DESC:FORM 2

THE PATENTS ACT 1970
(SECTION 39 OF 1970)
&
THE PATENT RULES, 2003

COMPLETE SPECIFICATION
(Section 10 and Rule 13)

TASTE MASKED GRANULES OF CAFFEINE AND ITS PREPARATION PROCESS

We, LYRUS LIFE SCIENCES PVT LTD,
a company incorporated under the companies act, 1956 having
address at # 54A & 54B [Part], KIDAB Industrial Area Hoskote,
Bangalore Rural – 562 114, Karnataka, India.
&
NOKHA TRADING LLP
a company incorporated under the companies act, 1956 having
address at No. 22, 7th Cross, Jaibharath Nagar,
Bangalore-560033, Karnataka, India.

The following specification particularly describes the invention and the manner in which it is to be performed:

FIELD OF THE INVENTION
The present invention relates to taste masked granule composition of Caffeine.

The present invention also relates to a taste masked granule composition comprising Caffeine and pharmaceutically acceptable excipients selected from diluents, sweetners, salivating agents, taste masking agents, flavoring agents, glidants and solvents.

The present invention also relates to a process for the preparation of taste masked granule composition of Caffeine.

BACKGROUND OF THE INVENTION
Caffeine, a xanthine derivative, is present in numerous foods, for example coffee, tea, cola drinks, “energy drinks”, guarana and cocoa and the products made therefrom. Caffeine is, in addition, added to foods, for example yogurt, ice cream, or confectionery products, as additive because of its stimulatory action. Caffeine is completely absorbed and achieves its maximum level in the blood after 30 to 60 minutes. Caffeine passes shortly after absorption into the brain and there exhibits stimulatory action, which in adults can persist for several hours. In addition, Caffeine promotes glycogenolysis and lipolysis, so that, in addition, more energy is provided to the body. In the fatigued people, the symptoms of fatigue are abolished and mental performance is increased (E. Hogervorst et al., Int. J. Sports Med. 1999, 20, 354-361).

US 10,149,850 B2 teaches a composition for human consumption comprising: a predetermined quantity of a base composition; and encapsulated Caffeine dispersed throughout at least a portion of the base composition, wherein the encapsulated Caffeine is a Caffeine complex including Caffeine and an organic acid. The base composition can include a liquid or a food.

US 10,798,961 B2 teaches a composition for human consumption comprising a predetermined quantity of a base composition Caffeine in an amount of about 20 mg to about 200 mg and one or more sensates. This also teaches that the application is directed to sensory technologies for beverages and other products that significantly reduce or fully mask bitterness and/or off-flavor associated with the presence of functional ingredients, such as Caffeine or L-phenylalanine.

US 2002/0197381 A1 teaches a compound of Caffeine and acesulfame-H and its solvates. This document specifically discloses the adduct of Caffeine and acesulfame-H. The present invention thus also comprises solid or liquid preparations, for example foods and drinks, for example in the form of chewing gum, tablets for chewing or compressed tablets, or else pharmaceuticals which comprise the inventive complexes or adducts and/or their Solvates. In addition, the corresponding premixes which comprise these compounds and are used in the production of foods, drinks or pharmaceuticals, are comprised for the present invention.

All the prior art references are related to different compositions of Caffeine and process for the preparations. However, the inventors of the present invention provide taste masked granule composition of Caffeine. The present invention also relates to taste masked granule composition comprising Caffeine and pharmaceutically acceptable excipients selected from diluents, sweetners, salivating agents, taste masking agents, flavoring agents, glidants and solvents. The present invention also relates to process for the preparation of taste masked granule composition of Caffeine.

The composition of present invention aids in easy administration and no suffocation risk resulting from physical obstruction by a solid dosage form especially to more general personnel requiring daily administration. Provides a smooth mouth feel while providing an excellent taste barrier. Rapidly dispersed within seconds (10 to 15 seconds) in the oral cavity. No water required for administration. Can be easily taken on the go. This is especially beneficial for drivers who are on the go and require immediate action.
OBJECTIVE OF INVENTION
The main objective of the present invention is to provide a taste masked granule composition of Caffeine.

Another objective of the present invention is to provide a taste masked granule composition comprising Caffeine and pharmaceutically acceptable excipients selected from diluents, sweetners, salivating agents, taste masking agents, flavoring agents, glidants and solvents.

Another objective of the present invention is to provide a process for the preparation of taste masked granule composition of Caffeine.

