Oral Soluble Film and Multi-layered Film Including an Oral Soluble Film Layer

Abstract

An oral soluble film contains at least one active agent. Alternatively, a multi-layered film includes a plurality of layers, at least one at least one of the plurality of layers being an oral soluble film layer containing at least one active agent. The oral soluble film may be made, e.g., by a method comprising providing a well of a predetermined size; depositing a film forming composition in the well; metering a predetermined amount of an active agent composition in the well separately from the film forming composition, the active agent composition being different than the film forming composition, the film forming composition and the active agent composition forming a single layer in the well; and drying the single layer in the well to form the oral soluble film containing the at least one active agent.

What is claimed is: 
     
         1 . An oral soluble film containing at least one active agent, the oral soluble film being made by a method comprising providing a well of a predetermined size; depositing a film forming composition in the well; metering a predetermined amount of an active agent composition in the well separately from the film forming composition, the active agent composition being different than the film forming composition, the film forming composition and the active agent composition forming a single layer in the well; and drying the single layer in the well to form the oral soluble film containing the at least one active agent. 
     
     
         2 . An oral soluble film containing at least one active agent, the oral soluble film being made by a method comprising continuously stirring a suspension of a film forming composition and particulates of at least one active agent in a tank; depositing the suspension of the film forming composition and the particulates of the at least one active agent separately into each of a plurality of wells while continuously stirring the suspension in the tank, the suspension of the film forming composition and the particulates of the at least one active agent having a yield stress of less than 30 Pa and forming a contact angle with the well of less than 90.degree., wherein the suspension of the film forming composition and the particulates of the at least one active agent flows into a film in the well within 20 seconds and has a viscosity below 600 centipoise; and
 drying the film using hot air currents to form the oral soluble film containing the at least one active agent.   
     
     
         3 . A multi-layered film, comprising a plurality of layers, at least one of the plurality of layers being an oral soluble film layer containing at least one active agent, the at least one oral soluble film layer being made by a method comprising providing a well of a predetermined size; depositing a film forming composition in the well; metering a predetermined amount of an active agent composition in the well separately from the film forming composition, the active agent composition being different than the film forming composition, the film forming composition and the active agent composition forming a single layer in the well; and drying the single layer in the well to form the at least one oral soluble film layer containing the at least one active agent. 
     
     
         4 . The multi-layered film according to  claim 3 , wherein the multi-layered film includes an insoluble backing layer. 
     
     
         5 . The multi-layered film according to  claim 3 , wherein the multi-layered film includes a semi-insoluble backing layer. 
     
     
         6 . The multi-layered film according to  claim 3 , wherein the multi-layered film includes multiple layers each with a different active agent. 
     
     
         7 . A multi-layered film, comprising a plurality of layers, at least one at least one of the plurality of layers being an oral soluble film layer containing at least one active agent, the oral soluble film layer being made by a method comprising continuously stirring a suspension of a film forming composition and particulates of at least one active agent in a tank; depositing the suspension of the film forming composition and the particulates of the at least one active agent separately into each of a plurality of wells while continuously stirring the suspension in the tank, the suspension of the film forming composition and the particulates of the at least one active agent having a yield stress of less than 30 Pa and forming a contact angle with the well of less than 90.degree., wherein the suspension of the film forming composition and the particulates of the at least one active agent flows into a film layer in the well within 20 seconds and has a viscosity below 600 centipoise; and drying the film using hot air currents to form the oral soluble film layer containing the at least one active agent. 
     
     
         8 . The multi-layered film according to  claim 7 , wherein the multi-layered film includes an insoluble backing layer. 
     
     
         9 . The multi-layered film according to  claim 7 , wherein the multi-layered film includes a semi-insoluble backing layer. 
     
     
         10 . The multi-layered film according to  claim 7 , wherein the multi-layered film includes multiple layers each with a different active agent.