DESC:4. DESCRIPTION
Technical Field of the invention

The present invention relates to the field of food and nutrition. More specifically it relates to a formulation and method of preparing a ready to drink electrolyte film/ strip.

Background of the Invention

Electrolytes are the minerals present in the tissues, cells and which travels all over the body. As the name suggest these consists of electrical charge in it. Some of the main electrolytes in the body fluids are sodium, potassium, chloride, phosphate and calcium. This are present in the body fluids and have multiple functions starting from regulating the chemical reactions occurring in our body, balances the fluid inside and outside of the cell, neuromuscular excitability, myocardial rhythm and contractility, acid-base balance, maintenance of osmotic pressure and fluid distribution.

Sodium chloride is necessary to retain the electrolyte and fluid balance in the body. It also helps in restoring the water and electrolyte loss which is caused due to dehydration. Further it aids in the distribution and maintenance of water balance, acid-base balance, heart function, nerve cell function and muscle function. Potassium chloride assists in maintaining kidney and adrenal function.

Sodium citrate acts as a urine alkalizer that makes urine less acidic and thus assists kidneys to get rid of uric acid. It mainly acts by neutralizing excess acid in the blood and urine.

An electrolyte imbalance is caused when there’s a loss of large amount of body fluids. The body generally losses too much of fluid in vomiting, diarrhea, excessive sweating, high fever and blood loss. The electrolyte imbalance symptoms are dizziness, cramps, fatigue, irregular heart rate and mental confusion. Physiologically, kidneys play an important role in regulating the body fluids and electrolytes; hence kidney problems can also cause the electrolyte imbalance. This imbalance is usually managed by consuming the required amount water initially followed by the necessary salts and sometimes combined.

There are several pills, powders and readymade drink that can be added to one’s diet that can help suffice the above-mentioned electrolyte imbalance. However, these come with additives that may or may not be suitable for every individual. The present invention aims to deliver a method and a formulation of a ready to drink electrolyte film to aid in the electrolyte imbalance.

ORS (oral rehydrating salt) ready to drink film is a mixture of salts that accelerate water and electrolyte absorption from the gut, thereby aids in the lost salts that may be caused due to several conditions for example metabolic acidosis, diarrhoea, vomiting etc.

A patent CN108904529A, discloses a kind of oral rehydration salts and preparation method thereof, oral rehydration salts described in every 1000ml includes following mm (mmol) of various components sodium chloride, sodium citrate, potassium chloride, zinc chloride, dextrose anhydrous, deionized water 91-110, ph regulator, and total sodium (na+) content is 83-94mmol/l, total chlorine (cl-) content is 82-95mmol/l, total potassium (k+) content is 4.2-8.9mmol/l, which is 6.2-6.4.the present invention is when dextrose anhydrous is add to deionized water while ph regulator, which is added drop wise, makes pH to 6.2-6.4, so that the dextrose anhydrous moment is in the liquid that pH is 6.2-6.4, it ensure that dextrose anhydrous is hardly degraded, obtained product is stabilized, and therapeutic effect is preferable.

Another patent No WO2013139274A1, disclose a sodium pyruvate oral rehydration salt composition for treating hypovolemia or hyponatration associated with hypohydration. It contains the following components such sodium pyruvate, sodium chloride; potassium chloride; glucose anhydrous or other carbohydrate. The weight of components constitutes 50-100% of the total weight of the composition.

Another Patent No.CN108904529A disclose a liquid oral rehydration salt which comprises the following components such as sodium chloride, potassium chloride, sodium citrate, glucose and water. The liquid oral rehydration salt is used for treating mild and moderate dehydration caused by diarrhea and dehydration caused by children diarrhea. Through accurate control of water dosage, asepsis operation and other treatment, the high liquid oral rehydration salt is stable in quality, more convenient to use and suitable for being taken by old people and children under water shortage conditions in the open air and in case of an emergency, and can better express the efficacy.

There are many other patents which provide different types of formulations for oral rehydration salts to aid the electrolyte imbalance. However there still exists a need to develop a formulation and a method for a ready to drink electrolyte film/strip which is convenient to carry and easy to use that has mixture of salts that accelerate water and electrolyte absorption from the gut, thereby aids in the lost salts that may be caused due to several conditions.

