ORAL DISPERSIBLE FILMS

• US 20150038594A1
• Filed: 07/31/2014
• Published: 02/05/2015
• Est. Priority Date: 07/31/2013
• Status: Active Grant

• Current Assignee: Bluepharma Co.
• Original Assignee: Bluepharma Co.
• Inventors: Borges, Ana Filipa Silva, Silva, Branca Margarida Almeida, Coelho, Jorge Fernando Jordao, Silva, Claudia Sousa, Simoes, Sergio Paulo
• Granted Patent: US 9,603,935 B2
• Time in Patent Office: Days
• US Class Current: 514/772.2
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays

Abstract

Described herein are orodispersible films comprising a film forming hydrophobic polymer, a disintegrant, a plasticizer and a stabilizer.

Claims

1. An orodispersible film comprising (i) a film forming polymer, (ii) a disintegrant and (iii) polyvinyl alcohol (PVA) or hydroxypropylmethyl cellulose (HPMC).

2. The orodispersible film of claim 1, wherein the film forming polymer is a hydrophobic film-forming polymer.

3. The orodispersible film of claim 2, wherein the film forming polymer is (i) polyvinyl acetate, (ii) shellac, or a (iii) methacrylate copolymer.

6. The orodispersible film of claim 1, wherein the disintegrant is (i) a cellulose derivative, (ii) a cellulose ether, (iii) carboxymethylcellulose or a salt thereof, or (iv) sodium carboxymethylcellulose.

9. The orodispersible film of claim 1 further comprising one or more dispersants.

10. The orodispersible film of claim 9, wherein the one or more dispersants comprises (i) sodium lauryl sulfate, (ii) povidone, (iii) macrogol cetostearyl ether, and (iv) sorbic acid and sodium hydroxide.

12. The orodispersible film of any one of claims 1 and 9 further comprising a plasticizer.

13. The orodispersible film of claim 12, wherein the plasticizer is (i) a citrate derivative, (ii) triethylcitrate, (iii) glycerol, (iv) polyethylene glycol, or (v) propylene glycol.

16. The orodispersible film of claim 1, wherein at least one of the polyvinyl alcohol or hydroxypropylmethylcellulose comprises about 5-17.5% by weight of the film.

17. The orodispersible film of claim 1 further comprising one or more of (i) one or more sweeteners, (ii) one or more colorants, (iii) one or more flavoring agents, and (iv) one or more saliva stimulants.

18. The orodispersible film of claim 1 wherein:

the film forming polymer is 30-95% by weight of polyvinyl acetate;

1-21% by weight of polyvinyl alcohol or hydroxypropylmethylcellulose; and

the disintegrant is 1-22% by weight of sodium carboxymethylcellulose,

wherein the total percentage by weight of all components in the orodispersible film does not exceed 100%.

19. The orodispersible film of claim 18, wherein the weight of polyvinyl acetate comprises about 30-60% by weight of the film.

22. The orodispersible film of claim 19, wherein the polyvinyl alcohol or hydroxymethylcellulose comprises 5-17.5% by weight of the film.

23. The orodispersible film of claim 22 further comprising a plasticizer.

25. The orodispersible film of claim 1 wherein:

the film forming polymer is 30-95% by weight of shellac;

1-21% by weight of polyvinyl alcohol or hydroxypropylmethylcellulose; and

the disintegrant is 1-22% by weight of sodium carboxymethylcellulose,

wherein the total percentage by weight of all components orodispersible film does not exceed 100%.

26. The orodispersible film of claim 25, wherein the shellac comprises about 30-60% by weight of the film.

27. The orodispersible film of claim 26, wherein the polyvinyl alcohol or hydroxypropylmethylcellulose comprises 5-17.5% by weight of the film.

30. The orodispersible film of claim 27 further comprising a plasticizer.

32. The orodispersible film of claim 1 wherein:

the film forming polymer is 19-95% by weight of methacrylate copolymer;

1-21% by weight of polyvinyl alcohol or hydroxypropylmethylcellulose; and

the disintegrant is 1-22% by weight of sodium carboxymethylcellulose,

wherein the total percentage by weight of all components in the orodispersible film does not exceed 100%.

33. The orodispersible film of claim 32, wherein the methacrylate copolymer is 19-60% by weight of the film.

35. The orodispersible film of claim 33, wherein the polyvinyl alcohol or hydroxypropylmethylcellulose comprises about 5-17.5% by weight of the film.

38. The orodispersible film of claim 35 further comprising a plasticizer.

40. The orodispersible film of any one of claims 1, 18, 25 and 32 further comprising an active agent that is a pharmaceutical agent, a nutraceutical agent, a supplement, or a cosmetic agent.

4-5. -5. (canceled)

7-8. -8. (canceled)

11. (canceled)

14-15. -15. (canceled)

20-21. -21. (canceled)

24. (canceled)

28-29. -29. (canceled)

31. (canceled)

34. (canceled)

36-37. -37. (canceled)

39. (canceled)

41-42. -42. (canceled)

43. A method of administering an orodispersible film comprising placing the film into the oral cavity for a sufficient period of time to disintegrate, wherein the film comprises (i) a film forming polymer, (ii) a disintegrant and (iii) polyvinyl alcohol (PVA) or hydroxypropylmethyl cellulose (HPMC).