Description:Field of invention
The present invention relates to a pharmaceutical composition comprising Lasmiditan or a pharmaceutically acceptable salt thereof. In particular, the invention relates to a dispersible/disintegrating tablet comprising lasmiditan or a pharmaceutically acceptable salt thereof.
Background
Lasmiditan is a selective and highly potent 5-HT1F receptor agonist, approved for the acute treatment of migraines, with or without aura, in adult patients. Its unique mechanism of action makes it an effective option for migraine relief, particularly for patients who may not tolerate traditional triptan therapies. Lasmiditan was first approved by the FDA in October 2019 under the trade name REYVOW®. Despite its clinical efficacy, Lasmiditan presents challenges in formulation due to its highly bitter taste and high solubility, which can compromise patient compliance and acceptability. Available as immediate-release (IR) tablets, Lasmiditan offered reliable efficacy but posed challenges for specific patient groups, such as those experiencing nausea, vomiting, or difficulty swallowing solid dosage forms during migraine attacks.
To address these issues, International patent application no. WO2022/236004 discloses an orally disintegrating tablet (ODT) formulation of Lasmiditan. This formulation incorporates reverse enteric coating technology to mask the drug’s inherently bitter taste by preventing release in the oral cavity. The ODT dissolves in saliva, allowing patients to take the medication without the need for water. However, while this innovation improved palatability and ease of administration, its dissolution and absorption were still dependent on gastric processes, potentially delaying the onset of therapeutic action.
Effective migraine treatment demands rapid drug dissolution and absorption to alleviate symptoms promptly. Thus, there is still a need in the art for a Lasmiditan formulation that addresses the pharmacokinetic limitations of the prior art ODT formulation. The inventors of the subject invention have developed Lasmiditan dispersible tablets (DT) which addresses the pharmacokinetic limitations of the ODT formulation. By leveraging Lasmiditan's high solubility in water (23.6 mg/mL), the DT formulation allows the drug to dissolve in water before administration. This ensures faster drug availability for absorption and potentially accelerates the onset of relief compared to the ODT.
The DT formulation of the invention will eliminate reliance on gastric dissolution, enabling pre-dissolution in water to ensure quicker absorption and action. For patients with severe nausea or vomiting, dissolving the DT in water before administration offers a more practical alternative to ODTs, which require saliva-mediated disintegration. DTs cater to a wider range of patients, including children or adults with severe dysphagia, who may struggle to use ODTs or conventional tablets.
The Lasmiditan DT of the subject invention represents a significant advancement in migraine management, combining the convenience of a water-dispersible dosage form with the pharmacokinetic benefits of rapid drug availability. By addressing the limitations of ODTs and offering faster onset of action, Lasmiditan DT provides an improved therapeutic option for patients requiring immediate relief from migraine symptoms.
Description
All technical and scientific terms used herein have the same meanings as commonly understood by someone ordinarily skilled in the art to which the present subject matter belongs. The following definitions are provided for clarity.
As used herein, lasmiditan include pharmaceutically acceptable salts thereof, including but not limited to 2,4,6-trifluoro-N-[6-(1-methyl-piperidin-4-ylcarbonyl)-pyridin-2-yl]-benzamide mono-hydrochloride salt, and 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide hemi-succinate salt. A synthetic route for the preparation of lasmiditan and it pharmaceutically acceptable salts are as per the available prior art.
The use of the terms "a" and "an" and "the" and similar referents in the context of describing the invention (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context.
As used herein, the term “disintegrating tablet” or "dispersible tablet formulation" refers to a tablet which disperses in aqueous phase, for example water, before administration Typically, dispersible tablets are solid pharmaceutical forms which are defined by their rate of disintegration in water and the uniformity of dispersion of the particles into which they disintegrate.
The present invention is a lasmiditan composition that eliminates all of the above-listed problems and featuring additional technical aspects.
