Claims for Patent: 8,663,687

Summary for Patent: 8,663,687

Title:	Film compositions for delivery of actives
Abstract:	The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. Desirably, the films contain at least one active agent, which may be administered to a user topically, transmucosally, vaginally, ocularly, aurally, nasally, transdermally or orally.
Inventor(s):	Myers; Garry L. (Kingsport, TN), Fuisz; Richard C. (Beverly Hills, CA)
Assignee:	MonoSol Rx, LLC (Warren, NJ)
Application Number:	12/779,316
Patent Claims:	1. A self-supporting film composition comprising: (i) a water soluble polymer composition comprising polyethylene oxide and a saccharide-based polymer; and (ii) a topical agent; wherein said topical agent is in the form of a small-scale particle selected from the group consisting of at least one type of nanoparticle, at least one type of micelle, at least one type of microdroplet, at least one type of microparticle, at least one type of liquid crystal, and combinations thereof, and wherein said small-scale particle of at least one agent is uniformly distributed in the film composition and uniformity is measured by equally sized individual unit doses which do not vary by more than 10% by weight of said small-scale particle of at least one agent from a desired dose. 2. The composition of claim 1, wherein said topical agent is in the form of at least one type of liquid crystal. 3. The composition of claim 1, wherein said topical agent is in the form of at least one type of micelle. 4. The composition of claim 1, wherein said topical agent is bound to at least one ligand. 5. A dosage composition comprising: a. A self-supporting film comprising: i. At least one polymer; and ii. At least one agent; wherein said at least one agent is in the form of a small-scale particle selected from the group consisting of at least one type of nanoparticle, at least one type of micelle, at least one type of microdroplet, at least one type of microparticle, at least one type of liquid crystal, and combinations thereof, and wherein said small-scale particle of at least one agent is uniformly distributed in the dosage composition and uniformity is measured by equally sized individual unit doses which do not vary by more than 10% by weight of said small-scale particle of at least one agent from a desired dose. 6. The composition of claim 5, wherein said agent is in the form of at least one type of liquid crystal. 7. The composition of claim 5, wherein said agent is in the form of at least one type of micelle. 8. The composition of claim 5, wherein said agent is bound to at least one ligand. 9. A method of forming a self-supporting film dosage composition, comprising the steps of: a. Providing a polymeric matrix; b. Forming a small-scale form of at least one agent; c. Dispersing said small-scale form of at least one agent throughout said polymeric matrix; d. Drying said polymeric matrix so as to form a self-supporting film dosage composition comprising said small-scale form of at least one agent; wherein said small-scale form of at least one agent is selected from the group consisting of at least one type of nanoparticle, at least one type of microparticle, at least one type of microdroplet, at least one type of micelle, at least one type of liquid crystal, and combinations thereof, and wherein said small-scale form of at least one agent is uniformly distributed in the film dosage composition and uniformity subsequent to dispersing and drying is measured by equally sized individual unit doses which do not vary by more than 10% by weight of said small-scale form of at least one agent from a desired dose. 10. The method of claim 9, wherein said agent is in the form of at least one type of microdroplet. 11. The method of claim 9, wherein said agent is in the form of at least one type of micelle. 12. The method of claim 9, wherein said small-scale form of at least one agent is formed through emulsion processing. 13. The method of claim 9, wherein said small-scale form of at least one agent is formed through milling. 14. The method of claim 9, wherein said small-scale form of at least one agent is formed through processing via a microfluidics pumping apparatus. 15. The method of claim 9, wherein said small-scale form of at least one agent is bound to at least one ligand. 16. The method of claim 9, wherein said step of drying said polymeric matrix comprises heating said polymeric matrix so as to rapidly form a visco-elastic mass to maintain a uniform distribution of said agent by locking-in or preventing migration of said agent within said visco-elastic mass within the first 10 minutes or less to maintain a uniform distribution of said agent by locking-in or preventing migration of said agent within said visco-elastic mass. 17. The method of claim 16, wherein said polymeric matrix containing said agent varies no more than 10% by weight of said agent throughout said polymeric matrix. 18. The method of claim 16, wherein said step of drying said polymeric matrix further comprises further drying said visco-elastic mass so as to provide a self-supporting film dosage composition having a solvent content of 10% or less. 19. The method of claim 16, wherein said step of forming a visco-elastic mass occurs within the first 0.5 to about 10 minutes of heating to maintain a uniform distribution of said agent by locking-in or preventing migration of said agent within said visco-elastic mass. 20. The method of claim 19, wherein said polymeric matrix containing said agent varies no more than 10% by weight of said agent throughout said polymeric matrix. 21. The method of claim 19, wherein said step of drying said polymeric matrix further comprises further drying said visco-elastic mass so as to provide a self-supporting film dosage composition having a solvent content of 10% or less. 22. The method of claim 9, wherein said small-scale form of at least one agent is formed through processing via a high shear apparatus. 23. The method of claim 9, wherein said small-scale form of said agent is in the form of at least one liquid crystal. 24. A method of forming a self-supporting film dosage composition, comprising the steps of: a. Providing a polymeric matrix; b. Forming a small-scale form of at least one agent; c. Applying said small-scale form of at least one agent to said polymeric matrix via deposition; and d. Drying said polymeric matrix so as to form a self-supporting film dosage composition comprising said small-scale form of at least one agent, wherein said small-scale form of at least one agent is selected from the group consisting of at least one type of nanoparticle, at least one type of micelle, at least one type of microdroplet, at least one type of microparticle, at least one type of liquid crystal, and combinations thereof, and wherein said small-scale form of at least one agent is uniformly distributed on the film dosage composition and uniformity subsequent to applying and drying is measured by equally sized individual unit doses which do not vary by more than 10% by weight of said small-scale form of at least one agent from a desired dose. 25. The method of claim 24, wherein said agent is in the form of at least one type of microdroplet. 26. The method of claim 24, wherein said agent is in the form of at least one type of micelle. 27. The method of claim 24, wherein said small-scale form of at least one agent is formed through emulsion processing. 28. The method of claim 24, wherein said small-scale form of at least one agent is formed through milling. 29. The method of claim 24, wherein said small-scale form of at least one agent is formed through processing via a microfluidics pumping apparatus. 30. The method of claim 24, wherein said small-scale form of at least one agent is bound to at least one ligand. 31. The method of claim 24, wherein said small-scale form of at least one agent is formed through processing via a high shear apparatus. 32. The method of claim 24, wherein said small-scale form of said agent is in the form of at least one liquid crystal.