SUMMARY OF INVENTION
One embodiment of the present invention provides a taste masked granule composition of Caffeine.

Another embodiment of the present invention provides a taste masked granule composition comprising Caffeine and pharmaceutically acceptable excipients selected from diluents, sweetners, salivating agents, taste masking agents, flavoring agents, glidants and solvents.

Another embodiment of the present invention provides a taste masked granule composition comprising;
a) 10% to 30% w/w of Caffeine,
b) 30% to 70% w/w diluents,
c) 5% to 40% w/w of sweetners,
d) 0.1% to 10% w/w of salivating agents,
e) 0.1% to 5% w/w of flavoring agents and
f) 0.1% to 2% w/w of glidants.

Another embodiment of the present invention provides a taste masked granule composition comprising;
a) 10% to 30% w/w of Caffeine,
b) 30% to 70% w/w diluents,
c) 5% to 40% w/w of sweetners,
d) 0.1% to 10% w/w of salivating agents,
e) 0.1% to 5% w/w of taste masking agents,
f) 0.1% to 5% w/w of flavoring agents and
g) 0.1% to 2% w/w of glidants.

Another embodiment of the present invention provides a taste masked granule composition comprising;
a) 10% to 30% w/w of Caffeine,
b) 30% to 70% w/w Mannitol,
c) 1% to 30% w/w of Sucralose,
d) 0.1% to 10% w/w of Citric acid anhydrous,
e) 0.1% to 5% w/w of Peppermint and
f) 0.1% to 2% w/w of Aerosil.

Another embodiment of the present invention provides a taste masked granule composition comprising;
a) 10% to 30% w/w of Caffeine,
b) 30% to 70% w/w Lactose,
c) 1% to 30% w/w of Sucrose,
d) 10% to 30% w/w of Sucralose,
e) 0.1% to 10% w/w of Acesulfame potassium,
f) 0.1% to 10% w/w of Citric acid anhydrous,
g) 0.1% to 5% w/w of Peppermint and
h) 0.1% to 2% w/w of Aerosil.

Another embodiment of the present invention provides a taste masked granule composition comprising;
a) 10% to 30% w/w of Caffeine,
b) 30% to 70% w/w Mannitol,
c) 10% to 30% w/w of Xylitol,
d) 1% to 20% w/w of Sucralose,
e) 0.1% to 5% w/w of Sodium Saccharin,
f) 0.1% to 10% w/w of Citric acid anhydrous,
g) 0.1% to 5% w/w of Malic acid,
h) 0.1% to 10% w/w of Hypromellose,
i) 0.1% to 5% w/w of Flavor and
j) 0.1% to 2% w/w of Aerosil.

Another embodiment of the present invention provides a process for the preparation of taste masked granule composition of Caffeine.

Another embodiment of the present invention provides a process for the preparation of taste masked granule composition comprising:
a) heating the water at 70-80°C,
b) adding Caffeine into hot water under heating and continue stirring until it forms a clear solution,
c) adding sweetners to the above drug solution under continued stirring,
d) discontinuing the heating and allowing to stand till it reaches room temperature
e) drying the material in tray dryer and passing the granules through #16 or #20 mesh,
f) loading the granules along with diluent, sweetner and salivating agent into blender and blend it for 30 mins,
g) sifting sweetners, flavor and glidant into the blender and blend it for 10 mins, and
h) packing the granules in pouches.

Another embodiment of the present invention provides a process for the preparation of taste masked granule composition comprising:
a) heating the water at 70-80°C,
b) adding Caffeine into hot water under heating and continue stirring until it forms a clear solution,
c) adding sucralose to the above drug solution under continued stirring,
d) discontinuing heating and allowing to stand till it reaches room temperature
e) drying the material in tray dryer and passing the granules through #16 or #20 mesh,
f) loading the granules with mannitol, sucralose and citric acid anhydrous into blender and blend it for 30 mins,
g) sifting acesulfame K, sucralose, peppermint and Aerosil into the blender and blend it for 10 mins, and
h) packing the granules in pouches.

Another embodiment of the present invention provides a process for the preparation of taste masked granule composition comprising:
a) mixing and blending caffeine, salivating agents,
b) sifting diluent, sweetner and adding to the above blend,
c) granulating the blend using binder solution and dried,
d) blending with extragranular materials diluents, sweetners, taste masking agents, flavour and glidants,
e) packing the granules in pouches.