On the basis of the field of invention, the object of this invention is to provide a stable lasmiditan composition with desired dissolution and absorption.
In an embodiment the present invention provides a pharmaceutical composition comprising Lasmiditan for acute treatment of migraines, with or without aura.
The present invention provides a dispersible solid oral dosage form comprising lasmiditan and one or more pharmaceutically acceptable excipients.
The dispersible solid oral dosage forms according to the present invention can be in the form of tablets, capsules, pellets, granules. powders, coated granules, coated pellets etc. The preferred dosage form of the present invention is a tablet. The coated granules or pellets can be filled in capsules or compressed into a tablet.
In an embodiment the present invention provides a pharmaceutical composition comprising lasmiditan, wherein the pharmaceutical composition is in the form of disintegrating or dispersible tablets.
In an embodiment the present invention provides a disintegrating or dispersible tablet comprising lasmiditan and pharmaceutically acceptable excipients for acute treatment of migraines, with or without aura.
In an embodiment lasmiditan is present in the amount of 5% to 20%. In an embodiment lasmiditan is present in the amount of 10% to 15%. In an embodiment lasmiditan is present in the amount of 10%, 11%, 12%, 13%, 14%, 15%.
In an embodiment the pharmaceutical acceptable excipients of the subject invention are selected from diluent, disintegrant, complexing agent, solubilizer, glidant, cooling agent, sweetener, flavor, taste masker, and the combination thereof.
Example of diluent that can be used in the subject invention are selected from but not limited to lactose, microcrystalline cellulose, silicified microcrystalline cellulose, dicalcium phosphate, sugar alcohols, dextrates, dextrin, calcium carbonate, calcium sulfate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, magnesium carbonate, magnesium oxide, starch, pregelatinized starch or combinations thereof
In an embodiment diluent of the subject invention is present in the range of 0.1% to 30%. In an embodiment diluent of the subject invention is present in the range of 2% to 25%. In an embodiment diluent of the subject invention is present in the amount of 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%.
In another embodiment more than one diluent are present or more than two diluents are present. In an embodiment the dispersible tablet of the subject invention comprises of atleast two different type of diluents.
Example of disintegrant that can be used in the subject invention are selected from but not limited to Polyvinylpolypyrrolidone (polyvinyl polypyrrolidone, PVPP, crospovidone, crospolividone or E1202) is a highly cross-linked modification of polyvinylpyrrolidone (PVP), calcium carbonate, sodium starch glycolate, croscarmellose sodium, microcrystalline cellulose, low-substituted hydroxypropyl cellulose (L-HPC), mannitol, colloidal silicon dioxide, hydrated silica and/or hypromellose, maize starch, salts of carboxy methyl cellulose, alginic acid, sodium alginate, guar gum or combinations thereof.
In an embodiment disintegrant of the subject invention is present in the range of 1% to 20% by weight of the total composition. In an embodiment disintegrant of the subject invention is present in the range of 3% to 12%. In an embodiment disintegrant of the subject invention is present in the amount of 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13% by weight of the total composition.
In an embodiment the subject invention comprises more than one, more than two, more than three disintegrants of different types are present in the subject invention. In an embodiment the disintegrating tablet of the subject invention comprises of three disintegrants.
Example of complexing agent that can be used in the subject invention are selected from but not limited to potassium form polyacrylic acid ion exchange resins (Polacrilin Potassium e.g. Kyron T-314), ß-cyclodextrin, lecithin and methacrylic acid copolymers or the likes thereof
In an embodiment complexing agent is present in the range of 1% to 10% by weight of the total composition. In an embodiment the complexing agent is present in the range of 1% to 5% by weight of the total composition. In an embodiment complexing agent is present in the amount of 1%, 2%, 3%, 4%, 5% by weight of the total composition.
Examples of cooling agent that can be used in the subject invention are selected from but not limited to eucalyptus, camphor, and peppermint, menthol, aloe vera, cucumber, watermelon or combinations thereof.
