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

Abstract

The invention relates to film products containing desired levels of active components and methods of their preparation. 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 may be exposed to temperatures above that at which the active components typically degrade without concern for loss of the desired activity.

1 - 18 . (canceled) 
     
     
         19 . A process for making a film having a substantially uniform distribution of components, comprising the steps of:
 (a) forming a flowable polymer matrix comprising a polymer selected from the group consisting of a water-soluble polymer, a water swellable polymer and combinations thereof, a solvent and an active selected from the group consisting of bioactive actives, pharmaceutical actives, drugs, medicaments and combinations thereof, said matrix having a substantially uniform distribution of said active;   (b) casting said flowable polymer matrix onto a surface;   (c) evaporating at least a portion of said solvent from said flowable polymer matrix to form a visco-elastic film to maintain said substantially uniform distribution of said active by applying heat to said bottom side of said surface with controlled air flow, wherein said air flow does not overcome the inherent viscosity of said flowable polymer matrix, thus locking-in or substantially preventing migration of said active within said visco-elastic film; and   (d) forming a resulting film from said visco-elastic film, wherein said substantially uniform distribution of active by said locking-in or substantially preventing migration of said active is maintained.   
     
     
         20 . The process of  claim 19 , wherein said controlled air flow substantially prevents flow migration and intermolecular force from creating aggregates or conglomerates of said active within said film. 
     
     
         21 . The process of  claim 19 , wherein said controlled air flow comprises balanced air flow, wherein any bottom air flow and any top air flow are controlled to provide a substantially uniform visco-elastic film. 
     
     
         22 . The process of  claim 21 , wherein said air flow forces at the top of the film do not cause sufficient movement of the polymer matrix so as to substantially disrupt the uniformity of the film. 
     
     
         23 . The process of  claim 19 , further comprising the step:
 (e) forming a plurality of individual film products from said resulting film, wherein the active content between individual film products varies by no more than 10%.   
     
     
         24 . The process of  claim 19 , wherein said step of forming a visco-elastic film prevents substantial aggregation of components in said visco-elastic film. 
     
     
         25 . The process of  claim 19 , wherein said active comprises an opiate or opiate derivative. 
     
     
         26 . The process of  claim 19 , wherein said active is an anti-emetic. 
     
     
         27 . The process of  claim 19 , wherein said active is a protein. 
     
     
         28 . The process of  claim 19 , wherein said active is insulin. 
     
     
         29 . The process of  claim 19 , wherein said active is an anti-diabetic. 
     
     
         30 . The process of  claim 19 , wherein said active is an antihistamine. 
     
     
         31 . The process of  claim 19 , wherein said active is an anti-tussive. 
     
     
         32 . The process of  claim 19 , wherein said active is a non-steroidal anti-inflammatory. 
     
     
         33 . The process of  claim 19 , wherein said active is an anti-asthmatics. 
     
     
         34 . The process of  claim 19 , wherein said active is an alkaloid. 
     
     
         35 . The process of  claim 19 , wherein said active is a biological response modifier. 
     
     
         36 . The process of  claim 19 , wherein said active is an anti-migraine. 
     
     
         37 . The process of  claim 19 , wherein said active is a dopamine receptor agonist. 
     
     
         38 . The process of  claim 19 , wherein said active is diphenhydramine 
     
     
         39 . The process of  claim 19 , wherein said active is a glycoprotein. 
     
     
         40 . The process of  claim 19 , wherein said active is an analgesic. 
     
     
         41 . The process of  claim 19 , wherein said active is a hormone. 
     
     
         42 . The process of  claim 19 , wherein said active is a decongestant. 
     
     
         43 . The process of  claim 19 , wherein said active is dextromethorphan. 
     
     
         44 . The process of  claim 19 , wherein said active is chlorpheniramine maleate. 
     
     
         45 . The process of  claim 19 , wherein said active is a gastrointestinal agent. 
     
     
         46 . The process of  claim 19 , wherein said active is a hypnotic. 
     
     
         47 . The process of  claim 19 , wherein said active is a glucagon. 
     
     
         48 . The process of  claim 19 , wherein said active is granisetron hydrochloride. 
     
     
         49 . The process of  claim 19 , wherein said visco-elastic film has a substantially uniform thickness. 
     
     
         50 . The process of  claim 19 , wherein said resulting film has a substantially uniform thickness. 
     