Our present invention addresses this need with a formulation which is different from the above-mentioned patents and consists of sodium chloride, potassium chloride, and sodium citrate as main ingredients.

Objective of the invention

The main objective of our system is to provide a method and formulation of a ready to drink electrolyte film.

The second objective of the present invention is for the formulation to comprise of sodium chloride, potassium chloride, sodium citrate as key ingredients.

Further objective of the present invention is an oral drink film which is a mixture of salts that accelerate water and electrolyte absorption from the gut, thereby aids in regaining the lost salts.

Brief Summary of the invention

The following summary is provided to facilitate a clear understanding of the new features in the disclosed embodiment and it is not intended to be a full, detailed description. A detailed description of all the aspects of the disclosed invention can be understood by reviewing the full specification, the drawing and the claims and the abstract, as a whole.

In one aspect of the present invention is it provides three different formulations with varying ingredients and its proportions which are used in the composition. The method includes adding each ingredient in a stainless-steel container one at a time and 2 minutes once with constant stirring.

In another aspect of the present invention is after the addition of the ingredients, a Wet slurry stir is done for 30 min to get uniform dispersion and which is subjected to vacuum degassing to obtain bubble free slurry.

In yet another aspect of the present invention is, the Wet slurry is processed at the parameters of Dr. Knife thickness of 700 to 780 microns with the Temperature 90±3°C in-direct drying for 22 min. The dried casted electrolyte film ready to drink is slit into 40mm x 80mm.

Our present invention also includes active agents, plasticizers, a sweetening agent, film forming agents, flavoring agent, coloring agent and a vehicle in the formulation of electrolyte film.

Brief Description of the Drawings

The manner in which the present invention is formulated is given a more particular description below, briefly summarized above, may be had by reference to the components, some of which is illustrated in the appended drawing It is to be noted; however, that the appended drawing illustrates only typical embodiments of this invention and are therefore should not be considered limiting of its scope, for the system may admit to other equally effective embodiments.

Throughout the drawings, the same drawing reference numerals will be understood to refer to the same elements and features.

The features and advantages of the present invention will become more apparent from the following detailed description a long with the accompanying figures, which forms a part of this application and in which:

Fig 1: Graph Diagram showing the comparative assay results for Marketed product and In-House product, in accordance with our present invention;

Detailed Description of the invention

It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. In addition, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

The use of “including”, “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “an” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.

The principles of operation, design configurations and evaluation values in these non-limiting examples can be varied and are merely cited to illustrate at least one embodiment of the invention, without limiting the scope thereof.
The embodiments disclosed herein can be expressed in different forms and should not be considered as limited to the listed embodiments in the disclosed invention. The various embodiments outlined in the subsequent sections are constructed such that it provides a complete and a thorough understanding of the disclosed invention, by clearly describing the scope of the invention, for those skilled in the art.
Throughout this specification various indications have been given as to preferred and alternative embodiments of the invention. It should be understood that it is the appended claims, including all equivalents, which are intended to define the spirit and scope of this invention.
The present invention relates to a formulation and method of preparing ready to drink electrolyte film which consists of sodium chloride, potassium chloride, sodium citrate as key ingredients.

The present invention is a ready to drink electoral film which helps in restoring lost electrolytes and fluids in the body. It is used as electrolyte replenisher in the treatment of dehydration caused by diarrhea, vomiting etc. It can also be suggested in the treatment of metabolic acidosis. Further it is indicated for use in muscle cramping caused due to lack of water and electrolytes in the body. In addition, it can also be used by people recovering from illnesses or those suffering from sun stroke.

