IP Library Granted Patent US 8,282,954
Granted Patent B2
US 8,282,954 · App. 12/334,906 · Granted Oct 9, 2012

Method for manufacturing edible film

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Quick Facts
Patent No.
US 8,282,954
App. No.
12/334,906
Granted
Oct 9, 2012
Kind
B2
Abstract

The present invention provides a process for making an edible film having a substantially uniform distribution of components, which includes the steps of combining a water-based film polymer solution and a slurry-type mixture comprising a water-active component and a solvent; mixing the polymer solution and slurry-type mixture for about 10 minutes or less; dispensing the mixed solution and slurry-type mixture to form a film; and drying the film to evaporate the water and solvent. Films made by the process are also provided.

Claims (34)

1. A process for making an edible film having a substantially uniform distribution of components, comprising the steps of: a. combining a water-based film polymer solution and a slurry mixture, wherein said slurry mixture comprises a water-active component and a solvent, said slurry mixture having no water-based materials added; b. mixing the polymer solution and slurry mixture for about 10 minutes or less; c. dispensing the mixed solution and slurry mixture to form a film; and d. rapidly removing said solvent from said film.

2. The process of claim 1 , wherein said water-active component is a pharmaceutically active agent.

3. The process of claim 1 , wherein said water-active component is a taste masking agent.

4. The process of claim 1 , wherein said steps of combining and mixing are performed using a meter-mix-dispense system.

5. The process of claim 1 , wherein said steps of combining and mixing are performed using a continuous metered flow through a static mixer.

6. The process of claim 1 , wherein said steps of combining and mixing are performed using a continuous metered flow through a dynamic mixer.

7. The process of claim 1 , wherein said steps of combining and mixing are performed using a small volume inline mixer, charged with aliquots of solution and slurry mixture, mixed and discharged.

8. The process of claim 1 , wherein said polymer solution and slurry mixture are mixed for 60 seconds or less.

9. The process of claim 1 , wherein said step of rapidly removing said solvent results in the film forming a visco-elastic structure.

10. The process of claim 1 , wherein said mixed polymer solution and slurry mixture are extruded to form said film.

11. The process of claim 1 , wherein said mixed polymer solution and slurry mixture are cast into a film.

12. The process of claim 1 , wherein said mixed polymer solution and slurry mixture are dispensed into a reservoir.

13. The process of claim 12 , wherein said mixed polymer solution and slurry mixture are coated onto a substrate.

14. The process of claim 1 , wherein said edible film comprises a polymer and an active, wherein said active is at least partially coated with a water-soluble or partially water-soluble coating and wherein said coating is substantially insoluble in organic solvent.

15. A method for reducing the interaction between a water-active component and water-based film polymer solution during formation of an edible film, comprising the steps of: a. combining a water-based film polymer solution and a slurry mixture, wherein said slurry mixture comprises a water-active component and a solvent, said slurry mixture having no water-based materials added; b. mixing the polymer solution and slurry mixture for about 10 minutes or less; c. dispensing the mixed solution and slurry mixture to form a film; and d. rapidly removing said solvent from said film.

16. The method of claim 15 , wherein said water-active component is a pharmaceutically active agent.

17. The method of claim 15 , wherein said water-active component is a taste masking agent.

18. The method of claim 15 , wherein said steps of adding a water-based film polymer solution into a mixer, simultaneously adding a slurry mixture into said mixer, mixing the polymer solution and slurry mixture for 10 minutes or less, and wherein dispensing said mixed solution and slurry mixture is performed using a meter-mix-dispense system.

19. The method of claim 15 , wherein said polymer solution and slurry mixture are mixed for 60 seconds or less.

20. The method of claim 15 , wherein said step of rapidly removing said solvent results in the film forming a visco-elastic structure.

21. The method of claim 15 , wherein said mixed polymer solution and slurry mixture are extruded to form said film.

22. The method of claim 15 , wherein said mixed polymer solution and slurry mixture are cast into a film.

23. The method of claim 15 , wherein said mixed polymer solution and slurry mixture are dispensed into a reservoir.

24. The method of claim 23 , wherein said mixed polymer solution and slurry mixture are coated onto a substrate.

25. The process of claim 15 , wherein said edible film comprises a polymer and an active, wherein said active is at least partially coated with a water-soluble or partially water-soluble coating and wherein said coating is substantially insoluble in organic solvent.