     
         51 . The process of  claim 19 , wherein said wet film has a thickness of about 500 to about 1500 microns. 
     
     
         52 . The process of  claim 19 , wherein said dried film has a thickness of about 3 to about 250 microns. 
     
     
         53 . The process of  claim 19 , wherein said resulting film has a variation of no more than 10% of active per unit volume. 
     
     
         54 . The process of  claim 19 , wherein said step (a) comprises forming a pre-mix comprising said polymer and solvent and separately adding said active to said pre-mix. 
     
     
         55 . The process of  claim 19 , wherein said step (c) comprises heating said wet film to an internal temperature of between 60° C. and 100° C. 
     
     
         56 . The process of  claim 19 , wherein said surface is a pre-formed and dried film product. 
     
     
         57 . The process of  claim 19 , wherein said surface is a non-edible backing layer. 
     
     
         58 . 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 comprising drug particles to form an edible matrix with a substantially uniform distribution of said components;   (b) providing a surface having a top and bottom side;   (c) forming a wet film from said matrix by depositing said matrix on said top side of said surface;   (d) initially drying said film within about 10 minutes or fewer, wherein said drying step comprises forming a viscoelastic film having said drug particles substantially uniformly distributed throughout said viscoelastic film by applying hot air currents to said bottom side of said surface with substantially no top air flow, so as to substantially prevent flow migration and intermolecular force from creating aggregates or conglomerates of said drug particles within said film; and   (e) further drying said viscoelastic film to provide a self-supporting edible film having drug particles substantially uniformly distributed throughout.   
     
     
         59 . The process of  claim 58 , wherein said surface is a pre-formed and dried film product. 
     
     
         60 . The process of  claim 58 , wherein said surface is a non-edible backing layer. 
     
     
         61 . The process of  claim 58 , wherein said step (d) of initially drying said film comprises balanced air flow, wherein any bottom air flow and any top air flow are controlled to provide a substantially uniform visco-elastic film. 
     
     
         62 . The process of  claim 61 , said air flow forces at the top of the film do not cause sufficient movement of the polymer matrix so as to substantially disrupt the uniformity of the film. 
     
     
         63 . The process of  claim 58 , further comprising the step:
 (f) forming a plurality of individual film products from said resulting film, wherein the active content between individual film products varies by no more than 10%.   
     
     
         64 . The process of  claim 58 , wherein said step (c) comprises heating said wet film to an internal temperature of between 60° C. and 100° C. 
     
     
         65 . The process of  claim 58 , wherein said active comprises an opiate or opiate derivative. 
     
     
         66 . The process of  claim 58 , wherein said active is a bioactive active. 
     
     
         67 . The process of  claim 58 , wherein said active is an anti-emetic. 
     
     
         68 . The process of  claim 58 , wherein said active is a protein. 
     
     
         69 . The process of  claim 58 , wherein said active is insulin. 
     
     
         70 . The process of  claim 58 , wherein said active is an anti-diabetic. 
     
     
         71 . The process of  claim 58 , wherein said active is an antihistamine. 
     
     
         72 . The process of  claim 58 , wherein said active is an anti-tussive. 
     
     
         73 . The process of  claim 58 , wherein said active is a non-steroidal anti-inflammatory. 
     
     
         74 . The process of  claim 58 , wherein said active is an anti-asthmatics. 
     
     
         75 . The process of  claim 58 , wherein said active is an alkaloid. 
     
     
         76 . The process of  claim 58 , wherein said active is a biological response modifier. 
     
     
         77 . The process of  claim 58 , wherein said active is an anti-migraine. 
     
     
         78 . The process of  claim 58 , wherein said active is a dopamine receptor agonist. 
     
     
         79 . The process of  claim 58 , wherein said active is diphenhydramine. 
     
     
         80 . The process of  claim 58 , wherein said active is a glycoprotein. 
     
     
         81 . The process of  claim 58 , wherein said active is an analgesic. 
     
     
         82 . The process of  claim 58 , wherein said active is a hormone. 
     
     
         83 . The process of  claim 58 , wherein said active is a decongestant. 
     
     
         84 . The process of  claim 58 , wherein said active is dextromethorphan. 
     
     
         85 . The process of  claim 58 , wherein said active is chlorpheniramine maleate. 
     
     
         86 . The process of  claim 58 , wherein said active is a gastrointestinal agent. 
     