Formulation 1

Table 1 showing the ingredients with % values and its function for formulation 1
S. No. Ingredients Function w/w
1 Sodium Chloride Active 2.90
2 Potassium Chloride Active 10.83
3 Sodium Citrate Active 10.20
4 Polysorbate 80 Plasticizer 1.89
5 Pullulan Film forming Agent 62.97
6 Maltodextrin Film forming Agent 2.51
7 Polyethylene Oxide Film forming Agent 2.52
8 Sucralose Sweetening Agent 1.89
9 Propylene Glycol Plasticizer 0.50
10 Sorbitol Plasticizer 0.50
11 Triethyl Citrate Plasticizer 0.50
12 Trusil Lemon Flavour Flavouring Agent 2.54
13 Yellow Colour Natural Colouring Agent 0.25
14 Purified Water* Vehicle -
Total 100.00

A method of preparation of ready to drink oral electrolyte film formulation 1 comprise of the following steps: Step 1: Weigh required quantity of purified water in SS container. Add Weigh required quantity of sodium chloride to step-1. Add Weighed quantity of Potassium chloride to step-2 and stir for 2min. Add Weighed quantity of Sodium citrate to step-3 and stir for 2min. Add Weighed quantity of polysorbate 80 to step-4 and stir for 2min. Add Weighed quantity of Pullulan to step-5 and stir for 5min. Add Weighed quantity of Maltodextrin to step-6 and stir for 5min. Add Weighed quantity of Polyethylene oxide to step-7 and stir for 5min. Add Weighed quantity of sucralose to step- 8 and stir for 2min. Add Weighed quantity of propylene glycol to step-9 and stir for 2min. Add Weighed quantity of sorbitol to step-10 and stir for 2min. Add Weighed quantity of Triethyl citrate to step-11 and stir for 2min. Add Weighed quantity of Lemon Flavour to step-12 and stir for 2min. Add Weighed quantity of Yellow Colour Natural to step-13 and stir for 15min. Finally, above step- 10 Wet slurry stir for 30 min to get uniform dispersion. Above step wet slurry subjected to vacuum degassing to obtain bubble free slurry. Cast the Wet slurry at process parameters of Dr. Knife thickness of 700 to 780 microns; Temperature 90±3°C; In-direct drying for 22 min. slit the dried casted film into 40mm x 80mm. The final product of film was obtained.

Formulation 2
Table 2 showing the ingredients involved for preparing the formulation 2

S. No. Ingredients Function %w/w
1 Sodium Chloride Active 2.96
2 Potassium Chloride Active 11.04
3 Sodium Citrate Active 10.39
4 Pullulan Film forming Agent 64.18
5 Maltodextrin Film forming Agent 2.56
6 Polyethylene Oxide Film forming Agent 2.57
7 Sucralose Sweetening Agent 1.93
8 Propylene Glycol Plasticizer 0.51
9 Sorbitol Plasticizer 0.51
10 Triethyl Citrate Plasticizer 0.51
11 Trusil Lemon Flavour Flavouring Agent 2.57
12 Yellow Colour Natural Colouring Agent 0.27
13 Purified Water* Vehicle -
Total 100.00

A method of preparation of ready to drink oral electrolyte film formulation 2, comprise of the following steps: Step 1: Weigh required quantity of purified water in SS container. Add Weigh required quantity of sodium chloride to step-1. Add Weighed quantity of Potassium chloride to step-2 and stir for 2min. Add Weighed quantity of Sodium citrate to step-3 and stir for 2min. Add Weighed quantity of Pullulan to step-4 and stir for 5min. Add Weighed quantity of Maltodextrin to step-5 and stir for 5min. Add Weighed quantity of Polyethylene oxide to step-6 and stir for 5min. Add Weighed quantity of sucralose to step- 7 and stir for 2min. Add Weighed quantity of propylene glycol to step-8 and stir for 2min. Add Weighed quantity of sorbitol to step-9 and stir for 2min. Add Weighed quantity of Triethyl citrate to step-10 and stir for 2min. Add Weighed quantity of Lemon Flavour to step-11 and stir for 2min. Add Weighed quantity of Yellow Colour Natural to step-12 and stir for 15min. Finally, above step- 13 Wet slurry stir for 30 min to get uniform dispersion. Above step, wet slurry subjected to vacuum degassing to obtain bubble free slurry. Cast the Wet slurry at process parameters of Dr. Knife thickness of 700 to 780 microns; Temperature 90±3°C; In-direct drying for 22 min. Slit the dried casted film into 40mm x 80mm and the final product was obtained using formulation 2.

