Gummy composition and method of preparation of the gummy composition

Abstract

Disclosed is a gummy formulation includes paracetamol ranging from 50 mg to 5000 mg of the gummy formulation, maltitol syrup ranging from 5% to 80% of the gummy formulation, potassium sorbate ranging from 0.01% to 1.0% of the gummy formulation, sodium chloride ranging from 0.01% to 5.0% of the gummy formulation, sucralose ranging from 0.01% to 0.50% of the gummy formulation, starch ranging from 0.02% to 10% of the gummy formulation, carrageenan ranging from 0.50% to 10% of the gummy formulation, mannitol ranging from 1% to 80% of the gummy formulation, banana powder ranging from 0.2% to 10% of the gummy formulation, and sodium citrate ranging from 0.1% to 0.5% of the gummy formulation. The present disclosure also relates to a method of preparation of the gummy formulation.

Description

[0001] Title: GUMMY COMPOSITION AND METHOD OF PREPARATION OF THE GUMMY COMPOSITION

[0002] TECHNICAL FIELD

[0003] The present disclosure relates to the field of pharmaceuticals. More particularly, the present disclosure relates to gummy composition and method of preparation of the gummy composition.

[0004] BACKGROUND

[0005] Paracetamol, also known as acetaminophen, is a common over-the-counter medication used to alleviate pain and reduce fever. It's often used to treat headaches, muscle aches, backaches, toothaches, and colds. It's generally considered safe when taken at recommended doses, but excessive use can lead to liver damage. It's important to follow the dosage instructions and consult a healthcare professional if you have any concerns or if you're taking other medications, as interactions can occur.

[0006] Existing Paracetamol Delivery Systems includes tablets, capsules, syrups, and effervescent formulations. Some other delivery system may also cover chewable tablets or softgel capsules containing paracetamol.

[0007] Delivery of paracetamol in the form of gummies may attract the children to consume without any hesitation.

[0008] Pre-existing methods for producing gummies involve a series of steps such as mixing, heating, molding, cooling, and drying. These methods may utilize different equipment, temperatures, and formulations which degrade the biomolecules that are present in the paracetamol active ingredient.

[0009] Further, molecules that are present in active ingredients are not compatible with the fillers and the non-active ingredients which results in products with ineffective results.

[0010] Further, the sugar-coated products has limitations that it provides sweet in taste for a limited time. The coating gets dissolved in the first lick or in 2-3 subsequent licks. When the consumer is keeping on chewing the product, the wild nature of paracetamol may cause the bitterness to the consumer. Therefore, there is a need for a composition and method to produce a composition that produce product which are effective against the target and compatible with the fillers and other non-active ingredients.

[0011] SUMMARY

[0012] In one aspect of the present disclosure, a gummy formulation is provided.

[0013] The gummy formulation includes paracetamol ranging from 50 mg to 5000 mg of the gummy formulation. The gummy formulation further includes maltitol syrup ranging from 5% to 80% of the gummy formulation. The gummy formulation further includes potassium sorbate ranging from 0.01% to 1.0% of the gummy formulation. The gummy formulation further includes sodium chloride ranging from 0.01% to 5.0% of the gummy formulation. The gummy formulation further includes sucralose ranging from 0.01% to 0.50% of the gummy formulation. The gummy formulation further includes starch ranging from 0.02% to 10% of the gummy formulation. The gummy formulation further includes carrageenan ranging from 0.50% to 10% of the gummy formulation. The gummy formulation further includes mannitol ranging from 1% to 80% of the gummy formulation. The gummy formulation further includes banana powder ranging from 0.2% to 10% of the gummy formulation. The gummy formulation further includes sodium citrate ranging from 0.1% to 0.5% of the gummy formulation.

[0014] In some aspects of the present disclosure, concentration of the maltitol syrup is 50- 70%.

[0015] In some aspects of the present disclosure, the gummy formulation further includes berry flavour ranging from 0.2 % to 10 % of the gummy formulation.

[0016] In some aspects of the present disclosure, the gummy formulation further includes colouring agent ranging from 0.01% to 1.0 % of the gummy formulation.

[0017] In some aspects of the present disclosure, the colouring agent is selected from natural beetroot or radish colour or combination thereof.

[0018] In second aspects of the present disclosure, a method for producing gummies is provided.

[0019] The method includes weighing required quantity of maltitol syrup 70% and heating it to 100-120°C in a steam jacket vessel. The method further includes adding paracetamol powder, banana powder, and mixing until dispersed completely free from lumps with a desired Brix between 60 to 90°.

