersible tablet according to claim 1, wherein the lubricant is selected from the group consisting of magnesium stearate, calcium stearate, stearic acid, and talc or any combinations thereof.

12. The orodispersible tablet according to claim 11, wherein the lubricant is magnesium stearate present in the range from about 0.1%w / w to about 10 %w / w, preferably in the range from about 0.5%w / w to about 5 %w / w.

13. The orodispersible tablet according to claim 1, wherein the glidant is selected from the group consisting of talc, colloidal silicon dioxide, magnesium stearate, silica gel, precipitated silica, or any combinations thereof.

14. The orodispersible tablet according to claim 13, wherein colloidal anhydrous silica is preferred as a glidant in the range from about 0.05 %w / w to about 5 %w / w, preferably in the range from about 0.1 %w / w to about 1 %w / w.

15. The orodispersible tablet according to claim 1, wherein one or more pharmaceutically acceptable excipients, are selected from the sweeteners or flavoring agent.

16. The orodispersible tablet according to claim 15, wherein the sweetener is selected from the group consisting of aspartame, saccharin, and sucralose or any combinations thereof.

17. The orodispersible tablet according to claim 15, wherein the flavoring agent is selected from the group consisting of peppermint, cherry, and orange or any combinations thereof.

18. The orodispersible tablet according to claim 15, further comprises sodium saccharin and orange flavor.

19. The orodispersible tablet according to claim 1, wherein the D90 particle size of carbamazepine or a pharmaceutically acceptable salts thereof is in the range from about 200pm to about 310 pm, preferably in the range from about 230pm to about 290pm.

20. The orodispersible tablet according to claim 1, wherein the orodispersible tablet of carbamazepine is manufactured by wet granulation method comprising the steps of:(a) Sieving separately carbamazepine, pregelatinized starch, mannitol and co-sifted through sieve #25;(b) Sieving separately Mannitol, crospovidone, sodium saccharin, colloidal anhydrous silica, and orange flavor through 40# sieve and magnesium stearate through 60# sieve;(c) Preparing binder solution by mixing of povidone and sufficient quantity of purified water;(d) Preparing dry mixture by mixing sifted quantity of carbamazepine, pregelatinized starch, mannitol in rapid mixer granulator;(e) Continuous mixing previously prepared binder solution with dry mixture of step- (d) in rapid mixer granulator;(f) Drying of granulated blend in a dryer and then sieved first through 30# and remaining granules were milled through 1.5mm screen and passed through 30## sieve;(g) Blending of Crospovidone, mannitol, sodium saccharine, colloidal anhydrous silica and orange flavour to the mixture formed in Step-(f) and mixed in blender for 15 minutes;(h) Adding of magnesium stearate to the final mixture of Step-(g) and mixed in blender for 5 minutes; and(i) Compressing the final blend into tablets and packing said tablets into Alu-Alu / PVC- PVDC-Blister and HDPE bottle with CR cap.

21. The orodispersible tablet according to claim 1, wherein the orodispersible tablet of carbamazepine is disintegrated upon contact with saliva in less than 3 minutes, preferably less than 2 minutes.

22. The orodispersible tablet according to claim 1, 90% of carbamazepine is released from said tablets in 60 minutes, preferably more than 90% is released within 45 minutes.

23. The orodispersible tablet according to claim 1, is used for the treatment of epilepsy, true trigeminal neuralgia, mixed seizures, partial seizures with complex symptoms, generalized tonic-clonic seizures, manic episodes and mixed manic-depressive episodes, alcohol withdrawal syndrome, and restless leg syndrome.

24. The orodispersible tablet according to claim 1, wherein:(a) 40%w / w to about 60%w / w, preferably in the range from about 45%w / w to about 55%w / w of carbamazepine or a pharmaceutically acceptable salt thereof;(b) a combination of mannitol and pregelatinized starch present in the range from about 15%w / w to about 65%w / w, preferably in the range from about 25%w / w to about 55%w / w;(c) 10%w / w to about 40%w / w, preferably in the range from about 15%w / w to about 30%w / w of mannitol;(d) 10%w / w to about 30%w / w, preferably in the range from about 15%w / w to about 25%w / w of pregelatinized starch;(e) 0.5 %w / w to about 10 %w / w, preferably in the range from about 1 %w / w to about 5 %w / w of Crospovidone;(f) 0.05%w / w to about 3.5%w / w, preferably in the range from about 0.5%w / w to 2.5%w / w of povidone;(g) 0.1%w / w to about 10 %w / w, preferably in the range from about 0.5%w / w to about 5 %w / w of magnesium stearate;(h) 0.05%w / w to about 5 %w / w, preferably in the range from about 0.1 %w / w to about 1 %w / w of colloidal anhydrous silica;(i) 0.01 %w / w to about 1 %w / w, preferably in the range from about 0.05%w / w to about 0.5 %w / w of sodium saccharin; and(j) 0.1%w / w to about 5%w / w, preferably in the range from about 0.5%w / w to about 3%w / w of orange flavour.

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