Details for Patent: 7,910,641

Title:	PH modulated films for delivery of actives
Abstract:	The invention relates to pH modulated films and methods of their preparation. The film compositions include at least one component having a non-neutral pH when combined with water; and a pH modulated polymer system selected to reduce or prevent synerisis when combined with the non-neutral component in combination with aqueous media. The films demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, extrusion process, or other process that maintains the required uniformity of the film.
Inventor(s):	Myers; Garry L. (Kingsport, TN)
Assignee:	Monosol Rx, LLC (Portage, IN)
Filing Date:	Dec 14, 2006
Application Number:	11/639,013
Claims:	1. A composition comprising: (a) at least one component having a non-neutral pH when combined with water; and (b) a pH modulated polymer system selected to reduce or prevent synerisis when combined with said non-neutral component in combination with water, wherein said pH modulated polymer system comprises a neutral polymer and propylene glycol alginate, wherein said neutral polymer is a combination of hydroxypropyl methylcellulose and polyethylene oxide. 2. The composition of claim 1, wherein the composition is in the form of a film. 3. The composition of claim 2, wherein the film includes an active. 4. The composition of claim 3, wherein the active is the non-neutral component. 5. The composition of claim 3, wherein the active is a different component from the non-neutral component. 6. The composition of claim 1, wherein said at least one non-neutral component is acidic, and said polymer system comprises a neutral or acidic polymer. 7. The composition of claim 1, wherein said at least one non-neutral component is acidic, and said polymer system comprises a neutral polymer, a basic polymer and a weak base. 8. The composition of claim 1, wherein said at least one non-neutral component is basic, and said polymer system comprises a neutral polymer, a basic polymer and a weak acid. 9. The composition of claim 1, wherein said at least one non-neutral component is basic, and said polymer system comprises at least one basic polymer. 10. The composition of claim 1, wherein said polymer system provides a neutral pH when combined with said non-neutral component in combination with water. 11. The composition of claim 1, wherein said polymer system comprises a buffer system. 12. The composition of claim 11, wherein said buffer system comprises a weak acid, a weak base, or salts thereof 13. The composition of claim 12, wherein said weak acid is selected from the group consisting of acetic acid, ascorbic acid, benzoic acid, butyric acid, carbonic acid, citric acid, formic acid, lactic acid, malic acid, nitrous acid, oxalic acid, phosphoric acid, propanoic acid, propionic acid, pyrophosphoric acid, pyruvic acid, valeric acid and combinations thereof. 14. The composition of claim 12, wherein said buffer system comprises a salt of an organic acid. 15. The composition of claim 14, wherein said organic acid salt is citrate. 16. The composition of claim 1, wherein said pH modulated system comprises 98% of said neutral polymer. 17. A composition comprising: (a) at least one component having a non-neutral pH when combined with water; and (b) a pH modulated polymer system selected to reduce or prevent synerisis when combined with said non-neutral component in combination with water, wherein said pH modulated polymer system comprises a neutral polymer and propylene glycol alginate, wherein said neutral polymer is polyethylene oxide. 18. The composition of claim 17, wherein the composition is in the form of a film. 19. The composition of claim 18, wherein the film includes an active. 20. The composition of claim 19, wherein the active is the non-neutral component. 21. The composition of claim 19, wherein the active is a different component from the non-neutral component. 22. The composition of claim 17, wherein said at least one non-neutral component is acidic, and said polymer system comprises a neutral or acidic polymer. 23. The composition of claim 17, wherein said at least one non-neutral component is acidic, and said polymer system comprises a neutral polymer, a basic polymer and a weak base. 24. The composition of claim 17, wherein said at least one non-neutral component is basic, and said polymer system comprises a neutral polymer, a basic polymer and a weak acid. 25. The composition of claim 17, wherein said at least one non-neutral component is basic, and said polymer system comprises at least one basic polymer. 26. The composition of claim 17, wherein said polymer system provides a neutral pH when combined with said non-neutral component in combination with water. 27. The composition of claim 17, wherein said polymer system comprises a buffer system. 28. The composition of claim 27, wherein said buffer system comprises a weak acid, a weak base, or salts thereof. 29. The composition of claim 28, wherein said weak acid is selected from the group consisting of acetic acid, ascorbic acid, benzoic acid, butyric acid, carbonic acid, citric acid, formic acid, lactic acid, malic acid, nitrous acid, oxalic acid, phosphoric acid, propanoic acid, propionic acid, pyrophosphoric acid, pyruvic acid, valeric acid and combinations thereof. 30. The composition of claim 27, wherein said buffer system comprises a salt of an organic acid. 31. The composition of claim 30, wherein said organic acid salt is citrate. 32. A composition comprising: (a) a component having an acidic pH when combined with water; and (b) a polymer system comprising at least one neutral or acidic polymer and propylene glycol alginate, wherein said neutral polymer is polyethylene oxide. 33. The composition of claim 32, wherein the composition is in the form of a film. 34. The composition of claim 33, wherein the film includes an active. 35. The composition of claim 34, wherein the active is the acidic component. 36. The composition of claim 34, wherein the active is a different component from the acidic component. 37. The composition of claim 32, wherein said a polymer system comprises 98% of said at least one neutral or acidic polymer. 38. A device comprising: (a) a film composition comprising (i) at least one component having a non-neutral pH when combined with water; and (ii) a pH modulated polymer system selected to reduce or prevent synerisis when combined with said non-neutral component in combination with water, wherein said pH modulated polymer system comprises a neutral polymer and propylene glycol alginate; and (b) a delivery substrate, wherein said delivery substrate is a bandage. 39. The composition of claim 38, wherein the film composition includes an active. 40. The composition of claim 39, wherein the active is the non-neutral component. 41. The composition of claim 39, wherein the active is a different component from the non-neutral component. 42. The device of claim 38, wherein said pH modulated system comprises 98% of said neutral polymer.