DESC:
FORM 2
THE PATENTS ACT, 1970
(39 OF 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10; rule 13)

1. Title of the invention – MOUTH DISSOLVING FILM OF VITAMINS AND CALCIUM CARBONATE
2. Applicant(s)
NAME: Avery Pharmaceutical Pvt Ltd
NATIONALITY: INDIAN
ADDRESS: Plot No- 12, 13, 14, Shubh Laxmi Industrial Estate, Opposite Eye Hospital, Sanand- Viramgam Highway, Village and Taluka – Sanand, District: Ahmedabad -382110, India.
3. Preamble to the description
The following specification particularly describes the invention and the manner in which it is to be performed.

MOUTH DISSOLVING FILM OF VITAMINS AND CALCIUM CARBONATE

FIELD OF THE INVENTION
The present invention is related to mouth dissolving film of vitamins and calcium carbonate. The present invention is particularly related to a mouth dissolving film of vitamins and high dose of calcium carbonate. The present invention is also related to mouth dissolving film of vitamins and calcium carbonate comprising active ingredients with at least two polymers, plasticizer, anti-oxidant and one or more inactive excipients and process for preparing the same.

BACKGROUND OF THE INVENTION
Humans needs a lot of essential vitamins and minerals for growth, development and good health. Calcium is one of the important mineral that is found naturally in foods. Calcium is necessary for many normal functions of the body, especially bone formation and maintenance. This essential mineral supports the bones, heart, muscles, and nervous system. Calcium is formulated into various supplements. These all contain different amounts of pure or elemental calcium. Among the various forms of calcium added to supplements, calcium carbonate is the most common. It contains 40% elemental calcium, the highest of any form. Calcium carbonate is used to prevent or to treat a calcium deficiency.

Cholecalciferol is vitamin D3. Vitamin D helps your body absorb calcium. Cholecalciferol is used as a dietary supplement in people who do not get enough vitamin D in their diets to maintain adequate health. Vitamin D3 serves many purposes in the body, from supporting bone density to maintaining healthy immune responses.

Vitamin K is a group of vitamins found in some green vegetables. Vitamins K1 (phytonadione) and K2 (menaquinone) are commonly available as supplements.
Vitamin K activates proteins that play a role in blood clotting, calcium metabolism, and heart health. One of its most important functions is to regulate calcium deposition. In simple words, it promotes the calcification of bones and prevents the calcification of blood vessels and kidneys by preventing calcium from being deposited in your arteries, vessels and kidneys. Vitamin K2 may lower the risk of cardiovascular damage and improve overall heart health. It also promotes healthy bone mineral density by carboxylating osteocalcin, a protein that binds calcium to bones.

There are different oral supplements of vitamins and calcium are present in the market. Oral route of drug administration is a most preferred route due to its ease of administration, non-invasiveness, adaptability, patient compliance and acceptability. There are different types of conventional dosage forms like, tablet, capsule, powder, granules, etc. However, these conventional dosage forms has various disadvantages like difficulty in swallowing, unpleasant taste, etc. In recent years, drug delivery technologies have grown extensively that go beyond conventional oral dosage forms. Hence, there is need to develop alternate dosage form for these supplements with better patient compliance.

Mouth Dissolvable films (MDFs) evolved over the past few years and became a novel and widely accepted form by consumers. Mouth disintegrating films (MDFs) are thin strips made up of hydrophilic polymers hence when placed on tongue, immediately hydrates by soaking saliva following disintegration and/or dissolution releasing active pharmaceutical agent from the dosage form. It gives quick absorption and instant bioavailability of drugs due to high blood flow and permeability of oral mucosa and achieves rapid dissolution upon contact with saliva. MDFs are fast, accurate, safe and efficacious dosage forms which does not need water or measuring devices.

There are few challenges in development of MDF’s like solubility and high drug loading. Solubility plays an important role in two stages i.e. solubility of drug in solvent during formulation and solubility or dissolution of drug in saliva after putting the film in oral cavity. High drug loading in oral films is challenging task due to its thin form. It is difficult to develop mouth dissolving film with high dose of active ingredient. High dose of drug can be incorporated in oral film by increase in the area of film or increasing thickness of the film. Thinner conventional films offer fast disintegration time as the loading of active pharmaceutical ingredient (API) in thin films is limited. However, the disintegration time will be increased accordingly with increasing film thickness, leading to delayed onset drug action. Hence, there is a need to provide a mouth dissolving thin film capable to load high content of active ingredients for fast absorption, good bioavailability and better patient compliance.

