Romanian Society of Pharmaceutical Sciences
 

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PHYSICHOCHEMICAL CHARACTERISATION OF TICAGRELOR AMORPHOUS SOLID DISPERSIONS PREPARED BY SPRAY-DRYING PROCESS

LOREDANA-MARIA MARIN 1*, MARCIN SKOTNICKI 2, JANINA LULEK 2, IULIAN SÂRBU 3, VALENTINA ANUȚA 4, JACEK KUJAWSKI 5, ABHAY CHANDAK 6, DOINA DRĂGĂNESCU 1

1 ”Carol Davila” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Physics, 020956, Bucharest, Romania
2 Poznan University of Medical Sciences, Faculty of Pharmacy, Chair and Department of Pharmaceutical Technology Industrial Pharmacy Division, Rokietnicka 3, 60-806, Poznan, Poland
3 Zentiva S.A., 50 Theodor Pallady Boulevard, 032266, Bucharest, Romania
4 ” Carol Davila” University of Medicine and Pharmacy, Faculty of Pharmacy, Department of Physical and Colloidal Chemistry, 020956, Bucharest, Romania
5 Poznan University of Medical Sciences, Faculty of Pharmacy, Chair and Department of Organic Chemistry, Rokietnicka 3, 60-806 Poznan, Poland
6 Zentiva Group, U Kabelovny 529/16, 102 00 Praha-Dolní Měcholupy, Czech Republic

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Solid dispersions are widely used in the pharmaceutical industry in order to enhance the oral bioavailability of poorly soluble active pharmaceutical ingredients (APIs). Ticagrelor (TICA) exhibits limited water solubility and poor permeability through biological membranes. Dosage forms present on the market contain TICA in a crystalline state. However, the amorphous state of a drug is preferred because it requires less energy to dissolve. Thus, the dissolution kinetics is favourable compared to its crystalline counterpart. The aim of this study was to prepare and characterise 1:1 mass ratio of ticagrelor amorphous polymer solid dispersions obtained by spray-drying method. The systems were characterised by employing standard Differential Scanning Calorimetry (DSC), Fourier transform-infrared spectroscopy (FTIR) and Powder X-ray Diffraction (PXRD). The results demonstrate that amorphous solid dispersions of TICA with two polymers – hydroxypropyl cellulose (HPC) and Soluplus (SLP) – were successfully prepared using the spray-drying process.