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Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
Published on: July 4, 2014
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Predicting the dissolution behavior of pharmaceutical tablets with NIR chemical imaging
Ketsia Yekpe1, Nicolas Abatzoglou2, Bernard Bataille3
1Pfizer Industrial Research Chair on Process Analytical Technology in Pharmaceutical Engineering, Department of Chemical & Biotechnological Engineering, Université de Sherbrooke, Sherbrooke, Quebec, Canada; Faculty of Pharmacy, Université Montpellier I, France.
International Journal of Pharmaceutics
|April 4, 2015
Summary
Near infrared chemical imaging (NIRCI) can predict active pharmaceutical ingredient (API) dissolution by analyzing disintegrant properties in tablets. This non-destructive technique offers a robust alternative to traditional dissolution testing for pharmaceutical analysis.
Area of Science:
- Pharmaceutical technology
- Analytical chemistry
- Process analytical technology
Background:
- Near infrared chemical imaging (NIRCI) is a non-destructive analytical technique used for pharmaceutical tablet analysis.
- NIRCI enables understanding of sample chemistry, ingredient spatial distribution, and size within tablets.
- Disintegrants are crucial for tablet disintegration and subsequent active pharmaceutical ingredient (API) dissolution.
Purpose of the Study:
- To develop and describe a methodology for predicting API dissolution using NIRCI-derived disintegrant information.
- To establish a link between disintegrant characteristics and tablet dissolution profiles.
- To evaluate NIRCI as a tool for monitoring critical material attributes in pharmaceutical formulations.
Main Methods:
- Production of multiple tablet batches with varying disintegrant characteristics.
- Application of NIRCI to acquire chemical images of the pharmaceutical tablets.
- Development of a Partial Least Squares (PLS) regression model to predict dissolution profiles.
Main Results:
- NIRCI successfully provided chemical images of pharmaceutical tablets.
- The PLS regression model accurately predicted tablet dissolution profiles based on NIRCI data.
- The study demonstrated NIRCI's capability in measuring disintegrant properties and predicting their impact on dissolution.
Conclusions:
- NIRCI is a robust and versatile technique for analyzing disintegrant properties in tablet formulations.
- NIRCI can effectively predict the influence of disintegrants on API dissolution profiles.
- NIRCI has the potential to complement or replace conventional dissolution testing by monitoring disintegrant content.
Keywords:
DisintegrantDissolution testingKollidon CLMultivariate data analysisNear infrared chemical imagingQuality by designMore Related Videos
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