There are challenges to load more than 50 mg of calcium carbonate in film which is having very limited solubility in the water. Such film formulation is very difficult in terms of process and patient acceptance.

The inventors of the present invention have surprisingly found the mouth dissolving film containing vitamins and high load of calcium carbonate. The inventors of the present invention has loaded more than 200 mg of calcium carbonate in the film and also the characteristic taste of calcium is masked with appropriate flavour. The objectives of the present invention are as described herein.

OBJECTIVE OF THE INVENTION
The main objective of the invention is to provide mouth dissolving film of vitamins and calcium carbonate.

The other main objective of the invention is to provide mouth dissolving film of vitamins and high dose of calcium carbonate.

Another objective of the invention is to provide mouth dissolving film of vitamins and calcium carbonate which has a better patient compliance.
Another objective of the invention is to provide mouth dissolving film of vitamins and calcium carbonate which provides faster absorption and higher bioavailability of the active constituents.

The other objective of the invention is to provide to mouth dissolving film of vitamins and calcium carbonate which does not need water for oral administration, yet dissolve / disperse/ disintegrate in the oral cavity.

SUMMARY OF THE INVENTION
The main aspect of the present invention is to provide mouth dissolving film of vitamins and high dose of calcium carbonate.

The other main aspect of the present invention is to provide mouth dissolving film of vitamins and calcium carbonate comprising active ingredients with at least two polymers, plasticizer, anti-oxidant and one or more inactive excipients.

Another aspect of the invention is to provide mouth dissolving film of vitamins and calcium carbonate and process of preparation of the same.

The details of one or more aspect of the invention are set forth in the description below. Other features, objects and advantages of the invention will be apparent from the description.

DESCRIPTION OF THE INVENTION
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods and materials are now described.

As used herein, the singular forms “a,” “an” and “the” specifically also encompass the plural forms of the terms to which they refer, unless the content clearly dictates otherwise.

As used herein, the term "formulation" or “composition”, unless otherwise defined refers to mouth dissolving film.

As used herein the body of the invention the “Mouth dissolving film” is defined as oral solid dosage form that disintegrate and dissolve when placed in mouth without taking water or chewing.

As used herein, the term “film” is defined as a thin long narrow piece of polymeric materials containing drug. The term “film” used herein can be interchangeably used with term “strip”.

The choice of particular types and amounts of excipients, and techniques for film preparation employed depends on the further properties of active ingredients and the excipients, e.g., film forming property, plasticity, solubility, particle size, compatibility, and density.

The films of the present invention may be prepared according to methods known in the art, including spray method, solvent casting method, semi-solid casting method, hot melt extrusion or rolling method and the type of excipients used will vary accordingly. It has been found that solvent casting method is particularly suitable for providing high film strength, low cracks films comprising relatively high concentrations on a scale suitable for commercial production.

As used herein the term “plasticizer” is primary ingredients of mouth dissolving films and defined as a substances or additives that makes the strip flexible and less fragile. It increases the plasticity or fluidity of a material.

As used herein the term “Polymer” is a major excipient in the film or strip formation. “Polymer” used herein is defined as a substances or additives which is crucial to produce a final formulation with quick dissolution and disintegration as defined. Hence it is obviously very important and the distribution of components within the system can be critical to the desired functionality.

Plasticizer are added to the polymers used as film forming agents in order to make the polymer pliable and soft, enhancing the flexibility and plasticity of the films. Hence the selection of proper ratio of polymer to plasticizer plays crucial role in making film that has good strength, foldable and yet not easily breakable.

As used herein the term “vitamins” is defined as organic substances that are generally classified as either fat soluble or water soluble.

As used herein the term “minerals” is defined as inorganic elements present in soil and water, which are absorbed by plants or consumed by animals.

As used herein the term “cooling agent” is defined as agent used in a number of different formulations, such as hard confectionery products or oral gums, films, to provide a pleasant taste and a cooling sensation.

The main embodiment of the present invention is mouth dissolving film of vitamins and calcium carbonate.

Another main embodiment of the present invention is mouth dissolving film of vitamins and calcium carbonate comprising active ingredients with at least two polymers, plasticizer, anti-oxidant and one or more inactive excipients.

As per on embodiment of the present invention, the active ingredients are vitamins and calcium carbonate.

As per on embodiment of the present invention, the vitamins can be selected from, vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, folate and combinations thereof.

As per preferred embodiment, the present invention contains one or more vitamins, preferably combination of two vitamins. As per another preferred embodiment, the present invention comprises combination of Vitamin D3 and Vitamin K2.

