Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom

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.

1 - 61 . (canceled) 
     
     
         62 . A process for making a self-supporting, edible film having a substantially uniform distribution of components comprising:
 (a) mixing an edible water-soluble polymer component, water and an active component to form an edible matrix with a compositionally uniform distribution of said components;   (b) deaerating said matrix by mixing;   (c) forming a wet film from said deaerated matrix;   (d) providing a surface having top and bottom sides;   (e) feeding said film onto said top side of said surface;   (f) rapidly forming a visco-elastic film within about the first 4.0 minutes by applying hot air currents to said bottom side of said surface with substantially no top air flow to maintain the compositional uniform distribution of components; and   (g) drying said visco-elastic film to form a self-supporting edible film.   
     
     
         63 . The process according to  claim 62 , wherein said visco-elastic film is formed at temperatures of about 60° C. to about 100° C. 
     
     
         64 . The process according to  claim 62 , wherein said active component comprises drug particles. 
     
     
         65 . The process according to  claim 62 , wherein the water content of said self-supporting edible film has an upper level of about 10% and a lower level of about 2%. 
     
     
         66 . The process according to  claim 62 , wherein said process further comprises the step of removing said self-supporting edible film from said surface. 
     
     
         67 . The process according to  claim 62 , wherein said process further comprises the step of dividing said self-supporting edible film into dosage forms of substantially equal dimensions, wherein each of said dosage forms is compositionally equal. 
     
     
         68 . The process according to  claim 67 , wherein each of said dosage forms has substantially the same mass. 
     
     
         69 . The process according to  claim 67 , wherein each of said dosage forms has substantially the same thickness. 
     
     
         70 . A process for making a self-supporting, edible film having a substantially uniform distribution of components comprising:
 (a) mixing an edible water-soluble polymer component, water and an active component to form an edible matrix with a compositionally uniform distribution of said components;   (b) deaerating said matrix by mixing;   (c) forming a wet film from said deaerated matrix;   (d) providing a surface having top and bottom sides;   (e) feeding said film onto said top side of said surface;   (f) rapidly forming a visco-elastic film by applying hot air currents at temperatures of about 60° C. to about 100° C. to said bottom side of said surface with substantially no top air flow to maintain the compositional uniform distribution of components; and   (g) drying said visco-elastic film to form a self-supporting edible film.   
     
     
         71 . The process according to  claim 70 , wherein said visco-elastic film is formed within about the first 4.0 minutes. 
     
     
         72 . The process according to  claim 70 , wherein said active component comprises drug particles. 
     
     
         73 . The process according to  claim 70 , wherein the water content of said self-supporting edible film has an upper level of about 10% and a lower level of about 2%. 
     
     
         74 . The process according to  claim 70 , wherein said process further comprises the step of removing said self-supporting edible film from said surface. 
     
     
         75 . The process according to  claim 70 , wherein said process further comprises the step of dividing said self-supporting edible film into dosage forms of substantially equal dimensions, wherein each of said dosage forms is compositionally equal. 
     
     
         76 . The process according to  claim 75 , wherein each of said dosage forms has substantially the same mass. 
     
     
         77 . The process according to  claim 75 , wherein each of said dosage forms has substantially the same thickness. 
     
     
         78 . A process for making an edible film dosage unit having a substantially uniform distribution of components comprising:
 (a) mixing an edible water-soluble polymer component, water and an active component comprising drug particles to form an edible matrix with a compositionally uniform distribution of said components;   (b) deaerating said matrix by mixing;   (c) forming a wet film from said deaerated matrix;   (d) providing a surface having top and bottom sides;   (e) feeding said film onto said top side of said surface;   (f) rapidly forming a visco-elastic film within about the first 4.0 minutes by applying hot air currents at temperatures of about 60° C. to about 100° C. to said bottom side of said surface with substantially no top air flow to maintain the compositional uniform distribution of components;   (g) drying said visco-elastic film to form a self-supporting edible film, wherein the water content of said self-supporting edible film has an upper level of about 10% and a lower level of about 2%;   (f) removing said self-supporting edible film from said surface; and   (g) dividing said self-supporting edible film into dosage forms of substantially equal dimensions, wherein each of said dosage forms is compositionally equal.