Another embodiment of the present invention provides a process for the preparation of taste masked granule composition comprising:
a) mixing and blending caffeine, citric acid and malic acid,
b) sifting mannitol, sucralose and adding to the above blend,
c) granulating the blend using water/IPA and dried,
d) blending with extragranular materials xylitol, sodium saccharin, sucralose, mannitol, hypromellose, flavour and colloidal silicon dioxide anhydrous for 10 mins at 15 RPM,
e) packing the granules in pouches.

DETAILED DESCRIPTION OF THE INVENTION
The term "comprising", which is synonymous with "including", "containing", or "characterized by" here is defined as being inclusive or open-ended, and does not exclude additional, unrecited elements or method steps, unless the context clearly requires otherwise.

The oral route of drug administration is the most common route for systemic effect of drug. Solid dosage forms are most popular because ease of administration, accurate dosage, self-medication, pain avoidance and most importantly patient compliance. The most commonly used solid dosage forms are tablets and capsules; one of the drawback for some patients, difficulty to swallow. Drinking water plays important role for swallowing of oral dosage forms. Often times people experience inconvenience in swallowing conventional dosage forms such as water whereas water is not available in case of motion sickness (kenetosis) and sudden episodes of coughing during common cough and cold, allergic condition and bronchitis.

The present invention is to provide a taste masked granule composition comprising Caffeine and pharmaceutically acceptable excipients selected from diluents, sweetners, salivating agents, taste masking agents, flavoring agents, glidants and solvents.

The concentration of the Caffeine used in the compositions of the present invention is in the range of 10% to 30% (w/w).

The diluents used alone or in combination in the compositions of the present invention include, but are not limited to sugars, starches, lactose, sucrose, sorbitol, fructose, dicalcium phosphate, erythitol, xylitol, mannitol, maltitol, isomalt, dextrose, maltose, lactose, microcrystalline celluloses and mixtures thereof.

Diluent as used herein in the compositions of the present invention is in the range of 30% to 70% (w/w).

Sweeteners used alone or in combination in the compositions of the present invention include, but are not limited to fructose (corn syrup), dextrose, sucrose, invert sugar, fructose, acesulfame potassium, saccharin and its various salts such as the sodium salt, sodium saccharin; dipeptide sweeteners such as aspartame; dihydrochalcone compounds, glycyrrhizin; Stevia rebaudiana (Stevioside); chloro derivatives of sucrose such as sucralose; sugar alcohols such as sorbitol, mannitol, xylitol, and the like.

The concentration of sweeteners used in the compositions of the present invention is in the range of 1% to 50% (w/w).

Salivating agent used alone or in combination in the compositions of the present invention include, but are not limited to citric acid, malic acid, tartaric acid, food salts such as sodium chloride and salt substitutes, potassium chloride, and mixtures thereof.

The concentration of salivating agent used in the compositions of the present invention is in the range of 0.1% to 10% (w/w).

Taste masking agents used alone or in combination in the compositions of the present invention include, but are not limited to Hypromellose, methyl cellulose, meth- acrylic copolymers, Carbomer 934, Carbomer 971, Carbomer 974, PEG-5M and mixtures thereof.

The concentration of taste masking agents used in the compositions of the present invention is in the range of 0.1% to 5% (w/w).

Flavours used alone or in combination in the compositions of the present invention include, but are not limited to volatile oils, synthetic flavour oils, flavoring aromatics, oils, liquids, oleoresins or extracts derived from plants, leaves, flowers, fruits, stems and combinations thereof. A non-limiting list of examples include peppermint, citrus oils such as lemon, orange, grape, lime and grapefruit and fruit essences including apple, pear, peach, grape, strawberry, raspberry, cherry, plum, pineapple, apricot or other fruit flavors.

The concentration of flavour used in the compositions of the present invention is in the range of 0.1% to 5% (w/w).

Glidants used alone or in combination in the compositions of the present invention include, but are not limited to talc, magnesium silicate, colloidal silicon dioxide, amorphous silicon dioxide and calcium silicate.

The concentration of glidant used in the compositions of the present invention is in the range of 0.1% to 2% (w/w).

Solvents used alone or in combination in the compositions of the present invention include, but are not limited to ethanol, propylene glycol, polyethylene glycol and purified water.

The taste masked granules of the present invention can be orally disintegrating dosage form.

The following examples describes the nature of the invention and are given only for the purpose of illustrating the present invention in more detail and are not limitative and relate to solutions, which have been particularly effective on bench scale.