As per one embodiment of the present invention, the vitamin D3 is used in the range of 0.01- 0.1 mg, preferably in the range of 0.01-0.05 mg, more preferably in the range of 0.01-0.03 mg.

As per one embodiment of the present invention, the vitamin K2 is used in the range of 0.001- 0.1 mg, preferably in the range of 0.001-0.05 mg, more preferably in the range of 0.01-0.01 mg.

As per one embodiment of the present invention, calcium carbonate is used in dispersed form.

As per one embodiment of the present invention, the calcium carbonate is used is in the range of 10-300 mg, preferably in the range of 100-300 mg, more preferably in the range of 100-250 mg.

As per one embodiment of the present invention, the polymers are selected from Polyvinyl alcohol, hydroxy propyl methyl cellulose, sodium carboxy methyl cellulose, polyvinyl pyrrolidone, and hydroxy propyl cellulose, HPMC E50, cellulose acetate, ethyl cellulose, gelatin, starch, pectin, chitosan, sodium alginate, polyethylene, Eudragit RL100, and combinations thereof.

As per preferred embodiment, the present invention contains one or more polymers, preferably combination of two polymers.

As per another preferred embodiment, the present invention comprises combination of HPCM E50 or Sodium CMC as polymers.

As per one embodiment of the present invention, HPMC E50 is used in the present invention is in the range from 1-15 mg, preferably the range is 1-12 mg, more preferably the range is 1-10 mg.

As per one embodiment of the present invention, Sodium CMC is used in the present invention is in the range from 10-60 mg, preferably the range is 20-60 mg, more preferably the range is 30-60 mg.

As per one embodiment of the present invention, the ratio of combination of HPMC E50 to Sodium CMC can be 1:0.10 to 1:0.20, more preferably, 1:0.14.

As per one embodiment of the present invention, the plasticizer is selected from propylene glycol, ethanol, diethyl phthalate, dibutyl phthalate, glycerine, triethyl citrate and polyethylene glycol 400.

As per preferred embodiment, plasticizer used in the present invention is glycerine.

As per one embodiment of the present invention, the plasticizer is used in the range of 10-40 mg, preferably the range is 10-30 mg, more preferably the range is 10-25 mg.

As per one embodiment of the present invention, the inactive excipients are flavouring agent, sweetening agent, cooling agent, antioxidant and oil.

As per one embodiment of the present invention, the flavouring agent is selected from vanilla, strawberry, cocoa, coffee, chocolate, citrus, apple, pineapple, raspberry, and cherry. As per preferred embodiment, flavouring agent used in the present invention is strawberry.

As per one embodiment of the present invention, the flavouring agent is used in the range of 1-20 mg, preferably the range is 5-20 mg, more preferably the range is 10-20 mg.

As per one embodiment of the present invention, the sweetening agent is selected from sucrose, maltose, glucose, xylose, sucralose, aspartame, acesulfame-k, and stevioside. As per preferred embodiment, flavouring agent used in the present invention is sucralose.

As per one embodiment of the present invention, the sweetening agent is used in the range of 0.1-2 mg, preferably the range is 0.1-1.5 mg, more preferably the range is 0.1-1 mg.

As per one embodiment of the present invention, the cooling agent is selected from monomethyl succinate, menthol, mannitol, Ecocool MP, WS3, WS23, and Utracoll II. As per preferred embodiment, flavouring agent used in the present invention is Ecocool MP.

As per one embodiment of the present invention, the cooling agent is used in the range of 1-5 mg, preferably the range is 1-4 mg, more preferably the range is 2-4 mg.

As per one embodiment of the present invention, vitamin E is used as antioxidant and used in the range of 0.001-0.02 mg, preferably the range is 0.001-0.01 mg, more preferably in the range of 0.001-0.005 mg.

As per one embodiment of the present invention, virgin coconut oil is used as fat and used in the range of 1-5 mg, preferably the range is 1-4 mg, more preferably the range is 2-4 mg.

As per one another embodiment of the present invention, the mouth dissolving film of vitamins and calcium carbonate comprises of 10-300 mg calcium carbonate, 0.01-0.1 mg Vitamin D3, 0.001-0.1 mg Vitamin K2, 1-15 mg HPMC E50, 10-60 mg Sodium CMC, 10-40 mg glycerin, 1-20 mg strawberry, 0.1-2 mg sucralose, 1-5 mg Ecocool MP, 0.001-0.2 mg vitamin E and 1-5 mg virgin coconut oil.

