Solid state evaluation of some thalidomide raw materials.

Thalidomide presents polymorphism and is a problematic drug due to its poor solubility and difficult tablet processability, which is the dosage form available in Brazil. In most cases, the pharmacopoeias specify do not address solid state characterization of drugs precisely. In this work, different thalidomide commercial samples were characterized by infrared spectroscopy, particle size analysis, scanning electron microscopy, and X-ray diffraction. In addition, the polymorphic forms were quantified for Rietveld analysis and their intrinsic dissolution rates were evaluated. The results demonstrated the market availability of different raw materials which lack of homogeneity due to differences related to crystalline constitution, crystal habit and intrinsic dissolution rate.