Polymer Composition And Dosage Forms Comprising The Same

Abstract

A composition comprising a high molecular weight, water soluble polymer having a cloud point from about 20 to about 90° C. and a gelling polymer is provided. The composition may be used as a component of a pharmaceutical dosage form, such as the shell of a dosage form, or as an edible matrix, i.e., a pharmaceutical dosage form per se.

1 - 43 . (canceled) 
   
   
       44 . A process for preparing a dosage form, which comprises coating a core with an aqueous dispersion of a high molecular weight, water soluble polymer in a gelling polymer at a temperature above the cloud point of the high molecular weight water soluble polymer, and then cooling the coated core. 
   
   
       45 . The process of  claim 44 , wherein the high molecular weight, water soluble polymer is selected from the group consisting of hydroxypropylmethyl cellulose, hydroxypropyl cellulose, methyl cellulose, polyvinyl alcohol, and mixtures thereof. 
   
   
       46 . The process of  claim 44 , wherein the high molecular weight, water soluble polymer comprises polyvinyl alcohol having a weight average molecular weight from about 30,000 to about 200,000. 
   
   
       47 . The process of  claim 44 , wherein the cloud point of the high molecular weight, water soluble polymer is about 20° C. to about 90° C. 
   
   
       48 . The process of  claim 44 , wherein the gelling polymer is a high temperature setting anionic polymer. 
   
   
       49 . The process of  claim 44 , wherein the gelling polymer is selected from the group consisting of carrageenan, agar, gellan gum, combinations of carrageenan and locust bean gum, and mixtures thereof. 
   
   
       50 . The process of  claim 44 , wherein the aqueous dispersion comprises about 15 to about 40 weight percent solids. 
   
   
       51 . The process of  claim 44 , wherein the high molecular weight water soluble polymer comprises about 15 to about 19 weight percent of the total weight of the aqueous dispersion. 
   
   
       52 . The process of  claim 44 , wherein the gelling polymer comprises about 1 to about 5 weight percent of the total weight of the aqueous dispersion. 
   
   
       53 . The process of  claim 44 , wherein the aqueous dispersion further comprises an inorganic cation. 
   
   
       54 . The process of  claim 53 , wherein the inorganic cation is selected from the group consisting of potassium cation, calcium cation, and mixtures thereof. 
   
   
       55 . The process of  claim 44 , wherein the aqueous dispersion further comprises a water-insoluble polymer. 
   
   
       56 . The process of  claim 55 , wherein the water-insoluble polymer is selected from the group consisting of ethyl cellulose, cellulose acetate, cellulose acetate butyrate, and mixtures thereof. 
   
   
       57 . The process of  claim 44 , wherein core is coated with the aqueous dispersion by molding.