     
         87 . The process of  claim 58 , wherein said active is a hypnotic. 
     
     
         88 . The process of  claim 58 , wherein said active is a glucagon. 
     
     
         89 . The process of  claim 58 , wherein said active is granisetron hydrochloride. 
     
     
         90 . The process of  claim 58 , wherein said visco-elastic film has a substantially uniform thickness. 
     
     
         91 . The process of  claim 58 , wherein said resulting film has a substantially uniform thickness. 
     
     
         92 . The process of  claim 58 , wherein said wet film has a thickness of about 500 to about 1500 microns. 
     
     
         93 . The process of  claim 58 , wherein said resulting film has a thickness of about 3 to about 250 microns. 
     
     
         94 . The process of  claim 58 , wherein said resulting film has a variation of no more than 10% of active per unit volume. 
     
     
         95 . The process of  claim 58 , wherein said step (a) comprises forming a pre-mix comprising said polymer and solvent and separately adding said active to said pre-mix. 
     
     
         96 . 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 substantially uniform distribution of said components;   (b) providing a surface having a top and bottom side;   (c) forming a wet film from said matrix by depositing said matrix on said top side of said surface;   (d) initially drying said film within about 10 minutes or fewer, wherein said drying step comprises forming a viscoelastic film having said active component substantially uniformly distributed throughout said viscoelastic film by applying hot air currents to said bottom side of said surface with substantially no top air flow, so as to substantially prevent flow migration and intermolecular force from creating aggregates or conglomerates of said active component within said film; and   (e) further drying said viscoelastic film to provide a self-supporting edible film having said active component substantially uniformly distributed throughout.   
     
     
         97 . The process of  claim 96 , wherein said surface is a pre-formed and dried film product. 
     
     
         98 . The process of  claim 96 , wherein said surface is a non-edible backing layer. 
     
     
         99 . The process of  claim 96 , wherein said step (d) of initially drying said film comprises using balanced air flow, wherein any bottom air flow and any top air flow are controlled to provide a substantially uniform visco-elastic film. 
     
     
         100 . The process of  claim 99 , wherein any present air flow forces at the top of the film do not cause sufficient movement of the polymer matrix so as to substantially disrupt the uniformity of the film. 
     
     
         101 . The process of  claim 96 , further comprising the step:
 (f) forming a plurality of individual film products from said resulting film, wherein the active content between individual film products varies by no more than 10%.   
     
     
         102 . The process of  claim 96 , wherein said step (c) comprises heating said wet film to an internal temperature of between 60° C. and 100° C. 
     
     
         103 . The process of  claim 96 , wherein said active comprises an opiate or opiate derivative. 
     
     
         104 . The process of  claim 96 , wherein said active is a bioactive active. 
     
     
         105 . The process of  claim 96 , wherein said active is an anti-emetic. 
     
     
         106 . The process of  claim 96 , wherein said active is a protein. 
     
     
         107 . The process of  claim 96 , wherein said active is insulin. 
     
     
         108 . The process of  claim 96 , wherein said active is an anti-diabetic. 
     
     
         109 . The process of  claim 96 , wherein said active is an antihistamine. 
     
     
         110 . The process of  claim 96 , wherein said active is an anti-tussive. 
     
     
         111 . The process of  claim 96 , wherein said active is a non-steroidal anti-inflammatory. 
     
     
         112 . The process of  claim 96 , wherein said active is an anti-asthmatics. 
     
     
         113 . The process of  claim 96 , wherein said active is an alkaloid. 
     
     
         114 . The process of  claim 96 , wherein said active is a biological response modifier. 
     
     
         115 . The process of  claim 96 , wherein said active is an anti-migraine. 
     
     
         116 . The process of  claim 96 , wherein said active is a dopamine receptor agonist. 
     
     
         117 . The process of  claim 96 , wherein said active is diphenhydramine. 
     
     
         118 . The process of  claim 96 , wherein said active is a glycoprotein. 
     
     
         119 . The process of  claim 96 , wherein said active is an analgesic. 
     
     
         120 . The process of  claim 96 , wherein said active is a hormone. 
     
     
         121 . The process of  claim 96 , wherein said active is a decongestant. 
     
     
         122 . The process of  claim 96 , wherein said active is dextromethorphan. 
     
     
         123 . The process of  claim 96 , wherein said active is chlorpheniramine maleate. 
     