[0020] The method further includes dry mixing carrageenan, mannitol, sodium chloride, trisodium citrate, and citric acid in a polybag.

[0021] The method further includes soaking the mixed content in purified water containing dissolved potassium sorbate and stirring well in a clean SS vessel.

[0022] The method further includes pouring the soaked content into a steam jacket and mixing well for about 10-30 minutes at 80-90 °C.

[0023] The method further includes mixing the mixtures for 10 minutes in a cooking tank, maintaining the temperature between 80 and 90 °C.

[0024] The method further includes adding natural color and mixed berry flavor and mixing well.

[0025] The method further includes transferring the viscous suspension from the mixing tank to a deposition unit, maintaining the temperature between 65 and 75 °C during deposition into a pre-lubricated mold.

[0026] The method further includes passing the gummy gel through a cooling tunnel with a temperature maintained below 10 °C.

[0027] In some aspects of the present disclosure, the method for producing gummies further includes collecting the gummies in trays and checking the average weight before drying.

[0028] In some aspects of the present disclosure, the method for producing gummies further includes drying the gummies at 45 °C ± 5 °C in trays kept in a drying room until the water content reaches below 15 % w / w.

[0029] In some aspects of the present disclosure, the method for producing gummies further includes coating the gummies using starch powder.

[0030] In some aspects of the present disclosure, the method for producing gummies further includes packing the coated gummies in a bottle pack.

[0031] BRIEF DESCRIPTION OF DRAWINGS

[0032] The accompanying drawings, which are incorporated in and constitute a part of this specification, show certain aspects of the subject matter disclosed herein and, together with the description, help explain some of the principles associated with the disclosed implementations. In the drawing,

[0033] Figure 1 illustrates a flowchart that depicts a method of producing the gummy formulation, in accordance with an aspect of the present disclosure.

[0034] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] Various embodiments of the disclosure are discussed in detail below. While specific implementations are discussed, it should be understood that this is done for illustration purposes only. A person skilled in the relevant art will recognize that other components and configurations may be used without parting from the spirit and scope of the disclosure. Thus, the following description and drawings are illustrative and are not to be construed as limiting. Numerous specific details are described to provide a thorough understanding of the disclosure. However, in certain instances, known details are not described in order to avoid obscuring the description.

[0036] References to one or an embodiment in the present disclosure can be references to the same embodiment or any embodiment; and, such references mean at least one of the embodiments.

[0037] Reference to "one embodiment", "an embodiment", “one aspect”, “some aspects”, “an aspect” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others.

[0038] The terms used in this specification generally have their ordinary meanings in the art, within the context of the disclosure, and in the specific context where each term is used. Alternative language and synonyms may be used for any one or more of the terms discussed herein, and no special significance should be placed upon whether or not a term is elaborated or discussed herein. In some cases, synonyms for certain terms are provided. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms discussed herein is illustrative only, and is not intended to further limit the scope and meaning of the disclosure or of any example term. Likewise, the disclosure is not limited to various embodiments given in this specification. Without intent to limit the scope of the disclosure, examples of instruments, apparatus, methods and their related results according to the embodiments of the present disclosure are given below. Note that titles or subtitles may be used in the examples for convenience of a reader, which in no way should limit the scope of the disclosure. Unless otherwise defined, technical and scientific terms used herein have the meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. In the case of conflict, the present document, including definitions will control.

[0039] Additional features and advantages of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or can be learned by practice of the herein disclosed principles. The features and advantages of the disclosure can be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features of the disclosure will become more fully apparent from the following description and appended claims or can be learned by the practice of the principles set forth herein.

[0040] As mentioned before, there is a need for a composition and method to produce a composition that produces products which are effective against the target and compatible with the fillers and other non-active ingredients. Therefore, the present disclosure addresses these limitations, by providing gummy formulation and method of producing the gummy formulation that facilitate the consumer to keep the product in mouth until the gummy gets dissolved.

[0041] In one aspect of the present disclosure, a gummy formulation is provided.

