Multiple speed process for preserving heat sensitive portions of a thermokinetically melt blended batch

Abstract

The present disclosure is directed to compositions and methods for making a pharmaceutical composition by thermokinetic compounding, wherein the compositions include one or more thermolabile components, for example one or more active pharmaceutical ingredients (API) with one or more pharmaceutically acceptable excipients. The methods comprise thermokinetic processing of the thermolabile components into a composite by blending certain thermolabile components in a thermokinetic mixer using multiple speeds during a single, rotationally continuous operation. The composite can be further processed into pharmaceutical compositions by conventional methods known in the art, such as hot melt extrusion, melt granulation, compression molding, tablet compression, capsule filling, film-coating, or injection molding.

What is claimed is: 
     
         1 . A thermokinetic mixer using replaceable impact face teeth with variable forward angles relative to an axis of a shaft comprising:
 (a) a substantially cylindrical mixing chamber with an inside surface enclosing part of the shaft rotatable by an external drive motor at relatively high speed substantially about the axis of the cylindrical mixing chamber, the mixing chamber being adapted to receive and release batches of particles of polymers and other material therein;   (b) shaft extensions arranged in three or more rows, where each shaft extension is arranged radially to the shaft and each row is aligned longitudinally to the shaft;   (c) each shaft extensions having a forward aligned tooth face and each tooth face is adapted to encounter particles and drive them at least in part to the inside surface such that substantial energy is imparted to them, generating thermokinetic heating thereby;   (d) each shaft extension is adapted to have a replaceable tooth face so that the angle of the tooth face relative to an axis of the shaft may be increased or decreased by replacing the tooth faces to provide, respectively, less or more impact energy to particles during thermokinetic processing.   
     
     
         2 . The thermokinetic mixer of  claim 1  wherein the angle of first tooth faces relative to an axis of the shaft may is about 15 degrees. 
     
     
         3 . The thermokinetic mixer of  claim 2  wherein first tooth faces are replaced with second tooth faces and the angle of second tooth faces relative to an axis of the shaft may is about 30 degrees. 
     
     
         4 . The thermokinetic mixer of  claim 3  wherein second tooth faces are replaced with first tooth faces and the angle of third tooth faces relative to an axis of the shaft may is about 45 degrees. 
     
     
         5 . The thermokinetic mixer of  claim 4  wherein third tooth faces are replaced with fourth tooth faces and the angle of fourth tooth faces relative to an axis of the shaft may is about 60 degrees.