26. A method of substantially limiting interaction of a pharmaceutical agent with a water-based solvent during the formation of an edible film, comprising the steps of: a. simultaneously adding a water-based film polymer solution and a slurry mixture into a mixer, wherein said slurry mixture comprises a pharmaceutical agent and a solvent, said slurry mixture having no water-based materials added; b. mixing said polymer solution and slurry mixture for about 10 minutes or less; c. dispensing the mixed solution and slurry mixture to form a film; and d. rapidly removing said solvent from said film.

27. The method of claim 26 , wherein said steps of combining and mixing are performed using a meter-mix-dispense system.

28. The method of claim 26 , wherein said polymer solution and slurry mixture are mixed for 60 seconds or less.

29. The method of claim 26 , wherein said step of rapidly removing said solvent results in the film forming a visco-elastic structure.

30. The method of claim 26 , wherein said mixed polymer solution and slurry mixture are extruded to form said film.

31. The method of claim 26 , wherein said mixed polymer solution and slurry mixture are cast into a film.

32. The method of claim 26 , wherein said mixed polymer solution and slurry mixture are dispensed into a reservoir.

33. The method of claim 32 , wherein said mixed polymer solution and slurry mixture are coated onto a substrate.

34. The process of claim 26 , wherein said edible film comprises a polymer and an active, wherein said active is at least partially coated with a water-soluble or partially water-soluble coating and wherein said coating is substantially insoluble in organic solvent.

Assignments (10)
RELEASE OF SECURITY INTEREST Recorded May 13, 2026
From: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION
To: AQUESTIVE THERAPEUTICS, INC.
Reel/Frame 075646/0258 →
SECURITY INTEREST Recorded Nov 2, 2023
From: AQUESTIVE THERAPEUTICS, INC.
To: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION
Reel/Frame 065446/0494 →
RELEASE OF SECURITY INTEREST Recorded Nov 1, 2023
From: U.S. BANK TRUST COMPANY NATIONAL ASSOCIATION (AS SUCCESSOR IN INTEREST TO U.S BANK NATIONAL ASSOCIATION)
To: AQUESTIVE THERAPEUTICS, INC.
Reel/Frame 065426/0642 →
SECURITY INTEREST Recorded Jul 15, 2019
From: AQUESTIVE THERAPEUTICS, INC.
To: U.S. BANK NATIONAL ASSOCIATION
Reel/Frame 049758/0082 →
RELEASE OF SECURITY INTEREST Recorded Jul 15, 2019
From: PERCEPTIVE CREDIT HOLDINGS, LP
To: AQUESTIVE THERAPEUTICS, INC.; MONOSOL RX, INC.; MSRX US, LLC
Reel/Frame 049757/0733 →
AMENDMENT TO PATENT SECURITY AGREEMENT RECORDED AT REEL/FRAME 039707/0194 Recorded Jan 30, 2018
From: AQUESTIVE THERAPEUTICS, INC.
To: PERCEPTIVE CREDIT HOLDINGS, LP
Reel/Frame 045279/0802 →
CHANGE OF NAME Recorded Jan 29, 2018
From: MONOSOL RX, LLC
To: AQUESTIVE THERAPEUTICS, INC.
Reel/Frame 045196/0389 →
RELEASE OF SECURITY INTEREST Recorded Aug 22, 2016
From: WHITE OAK GLOBAL ADVISORS, LLC
To: MONOSOL RX, LLC
Reel/Frame 039774/0782 →
SECURITY INTEREST Recorded Aug 16, 2016
From: MONOSOL RX, LLC; MONOSOL RX, INC.; MSRX US, LLC
To: PERCEPTIVE CREDIT HOLDINGS, LP
Reel/Frame 039707/0194 →
SECURITY AGREEMENT Recorded Dec 18, 2012
From: MONOSOL RX, LLC
To: WHITE OAK GLOBAL ADVISORS, LLC, AS AGENT
Reel/Frame 029490/0156 →