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The impacts of Spray Drying on the polymorphism of pharmaceutical and organic compounds

Abstract : The impacts of Spray Drying on the polymorphism of organic and pharmaceutical compounds have been investigated with the following compounds: pyrazinamide, olanzapine, 1,3-dimethylurea and N-methylurea. The experiments carried out by Spray Drying highlighted the flexibility of this crystallization technique to access to metastable forms. Co-spray drying tests of pyrazinamide with several excipients allowed to bring out the feature of two excipients on the crystallization of the active ingredient: -A polymer (polyvinylpyrrolidone) has enabled the crystallization of the δ form pyrazinamide. -1,3-dimethylurea (Form I) blocked the transition of the γ form of pyrazinamide to other polymorphic stable forms for two years of storage at room temperature. A surface action has been proposed to explain this fact. This work also presents the phase diagram between 1,3-dimethylurea and water in which several invariants including: metatectic, peritectic and stable and metastable eutectics are detected. Melt-quenching applied to the N-methylurea serves to characterize two new polymorphic forms at low temperatures, with a similarity in : the space group, the asymmetric unit and intermolecular bonds. A first order mechanism governed by cooperative shear movement was proposed to explain the good reversibility between these two forms despite the low diffusion at low temperatures (≈ -120 °C).
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Grace Baaklini. The impacts of Spray Drying on the polymorphism of pharmaceutical and organic compounds . Chemical Sciences. Université de Rouen, 2015. English. ⟨tel-01685045⟩

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