Formulation 3
Table 3 showing the ingredients for formulation 3

S. No. Ingredient Function %w/w
1 Sodium Chloride Active 2.97
2 Potassium Chloride Active 11.08
3 Sodium Citrate Active 10.44
4 Pullulan Film forming Agent 64.43
5 Maltodextrin Film forming Agent 2.57
6 Polyethylene Oxide Film forming Agent 2.57
7 Sucralose Sweetening Agent 1.93
8 Propylene Glycol Plasticizer 0.51
9 Trusil Lemon Flavour Flavouring Agent 3.23
10 Yellow Colour Natural Colouring Agent 0.27
11 Purified Water Vehicle -
Total 100.00

A method of preparation of ready to drink oral electrolyte film, formulation 3 comprise of the following steps: Step 1: Weigh required quantity of purified water in SS container. Add Weigh required quantity of sodium chloride to step-1. Add Weighed quantity of Potassium chloride to step-2 and stir for 2min. Add Weighed quantity of Sodium citrate to step-3 and stir for 2min. Add Weighed quantity of Pullulan to step-5 and stir for 5min. Add Weighed quantity of Maltodextrin to step-6 and stir for 5min. Add Weighed quantity of Polyethylene oxide to step-7 and stir for 5min. Add Weighed quantity of sucralose to step- 8 and stir for 2min. Add Weighed quantity of propylene glycol to step-9 and stir for 2min. Add Weighed quantity of Lemon Flavor to step-12 and stir for 2min. Add Weighed quantity of Yellow Color Natural to step-13 and stir for 15min. Finally, above step- 10 Wet slurry stir for 30 min to get uniform dispersion. Above step wet slurry subjected to vacuum degassing to obtain bubble free slurry. Cast the Wet slurry at process parameters of Dr. Knife thickness of 700 to 780 microns; Temperature 90±3°C; In-direct drying for 22 min. Slit the dried casted film into 40mm x 80mm and thus final product was obtained.

Water get evaporated during the coating processes and traces of water content will remain in the product.

Further two different embodiments of our present invention, their ingredient composition, their manufacturing procedure, the evaluation results of the embodiment’s stability, the disintegration time, folding endurance and Assay are given below:

Embodiment- 1

* Water gets evaporated during the coating process and traces of water content will remain product.
Embodiment- 1
Manufacturing procedure
1. Weighed quantity of purified water was taken in a ss container and kept under stirring at 450 RPM.
2. Weighed quantity of polyvinyl alcohol was added to above step-1 under stirring at 750 RPM for 20 min.
3. Weighed quantity of Sodium chloride was added to above step-2 under stirring at 1000 RPM for 10 min.
4. Weighed quantity of Potassium chloride was added to above step-3 under stirring at 1000 RPM for 10 min.
5. Weighed quantity of Tri-sodium citrate dihydrate was added to above step-4 under stirring at 1000 RPM for 10 min.
6. Weighed quantity of Sucralose was added to above step-5 under stirring at 1000 RPM for 10min.
7. Weighed quantity of Maltodextrin was added to above step-6 under stirring at 1250 RPM for 15min.
8. Weighed quantity of Polyethylene oxide was added to above step-7 under stirring at 1250 RPM for 10min.
9. Weighed quantity of Pullulan was added to above step-8 under stirring at 1250 RPM for 30min.
10. Weighed quantity of Propylene Glycol was added to above step-9 under stirring at 1560 RPM for 15min.
11. Weighed quantity of Trusil lemon Special was added to above step-10 under stirring at 1560 RPM for 10min.
12. Weighed quantity of Neelicol Tartrazine colour l was added to above step-11under stirring at 1500 RPM for 15min.
13. Above step wet slurry after completion of mixing subjected to vacuum degassing for 60mins to obtain bubble free slurry.
14. The Wet slurry was casted at process parameters of Dr. Knife thickness of 800 to 1000 microns; Temperature 90±3°C; In-direct drying for 21 min.
15. The dried casted film was Slitted into 80mm x 40mm.