In an embodiment the cooling agent is present in the range of 5% to 15% by the weight of the total composition. In another embodiment the cooling agent is present in the range of 7% to 13% by weight of the total composition. In an embodiment the cooling agent is present in the amount of 7%, 8%, 9%, 10%, 11%, 12%, 13% by weight of the total composition.
Examples of sweeteners that can be used in the subject invention are selected from but not limited to sorbitol, sucrose, dextrose, fructose, mannitol, xylitol, aspartame, stevia extract, glycyrrhiza, saccharine, saccharine sodium, acesulfame, sucralose, dipotassium glycyrrhizinate, galactose, fructose, high fructose corn syrup, dextrose, sucrose, sugar, maltose, partially hydrolyzed starch, corn syrup solids, D-tryptophan, erythritol, fructose, galactose, glycerol, glycyrrhizin, glucose, isomalt, xylitol, xylose, lactitol, lactose, levulose, maltitol, maltodextrin, maltol, maltose, corn syrup, neohesperidin dihydrochalcone, neotame, sodium saccharin, siclamate, tagatose, taumatin, trehalose or combinations thereof.
In an embodiment the sweeteners are present in the range of 10% to 20% by the weight of the total composition.
Examples of solubilizers the can be used in the subject invention are selected from but not limited to sodium lauryl sulfate, betaine, quaternary ammonium salts, polysorbates, sorbitan ester, poloxamer, alkyl naphthalene sulfonate, formaldehyde condensate, condensed methyl naphthalene sulfonate, sodium salt, fatty alcohol ethoxylate, alkoxylated alcohol, silicone surfactant, hydrophobically modified polyacrylate, alcohol alkoxylates, lignosulphonates or combinations thereof.
In an embodiment the solubilizers are present in the amount of 0.5% to 3%.
Examples of glidant that can be used in the subject invention are selected from but not limited to colloidal silicon dioxide, aluminum silicate, magnesium silicate, powdered cellulose, talc, tribasic calcium phosphate or combinations thereof.
In an embodiment the glidant are present in the amount of 0.1% to 2% by weight of the total composition.
Examples of lubricant that can be used in the subject invention are selected from but not limited to talc or silica, and fats, e.g. vegetable stearin, magnesium stearate or stearic acid, sodium oleate, sodium stearate, sodium benzoate, sodium stearate, sodium chloride, stearic acid, sodium stearyl fumarate, calcium stearate, magnesium lauryl sulfate, sodium stearyl fumarate, sucrose esters or fatty acids, zinc, polyethylene glycol or combinations thereof.
In an embodiment the lubricant is present in the amount of 0.5% to 4% by weight of the total composition.
Examples of flavoring agent that can be used in the subject invention are selected from but not limited to anethole, acetic acid, ascorbic acid, phosphoric acid, fumaric acid, lactic acid, lemon, linalool, malic acid, menthol, eucalyptol, orange, citric acid, cinnamon, tartaric acid, thymol, vanilla, strawberry, cherry flavor, chocolate aroma or peppermint aroma or combinations thereof.
In an embodiment the flavoring agent is present in the amount of 2% to 7% by weight of the total composition.
Examples of taste masking agents that can be used in the subject invention are selected from but not limited to anethole, acetic acid, ascorbic acid, phosphoric acid, fumaric acid, lactic acid, lemon, linalool, malic acid, menthol, eucalyptol, orange, citric acid, cinnamon, tartaric acid, thymol, vanilla, strawberry, cherry flavor, chocolate aroma or peppermint aroma or combinations thereof.
In an embodiment the taste masking agents are present in the amount of 1% to 10% by weight of the total composition.
In an embodiment the present invention provides a disintegrating tablet comprising lasmiditan in the amount of 10% to 15% by the weight of the total composition and pharmaceutically acceptable excipients, wherein the pharmaceutically acceptable excipients are one or more diluent in the amount of 2% to 25%, one or more disintegrant in the amount of 3% to 12% and complexing agent in the amount of 1% to 5%.
In an embodiment the present invention provides a disintegrating tablet comprising lasmiditan in the amount of 10% to 15% by the total weight of the composition and pharmaceutically acceptable excipients, wherein the pharmaceutically acceptable excipients are one or more diluent in the amount of 2% to 25%, one or more disintegrant in the amount of 3% to 12%, complexing agent in the amount of 1% to 5% and solubilizer in the amount of 0.5% to 3%.
