Process for manufacturing chewable dosage forms for drug delivery and products thereof

Abstract

A palatable, soft chewable medication vehicle for delivery of a pharmaceutically acceptable active ingredient, such as a drug, to an animal or human subject. The soft chews contain only food grade or better inactive ingredients, and preferably do not contain ingredients of animal origin. Processes for manufacturing the soft chews do not require the generation of heat during mixing of active and inactive ingredients, provide stable concentrations of the active ingredient, and produce chews of consistent weight and texture.

1 . A process for manufacturing a soft chewable medication vehicle for delivery of a pharmaceutically active ingredient, the method comprising: 
 (a) providing the active ingredient and dry inactive ingredients of the medication vehicle to a mixing chamber of a mixer, wherein: 
 (i) the chamber is generally horizontally disposed and has a space therein defined by walls to receive material to be mixed;  
 (ii) a rotatable mixing shaft extends longitudinally through the chamber space; and,  
 (iii) a drive apparatus is operably coupled to the mixing shaft for rotating the shaft,  
   (b) blending the dry active and inactive ingredients in the mixing chamber by causing the mixing shaft to be rotated to cast the ingredients in a pattern away from and between the walls of the mixing chamber space until a dry mixture is formed;    (c) adding a softening agent to the dry mixture and blending it therein to form a soft chewable mixture; and,    (d) forming the soft chewable mixture into individual masses, wherein the masses are of consistent weight,    wherein further no heat is applied to the dry or blended chewable mixture during any of the mixing or forming steps.    
     
     
         2 . The process according to  claim 1 , further comprising the step of preparing a trituration of the active ingredient with an excipient before the active ingredient is added to the mixing vessel in step (a).  
     
     
         3 . The process according to  claim 1 , further comprising the step (c)′ of adding melted paraffin wax to the soft chewable mixture and blending it therein.  
     
     
         4 . The process according to  claim 1  or  claim 2 , further comprising the step (d)′ of coating the active ingredient with a food grade coating before the active ingredient is added to the mixing vessel in step (a).  
     
     
         5 . The process according to  claim 1 , further comprising step (e) wherein the individual masses are placed into a pharmaceutically acceptable container.  
     
     
         6 . A medication vehicle comprising of a pharmaceutically acceptable active ingredient in a soft chewable mass, wherein the medication is produced according to the process of  claim 1 .  
     
     
         7 . The medication vehicle according to  claim 6 , further comprising inactive ingredients, wherein all of the inactive ingredients are of food grade quality.  
     
     
         8 . The medication vehicle according to  claim 7 , wherein the inactive ingredients are irradiated or pasteurized.  
     
     
         9 . The medication vehicle according to  claim 6 , further comprising inactive ingredients, wherein none of the inactive ingredients are of animal origin.  
     
     
         10 . The medication vehicle according to  claim 7 , wherein the inactive ingredients include flavorings of food grade quality.  
     
     
         11 . The medication vehicle according to  claim 9 , wherein the inactive ingredients include flavorings of non-animal origin.  
     
     
         12 . The medication vehicle according to  claim 11 , wherein the flavoring is a soy protein product.  
     
     
         13 . The medication vehicle according to  claim 12 , wherein the flavoring is an artificially bacon flavored soy protein product.  
     
     
         14 . The medication vehicle according to  claim 6 , further comprising a lubricant, a humectant, and a bulking agent.  
     
     
         15 . The medication vehicle according to  claim 6 , wherein the pharmaceutically active ingredient is prepared in a trituration with an excipient.  
     
     
         16 . The medication vehicle according to  claim 14 , wherein the softening agent comprises an oil.  
     
     
         17 . The medication vehicle according to  claim 14 , wherein the softening agent comprises wax.  
     
     
         18 . The medication vehicle according to  claim 6 , wherein the pharmaceutically active agent is coated.  
     
     
         19 . The medication vehicle according to  claim 6 , further comprising a preservative.  
     
     
         20 . The medication vehicle according to  claim 14 , wherein the softening agent comprises an oil and a wax, the humectant comprises glycerin, and the lubricant comprises a stearate.  
     
     
         21 . The medication according to  claim 20 , wherein the pharmaceutically active ingredient is selected from the group of ingredients consisting of anthelmetics, analgesics, antibiotics, antivirals, anti-inflammatories, endo-parasiticides, ecto-parasiticides and antifungals.  
     
     
         22 . The medication according to  claim 21 , wherein the pharmaceutically active ingredient is an anthelmetic.  
     
     
         23 . The medication according to  claim 22 , having the ingredients of Formula 1 and an active ingredient.