Shaped body and method for production of said body

Abstract

Water-dispersible or water-soluble polymers, particularly those of the family of compounds comprising the poloxamers or the polyesters or amphiphilic agents (emulsifiers), and also lipophilic materials are dispersed by melting the components at suitable temperatures with admixture of pharmaceutically active substances by mechanical procedures, i.e. a lipophilic disperse phase is distributed in a hydrophilic continuous polymer phase to form a stable dispersion. By controlled cooling, curing, and storage followed by high-pressure molding at defined temperatures and operating pressures there are produced, in addition to other types of shaped bodies, dispersed polymeric fatty sticks distinguished by particularly good fracture strength, flexibility, and variable time-specific dimensional stability.

1 - 17 . (canceled) 
   
   
       18 . Process for the production of a shaped body for medical administration in body cavities and/or wound cavities in humans or animals, wherein
 a) at least one hydrophilic continuous phase is melted together with at least one lipophilic component as disperse phase to form a melt, to which at least one active substance or combination of active substances is added and the whole is mechanically dispersed under constant temperature conditions to produce a composition,   b) said composition is poured into a receptacle, where it is cooled and stored for a definable period of time at a constant temperature and   c) the composition thus obtained is heated to a temperature which is not far below its softening point, is rendered flowable by the application of pressure or shear forces and is compressed to a predefined shaped body, during which operation the operating pressure does not fall below 50 bar, and the operating temperature is below the softening point of the composition.   
   
   
       19 . Process as defined in  claim 18 , wherein the active substance or active substances or combination of active substances is added to a low-molecular molten polymer, which premix is dispersed and added to the melt. 
   
   
       20 . Process as defined in  claim 18 , wherein the composition is compressed at constant temperature and under a specific operating pressure to form a dispersed solid shaped body. 
   
   
       21 . Process as defined in  claim 18 , wherein the composition is compressed in an extruder to form extrudates of from 2 to 19 mm and is cut up into lengths of from 40 to 100 mm. 
   
   
       22 . Process for the production of compressed shaped bodies having a composition, as defined in  claim 18 , wherein
 d) beads derived from a cooled melt of the composition are compressed into a compressed shaped body, or   e) spherules of the predefined shaped body are formed, and are pulverized and compressed into the compressed shaped body, or   f) a cooled powder obtained form the predefined shaped body is filled into capsules.   
   
   
       23 . The method of  claim 18 , wherein at least one hydrophilic continuous phase is a water-soluble or water-dispersible polymer. 
   
   
       24 . The method of  claim 21 , wherein the composition is compressed in the extruder to form extrudates of from 2 to 10 mm in diameter.