     
         124 . The process of  claim 96 , wherein said active is a gastrointestinal agent. 
     
     
         125 . The process of  claim 96 , wherein said active is a hypnotic. 
     
     
         126 . The process of  claim 96 , wherein said active is a glucagon. 
     
     
         127 . The process of  claim 96 , wherein said active is granisetron hydrochloride. 
     
     
         128 . The process of  claim 96 , wherein said visco-elastic film has a substantially uniform thickness. 
     
     
         129 . The process of  claim 96 , wherein said resulting film has a substantially uniform thickness. 
     
     
         130 . The process of  claim 96 , wherein said wet film has a thickness of about 500 to about 1500 microns. 
     
     
         131 . The process of  claim 96 , wherein said resulting film has a thickness of about 3 to about 250 microns. 
     
     
         132 . The process of  claim 96 , wherein said resulting film has a variation of no more than 10% of active per unit volume. 
     
     
         133 . The process of  claim 96 , wherein said step (a) comprises forming a pre-mix comprising said polymer and solvent and separately adding said active to said pre-mix. 
     
     
         134 . 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 comprising an opiate or opiate derivative to form a flowable polymer matrix with a substantially uniform distribution of said components;   (b) providing a surface having a top and bottom side;   (c) forming a wet film from said matrix by depositing said matrix on said top side of said surface;   (d) initially forming a viscoelastic film having said opiate or opiate derivative substantially uniformly distributed throughout said viscoelastic film by applying hot air currents to said bottom side of said surface with controlled air flow, so as to substantially prevent flow migration and intermolecular force from creating aggregates or conglomerates of said opiate or opiate derivative within said film; and   (e) further drying said viscoelastic film to provide a self-supporting edible film having said opiate or opiate derivative substantially uniformly distributed throughout.   
     
     
         135 . The process of  claim 134 , wherein said opiate or opiate derivative is in the form of drug particles. 
     
     
         136 . The process of  claim 134 , wherein said controlled air flow comprises drying said wet film with substantially no top air flow. 
     
     
         137 . The process of  claim 134 , wherein said controlled air flow comprises balanced air flow, wherein any bottom air flow and any top air flow are controlled to provide a substantially uniform visco-elastic film. 
     
     
         138 . The process of  claim 134 , wherein said air flow forces at the top of the film do not cause sufficient movement of the polymer matrix so as to substantially disrupt the uniformity of the film. 
     
     
         139 . The process of  claim 134 , wherein any top air flow during said step (d) is insufficient to overcome the inherent viscosity of said wet film. 
     
     
         140 . The process of  claim 134 , further comprising the step:
 (f) forming a plurality of individual film products from said self-supporting edible film, wherein the active content between individual film products varies by no more than 10%.   
     
     
         141 . The process of  claim 134 , wherein said step (c) comprises heating said wet film to an internal temperature of between 60° C. and 100° C. 
     
     
         142 . The process of  claim 134 , wherein said visco-elastic film has a substantially uniform thickness. 
     
     
         143 . The process of  claim 134 , wherein said self-supporting edible film has a substantially uniform thickness. 
     
     
         144 . The process of  claim 134 , wherein said wet film has a thickness of about 500 to about 1500 microns. 
     
     
         145 . The process of  claim 134 , wherein said self-supporting edible film has a thickness of about 3 to about 250 microns. 
     
     
         146 . The process of  claim 134 , wherein said self-supporting edible film has a variation of no more than 10% of active per unit volume. 
     
     
         147 . The process of  claim 134 , wherein said step (a) comprises forming a pre-mix comprising said polymer and solvent and separately adding said active to said pre-mix. 
     
     
         148 . The process of  claim 134 , wherein said surface is a pre-formed and dried film product. 
     
     
         149 . The process of  claim 134 , wherein said surface is a non-edible backing layer. 
     
     
         150 . 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 substantially uniform distribution of said components;   (b) providing a surface having a top and bottom side;   (c) forming a wet film from said matrix by depositing said matrix on said top side of said surface;   (d) initially drying said film within about 10 minutes or fewer, wherein said drying step comprises forming a viscoelastic film having said active component substantially uniformly distributed throughout said viscoelastic film by applying hot air currents to said bottom side of said surface such that said air flow present is insufficient to cause one or more of the following: (i) surface skinning prior to creating said viscoelastic and substantially uniform film, (ii) substantial surface rippling, (iii) substantial self-aggregation of the components, (iii) non-uniformity in the content of active in the film per unit volume; and   (e) further drying said viscoelastic film to provide a self-supporting edible film having said active component substantially uniformly distributed throughout.   
     