The films were evaluated for disintegration time, folding endurance and Assay. The films were subjected to stability study under 40°C ± 2°C and 75% ± 5% RH condition for six month and evaluated above test parameters and results are tabulated.
Results:
S. No. Test Parameters Limits Results
Initial 1M 3M 6M
1 Disintegrating time NMT 60sec 27sec 22 sec 29sec 26 sec
2 Folding Endurance NLT 10 MT 150F MT 150F MT 150F MT 150F
3 Assay (Sodium) NLT 80% 112.9 113.2 108.9 107.1
Assay (Potassium) NLT 80% 97.3 97.3 95.1 91.2
Assay (Chloride) NLT 80% 99.1 96.4 90.1 90.3
4 Water content NMT 10% 4.12 6.64 6.39 5.17

Conclusion:
Based on the experimental data embodiment-1 satisfactory in terms of physical & chemical properties.

Embodiment 2
* Water gets evaporated during the coating process and traces of water content will remain product.

Embodiment- 2
Manufacturing procedure
1. Weighed quantity of purified water was taken in a ss container and kept under stirring at 900 RPM.
2. Weighed quantity of polyvinyl alcohol was added to above step-1 under stirring at 900 RPM for 5 min.
3. Weighed quantity of Polyethylene oxide was added to above step-2 under stirring at 900 RPM for 5min.
4. Weighed quantity of Sodium chloride was added to above step-3 under stirring at 900 RPM for 2 min.
5. Weighed quantity of Potassium chloride was added to above step-4 under stirring at 900 RPM for 2 min.
6. Weighed quantity of Tri-sodium citrate dihydrate was added to above step-5 under stirring at 900 RPM for 3 min.
7. Weighed quantity of Maltodextrin was added to above step-6 under stirring at 950 RPM for 3min.
8. Weighed quantity of Sucralose was added to above step-7 under stirring at 950 RPM for 3min.
9. Weighed quantity of Pullulan (Kopulan) was added to above step-8 under stirring at 1400 RPM for 90min.
10. Weighed quantity of Propylene Glycol was added to above step-9 under stirring at 1400 RPM for 3min.
11. Weighed quantity of Glycerol was added to above step-10 under stirring at 1400 RPM for 3min.
12. Weighed quantity of Neelicol Sunset yellow colour was added to above step-11 under stirring at 1400 RPM for 5min.
13. Weighed quantity of Orange 1235 (Orange flavour) l was added to above step-12under stirring at 1400 RPM for 5min.
14. Above step wet slurry after completion of mixing subjected to vacuum degassing for 60mins to obtain bubble free slurry.
15. The Wet slurry was casted at process parameters of Dr. Knife thickness of 800 to 1000 microns; Temperature 95±3°C; In-direct drying for 18 min.
16. The dried casted film was Slitted into 80mm x 40mm.

The films were evaluated for disintegration time, folding endurance and Assay. The films were subjected to stability study under 40°C ± 2°C and 75% ± 5% RH condition for 6M and evaluated above test parameters and results are tabulated.
Results:
S. No. Test Parameters Limits Results
Initial 1M 3M 6M
1 Disintegrating time NMT 60sec 19 19 23 21
2 Folding Endurance NLT 10 MT 150F MT 150F MT 150F MT 150F
3 Assay (Sodium) NLT 80% 103.93 105.89 104.56 101.23
Assay (Potassium) NLT 80% 98.04 97.44 98.10 96.56
Assay (Chloride) NLT 80% 96.9 97.2 98.58 97.02
4 Water content NMT 10% 4.76 5.64 5.89 6.03

Conclusion:
Based on the experimental data embodiment-2 found satisfactory in terms of physical & chemical properties and comparatively assay of In-house product is found good respectively with marketed product and stability up to 6M also found satisfactory.

The present invention can be also used to improve fluid levels in the body after heavy exercising or prolonged exposure to sun during summer.