In an embodiment the present invention provides a dispersible tablet comprising lasmiditan in the amount of 10% to 15% by the total weight of the composition and pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipient are one or more diluents in the amount of 2% to 25%, disintegrant in the amount of 3% to 12%, complexing agent in the amount of 1% to 5%, solubilizer in the amount of 0.5% to 3%, glidant in the amount of 0.1% to 2%, lubricant in the amount of 0.5% to 4%, taste masking agent in the amount of 1% to 10%, and flavoring agent in the amount of 2% to 7%.
In an embodiment the present invention provides a dispersible tablet comprising lasmiditan in the amount of 10% to 15% by the total weight of the composition and pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipients are:
i. One or more diluent in the amount of 2% to 25%, wherein the diluents are dibasic calcium, microcrystalline cellulose or combination thereof,
ii. One or more disintegrant in the amount of 3% to 12%, wherein the disintegrant are sodium starch glycolate, crospovidone, croscarmellose sodium (Ac-Di-Sol) or a combination thereof
iii. Complexing agent in the amount of 1% to 5%, wherein the complexing agent is polacrilin potassium (Kyron T-314)
iv. solubilizer in the amount of 0.5% to 3%, wherein the solubilizer is sodium lauryl sulphate
v. glidant in the amount of 0.1% to 2%, wherein the glidant is colloidal silicon dioxide
vi. lubricant in the amount of 0.5% to 4%, wherein the lubricant is sodium steryl fumarate
vii. taste masking agent in the amount of 1% to 10%, wherein the taste masking agents is citric acid monohydrate
viii. flavoring agents in the amount of 2% to 7%.
In an embodiment the present invention provides a process for preparation of disintegrating tablets, wherein the process involves sifting of all raw material alone or in combination with two or more raw material through sieve no. 30#/40# ASTM by using Vibro sifter.
In an embodiment the process involves sifting of Lasmiditan, Kyron, Sodium starch glycolate, Dicalcium phosphate dihydrate, sucralose, peppermint flavor, lemon flavor, microcrystalline cellulose, crospovidone, Croscarmellose sodium (Ac-Di-Sol), colloidal silicon dioxide, sodium lauryl sulphate, citric acid monohydrate, alone or in combination of two or more ingredients, through sieve no# 30 by using Vibro sifter. In an embodiment sodium stearyl fumarate are sifted through sieve no#40 by using vibro sifter.
The dispersible tablets of the invention have a disintegration time, e.g. in aqueous media, e.g. in water, of 5 minutes or below 5 minutes. The dispersible tablets of the invention are, despite the high drug loading, dispersible, e.g. in aqueous media, e.g. in water, in less than 5 minutes, preferably less than 3 minutes, and, therefore, convenient to administer, e.g. to patients. This leads to a better patient compliance
In an embodiment the present invention provides a process for preparation of dispersible tablets, wherein the sifted materials - Lasmiditan, Kyron, Sodium starch glycolate, Dicalcium phosphate dihydrate, sucralose, peppermint flavor, lemon flavor, microcrystalline cellulose, crospovidone, Croscarmellose sodium (Ac-Di-Sol), colloidal silicon dioxide, sodium lauryl sulphate, citric acid monohydrate, are blended in a blender at 5-20 RPM for 5-15 minutes.
In an embodiment the present invention provides a process for preparation of disintegrating tablet which involves preparation of lubrication by adding sodium stearyl fumarate into the blender containing the blended materials and mixing for 3-10 minutes.
In an embodiment the present invention provides a process for preparation of dispersible tablet which involves compression of the blended materials into tablets.
While the present invention has been described in terms of its specific embodiments, certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the present invention. The details of the invention, its objects and advantages are explained hereunder in greater detail in relation to non-limiting exemplary illustrations.
EXAMPLES
Example 1- Formulation details of 100 mg Lasmiditan dispersible tablet
Ingredient Role Mg Percentage (%)
Lasmiditan Active 115.65 13.45
Dibasic Calcium Phosphate Dihydrate Diluent 166.35 19.34
Polacrilin Potassium (Kyron T-314) Complexing agent 30 3.49
Sodium Starch Glycolate Disintegrant 60 6.98
Sucralose Sweetener 130 15.12
Dry Flavour Peppermint Cooling agent 80 9.3
Dry Flavour Lemon Flavor 42 4.88
Microcrystalline Cellulose IP (PH102) Diluent 50 5.81
Crospovidone XL10 Disintegrant 90 10.47
Citric acid monohydrate Taste masker 30 3.49
Ac-di-sol Disintegrant 40 4.65
Sodium Lauryl Sulphate Solubilizer 9 1.05
Colloidal silicone dioxide Glidant 7 0.81
Sodium Stearyl Fumarate Lubricant 10 1.16