     
         151 . The process of  claim 150 , wherein said active component is in the form of drug particles. 
     
     
         152 . The process of  claim 150 , further comprising the step:
 (f) forming a plurality of individual film products from said self-supporting edible film, wherein the active content between individual film products varies by no more than 10%.   
     
     
         153 . The process of  claim 150 , wherein said step (c) comprises heating said wet film to an internal temperature of between 60° C. and 100° C. 
     
     
         154 . The process of  claim 150 , wherein said visco-elastic film has a substantially uniform thickness. 
     
     
         155 . The process of  claim 150 , wherein said self-supporting edible film has a substantially uniform thickness. 
     
     
         156 . The process of  claim 150 , wherein said wet film has a thickness of about 500 to about 1500 microns. 
     
     
         157 . The process of  claim 150 , wherein said self-supporting edible film has a thickness of about 3 to about 250 microns. 
     
     
         158 . The process of  claim 150 , wherein said self-supporting edible film has a variation of no more than 10% of active per unit volume. 
     
     
         159 . The process of  claim 150 , wherein said step (a) comprises forming a pre-mix comprising said polymer and solvent and separately adding said active to said pre-mix. 
     
     
         160 . The process of  claim 150 , wherein said surface is a pre-formed and dried film product. 
     
     
         161 . The process of  claim 150 , wherein said surface is a non-edible backing layer. 
     
     
         162 . The process of  claim 150 , wherein said active is an opiate or opiate derivative. 
     
     
         163 . The process of  claim 150 , wherein said active is a bioactive active. 
     
     
         164 . The process of  claim 150 , wherein said active is an anti-emetic. 
     
     
         165 . The process of  claim 150 , wherein said active is a protein. 
     
     
         166 . The process of  claim 150 , wherein said active is insulin. 
     
     
         167 . The process of  claim 150 , wherein said active is an anti-diabetic. 
     
     
         168 . The process of  claim 150 , wherein said active is an antihistamine. 
     
     
         169 . The process of  claim 150 , wherein said active is an anti-tussive. 
     
     
         170 . The process of  claim 150 , wherein said active is a non-steroidal anti-inflammatory. 
     
     
         171 . The process of  claim 150 , wherein said active is an anti-asthmatics. 
     
     
         172 . The process of  claim 150 , wherein said active is an alkaloid. 
     
     
         173 . The process of  claim 150 , wherein said active is a biological response modifier. 
     
     
         174 . The process of  claim 150 , wherein said active is an anti-migraine. 
     
     
         175 . The process of  claim 150 , wherein said active is a dopamine receptor agonist. 
     
     
         176 . The process of  claim 150 , wherein said active is diphenhydramine. 
     
     
         177 . The process of  claim 150 , wherein said active is a glycoprotein. 
     
     
         178 . The process of  claim 150 , wherein said active is an analgesic. 
     
     
         179 . The process of  claim 150 , wherein said active is a hormone. 
     
     
         180 . The process of  claim 150 , wherein said active is a decongestant. 
     
     
         181 . The process of  claim 150 , wherein said active is dextromethorphan. 
     
     
         182 . The process of  claim 150 , wherein said active is chlorpheniramine maleate. 
     
     
         183 . The process of  claim 150 , wherein said active is a gastrointestinal agent. 
     
     
         184 . The process of  claim 150 , wherein said active is a hypnotic. 
     
     
         185 . The process of  claim 150 , wherein said active is a glucagon. 
     
     
         186 . The process of  claim 150 , wherein said active is granisetron hydrochloride. 
     
     
         187 . 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 comprising an opiate or opiate derivative to form an edible matrix with a substantially uniform distribution of said components;   (b) providing a surface having a top and bottom side;   (c) forming a wet film from said matrix by depositing said matrix on said top side of said surface;   (d) initially forming a viscoelastic film having said opiate or opiate derivative substantially uniformly distributed throughout said viscoelastic film by applying hot air currents to said bottom side of said surface such that said air currents are insufficient to cause one or more of the following: (i) surface skinning prior to creating said viscoelastic and substantially uniform film, (ii) substantial surface rippling, (iii) substantial self-aggregation of the components, or (iv) non-uniformity in the content of active in the film per unit volume; and   (e) further drying said viscoelastic film to provide a self-supporting edible film having said opiate or opiate derivative substantially uniformly distributed throughout.   
     
