Method and apparatus for minimizing heat, moisture, and shear damage to medicants and other compositions during incorporation of same with edible films

Abstract

A medicant composition is provided. The composition includes a film layer and a powder matrix layer. The powder matrix layer includes a medicant. The powder matrix layer is applied to the film layer by admixing particulate to form a powder matrix and by then applying the powder matrix to the film layer by any desired method. The composition of the powder matrix is varied to alter the dissolution rate of the medicant, the adhesion of the medicant composition, and other physical properties of the powder matrix. The powder matrix layer can be cured.

1 . (canceled) 
   
   
       2 . A method of treating a patient that has a cough, comprising the steps of
 (a) preparing at least one dissolvable film layer including a film forming composition and free of oils, herbs, tree and plant components and extracts, and medicants; and   (b) administering said film layer in the mouth of the patient to dissolve at least a portion of said film layer.   
   
   
       3 - 25 . (canceled) 
   
   
       26 . A bilayer composition comprising:
 a film layer; and   a powder matrix coating wherein the coating is applied to at least one side of the film layer.   
   
   
       27 . The composition of  claim 26  wherein the film layer, the powder matrix coating, or both comprise a medicant. 
   
   
       28 . The composition of  claim 27  wherein the film layer dissolves within thirty seconds of being placed in the oral cavity. 
   
   
       29 . (canceled) 
   
   
       30 . The composition of  claim 27  wherein said medicant is selected from the group consisting of anti-inflammatory steroids, anti-inflammatory anodynes, anti-inflammatory enzymes, antihistamine agents, oral sterilizing agents, antibiotics, chemically therapeutic agents, cardiac strengthening agents, blood vein dilating agents, local narcotic agents, cough curing agents, sore throat and mouth treatment agents, periodontal disease treatment agents, digesting organ curing agents, anti-diabetic agents, other enzymes, blood pressure depressing agents, tranquilizers, styptic agents, sexual hormones, and agents for curing virulent carcinoma or ulcers. 
   
   
       31 . (canceled) 
   
   
       32 . (canceled) 
   
   
       33 . The composition of  claim 27  wherein the film layer comprises one or more of pullulan, modified starch, pectin, carageenan, a maltodextrin or alginate. 
   
   
       34 . The composition of  claim 27  wherein the film layer comprises a natural or synthetic water soluble polymer. 
   
   
       35 - 47 . (canceled) 
   
   
       48 . A method of manufacturing a rapidly dissolving thin film comprising the steps of:
 providing a film layer;   applying a coating to said film layer wherein said coating comprises a powder matrix.   
   
   
       49 . (canceled) 
   
   
       50 . (canceled) 
   
   
       51 . The method of  claim 48  wherein the powder matrix, the film layer or both comprises a medicant. 
   
   
       52 . The method of  claim 51  further comprising the step of drying the film layer and powder matrix. 
   
   
       53 . The method of  claim 52  wherein the step of drying comprises the steps of curing and heating. 
   
   
       54 . The method of  claim 52  wherein the powder matrix comprises a flow agent and wherein the step of drying is at a temperature at about the softening point of the flow agent. 
   
   
       55 . The method of  claim 54  wherein the flow agent comprises a lipid, wax or polyol. 
   
   
       56 . The method of  claim 51  wherein said medicant is selected from the group consisting of anti-inflammatory steroids, anti-inflammatory anodynes, anti-inflammatory enzymes, antihistamine agents, oral sterilizing agents, antibiotics, chemically therapeutic agents, cardiac strengthening agents, blood vein dilating agents, local narcotic agents, cough curing agents, sore throat and mouth treatment agents periodontal disease treatment agents, digesting organ curing agents, anti-diabetic agents, other enzymes, blood pressure depressing agents, tranquilizers, styptic agents, sexual hormones, and agents for curing virulent carcinoma or ulcers. 
   
   
       57 - 62 . (canceled) 
   
   
       63 . The method of  claim 51  further comprising the step of preparing the coating in a fluidized bed. 
   
   
       64 . The method of  claim 63  wherein the coating is applied by sifting, screening, atomization, static or mechanical agitation. 
   
   
       65 . The method of  claim 63  wherein the powder particles are charged. 
   
   
       66 . The method of  claim 63  wherein the coating is applied using a static spray gun. 
   
   
       67 . The method of  claim 66  wherein the static spray gun charges the powder particles such that the powder particles adhere to the surface of the film layer. 
   
   
       68 . The method of  claim 51  further comprising:
 mixing the powder matrix with a liquid carrier to form a particle liquid solution wherein the coating is applied to the film layer by spraying the liquid solution on the film layer and evaporating the liquid carrier.   
   
   
       69 - 85 . (canceled)