Throughout this specification various indications have been given as to preferred and alternative embodiments of the invention. It should be understood that it is the appended claims, including all equivalents that are intended to define the spirit and scope of this invention.
,CLAIMS:5. CLAIMS
I/We Claim:
1. A method and composition of preparing an electrolyte oral drink in film/strip, wherein:
I. The oral electoral film consists of sodium chloride, potassium chloride, and sodium citrate as main ingredients and other ingredients like active agents, plasticizers, a sweetening agent, film forming agents, flavoring agent, coloring agent and a vehicle in the formulation of electrolyte film, wherein using the above ingredients three different formulations have been prepared.
II. The method includes:
a. adding each ingredient in a stainless-steel container 2 minutes once with constant stirring.
b. After the addition of the ingredients a wet slurry stir is done for 30 min to get uniform dispersion.
c. Then it is subjected to vacuum degassing to obtain bubble free slurry solution.
d. The wet slurry is processed at the parameters of Dr. Knife thickness of 700 to 780 microns; Temperature 90±3°C; in-direct drying for 22 min. The dried casted electoral film is slit into 40mm x 80mm.
2. The formulation and method of preparing ready to drink electrolyte film/strip, as claimed in claim 1, wherein:
I. formulation-1 comprises of:
(a) Sodium Chloride (active, 2.90 %w/w), Potassium Chloride (Active, 10.83%w/w), Sodium Citrate Active, 10.20%w/w), Polysorbate 80 ( Plasticizer, 1.89%w/w), Pullulan (Film forming Agent, 62.97%w/w), Maltodextrin (Film forming Agent, 2.51%w/w), Polyethylene Oxide (Film forming Agent, 2.52%w/w), Sucralose(Sweetening Agent, 1.89%w/w), Propylene Glycol(Plasticizer, 0.50%w/w), Sorbitol (Plasticizer, 0.50%w/w), Triethyl Citrate(Plasticizer 0.50%w/w), Trusil Lemon Flavour (Flavouring Agent, 2.54%w/w), Yellow Colour(Natural Colouring Agent ,0.25%w/w), Purified Water(Vehicle )
(b) The method of preparation of formulation-1 comprises of the following steps:
(1) Weigh required quantity of purified water in SS container.
(2) Add Weigh required quantity of sodium chloride to step-1.
(3) Add Weighed quantity of Potassium chloride to step-2 and stir for 2min.
(4) Add Weighed quantity of Sodium citrate to step-3 and stir for 2min.
(5) Add Weighed quantity of polysorbate 80 to step-4 and stir for 2min.
(6) Add Weighed quantity of Pullulan to step-5 and stir for 5min.
(7) Add Weighed quantity of Maltodextrin to step-6 and stir for 5min.
(8) Add Weighed quantity of Polyethylene oxide to step-7 and stir for 5min.
(9) Add Weighed quantity of sucralose to step- 8 and stir for 2min.
(10) Add Weighed quantity of propylene glycol to step-9 and stir for 2min.
(11) Add Weighed quantity of sorbitol to step-10 and stir for 2min.
(12) Add Weighed quantity of Triethyl citrate to step-11 and stir for 2min.
(13) Add Weighed quantity of Lemon Flavour to step-12 and stir for 2min.
(14) Add Weighed quantity of Yellow Colour Natural to step-13 and stir for 15min.
(15) Finally, above step- 10 Wet slurry stir for 30 min to get uniform dispersion.
(16) Above step wet slurry subjected to vacuum degassing to obtain bubble free slurry. Cast the Wet slurry at process parameters of Dr. Knife thickness of 700 to 780 microns; Temperature 90±3°C; In-direct drying for 22 min. slit the dried casted film into 40mm x 80mm. The final product of film was obtained.
II. The formulation and method of preparing ready to drink electrolyte film/strip formulation-2 comprises of:
(a) Sodium Chloride (Active, 2.96 %w/w), Potassium Chloride (Active, 11.04 %w/w), Sodium Citrate(Active, 10.39 %w/w), Pullulan (Film forming Agent, 64.18%w/w), Maltodextrin (Film forming Agent, 2.56%w/w), Polyethylene Oxide (Film forming Agent, 2.57%w/w), Sucralose (Sweetening Agent, 1.93%w/w), Propylene Glycol (Plasticizer, 0.51%w/w), Sorbitol (Plasticizer, 0.51%w/w), Triethyl Citrate (Plasticizer, 0.51%w/w), Trusil Lemon Flavour (Flavouring Agent, 2.57%w/w), Yellow Colour(Natural Coloring Agent, 0.27%w/w), Purified Water(Vehicle)
(b) The method of preparation of ready to drink oral electrolyte film formulation-2 comprise of the following steps:
(1) Weigh required quantity of purified water in SS container.
(2) Add Weigh required quantity of sodium chloride to step-1.
(3) Add Weighed quantity of Potassium chloride to step-2 and stir for 2min.
(4) Add Weighed quantity of Sodium citrate to step-3 and stir for 2min.
(5) Add Weighed quantity of Pullulan to step-4 and stir for 5min.
(6) Add Weighed quantity of Maltodextrin to step-5 and stir for 5min.
(7) Add Weighed quantity of Polyethylene oxide to step-6 and stir for 5min.
(8) Add Weighed quantity of sucralose to step- 7 and stir for 2min.
(9) Add Weighed quantity of propylene glycol to step-8 and stir for 2min.
(10) Add Weighed quantity of sorbitol to step-9 and stir for 2min.
(11) Add Weighed quantity of Triethyl citrate to step-10 and stir for 2min.
(12) Add Weighed quantity of Lemon Flavour to step-11 and stir for 2min.
(13) Add Weighed quantity of Yellow Colour Natural to step-12 and stir for 15min.
(14) Finally, above step- 13 Wet slurry stir for 30 min to get uniform dispersion. Above step, wet slurry subjected to vacuum degassing to obtain bubble free slurry. Cast the Wet slurry at process parameters of Dr. Knife thickness of 700 to 780 microns; Temperature 90±3°C; In-direct drying for 22 min. Slit the dried casted film into 40mm x 80mm and the final product is thus obtained using formulation 2.
III. The formulation and method of preparing ready to drink electrolyte film/strip, formulation-3 comprises of:
(a) Sodium Chloride (Active, 2.97%w/w), Potassium Chloride (Active, 11.08%w/w), Sodium Citrate Active, 10.44%w/w), Pullulan (Film forming Agent, 64.43%w/w), Maltodextrin (Film forming Agent, 2.57%w/w), Polyethylene Oxide (Film forming Agent, 2.57%w/w), Sucralose (Sweetening Agent, 1.93%w/w), Propylene Glycol (Plasticizer, 0.51%w/w), Trusil Lemon Flavour (Flavouring Agent, 3.23%w/w), Yellow Colour (Natural Colouring Agent, 0.27%w/w), Purified Water (Vehicle)
(b) The method of preparation of ready to drink oral electrolyte film formulation-3 comprise of the following steps:
(1) Weigh required quantity of purified water in SS container.
(2) Add Weigh required quantity of sodium chloride to step-1.
(3) Add Weighed quantity of Potassium chloride to step-2 and stir for 2min.
(4) Add Weighed quantity of Sodium citrate to step-3 and stir for 2min.
(5) Add Weighed quantity of Pullulan to step-4 and stir for 5min.
(6) Add Weighed quantity of Maltodextrin to step-5 and stir for 5min.
(7) Add Weighed quantity of Polyethylene oxide to step-6 and stir for 5min.
(8) Add Weighed quantity of sucralose to step- 7 and stir for 2min.
(9) Add Weighed quantity of propylene glycol to step-8 and stir for 2min.
(10) Add Weighed quantity of Lemon Flavor to step-9 and stir for 2min.
(11) Add Weighed quantity of Yellow Color Natural to step-10 and stir for 15min.
(12) Finally, above step- 11 Wet slurry stir for 30 min to get uniform dispersion. Above step wet slurry subjected to vacuum degassing to obtain bubble free slurry. Cast the Wet slurry at process parameters of Dr. Knife thickness of 700 to 780 microns; Temperature 90±3°C; In-direct drying for 22 min. Slit the dried casted film into 40mm x 80mm and thus final product was obtained.