Example 2 – Formulation details of 50 mg Lasmiditan dispersible tablet
Ingredient Role Mg Percentage (%)
Lasmiditan Active 57.8 13.44
Dibasic Calcium Phosphate Dihydrate Diluent 83.176 19.34
Polacrilin Potassium (Kyron T-314) Complexing agent 15 3.49
Sodium Starch Glycolate Disintegrant 30 6.98
Sucralose Sweetener 65 15.12
Dry Flavour Peppermint Cooling agent 40 9.3
Dry Flavour Lemon Flavor 21 4.88
Microcrystalline Cellulose IP (PH102) Diluent 25 5.81
Crospovidone XL10 Disintegrant 45 10.47
Citric acid monohydrate Taste masker 15 3.49
Ac-di-sol Disintegrant 20 4.65
Sodium Lauryl Sulphate Solubilizer 4.5 1.05
Colloidal silicone dioxide Glidant 3.5 0.81
Sodium Stearyl Fumarate Lubricant 5 1.16

Example-3 Stability study
i. Stability study data summary report of lasmiditan dispersible tablets 50 mg
Stability condition: 30°C ± 2°C / 75% ± 5% RH
Test Acceptance criteria Initial Time period
3 months
Description White to off white coloured, round shape, biconvex, plain on both side, uncoated dispersible tablet Off white coloured, round shape, uncoated dispersible tablet Off white coloured, round shape, uncoated dispersible tablet
Average weight 430 mg ± 5% 430.83 mg 432.70 mg
Disintegration time Not more than 3 minutes 01 minute 12 second 01 minute 20 second
Dissolution
Lasmiditan Hemisuccinate 57.824 mg Eq. to Lasmiditan 50 mg Not less than 75% in 30 minutes Avg 95.96%
Min 93.76%
Max 96.78% Avg 96.81%
Min 95.77%
Max 99.60%
Assay: Each dispersible tablet contains:
Lasmiditan Hemisuccinate 57.824 mg Eq. to Lasmiditan 50 mg Not less than 45.00 mg and not more than 55.00 mg
(Note less than 90.00% and not more than 110.00% of label claimed) 50.58 mg

