Oral dissolvable film containing vitamin D3

1. A method of delivering cholecalciferol (vitamin D 3 ) to a human subject in need thereof, the method comprising orally administering to the human subject an oral dissolvable film comprising:

(i) water;

(ii) sodium carboxymethyl cellulose (Na CMC);

(iii) polyvinylpyrrolidone (PVP);

(iv) natural deodorized cocoa butter, present in 4.53±0.5 wt. % of the oral dissolvable film;

(v) glycerin;

(vi) polysorbate 80;

(vii) microcrystalline cellulose (MCC);

(viii) vitamin E;

(ix) a.scorbyl palmitate;

(x) vitamin D 3 ;

(xi) optionally flavoring agent;

(xii) optionally sweetener; and

(xiii) optionally coloring agent, wherein one oral dissolvable film is administered to the subject once per week.

2. The method of claim 1 , wherein upon orally administering to the human subject the oral dissolvable film, the cholecalciferol (vitamin D 3 ) is delivered enterally.

3. The method of claim 1 , wherein the oral dissolvable film is administered to the subject to prevent vitamin D deficiency, to treat vitamin D deficiency, or a combination thereof.

4. The method of claim 1 , wherein the oral dissolvable film comprises the water as a solvent, and is present in 8.00±3 wt. % of the oral dissolvable film.

5. The method of claim 1 , wherein the oral dissolvable film comprises the sodium carboxymethyl cellulose as a binder, and is present in 19.19±2 wt. % of the oral dissolvable film.

6. The method of claim 1 , wherein the oral dissolvable film comprises the polyvinylpyrrolidone, as a thickening agent, and is present in 11.71±1 wt. % of the oral dissolvable film.

7. The method of claim 1 , wherein the oral dissolvable film comprises the glycerin as a plasticizer, and is present in 9.16±1.5 wt. % of the oral dissolvable film.

8. The method of claim 1 , wherein the oral dissolvable film comprises the polysorbate 80 as an emulsifier, and is present in 7.32±1 wt. % of the oral dissolvable film.

9. The method of claim 1 , wherein the oral dissolvable film comprises the microcrystalline cellulose (MCC) as a filler, and is present in 9.27±1.5 wt. % of the oral dissolvable film.

10. The method of claim 1 , wherein the oral dissolvable film comprises the vitamin E as an antioxidant, and is present as vitamin E oil in 9.20±1.5 wt. % of the oral dissolvable film.

11. The method of claim 1 , wherein the oral dissolvable film comprises the ascorbyl palmitate as an antioxidant, and is present in 0.05±0.01 wt. % of the oral dissolvable film.

12. The method of claim 1 , wherein the oral dissolvable film comprises vitamin D 3 in an amount of 1.95±0.3 wt. % of the oral dissolvable film.

13. The method of claim 1 , wherein the oral dissolvable film comprises vitamin D 3 in an amount of 50K±10K IU.

14. The method of claim 1 , wherein the oral dissolvable film comprises vitamin D 3 in an amount of 40K±10K IU.

15. The method of claim 1 , wherein the oral dissolvable film comprises at least one of mountain berry and natural & artificial mixed berry as a flavoring agent, and is present in an aggregate amount of 17.27±2.2 wt. % of the oral dissolvable film.

16. The method of claim 1 , wherein the oral dissolvable film comprises sucralose as a sweetener, and is present in 2.33±0.5 wt. % of the oral dissolvable film.

17. The method of claim 1 , wherein the oral dissolvable film comprises FD&C Red #40 as a coloring agent, and is present in 0.01±0.001 wt. % of the oral dissolvable film.

18. The method of claim 1 , wherein the oral dissolvable film comprises

Ingredient

Amount (wt. %) in hydrous strip

Water

8.00 ± 3

wt. %

Sodium Carboxymethyl Cellulose

19.19 ± 2

wt. %

(Na CMC)

Polyvinylpyrrolidone (PVP)

11.71 ± 1

wt. %

Natural Deodorized Cocoa Butter

4.53 ± 0.5

wt. %

Glycerin (99.7% USP)

9.16 ± 1.5

wt. %

Polysorbate 80, NF

7.32 ± 1

wt. %

Mountain Berry

9.61 ± 1.5

wt. %

Sucralose USP/NF

2.33 ± 0.5

wt. %

Microcrystalline Cellulose (MCC)

9.27 ± 1.5

wt. %

Vitamin E Oil 1000 IU

9.20 ± 1.5

wt. %

Ascorbyl Palmitate

0.05 ± 0.01

wt. %

Vitamin D 3

1.95 ± 0.3

wt. %

Natural & Artificial Mixed Berry

7.66 ± 0.7

wt. %

FD&C Red #40

0.01 ± 0.001

wt. %

Total

100.00

wt. %.

19. The method of claim 1 , wherein the oral dissolvable film comprises

Ingredient

Amount (wt. %) in hydrous strip

Water

8.00

wt. %

Sodium Carboxymethyl Cellulose

19.19

wt. %

(Na CMC)

Polyvinylpyrrolidone (PVP)

11.71

wt. %

Natural Deodorized Cocoa Butter

4.53

wt. %

Glycerin (99.7% USP)

9.16

wt. %

Polysorbate 80, NF

7.32

wt. %

Mountain Berry

9.61

wt. %

Sucralose USP/NF

2.33

wt. %

Microcrystalline Cellulose

9.27

wt. %

(MCC)

Vitamin E Oil 1000 IU

9.20

wt. %

Ascorbyl Palmitate

0.05

wt. %

Vitamin D 3

1.95

wt. %

Natural & Artificial Mixed Berry

7.66

wt. %

FD&C Red #40

0.01

wt. %

Total

100.00

wt. %.

20. The method of claim 1 , wherein the oral dissolvable film has a thickness of 0.130±0.004 mm.

21. The method of claim 1 , wherein the oral dissolvable film has a water content of 8±5 wt. %.

22. The method of claim 1 , wherein the oral dissolvable film has a. disintegration time of 5 to 40 seconds, upon application to a surface of the oral cavity.

23. The method of claim 1 , wherein the oral dissolvable film has a content uniformity such that the vitamin D 3 ranges from about 90-110%, with the standard deviation of up to about 6%.

24. The method of claim 1 , wherein the oral dissolvable film has a mass of 80±15 mg.

25. The method of claim 1 , wherein the oral dissolvable film is administered to a subject: (i) afflicted with deficiency of vitamin D; (ii) at risk of deficiency of vitamin D; (iii) undergoing chemotherapy; (iv) undergoing treatment for cancer; (v) undergoing bone marrow transplant; or any combination thereof.

26. The method of claim 1 , wherein the oral dissolvable film comprises:

(i) water;

(ii) sodium carboxymethyl cellulose (Na CMC);

(iii) polyvinylpyrrolidone (PVP);

(iv) natural deodorized cocoa butter, present in 4.53±0.5 wt. % of the oral dissolvable film;

(v) glycerin;

(vi) polysorbate 80;

(vii) microcrystalline cellulose (MCC);

(viii) vitamin E;

(ix) ascorbyl palmitate;

(x) vitamin D 3 ;

(xi) flavoring agent;

(xii) sweetener; and

(xiii) coloring agent.