Pharmaceutical formulation

Abstract

The present invention provides processes for making and forms of solid dispersions of pharmaceutical active ingredients.

1 - 26 . (canceled) 
   
   
       27 . A process for preparing a pharmaceutical product using an extrusion device comprising the steps of
 combining a pharmaceutical active ingredient, a polymer and a polyol to create a lubricated mixture;   liquefying or softening the lubricated mixture;   injecting said liquefied or softened mixture into an extruder device;   then forcing said liquefied or softened lubricated mixture through the extrusion device in to form a lubricated molecular dispersion of the pharmaceutical active ingredient, the polymer and the polyol;   extruding said lubricated molecular dispersion from the tip of the extruder; and   then solidifying said lubricated molecular dispersion in order to create a solid dispersion.   
   
   
       28 . The process of  claim 27  wherein said polyol is selected from the group consisting of a six carbon sugar and six carbon sugar alcohol. 
   
   
       29 . The process of  claim 27  wherein said polyol is sorbitol. 
   
   
       30 . The process of  claim 27  wherein the pharmaceutical active ingredient is first added to a melt extrusion device and heated to a temperature above its glass transition point order to liquefy or soften it and then the polymer and the polyol are added to the liquefied or softened active ingredient in the melt extrusion device. 
   
   
       31 . The process of  claim 27  wherein the pharmaceutical active ingredient is in an amorphous state. 
   
   
       32 . The process of  27  wherein the pharmaceutical active substance is selected from the following group consisting of central nervous system active agents, peripheral nervous system active agents, vascular active agents, dermatologic active agents, gastrointestinal active agents, oncologic and anti-tumor agents, bone active agents, hormonal active agents, immune-system active agents, anti-infective agents, respiratory active agents, neuro-muscular active agents, and anti-diabetic agents. 
   
   
       33 . The process of  claim 32  wherein the pharmaceutical active agent is selected from the group consisting of TKA731, NKP608, LAB687, ASM981, and fenofibrate. 
   
   
       34 . The process of  claim 27  wherein the lubricated mixture further comprises an pharmaceutically acceptable excipient. 
   
   
       35 . The process of  claim 27  wherein the polymer is water-soluble or partially water soluble. 
   
   
       36 . The process of  claim 27  wherein the melt extrusion device comprises screw elements or paddles.