Spectroscopic characterization of tablet properties in a continuous powder blending and tableting process.
By the advent of continuous pharmaceutical manufacturing, fast and accurate characterization of product quality has become of a major interest. Although it also promotes the real-time release testing approach, so far mainly content uniformity studies were performed by near-infrared (NIR) spectroscopy. This paper proposes the simultaneous application of NIR and Raman spectroscopy to nondestructively analyze the critical quality attributes of continuously produced tablets in a real-time release testing procedure. A face-centered composite design was applied to determine the impact of lubrication and compression force on the properties of a tablet formulation containing caffeine, glucose-monohydrate and magnesium stearate and to provide a systematic comparison of the applicability of spectroscopic methods. Quantitative methods were developed to evaluate different lubrication approaches in a continuous blending and tableting line. The simultaneous application of NIR and Raman spectroscopy revealed that NIR spectroscopy is more suitable to follow the changes of compression force, while Raman spectroscopy could be successfully applied for the detection of overlubrication. The presented approach can be a part of a comprehensive real-time release strategy, where NIR and Raman spectroscopy provide complementary information about multiple critical quality attributes, such as content uniformity, tablet hardness, friability and dissolution.
['Nagy|Brigitta|B|', 'Farkas|Attila|A|', 'Magyar|Krisztina|K|', 'Démuth|Balázs|B|', 'Nagy|Zsombor Kristóf|ZK|', 'Marosi|György|G|']
D002626:Chemistry, Pharmaceutical D004339:Drug Compounding D006801:Humans D011208:Powders D013057:Spectrum Analysis D013607:Tablets
Real-time release testing Raman spectroscopy Lubrication Continuous blending NIR spectroscopy Process analytical technology Tablet compression