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EP-4739316-A1 - TASTE MASKED GRANULE COMPOSITION OF CAFFEINE AND ITS PROCESS OF PREPARATION

EP4739316A1EP 4739316 A1EP4739316 A1EP 4739316A1EP-4739316-A1

Abstract

The present invention relates to a 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, flavoring agents, glidants and solvents. The present invention also relates to a process for the preparation of taste masked granule composition of Caffeine.

Inventors

  • BOTHRA, Chandanmal pukhraj
  • BOTHRA, Hemanth Kumar
  • NATARAJAN, Elayaraja
  • VARMA, CHITRA AJITHAN
  • PUTTURU, Ramesh

Assignees

  • Lyrus Life Sciences Pvt. LTD.
  • Nokha Trading LLP

Dates

Publication Date
20260513
Application Date
20240706

Claims (10)

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.

Description

TASTE MASKED GRANULES OF CAFFEINE AND ITS PREPARATION PROCESS 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 Al 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/