Contractor (Scientific Researcher) U S Food and Drug Administration Saint Louis, Missouri
In comparison to conventional spectroscopic imaging approaches, laser-directed infrared (LDIR) imaging produces high resolution spectroscopic images within seconds to minutes for entire pharmaceutical tablet surfaces. LDIR imaging can differentiate between polymorphic forms. Ritonavir was tested here to understand real-time evolution between amorphous, form I and form II at 40 ℃ and 75% relative humidity to understand observation of polymorphism in real-world samples. An LDIR imaging method was used to collect data for an area of 4 mm2 with a step-size of 5 µm in 2 min on in-house prepared ritonavir tablets. Hence, LDIR imaging allowed for tracking the evolution of API in the tablet surface with samples only needing to be removed from the stability chamber for less than 5 minutes. Amorphous ritonavir was found to aggregate and transform into form I only at the experimental condition regardless of the origin of amorphous ritonavir (form I or II).
Learning Objectives:
Upon completion participant will be able to understand principal of Laser direct infrared imaging technology, an emerging technology for spectroscopic imaging.
Upon completion, participant will be able to get insights on polymorphic transformation of Ritonavir, a protease inhibitor, inside stability chamber at accelerated condition.
Upon completion participant will be able to understand the potential application of an at-line PAT tool LDIR imaging.
