FILM COMPOSITIONS FOR DELIVERY OF ACTIVES
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.
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.