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.

What is claimed is: 
     
         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 microparticle, and combinations thereof.   
     
     
         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 . The composition of  claim 1 , wherein said film dosage composition has a substantially uniform distribution of said topical agent. 
     
     
         6 . 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 microparticle, and combinations thereof.   
     
     
         7 . The composition of  claim 6 , wherein said agent is in the form of at least one type of liquid crystal. 
     
     
         8 . The composition of  claim 6 , wherein said agent is in the form of at least one type of micelle. 
     
     
         9 . The composition of  claim 6 , wherein said agent is bound to at least one ligand. 
     
     
         10 . The composition of  claim 6 , wherein said film dosage composition has a substantially uniform distribution of said at least one agent. 
     
     
         11 . 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, and combinations thereof.   
     
     
         12 . The method of  claim 11 , wherein said agent is in the form of at least one type of microdroplet. 
     
     
         13 . The method of  claim 11 , wherein said agent is in the form of at least one type of micelle. 
     
     
         14 . The method of  claim 11 , wherein said film dosage composition has a substantially uniform distribution of said at least one agent. 
     
     
         15 . The method of  claim 11 , wherein said small-scale form of at least one agent is formed through emulsion processing. 
     
     
         16 . The method of  claim 11 , wherein said small-scale form of at least one agent is formed through milling. 
     
     
         17 . The method of  claim 11 , wherein said small-scale form of at least one agent is formed through processing via a microfluidics pumping apparatus. 
     
     
         18 . The method of  claim 11 , wherein said small-scale form of at least one agent is bound to at least one ligand. 
     
     
         19 . The method of  claim 11 , 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 substantially 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 19 , 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 substantially preventing migration of said agent within said visco-elastic mass. 
     
     
         23 . The method of  claim 22 , wherein said polymeric matrix containing said agent varies no more than 10% by weight of said agent throughout said polymeric matrix. 
     
     
         24 . The method of  claim 22 , 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. 
     
     
         25 . The method of  claim 11 , wherein said small-scale form of at least one agent is formed through processing via a high shear apparatus. 
     
     
         26 . The method of  claim 11 , wherein said small-scale form of said agent is in the form of at least one liquid crystal. 
     
     
         27 . 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.   
     
     
         28 . The method of  claim 27 , wherein said agent is in the form of at least one type of microdroplet. 
     
     
         29 . The method of  claim 27 , wherein said agent is in the form of at least one type of micelle. 
     
     
         30 . The method of  claim 27 , wherein said small-scale form of at least one agent is formed through emulsion processing. 
     
     
         31 . The method of  claim 27 , wherein said small-scale form of at least one agent is formed through milling. 
     
     
         32 . The method of  claim 27 , wherein said small-scale form of at least one agent is formed through processing via a microfluidics pumping apparatus. 
     
     
         33 . The method of  claim 27 , wherein said small-scale form of at least one agent is bound to at least one ligand. 
     
     
         34 . The method of  claim 27 , wherein said small-scale form of at least one agent is formed through processing via a high shear apparatus. 
     
     
         35 . The method of  claim 27 , wherein said small-scale form of said agent is in the form of at least one liquid crystal.