101.61% 49.80 mg

99.60%
Related substance by HPLC:
Single minimum unknown impurity Not more than 0.2% 0.015% 0.021%
Total impurities Not more than 1.0% 0.015% 0.025%
Microbial contamination As below
Total viable count
Total aerobial microbial count Not more than 1000 cfu/g complies NA
Total combined Yeast and mould count Not more than 100 cfu/g complies NA
Test for specified microorganisms
Escherichia Coli Should be absent/g complies NA

ii. Stability condition: 40°C ± 2°C / 75% ± 5% RH
Test Acceptance criteria Initial Time period
3 months
Description White to off white coloured, round shape, biconvex, plain on both side, uncoated dispersible tablet Off white coloured, round shape, uncoated dispersible tablet Off white coloured, round shape, uncoated dispersible tablet
Average weight 430 mg ± 5% 430.83 mg 429.97 mg
Disintegration time Not more than 3 minutes 01 minute 12 second 01 minute 21second
Dissolution
Lasmiditan Hemisuccinate 57.824 mg Eq. to Lasmiditan 50 mg Not less than 75% in 30 minutes Avg 95.96%
Min 93.76%
Max 96.78% Avg 92.68 %
Min 88.93 %
Max 99.01 %
Assay: Each dispersible tablet contains:
Lasmiditan Hemisuccinate 57.824 mg Eq. to Lasmiditan 50 mg Not less than 45.00 mg and not more than 55.00 mg
(Note less than 90.00% and not more than 110.00% of label claimed) 50.58 mg

101.61% 49.58 mg

99.16%
Related substance by HPLC:
Single minimum unknown impurity Not more than 0.2% 0.015% 0.021%
Total impurities Not more than 1.0% 0.015% 0.025%
Microbial contamination As below
Total viable count
Total aerobial microbial count Not more than 1000 cfu/g complies NA
Total combined Yeast and mould count Not more than 100 cfu/g complies NA
Test for specified microorganisms
Escherichia Coli Should be absent/g complies NA

Example-4 Stability study
i. Stability study data summary report of lasmiditan dispersible tablets 100 mg
Stability condition: 30°C ± 2°C / 75% ± 5% RH
Test Acceptance criteria Initial Time period
3 months
Description White to off white coloured, round shape, biconvex, plain on both side, uncoated dispersible tablet Off white coloured, round shape, uncoated dispersible tablet Off white coloured, round shape, uncoated dispersible tablet
Average weight 860 mg ± 5% 860.62 mg 859.81 mg
Disintegration time Not more than 3 minutes 01 minute 40 second 01 minute 45 second
Dissolution
Lasmiditan Hemisuccinate 115.65 mg Eq. to Lasmiditan 100 mg Not less than 75% in 30 minutes Avg 96.54%
Min 94.70%
Max 97.71% Avg 96.08%
Min 94.70%
Max 98.09%
Assay: Each dispersible tablet contains:
Lasmiditan Hemisuccinate 115.65 mg Eq. to Lasmiditan 100 mg Not less than 90.00 mg and not more than 110.00 mg
(Note less than 90.00% and not more than 110.00% of label claimed) 100.61 mg

100.61% 99.56 mg

99.56%
Related substance by HPLC:
Single minimum unknown impurity Not more than 0.2% 0.016% 0.021%
Total impurities Not more than 1.0% 0.016% 0.021%
Microbial contamination As below
Total viable count
Total aerobial microbial count Not more than 1000 cfu/g complies NA
Total combined Yeast and mould count Not more than 100 cfu/g complies NA
Test for specified microorganisms
Escherichia Coli Should be absent/g complies NA

ii. Stability condition: 40°C ± 2°C / 75% ± 5% RH
Test Acceptance criteria Initial Time period
3 months
Description White to off white coloured, round shape, biconvex, plain on both side, uncoated dispersible tablet Off white coloured, round shape, uncoated dispersible tablet Off white coloured, round shape, uncoated dispersible tablet
Average weight 860 mg ± 5% 860.62 mg 859.64 mg
Disintegration time Not more than 3 minutes 01 minute 40 second 01 minute 52 second
Dissolution
Lasmiditan Hemisuccinate 115.65 mg Eq. to Lasmiditan 100 mg Not less than 75% in 30 minutes Avg 96.54%
Min 94.70%
Max 97.71% Avg 95.33 %
Min 92.52 %
Max 96.83 %
Assay: Each dispersible tablet contains:
Lasmiditan Hemisuccinate 115.65 mg Eq. to Lasmiditan 100 mg Not less than 90.00 mg and not more than 110.00 mg
(Note less than 90.00% and not more than 110.00% of label claimed) 100.61 mg