Example 1
Sr. No. Ingredients mg/sachet % w/w
1 Caffeine 100.00 20.00
2 Purified water QS QS
3 Sucralose (Part 1) 80.0 16.00
Total 180.0 -
4 Mannitol SD 100 275.00 55.00
5 Sucralose (Part 2) 15.00 3.00
6 Citric acid anhydrous 12.00 2.40
7 Acesulfame potassium 5.00 1.00
8 Sucralose (Part 3) 5.00 1.00
9 Flavour: Pepper mint 6.00 1.20
10 Aerosil 200 pharma 2.00 0.40
Total 500.00 100.00

Manufacturing process:

Purified water heated at 70-80°C and Caffeine added into hot water under heating and continued stirring until a clear solution formed. Sucralose added to the above drug solution continued stirring for 4 to 6 hrs. Stop heating and allow to stand till it reaches room temperature. Material loaded into tray dryer and dried at 60-70°C Semi dried granules passed through #16 or #20 mesh and continue the drying until reach the desired LOD. Dried material passed through #60 or #80 mesh (Mill the granules if required). Sized material loaded along with Mannitol, Sucralose and Citric acid anhydrous into blender and blended for 30 mins at 15 RPM. Sifted Acesulfame K, Sucralose, Pepper mint and Aerosil 200 to the blender and blend it for 10 mins at 15 RPM. Packed the material in pouches.

Example 2

Sr. No. Ingredients mg/sachet % w/w
1 Caffeine 100.00 20.00
2 Purified water QS QS
3 Sucrose 50.0 10.00
Total 150.0 -
4 Mannitol SD 100 305.00 55.00
5 Sucralose 15.00 3.00
6 Citric acid anhydrous 12.00 2.40
7 Acesulfame potassium 5.00 1.00
8 Sucralose 5.00 1.00
9 Flavour: Pepper mint 6.00 1.20
10 Aerosil 200 pharma 2.00 0.40
Total 500.00 100.00

Manufacturing process:

Purified water heated at 70-80°C and Caffeine added into hot water under heating and continued stirring until a clear solution formed. Sucrose added to the above drug solution continued stirring for 4 to 6 hrs. Stop heating and allow to stand till it reaches room temperature. Material loaded into tray dryer and dried at 60-70°C Semi dried granules passed through #16 or #20 mesh and continue the drying until reach the desired LOD. Dried material passed through #60 or #80 mesh (Mill the granules if required). Sized material loaded along with Mannitol, Sucralose and Citric acid anhydrous into blender and blend it for 30 mins at 15 RPM. Sifted Acesulfame K, Sucralose, Pepper mint and Aerosil 200 to the blender and blend it for 10 mins at 15 RPM. Packed the material in pouches.

Applicant has done the several evaluation tests for the above exemplified compositions and the results are as given below:
Sr. No. Parameters Limit Initial 3 Month 6 Month
1 Description Off white powder Complies
2 Water content NMT 6 % 0.65 % 0.70 % 0.30 %
3 Assay 90 – 100 % 99.08 % 100.35 % 99.70 %
4 Related substances
Any secondary peak NMT 0.2 % ND 0.01 0.01
Total NMT 0.5 % ND 0.01 0.01

Dissolution test
Timepoints % drug release
0.1M HCl (paddle apparatus)
5 minutes 85 %
10 minutes 92 %
15 minutes 101 %

Example 3

Sr. No. Ingredients mg/sachet % w/w
1 Caffeine 100.00 20.00
2 Purified water QS QS
3 Sucralose (Part 1) 80.0 16.00
4 Mannitol SD 100 275.0 55.00
Total 455.0 -
5 Sucralose (Part 2) 15.00 3.00
6 Citric acid anhydrous 12.00 2.40
7 Acesulfame potassium 5.00 1.00
8 Sucralose (Part 3) 5.00 1.00
9 Flavour: Pepper mint 6.00 1.20
10 Aerosil 200 pharma 2.00 0.40
Total 500.00 100.00

Manufacturing process:

Purified water heated at 70-80°C and Caffeine added into hot water under heating and continued stirring until a clear solution formed. Sucralose added to the above drug solution continued stirring for 4 to 6 hrs. Stop heating. Add Mannitol under stirring and allow the mixture to reach room temperature. Material loaded into tray dryer and dried at 60-70°C Semi dried granules passed through #16 or #20 mesh and continue the drying until it reaches the desired LOD. Dried material passed through #60/#80 mesh (Mill the granules if required). Sized material loaded along with Sucralose and Citric acid anhydrous into blender and blend it for 30 mins at 15 RPM. Sifted Acesulfame K, Sucralose, Pepper mint and Aerosil 200 to the blender and blend it for 10 mins at 15 RPM. Packed the material in pouches.

