Ex parte SUTTON et al. - Page 4




              Appeal No.  1999-2230                                                                                        
              Application 08/465,236                                                                                       





                                                       Discussion                                                          
                     The present invention relates to the preparation of ultrasound contrast agents                        
              comprising hollow microcapsules, used to enhance ultrasound imaging techniques.  More                        
              specifically, the invention relates to hollow microcapsules enclosing a gas- or vapor-filled                 
              space essentially without solid material therein, where more than 30% of the                                 
              microcapsules have a diameter within a 2 :m range and at least 90% have a diameter                           
              within the range 12.0-25.0 :m.  The microcapsules are suitable for intra-arterial                            

              administration, and are capable of being dried to form a powder of such microcapsules.                       
              The present invention further relates to a process for preparing such microcapsules, and to                  

              pharmaceutical compositions comprising the microcapsules.                                                    
                     Prior art echocontrast agents suffer from several drawbacks making them                               
              unsuitable for perfusion mapping of the myocardium or similar capillary beds, including                      
              poorly controlled size distribution, low pressure resistance, and weak echogencity.  In                      
              contrast, the microcapsules of the present invention possess unique properties which                         
              make them particularly advantageous for use as a deposit echocontrast agent to delineate                     
              under-perfused areas of microcirculation.  The novel microcapsules are produced by a                         
              spray-drying process wherein the median size and size distribution of the microcapsules                      
              are tightly controlled.  Applicants have discovered that by manipulating the parameters of                   

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