Uniform films for rapid dissolve dosage form incorporating taste-masking compositions

Abstract

The present invention relates to rapid dissolve thin film drug delivery compositions for the oral administration of active components. The active components are provided as taste-masked or controlled-release coated particles uniformly distributed throughout the film composition. The compositions may be formed by wet casting methods, where the film is cast and controllably dried, or alternatively by an extrusion method.

1 . A drug delivery vehicle comprising:
 a dry mucoadhering film having a thickness defined by opposed surfaces; said film comprising:   (i) a water-soluble polymer;   (ii) a pharmaceutically active particle comprising a pharmaceutically active agent; and a taste-masking agent;   wherein said particle having a particle size of less than about 200 microns and said taste-masking agent being present in amounts of about 15-80% by weight of the particle.   
     
     
         2 . A method of preparing a thin film drug delivery vehicle comprising:
 (a) providing a pharmaceutically active agent/taste-masking agent complex;   (b) combining the complex with a water-soluble polymer and a solvent to form a mixture with uniform distribution of said complex therein;   (c) casting said mixture onto a planar carrier surface to form a thin film on said carrier surface; and   (d) controllably drying said thin film to form a distribution variance of said complex having less than about 10% variance throughout any given area of said thin film.   
     
     
         3 . The method of  claim 2 , wherein said drying includes applying heat to the bottom of said carrier surface. 
     
     
         4 . The method of  claim 2 , wherein said pharmaceutically active agent/taste-masking agent complex comprises a particulate active agent and a thin film coating of said taste-masking agent over said particulate active agent. 
     
     
         5 . A method of preparing a thin film drug delivery vehicle having a substantially uniform distribution of components comprising:
 (a) forming a masterbatch pre-mix of an edible water-soluble polymer component and water;   (b) feeding a predetermined amount of the premix to at least one mixer;   (c) adding to the at least one mixer a predetermined amount of a taste-masked active component comprising a particulate active component and a taste masking agent coating the particulate active component;   (d) mixing the premix and the taste-masked active component in the at least one mixer to form a uniform matrix;   (e) forming a wet film from the matrix;   (f) rapidly forming a visco-elastic film by applying hot air currents to the bottom side of the wet film with substantially no top air flow; and   (g) drying the visco-elastic film to form a self-supporting edible film.   
     
     
         6 . The method of  claim 5 , wherein the wet film is fed onto a substrate having a top and a bottom side, and the wet film forms a visco-elastic film by applying hot air currents to the bottom side of the substrate while minimizing air flow on the top side of the film. 
     
     
         7 . The method of  claim 5 , wherein the taste-masked active component is stable for a sufficient time prior to drying for the visco-elastic film to form a self-supporting edible film. 
     
     
         8 . The method of  claim 5 , wherein the temperature at which the film is dried does not exceed 100° C. 
     
     
         9 . The method of  claim 5 , wherein the temperature at which the film is dried does not exceed 80° C. 
     
     
         10 . A process for making a self-supporting, edible film having a substantially uniform distribution of components comprising:
 (a) forming a premix of an edible water-soluble polymer component containing polyethylene oxide and optionally one or more additional polymers;   (b) blending into the premix a taste-masked active component comprising a particulate active component coated with a taste masking agent, to form a uniform matrix;   (c) extruding a film from the matrix; and   (d) cooling the film to form a self-supporting edible film.   
     
     
         11 . The drug delivery vehicle of  claim 1 , wherein said particle has a particle size of 150 microns or less. 
     
     
         12 . The drug delivery vehicle of  claim 1 , wherein said particle has a particle size of 100 microns or less. 
     
     
         13 . The drug delivery vehicle of  claim 1 , wherein said taste-masking agent is a thin film coating over portions of said pharmaceutically active agent. 
     
     
         14 . The drug delivery vehicle of  claim 1 , wherein the taste-masking agent is a polymer. 
     
     
         15 . The drug delivery vehicle of  claim 1 , wherein the taste-masking agent is a water-soluble polymer. 
     
     
         16 . The drug delivery vehicle of  claim 6 , wherein said water-soluble polymer has an average molecular weight of equal to or greater than about 40,000. 
     
     
         17 . The drug delivery vehicle of  claim 1 , wherein the taste-masking agent is selected from the group consisting of acrylic polymers, cellulosic polymers, vinyl polymers, crown ethers, hydrogenated oils and waxes, and combinations thereof. 
     
     
         18 . The drug delivery vehicle of  claim 1 , wherein the particle has a shape selected from the group consisting of spherically shaped particles, ellipsoidally shaped particles, irregularly shaped particles, and combinations thereof. 
     
     
         19 . The drug delivery vehicle of  claim 1 , wherein said taste-masking agent is present in the amount of about 20-60% by weight of the particle. 
     
     
         20 . The drug delivery vehicle of  claim 1 , wherein said taste-masking agent is present in the amount of about 25-35% by weight of the particle. 
     
     
         21 . The drug delivery vehicle of  claim 1 , wherein said pharmaceutically active agent is selected from the group consisting of antimicrobial agents, non-steroidal anti-inflammatory drugs, anti-tussives, decongestants, antihistamines, expectorants, anti-diarrheals, H 2  antagonists, proton pump inhibitors, general non-selective CNS depressants, general non-selective CNS stimulants, selective CNS functional modifiers, anti-parkinsonism drugs, narcotics, analgesics, erectile dysfunction therapies, anti-pyretics, psychopharmacological drugs and combinations thereof.