Example 4

Sr. No. Ingredients mg/sachet % w/w
1 Caffeine 100.00 20.00
2 Purified water QS QS
3 Sucralose (Part 1) 80.0 16.00
4 Lactose 275.0 55.00
Total 455.0 -
5 Sucralose (Part 2) 15.00 3.00
6 Citric acid anhydrous 12.00 2.40
7 Acesulfame potassium 5.00 1.00
8 Sucralose (Part 3) 5.00 1.00
9 Flavour: Orange 6.00 1.20
10 Aerosil 200 pharma 2.00 0.40
Total 500.00 100.00

Manufacturing process:

Purified water heated at 70-80°C and Caffeine added into hot water under heating and continued stirring until a clear solution formed. Sucralose added to the above drug solution continued stirring for 4 to 6 hrs. Stop heating. Add Lactose under stirring and allow the mixture to reach room temperature. Material loaded into tray dryer and dried at 60-70°C Semi dried granules passed through #16 or #20 mesh and continue the drying until it reaches the desired LOD. Dried material passed through #60/#80 mesh (Mill the granules if required). Sized material loaded along with Sucralose and Citric acid anhydrous into blender and blend it for 30 mins at 15 RPM. Sifted Acesulfame K, Sucralose, Orange and Aerosil 200 to the blender and blend it for 10 mins at 15 RPM. Packed the material in pouches.

Example 5

Sr. No. Ingredients mg/sachet % w/w
1 Caffeine 100.00 20.00
2 Purified water QS QS
3 Sucralose (Part 1) 80.0 16.00
4 Mannitol SD 100 275.0 55.00
Total 455.0 -
5 Sucralose (Part 2) 15.00 3.00
6 Citric acid anhydrous 12.00 2.40
7 Acesulfame potassium 5.00 1.00
8 Sucralose (Part 3) 5.00 1.00
9 Flavour: Pepper mint 6.00 1.20
10 Aerosil 200 pharma 2.00 0.40
Total 500.00 100.00

Manufacturing process:

Purified water heated at 70-80°C and Caffeine added into hot water under heating and continued stirring until a clear solution formed. Sucralose added to the above drug solution continued stirring for 4 to 6 hrs. Stop heating. Add Mannitol under stirring and allow the mixture to reach room temperature. Material loaded into tray dryer and dried at 60-70°C. Semi dried granules are extruded and spheronized to get granules and dried to attain desired LOD. Sized material loaded along with Sucralose and Citric acid anhydrous into blender and blend it for 30 mins at 15 RPM. Sifted Acesulfame K, Sucralose, Pepper mint and Aerosil 200 to the blender and blend it for 10 mins at 15 RPM. Packed the material in pouches.

Applicant has done the several evaluation tests for the above exemplified compositions and the results are as given below:
Sr. No. Parameters Limit Initial 3 Month 6 Month
1 Description Off white powder Complies
2 Water content NMT 6 % 1.0 % 0.90 % 1.20 %
3 Assay 90 – 100 % 99.00 % 101.05 % 99.50 %
4 Related substances
Any secondary peak NMT 0.2 % ND ND ND
Total NMT 0.5 % ND ND ND

Dissolution test
Timepoints % drug release
0.1M HCl (paddle apparatus)
5 minutes 82 %
10 minutes 95 %
15 minutes 100 %

Example 6
S. No: Ingredients mg/sachet %w/w
1. Caffeine 100.00 20.00
2. Citric acid anhydrous 20.00 4.00
3. Malic acid 10.00 2.00
4. Mannitol 150.00 30.00
5. Purified water qs qs
6. Xylitol 100.00 20.00
7. Sodium Saccharin 10.00 2.00
8. Sucrolose 30.00 6.00
9. Mannitol 67.50 13.50
10. Hypromellose (HPMC) 10.00 2.00
11. Flavour 1.00 0.20
12. Aerosil 200 pharma 1.50 0.30
Total 500.00 100.00

Manufacturing process:

Caffeine, Citric acid, and Malic acid sifted and mixed/blended well. Sifted Mannitol, Sucralose added to the above material mixed and granulated with granulation fluid (water/IPA), after completion of granulation, granules were dried well. The dried granule are sized and passed through #20mesh and blended with extra granular material of Xylitol, Sodium Saccharin, Sucralose, Mannitol, Hypromellose, Flavour, and colloidal silicon dioxide anhydrous for 10 mins at 15 RPM. Packed the material in pouches or compressed into tablets.