     
         188 . The process of  claim 187 , wherein said surface comprises a pre-formed and dried film. 
     
     
         189 . The process of  claim 188 , wherein said pre-formed and dried film is an edible film. 
     
     
         190 . The process of  claim 187 , wherein said surface is a non-edible backing layer. 
     
     
         191 . The process of  claim 187 , further comprising the step:
 (f) forming a plurality of individual film products from said self-supporting edible film, wherein the active content between individual film products varies by no more than 10%.   
     
     
         192 . The process of  claim 187 , wherein said step (c) comprises heating said wet film to an internal temperature of between 60° C. and 100° C. 
     
     
         193 . The process of  claim 187 , wherein said visco-elastic film has a substantially uniform thickness. 
     
     
         194 . The process of  claim 187 , wherein said self-supporting edible film has a substantially uniform thickness. 
     
     
         195 . The process of  claim 187 , wherein said wet film has a thickness of about 500 to about 1500 microns. 
     
     
         196 . The process of  claim 187 , wherein said self-supporting edible film has a thickness of about 3 to about 250 microns. 
     
     
         197 . The process of  claim 187 , wherein said self-supporting edible film has a variation of no more than 10% of active per unit volume. 
     
     
         198 . The process of  claim 187 , wherein said step (a) comprises forming a pre-mix comprising said polymer and solvent and separately adding said active to said pre-mix. 
     
     
         199 . 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 comprising an analgesic to form a flowable polymer matrix with a substantially uniform distribution of said components;   (b) providing a surface having a top and bottom side;   (c) forming a wet film from said matrix by depositing said matrix on said top side of said surface;   (d) initially forming a viscoelastic film having said analgesic substantially uniformly distributed throughout said viscoelastic film by applying hot air currents to said bottom side of said surface with controlled air flow, so as to substantially prevent flow migration and intermolecular force from creating aggregates or conglomerates of said analgesic within said film; and   (e) further drying said viscoelastic film to provide a self-supporting edible film having said analgesic substantially uniformly distributed throughout.   
     
     
         200 . The process of  claim 199 , wherein said analgesic is in the form of drug particles. 
     
     
         201 . The process of  claim 199 , wherein said controlled air flow comprises drying said wet film with substantially no top air flow. 
     
     
         202 . The process of  claim 199 , wherein said controlled air flow comprises balanced air flow, wherein any bottom air flow and any top air flow are controlled to provide a substantially uniform visco-elastic film. 
     
     
         203 . The process of  claim 199 , wherein said air flow forces at the top of the film do not cause sufficient movement of the polymer matrix so as to substantially disrupt the uniformity of the film. 
     
     
         204 . The process of  claim 199 , wherein any top air flow during said step (d) is insufficient to overcome the inherent viscosity of said wet film. 
     
     
         205 . The process of  claim 199 , further comprising the step:
 (f) forming a plurality of individual film products from said self-supporting edible film, wherein the active content between individual film products varies by no more than 10%.   
     
     
         206 . The process of  claim 199 , wherein said step (c) comprises heating said wet film to an internal temperature of between 60° C. and 100° C. 
     
     
         207 . The process of  claim 199 , wherein said visco-elastic film has a substantially uniform thickness. 
     
     
         208 . The process of  claim 199 , wherein said self-supporting edible film has a substantially uniform thickness. 
     
     
         209 . The process of  claim 199 , wherein said wet film has a thickness of about 500 to about 1500 microns. 
     
     
         210 . The process of  claim 199 , wherein said self-supporting edible film has a thickness of about 3 to about 250 microns. 
     
     
         211 . The process of  claim 199 , wherein said self-supporting edible film has a variation of no more than 10% of active per unit volume. 
     
     
         212 . The process of  claim 199 , wherein said step (a) comprises forming a pre-mix comprising said polymer and solvent and separately adding said active to said pre-mix. 
     
     
         213 . The process of  claim 199 , wherein said surface is a pre-formed and dried film product. 
     
     
         214 . The process of  claim 199 , wherein said surface is a non-edible backing layer.