100.61% 99.62 mg

99.62 %
Related substance by HPLC:
Single minimum unknown impurity Not more than 0.2% 0.016% 0.020 %
Total impurities Not more than 1.0% 0.016% 0.020 %
Microbial contamination As below
Total viable count
Total aerobial microbial count Not more than 1000 cfu/g complies NA
Total combined Yeast and mould count Not more than 100 cfu/g complies NA
Test for specified microorganisms
Escherichia Coli Should be absent/g complies NA
, Claims:1. A dispersible tablet comprising lasmiditan or a pharmaceutically acceptable salt thereof present in an amount of 10% to 15%.
2. The dispersible tablet as claimed in claim 1 is a water dispersible tablet.
3. The dispersible tablet as claimed in claim 1, wherein tablet comprises disintegrant in an amount of 3 to 12%.
4. The dispersible tablet as claimed in claim 1, wherein disintegrant is selected from polyvinylpolypyrrolidone, calcium carbonate, sodium starch glycolate, croscarmellose sodium, microcrystalline cellulose, low-substituted hydroxypropyl cellulose (L-HPC), mannitol, colloidal silicon dioxide, hydrated silica and/or hypromellose, maize starch, salts of carboxy methyl cellulose, alginic acid, sodium alginate, guar gum or combinations thereof.
5. The dispersible tablet as claimed in claim 1 wherein tablet comprises complexing agent in an amount of 1 to 5%.
6. The dispersible tablet as claimed in claim 4, wherein complexing agent is selected from polyacrylic acid ion exchange resins (Polacrilin Potassium e.g. Kyron T-314), ß-cyclodextrin, lecithin and methacrylic acid copolymers
7. The dispersible tablet as claimed in claim 1 wherein tablet comprises atleast one pharmaceutically acceptable excipients:
i. About 2 to 25% of diluent and;
ii. About 0.5 to 3% of solubilizer and;
iii. About 0.1% to 2% of glidant and;
iv. About 0.5% to 4%, of lubricant and;
v. About 0.5% to 4%, of taste masking agent and;
vi. About 2% to 7% of flavoring agents
8. The dispersible tablet as claimed in claim 6 wherein the tablet comprises:
i. Diluent in the amount of 2% to 25%, wherein the diluents are dibasic calcium, microcrystalline cellulose or combination thereof,
ii. solubilizer in the amount of 0.5% to 3%, wherein the solubilizer is sodium lauryl sulphate
iii. glidant in the amount of 0.1% to 2%, wherein the glidant is colloidal silicon dioxide
iv. lubricant in the amount of 0.5% to 4%, wherein the lubricant is sodium stearyl fumarate
v. taste masking agent in the amount of 1% to 10%, wherein the taste masking agents is citric acid monohydrate
vi. flavoring agents in the amount of 2% to 7%.
9. The dispersible tablet according to claim 1 wherein the disintegration time of the tablet is of 5 minutes or less.
10. A process of preparing water dispersible tablet comprising:
i. Blending of sifted materials such as Lasmiditan, Kyron, sodium starch glycolate, dicalcium phosphate dihydrate, sucralose, peppermint flavor, lemon flavor, microcrystalline cellulose, crospovidone, croscarmellose sodium (Ac-Di-Sol), colloidal silicon dioxide, sodium lauryl sulphate, citric acid monohydrate at 5-20 RPM for 5-15 minutes
ii. Lubricate the blended materials by adding sodium stearyl fumarate into the blender and mix it for 3-10 minutes.
iii. Compressing the lubricated materials into dispersible tablet