Applicant has done the several evaluation tests for the above example 6 composition and the results are as given below:

Sr. No. Parameters Limit Initial 3 Month 6 Month
1 Description Off white powder Complies
2 Water content NMT 6 % 1.2 % 1.5 % 1.7 %
3 Assay 90 – 100 % 99.00 % 98.7 % 100.1 %
4 Related substances
Any secondary peak NMT 0.2 % ND ND ND
Total NMT 0.5 % ND ND ND

Dissolution test
Time points % drug release
0.1M HCl (paddle apparatus)
5 minutes 86 %
10 minutes 97 %
15 minutes 100 % ,CLAIMS:WE CLAIM:

1. A taste masked granule composition comprising Caffeine and pharmaceutically acceptable excipients selected from diluents, sweetners, salivating agents, taste masking agents, flavoring agents, glidants and solvents.

2. The composition as claimed in claim 1, wherein said diluents are selected from sugars, starches, lactose, sucrose, sorbitol, fructose, dicalcium phosphate, erythitol, xylitol, mannitol, maltitol, isomalt, dextrose, maltose, lactose, microcrystalline celluloses and mixtures thereof.

3. The composition as claimed in claim 1, wherein said sweetners are selected from fructose (corn syrup), dextrose, sucrose, invert sugar, fructose, acesulfame potassium, saccharin and its various salts such as the sodium salt, sodium saccharin, aspartame, glycyrrhizin, stevioside, sucralose, sorbitol, mannitol and xylitol.

4. The composition as claimed in claim 1, wherein said salivating agent are selected from citric acid, malic acid, tartaric acid, sodium chloride and salt substitutes, potassium chloride and mixtures thereof.

5. The composition as claimed in claim 1, wherein said taste masking agents are selected from Hypromellose, methyl cellulose, meth- acrylic copolymers, Carbomer 934, Carbomer 971, Carbomer 974, PEG-5M and mixtures thereof.

6. The composition as claimed in claim 1, wherein said flavours are selected from olatile oils, synthetic flavour oils, flavoring aromatics, oils, liquids, oleoresins or extracts derived from plants, leaves, flowers, fruits include peppermint, citrus oils such as lemon, orange, grape, lime and grapefruit and fruit essences including apple, pear, peach, grape, strawberry, raspberry, cherry, plum, pineapple, apricot or other fruit flavors.

7. The composition as claimed in claim 1, wherein said glidants are selected from talc, magnesium silicate, colloidal silicon dioxide, amorphous silicon dioxide and calcium silicate and wherein said solvents are selected from ethanol, propylene glycol, polyethylene glycol, isopropyl alcohol and purified water.

8. The composition as claimed in claim 1, wherein said taste masked granule composition comprising;
a) 10% to 30% w/w of Caffeine,
b) 30% to 70% w/w diluents,
c) 5% to 40% w/w of sweetners,
d) 0.1% to 10% w/w of salivating agents,
e) 0.1% to 5% w/w of flavoring agents and
f) 0.1% to 2% w/w of glidants.

9. The process for the preparation of taste masked granule composition as claimed in claim 1, wherein said process comprising:
a) heating the water at 70-80°C,
b) adding Caffeine into hot water under heating and continue stirring until it forms a clear solution,
c) adding sweetners to the above drug solution under continued stirring,
d) discontinuing the heating and allowing to stand till it reaches room temperature
e) drying the material in tray dryer and passing the granules through #16 or #20 mesh,
f) loading the granules along with diluent, sweetner and salivating agent into blender and blend it for 30 mins,
g) sifting sweetners, flavor and glidant into the blender and blend it for 10 mins, and
h) packing the granules in pouches.

10. The process for the preparation of taste masked granule composition as claimed in claim 1, wherein said process comprising:
a) mixing and blending caffeine, salivating agents,
b) sifting diluent, sweetner and adding to the above blend,
c) granulating the blend using binder solution and dried,
d) blending with extragranular materials diluents, sweetners, taste masking agents, flavour and glidants,
e) packing the granules in pouches.

Dated this Sixth (6th) day of July, 2024

__________________________________
Dr. S. Padmaja
Agent for the Applicant
IN/PA/883