As per one another embodiment of the present invention, the mouth dissolving film of vitamins and calcium carbonate comprises 100-250 mg calcium carbonate, 0.01-0.03 mg Vitamin D3, 0.001-0.01 mg Vitamin K2, 1-10 mg HPMC E50, 30-60 mg Sodium CMC, 10-25 mg glycerin, 10-20 mg strawberry, 0.1- 1 mg sucralose, 2-4 mg Ecocool MP, 0.001-0.05 mg vitamin E and 2-4 mg virgin coconut oil.

As per one another embodiment of the present invention, the mouth dissolving film of vitamins and calcium carbonate comprises 225 mg calcium carbonate, 0.025 mg Vitamin D3, 0.009 mg Vitamin K2, 48.663 mg HPMC E50, 7 mg Sodium CMC, 20 mg glycerin, 12.6 mg strawberry, 0.7 mg sucralose, 3 mg Ecocool MP, 0.003 mg vitamin E and 3 mg virgin coconut oil.

As per another main embodiment of the present invention, the process of preparation of mouth dissolving film of vitamins and high dose of calcium carbonate comprises the steps of:
a) Dissolving HPMC E50 and sodium CMC in the hot water (85º) to make polymer solution;
b) Addition of Glycerin in the solution of step (a) and mixing to get a solution;
c) Dispersing calcium carbonate in water (at room temperature) to get dispersion of calcium carbonate;
d) Dissolving Vitamin E, sucralose, Ecocool MP, flavouring agent in the water to get drug solution.
e) Mixing dispersion of step (C) and drug solution of step (d);
f) Dissolving Vitamin D3 and vitamin K2 in the virgin coconut oil to get clear drug solution.
g) Mixing of solutions of step (b), (e) and (f) to get uniform mixture;
h) Sifting of the mixture of step (g);
i) Casting of the mixture of step (h);
j) Cutting of the films obtained in step (i) into desired size;
k) Storing the final films of step (j) into suitable container.

As per one embodiment of the present invention, mouth dissolving film of vitamins and calcium carbonate provides thin film with higher amount of calcium carbonate and better patient compliance.

The invention is further illustrated by the following examples which are provided to be exemplary of the invention and do not limit the scope of the invention. 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.

EXAMPLE 1: TRIAL BATCHES FOR OPTIMIZATION OF A MOUTH DISSOLVING FILM OF VITAMINS AND CALCIUM CARBONATE
Sr. No. Material Name Trial batch 1 Trial batch 2 Trial batch 3 Trial batch 4
mg/strip mg/strip mg/strip mg/strip
1 Calcium Carbonate 225.000 225.000 225.000 225.000
2 Vitamin D3 0.025 0.025 0.025 0.025
3 Vitamin K2 0.009 0.009 0.009 0.009
4 HPMC E50 40.163 47.663 40.663 48.663
5 Sodium CMC 16.500 9.000 23.000 7.000
Ratio of HPMC E50: Sodium CMC 1:0.41 1:0.19 1:057 1:014
6 PVP K30 10.000 - - -
7 Glycerin 2.000 9.000 7.000 20.000
8 PEG 400 7.000 10.000 10.000 -
9 Sodium alginate - 10.000
5.000 -
10 Orange Flavour 12.600 - -
11 Strawberry Flavour - 12.600 12.600 12.600
12 Sucralose 0.700 0.700 0.700 0.700
13 Ecocool MP 3.000 3.000 3.000 3.000
14 Extra Virgin Coconut Oil 3.000 3.000 3.000 3.000
15 DL-Alpha Tocopherol 0.003 0.003 0.003 0.003
16 Purified Water Q.S. Q.S. Q.S. Q.S.
Total 320.000 330.000 330.00 320.00
Table 1: Trial batches for optimization of a mouth dissolving film of vitamins and calcium carbonate

Results:
Trial Batches Observation
Trial-1 Film Not Formed Properly
Trial-2 Film Not Formed Properly
Trial-3 Film Not Formed Properly
Trial-4 Smooth film formed
Table 2: Results for trial batches for optimization of a mouth dissolving film of vitamins and calcium carbonate
As per the results, it was concluded that trial batch 4 with combination of HPMC E50: Sodium CMC in the ratio, 1:014 is selected as an optimized batch.