[0042] The gummy formulation may include paracetamol, maltitol syrup, potassium sorbate, sodium chloride, sucralose, starch, carrageenan, mannitol, banana powder, sodium citrate, berry flavour, and colouring agent. In some aspects of the present disclosure, the paracetamol may range from 50 mg to 5000 mg of the gummy formulation. In some aspects of the present disclosure, the maltitol syrup may range from 5% to 80% of the gummy formulation. In some aspects of the present disclosure, the potassium sorbate may range from 0.01% to 1.0% of the gummy formulation. In some aspects of the present disclosure, the sodium chloride may range from 0.01% to 5.0% of the gummy formulation. In some aspects of the present disclosure, the sucralose may range from 0.01% to 0.50% of the gummy formulation. In some aspects of the present disclosure, the starch may range from 0.02% to 10% of the gummy formulation. In some aspects of the present disclosure, the carrageenan may range from 0.50% to 10% of the gummy formulation. In some aspects of the present disclosure, the mannitol may range from 1% to 80% of the gummy formulation. In some aspects of the present disclosure, the banana powder may range from 0.2% to 10% of the gummy formulation. In some aspects of the present disclosure, the sodium citrate may range from 0.1% to 0.5% of the gummy formulation.

[0043] In some aspects of the present disclosure, concentration of the maltitol syrup is 50- 70%.

[0044] In some aspects of the present disclosure, the gummy formulation further includes berry flavour ranging from 0.2 % to 10 % of the gummy formulation.

[0045] In some aspects of the present disclosure, the gummy formulation further includes colouring agent ranging from 0.01% to 1.0 % of the gummy formulation.

[0046] In some aspects of the present disclosure, the colouring agent is selected from natural beetroot or radish colour or combination thereof.

[0047] Figure 1 illustrates a flowchart that depicts a method 100 of producing the gummy formulation, in accordance with an aspect of the present disclosure. The method 100 may include the following steps:

[0048] At step 102, the method 100 may include weighing required quantity of maltitol syrup 70% and heating it to 100-120°C in a steam jacket vessel.

[0049] At step 104, the method 100 may further include adding paracetamol powder, banana powder, and mixing until dispersed completely free from lumps with a desired Brix between 60 to 90°. At step 106, the method 100 may further include dry mixing carrageenan, mannitol, sodium chloride, trisodium citrate, and citric acid in a polybag.

[0050] At step 108, the method 100 may further include soaking the mixed content in purified water containing dissolved potassium sorbate and stirring well in a clean SS vessel.

[0051] At step 110, the method 100 may further include pouring the soaked content into a steam jacket and mixing well for about 10-30 minutes at 80-90 °C.

[0052] At step 112, the method 100 may further include mixing the Step 104 and Step 102 mixtures for 10 minutes in a cooking tank, maintaining the temperature between 80 and 90 °C.

[0053] At step 114, the method 100 may further include adding natural colour and mixed berry flavor and mixing well.

[0054] At step 116, the method 100 may further include transferring the viscous suspension from the mixing tank to a deposition unit, maintaining the temperature between 65 and 75 °C during deposition into a pre-lubricated mold.

[0055] At step 118, the method 100 may further include passing the gummy gel through a cooling tunnel with a temperature maintained below 10 °C.

[0056] At step 120, the method 100 may further include collecting the gummies in trays and checking the average weight before drying.

[0057] At step 122, the method 100 may further include drying the gummies at 45 °C ± 5 °C in trays kept in a drying room until the water content reaches below 15 % w / w. At step 124, the method 100 may further include coating the gummies using starch powder.

[0058] At step 126, the method 100 may further include packing the coated gummies in a bottle pack.

[0059] In some aspects of the present disclosure, the heating of maltitol syrup 70% in Step 102 may be performed under a pressure of 10 psi to 20 psi.

[0060] In some aspects of the present disclosure, the mixing of paracetamol powder, banana powder, and maltitol syrup 70% in Step 104 may be performed using a high- shear mixer for 5 to 10 minutes. In some aspects of the present disclosure, the dry mixing of carrageenan, mannitol, sodium chloride, trisodium citrate, and citric acid in Step 106 may be performed for 2 to 5 minutes.

[0061] In some aspects of the present disclosure, the soaking of the mixed content in purified water containing dissolved potassium sorbate in Step 108 may be performed for 10 to 20 minutes.

[0062] In some aspects of the present disclosure, the mixing of the Step 104 and Step 102 mixtures in Step 112 may be performed using a double-blade mixer for 5 to 10 minutes.

[0063] In some aspects of the present disclosure, the deposition of the viscous suspension into the pre-lubricated mold in Step 116 may be performed using a pump at a rate of 10 ml to 20 ml per minute.

[0064] In some aspects of the present disclosure, the cooling of the gummy gel in the cooling tunnel in Step 118 may be performed for 5 to 10 minutes.

