Patent ID: 8114455
Filing Date: 2012-02-14
Classification: A61K,A61P

Abstract:
1. A process for manufacturing a palatable soft chewable pharmaceutical product (a “soft chew”) having consistent unit-to-unit weight and active content without use of extrusion, comprising: (a) providing at least one active agent whose stability or potency can be adversely affected by temperatures typically generated during extrusion, an active agent that is not palatable, or both; (b) blending the active agent with dry inactive ingredients under low shear conditions to produce a edible soft chew mixture having the active agent uniformly blended therein; (c) adding anon-aqueous fluid to the dry mixture and blending it under low shear conditions to form an edible soft chewable mixture; and, (d) forming the edible soft chewable mixture into soft chews without application of compression heat thereto, wherein the edible soft chew mixture and the ingredients thereof are maintained at room temperature or no more than +1/−10° C. thereof during performance of each step of the process; and, wherein further the soft chews are more palatable than tablet dosage forms of the active agent.