Chewable composition comprising a pharmaceutically active ingredient

Abstract

A chewable composition, comprising:—at least one pharmaceutically active ingredient component;—solid components including:—at least one flavor;—at least one disintegrant including at least one non-starch disintegrant;—flowable components including:—a flowable oil;—at least one wetting agent other than water.

1 . An extruded chewable composition, comprising, in percentages by weight of a total weight of the composition (w/w):
 at least one pharmaceutically active ingredient component;   solid components including:
 at least one flavor; and 
 at least one disintegrant including at least one non-starch disintegrant, and 
   flowable components including:
 at least 5% of a flowable oil; and 
 at least 10% of a wetting agent other than water, 
   wherein a relative amount of the flowable oil is from 20 parts to 60 parts for 100 parts (w/w) of the flowable oil and wetting agent,   wherein the composition contains less than 2% (w/w) unbound water.   
     
     
         2 . The chewable composition of  claim 1 , wherein the flavor includes a meat flavor. 
     
     
         3 . The chewable composition of  claim 1 , wherein the flavor includes a meat powder. 
     
     
         4 . The chewable composition of  claim 1 , wherein the non-starch disintegrant is croscarmellose sodium. 
     
     
         5 . The chewable composition of  claim 1 , wherein the flowable oil is a liquid oil. 
     
     
         6 . The chewable composition of  claim 1 , wherein the wetting agent is glycerin and the flowable oil is soybean oil. 
     
     
         7 . The chewable composition of  claim 1 , comprising:
 at least 25% of the flavor; and   at least 15% of the disintegrant including at least 10% of the non-starch disintegrant.   
     
     
         8 . The chewable composition of  claim 1 , wherein the flavor includes at least 12% of a meat flavor. 
     
     
         9 . The chewable composition of  claim 1 , wherein the flavor includes at least 10% of a sweet flavor. 
     
     
         10 . The chewable composition of  claim 1 , comprising:
 at least 12% of a meat flavor; and   at least 10% of the non-starch disintegrant.   
     
     
         11 . The chewable composition of  claim 10 , comprising:
 from 15% to 25% of the meat flavor;   from 10% to 20% of the non-starch-based disintegrant;   from 10% to 20% of the wetting agent other than water; and   from 5% to 15% of the flowable oil.   
     
     
         12 . The chewable composition of  claim 1 , comprising:
 from 5% to 15% of polyethylene glycol,   from 5% to 15% of a sweet flavor,   from 2% to 12% of starch-based filler, and/or   from 15% to 35% of the combined amount of the wetting agent and the flowable oil.   
     
     
         13 . The chewable composition of  claim 1 , which contains less than 5% of cellulose-, soy- and silicone-based fillers. 
     
     
         14 . (canceled) 
     
     
         15 . The chewable composition according to  claim 1 , comprising:
 from 0.01% to 10% of the at least one pharmaceutically active ingredient;   from 25 to 35% of the flavor including at least 12% of a meat flavor and at least 10% of a sweet flavor;   from 5 to 12% of PEG, cocoa butter, or a mixture thereof;   from 10 to 20% of the non-starch disintegrant;   from 5 to 12% of a starch;   from 12 to 15% of glycerin, PPG, or a mixture thereof;   from 8 to 12% of a liquid oil.   
     
     
         16 . A process for producing a chewable composition, comprising:
 providing a mixture of the solid components,   mixing the flowable components to the solid components,   extruding the composition,   so as to obtain the extruded chewable composition according to  claim 1 .   
     
     
         17 . The process according to  claim 16 , wherein the flowable oil is present in an amount sufficient to act as a lubricant during extrusion. 
     
     
         18 . The process according to  claim 16 , wherein the extrusion temperature is a range of from 80 to 150° F. 
     
     
         19 . The process according to  claim 16 , wherein the wetting agent is added to the solid components no later than the flowable oil. 
     
     
         20 . The process according to  claim 19 , wherein the flowable components are mixed together before mixing to the solid components. 
     
     
         21 . The process according to  claim 16 , wherein the chewable composition is stable for 6 months at 25° C./60% RH.