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 - 31 . (canceled) 
     
     
         32 . A method of orally administering an active comprising the steps of:
 (a) preparing a film by the steps of:
 (i) combining a polymer, an active component comprising drug particles, and water to form a material with a compositionally uniform distribution of said components; 
 (ii) forming said material into a film having a bottom side and a top side; and 
 (iii) drying said film by:
 (1) forming a visco-elastic film having said drug particles uniformly distributed throughout by applying hot air currents at temperatures of about 60° C. to about 100° C. to said bottom side of said film with substantially no top air flow to prevent migration and intermolecular forces from creating aggregates or conglomerates of said drug particles thereby maintaining the compositional uniform distribution of components and 
 (2) further drying said visco-elastic film to form a self-supporting edible film having drug particles uniformly distributed throughout; and 
 
   (b) introducing said film to the oral cavity of a mammal.   
     
     
         33 . A method of introducing an active component to liquid comprising the steps of:
 (a) preparing a film by the steps of:
 (i) combining a polymer, an active component comprising drug particles, and a polar solvent to form a material with a compositionally uniform distribution of said components; 
 (ii) forming said material into a film having a bottom side and a top side; and 
 (iii) drying said film by:
 (1) forming a visco-elastic film having said drug particles uniformly distributed throughout by applying hot air currents at temperatures of about 60° C. to about 100° C. to said bottom side of said film with substantially no top air flow to prevent migration and intermolecular forces from creating aggregates or conglomerates of said drug particles thereby maintaining the compositional uniform distribution of components; and 
 (2) further drying said visco-elastic film to form a self-supporting edible film having drug particles uniformly distributed throughout; 
 
   (b) placing said film into a liquid; and   (c) allowing said film to dissolve.   
     
     
         34 - 35 . (canceled) 
     
     
         36 . The method of  claim 33 , wherein said liquid is ingestible. 
     
     
         37 - 43 . (canceled) 
     
     
         44 . A method of preparing a dosage form for the administration of an active comprising the steps of:
 a. combining a polymer, an active component and a polar solvent to form a material with a compositionally uniform distribution of said components;   b. forming said material into a film having a bottom side and a top side; and   c. drying said film by:
 (1) forming a visco-elastic film having said drug particles uniformly distributed throughout by applying hot air currents at temperatures of about 60° C. to about 100° C. to said bottom side of said film with substantially no top air flow to prevent migration and intermolecular forces from creating aggregates or conglomerates of said drug particles thereby maintaining the compositional uniform distribution of components and 
 (2) further drying said visco-elastic film to form a self-supporting edible film having drug particles uniformly distributed throughout. 
   
     
     
         45 . A method of administering an active comprising the steps of:
 (a) preparing dosage form by the steps of:
 (i) combining a polymer, an active component comprising drug particles, and a polar solvent to form a material with a compositionally uniform distribution of said components 
 (ii) forming said material into a film having a bottom side and a top side on a substantially non-water soluble support; and 
 (iii) drying said film by:
 (1) forming a visco-elastic film having said drug particles uniformly distributed throughout by applying hot air currents at temperatures of about 60° C. to about 100° C. to said bottom side of said film with substantially no top air flow to prevent migration and intermolecular forces from creating aggregates or conglomerates of said drug particles thereby maintaining the compositional uniform distribution of components and 
 (2) further drying said visco-elastic film to form an edible film having drug particles uniformly distributed throughout: 
 
   (b) removing said film from said support; and   (c) applying said film to the oral cavity of a mammal.   
     
     
         46 . The method of  claim 45 , wherein said active is released as said film dissolves. 
     
     
         47 - 61 . (canceled) 
     
     
         62 . The method of  claim 32 , further comprising the step of deaerating said material of step (i) prior to forming said material into a film. 
     
     
         63 . The method of  claim 32 , wherein said drying step (iii) occurs within about 10 minutes or fewer. 
     
     
         64 . The method of  claim 32 , wherein said step of rapidly forming a visco-elastic film having said drug particles uniformly distributed throughout occurs within about the first 4.0 minutes. 
     
     
         65 . The method of  claim 32 , wherein said step of forming said material into a film comprises coating or casting the film. 
     
     
         66 . The method of  claim 44 , further comprising the step of deaerating said material of step (a) prior to forming said material into a film. 
     
     
         67 . The method of  claim 44 , wherein said drying step (c) occurs within about 10 minutes or fewer. 
     
     
         68 . The method of  claim 44 , wherein said step of rapidly forming a visco-elastic film having said drug particles uniformly distributed throughout occurs within about the first 4.0 minutes. 
     
     
         69 . The method of  claim 44 , wherein said step of forming said material into a film comprises coating or casting the film. 
     
     
         70 . A method of preparing a dosage form for the administration of an active comprising the steps of:
 (a) combining a polymer, an active component comprising drug particles, and a polar solvent to form a material with a compositionally uniform distribution of said components;   (b) forming said material into a film having a bottom side and a top side; and   (c) drying said film by:
 (1) forming a visco-elastic film having said drug particles uniformly distributed throughout by applying hot air currents at temperatures of about 60° C. to about 100° C. to said bottom side of said film, wherein said air currents are applied to said bottom side of said film at a velocity greater than to said top side of said film; and 
 (2) further drying said visco-elastic film to form a self-supporting edible film having drug particles uniformly distributed throughout. 
   
     
     
         71 . The method of  claim 70 , further comprising the step of deaerating said material of step (a) prior to forming said material into a film. 
     
     
         72 . The method of  claim 70 , wherein said drying step (c) occurs within about 10 minutes or fewer. 
     
     
         73 . The method of  claim 70 , wherein said step of rapidly forming a visco-elastic film having said drug particles uniformly distributed throughout occurs within about the first 4.0 minutes. 
     
     
         74 . The method of  claim 70 , wherein said step of forming said material into a film comprises coating or casting the film.