EXAMPLE 2: OPTIMIZED COMPOSITION OF A MOUTH DISSOLVING FILM OF VITAMINS AND CALCIUM CARBONATE
Sr. No. Material Name Quantity
mg/strip %w/w
1 Calcium Carbonate (90 mg) 225 70.31
2 Vitamin D3 (1000 IU) 0.025 0.01
3 Vitamin K2 (9 µg) 0.009 0.003
4 HPMC E50 (Methocel) 48.663 15.21
5 Sodium CMC 7.000 2.19
6 Glycerin 20.000 6.25
7 Flavour Powder (Strawberry) 12.600 3.94
8 Sucralose 0.700 0.22
9 Ecocool MP 3.000 0.94
10 Virgin Coconut Oil 3.000 0.94
11 Vitamin E 50 % Powder 0.003 0.0009
12 Purified Water Q.S. -
Total 320 100
Table 3: Optimized Formulation of a mouth dissolving film of vitamins and calcium carbonate
Process of preparation:
a) HPMC E50 and sodium CMC was dissolved in the hot water (85º) to make polymer solution;
b) Glycerin was added in the solution of step (a) and mixed to get a solution;
c) Calcium carbonate was dispersed in water (at room temperature) to get dispersion of calcium carbonate;
d) Vitamin E, sucralose, Ecocool MP, flavouring agent was dissolved in the water to get drug solution;
e) The dispersion of step (C) was mixed in drug solution of step (d);
f) Vitamin D3 and vitamin K2 were dissolved in the virgin coconut oil to get clear drug solution;
g) The solutions of step (b), (e) and (f) were mixed to get uniform mixture;
h) The mixture of step (g) was sifted;
i) The mixture of step (h) was casted;
j) The films obtained in step (i) were cutted into desired size;
k) The final films of step (j) were stored into suitable container.

EXAMPLE 3: EVALUATION OF A MOUTH DISSOLVING FILM OF VITAMINS AND CALCIUM CARBONATE
The mouth dissolving films were evaluated for appearance, weight variation, moisture content, disintegration, drug content by HPLC and content uniformity.
Result:
Sr. No. Test Result
1. Description White coloured thin film
2. Average Weight 332.90 mg
3. Thickness 0.249 mm
4. Weight Variation Minimum: 328.53 mg
Maximum: 335.56 mg
5. Moisture Content 3.02 %
6. Disintegration Test 253 seconds
7. Assay (By HPLC) 1) Cholecalciferol: 116.87%
2) Vitamin K2: 110.24%
3) Calcium Carbonate: 98.04%
8. Uniformity of Dosage Unit Cholecalciferol Vitamin K2
Min. 108.62% 99.44%
Max. 117.38% 105.34%
Avg. 113.68% 101.99%
L1 5.47 4.15
Table 4: Results for evaluation of mouth dissolving film
EXAMPLE 4: STABILITY TESTING OF MOUTH DISSOLVING FILM OF VITAMINS AND CALCIUM CARBONATE
The mouth dissolving films were evaluated for their stability, at 40ºC and 75% room humidity. The results shows that the product is stable up to 6 months at 40 ºC and 75% RH.
Test Specification Criteria Initial 3 Months 6 Months
Description White coloured thin film White colour thin film White colour thin film White colour thin film
Average weight 320 mg + 7.5% (296 mg to 344 mg) 321.54 mg 326.73 mg 322.17 mg
Moisture content Not more than 15% 2.83% 3.58% 2.55%
Disintegration Test Less than 300 second 253 seconds 251 seconds 253 seconds
Assay Vitamin D3 (By HPLC) Not less than 70% of labelled amount of Vitamin D3. 109.68% 100.76% 86.80%
Vitamin K2 (By HPLC) Not less than 70% of labelled amount of Vitamin K2. 117.52% 102.08% 103.985
Calcium carbonate (By chemical) Not less than 80% of labelled amount of Calcium carbonate 98.30% 98.00% 97.93%
Table 5: Preliminary stability testing result
Microbial Analysis
Total Bacterial Count 100 cfu/gm 80 cfu/gm NA 55 cfu/gm
Total yeast and mold count 10 cfu/gm <10cfu/gm NA < 10 cfu/gm
E.coli Should be absent/gm Absent NA Absent
Pseudomonas aeruginosa Should be absent/gm Absent NA Absent
Staphylococcus aureus Should be absent/gm Absent NA Absent
Salmonella Should be absent/gm Absent NA Absent
Clostridia Should be absent/gm Absent NA Absent
S Candida Should be absent/gm Absent NA Absent
Table 6: Microbial analysis
As per the results of stability study it can be concluded that the product is stable up to 6 months, 40 ºC and 75% RH.

