Crystallization studies and identification of crystalline forms suitable for inhalation in drug discovery

Abstract

The work carried out during the three years was focused on the study of solid state properties and polymorphism of different molecules of industrial interest. In particular, those studies emphasized the efforts putted in the identification of suitable crystalline forms of New Chemical Entities (NCEs) in a very early phase of drug development and in the studies of their solid state properties. The aim of the manuscript is to review the state of the art of academic and industrial knowledge about the design and characterization of solid state forms of NCEs, in order to contribute some guidelines and present selected information which can be useful to industrial research laboratories which do not have usually a deep insight into crystallography. During this thesis work, these concepts were practically applied during the laboratory work, mixing approaches and techniques well known and established in the pharmaceutical industry with some others peculiar to the academic word. Only a general description of the performed crystallization studies on different molecules of industrial interest will be here reported. All the results obtained from the different studies has to be considered confidential and no one of these is reported in this thesis.