[0065] In some aspects of the present disclosure, the drying of the gummies in Step 122 may be performed for 4 to 6 hours.

[0066] Example 1: Preparation of composition

[0067] Boiled the Maltitol liquid at 100°C and then added Potassium sorbate and Sodium chloride until they were completely dissolved. Following this, Sucralose and Aspartame were added and allowed to dissolve completely. Then, Paracetamol was added to the malty liquid, ensuring it dissolved fully in the Maltitol liquid. The Carrageenan base, along with banana powder, Pure coat starch, Sodium citrate, and mannitol, was added to the required quantity of water and cooked well at 80 °C until a smooth solution was formed. Finally, the prepared Paracetamol solution was mixed into the Carrageenan solution and stirred thoroughly at 90 °C.

[0068] Example 2: Moulding of gummies

[0069] Mixed berry flavour was added and mixing well for 5 minutes. Followed by adding the Natural vivid red colour. The resultant mixture was mixed for 5 minutes and deposited into the mold.

[0070] Example 3: Comparison of each component with the present composition

[0071] The implementation set forth in the foregoing description does not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. Although a few variations have been described in detain above, other modifications or additions are possible. In particular, further features and / or variations can be provided in addition to those set forth herein. For example, the implementation described can be directed to various combinations and sub combinations of the disclosed features and / or combinations and sub combinations of the several further features disclosed above. In addition, the logic flows depicted in the accompany figures and / or described herein do not necessarily require the particular order shown, or sequential order, to achieve desirable results. Other implementations may be within the scope of the following claims.

Claims

CLAIMS:

1. A gummy formulation comprising: paracetamol ranging from 50 mg to 5000 mg of the gummy formulation; maltitol syrup ranging from 5% to 80% of the gummy formulation; potassium sorbate ranging from 0.01% to 1.0% of the gummy formulation; sodium chloride ranging from 0.01% to 5.0% of the gummy formulation; sucralose ranging from 0.01% to 0.50% of the gummy formulation; starch ranging from 0.02% to 10% of the gummy formulation; carrageenan ranging from 0.50% to 10% of the gummy formulation; mannitol ranging from 1% to 80% of the gummy formulation; banana powder ranging from 0.2% to 10% of the gummy formulation; and sodium citrate ranging from 0.1% to 0.5% of the gummy formulation.

2. The gummy formulation as claimed in claim 1, wherein concentration of the maltitol syrup is 50-70%.

3. The gummy formulation as claimed in claim 1, further comprising berry flavour ranging from 0.2 % to 10 % of the gummy formulation.

4. The gummy formulation as claimed in claim 1 , further comprising colouring agent ranging from 0.01% to 1.0 % of the gummy formulation.

5. The gummy formulation as claimed in claim 4, wherein the colouring agent is selected from natural beetroot or radish colour or combination thereof.

6. A method (100) for producing gummies comprising: weighing (102) required quantity of maltitol syrup 70% and heating it to 100-120°C in a steam jacket vessel; adding (104) paracetamol powder, banana powder, and mixing until dispersed completely free from lumps with a desired Brix between 60 todry mixing (106) carrageenan, mannitol, sodium chloride, trisodium citrate, and citric acid in a polybag; soaking (108) the mixed content in purified water containing dissolved potassium sorbate and stirring well in a clean SS vessel; pouring (110) the soaked content into a steam jacket and mixing well for about 10-30 minutes at 80-90 °C; mixing (112) the Step 2 and Step 1 mixtures for 10 minutes in a cooking tank, maintaining the temperature between 80 and 90 °C; adding (114) natural color and mixed berry flavor and mixing well; transferring (116) the viscous suspension from the mixing tank to a deposition unit, maintaining the temperature between 65 and 75 °C during deposition into a pre-lubricated mold; and passing (118) the gummy gel through a cooling tunnel with a temperature maintained below 10 °C.

7. The method (100) for producing gummies as claimed in claim 6, further comprising collecting (120) the gummies in trays and checking the average weight before drying.

8. The method (100) for producing gummies as claimed in claim 6, further comprising drying (122) the gummies at 45 °C ± 5 °C in trays kept in a drying room until the water content reaches below 15 % w / w.

9. The method (100) for producing gummies as claimed in claim 6, further comprising coating (124) the gummies using starch powder.

10. The method (100) for producing gummies as claimed in claim 6, further comprising packing (126) the coated gummies in a bottle pack.

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