Identification of drug polymorphs in tablets

• Main Authors: Kontoyannis, Christos, Orkoula, Malvina, Karampas, Ioannis, Zissi, Georgia, Skorda, Dimitra, Serpi, E
• Other Authors: Κοντογιάννης, Χρήστος
• Format: Conference (paper)
• Language: English
• Published: 2012
• Subjects: Polymorphs; Active Pharmaceutical Ingredient (API); Donepezil HCl; Atorvastatin Calcium; X-ray powder diffraction; IR; Crystal phase; Tablets; Πολύμορφα; Δραστική φαρμακευτική ουσία; Υδροχλωρική Δονεπεζίλη; Ατορβαστατίνη; Περίθλαση ακτίνων Χ; Φασματοσκοπία υπερύθρου; Κρυσταλλική φάση; Δισκία

Polymorphs of an Active Pharmaceutical Ingredient (API) can have different chemical and physical properties and, thus, a direct impact on the process-ability of the drug substance and the quality/performance of the drug product, such as stability, dissolution, and bioavailability. Therefore, identification of the crystal phase of an API is of outmost importance. In this work methodologies were developed based on X-ray powder diffraction and IR for the identification of the crystal phase of two APIs (Atorvastatin Calcium and Donepezil HCl) in commercial tablets.