From the all study data it can be concluded that the oral films of the present invention satisfies all the parameters of good film even with high dose loading of calcium carbonate and is also stable up to 6 month.
,CLAIMS:CLAIMS

We claim,

1. A mouth dissolving film of vitamins and calcium carbonate comprising, vitamins and calcium carbonate as active ingredients with at least two polymers, plasticizer, anti-oxidant and one or more inactive excipients.

2. The mouth dissolving film of vitamins and calcium carbonate as claimed in claim 1, wherein said vitamins can be selected from, vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, vitamin B12, folate and combinations thereof.

3. The mouth dissolving film of vitamins and calcium carbonate as claimed in claim 1, wherein said calcium carbonate is used in dispersed form.

4. The mouth dissolving film of vitamins and calcium carbonate as claimed in claim 1, wherein said polymers are selected Polyvinyl alcohol, hydroxy propyl methyl cellulose, sodium carboxy methyl cellulose, polyvinyl pyrrolidone, and hydroxy propyl cellulose, HPMC E50, cellulose acetate, ethyl cellulose, gelatin, starch, pectin, chitosan, sodium alginate, polyethylene, and Eudragit RL100, more preferably HPCM E50, or Sodium CMC or a combination thereof.

5. The mouth dissolving film of vitamins and calcium carbonate as claimed in claim 1, wherein said combination of polymers used in the ratio 1:0.10 to 1:0.20, more preferably, 1:0.14.

6. The mouth dissolving film of vitamins and calcium carbonate as claimed in claim 1, wherein said plasticizer is selected from propylene glycol, ethanol, diethyl phthalate, dibutyl phthalate, glycerine, triethyl citrate and polyethylene glycol 400, more preferably glycerin.

7. The mouth dissolving film of vitamins and calcium carbonate as claimed in claim 1, wherein the inactive excipients are flavouring agent, sweetening agent, cooling agent, antioxidant and oil.

8. The mouth dissolving film of vitamins and calcium carbonate as claimed in claim 1, comprising 10-300 mg calcium carbonate, 0.01-0.1 mg Vitamin D3, 0.001-0.1 mg Vitamin K2, 1-15 mg HPMC E50, 10-60 mg Sodium CMC, 10-40 mg glycerin, 1-20 mg strawberry, 0.1-2 mg sucralose, 1-5 mg Ecocool MP, 0.001-0.2 mg vitamin E and 1-5 mg virgin coconut oil.

9. The mouth dissolving film of vitamins and calcium carbonate as claimed in claim 1, comprising 100-250 mg calcium carbonate, 0.01-0.03 mg Vitamin D3, 0.001-0.01 mg Vitamin K2, 1-10 mg HPMC E50, 30-60 mg Sodium CMC, 10-25 mg glycerin, 10-20 mg strawberry, 0.1- 1 mg sucralose, 2-4 mg Ecocool MP, 0.001-0.05 mg vitamin E and 2-4 mg virgin coconut oil.

10. The mouth dissolving film of vitamins and calcium carbonate as claimed in claim 1, comprising 225 mg calcium carbonate, 0.025 mg Vitamin D3, 0.009 mg Vitamin K2, 48.663 mg HPMC E50, 7 mg Sodium CMC, 20 mg glycerin, 12.6 mg strawberry, 0.7 mg sucralose, 3 mg Ecocool MP, 0.003 mg vitamin E and 3 mg virgin coconut oil.

11. The mouth dissolving film of vitamins and calcium carbonate as claimed in claim 1 having thickness 0.249 mm.

12. The process for preparation of mouth dissolving film of vitamin and calcium carbonate as claimed in claim 1, comprises the following steps of:
a) Dissolving HPMC E50 and sodium CMC in the hot water (85º) to make polymer solution;
b) Addition of Glycerin in the solution of step (a) and mixing to get a solution;
c) Dispersing calcium carbonate in water (at room temperature) to get dispersion of calcium carbonate;
d) Dissolving Vitamin E, sucralose, Ecocool MP, flavouring agent in the water to get drug solution;
e) Mixing dispersion of step (C) and drug solution of step (d);
f) Dissolving Vitamin D3 and vitamin K2 in the virgin coconut oil to get clear drug solution;
g) Mixing of solutions of step (b), (e) and (f) to get uniform mixture;
h) Sifting of the mixture of step (g);
i) Casting of the mixture of step (h);
j) Cutting of the films obtained in step (i) into desired size;
k) Storing the final films of step (j) into suitable container.

Dated this 06th Sept 2023